This action might not be possible to undo. Are you sure you want to continue?
Quality System Audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
Table of contents
4rd Revised Edition 1998
Quality System Audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1 4 Revised Edition 1998
Verband der Automobilindustrie e.V. (VDA)
Non-Obligatory VDA Standard Recommendation. The Association of German Automotive Industry (VDA) recommends it’s members apply the following standard when introducing and maintaining quality systems. Exclusion of Liability This VDA volume is a recommendation which is available to everyone. Anyone applying it is responsible for ensuring that it is used correctly in each case. This VDA volume takes into account state of the art technology, current at the time of issue. Implementation of VDA recommendations excludes no one from responsibility for their own actions. In this respect everyone acts at their own risk. The VDA and those involved in VDA recommendations shall bear no liability. If during the use of VDA recommendations, errors or the possibility of misinterpretation are found, it is requested that these be notified to the VDA immediately so that any possible faults can be corrected. Referenced standards The quotations from standards identified with their DIN number and date of publication are reproduced with the permission of the DIN Deutsches Institut für Normung e.V. The version with the latest issue date, available from the publishers Beuth Verlag GmbH, 10772 Berlin, is definitive for the use of the standard. Copyright This publication is protected by copyright. Any use outside the strict limits of copyright law is not permissible without the consent of the VDA and is liable to prosecution. This applies particularly to copying, translations, microfilming and the storage or processing in electronic systems. Translations This publication will also be issued in other languages. The current status must be requested from VDA-QMC.
ISSN 0943-9412 Copyright 1998 by Verband der Automobilindustrie e. V. (VDA) Quality Management Center (QMC) D-60325 Frankfurt am Main, Lindenstraße 5 Printed and published by: Druckerei Henrich GmbH D-60528 Frankfurt am Main, Schwanheimer Str. 110 Printed on chlorine-free bleached paper
This VDA Volume 6 very quickly received a good response both outside the industry and on an international level. certification notes were incorporated. In order to do justice to this development. rd th 5 . The new edition of the standard series DIN EN ISO 9000 (Edition 8/94) made revision of the second edition necessary.it covers and integrates all divisions of the company in it’s vertical and horizontal structures (crosssectional function). Furthermore. Shorter model cycles and development times. Practical experience has shown that this publication is not only suitable for the preparation of internal audits. a working circle of the VDA/DGQ specialist group "Quality Control in the Automotive Industry" has drawn up a questionnaire on quality system evaluation based on DIN EN ISO 9004 (Edition 5/90) which was published with the first edition in 1991. greater expectations placed on products and a stricter product liability demand highly effective quality assurance systems (quality systems) in all areas of the automotive industry among automotive manufacturers as well as their suppliers. Quality assurance therefore has a decisive influence on the company's result.Foreword to the 4 Edition Quality assurance has a new dimension today . This simplified handling and a uniform assessment method was achieved. The 3 Edition also includes requirements from the guidelines EAQF/94 (France) and QS-9000/95 (America). greater international competition and increasing cost pressure. This allows comparison of the audit results. Quality assurance has become an interdisciplinary key function (cooperation of all involved divisions at the right time). The practical experience of auditors led to the volume being revised and defined in more precise terms as a second edition (12/92). but also represents an excellent aid for preparation of a certification. new organization forms (just in time).
see Para. In contrast to the standard which treats the same subject matter partially in various places and varying depth the questionnaire in this publication normally contains the subject matter only once in order to. In order to make the decision on the issuance of a VDA 6. These questions lead to determined consequences during the overall evaluation. as far as possible.3.M Company Management . th 6 . Quality and quality management problems are predominantly not of a purely technical nature. organization and structure. Since the company management and the lower management levels have a decisive influence on the definition. The audited organization is now referred to as „the company“ throughout the questionnaire. together with specific requirements from DIN EN ISO 9004 (Edition 8/94) and supplemented with the practical experience of the automotive industry. Comments from the users and the auditor’s symposia were considered (see Para. This is expressed in the structure of the questionnaire and is taken into account in the questions accordingly. The element Z1.1 certificate supplement even more definite certain questions which are particularly important for product and process and for which noncompliance could lead to the failure of the quality system have been specially identified. it’s incorporation is the fundamental requirement of the standard. implementation and monitoring of quality assurance. so far only required for companies with international business activities. Questions were formulated from the requirements profile of this standard relating to the explanation of a quality management system. DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality system audit which describes a comprehensive system of industrial quality management with its elements. but often related to management. 12.1).4.3. now has to be considered generally during audits/certification.In the 4 Edition further corrections and up-dates were included.3. The questionnaire is therefore divided up into the following two parts: .P Product and Process. and 3. avoid the repetitions contained in the standard. The questions are therefore to be answered by the person responsible for the particular division of the company. 3.
Recognition of the systemrelated audit allows concentration on more specific product.and processrelated audits. The quality standard of the German Automotive Industry contains further types of audits which are described in the following VDA Volumes.This VDA Volume represents a supplement to those volumes already published and serves the evaluation of quality management systems under comparable conditions. as far as possible. Car manufacturers and suppliers agree to mutually recognize. It is intended to help identify weaknesses. audits carried out on the basis of this uniform questionnaire and evaluation system for rationalization reasons. Quality Standard of the german Automotive Industrie VDA 6 Basics for Quality Audits VDA 6 Part 1 VDA 6 Part 3 VDA 6 Part 4 Auditing and Certification VDA 6 Part 5 Quality System Audit VDA 6 Part 2 Quality System Audit Services Process Audit Quality System Audit Production Means VDA 6 Part 6 Product Audit Services Audit 7 . The aim of this work is to unify the necessary audits in order to reduce the working expenditure for the auditor as well as for those to be audited. to remedy them through corrective actions and thereby continually improve the company's productivity.
Hannover Volkswagen AG. Obertshausen. Wiesbaden Happich Fahrzeug und Industrieteile GmbH. Babenhausen Pierburg AG. Remscheid Lemförder AG & Co.V. & Co. F. Düsseldorf WABCO Standard GmbH. (VDA) 8 . Munich BOGE GmbH. h. Berlin Edscha Gruppe. Frankfurt/Main. Wuppertal Hella KG. Stuttgart Mannesmann Sachs AG. GLYCO B. Frankfurt. Rüsselsheim BMW AG. Schweinfurt Mannesmann VDO AG. Cologne General Motors Europe. Wolfsburg YMOS AG. Heidelberg TRW Fahrwerkssysteme GmbH & Co. Lippstadt ITT Automotive Europe GmbH. Schweinfurt Teroson GmbH. Thanks also to all those who offered suggestions for improvement and those companies represented in the editorial circle. V. Fahrwerktechnik Lemförde Mahle GmbH. Zurich GLYCO-Metall-Werke.. Essen DQS (Deutsche Gesellschaft zur Zertifizierung von Qualitätssicherungssystemen mbH).c.We thank those companies involved and their employees for their work in drawing up these guidelines: Audi AG. Eitorf Robert Bosch GmbH. UB Fahrzeugbremsen. Frankfurt Keiper Recaro GmbH & Co. Stuttgart SKF GmbH. KG. Porsche AG. November 1998 VERBAND DER AUTOMOBILINDUSTRIE E. Remscheid FORD-Werke AG. Neuss Dr. KG.. Hueck & Co. Ing. Stuttgart Daimler-Benz AG.. Ingolstadt Adam Opel AG. Stuttgart DNV (Det Norske Veritas Zertifizierung GmbH.
1.4 #.3 3.1.5 #.5 3.1.19 INTRODUCTION QUALITY SYSTEM ACCORDING TO THE DIN EN ISO 9000 SERIES Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Assurance Model QUALITY SYSTEM AUDIT General Selection of the Quality Elements and Relevant Questions Evaluation and Rating Individual Rating of Questions and Quality Elements Overall Rating of Audit Result nd Rating during Customer/Supplier Audits (2 Party) rd Awarding of the VDA 126.96.36.199.2.9 #.15 #.2.1 #.1 3.1 Certificate DEFINITIONS General terms according to DIN EN ISO 8402/1995 (Extract) Unit Process Procedure Product Service Organization Organizational structure Customer Supplier Quality-related Definitions according to DIN EN ISO 8402/1995 (Extract) Quality Requirements Inspection and Testing Verification Validation Evidence 13 15 15 16 18 18 19 20 20 22 23 24 25 25 25 25 27 27 27 27 27 28 28 28 28 29 29 29 29 30 30 30 30 9 .4 3.1.1 188.8.131.52 #.3 #.2.4 3.3.3 #.3 3.2 3.6 3.Contents Page 1 2 2.17 #.7 #.184.108.40.206 Certificate Supplement (3 Party): Summary of Results Close out Meeting and Report Corrective Actions VDA 6.7 4 4.1 #.1 2.2 3 3.3.2 #.10 4.2 3.8 #.2.2 #.
3 #.220.127.116.11.5 18.104.22.168 #.3 4.9 #.1 4. (Product Design and Development) Process Planning (Process Development) Document and Data Control 31 31 31 31 32 32 32 33 33 33 33 33 34 34 35 6 36 38 39 47 57 63 71 75 81 87 93 101 111 7 01 02 03 04 05 06 Z1 07 08 09 10 10 .5.10 #.4 #.6 #.5.4.14 4.2 4.12 4.3.5 5 Definitions for Quality Systems according to DIN EN ISO 8402/1995 (Extract) Quality Policy Quality System Quality Manual Definitions for Tools and Techniques according to DIN EN ISO 8402/1995 (Extract) Quality Audit Quality Audit Findings Corrective Action Additional Terms (Definitions for the present volume) System Method Serial Production Quality Procedures Work Instructions (Inspection and Testing Instructions) CROSS-REFERENCE LIST OF PARAGRAPH NUMBERS FOR CORRESPONDING TOPICS STRUCTURE AND NUMBER OF QUESTIONS PER QUALITY ELEMENT QUALITY SYSTEM AUDIT QUESTIONNAIRE Management Responsibility Quality System Internal Quality Audits Training Financial Considerations to Quality Systems Product Safety Corporate Strategy Contract Review.5. Quality in Marketing Design Control.4 4.3.
Preservation and Delivery Control of Quality Records Servicing.11 12 13 14 15 16 17 18 19 20 21 22 8 9 9. (After Sales. Inspection and Test Status) Process Control Inspection and Testing (Product Verification) Control of Inspection.2. Storage. Post-production Activities) Statistical Methods FORMS FOR THE QUALITY SYSTEM AUDIT LITERATURE VDA-Series "Quality Management in the Automotive Industry": AGREEMENT WITH INDUSTRIAL ASSOCIATIONS Introduction Summary of the National Associations International Agreement on Mutual Recognition NOTES ON A CERTIFICATION ACCORDING TO VDA 6.3 11 12 12.2.1 / DIN EN ISO 900194 Comparison Matrix DIN EN ISO 900494 / VDA6.2 12.2 Other VDA-Forms 11 .1 12.2 10.1 APPENDIX th rd Changes of the 4 Edition compared to the 3 Edition Comparison Tables Comparison Matrix VDA 6.1 117 125 129 137 147 153 159 163 169 175 181 187 191 199 199 203 203 203 204 206 207 207 210 210 214 218 10 10. Measuring and Test Equipment Control of Nonconforming Product Corrective and Preventive Action Handling.1 Purchasing Control of Customer-Supplied Product Product Identification and Traceability (Process Control. Packaging.1 12.1 10.
Effective quality management assigns priority to planning and prevention activities for identification of interrelations and interdependencies. It is not only sensible. Management must prove that due diligence has been shown in all areas of the business.in contrast to the previous practices of identifying. It is therefore a primary function of business management. „Quality Assurance System" and "Quality Assurance Manual". „Quality System" and "Quality Manual". from planning to design. agreeing and monitoring quality objectives Assuring cross-functional activities and interfaces during interdisciplinary co-operation * Note: The terms "Quality Management“. and the associated duties of quality management have changed in recent years and include new additional content and dimensions. Quality management affects all areas of the business. as well as for appropriate measures to prevent nonconformities occurring . production.1 Introduction Quality management* is an interdisciplinary key function. implemented and combined in a quality system. authorities and. A well-functioning quality system* described in a quality manual.* is an essential requirement for every business in order to fulfil the demands for quality deliveries and services in a proactive and economic way. but essential that all quality management activities be planned. 13 . procurement. This applies especially in the event of a claim for damages. analyzing and rectifying nonconformities which have already occurred. mainly shaped by the product. according to DIN EN ISO 8402 replace the earlier used terms "Quality Assurance“. therefore: Definition of the quality policy. sales and user information through to the observation of a product's market position. insurers confidence in the business's ability to comply with quality requirements. Only a well planned and purposefully selected quality system gives business partners. The original understanding of quality. The main duties of management are. increasingly. The quality of products and services is always the combined result of activities in every phase of the total business process.
in the appropriate field of the coversheet of the quality system audit. The purpose of this volume is to define an agreed general procedure for the uniform evaluation of a defined quality system. Through the evaluation of the quality system with the help of the questionnaire. Here.1 Certificate Supplement through VDA approved rd certification bodies (3 Party). The product. to be handled confidentially. The audited company confirms with it’s signature that the identified result has been discussed with him. overall economic performance and quality. cross-functional activities gain in importance.and process-related elements are covered in part P of the questionnaire with respect to the quality management system. the customer is given a general view of the supplier's ability to deliver products and services which meet his quality requirements. the certification body. other than for the use of the audit itself. 14 . by other customers.- Definition and monitoring of quality-related costs Consideration of product safety and product liability Involving all employees in the responsibility for quality These duties are covered in part M of the questionnaire with respect to the quality management system. for example. In this way. the working expenditure required for further quality system audits. Following written release by the auditing company. The result of the evaluation shall show the audited company where his quality system meets the requirements and in which elements improvements are necessary. can be reduced. customer/supplier audits (2 Party) and for audits with VDA 6. or respectively. As operations and the interrelations of systems and processes become more extensive and complex. Part 1 is the basis for internal quality system st nd audits (1 Party). Information acquired during the performance of the audit is. many resources are available. The audit result is signed by the auditor and the audited company. He is free to provide his own response. the audited company is free to present the audit result to other customers. which have a great influence on productivity. This VDA Volume 6.
it describes the obligations of the business with respect to quality management. In the meantime.2 Quality system according to the DIN EN ISO 9000 Series The DIN EN ISO 9000 series is applied as a standard in the European Union (EU) and EFTA. 2. Users of this standard are enabled to select from the presented basis of elements according to extent.1 Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements. It can be assumed that branch-specific quality regulations will thereby be replaced. The standard is to be viewed as a universal set of regulations for quality management to achieve the quality of products and services. which quality elements may nowadays be included in a quality system corresponding to the "State of the Art Technology". This also applies to the contents of the European Standard on quality management. Their compliance is therefore to be proven upon request. The German edition is identical in Austria. The scope of application is not limited. depth and overall requirements of the business in order to be able to completely fulfill the tasks of their own company-specific quality system. 15 . Germany and Switzerland. in fulfillment of which the critical preconditions for achieving quality capability within the company should be created. Part 1: Guideline This standard is an internationally agreed guideline in which the elements of a quality system (quality elements) are described. In addition. descriptively and clearly. When delivering in accordance with the regulations of the EU it is compulsory to comply with the contents of the EN standard in order to guarantee free movement of goods under the same conditions. this standard has gained a fundamental significance. It represents a further development of formerly known national and branch-specific regulations with the express objective of showing.
Quality Assurance Model (according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality system may depend on the type of products to be supplied, the applied technology and the size of the evaluated company. The following paragraphs are taken from the national foreword and the introduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated: Gaining confidence in the supplier’s ability to fulfill the defined minimum requirements on his quality system is nowadays becoming more and more a precondition throughout the world for cooperation between the customer and his supplier. This confidence can be built up by presenting the quality system to the customer or an authorized body. All systematic and confidencebuilding activities planned within the scope of this are designated by DIN EN ISO 8402 as quality assurance or quality management systems (or quality systems). The standards DIN EN ISO 9001, DIN EN ISO 9002 and DIN EN ISO 9003 each contain a quality assurance model. Only these three standards of the DIN EN ISO 9000 series are intended for demonstration purposes. They show a way to create confidence in the capability of a supplier. It has to be emphasized that the quality system requirements specified in the International Standards ISO 9001, ISO 9002 and ISO 9003 are a supplement (not an alternative) to the established 1) quality requirements (on products ). It is intended that these International Standards are applied in their present form. However, occasionally they may need to be tailored for special contractual situations by the addition or omission of certain requirements. ISO 9000-1 provides guidance on such tailoring as well as on the selection of the appropriate model, … namely ISO 9001, ISO 9002 or ISO 9003.
1) According to DIN EN ISO 8402, 1.4 may include product as well as services.
The following alternative models for quality assurance described in three international standards represent three differing forms of "the functional or organizational quality capability" which are suitable for use in contracts between two partners (see Chapter 5: Cross-Reference List of Section Numbers) ISO 9001Quality systems Model for quality assurance in design , development, production, installation and servicing. To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during design, development, production, installation and servicing. ISO 9003 Quality systems Model for quality assurance in production, installation and servicing. To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during production, installation and servicing. ISO 9002 Quality systems Model for quality assurance at final inspection and testing. To be applied, when conformance to specified requirements is to be ensured by the supplier/contractor only during final inspection and testing.
Quality System Audit
Evaluation of the quality system is performed with the help of a questionnaire. The questions of the present VDA 6.1 volume are primarily foreseen for the evaluation of companies which produce material (or tangible) products (For non-material or non-tangible products/services - see VDA Volume 6, Part 2). The evaluation of a company is performed either as an internal audit by the st nd company itself (1 Party), through a representative of the customer (2 rd Party) or through an accredited certification body (3 Party). Auditors must be competent in the elements which they have to evaluate, as well as in the quality techniques used. They must be qualified to judge the suitability of the implemented quality measures, taking into account the production processes used, the state of technology and the required product quality. The extensive commercial and technical evaluation of a company in line with this quality system audit places great requirements on the auditor. In addition to this, the auditor must have, among other things, relevant training and industrial experience, integrity and the ability to deal with people. Particularly the following quality elements: management responsibility quality system internal quality audits training/personnel financial considerations to quality systems product safety corporate strategy
demand special qualification requirements of the auditors, as they must be competent to discuss the above topics with the company’s management. Department-specific questions are to be answered by the persons responsible in the company for marketing, design, procurement, production planning, production or personnel and not by the Quality Manager. He, generally, only answers specific questions about quality function issues, e.g. about testing and documentation. 18
If the quality system of a company, on the occasion of a system audit, has been found to be satisfactory in accordance Paragraph 3.3, then a periodic quality system audit is to be carried out at appropriately defined intervals. In the case of an unsatisfactory result during a quality system audit, corrective actions and a time schedule are to be established to improve the system. The evaluation of their effectiveness is the subject of a follow-up audit that examines the unsatisfactory areas.
Selection of the Quality Elements and Relevant Questions
The relevant elements and corresponding questions for the evaluation of the quality system of a company are to be defined. The elements 08, 12 and 21 can, under special circumstances, be completely/ partly omitted. Comments regarding this are given with the relevant elements. During internal quality audits (1 Party) and customer audits (2 Party) further quality elements and questions may also be added. Furthermore, elements of a quality system may be adapted, deleted (in exceptional cases) or extended to meet company or product-specific needs. Additional questions to the quality system must be communicated to the company/ organization to be audited beforehand. During certification audits (3 Party) additional requirements can only be added if they form part of the quality system of the company to be audited. In this case, their compliance and effectiveness are to be assessed. The point rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable. Individual questions can only be omitted if they are unusual or not able to be evaluated for the company size or branch. In cases of doubt, clarification with the customer is sensible. Questions that are not applicable and supplementary questions are to be identified and justified in the audit report (Identification for non-applicable i.e. questions that have not be evaluated = na). In the following questionnaire, elements of a quality system which have a particular influence on product and process or which can lead to the failure of the quality system are identified by the relevant
rd st nd
in operational procedures with relationships and responsibilities? (e. The type of evidence or records listed as examples must not be supplied if they are not appropriate to the industry sector. 3.3. The „Requirements/explanations“ to the question are always to be seen as an example and not as a complete checklist.g. Non compliance with these requirements has particular influence on the overall rating or awarding of a VDA 6.: in the quality manual.3. This can make a separate assessment (product / process audit) necessary.1 Certificate Supplement (see 3.1 Individual Rating of Questions and Quality Elements The auditor evaluates the definition and effectiveness of the quality management activities in complying with the respective requirements by initially determining: Is the subject in question defined in writing in the quality system.4). in a documented procedure or work instruction)? He must then further evaluate: Is the subject in question proven to be effective in practice? 20 .3 and 3. Some questions concerning the quality system can only be answered in conjunction with an evaluation of the product to be supplied and/or the corresponding technology or process applied.3 Evaluation and Rating 3.questions with an *.3.
every question is equally weighted. Thereby. . 21 . Questions which are not applicable are not considered in the rating. answers to the questions lead to a rating for each relevant question.According to the following table. Rating 10 points: 8 points: 6 points: 4 points: 0 points: completely defined in the quality system and proven to be effective not completely defined in the quality system but proven to be effective completely defined in the quality system and mainly proven to be effective not completely defined in the quality system but mainly proven to be effective not proven to be effective regardless of completeness of definition in the quality system When compiling a summarized rating for a quality element. 4. The element rating is expressed as a percentage which results from the total points assessed for all relevant questions related to the total points possible for all relevant questions. 6. This rating can result in 0. If all relevant answers in an element achieve 10 points. then the level of compliance CE is 100%. the following point rating is valid for each question: Subject in question Defined completely in the quality system Proven effective in practice Point score yes yes 10 Bewertung der Antworten no yes 8 6 yes mainly *) 4 no yes/no no 0 * Under "mainly" it is understood that all applicable requirements are proven effective in more than 3/4 of all relevant application cases and that no special risk exists.8 or 10 points per question.
22 .3. CP = sum of levels of compliance of all relevant elements ——————————————————————————— no. M (management) and P (product and process). They are established by calculating the average value of the levels of compliance for the relevant evaluated quality elements CM resp. the individual levels of compliance CM and CP are calculated. of relevant quality elements [%] The two levels of compliance CM and CP are combined to give an overall rating. 3 CTOT = The rating system may also be applied if further elements or questions are added or if elements or questions are omitted. If additional questions relate to product.2 Overall Rating of Audit Result For the two parts of the audit. services or applied process technology.Calculation of element ratings: total points assessed for relevant questions ———————————————————— total possible points for relevant questions CF = x 100 [%] 3. whereby the management-specific section is given one third weighting and the product-related and process-related section is given a two thirds weighting: CM + 2 * CP ——————— [%]. it may then be necessary to adapt the point and rating system accordingly.
Downgrading according to 1. * CTOT is referred to as E GES in the original German version 3. 4. If a question marked with * which has particular influence on product and process or which can lead to a failure of the quality system is graded with less than 8 points then the company being audited is to be downgraded from A to AB or from AB to B. 2) or 3) above may be applied only once. are treated with more importance in the quality rating system.3 Rating during Customer/Supplier Audits (2 Evaluation of quality system full compliance mainly compliant conditionally compliant not compliant nd Party) Description of rating A *) AB *) B C Overall level of compliance in percent 90 to 100 80 to less than 90 60 to less than 80 less than 60 *) Notes 1. If a question not marked with * is graded with 0 points. 3. 5. as appropriate.33/ 0.30 * CM + 0. 2. The elements of CM are therefore more heavily weighted by a factor of 0. Thereby the elements of management. In order to retain a simple formula and also to give more weight to the Part M quality elements. then the audited company is to be downgraded from A to AB.Note on the formula for CTOT* The formula arises from the following consideration: On condition that the 7 quality elements concerning management and the 16 quality elements concerning product and process (from Chapter 6) are equally weighted in CTOT Then: CTOT = 7 * CM + 16 * CP ———————— 23 = 0. as an essential part of quality assurance.30 = 1. Companies audited and having received an overall level of compliance exceeding 90% (or respectively 80 %) but which have a level of compliance for one or more elements of less than 75% will have their rating dropped from A to AB (or respectively AB to B). Downgrading are to be justified in a commentary sheet.3. 23 .1. the committee defined the formula for CTOT as presented above (no mathematical background).70 * CP should be calculated.
if . if all questions marked with * are rated with at least 8 points and all questions not marked with * are rated with at least 4 points. Exception: A VDA 6. The same rules apply as for a follow-up audit.1 Certificate Supplement).4 Awarding of the VDA 6. rd 24 . A follow-up audit is not possible if more than one question marked with * is rated with 0 points (Status : failed) A re-audit is only possible at the earliest after 90 days. 2.1 Certificate Supplement is awarded after a follow-up audit.one or more questions marked with * are graded with less than 8 points or .1 Certificate Supplement (3 Party): 1. A VDA 22.214.171.124 Certificate Supplement to an ISO 9001/9002 certificate is awarded at an overall level of compliance exceeding 90% (the level of compliance [%] is not shown on the VDA 6.one question not marked with * is graded with 0 points. Follow-up /Re-audit A follow-up audit is possible within 90 days after completion of the audit under the following conditions (Status : Open): a) a maximum of one question marked with * was graded with 0 points and/or b) one or more questions marked with * were graded with 4 or 6 points and/or c) one or more questions not marked with * were graded with 0 points and/or d) no element achieved a level of compliance below 75% A VDA 6.1 Certificate Supplement will not be awarded.one or more quality elements achieve a level of compliance below 75% or .
serves the management of the audited company as a basis for corrective actions. If necessary. These will be presented in an summary sheet "Nonconformances/Corrective Actions".4 Summary of Results The results of the quality system audit of Part M (management) and Part P (product and process) are to be presented as shown in the sample forms (Chapter 8). This has to be communicated to the lead auditor responsible for heading the audit.1 certificate may also be carried out under consideration of existing certificates according to DIN EN ISO 9001/9002 or QS 9000 with supplementary auditing (see VDA Volume 6). presented as shown in the main paragraphs 3.3. 25 .7 VDA 6. After completion of the quality system audit. The awarding of a VDA 6. It is the duty of the audited company to work out and implement an improvement program. The certificate is valid for 3 years after the date of issue. the auditor informs the audited company's management which nonconformances are present and to what extent corrective actions are necessary.1 certificate can only be awarded if the overall rating achieved is A (see 3.1 certificate from the VDA at the request of the company being audited.6 Corrective Actions The result of the quality system audit.5 above.4 and 3.5 Close out Meeting and Report In the course of a close out meeting regarding the quality system audit. 3. The results of each element will be entered on the sheet "Summary of Results". 3. A precondition for this is that the auditor is registered as a Lead Auditor with the VDA. The auditor decides on the basis of the presented improvement program to what extent a follow-up audit is carried out.3). 3.1 Certificate A VDA 6. a follow-up audit date is agreed. the auditor raises an audit repot and establishes a time schedule with the audited company for the corrective actions (see sample forms – Chapter 8). The representative of the certifying body applies for the VDA 6.3.
Teil 1 des Qualitätsstandards der deutschen Automobilindustrie“ auf Grundlage DIN EN ISO 9001 / 9004-1 wirksam eingeführt hat. V.1-URKUNDE Es wurde nachgewiesen. daß das Unternehmen ein Qualitätsmanagement-System nach VDA 6. Nachweis mit/ohne Produktentwicklung. ________ _________________________ Firma / Unterschrift des Bevollmächtigten Lead-Auditor(en): __________________ _________________________________ Datum ___________________ Unterschrift _____________________ ________________________________________________________________________________ VDA-Stempel 26 .VDA Unternehemen: Betriebsteil: Produktgruppe/n: VERBAND DER AUTOMOBILINDUSTRIE E. Ausgestellt am: Das Audit wurde durchgeführt von: gültig bis: Registriert VDA Nr. VDA 6.
(The numbering according to # corresponds to the DIN EN ISO Standard 8402/1995). When a procedure is documented.an activity or a process (1. a system or a person or any combination thereof.6)). equipment and documents have to be used.1. finances. #.1 General terms according to DIN EN ISO 8402/1995 (Extract) #. A written or documented procedure normally contains the purpose and scope of application of an activity. Note: Resources can include personnel. what needs be done and by whom.3 Procedure A defined manner in which an activity is carried out.7). Note: A unit can be e.g.g. the terms "written procedure" or a "documented procedure" are often used. plants. where and how it needs be done.2 Process A set of interactive resources and activities which transform inputs into outputs. Note 1: Note 2: Note 3: In many cases procedures are documented (e. #.an organization (1. techniques and methods.1. procedures of a quality system (3.: . equipment. when. 4.a product (1.2) .1.4) . and how these must be controlled and recorded.4 Definitions For each of the individual elements definitions and explanations of terms are given within the questionnaire.1 Unit That which can be individually described and examined. which materials. Generic terms are briefly summarized in the following. 27 .
#. hardware. Customer activities at the interface with the supplier may be essential to the service provision (1.9)) or unintended (e. with its own functions and administration.g.g. business.5 Service The result generated at the interface between the supplier (1. Note 1: Note 2: Note 3: The term product may include a service (1. Note 1: Note 2: Note 3: Note 4: The supplier or the customer may be represented at the interface by personnel or equipment.#. A product can be tangible (e.9).7) performs its functions. authorities and relationships.10) and the customer (1. processed materials.1. Supply or use of tangible products (1. registered or non-registered.7 Organization A company. knowledge or concepts) or a combination thereof.5). arranged in a pattern through which an organization (1.10) to meet the customer needs. A service may be linked with the manufacture and supply of tangible product.g.2). A product can be intended (e.4 Product The result of activities and processes (1. #.6). offered product to customers (1. public or private. corporation.g. 28 . enterprise or institution or part thereof. assemblies or processed materials) or intangible (e.8 Organizational structure The responsibilities.1.4) may form part of the service provision. software or combinations thereof. #.1.1. pollutants or unwanted effects). as well as by internal activities of the supplier (1.
importer.9 Customer The recipient of a product (1. the end user. A supplier may be. The supplier can be either external or internal. the producer. 4. for example. for example. #.1.10). Note 3: Note 4: 29 .7). limit deviations and tolerances.4) to the customer (1. ratings. defined and updated in the various planning phases.3 Quality Requirements The formulation of needs or their conversion into a set of established quantitative or qualitative requirements for the characteristics of a unit (1. The customer. in relation to the organization. user.11). Note 1: Note 2: Note 3: In a contractual situation. as well as internal requirements of a company (1. Note 1: Note 2: It is essential that quality requirements fully reflect the established and given needs of the customer. the supplier may be called the "contractor" (1. They may be developed. distributor.9). nominal values. The quality requirements should be expressed in functional conditions and be documented. to enable its realization and verification.12).1. assembler or service organization.10 Supplier The organization (1.#. Established quantitative requirements of the characteristics include e.4) provided by the supplier (1.2 Quality-related Definitions according to DIN EN ISO 8402/1995 (Extract) #. Note 1: Note 2: Note 3: In a contractual situation. may be either external or internal. the "customer" may be called "purchaser" (1. The customer can be.g.2.7) which provides a product (1. contractual. beneficiary or purchaser.1). The term "requirement" includes market-based.
30 .4) to determine its conformity (2.17 Verification Confirmation based on an examination and the provision of evidence (2.#. "Verified" is used to describe the corresponding status.19 Evidence Information which can be proven to be correct and which is based on facts obtained through observation.19) that the special requirements have been fulfilled for a given application. validation concerns the process (1.9) of this activity with the set requirements.2. whether conformity (2. The term "validated" is used to describe the corresponding status. Note 1: In design and development. Note 1: In design and development.9) for every characteristic has been reached.2.9) with the needs of the user. Note 2: #. if different applications are intended.2.2. Note 2: Note 3: Note 4: #. examination or other means of investigation. It may be necessary at an earlier stage. measurement.1).15 Inspection and Testing Activities such as the measuring and examining of one or more characteristics of a unit (1. Multiple validations can be carried out. Validation is normally performed on the end product under defined operating conditions.2) of examining a product (1. #. verification concerns the process of evaluating the result of a given activity to determine the conformity (2. to establish.19) that established requirements have been met. as well as comparing of the results with set requirements.18 Validation Confirmation based on an examination and provision of evidence (2.
3.6) of an organization (1.7). b) the responsibilities and authorities (jurisdiction). Note 1: Note 2: The quality system should be as comprehensive as required to meet the quality objectives.8).3.2) and resources required for the realization of quality management. 31 .6).7) is aimed primarily at satisfying the internal needs of the company.4.3 Definitions for Quality Systems according to DIN EN ISO 8402/1995 (Extract) #.12 Quality Manual A document stating the quality policy (3. The quality system of a company (1. A quality manual normally contains or refers at least to: a) he quality policy. Title and purpose of the manual reflect the scope of application. It is more extensive then the requirements of a single customer (1.3). For contractual or other obligatory purposes of quality assessment (4. assess or evaluate quality-related activities.1) and describing the quality system (3. as well as the interrelations personnel who manage. Note 1: Note 2: A quality manual may relate to the entire company activity or just parts of it.7) with regard to quality (2. demonstration of the implementation of defined quality system elements may be required. processes (1. Note: The quality policy is an element of the corporate policy and is approved by the management. #.9) who only evaluates the part of the quality system relevant (to him).6 Quality System The organizational structure (1.1 Quality Policy Comprehensive intentions and objectives of an organization (1. as formally defined by management. Note 3: #.3.1). perform. procedures (1.
3) of the quality system (3. processes (1.2) or products (1. "Process Audit". Depending on the purpose of the manual.7) or reviewing (2. Note 3: A quality manual may differ in comprehensiveness and format in order to refelct the needs of a company.4 Definitions for Tools and Techniques according to DIN EN ISO 8402/1995 (Extract) #. Quality audits are carried out by persons who have no direct responsibility in the area to be audited.6) or elements thereof.4. One purpose of a quality audit is to evaluate the need for improvement or corrective action (4.c) the procedures (1. a title may be used such as „Quality assurance manual“ . whether the qualityrelated activities and related results comply with planned instructions and whether these instructions are actually implemented and are suitable to meet the objectives. "Product Audit" or "Service Audit". but is not limited to a quality system (3.6) and corresponding instructions. revision and administration of the manual.19). 32 . Note 1: The quality audit is typically applied. d) a stipulation for reviewing.9 Quality Audit Systematic and independent examination to determine. Such quality audits are often called "System Audit". A quality audit should not be confused with the activities of quality monitoring (4. however. 4.10 Quality Audit Findings A statement of fact made during a quality audit (4.14).4) (including services (1.15) which are carried out for process control or material receiving.5)). preferably they should be working together with the relevant personnel. Note 2: Note 3: Note 4: #.9) and substantiated by evidence (2. It may consist of more then one document. Quality audits may be carried out for internal or external purposes.4.
1. 4. One has to differentiate between a "correction" and a "corrective action": .1.11) or other undesirable situation in order to prevent its recurrence.18). as well as procedures (#.A " corrective action" refers to the elimination of the cause of the nonconformity.5.10).5. Note 1: Note 2: Corrective actions can bring about changes in e.3) to given means and a given purpose which leads to technical proficiency in the solution of theoretical and practical tasks.g.5 Additional Terms (Definitions for the present volume) 4.2) are defined with the necessary resources for the realization of a task. 4.2 Method A scheduled procedure (#.19) or an adjustment and refers to the treatment of an existing nonconformity. procedures (1.14 Corrective Action An action taken to eliminate the causes of an existing nonconformity (2. . a rework (4. 33 . in recurrent orders.4) of the same type and design.3) and systems to achieve quality improvement at any stage of the quality cycle (4.#.1). 4. authorities) and interrelations.3 Serial Production The manufacturing of products (#. defect (2.1 System The structure of a company in which the jurisdiction (responsibilities.A " correction" concerns a repair (126.96.36.199.4.3) and processes (#.
4.5. They are to be put into force by signature.4. as well as order-related.5 Work Instructions (Inspection and Testing Instructions) Detailed description of the working steps of an activity. Note: Includes technical know-how. 34 .5. order-neutral. Definition of individual activities and detailed instructions.4 Quality Procedures Quality procedures are specific instructions that are required in order to fulfil given quality-related activities.
in the standard DIN EN ISO 9001 9002 9003 9004-1 4.4-11.5 Cross-reference List of Paragraph Numbers for Corresponding Topics (according to DIN EN ISO 9000-1. and test status (control of insp. 16.14 4.16 4.7 4.4. 5.9 4.6 11.4 l 4.5 9 4. 17. storage.2 delivery (post-production activities) 10.18 l − − − − − − 4.4.5 18 6 19 − 7 8 (8) l l 4. 17. traceability and identification) (Process control) Insp. VDAQuestionnaire N°. 7.9 4.12 4.15 4. packaging.10 4.11 4. 9002.2 4. 16. 5 4. 5.6 − 11. (post-production activities) 16.3. & test status) Process control (quality of processes) Corresponding paragraph or subparagraph No.8 4. 16. measuring and test equipment 13 17 Control of nonconforming product 14 18 Corrective and preventive action 15 19 Handling.5.2 21 Servicing.product design (Quality in specification and design) Process planning . 9003 and 9004-1. 1994-08) Cross-reference list which gives the paragraph numbers for corresponding topics of the questionnaire of Chapter 7 to the paragraphs and subparagraphs of the standards DIN EN ISO 9001.17 (4.3 22 Statistical techniques 20 Italic: Elements which extend beyond the scope of the standard Key: l ffull requirement m − less comprehensive than ISO 9001 and 9002 quality element not present 35 .1 l l m 5 5. 01 02 03 04 05 06 Z1 07 08 09 10 11 12 13 Paragraph Title according to 9001 / (9004-1) Management responsibility Quality system (quality system elements) Internal quality audits (auditing the quality system) Training (Personnel) Financial considerations of quality systems Product safety Corporate strategy Contract review (Quality in marketing) Design control .process design Document and data control (Quality documents) Purchasing (Quality in purchasing) Control of customer-supplied product Product identification and traceability (Material control.4) l l l − − − l − − l l l l l l l l l l l l l l l m m m − − − l − − l − l m − l − m l m m l m − m 17.13 4.20 − l l l l l l l l l l l l l l l 14 15 16 Inspection and testing (Product verification) 12 Control of inspection. Appendix D.19 4.3 l 4.2 11.7 10 4.1.3 4.4 20 Control of quality records (quality documents/records) 17. preservation and 16.6.
Section 6 Product Safety DIN EN ISO 9004-1. Training. 47 Section 4. Company Strategy Subtotal of questions in section M 4 4 5 36 36 .18 Section 18 71 75 Section 19 81 6 03 4 04 7 05 06 Z1 Financial Considerations of Quality Systems DIN EN ISO 9004-1.6 Structure and Number of Questions per Quality Element Page No. Personnel DIN EN ISO 9001. of questions M Management 01 Management Responsibility DIN EN ISO 9001. Internal Audits DIN EN ISO 9001.2 Section 5 57 Section 4.17 Section 5 63 Section 4. DIN EN ISO 9004-1.1 Section 4 6 02 Quality System DIN EN ISO 9001 DIN EN ISO 9004-1. DIN EN ISO 9004-1. 39 Section 4. DIN EN ISO 9004-1.
P 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 Product and Process Contract Review, Quality in Marketing 9001, Section 4.3 / 9004-1, Section 7 Design Control (Product Design) 9001, Section 4.4 / 9004-1, Section 8 Process Planning (Process Design) 9001, Section 4.4 / 9004-1, Section 8 Document and Data Control 9001, Section 4.5 / 9004-1, Section 17.3 Purchasing 9001, Section 4.6 / 9004-1, Section 9 Control of Customer Supplied Product. 9001, Section 4. Product Identification and Traceability (Process Control, Inspection and Test Status) 9001, Section 4.8 (4.9, 4.11, 4.12)/9004-1, Section11 Process Control 9001, Section 4.9 / 9004-1, Section 10 Inspection and Testing (Product Verification) 9001, Section 4.10 / 9004-1, Section 12 Control of Inspection Measuring and Test Equipment. 9001, Section 4.11 / 9004-1, Section 13 Control of Nonconforming product 9001, Section 4.13 / 9004-1, Section 14 Corrective and Preventive action 9001, Section 4.14 / 9004-1, Section 15 Handling, Storage, Packaging, Preservation and Delivery 9001, Section 4.15 / 9004-1, Section 16 Control of Quality Records 9001, Section 4.16 / 9004-1, Section 17.2 Servicing, (After Sales and Post-production Activities) 9001, Section 4.19 / 9004-1, Section 16 Statistical Techniques 9001, Section 4.20 / 9004-1, Section 20 Sub-total of questions in section P Total of all questions
No. of questions
5 7 7 4 7 4 7 7 6 5 4 4 6 4 5 6 89 125
77 83 91 99 105 113 117 125 133 139 145 149 155 159 163 167
Quality System Audit Questionnaire
For application in companies which manufacture tangible products STRUCTURE For every quality element the general requirements are described in an introduction, the subject in its context is briefly explained and the questions are stated.. In addition, reference is made to other applicable VDA Volumes which are to be considered during the realization of the quality system. Equal procedures and processes are permitted. Questions on the quality system which have a special influence on the product or process or may lead to the failure of the quality system are marked with an *. Each question is structures as follows: 1. 2. The Question Definition
Where required, the terms used in the question are defined according to the relevant standard and the standard or an extract thereof is cited. The source is stated respectively. Explanation of terms Where required, the terms used in the question are explained, if no definition is given, to provide a better understanding. 3. Requirements/Explanations
In the section ‘Requirements/Explanations’, requirements on the quality system are defined and supplemented by an explanations, if necessary.
Note: For each applicable question, the auditor has to evaluate the definition nad effectiveness of the quality measures.
The requirements and explanations are partially described in an abreviated form. Therefore, further VDA Volumes which are significant and which have to be considered are referenced (see the note in the introduction to the quality elements). Usually there is a special note in the respective question.
Part M: Company Management 01 Management Responsibility DIN EN ISO 9001, Section 4.1 DIN EN ISO 9004-1, Section 4, 5 The Management (e.g. Board of Management, Plant Management, Section Management) develops the quality policy for the company, defines it and commits all areas and levels to it. Hereby specific quality objectives and a quality management system (quality system) are to be agreed. Quality must be regarded as an overall management task. "Management" describes the organizational unit within the company that is responsible for profit and loss.
Reference DIN EN ISO 9001 9004-1 01.1 * 01.2 * 01.3 * 01.4 01.5 * 01.6 * Has the quality policy been defined by management and has it been made known to all levels? Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results monitored? Is a continuous improvement process part of the quality policy? Have the necessary resources been provided by the company management? Has a management representative been assigned and are his duties, authorities and responsibilities defined? Does management regularly evaluate the effectiveness of the quality system? 4.1.1 4.2
188.8.131.52 5.2.4 184.108.40.206 5.2.2 220.127.116.11 5.2.3 4.1.3 5.5
Has the quality policy been defined by management and has it been made known to all levels?
Definition: Quality Policy (according to EN ISO 8402/3.1): The overall intentions and objectives of an organization with regard to quality as formally expressed by the management.
Note: The quality policy forms one element of the corporate policy and is approved by management.
Requirements/Explanation: The quality policy must be formulated in such a way that it can be understood, implemented and applied by employees at all levels The principles of the quality policy are to be described in a quality manual or an equivalent document (see Question 02.1). The publication of the quality policy is achieved, for example, by notices memoranda organizational guidelines and instructions informative presentations about the quality policy.
The quality objectives of the company are established from the quality policy (see Question 01.2) which are authoritative for the organization of the company and which incorporate the expectations of the customer(s). Evidence is given by, for example, a declaration of commitment from management within the scope of the quality policy, according to which all quality requirements for activities, not only in production but in all organizational units, are reliably fulfilled and the prevention of nonconformances has significant priority over the detection of nonconformances (Zero Defect Strategy).
operations and services. reducing the number of customer complaints change %) • Reduction in the reaction time when dealing with complaints (difference in days) • Improving delivery reliability (on-time performance). c) Customer-related objectives • Shortening of order processing time (inquiries. These objectives are derived from customer requirements.g. processes. the legal environment and internal requirements. orders etc. directives) • Improving market acceptance • Making profit • Ensuring the continued existence of the company • Continuous quality improvement (see Question 01. 41 .2* Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results monitored? Explanation of terms: "Quality objectives" are specifications for products. as well as adherence to the „zero defect strategy. b) Product-related objectives • Scrap-/ failure rates (%) • Supplier delivery quality (ppm) • Improving product quality • Improving process capability (Cpk) • Improving reliability • Environmental tolerance. for example: a) Corporate-wide objectives • Fulfillment of the general company requirements (laws. the competitive situation.01.) (difference in days) • Improving customer satisfaction (e.“ Requirements/Explanation: Objectives for quality within the scope of the quality policy might be. that are defined for all levels. regulations.3).
) • Calculating and evaluating the costs assigned to all quality elements in order to minimize any loss of quality • Monitoring the effectiveness of corrective actions on the basis of audit results • Quality of the development of products and processes (time. measurable.) • Quality system upgrade from ISO 9001/2 to VDA 6. equipment. practicability. The achievement of objectives must be monitored thoroughly at all management levels (specified/actual comparison). Without the definition of objectives. if possible. no efficient improvement in quality and increase in productivity in all company areas can be followed or achieved.7 The quality objectives to be agreed must be achievable and. e. feasibility etc. implemenation. operations etc. The objectives must be practically.5) • Increasing improvement suggestion activities (methods.d) Higher objectives • Reducing costs but not to the detriment of quality • Advance quality planning (see Question 02. as well as periodically revised and presented in a suitable format.1.see Question 04. clearly and comprehensively explained to the employees during informative discussions. using data processing systems.g. Note: The demonstration of achieved quality in comparison to objectives . EQA etc. Further development towards TQM. 42 .
Improvements refer to. repairs) Simplification of processes/Optimization of production methods. all production processes.2 are possible. In the continuous improvement process. for example: the logistical chain the building / factory area the equipment environmental protection The strategy of continuous improvement applies to employees.01. This includes.3* Is a continuous improvement process part of the quality policy? Requirements/Explanation: Improvement programs for the operating units and for the commercial and technical functional units of a company must be introduced and maintained. The working methods applied can be selected on a company-specific basis. 43 . careful handling and economical use of resources must also be taken into account. for example: Quality Price Service Delivery reliability. It does not replace necessary innovative improvements. Items for improvement include. Minimization of waste Reducing unplanned down-time of machines Shortening setting-up and tool change times Increasing service life/cycle times of products and equipment Improving the ease of repair of products and equipment Reducing water.2 and 04.g. services and business operations of a company. rework. The methods cited elsewhere (see Questions 04. air and energy expenditures Optimization of activity times Improved handling in all areas Connections to Question 01. for example: Note: Reducing non-value-adding activities (e.5) must be used here.
implementation and inspection activities (including project management) inspection and testing equipment for product development and manufacture computer support. the company management has the task of providing the financial and personnel resources needed to fulfil the requirements in the quality elements. graphic displays. statistics. 44 .g.01. - The effectiveness and efficiency of the quality system depends on the provision of the necessary resources for the realization of the quality policy and the quality objectives. These include. for data analysis.4* Have the necessary resources been provided by the company management? Requirements/Explanation: So that the quality system can operate effectively. quality plans. Note: This question cannot be finally evaluated until the entire quality system has become transparent as a result of the audit and until it has been ascertained that all necessary resources are available. for example: qualified staff with task-related capabilities for management. e.
He/she always reports to that level of management. authorities and responsibilities defined? Explanation of terms: The "Management representative" is the person who represents the interests of management regarding strategic quality management at all management levels. but does not have to be a member of the management. The representative may at the same time be responsible for the organizational functions "quality department". The representative must belong to the management team of the company. Note: 45 . which is responsible for profit and loss. Requirements/Explanation: Responsibilities and authorities of the representative include: Reporting on the quality situation Defining. realizing and maintaining the quality system in accordance with the requirements of this questionnaire. "quality management„ etc.01.5* Has a management representative been assigned and are his duties. which includes branch-specific adjustments Monitoring the strategic quality objectives Controlling and coordinating quality activities using interdisciplinary cooperation Demonstrating the effectiveness of the quality system and determining possible improvements. "quality assurance".
technology etc.2) Internal quality audit reports with derived measures (see Question 03. The aim of this assessment is to achieve a continuous optimization and adaptation to changed conditions (market.4).3) Status of the continuous improvement process (see Question 01.3) Results of product and process analysis with corrective actions Reports on customer satisfaction (see question Z1.). for example: Reports on the quality situation Regularly scheduled quality meetings Quality indices with respect to objectives (see Question 01.01. Requirements/Explanation: Company management must periodically (at least once each year) assess and satisfy itself about the effectiveness of the established quality system.9): A formal evaluation by top management of the status and adequacy of the quality system (quality management system) with respect to the quality policy and quality objectives.2 and 03. The review is carried out by comparing the findings with the objectives of the quality policy and usually results in preventive and corrective actions. 46 . This can be done by collecting and evaluating the following information.6* Does management regularly evaluate the effectiveness of the quality system? Definition: Management Review (in accordance with DIN EN ISO 8402/3.
the responsibilities.2 5.3 is also applicable for this element.5 * 02. responsibilities and authority levels for quality activities? Is there a cross-functional project management established which includes the quality planning process? Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements? Are there quality plans resulting from the quality planning process? 4. Note: VDA Volume 4.1.1 * 02.2.2. The quality system shall be defined and implemented by management.1 5.3 47 .2.1 18.104.22.168. procedures. preferably in a quality manual and in supplementary documented procedures or equivalent documentation.1.6 4. The quality system is intended to promote continuous quality improvement.3.4. 5. Reference DIN EN ISO 9001 9004-1 02.02 Quality System DIN EN ISO 9001.3 5.1 4.2 (4.6 02.2 Is the quality system described in a quality manual or an equivalent document? Does the quality system encompass all areas.4 * 02.4.3.6 * 4.2 5.2 Section 5 A quality system consists of the organizational structure.3 5.2. levels and employees of the company? Are there documented procedures defining duties.2. Section 4.3) 5.3 * 02.2 4. DIN EN ISO 9004-1. processes and resources for the implementation of quality management.3 4.
This also include instructions on project management (see Question 02.02. The documentation covers: Organizational structure Names of responsible individuals Implementation process for all activities affecting quality in the company. to serve as a permanent reference for the implementation and maintenance of this system. (see Paragraph 4. regulations etc. the validity date and the revision status. revision service and the distribution list must be defined. Responsibility for it’s updating. The manual must display the approval of the company management.12). In addition. at the same time. quality assurance plans etc. standards.3 #3.1* Is the quality system described in a quality manual or an equivalent document? Definition: Quality manual (according to DIN EN ISO 8402/3.4). special processes can be separately defined in documented procedures. Requirements/Explanation: All quality elements necessary for conducting the business of a company must be described in the quality manual with reference to applicable internal and external instructions. 48 . The main purpose of a quality manual is to define the structure of the quality system and.12): A document stating the quality policy and describing the quality management system of an organization.
02. Job descriptions and organization charts serve.1) and all value-adding processes involved. The understanding of quality management as a task of all employees can be demonstrated by. It’s interacting functions are a precondition for the continuous compliance with the requirements of customers.6): The organizational structure. They make the organization transparent. levels and employees of the company? Definition: Quality system/(Quality management system) (according to DIN EN ISO 8402/3. simplify personnel qualification and assignment and promote motivation and enthusiasm for decision-making. responsibilities. among other things. procedures. A universal understanding of quality and quality assurance should extend as a „leading theme“ throughout the entire company. processes and resources needed to implement quality management. legislators and society. 49 . Requirements/Explanation: The quality system extends to all phases of the life cycle of a product (DIN EN ISO 9004-1 Paragraph 5. presentations. clarify relationships at interfaces and provide evidence of relevant duties.2 Does the quality system encompass all areas. publications department-related objectives for quality improvement responsibilities matrices. for example: actions including various departments appropriate training. to endorse employees.
coordination and interfaces between various departments and activities must be observed. Thereby. in: Quality documented procedures Responsibility matrices Job descriptions. for example: can stop faulty products or processes is responsible for suggesting and monitoring problem solutions monitors conformity with quality requirements. They come into effect when signed. for example. Requirements/Explanation: Duties. 50 . responsibilities and authority levels for quality activities? Explanation of terms: „Activities affecting quality“ relate both preventatively and reactively to the entire life history of a product. it must be ensured that duties are clearly defined with the necessary independence to fulfill stipulated requirements. "Quality documented procedures" are special stipulations which are necessary for the fulfillment of the defined quality-related activity. responsibilities and authorities are to be unambiguously and clearly defined for those departments and employees which influence product and process quality.02. which come into effect when signed.3* Are there documented procedures defining duties. Hereby. particularly after changes is responsible for quality-relevant documentation. These definitions are best made. This requires a definition as to who.
are also be included. PFMEA. the joint activities include: raising the specification concept / design. the project team should include staff from Development..Project implementation). DFMEA. among other things. Quality methods (such as QFD.g. is interpreted as "Project management " in this questionnaire (also see DIN 69905[12. for example. must be raised and developed at a very early stage.. The Purchasing department and suppliers must be included when necessary. Production Planning. The duties and responsibilities must. the manufacturing process.90] . The appointment of a project representative (project manager) is advantageous for all projects. through to product utilization and disposal. among other things for the management of a project. This task begins as early as possible and encompasses the concept/design phase. protection and security of data is guaranteed through appropriate procedures for those involved in the project. aimed at the realization of a particular project (e. Section 5. quality planning (see Question 02. start of a series [see Element 14]). introduction of a new product [see Question 08.6). Quality and Production departments etc.4* Is there a cross-functional project management established which includes the quality planning process? Explanation of terms: „Project management“ is defined as the management of activities across several departments within a company. in product and process development plans. In the case of new projects. Note: The requirement for a "Configuration management" in the standard DIN EN ISO 9004-1. development production utilization disposal which must be outlined and explained in the context of simultaneous engineering taking interface issues into account. Here.10. Requirements/Explanation: Project flow charts with the main details. it must be ensured that confidentiality. It includes.. DOE.6 and 8. Depending on the task. be defined in project plans or respectively.1]. a new process. 51 . Suppliers.) must be applied on a project-specific basis.02.2.5) and the quality plan (see Question 02. if necessary.
3): activities that establish the objectives and quality requirements. Quality. Quality planning must take into account the tasks and deadlines stipulated by the customer and must contain specially defined methods. structure and working methods used (e. Process Planning. as well as the requirements for the application of the elements of the quality system. b) planning managerial and operational activities: preparing the application of the quality system including operational and time schedules. Requirements/Explanation: Quality planning (also known as advanced quality planning) must be regarded as an interdisciplinary task which defines how the quality requirements should be fulfilled. through reference to appropriate procedures/already existing planning schedules or descriptions). c) the preparation of quality plans and the making of provisions for quality improvement. to DIN EN ISO 8402/3. 52 . Marketing).g.g. Note: Quality planning covers: a) product planning: identifying. classifying and weighting the characteristics for quality. Interdisciplinary teams must be used for the activities to be carried out (e. as well as establishing the objectives. quality requirements and constraints. It must be compatible with the quality elements of the company and match the size.02.5* Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements? Definition: Quality planning (acc. Product Development.
evaluation and corrective measures .If the design responsibility lies with the customer.The quality planning team responsible for the product must consider all development aspects in the planning process in order to ensure that the end product meets the customer's expectations.Development of a process system with the quality plans to be used .The quality planning team responsible for the product should verify that the quality plan and the process plan are fulfilled and that the products meet the customer's requirements.All activities must be carried out from the view of the customer (end user.Determining the customer's requirements and expectations . consumer). • Process and product validation . needs and expectations of the customer are met.The production process must be validated by evaluating a trial series. .The results of the trial series have to be evaluated to ensure that the products meet the customer's requirements. • Process design and process development. . including verification . • Feedback. including verification .The stated input data and results represent recommendations. .The quality planning phases for new products are: • Planning and definition .Input data and results can vary . • Product design and product development.The process system must ensure that the requirements.The effectiveness of the product quality planning process must be newly evaluated 53 . . design aspects must also be considered.
modules. subassemblies. a quality plan can be an independent document or the relevant stipulations are incorporated into a different document. are outlined. An alternative description. in a project plan.Activities include. e. Depending on the customer’s requirements and company practice. 54 .g. Note 1: Note 2: A quality plan normally refers to those parts of the quality manual which apply in a specific case. depending on the area of application of the plan. FMEAs) and the resulting measures. for example.2) Are there quality plans resulting form the quality planning process? Definition: Quality plan (according to DIN EN ISO 8402/3. as well as the sequence of activities with regard to an individual product. Development and review of quality plans (see Question 02. production equipment.13): A document in which the specific-related work instructions and aids.g. personnel. such as. for example.6) Determining the required resources (e.6* Definition and identification of significant characteristics (tailored to the customer's stipulations) Development and review of risk analyses (e. measuring systems) Clarification of acceptance criteria Examination of the realization of the process Determining manufacturing feasibility/practicality (see Question 07. "quality assurance plan" can be used. an individual project or an individual contract.: 02.g. Requirements/Explanation: Quality plans must include components. parts and materials and the production processes associated with the marketable product.
• Series phase Comprehensive documentation of the product and process characteristics.Inspection instructions • Inspection .) . material and functional inspections and tests which must be carried out after prototype construction and before series production.The quality plan must normally be drawn up for the following 3 phases: • Prototype phase A description of the dimensional. • • • • • 55 .Monitoring methods (quality control charts.Geometric/material/functional characteristics • Documentation. for example. a distinction is made between various versions.Responsibilities (operator inspection. • Process monitoring . the inspections and tests and measuring systems which must be observed during series production. • Pre-series phase A description of the dimensional. the following content: Part name Process plan (manufacture / inspection / storage) Process stages (working steps) Work instructions Identification of the quality-relevant characteristics which have to be monitored during production.) . automatic recordings etc. When quality plans are drawn up. quality inspection etc.Parameters . the process control measures. These are related to tangible products in a) plans for a part manufacturing process with. material and functional inspections and tests which must be carried out during prototype construction (when required by the customer).Process description .
the following content: • • • • • • Responsibilities (organizational units) Review of the customer requirements Contract review Design review Production Product inspection and testing including • • • • Associated management plan Design and development plan Product quality plan for purchased products Manufacturing plan (provision of machines. testing and inspection equipment) • Control plan (see Question 15. for example. Quality plans are living documents and must be reviewed and updated if: the product has been modified the processes have been changed the processes are no longer stable or capable 56 .b) plans for a finished product with. equipment. tools. the quality plan must be agreed upon with the customer.1) • Service plan If required.
It requires constant development and monitoring.5 4.are suitable for achieving the objectives and .5 are also applicable for this element.3 * 03.5 5.2 * 03. should lead to corrective actions being implemented. aspects and components of a quality system should be regularly subjected to internal reviews (internal quality audits).17 5. the prevention of nonconformities. or quality system procedure. Internal quality audits carried out by trained and qualified staff serve the purpose of systematic and continuous review as to whether the activities defined in the quality system and their results: . Reference DIN EN ISO 9001 9004-1 03. most importantly.actually meet the requirements . Section 4. works automatically when it is put into place.4 5.17 Section 5 No organizational measure.17 - 57 .4. elimination and. Audit reports are quality records.5 5.demonstrate improvement possibilities (CIP – continual improvement process) All the elements.17 5.03 Internal Quality Audits DIN EN ISO 9001.1 * 03. DIN EN ISO 9004-1. if necessary.3 and 6.4. Note: VDA Volume 6. An internal audit encompasses all quality elements and thereby provides the objective evidence about the necessity for the reduction.4 * Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited? Are all elements of the quality system regularly subjected to internal audits and evaluated according to an audit plan? Do deviations lead to corrective actions and are these documented? Are the demands placed on products and processes audited and evaluated internally on the basis of an audit plan? 4. The audit results shall be presented to management for their review in documented form and.3 4.
e. evaluation and reporting (e. Personnel tasked with carrying out audits must be independent of the areas on which they are reporting. organization. VDA Volume 6.1) • Skills that are essential for the management of a quality audit. Note: For further information. good judgement. Chapter 6. communication and leadership • Experience in quality management and quality techniques • Personal characteristics. They must not come from the organizational unit to be audited. integrity. interview.11): Person qualified to perform quality audits. see VDA 6. analytical ability.1* Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited? Definition: Quality auditor (according to DIN EN ISO 8402/4. • Knowledge and understanding of the standards which might form the basis for audits of quality systems (DIN EN ISO 9000 .g. Depending on the type of audit and size of the company . such as planning.1 * Ist das Personal (Auditoren) für die Durchführung von inter03. Evidence of training can also be supplied through internal training courses. Part 1) • Evidence about the methods of grading through investigation. Explanation of terms: "Quality auditors" (see DIN ISO 10011. auditor training in accordance with VDA 6. Part 2) must be impartial and free from any influences which might affect their objectivity.9004. the following aspects are particularly relevant: • Qualification in accordance with DIN ISO 10011-2 and training in accordance with EOQ or equivalent guidelines.g.03. The qualification profile must be appropriately demonstrated. Requirements/Explanation: Auditors must be qualified to manage and perform internal quality audits. 58 . such as. open-mindedness • Upholding of relevant qualifications with certificates. The required qualification profile must be defined.
etc. Individual quality elements or parts thereof can also be inspected and evaluated at different times.) Areas and quality elements to be audited Audit sequence Questionnaire / checklist Scheduled dates Auditors / audit team After completion of an audit. in all areas.2* Are all elements of the quality system regularly subjected to internal audits and evaluated according to an audit plan? Explanation of terms: The different types of audits with scheduled dates and the areas to be audited have to be defined in an „audit plan“ (according to DIN ISO 100111). procedures. All quality elements. This auditing is the systematic review of all quality elements with regard to their effectiveness. quality manual. Audit plans tailored to the quality elements to be audited must be available in the organizational units. Requirements/Explanation: System audits must be planned and carried out. and at all company sites must be audited within 3 years. compliance with the requirements and their topicality. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01. An audit plan must contain the following information: Reference documents (standards.6). an audit report with the nonconformances found and suggested corrective actions is to be raised.03. 59 . It is to be distributed to the organizational units involved in the audit and the company management.
for example: a) Deviations . The action plan contains.Image .Instructions are not suitable to achieve the objective .3* Do deviations lead to corrective actions and are these documented? Definition: Corrective action (in accordance with DIN EN ISO 8402/ 4. defect or other undesirable situation in order to prevent it’s recurrence.03. Requirements/Explanation Detected deviations must lead to immediate corrective actions.e. A plan of action must be presented within an agreed time regarding the deviations and proposed corrective actions. i. remedying the cause of one or more nonconformances.Economy c) Remedial measures d) Responsibilities/deadlines e) Effectiveness check f) Reporting g) Adapting the documentation (including the quality system) 60 .14) An activity carried out to eliminate the causes of an existing nonconformity.Non-compliance with a requirement of a standard .Risk/product safety .Activity does not correspond to the instructions .Instructions not actually implemented b) Evaluating / weighting deviations with respect to .
The appropriateness of the working and ambient conditions should also be examined during these audits (see Question 14. Requirements/Explanation Product and process audits must be planned and carried out Audit plans must be defined for products and processes and must include the following information: Audit aim Reference documents Products/processes to be audited Audit sequence Questionnaire/checklist Deadlines Auditors Reporting with distribution list Pursuit of corrective measures After completion of an audit. A "process audit" serves to check whether the product complies with the quality requirements and that the process is mastered and capable. 61 .4* Are the demands placed on products and processes audited and evaluated internally on the basis of an audit plan? Explanation of terms: A "product audit" serves to assess the compliance of the workmanship with the defined quality requirements on the product after the final inspection.6).03. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01. an audit report with the nonconformances found and suggested corrective actions is to be raised and issued to the involved parties.6).
business procedures etc.1 18.18 grams for new and transferred employees and for the introduction of new or modified processes.2 04.18 on an individual and function-related basis and is a differentiated training program for all levels of the company derived from this? Does the training program also include actions 22.214.171.124 18.1.3 04.1 04.18 for further training in quality techniques? Are top management and other management staff included in the vocational training program? 18. qualify and motivate employees should be planned and implemented for employees in all areas and at all levels of the company.2.3 126.96.36.199 63 . Reference DIN EN ISO 9001 9004-1 04.2 4.1.04 Training DIN EN ISO 9001.? Do employees possess the formal qualification 4.4 * Are there introduction and instruction pro4.7 * 18. Section 4.3.6 04. DIN EN ISO 9004-1. measures to train.18 for their activities? Are there measures for the motivation and promotion of quality awareness? Do clear and understandable representations of the achieved quality compared to the set objectives exist in the company? 04.18 Section 18 The employees utilized in a company are an essential factor contributing to the quality capability of that company. In order to achieve this.1 4.2 18.18 18.1 Are training requirements regularly determined 4.5 * 04.
1 Are training requirements regularly determined on an individual and function-related basis and is a differentiated training program for all levels of the company derived from this? Explanation of terms: "Training program" means the determination of the entire training needs and the derived measures in all areas of the company. The training and further training activities must be summarized on an individual basis. Evidence of training performed can be in the form of grades. The further training of employees and maintenance of their qualifications is the responsibility of the direct supervisor. The summary should clearly show completed and still-open training measures. Requirement profiles must be defined on a function-related basis. certificates or confirmations of participation. 64 . One person is to be made responsible for the overall training program. The training program encompasses all internal and external training activities and it’s effectiveness should be examined periodically. Requirements/Explanation: All employees at all levels who carry out activities which affect quality must be included. and the qualification status must be clearly recognizable.04.
The training program must be open to all employees.2 Does the training program also include actions for further training in quality techniques? Requirements/Explanation: The following topics are relevant. 65 .04. process and product audit supplier evaluation problem solving techniques evaluation procedures. for example: risk analyses design of experiments test and measurement technology capability studies statistical process control quality control chart system system.
3 Are top management and other management staff included in the vocational training program? Requirements/Explanation: Training sessions must be held regularly to define and increase understanding of the elements of the quality system. for example: Quality objectives Quality management / TQM Quality development Quality related costs Quality information Tools and methods of quality assurance Product safety The company management and other managers. for example from: Marketing and Sales Design Purchasing and Logistics Production scheduling and tooling Production Quality Customer Services Personnel represent the circle of participants to be addressed.04. These elements in particular include. Sufficient management understanding of the potential of quality techniques forms the basis for their targeted application in a company. 66 .
Introduction and instruction programs have to be developed and defined. Training and instruction involves employees in the responsibility for equipment and production results. workers on temporary contracts. This inevitably leads to the strengthening of the relationship between employee and supervisor. When selecting suitable employees. and to use production equipment correctly.? Explanation of terms: "Introductions and instructions" are individual training measures which enable employees to understand technical and commercial documents and operational procedures. Requirements/Explanation: The supervisor (foreman. all affected employees in production must be trained regarding their quality management duties. business procedures etc. superintendent. Prior to the introduction of operators performing their own inspections. their personal characteristics and their specialist knowledge / capabilities must be considered. group leader) must instruct his employees on the appropriate use and operation of production tools and equipment and regarding the correct interpretation of internal instructions. workers on loan and personnel entrusted with new duties. Evidence of the instruction is shown by signature.4* Are there introduction and instruction programs for new and transferred employees and for the introduction of new or modified processes. These requirements should sensibly be applied to all organizational areas of the company. as well as the necessary techniques/methods required for their duties. Special attention should be paid to the selection and training of new personnel. 67 . The supervisor must satisfy himself as to the effectiveness of the instruction.04.
records for the following are to be provided: Qualification in accordance with DIN ISO 10011-2 and training in accordance with EOQ guidelines or equivalent training with certificate.g. The following. evaluation and reporting (e. can be classed as qualification records: materials inspector certificate welder certificate certificate for non-destructive materials testing (e. Knowledge and understanding of the standards which might form the basis for audits of quality systems (DIN EN ISO 9000 9004. Requirements/Explanation: Records of formal qualification are necessary when legal and/or contractual issues must be taken into account.g.5* Do employees possess the formal qualification for their activities? Explanation of terms: The "formal qualification" is the professional status given an employee when he has demonstrated that he is suitable to perform the defined activities. interview. VDA Volume 6. radiographic testing) Regular internal instruction (first and subsequent instruction) of employees is also required.1) Skills that are essential for the management of a quality audit. analytical ability. - - - 68 . communication and leadership Experience in quality management and quality techniques Personal characteristics. auditor training in accordance with VDA 6. organization. as well as a check as to whether the employees are suitable for their specific duties and that substitution of employees is controlled. open-mindedness Upholding of relevant qualifications with certificates. integrity. such as.04. Parts 1 to 6) Evidence about the methods of grading through investigation. for example. e. such as planning. For auditors who carry out external quality audits.g. good judgement.
Evidence must be provided for development and testing activities. competitions Training. 69 . „Quality awareness“ is shown by the attitude of individual employees to quality issues. on the qualification and readiness of employees to perform well.6 Quality Function Deployment (QFD) FMEA Design of Experiments (DOE) CAD/CAM Value analysis Simulation techniques Are there measures for the motivation and promotion of quality awareness? Explanation of terms: „Motivation“ means the readiness of employees to perform well. information meetings Awards Workshops. The quality and performance capabilities of a company are not only dependent on the technical and organizational capabilities and the business resources. but far more so. for example. Requirements/Explanation: The continuous improvement of quality awareness in all organizational units may be achieved. through: Improvement suggestions Quality circles Zero defect programs Poster campaigns. for example: 04.
2 „Quality objectives". The representations must be easily comprehensible and interpretable for the employees and must allow the comparison between the set objectives and achievements to be easily recognized. by quality indices. Periodic quality reports and general information with "specified/actual" comparisons.7* Do clear and understandable representations of the achieved quality compared to the set objectives exist in the company? Requirements/Explanation: This is related to the named objectives. for example: Representation of quality related costs Representation of rework (amount/costs) Presentation of audit results Comparison of development objectives and development status Representation of the satisfaction of internal and external customers are documents which give information about this. defined in Question 01. The current achieved quality levels is to be represented.04. 70 . This makes a comparison between set objectives and achievements possible. for example. graphical representations and other methods of communication at all levels.
2. Reference DIN EN ISO 9001 9004-1 05.2 * 05. or respectively. losses are reduced and customer satisfaction raised. - - The collection of quality costs can be performed parallel to.3 6.2 71 .2.05 Financial Considerations to Quality Systems DIN EN ISO 9004-1.3) by the persons responsible take place? Is there evidence about internal losses as a result of unacceptable quality (nonconformity)? Is there evidence of external losses as a results of unacceptable quality (nonconformity)? 6. It is therefore important that the effectiveness of the quality system is measured in economic terms. „non-quality“ has considerable effect on the profit and loss situation of a company and it’s organizational units.2 Does regular financial reporting and evaluation (4.4 * Is there a procedure for financial reporting of the effectiveness of the quality system? 6. the classical industrial cost accounting system. It must be clearly defined and enable long term comparisons/trends to be identified. by improving effectiveness and efficiency of work. or in connection with. Note: Characteristic figures and trends.1 6.3 * 05. Section 6 Financial considerations to quality systems are necessary because: quality.1. but not absolute values/ amounts must be demonstrated to the external auditor.1 05.
It must also introduce and monitor the effectiveness of improvement and preventive measures. it’s activities and the maturity of the quality system. The financial reporting methods used depend on the individual structure of each company and it’s organizational units.conformity costs .internal and external material losses (non-fulfillment of quality requirements). Only the existence of the procedure must be proven to an external auditor.g.1 Is there a procedure for financial reporting of the effectiveness of the quality system? Requirements/Explanation: There are various methods for collecting.Fault prevention . with instructions.4) must be defined (e. trend and analysis of costs related to nonconformances and their causes. for example: • Quality-related costs . distribution list. or their adaptation and/or combination. Reports to management must be prepared concerning the extent. cost center and cost plan and a summary of all financial outlays for the company management). analyzing and outlining on a causerelated and time-related basis the financial figures which illustrate the effectiveness of the quality system.Internal and external faults • or process-related costs (profit/cost ratio calculation) with . analyzing and displaying financial data about the quality elements. The appropriate procedure.05. Methods of financial reporting on activities in the quality system include. method and cost structure (see Questions 05. The company has the task of recording. Traditional methods do not exclude the use of others.Inspection and testing .2 to 05. Note: Detailed information is only the subject of internal audits. 72 .nonconformity costs • or quality-related losses (calculating the quality loss) with .
production.05. renewed production. Trends and potential areas for improvement must be identifiable. re-inspection and testing. poor ergonomics etc.3* Is there evidence about internal losses as a result of unacceptable quality (nonconformity)? Explanation of terms: „Internal losses“ are losses before delivery as a result of unacceptable quality. Characteristic parameters and measured values must be in line with target values. They also include nonconformity costs resulting from the non-fulfillment of quality requirements by a product prior to delivery (e. turnover or value-added figures. rework. such as sales. Requirements/Explanation: The reports must relate clearly to business parameters. in a time-.and product-related manner. 73 . in order to provide a realistic view the company. Improvements and objectives can be derived from this. repeated performance of a service. rejects). They may arise from reduced work efficiency caused by rework.2* Does regular financial reporting and evaluation by the persons responsible take place? Explanation of terms: Financial reports on quality-related activities should be compiled and evaluated regularly by the persons responsible. 05. for example: Rejects Rework Quantity deviation Value reduction Unplanned sorting action Re-inspection and testing Investigation of the problem Down-time caused by failures Development targets not achieved. Quality and cost targets and improvement measures must be defined for the subsequent period. Requirements/Explanation: These costs/expenditures include.g. Key cost items must be shown with their causes.
4* Is there evidence about external losses as a result of unacceptable quality (nonconformity)? Explanation of terms: „External losses“ are tangible and intangible losses which are identified as resulting from unacceptable quality.g.and product-related manner. rework and repair.05. for example. direct costs and compensation. costs of product recalls. Typical intangible losses include. production. warranty performances and return shipments. sorting. Tangible losses are nonconformity costs which result from the nonfulfillment of quality requirements by a product after delivery (e. Requirements/Explanation: These costs include. 74 . product liability costs). for example: Warranty (on delivery/"0 km" and after use by the customer) Goodwill cases Investigation of the problem Recall action Product liability also possible costs from Loss of image Loss of customers due to dissatisfaction. Key cost items must be shown with their causes. lost future sales as a result of customer dissatisfaction. in a time-.
e 06.3 19 products and special characteristics.2. must. particularly executive/ management personnel.06 Product Safety DIN EN ISO 9004-1 Section 19 The safety aspects of a product should be identified. The quality system must always be directed towards the reliable prevention of nonconformities. with the aim of enhancing product safety.g) special documented evidence of the quality is required? Have procedures for identifying product risks been defined? Do emergency plans and procedures for containing nonconforming products exist? (4. Note: VDA Volume 1 is also applicable for this element.4 75 .8) 19a. in accordance with their activities.2 Are the principles of product liability known throughout the company? - Is there a procedure to define and identify (4. be appropriately informed of the effects of product nonconformities and the consequences for the company arising from product liability. for which a. b 19d. The employees of a company.3 * 06. Reference DIN EN ISO 9001 9004-1 06.1 06.
in accordance with their activities. the company employees.1 Are the principles of product liability known throughout the company? Definition: Product liability (according to DIN EN ISO 8402/2. Requirements/Explanation: Indications concerning the knowledge of the principles of product liability can be.12): A generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury. amongst others. liability for direct damages and consequential damages caused by a defect It must be demonstrated that the manufacturing process (design.e. the burden of proof lies with the defendant) Liability independent of blame (new product liability law). Principles of product liability are (amongst others): Liability dependent on blame (characterized by the reversal of the burden of proof.simply complying with the applicable standards is not sufficient Responsibilities must be defined in writing Inspection and testing documentation with archiving Traceability must be ensured (limitation of damages) Warning of possible risks when the product is put into action by the user. must have appropriate knowledge of the principles of product liability. - - - 76 . i.06. manufacturing and testing) is "state of the art" . Therefore. evidence of: Instruction and qualification of responsible individuals Legal services (internal / external) Product liability insurance Observation of science and technology Product safety deficiencies can lead to liability claims against the company. particularly the management personnel. Note: The legal and financial implications of product liability may vary from one jurisdiction to another. property damage or other harm caused by a product.
for example: Recognition of product risks (see question 06.06 . Requirements/Explanation: The system should take into consideration. Volume 1). The documentation includes. All products with at least one such characteristic require documentation with special archiving. - All documents which relate to such a characteristic must be specially identified. medical examinations. knowledge. Their special treatment is based on general and specific safety standards related to the state of the art and customer requirements. for example: Test results.2 Is there a procedure to define and identify products and special characteristics. Departments involved must be informed about the need for special handling of these documents. competence and suitability of personnel (e. such. as eye tests) Special processes for products with characteristics subject to documentation. for which special documented evidence of the quality is required? Explanation of terms: Products and characteristics. 77 . which require the corresponding documentation to be specially archived. test decisions. have either special significance for functional safety (operation and use) or are directly subject to requirements derived from official specifications (see VDA. process parameters Records of the calibration of test equipment Records of the instruction.3) Definition of the characteristics concerned Identification of these characteristics on all relevant documents Identification and handling of these products Documentation system with rules for retention periods and responsibilities.g.
Proper documentation can contribute towards exoneration in warranty and product liability cases. The applicable procedures serve to identify and estimate the potential dangers. 06.3* Have procedures for identifying product risks been defined? Explanation of terms: "Product Risks" are safety risks that are involved in the product fulfilling it’s own function. This applies equally to product descriptions (e. if agreed. which arise from an incorrectly developed. Requirements/Explanation: Product risks are identifiable through. amongst others) Load-bearing tests Service life tests Crash tests Material testing Installation trials Environmental simulation tests Investigations of environmental compatibility and disposal and the derived measures resulting from these. The company obligates itself with the order confirmation to follow the appropriate procedure. manufactured and/or described product. manuals). 78 . If necessary.g.A retention period of 15 years (differences specified by the customer must be taken into account) is also valid after discontinuation of production (for further instructions. The safety aspects are of predominant importance during these examinations. they must lead to decisions regarding actions to be taken. see VDA Volume 1). for example: Risk analyses (FMEA. this also refers to the risks that a component brings to a complete assembly. Furthermore.
6). for example. Procedures to contain nonconforming products (see also Questions 11. 79 .4 Do emergency plans and procedures for containing nonconforming products exist? Explanation of terms: "Procedures to contain nonconforming items" serve damage limitation. They facilitate the traceability of products in a manufacturing operation back to the material and processes used. documentation Product identification during transport and storage Following the "first-in/first-out" principle Stating and observing use-by dates Recognized nonconformities which are relevant to safety can thereby be limited (damage limitation) in the field (during use) and possibly remedied by improvement or recall actions. can be: Identification on the part/product Lot/batch identification Product verification.7 and 13. Requirements/Explanation: Emergency plans for product recalls must be defined commensurate with the product risks.06. which are derived from the safety relevance of a product and possible risks in the entire process chain.
5 - - - 81 . Reference DIN EN ISO 9001 9004-1 Z1.2 - - Z1.? Are there methods to measure business results and are they used regularly in order to introduce improvements? - Z1. e. Company management. must therefore concern itself with the following subjects.4 * Z1. in addition to stronger international business relationships.1 Is there a strategic business plan in the company which contains aspects relating to costs.g. if necessary? Is there a procedure which enables customer satisfaction to be measured and changes to be detected? Is employee satisfaction in the company one of the principles of management and is it maintained on a continuous basis? - - Z1. but not absolute values/amounts. quality etc. sales.Z1 Corporate Strategy Improved and constant quality. plus more intensive confidence-building customer/supplier relationships on the other hand.3 Is company-wide performance data compared with results from benchmarking or similar methods and are improvement measures derived from this.: Business plan Business results Customer satisfaction Comparison of internal and external performance data Employee satisfaction Note: Characteristic figures and trends. today force many companies to adapt their strategy to these requirements. including immediately subordinate executive level. must be proven to the external auditor. delivery reliability in the agreed time frame and cost reductions on the one hand.
quality etc.Z1.Personnel planning .Growth projects .4) c) Overall corporate aspects .Important characteristic data of process performances .Comparison with other companies (benchmarking) d) Development aspects .Market data .Important quality related figures (see Question 01.Product analyses of competition results e) Process and quality aspects .Development and trial projects .1 Is there a strategic business plan in the company which contains aspects relating to costs.Customer satisfaction criteria (see Question Z1.? Definition of terms: A "business plan" is a document with company-specific strategic projects and targets which must be fulfilled or achieved in a defined period.2) 82 . personnel and material costs) .Cost targets b) Salevda-0s and marketing aspects . sales. Requirements / explanation: A business plan normally includes the following: a) Cost aspects .Turnover/sales targets .Finance and cost planning (investments.Plant structure plans .
for example: Market share Rejects achieved − Variability of products − Customer service level 83 . Starting points for non-financial variables can be. trend analyses but not absolute values/amounts and also not for all aspects. tendencies. Requirements/Explanation: Starting points for financial variables can be. Attention must be paid to company-specific matters. and adapted to any changes serve the purpose of process and quality improvement Business planning activities must be carried out on an interdisciplinary basis Note: External auditors are to be provided with evidence of : characteristic figures. time frame. for example: Profit Cash flow Turnover Value added shareholders − − − − Capital Liquidity Dividends Long-term value for (shareholder value) In practice.All aspects should: have time details be based on project-related knowledge take into account present and future customer expectations be understandable and monitored. these values are shown partly as absolute values and partly as ratios per capital unit or per employee. Z1.2 Are there methods to measure business results and are they used regularly in order to introduce improvements? Definition of terms: The "business result" expresses what the company achieves with respect to it’s planned performance.
Note: 84 . not the absolute values/ amounts themselves. analysis and use of company-wide performance data in comparison with the data of competitors or other companies through benchmarking must give information on. 2. if necessary? Requirements/Explanation: The evaluation. not the absolute values / amounts themselves. Note: Only the existing system must be evaluated. This question can be omitted for companies (particularly small companies) which do not operate on international markets. for example: Productivity Economy Quality situation Efficiency Trends in the data and information should be compared with the progress made towards the company's overall targets and converted into useable information for the purpose of: development of priorities for the rapid solving of customerrelated problems determining the important customer-related trends and interrelationships in order to make a review of the company's situation. Z1.Cycle times such as: Innovation time Time until the profit threshold is reached Stock turnover frequency The measured variables are orientated towards the company strategy and to the corporate aims and plans.3 Is company-wide performance data compared with results from benchmarking or similar methods and are improvement measures derived from this. 1. Only the existing system must be evaluated. They contain measured variables which enable the internal economy and effectiveness to be recognized and which are decisive for continued corporate success. decision-making policies and long-term planning possible.
amongst others: Flexibility regarding inquiries to new/changed products/ processes Achievement of targets Product quality at delivery Delivery reliability (see Question 19. not the absolute values/ amounts themselves. not only the direct customer but also the end consumer should be involved.Z1. Measures which lead to greater customer satisfaction should be derived from the knowledge gained. 85 .4* Is there a procedure which enables customer satisfaction to be measured and changes to be detected? Requirements/Explanation: The procedure must consider the following criteria.: Method application Recognition frequency Data evaluation and representation Interpretation of trends Responsibility Distribution list Measurable variables can be. e.6) Speed of reactions when quality problems occur Comparisons with competitors and benchmarking methods are helpful. As far as possible. Note: Only the existing system must be evaluated.g.
86 .g. not the absolute values/ amounts/results themselves. equipment Health and safety measures Communication on an individual and company-wide level Employee performance evaluation. work location. Requirements/Explanation: Points which effect employee satisfaction are. e. The needs and expectations of employees must be satisfied by a comprehensive quality approach.Z1.5 Is employee satisfaction in the company one of the principles of management and is it maintained on a continuous basis? Definition of terms: "Employee satisfaction" is measured by the way the employees perceive their company.: Working conditions. agreed goals. career planning Knowledge of work requirements Knowledge of quality policy and corporate strategy Involvement in quality matters System for recognizing and rewarding performance Management style Job security Further indicators for employee satisfaction can be. for example: Note: Results of employee surveys (questionnaire) Absenteeism and sickness quota Personnel turnover Ease in hiring recruits/trainees Use of company facilities Only the existing system must be evaluated. in order to advance the employees readiness to work well. environment.
feasibility. quotations.3. This applies equally to contract changes.3 DIN EN ISO 9004-1. Section 7 This quality element deals with the contract review.1 4. Section 4. the requirements contained therein are to be checked for completeness. contracts/orders checked for completeness and feasibility and approved? Are technical and commercial costs ascertained when preparing a quotation? 4.3. Marketing includes market research.1a-c 7.2a Is a procedure available that ensures the early 4.1 07. the market demand and the customer requirements.5 Has a function ‘marketing’ been incorporated into the process organization? Are inquiries.3.1d 7. marketing and sales. ability to fulfill etc. Quality in Marketing DIN EN ISO 9001.Part P: Product and Process 07 Contract Review.4 07.2 * 07.3 07.2c and clear notification of all product specifications to all areas involved? 87 .2 7. They determine the requirements for a product. Before a quotation is submitted or a contract or order is accepted. (Contract Review). The requirements of the customer should be documented in a performance specification and should be clearly communicated. The marketing function should take priority when defining the quality requirements of the product.3 product and the quality system available? 4. a marketing duty.1a 7.3. Reference DIN EN ISO 9001 9004-1 07.2 Are the customer's quality requirements on the 4.2.
for example: Projection of production numbers Providing information on prices and utilization deadlines Informing about specific customer requirements/expectations and evaluating feasibility Guaranteeing internal acceptance for the manufacture of a product with defined requirements Taking into account logistical concerns Providing for disposal. define and document the quality requirements and expectations for a product.1 Has a function ‘marketing’ been incorporated into the operational organization? Definition: The process organization determines the sequence of actions (control mechanism) for dealing with a very specific process. from the market analysis through product development to the payment of invoices. This can be part of the project management (see Question 02.4). Requirements/Explanations: The function ‘marketing’ and its tasks must be described. Marketing must determine.07. for example. To do this. Tasks are. a process organization has to be established in which all involved functional or organizational units are included and their tasks defined. 88 .
g.: requirements are complete. production preparation. among others.e. i. Requirements/Explanations: Prior to the submittal of a quotation or the acceptance of a contract/order the contract documents (specifications. drawings. appropriate and documented agreement exist for verbally placed orders prior to acceptance ambiguities and deviations are clarified early. development. production. When contradictions are detected and requirements are not able to be maintained the customer (normally the responsible developer. free from ambiguities. even prior to the submittal of a quotation. documented and can be realized by the supplier.) must be checked for completeness. contracts/orders checked for completeness and feasibility and approved? Definition: Contract Review (according to DIN EN ISO 8402/3. The contract review includes. 89 . Hereby it must be ensured that.2 * Are inquiries. e. logistical stipulations etc. The interfaces to the customer are to be defined. quality department and material management) confirm that they are able to fulfill customer requirements. quality agreements. for: • clarity of the individual requirements • inconsistency of individual requirements • missing of individual requirements • given deadlines. for example: a defined sequence of events in the quality manual/procedures (flow chart) Approval ruling prior to submittal of quotation to the customer (form with approval by the responsible organizational units) Review of contract documents. For this a system must be in place in which all responsible functions of the company and its organizational units (e.07. The same sequence of events also applies for contract changes. requirement specifications.g. quotations. sales. standards. purchaser) must immediately be informed.10): Systematic activities carried out by the supplier prior to signing the contract to ensure that the quality requirements are adequately defined.
defined and thereby the customer’s requirements completely taken into account. Products can be tangible or non-tangible. All relevant functional/organizational units are to be included in these sequences. 90 .4 Are the customer’s quality requirements on the product and the quality system available? Definition: Quality requirement (see Para.2. 4. 07. Requirements/Explanations: For a quotation. for example: Note: development costs material costs investments (including hardware/software) costs for quality measures transportation costs packaging costs value-added portions/calculated profit overheads (administration and marketing cost) The procedures in practice must be proven to the auditor.07.3) Requirements/Explanations: The quality requirements for a product must be documented.3 Are technical and commercial costs ascertained when preparing a quotation? Definition: In a quotation a customer (the market) is offered a product for purchase or it is provided to him as property or for use.2/#. all decisive cost elements must be established and taken into consideration. The costs are compiled by the responsible divisions and are incorporated into the overall calculation. The individual cost elements contain. rather than the absolute values.
5 Is a procedure available that ensures the early and clear notification of all product specifications to all areas involved? Definition: Requirements Specification (according to DIN 69905): The entirety of the customer requirements concerning the supplies and services of the supplier. all requirements from the user’s perspective. are to be described. 91 . Special requirements with regard to type. These should be quantifiable and able to be verified It is defined in the requirements specification what sort of task lies before and why it is to be solved. The definitions also include requirements based on. for example: Delivery call offs Delivery dates Prices Packaging/Identification Disposal. for example. scope and structure of the quality system are to be agreed separately.The quality requirements (of the customer) are described. 07. including all boundary conditions. in: Specifications Quality agreements Drawings Performance specifications Standards Purchasing conditions Order documents. According to VDI/VDE 3694: In the requirements specification.
Performance Specification (according to DIN 69905): All the realization requirements worked out by the supplier based on the implementation of the requirements specification. it must be ensured that the requirements are generally comprehensible. requirements specification etc. in the requirements specification and as realization requirements drawn up by the contractor. they also contain assembly instructions. Thereby. Apart from the performance characteristics. applicable standards. i. • the customer contacts for specific topics (development. for example in the performance specification. They are defined. explanation of customer-specific abbreviations). How and with what the requirements are to be realized is defined in the performance specification. The entirety of the customer requirements on a product is to be regarded as the product specifications. The user requirements are detailed in the performance specification and described in an expansion of the realization requirements under consideration of concrete solutions. quality assurance methods. for example.) are known to those responsible • product function and assembly status are known.). According to VDI/VDE 3694: The performance specification contains the requirements specification. • are explained and clarified (e. translations of foreign language customer standards. packaging etc. Requirements/Explanations: Evidence must be provided for a procedure which ensures the maintenance and distribution of all relevant documents to the responsible organizational units.g. quality assurance etc. purchasing. quality agreements. if necessary: • are translated (e.e.g. 92 .
10 4.: personnel.4.5 93 .4. This element is to be evaluated except when design responsibilities are contractually defined.5 8.4 8.7 8.5 8.2.8 4.8 8.3.3 4. e..4.4 8. VDA Volume 3.7 4.9 08. Note: 1.3 8. equipment.2 8.6.4. 8.6 08.6 08.4 DIN EN ISO 9004-1. Bezug DIN EN ISO 9001 9004-1 08.5 4.4.2a und b 8. Section 4.1 * 08.4.2.8. lease of the product design and its realization? . Section 8 The quality element design control also called the quality at interpretation and design describes the quality-ensuring tasks in the area of product design and development.4 * 4. The provision of resources for.3. It is not applicable when a completed product design is adopted.4.4.08 Design Control.5 08.3 8.2.4. trials is a precondition for product development.2 Does an appropriate product development plan for a new product exist? Is it ensured that all product requirements can be realized? Are product trials planned during the development and pre-series phase? Are procedures and methods available to carry out a quality evaluation of designs. 2. These should take care of the transferal of the customer needs from the requirements specification into a performance specification and technical specifications for products and prepare for a timely realization in conformance with customer requirements.4..6.7 Are all responsible functions involved in the re. 8. design models and pre-series products in accordance with the particular project phase? 4.4.g. 8.4. Volume 4 Part 1.4. 8.2 8. . 2 and 3 are also applicable to this element.1. (Product Design and Development) DIN EN ISO 9001. .1.5 Is the result of the product design and development documented in specifications? Are the experiences of product design and development experiences of products documented and are they available to other areas? 4.3 08.
Monitoring must cover the compliance with all given targets such as. Evidence must be furnished on the basis of examples whereby depending on the company and product not every steps stated below must occur.08.: deadlines product qualifications costs. 94 .1* Does an appropriate product development plan for a new product exist? Requirements/Explanations: For the product development plan current milestone plans. e.5 Up-dating product development plan. A person responsible for the project and all involved areas with their tasks must be name (see Question 02.g. To limit costs it is appropriate to design inspection and testing tools and equipment (including software) so that most of it can be reused for series production. with detailed plans must be produced which show all activities from placement (design and development) through to start of series. The systematic processing of the planned tasks (project planning) must be guaranteed.4). Central monitoring of the project’s progress must be guaranteed (specified/actual comparison). The plan for the development of a new product is normally characterized by the following steps: Checking design requirements with regard to appropriateness Documenting design result Checking the design results with other competent organizational units Verifying design (checking) as to whether the requirements of the design tasks are fulfilled Validating the design (approving/enforcing) to determine whether the customer’s requirements are met Identifying.4 and 08. checking and approving design changes and modification according to Question 08. documenting. network plans etc.
disposal). Thereby it has to be ensured that a problem-free data exchange with the customer is guaranteed. comprehensible measures are to be taken to fulfill the requirements.. inspection and test equipment. with the company. Unclear.3) external or internal standards/specifications or instructions legal requirements (safety. Points to be considered are.2 to 07. If the development responsibility for a particular product lies. in: laws.: producibility. then it should use computer-supported design and engineering (CAD.2 Is it ensured that all product requirements can be realized? Definition: "Quality Requirements" (see also definition in Para. testability. precision inspection and test set-up. described in the requirements specification (compare Questions 07.2). as agreed. e. e.g. for FMEA.g. specifications special standards or requirements specifications (these may contain special inspection and test instructions also for hardware and software). for example. e.5. 95 .g.5) must be checked for feasibility within the scope of a design review (compare DIN EN ISO 9004. guidelines. CAM.08.4 and 07. contradictory requirements must be clarified with the person responsible.2. Requirements/Explanations: The quality requirements as. ordinances.4). Suppliers tasks are also to be included in the review. Overall responsibility remains with the company. In cases where fulfillment is not possible. etc. 4. general standards. computer support release criteria experience from production and use (compare Question 21. The design requirements must consider the bases and results of the contract review (compare Questions 07. QFD and quality plans.2/ #. Part 1/8. CAQ). environmental compatibility.3) are described.
The competence of external bodies must be proven. They may be documented in.g. customers). accredited bodies are to be used.g. The results of the product trials must be compared to the requirements.3 Are product trials planned during the development and preseries phase? Requirements/Explanations: Product trials must be considered in the project plan.: product life cycles test reports trial plans 96 . Product trials are. if required.: assembly trials functional testing durability testing environmental simulation testing. independent inspection agencies.g.08. The trial conditions for the product are to be determined and agreed with the customer. When the requirements are not met the corrective actions must be comprehensible. e. The product trials may also be performed by an external body (e. e.
safety. according to Taguchi. e. Shainin). A quality evaluation may be performed using various methods. e) practical preliminary planning for the quality of the series and purchasing f) consideration of test results and field experiences. Failure Mode and Effects Analysis. 2 and 3).g. Part 1. reliability. as well as introduction of corrective actions (compare Question 06. maintainability under the anticipated storage and usage conditions.4 * Are procedures and methods available to carry out a quality evaluation of designs. Fault Tree Analysis) Functional tests and release Reliability testing/durability testing QFD. c) timely identification of problem areas and shortcomings. design models and pre-series products in accordance with the particular project phase? Requirements/Explanations: The quality evaluations should include: a) assessment of function. Part 1 and 2) Design of Experiments (statistical test methodology. d) the result of the product design must be tailored to the possible processes (operating means.g. In the appropriate project phases (development progress) for products and processes these are.: "Design" Phase Risk analyses (e. "Development sample/Prototype" phase: Risk analysis (e.08.g. 97 .03 and VDA Volume 4. Failure Mode and Effects Analysis. b) qualification tests to confirm that all individual requirements on the quality characteristics of the design are fulfilled and that all approved design modifications are implemented and recorded. e. equipment) (process capability).g. Fault Tree Analysis) (compare VDA Volume 4.
among others. delivery location of development samples (prototypes) and first samples Form and contents of the inspection reports in agreement with the customer Release of samples Qualification and monitoring of product and cost trends.5 (Process).5 Are all responsible functions involved in the release of the product design and its realization? Requirements/Explanations: A procedure for the release to realization including responsibilities is to be established. Release is based on the evaluation of the feasibility of the design by. also at suppliers involved. Procedure for release of series production see Question 14. quality assurance."Production prior to series start“ phase (see also Quality Element 09): Note: Process analyses Process optimization Process review Compliance with specification limits. (List of approved suppliers compare Question 11.2 (Product) and Question 09. 08. 98 . among others. must be defined for realization: Number. state. together with the customer (Project launch meeting). development. packaging. delivery date. It represents the approval that the design may be realized. The following. purchasing. production. sales.2).
08.14): A document stating requirements. These documents for the realization of the quality requirements must be complete and unambiguous. Furthermore. 99 . "as per manufacturer's choice". Requirements/Explanations: The results of design and development must be appropriately documented in the specifications (see Quality Element 10). For products that are not clearly specified in the customer's drawings ("as delivered". Company specifications must cover the requirements specified by the customer. “without information on inspection and test instructions“ etc.).6 Is the result of the product design and development documented in specifications? Definition: Specification (according to DIN EN ISO 8402/3. the corresponding information in the company’s detailed drawings and the finished part drawings must be completed. the narrowing of tolerances on the customer's drawings might be necessary.
e.. documented in writing or stored on a computer system. e. for example.g. 100 . - It is an objective to have the development experiences in the company readily available independent of persons thereby avoiding repeated nonconformities in design.7 Are the experiences of product design and development experiences of products documented and are they available to other areas? Requirements/Explanations: The experiences/results gained during development and trials which are. applicable to other development plans must be evaluated. in: design manuals data bases for design FMEA product life cycles with. adaptation through modified/improved production procedures documentation of test results corresponding reports on materials and procedures.. product optimization/ improvements.g. This may be done.08. This information is to be made available to all relevant areas.
1.4. .4.g. technology.2a /b) (8.5) 101 . .7) (8.4 8.4. 8. Sections 4.7 (8.5) (4.1 * 09. Note: VDA Volume 4..3 8.8. it also includes the production organization.2.3 8.4.4. the special structure as well as measures for safeguarding production.9a) (4.1) 09.5) (4.2 Does an appropriate process development plan for new/modified products exist? Are production.5) (4.3 4. .1 4.4. equipment.6. 8. Section 8 The planning and development of processes and procedures for manufacturing products are an essential part of all activities prior to the start of new/modified processes. They incorporate the planning of all necessary resources such as.4. method. Process planning is performed at the earliest possible time parallel to product development (design control).2.5 09. Within the scope of production preparation.3. the planning of material and production flow.8) (8.2.2) (8.9 DIN EN ISO 9004-1.6 09. assembly and maintenance processes and the material flow planned according to quality aspects and are process control requirements defined? Is it ensured that all product requirements are met by the process? Are procedures and methods available to carry out a quality evaluation of processes and procedures in accordance with the respective project phases? Are all responsible functions involved in the release of processes and procedures? Is the result of process planning/development documented in process specifications/ procedures? Are the experiences from process planning and development documented and are they available to all relevant areas? (4.6) (8. (Activities prior to the initial start of series production are discussed in the Quality Element 14 "Process Control").1. plants. 2 and 3 also applies to this element. e. or is performed additionally after completion of product development timely prior to serial production in order to realize production processes and process sequences. .2 8.4 * 09.6.2c) (4. Reference DIN EN ISO 9001 9004-1 09.09 Process Planning (Process Development) DIN EN ISO 9001.3. personnel and transports.1. 4. . Part 1.4.4. 8.4.3 09.10) (10.9) (4.9 Abs. including tool management.
To limit costs it is appropriate to design testing tools and equipment (including software) so that most of it can be reused for series production. The systematic processing of the planned tasks (project planning) must be guaranteed. 102 . components) from suppliers Operating equipment construction External developments Purchasing and the procurement of production and manufacturing equipment Updating the process development plan. materials.09.: Deadlines Process Qualifications Costs. whereby depending on the company and product. network plans etc.1 * Does an appropriate process development plan for new/ modified products exist? Requirements/Explanations: For the process development plan. The following (amongst others) applies to the development of processes for manufacturing the new product: Production planning Equipment/tool design and construction Procurement (of products. A project manager and all involved areas with their tasks must be named. not every steps outlined below must occur. The personnel and finance resources are also to be considered in the development plan. suitable technical resources are to be used. Central monitoring of the project’s progress must be ensured (specified/ actual comparison). e. Monitoring must cover compliance with all stated targets such as.g. with detailed plans must be produced which show all activities from placement (development) to series start. Evidence must be furnished on the basis of examples. For this. current milestone plans.
as well as the material flow which have a direct influence on the quality of the products to be manufactured. 103 . for example. These documents must be available at site. tooling plans) monitoring the compliance with given requirements approval procedures to be introduced standards and guidelines to be observed. process parameters machines. inspection. equipment. assembly and maintenance processes and the material flow planned according to quality aspects and are process control requirements defined? Definition: Process control Process control is a quality control where the observed unit (tangible or nontangible object of an observation) is a process. facilities.2 Are production.09. It must be ensured that controlled conditions are available. When an operator inspection is carried out references must be available in the work instruction to a defined inspection and test responsibility. Requirements/Explanations: Processes such as production. continuously updated and provided with a revision status. measuring and test equipment (including identification) recording of process nonconformities and corrective measures working conditions (work plans. The documents (procedures/quality plan) to be produced by the supplier must include not only individual work steps but also inspection and test steps or references to inspection and test instructions. the definition of: process sequences. assembly and maintenance. The relation to the revision status must be comprehenisble. The conditions to be controlled include. are to be defined.
especially where special visual requirements and damage risks exists. They make the decision-making easier when carrying out activities in production. through: examination.: material control release of equipment for production.g. General standards. guidelines. e. Note: Packaging and storage.To achieve and maintain controlled processes.3) are described in: Laws. 104 . see Quality Element 19. comparison and limit patterns photographs quality guidelines packing instructions. it is also necessary to carry out a systematic planning for.3 Is it ensured that all product requirements are met by the process? Definition: "Quality Requirements" (see also definitions in Para. for example.2. 4. assembly and maintenance approval of procedures and work instructions quality plans computer software documentation requirements as well as to describe and verify the requirements placed on the execution of work. 09.2/#. etc. ordinances. specifications Special standards or requirements specifications (these may contain special inspection and test instructions).
105 . for example. the requirements specification must be checked for their ability to be complied with within the scope of a process review (compare DIN EN ISO 9004. The process requirements must take into account the bases and results of the contract review (compare Questions 07.: customer-specific requirements (including performance-related and visual items) producibility. for FMEA. e. test capability. inspection and test equipment. comprehensive measures are to be taken. In cases of noncompliance. e. Overall responsibility remains with the company. Tasks for suppliers are also to be included in the review. The compliance with legal requirements must be guaranteed in the process.5. The inspections are based on the relevant national requirements.4) as described in.3) external or internal standards/specifications or instructions legal requirements (safety. The company should use computer-supported design and engineering (CAD. Points to be considered are. A quality plan must be drawn up. Part 1/8. environmental compatibility. disposal).g.g.Requirements/Explanations: The quality requirements (compare Question 07. QFD. precision inspection and test arrangements. computer support release criteria experience from production and use (compare Question 21.. quality plans to guarantee problem-free data exchange with the customer.4).2). CAQ).2 to 07. CAM.
results from FMEA.g. fatigue test. • identify potential weak spots early through the appropriately timed application corresponding to each project phase and initiate the introduce of corrective actions • guarantee and clarify the implementation of corrective actions (e. Part 1 and 2) .g.09.g. e. the process shall : • ensure that the best possible and most comprehensive picture of the desired quality of the new product is produced by involving and systematically questionning all affected functional areas. A quality evaluation may be performed using various methods. Failure Mode and Effects Analysis. Shainin) 106 . for example: • “Design“ Phase: . In detail. Fault Tree Analysis) (compare VDA Volume 4. field trial and assembly test) • document all important results of the quality assurance activities during the development of a new process/procedure • include the practical preliminary planning for the quality of the series and purchasing.4 * Are procedures and methods available to carry out a quality evaluation of processes and procedures in accordance with the respective project phases? Requirements/Explanations: The method of quality evaluation for processes is applied to ensure that all quality-relevant findings from the various phases of product development can be realized.Risk analyses (e. according to Taguchi.Design of Experiments (statistical test methodology. In the relevant project phases (development progress) these are.
It represents the approval that the design may be realized. delivery location of development samples (prototypes) and first samples the form and contents of the inspection reports.process optimization .5 Are all responsible functions involved in the release of processes and procedures? Requirements/Explanations: A procedure with responsibilities (of the individual organizational units) is to be established for the release to realization. state. The release is based on the evaluation of the producibility of the design and. production.compliance with specification limits Note: Procedure for release of series production.: number. e. together with the customer.g.• “Production prior to series start“ Phase: . through development. e. quality assurance. cause/effects diagram . delivery date. fault tree analysis.2.Process analyses • Causes of dispersions • Appropriate inspection and test methods. see Question 14. sales. test methodology.process review . packaging.2. beside others. To be considered are. Note: Procedure for release of serial production see Question 14. 107 . in agreement with the customer release of samples production and provision of production and inspection and test equipment qualification and monitoring of process and cost trends at suppliers involved. purchasing. 09.g.
14): A document stating requirements. This includes. among others: description of process process parameters important product and process characteristics inspection and test plans and work plans/instructions These documents for the realization of the quality requirements must be complete and unambiguous. 108 . Requirements/Explanations: The results of the design work must be appropriately documented in specifications or process descriptions/procedures (see Quality Element 10).6 Is the result of process planning/development documented in process specifications/ procedures? Definition: Specification (according to DIN EN ISO 8402/3.09.
plants and processes plant life cycles with. put down in writing or stored in a computer system. applicable to other requirements or production processes are to be evaluated.g. It is an objective to have the development experiences in the company readily available independent of persons thereby avoiding repeated nonconformities in design. e.7 Are the experiences from process planning and development documented and are they available to all relevant areas? Requirements/Explanations: The experiences/results gained during the development and trial of new processes which are. adaptation through modified/improved production procedures. process data. process optimization/ improvements. in: processes. especially inspection and test and production planning.09. 109 . This information is to be made available to all relevant areas. for example. feasibility studies data bases for process FMEA documentation of test results and process problems capability studies of machines.. This can be done. for example.
5 17. storage and maintenance must be taken into account.5 DIN EN ISO 9004-1.3 10.5. where. magnetic tapes or visual data carriers.3 17. maintenance.1 4. as well as • the products to be manufactures. order.2 188.8.131.52 4. Section 17 Quality management requires documents and data which describe • the structure and processes of the quality elements. The legibility is to be ensure within the scope of the archiving period. distribution. review and approval of the documents defined? Is there a distribution and maintenance system with revision service available for the documents? Is it defined.5. Thereby.3 17. the identification.3 17. Section 4. Documents and data may be available on media such as paper. Reference DIN EN ISO 9001 9004-1 10.1 * 10. Note: VDA Volume 1 also applies to this element.1 10.4 10.2 Are the responsibilities and procedures for the identification.5.5.10 Document and Data Control DIN EN ISO 9001.3 4. distribution.1 17.4 4. how and for how long the documents are to be archived? Is the timely introduction and control of external documents ensured? Is it ensured that invalid documents are not used? 4.5.2 4.1 111 .
procedures and responsibilities are to be defined: Affected are. regulations. "Review" includes. for example: documents for contract review specifications drawings formulations standards. processes or products. control plans. beside others.1* Are the responsibilities and procedures for the identification. Requirements/Explanations: The processes are to be comprehensively laid out from the customer to the company integrating all relevant internal departments. "Release" is the approval given by the responsible departments.10. the comparison and translation between internal and customer specifications. Documents must be available with the valid revision status to all involved organizational units. maintenance. "Maintenance" encompasses the revision service and archiving whereby the ability to retrieve records must be guaranteed. internal standards inspection and test instructions inspection and test plans. For the following documents. review and approval of the documents defined? Definition: “Identification" serves the clear relation to events. 112 . Special identification instructions from customers are to be followed A clear presentation of all types of documents is useful. inspection and test instructions work instructions work procedures. measuring programs quality plans quality procedures quality manual procedures for quality verification reference samples trial procedures. as well as the formal and contextual review of documents.
Note: Listing of quality relevant documents. e. destruction of invalid documents. The responsibilities for this must be defined. The system must exclude misuse. Summary sheets are to be established for a complete presentation of all changes. availability completeness (reference documents) safeguarding the latest revision status (current revision status) approval of changes method of identifying changes in the document invalidation. i. The introduction and realization of changes must be documented. for: distribution.g.1 113 . Aprocedure must be available which monitors the validity of the documents at regular intervals.10.. The regulations relating to the approval and distribution system must describe a process which ensures that the correct documents are available at the correct time. This includes: withdrawal. invalidation.2 Is there a distribution and maintenance system with revision service available for the documents? Requirements/Explanations: Processes and responsibilities must be defined. in the product life cycle). in the correct place and that a confusion with invalid documents is excluded.g. signature and countersignature or similar). see Question 10. must be provable and traceable (e.e.
in order to be able to prove also at a later stage that the quality system. additional back-up files (e.: protection against fire. The retention of documents .). see Question 10. e.g. double archiving. customers and product liability aspects (see VDA Volume 1). Note: Listing of quality-relevant documents.1 114 .g.10.including outdated ones . storage media (files.has to be controlled. general guidelines. how and for how long the documents are to be archived? Requirements/Explanations: This requires stipulations on e. water etc. requirements of laws. amongst other things. Thereby.g. process and the product fulfilled the quality requirements in a particular time period.3 Is it defined. back-up copy etc.: retention period filing system filing location. microfilm. DP storage) if necessary. The retention time (archiving) must also be in line with. the following must be considered. where.
standards.g. Immediately after new documents are received. the invalid documents must be recalled and destroyed by the person responsible. documented procedures and their revisions are reviewed. Evidence of this must be provided for particularly important and identified documents.5 Is it ensured that invalid documents are not used? Requirements/Explanations: The exchange of documents at site must be regulated so that invalid documents can no longer be used.. e. Records of this must be kept in the same way as for internal documents. specifications. Summary of the external documents at a central location is possible.10.4 Is the timely introduction and control of external documents ensured? Requirements/Explanations: The company must set up a procedure which ensures that all external documents such as. 10. 115 . distributed or introduced at the appropriate time.
6 Part 3 and 6 Part 4 are also applicable.3 11.6.8 9.4 11. subassemblies.6 Section 9 The quality element describes the quality assurance measures which must be implemented by the company when purchasing products from his suppliers. VDA Volume 2. parts and services) form part of the customer’s end product and thereby directly influence the quality of this product.8 9.2c 184.108.40.206 Are the quality requirements on the products and services clearly and completely specified in the order documents for suppliers? Are the evaluation and selection of suppliers defined? Are sample tests for purchased products defined? Does the company provide procedures for the regular evaluation of its suppliers? Do agreements with the suppliers regarding the method and responsibilities for quality inspections exist? Is the quality of delivered products and services ensured? Is the traceability of delivered products to the suppliers ensured? 4.4.6. Reference DIN EN ISO 9001 9004-1 220.127.116.11 9.2a 4. Section 4. components.1 4.2b 4.1 4.3b 9.2b (4. Note: 1.2 11. 18.104.22.168.5 11.6.6. These products purchased by suppliers (materials.2 4. DIN EN ISO 9004-1. This element may also be applied to internal customer/supplier relationships.5 9.11 Purchasing DIN EN ISO 9001.1 4.6 * 11.1 4.7 * 22.214.171.124.4) 4.8 117 .2 * 11.3 9.6. 9.3 4.4 4.1 4. 6 Part 1.2a 4.
but must at least contain all these requirements on which the supplier has an influence or which affect him. Hereby. production. standards. Only an order or order confirmation which is completed with all details contributes to the complete fulfillment of the purchasing and quality requirements. When purchasing tools and capital goods the following must be considered and defined. The company must agree these specifications with the supplier. Specifications passed on to suppliers may exceed the quality requirements of the companies’ customers. work and inspection and test instructions.11. these must be checked for clarity and completeness. if this is contractually agreed. - 118 . requirements of test certificates.). quality assurance supervision during the design phase with progress reports computer-supported design and data processing.1 Are the quality requirements on the products and services clearly and completely specified in the order documents for suppliers? Requirements/Explanations: Specifications which are clearly defined and easily understood by the suppliers must be an integral part of orders (drawings. for example: development. etc. quality agreements. beside others: interdisciplinary cooperation on placement and acceptance through. packaging and dispatch instructions. This also includes visits of the companies’ customers at his suppliers. a defined and continually updated revision status is important. Processes and responsibilities must be defined. Prior to release of the order documents.
the documentation of which requires special archiving.2* Are the evaluation and selection of suppliers defined? Requirements/Explanations: Suppliers must be evaluated by the company prior to their acceptance. The suitability of a supplier may be demonstrated by means of: a) Assessment of his quality system through systems and process audits of the company system audit results of other customers of the supplier certifications through accredited certification bodies.3) quality assessments of capital goods (compare Question 14.: re-location of production at the supplier new products/ product group repeated occurrence of quality deficiencies. Therefore the requirements and assessment criteria.) b) Assessment of the product quality of all obtained product through product audits first sample testing (compare Question 11. (Such system audits also serve as a support for the supplier in setting up his quality system. e. as well as the selection mode must be defined. They also serve the purpose of system consultancy.11. 119 . An evaluation should be repeated in case of.2) A list of approved suppliers is to be maintained and to be taken into account by the involved parties.g. Special care is to be paid to the selection of suppliers for products with special characteristics.
The first 120 .11. It must contain statements on: geometry material (special attention to hazardous material) function reliability. Requirements/Explanations: For all products of a supplier a production process and product approval (PPA) must be carried out (internal or external) for new or modified products/processes prior to serial use. For important characteristics. proof of capability is to be produced. The results of the first sample inspection are to be documented in writing in the first sample report with specified and actual values (VDA form).3 Are sample tests for purchased products defined? Definition: Sample (according to DGQ 11-04/95): Material unit which is subjected to a quality inspection for a particular reason or which is required within the scope of a quality inspection. The scope and documentation of the first sample inspection is to be coordinated between the company and the supplier based on existing experience. First sample (according to VDA Volume 2): First samples are products and materials which have been completely manufactured with standard equipment under series conditions. First sampling provides evidence that the supplier is able to fulfil the required specifications with the applied procedures and equipment.
2) and forms part of the overall assessment. 121 . For the release procedure of series products see VDA Volume 2. A release of the first samples by the inspector does not relieve the supplier of the responsibility for the series of these products. A quality history of the products delivered is to be provided. there are various types of samples. The above requirements apply in corresponding form to all sample types. for example. The assessment of the supplier’s quality system is performed by audits (compare Question 11. 2. Note: Depending on the application purpose. 11. for example. "First delivery". through: Note: results of material receiving inspection (compare Question 15.samples give the company important evidence on the quality of the series to be expected.3) reject results delivery fulfillment (deadline/quantity) complaints warrant. "First lot". 1. The suppliers should be informed about their evaluation on a regular basis. In many branches other designations are used instead of "first sample" such as.4 Does the company provide procedures for the regular evaluation of its suppliers? Definition: A "regular evaluation" includes the periodic evaluation of the quality of the delivered products and services and the assessment of the supplier's quality system. Requirements/Explanations: The performance of a supplier should be reviewed with a frequency that is suited to the complexity and technical requirements on the product and the previous performance of the supplier and must be recorded in a list.
regarding e. then control tests are to be performed periodically.11.5 Do agreements with the suppliers regarding the method and responsibilities for quality inspections exist? Requirements/Explanations: Where necessary. the company has to set up clear agreements with its suppliers.g. When the supplier provides quality records (e. 11.1b). If it has been agreed with the supplier that product inspections are only carried out at his premises. 122 . random sample or 100% inspection (compare Question 22. The visits shall be carried out depending on the quality capability of the supplier and on the importance of the product. The company must demonstrate this by means of visit reports. test certificates according to DIN EN 10204/3. when they are provided by the supplier. The certificate must be based on tests carried out on goods ready for delivery. An agreement on the methods of quality inspections serves the comparability of test results and is prerequisite for their acceptance. then the company has to satisfy itself as to the proper execution at the supplier.: inspection and test procedures inspection and test equipment the scope of inspection and testing.3).6 * Is the quality of delivered products and services ensured? Requirements/Explanations: Appropriate measures must be taken to ensure that the received deliveries are sufficiently monitored.g. The characteristics to be shown on the quality records are to be agreed. A material receiving inspection must be performed according to the inspection and test plan and may be carried out as an identification.
via delivery number. 2.16) Ability to trace the development. 123 . Requirements/Explanations: Corresponding to a risk assessment. This applies particularly to products and related characteristics where a special archiving of the corresponding documents is to be provided (compare VDA Volume 1). Traceability may be realized.A clear identification of the identity of the delivery lots and a differentiation of released and non-released lots is to be carried out. a procedure (special concession) must be implemented (traceability). a system for traceability must be established. The material receiving system must bar goods that have not been released. application or location of a unit by means of recorded identifications. 11.g. e.7 * Is the traceability of delivered products to the suppliers ensured? Definition: Traceability (according to DIN ISO 8402/3. In the event of use of the delivered product prior to the completion of inspection. Acceptance conditions for services (non-tangible products) must also be defined. Ensuring traceability serves the localization of nonconforming products and the limitation of damages in case of nonconformities. Note: 1. The first sample status must be known at material receiving. batch number or order number. A consequent management of suppliers contributes to the minimization of complaints or to ensure a consistent quality level of the final product and may eventually lead to the reduction of the material receiving inspection..
The contractual aspects are to be considered in the Quality Element 07 Contract Review.2 * 12. storage and receipt of customersupplied products? Is a procedure defined for reporting nonconformities or losses of customer-supplied products to the customer? Does a documentation on the quality of customer-supplied products exist? 4. Reference DIN EN ISO 9001 9004-1 12.1 Do agreements with the customer on quality measures for customer-supplied products exist? Is a definition available for the control. The customer has full quality responsibility for the products provided.4 4.7 12.7 125 . as defined above. Note: This element does not apply when no customer-supplied products. beside others.7 "Customer-supplied products" are products which are the property of the customer and are provided to the company in fulfillment of the contract requirements. Section 4.12 Control of Customer-Supplied Product DIN EN ISO 9001. are present.3 4.7 12. tools and packaging. Products sold by the customer to the company are not the subject of this quality element as the normal customer/supplier relationship applies. This also includes. verification.7 4.
storage and receipt of customer-supplied products? Requirements/Explanations: In the event that no special agreements with the customer have been made.2 * Is a definition available for the control.1 Do agreements with the customer on quality measures for customer-supplied products exist? Definition: "Customer-supplied products" are those provided to the customer. according to delivery papers Establishing the external condition and integrity (transport damage) Correct identification Appropriate storage and maintenance of value (special attention on products with limited storage life). 12. Requirements/Explanations: At contract finalization the required quality assurance activities on the customer-supplied products to be carried out by the company should be agreed with the customer. for example: test certificates (documentation) inspections and tests (type and scope of material receiving inspection.2). 126 . identification check) identification traceability warranty.12. generally at no cost. verification. Where no agreements exist.added activities (compare Question 12. These agreements control. a documented procedure must define responsibilities for at least the following measures: Establishing the identity and quantity. for further processing. the company can only take quality responsibility for his value.
3 Is a procedure defined for reporting nonconformities or losses of customer-supplied products to the customer? Requirements/Explanations: When nonconforming products are delivered or when products are lost the customer must be informed of the following.4 Does a documentation on the quality of customer-supplied products exist? Definition: The documentation describes the quality history of customer-supplied products. 127 . Deviations from defined quality characteristics are. The recordings showing the type of deviation may be carried out. It provides a summary of the quality situation during a particular period. Process and responsibility are to be controlled. Requirements/Explanations: The delivery quality of customer-supplied products can have a significant influence on further processing. for example.12. in: nonconformity tally cards quality control charts Statistics. for example. 12. to be: documented upon receipt recorded within the area of the production process recorded in the case of a product ready for dispatch assigned to the delivery lot stored for a defined period. for example: Delivery condition/damage Incorrect delivery Quantity deviation/lost goods malfunction Deterioration of quality during processing Rework.
1 13.2 (Abs.2) 4. 4.13 Product Identification and Traceability (Process Control.7 from DIN EN ISO 9004-1 are additionally discussed here.8.4 13. (4. Section 4.1 129 .9 11. Reference DIN EN ISO 9001 9004-1 13.8 11.2 Is the identification of products for internal pro. identification of materials and products. Inspection and Test Status) DIN EN ISO 9001. measuring and test equipment appropriately stored and protected during interruptions in use? Is it guaranteed that only products which fulfill the quality requirements reach the next process/process phase and dispatch? Is the known product data traceable from dispatch to material receiving? Is there a procedure available for the rerelease to serial production? 11.4 (Abs.5 4.5 * 13.9.12) DIN EN ISO 9004-1 Section 11 This quality element covers all activities which are necessary to ensure the required production quality in series production.11.9e 11. 4.8 cesses defined? 4.7 4. It includes the monitoring of processes. traceability. Note: To complete this element.3 4.6 13.16 4.4 13. 4) 11.3 13.2 and 11.4.12 11.12 Is the fulfillment of the quality requirements on 4.2 11.2 h 11. Sections 11.7 * 4. inspection and test status and documentation of results and measures.11.9d the product ensured through process control measures? Are process parameters recorded and deviations including corrective actions reported? Are production as well as inspection.
Requirements/Explanations: The system shall ensure that products are unambiguously identified in every stage of the material flow.13. e. see Question 13. part number or comparable and of the revision status. Products missing identification may lead to mix-ups and incorrect deliveries and are to be regarded as barred until their identity is cleared. The identification of products must be effective in all production areas from entry until its departure. For products with a limited storage life. numberings bar codes stampings labels inspection and test reports. Identification for traceability. inspection and testing and modification status in order to avoid mix-ups.g. The relation to the lot or batch must be traceable.6 130 . also with regard to their operational state. Note: 1. This may be achieved by means of. The identification system used by the company must allow the clear relation to the customer’s drawing with revision index at the interface to the customer (dispatch). 2.1 Is the identification of products for internal processes defined? Definition: "Identification of products" means the clear and traceable identification through subject number. the storage limitation must also be identified.: accompanying product documents tags markings. The corresponding work instructions must be available at site.
Requirements/Explanations: Inspections and tests accompanying the process must be carried out so that timely detection of deviations is guaranteed. Processes. This allows the timely introduction of corrective actions and prevents further processing of defective materials.2 Is the fulfillment of the quality requirements on the product ensured through process control measures? Definition: “Process control measures“ include. It is carried out according to the stipulations of the inspection and test instruction. all inspections and tests accompanying the process in the complete production sequence used for controlling. 131 . the traceability of the inspection and test results to the inspector is sensible. In the case of an automated 100 % inspection. Independent of the selected storage medium. notes concerning measures and responsibilities must be defined. The inspection during production is a comparison between the requirement (specification) and the actual result of each work sequence on the product. The documentation must also contain the results from manual and/or automatic 100 % inspections. The results of all planned inspections and tests are to be documented so that trends can be identified and targeted corrective actions can be introduced. a recording of inspected and rejected products must be carried out. among others.13.
Requirements/Explanations: Typical process parameters are. for example: Pressure Temperature Time Torque Distance Electric current Voltage Frequency Humidity Velocity. Monitoring of the process parameters may be performed either automatically or manually. Process parameters must always be specified with tolerances. The monitoring or control elements are to be treated as inspection and test equipment and must be monitored regularly.13.3 Are process parameters recorded and deviations including corrective actions reported? Definition: "Process parameters" are process-influencing quantities that serve to control and regulate the process. For manual inspections and tests the results are to be documented. Note: The control elements for process-influencing should be protected from unauthorized interference. 132 . In the case of automatic monitoring of the process parameter the review by means of a process audit is sufficient. When deviations are found corrective actions must be recorded.
This can only be excluded through a clear process organization.13. with responsibilities. must be defined. The sequence organization. Tools specifically linked to parts and inspection and test equipment must be related to a defined release or revision status of the related product. Hereby customer requirements must be considered. the tool crib etc. additional set-up costs etc.1). must be included in the file for production means. Where the identification of products is not possible or economically justifiable the type of identification must be agreed and proven. complaints. In the production means store. This is intended to ensure that only those products which have been released in accordance with the work instructions and which are usable reach the next operational stage or dispatch.5* Is it guaranteed that only products which fulfill the quality requirements reach the next process/process phase and dispatch? Requirements/Explanations: Products must be given an inspection status after each process step (except for interlacing) which shows whether the products have been inspected.g. e. Mix-ups lead to nonconforming production. The revision status must be securely attached to the production mean or. the difference between tools ready for production and those still to be inspected and reconditioned must be identifiable (release status). rework costs. This also applies to computers and data storage media. measuring and test equipment appropriately stored and protected during interruptions in use? Requirements/Explanations: Production and inspection and test equipment must be appropriately stored and protected from damage and dirt so that the performance capability is not affected.. 133 . which quality inspections have been carried out and whether or not they meet the quality requirements (see Question 13.4 Are production as well as inspection. 13. This applies particularly where operator inspection is practiced.
13. 134 . The mixing of products with differing revision status is prevented. Traceability is guaranteed through the connection of the known data of the processed materials and products with the delivery goods. The FIFO principle shall prevent products with various production dates or revision status being mixed.6 Is the known product data traceable from dispatch to material receiving? Definition: "Traceability of products" relates to the origin of the material and components (identification. Clearly separated production lots/batches facilitate the traceability when probems occur. Requirements/Explanations: Corresponding to a risk analysis a traceability system must be developed and described. Exceptions are to be agreed with the customer and demonstrated. date of inspection) the processing history the distribution and positioning of the product following its delivery. Known product data is (among others): se data (parts number. "First in – First out" (FIFO) and/or consequent separation of lots and batches serve as supporting systems in order to prevent mixing of various manufacturing periods. revision status) t/batch number oduction date oduction facility ift. A transparent material flow is guaranteed and thus the material disposition more accurate.
1). production. 135 . in-process. etc. A clear date identification on the material traveler cards is required.The FIFO principle must be followed in all production areas (material receiving. especially for reserved and fixed storage areas and products with a expiration date. The individual production lots and batches are to be identified and kept sepaate.).) up to the point of use. delivery and external stores) (for example through transient or electronically controlled stores with storage date as a sorting criteria. Identification is placed directly on the parts and/or on the containers/ packaging (compare Question 13. stores. The identification applies to all areas of the company (material receiving. etc. Instructions must be available at the individual work stations.
corrective actions etc. Para. then the products must definitely be clearly identified and barred until their release is granted. Requirements/Explanations: The renewed release of the production start shall be carried out by an “authorized“ employee who performs quality assurance functions in a responsible position.2.7 * Is there a procedure available for the re-release to serial production? Definition: "Re-release for serial production" is the order-related release for the renewed start of production.13. corrective actions etc. 136 .) Completeness of equipment and documents for production and inspection and testing Determination of responsibilities for release after set-up Determination of the treatment of lead products and set-up scrap Proof of release at site Setting of process parameters The release of the serial production for products manufactured for the first time is evaluated in Question 14. beside others: Note: Documentation of the last series order (quality records.3) includes. 4.5. The performed release inspection is to be documented with its result. The particular proceedings are to be collated in a procedure. If a release cannot be given directly for time reasons.) Documentation of the data of the last series order (quality records. The re-release of serial production (see definition. The release is required for product and process.
2 10.9d 10. Activities which are necessary for restart of series production are treated under Question 13. e 10.9g 14. the spatial structuring.2 * 4.1 Are capability studies carried out on new/overhauled machines (plants) and also on new/ modified products? Are the conditions for a release to series production for new and modified products/processes regulated and are they agreed with the customer)? Is the monitoring and control (regulation) of the relevant process parameters and product characteristics ensured? Does a tool management and a planned maintenance/servicing for equipment and tools exist? Are the requirements on special processes defined? Are the environmental conditions which influence product and process controlled? Is the effectiveness of production processes evaluated with suitable methods? 4. Note: Remark: VDA Volume 2 and Volume 4.3 - 137 .9 Section 10 This quality element covers the planning and implementation of all necessary activities as an interdisciplinary task of preparing production. Section 4. including tool management.3 4.2g - 11. 2 and 3 also apply. the planning of material and production flow.6 14.9b 4.2.5 14. d.7 Reference DIN EN ISO 9001 14.9 Abs.3 14. as well as measures for ensuring production.1.2 11. Part 1.1. assembly and maintenance processes for the initial start of series production.7 4.3 10.4 Abs. DIN EN ISO 9004-1.4 4.9b 9004-1 10.1.11. Within the scope of production preparation it also covers production organization.9 c.1 14.14 Process Control DIN EN ISO 9001.1 14.3 4.
Determination and evidence is normally established through mathematical-statistical methods whereby only the short term distribution is considered largely excluding the processinfluencing but machine-independent factors (compare VDA Volume 4. If this is not the case. Part 1). when looking at the long term distribution under consideration of the process-influencing parameters then one uses the term “Process Capability“. the process capability must be reached through process analysis and optimization. A process is capable when the statistical parameters for distribution and position in relation to the specified value and tolerance value meet the requirements (at least Cpk = 1. Requirements/Explanations: The characteristics and method for performing the capability study are to be defined. 138 . Process Capability However.1 Are capability studies carried out on new/overhauled machines (plants) and also on new/modified products? Definition: Machine Capability "Machine capability" is given by the relationship between tolerance and production distribution of a production facility. Machine Capability The capability of newly aquired machinery including tools is to be demonstrated either by the machine and tool manufacturer or recipient prior to application.33).14.
67. for: new parts orders new tools/equipment narrowing of tolerances modification of production processes/original state following repair (with influence on the product) following relocation of machine following longer production stops. 139 . If deviations occur corrective actions must be determined and a new capability study is to be carried out after these actions have been implemented. capability studies must be repeated in coordination with the customer. e.g. integrated test and control equipment is to be treated as a unit. All characteristic values must generally lie within the tolerance range. If process capability cannot be proven for important characteristics measures must be defined. These can be. The characteristics important to product quality must be defined and agreed with the customer. for example: 100% inspections of a production lot Constructive measures with. In capability studies the machine with tools and.Under specific conditions. if necessary. The results of a 100% inspection must be recorded. Process capability Process capability is to be demonstrated for product characteristics and process parameters which have a crucial influence on product quality (compare VDA Volume 4. tolerance modifications. Evidence of machine capability should be available for the assessment of the process capability. Part 1).. The short term distribution must have a capability characteristic number of at least cmk 1. if applicable.
6) Qualified personnel Site determination Defined production sequences.1). When determining capacities all production factors must be considered. The capability characteristic number for the long-term distribution must be at least Cpk = 1. • provisional • final 140 .3) all production factors must be available. equipment.4) Approved suppliers (compare Question 11. operating material Maintenance instructions (compare Question 14. 14. Production factors are. a 100% inspection requires process optimization. Section 4.5. e. A new capability study must be carried out after these actions have been implemented.: Specifications. production plan. Thereby. standards with latest revision status Quality plan (compare Question 02. When deviations occur corrective actions must be defined. all actions should have the aim to continually improve the processes within the scope of a zero-failure strategy.4) Required inspection and test equipment including capability evidence (compare Question 16. Bottlenecks lead to quality impairments and additionally to exceeding of costs and deadlines.g. the 100% inspection is the only procedure for sorting out defective products and introducing fault analysis and corrective actions. In the case of non-capable processes.For cost and risk reasons. production environment Released machines.33. Only the consideration of all production factors ensures the problem-free start of series.2 * Are the conditions for a release to series production for new and modified products/processes regulated and are they agreed with the customer)? Requirements/Explanations: For release to series production (see Definition. drawings. formulations.2) Approved materials/supplied products Inspection and work instructions Process capability (compare Question 14.
as well as the capability studies. This includes. review and correction of technical documents and specifications must be completed prior to start of series. the PPA procedure has to be applied. 2 and 3).g. system optimization etc. checklist) must be defined. modified/relocated processes) it is necessary to agree the release conditions (series and modifications) with the customer in advance.g. The conditions for a release and the type of documentation (e. 141 . In any case. an internal new sampling is required.). quality analysis (quality evaluation. the production process and product approval procedure (PPA) (compare VDA Volume 2) and the procedures/methods prior to start of series (compare VDA Volume 4. Part 1. among other things. It is useful and in certain cases (e.- - - Product qualification review • Acceptance criteria • Functional performance First sample with first sample inspection report (VDA Volume 2) • geometric • material • functional • visual Production release • provisional • final The selection and training of personnel. if necessary. When changed or relocated processes are concerned the customer must be informed and. FMEA.
As the compliance with the product characteristics (special customer requirements are also to be considered) depends on various process parameters. In the event of deviations from the specified value they must be (manually or automatically) regulated again (e.g. Changed requirements and agreements with the customer must be included in the quality plan (compare Question 02.3 Is the monitoring and control (regulation) of the relevant process parameters and product characteristics ensured? Requirements/Explanations: The monitoring of the relevant process parameters and characteristics are to be defined in the quality plan. Instructions and sequences must be available at the work stations as instructions (documented procedures). Documentation must also contain and justify every change to the defined production parameters. The parameters and monitoring frequency must be defined. The results of the monitoring must be documented and cross-referenced to the product. their influence on product quality must be investigated prior to series start.14. 142 . A change to the production parameter may require a new process capability study.6). SPC). The necessary activities in the event of deviations from the requirements must also be stated herein.
g.14. Note: This serves to ensure the continuing quality capability of the process and may also include computer and software. 143 . Maintenance is to be presented in a clear form with time structure (e.4 Does a tool management and a planned maintenance/servicing for equipment Explanation of term: “Tool management“ is a system in which tools. Scheduled/preventive maintenance refers to all servicing. are documented. Definition: Planned maintenance (according to VDI Guideline 2890): A maintenance is scheduled when the servicing and inspection of a machine/plant is carried out to a defined scope and time interval. Suppliers of tools must also be included therein. Maintenance work can be carried out by the machine operator or by maintenance personnel. Requirements/Explanations: Tool management includes. must be included. inspection and maintenance work performed on the production equipment in order to avoid any unforeseen machine failure or a process deviation. accessory instruments etc. data file). The completion of the work performed is to be documented and work to be done must be sorted according to due date. All production equipment. blackboard. This also includes that necessary maintenance actions are planned ahead or. appliances. among other things: autonomous maintenance and repairs storage and overhauling of tools tool change program for wearing tools. monitored and controlled. including appliances and tools. if necessary. The maintenance plan covers all necessary activities relating to preventive actions in a timedependent or number-dependent definition and must be performed for all machinery (including computers and software). are performed on a preventive basis. book.
A history on the production equipment is to be kept to identify weak points. 14.g.Based on a risk analysis a minimum amount of spare parts must be kept in stock for bottleneck machines and equipment. Recording of wear are useful to prevent failures at an early stage. equipment and personnel must be given. such as. e. To do this.5 Are the requirements on special processes defined? Definition: “Special processes“ are processes the results of which can only be verified (checked) on the product at a later time or not at all. Special attention must be given to the maintenance of equipment for "special processes“ (compare Question 14. The control and monitoring of the processes must correspond to the process situation. The unambiguous allocation of the documentation for processes.: Characteristics Parameters Sequences Targets.5) Note: The evaluation results of measurements on product and process characteristics have a significant influence on preventive maintenance. Requirements/Explanations: These processes must be qualified. qualification criteria must be defined. 144 . Personnel assigned for these processes must be appropriately qualified and trained.
beside other: production/work plan adapted automization ergonomic and human factors value-adding work sinventory management system.g: process audit (compare Question 03. Where possible. ordered. well-illuminated workplaces and inspection places clear identification systems (e.4) CIP (compare Question 01. if possible synchronous material flow appropriate disposal containers appropriate room and storage conditions.14. Products with "special visual requirements" have to fulfill special requirements. Potential methods are. Order and cleanliness have a significant influence on the work result. damage and mix-ups. Recognized improvement possibilities must be implemented without delay according to a plan to be defined. escape routes) clear. e. e.g. descriptions of the standards should be available. 14.3) Quality circle (compare Question 04.g. Personnel active in the process must be involved in the evaluation so that their experiences are taken into account.: definition of the responsibilities for order and cleanliness clean.6 Are the environmental conditions which influence product and process controlled? Requirements/Explanations: The environmental conditions must be tailored to the work contents and products in order to prevent contamination. 145 .7 Is the effectiveness of production processes evaluated with suitable methods? Requirements/Explanations: The production process must be continually monitored for deviations from requirements and possible improvement potential. intact transport and operating equipment clean. Criteria are.6) The following must be evaluated.
4 Are the quality inspections in the process and 126.96.36.199.3 15.10.2 4.12 4.10.6 12.15 Inspection and Testing (Product Verification) DIN EN ISO 9001.3 b bis e 10.10 DIN EN ISO 9004-1.1) 12. Reference DIN EN ISO 9001 9004-1 15. as well as through certification about this for the client (the customer).2 Are all inspection activities covered by control plans with inspection instructions? 4. Section 4. Prevention of nonconformances has priority over detection of nonconformances.5 * 15.1 -3.1 4.1 the appropriate methods/techniques defined in inspection instructions? Are the defined quality records maintained for all incoming products? Are the defined quality records maintained during the processes/working stages? Are the defined quality records maintained on the end product? Are there records about periodic inspections and tests? 4.4 15. Section 12 Quality inspections serve to ensure quality requirements are met and provide evidence through records. Recording of evidence should be carried out in all phases of production.1 15.10.3 10.2.10.3a (4. This evidence can be provided both through internal records which directly or indirectly prove the quality of the product (product or process data.1 12.1 4.3b 147 . 4.4 12.2 15.10.1.
accredited laboratory facilities are to be used.1 Are all inspection activities covered in control plans with inspection instructions? Explanation of Terms: The "control plan" is a product-related representation of all quality inspections. place on hold. DOE). designation) quality characteristics at the relevant process stage reference to supplementary process descriptions reference to supplementary inspection descriptions/inspection instructions references to decision possibilities (release. from incoming goods through to delivery. : Process plan System-/Product-/Process-FMEA Special characteristics which were agreed upon Knowledge obtained from similar parts / processes Knowledge obtained from the development phases Other analytical techniques (optimization methods. Requirements/Explanation: All inspections (including destructive testing) during the construction process of a product must be recorded in control plans and these plans must be kept available on site. When drawing up control plans. different information is used and obtained from. among other things: specific parts data (part number. QFD. The inspection control plan must be in line with the quality management plan.15. 148 . the same regulations apply.g. rework). e. When required by the customer. The control plans must include. A single inspection control plan can apply to a group or family of parts which are manufactured using the same process and the same equipment. If inspections are carried out externally. with reference to inspection instructions. The company must regularly satisfy itself of the correctness of the operations performed. It can also be included within the quality management plan.
or as a result of particular knowledge obtained (e. for example: inspection and test methods inspection and test equipment random sampling method (acceptance number C=0/"0" defects) evaluation methods quality control charts documentation types. Inspection instructions are necessary for complex inspections. 149 . limit patterns have to be defined and if necessary agreed with the customer. They represent a constantly available reference in the workplace and support management when familiarizing/instructing new employees. For visual inspection characteristics.g. All quality evidence which must be furnished is defined in them (see Questions 15.15. This includes.2 Are the quality inspections in the process and the appropriate methods/techniques defined in inspection instructions? Requirements/Explanation: The way in which a product is to be inspected and tested must be defined in inspection instructions for every relevant inspection characteristic in the production process. inspections following rework). Inspection instructions are also necessary for repeat inspections (e.5). right through to delivery.3 to 15. from series production).g.
periodic cross-checks and repeated inspections and tests must be performed. then the lots not inspected must be documented with date of receipt and quantity of delivered parts. materials. (see Question 11.6). related to the subject number. It has to be ensured.3 Are the defined quality records maintained for all incoming products? Requirements/Explanation: The inspection results from material receiving inspections are to be comprehensively documented.15. function and reliability with the date and name of the inspector. In order to fulfill the obligation to show due care and attention. for example: type and scope of inspections and tests information about when the goods were received quantity of received and inspected units/products scope of inspection inspection results and decisions for geometry. When material receiving inspections are reduced on the basis of previous positive inspection results. it must be checked and documented (repeat inspections). must contain. the documentation. Inspection documentation from suppliers (results from inspections on the delivery or on the relevant units by the manufacturer) with details of the values determined for the specially required quality characteristics can also serve as evidence. that only released products are submitted for further processing. 150 . If rework has to be carried out on delivered products.
types and numbers of nonconformances) Inspection decisions (release. must be documented here: Inspection scope (number of tested products and characteristics) Inspection results (actually measured values. Quality evidence also includes.4 Are the defined quality records maintained during the processes/working stages? Requirements/Explanation: In all production areas. in this case the implementation of corrective actions must be evident. construction deviation. results from series production/set-up inspection releases automatic inspection/process control process monitoring running tests batch inspections. rework. among others. return shipment.1). after rework - Inspection results showing unacceptable quality must also be documented and evaluated. for example. for example. special treatment) Results of repeat inspections.15. reject. The following. Possible records are. reject quantities.g. nonconformity tally charts dimensional reports quality control charts records of original values. (see Question 14. e. concession. 151 . inspections must be carried out in accordance with the inspection control plan/quality management plan and inspection instructions.
g. Repeated inspections. if this does not apply. results from Note: final inspections and tests functional inspections (under conditions of use) acceptance tests product audits reliability testing. Quality evidence also includes. ozone. from serial inspections.5* Are the defined quality records maintained on the end product? Requirements/Explanation: The inspections must be carried out in accordance with the inspection control plan and inspection instructions. for example. e. They can be performed at different times for differing requirements. for example. can also become necessary and be carried out for a limited period as a result of special findings.4 for further requirements/explanation. 152 . performed as and when required. 15. Refer to Question 15. The type and scope of these inspections go beyond the normal inspections and tests during production. such as: long term tests (weathering.15. corrosion testing) re-qualification tests durability tests Records about verification checks on products which are delivered with quality evidence conforming to DIN EN 10204 are included in the periodic inspections. These periodic inspections and tests should prove that all quality requirements of the product are fulfilled. the results are to be documented.6 Are there records about periodic inspections and tests? Requirements/Explanation: Periodic inspections and tests should also be defined in the control plan or quality management plan. Special agreements must be made. It must be guaranteed that all inspections and tests are carried out before the goods are dispatched to the customer. "Periodic inspections" are inspections. The defined evidence must be provided for repeat inspections (rework).
4 153 . is of particular importance as inaccurate measurements could lead not only to nonconformance of an "assured characteristic".2 13.4 16. Section 13 Prior to the use of inspection and test equipment (measuring and testing equipment. official specifications and contractual agreements.11.2 16.1 13. measuring and test equipment.1 * 16. This procedure corresponds with „recognized rules of technology". for example. it has to be ensured that the equipment is suitable for the foreseen purpose.11.1 4.5 Is there a procedure for the approval. evidenced in it’s documentation. standards.11 DIN EN ISO 9004-1. through equipment capability evidence and comparison measurements.2a 13.2b 4.2b 13. the regular calibration of the equipment and thereby the traceability of measured results to national standards is guaranteed.1 4. as defined and required in relevant national and international regulations.11.11.3 16.2a) 13. calibration.11.2 b . but could also present a risk when testing quality and safety-relevant characteristics. The control of the inspection and test equipment in all areas is a basic requirement to ensure the necessary confidence in the accuracy of measuring results and subsequent decisions made based on those results. The accuracy of the results from a piece of equipment. Through control of the inspection.2 f 13. Section 4.16 Control of Inspection.11. identification. control and maintenance of inspection and test equipment? Is the adherence (traceability) of inspection and test equipment to the requirements of national and international standards regulated? Are only pieces of inspection and test equipment used that have a sufficiently low measurement uncertainty? Is there a procedure defined to record the inspection and test equipment capability? Are corrective actions defined following the detection of defective and damaged inspection and test equipment? 4. Reference DIN EN ISO 9001 9004-1 16. -i 4. including software and gauges). Measuring and Test Equipment DIN EN ISO 9001.2b (4.e.
16. e. inspection and test records. The system for controlling equipment must be described in a documented procedure or similar. production. identification. master gauges control of test equipment used by customer services control of supplied inspection and test equipment with clear regulation in the contract permitting it’s use definition of the testing/calibration intervals dependent on the wear and tear and frequency of use examination of the equipment following changes. control and maintenance of inspection and test equipment? Requirements/Explanation: The control of all inspection and test equipment in all areas. measuring and test equipment. in development. calibration. maintenance. devices. for example: initial inspection and approval for use of new test equipment identification system recording of the equipment in a supply source record/approval list inspection instructions for the testing/calibration of inspection and test equipment with defined inspection intervals and documentation (see VDI / VDE / DGQ Guideline 2618 for „Inspection instructions for the control of inspection and test equipment") internal/external control body reference standards. and suspicion of false indications maintenance of inspection. among other things: standard inspection and test equipment of all kinds gauges measuring instruments sensors measurement recorders special test equipment and the corresponding software. must be guaranteed in order to provide confidence in decisions and actions based on the measured results of tests and inspections. tool making. assembly. quality and customer services. comparison references and process monitoring instruments which might influence the quality of a product or a process must be controlled in the same way.1* Is there a procedure for the approval. Inspection and test equipment must be approved for use and calibrated regularly in order to guarantee it’s accuracy throughout it’s entire service life.g. In addition. The control must cover. damage. including the following. - 154 .
when required by the customer. measuring and test equipment has to be provided. under specified conditions. the relationship between values indicated by a measuring device or system. realize. The results provide additional information about wear and tear and the likely time the inspection and test equipment will become obsolete. the calibration processes and the skills of the operating personnel must be guaranteed. as well as their current revision status in order to prevent confusion.2 Is the adherence (traceability) of inspection and test equipment to the requirements of national and international standards regulated? Definition: Calibration (according to DIN EN ISO 10012 Part 1): The set of operations which establish. e) cesium atomic frequency standard. conserve or reproduce a unit or one or more values of a quantity in order to transmit them to other measuring instruments by comparison. Appropriate equipping of the calibration room. 155 . c) 100 Ω standard resistor. Access to technical data and records about inspection. solution of cortisol in human serum as a standard of concentration. measuring instrument. b) standard gauge block. d) Weston standard cell. reference material or system intended to define. (Measurement) standard (according to DIN EN ISO 10012 Part 1): A material measure. 16. Actual calibration and measurement values are to be documented (including initial calibration values prior to first use). and the corresponding values of a quantity realized by a reference standard on the other. or values represented by a material measure or a reference material on the one hand. The test and calibration intervals depend on the frequency of use and must be evident from the files or directly on the equipment itself. Examples: a) 1 kg mass standard.Gauges linked to specific parts must be able to be clearly cross-referenced to the subject numbers of the parts.
which must be known. as accuracy.b): Result of the evaluation aimed at characterizing the range within which the true value of a measure is estimated to lie. to the reference standard. temperature.3 Are only pieces of inspection and test equipment used that have a sufficiently low measurement uncertainty. calibration is necessary. Definition: Uncertainty of measurement (according to DIN EN ISO 10012 Part 1/3. generally with a given likelihood. via the national standard through to the primary standard. These factors and the corresponding surrounding conditions (e. The uninterrupted chain goes in rising form (calibration hierarchy) from the used standard. In the case of measuring devices and material measures. research facilities or manufacturer’s standard) with validity certificates must be furnished. contrary to the standard. equivalent national organization. humidity) must be taken into account when selecting the necessary inspection and test equipment.g.Traceability according to DIN EN ISO 10012 Part 1: The property of a result of a measurement whereby it can be related to appropriate measurement standards. Note: The measurement uncertainty is frequently incorrectly described. Traceability forms part of ensuring the correctness and precision of measurements and is legally regulated. Requirements/Explanation: Complete evidence of the traceability to the next highest level of adherence (e. 16. 156 . The highest permissible measuring uncertainty is dependent on the process/product specification and the inspection instructions of the customer. Requirements/Explanation: Testing equipment must be selected so that the characteristics to be tested can be measured with an acceptable level of uncertainty. Deutscher Kalibrierdienst [DKD]. through an unbroken chain of comparisons. generally international or national standards.g. Physikalisch-Technische Bundesanstalt [PTB]. Calibration takes place against a standard.
16. 157 . with the help of the range method or the mean value and range method under consideration of the chance variance (95/97. but also through other influences. the inspection and test equipment capability must. if necessary. When technical modifications are made to products. as far as possible and other procedures are to be agreed. Special customer requirements must also be considered here. for example: composition of the tested products operator measurement records holding devices surrounding conditions. 5/99%). if necessary. The necessity for evidence of the capability of inspection and test equipment is dependent on: the measurement uncertainty of the inspection and test equipment the complexity of the inspection and test equipment the use of interlocking inspection and test equipment/methods. The inspection and test equipment capability is determined using the repeatability or comparability of measurements. be reassessed.4 Is there a procedure defined to record the inspection and test equipment capability? Explanation of Terms: The "capability of inspection and test equipment" is determined from the measurement uncertainty of the inspection and test equipment in relation to the tolerance of the characteristic to be measured. The result of the study is not only determined by the test equipment itself. This applies especially to complex inspection and test equipment such as: Note: measuring machines multi-point measuring devices measuring equipment for statistical recording test equipment for electrical quantities. Requirements/Explanation: The capability study of inspection and test equipment is to be proven on the basis of the statistical evaluation of ranges of measurements. This may be done by calculation or graphically (correlation diagram).
calculate the deviations and to initiate suitable measures. 158 . e. re-testing complete rejection informing the customer.16.g. such as. The responsibilities and procedures are to be defined for: reporting of nonconformities and/or damage actions on inspection and test equipment actions on products. with notification to the customer detection and elimination of cause(s) These must also form part of the content of employee instructions. In order to prevent reoccurrence. if necessary.5 Are corrective actions defined following the detection of defective and damaged inspection and test equipment? Requirements/Explanation: When it is determined that inspection and test processes are no longer controlled or the inspection and test equipment can no longer maintain it’s highest permissible level of measurement uncertainty or is damaged. An evaluation is to be carried out to determine the effects on finished products. corrective actions are required .: rework. an investigation of the cause is to be carried out.
delivery or use.10: "The failure to comply with a defined requirement" Should.5 17. the recurrence of identified nonconformities.14. The quality control systems must initiate cause analyses and corrective actions and prevent. then procedures must be put into place which ensure that nonconforming products at any phase of production are quickly and accurately identified and excluded from further processing.13.2 14. Reference DIN EN ISO 9001 9004-1 17.4 4.2 14.2 4. on a long term basis.13.2 a 14. Section 4. despite continuous efforts to improve quality and to prevent nonconformities.6 14.1 * 17.17 Control of Nonconforming Product DIN EN ISO 9001. product nonconformities not be completely avoidable.13. prior to shipment of products which deviate from the specification? Is rework executed according to a plan and documented? Is there a procedure for the identification of recurrent nonconformities? 4.7 159 .1 4.13 DIN EN ISO 9004-1 Section 14 A nonconformity according to DIN ISO 8402 / 2.13.3 17.2 Are there procedures for the handling of nonconforming units? Is the agreement of the customer obtained.2 4.
The procedure must contain instructions for identification. These decisions can be. or deviations are subsequently detected at calibration of inspection and test equipment or a corrective production step has been forgotten. segregation. for example: rework acceptance with or without repair. on the basis of a concession downgrade for another use rejection scrap. whereby tags and markings must be protected from unintended removal.1* Are there procedures for the handling of nonconforming units? Requirements/Explanation: There must be a procedure that guarantees an unambiguous separation of good and nonconforming products. This must also include units which are suspected of being nonconforming. if. Should nonconformities be suspected on products already shipped. They must be documented. special containers or markings on the product. product liability and customer satisfaction can lead to a finished product being recalled. The processes addressed here must describe all activities which are carried out in conjunction with the control of nonconforming products in order to remedy faults. for example. Nonconformities detected in retrospect.17. Nonconformities may be detected or suspected in retrospect. an inspection or work stage is left out. This can necessitate an inspection of other products which have been developed and manufactured using the same process and/or of preceding lots of the same product. following prolonged functional or life testing or as a result of late evaluation of control charts. for example. and must be known to all involved employees. as well as responsibilities. Decisions about the disposition of nonconforming products must be made by competent persons on the basis of understandable criteria. must be communicated to the customer. then the customer must be informed immediately. 160 . corrective actions and evidence of effectiveness. The identification can be in the form of tags. Considerations about safety.
1. the products must be identified and the approved.g. rejections. Products deviating from the specification . prior to shipment of products which deviate from the specification? Definition: Concession (in accordance with DIN EN ISO 8402/4. 161 . Requirements/Explanation: The internal and external concession procedure until the agreed delivery to the customer (internal/external) must be defined.2 Is the agreement of the customer obtained. as well as the dispatched quantity is to be recorded. 17. Documentation should include. The performance of the orderly work is to be monitored and documented. must be defined.may only be shipped if the customer has given his agreement.17): Written authorization to use or release a product which does not conform to the specified requirements. scrapping) Concessions Construction deviations The responsibilities for the initiation and monitoring of corrective actions are evaluated in Question 18. for example: Note: Rework inspection reports Product designations (e.3 Is rework executed according to a plan and documented? Requirements/Explanation For any required rework.even where the deviation does not appear critical to the company .17. If necessary. together with the associated production and testing equipment. This procedure. Qualified staff must be used. if necessary including the validity period of the concession. The deviation from the specification must be presented in detail to the customer and documented. must be documented. the working and inspection steps.
Such a procedure must highlight problems with a similar nonconformity profile.4.4 Is there a procedure for the identification of recurrent nonconformities? Explanation of Terms: „Recurrent nonconformities“ mean nonconformities which reoccur because their actual cause was not correctly identified and remedied during previous corrective actions. The evaluation should consider internally and externally encountered nonconformities. by means of: continuous. to create a nonconformities file. systematic nonconformity evaluation evaluation of complaints rework evaluation.17. 162 . for example. To do this. Note: The procedure for the prevention of recurrent nonconformities is evaluated in Question 18. it is helpful. Requirements/Explanation: The procedure must describe the activities regarding further analyses and corrective actions. so that they can be distinguished from those which represent unique occurrences. for example.
The necessity for a corrective action to remedy a nonconformity cause can.14. The implementation of a corrective action begins with the detection of a quality-related problem and includes the implementation of actions to eliminate or minimize the repetition of the problem.6 18.2 15.14 DIN EN ISO 9004-1 Section 15 This quality element concerns corrective actions for the elimination of problem causes and for continuous quality improvement.Analyses of potential nonconformity possibilities .6).7 15.3 18. Reference DIN EN ISO 9001 9004-1 188.8.131.52 15.2 b 4.3 15.Service reports .Management reviews (see Question 01.Feedback from the market . Section 4.18 Corrective and Preventive Action DIN EN ISO 9001.1 4.2 Are the responsibilities for the initiation and monitoring of corrective actions clearly defined? Are there procedures to estimate potential nonconformity risks and to implement corresponding preventive actions? Are there procedures for the analysis of nonconformity causes? Are there procedures to prevent recurrent nonconformities? 4.2 d 15.14. Corrective actions in design documents.4 * 4.4 15.Development evaluations .Reports on process nonconformities .1 * 18.2 4.8 163 .Quality inspections and audits . for example. be recognized through: .Customer complaints . on the product itself and on quality system elements are to be differentiated. in the manufacturing process.14.
Procurement. if necessary.14): Action taken to eliminate the causes of an existing nonconformity. it must be ensured that pertinent information concerning preventive and corrective actions (e. changes to procedures and to the quality system) is made known to the company management. Development. Through the management review (see Question 01. Production. for example. The responsibility and authority for the initiation of corrective actions must be defined.6). Requirements/Explanation: The correction of internally and externally encountered deviations must be organized so that a prompt and effective elimination of the problem is guaranteed.18.g. 164 . Responsible persons must be also defined for the coordination. recording and monitoring of corrective actions. The monitoring activity includes both the performance of the remedial action and the check of it’s effectiveness. The analysis and performance could involve a variety of functional departments of the business. Sales and Quality (see also the quality loop). for example. defect or other undesirable situation in order to prevent it’s recurrence.1* Are the responsibilities for the initiation and monitoring of corrective actions clearly defined? Definition: Corrective action (in accordance with DIN EN ISO 8402/4. through: root cause analysis and identification determination of actions and responsibilities informing the affected and responsible departments determination of monitoring mechanisms. relevant instructions must be available at the relevant workplaces. An appropriate operational organization must be defined in writing and.
Requirements/Explanation: The significance. Feedback of findings from nonconformities encountered where risk analyses already exist (e.2 Are there procedures to estimate potential nonconformity risks and to implement corresponding preventive actions? Explanation of Terms: The significance of a quality problem should be evaluated with regard to it’s possible effect on: process costs quality-related costs. in order to derive preventive measures from it. preventive measures must be used so that potential nonconformities are identified at an early stage and translated into corrective actions. Design and/or Process FMEA Fault tree analysis (FTA) Failure mode analysis Design of experiments. lower total costs and with ever shorter innovation times can no longer be realized. functional capability and safety of the product. offer assistance: System. even before nonconformities arise. The following formalized methods. Risk analyses.18.g. Instead. performance. for example. frequency of occurrence and detectability of the nonconformity must be considered in the procedure for estimating risks. Design/Process FMEA) must take place. technical systems with greater safety and reliability. With the classical method of eliminating a nonconformity after it has occurred. for example. form the basis for the optimization of and changes to: specifications operations test and manufacturing equipment instructions. high level of quality. 165 . customer satisfaction.
may be helpful: Fish bone diagrams (Ishikawa diagrams) Stratification (separating data and dividing it into categories) Pareto analyses (ABC analysis) Capability studies Histograms Correlation diagrams Failure mode analyses Probability charts Data collection Recording with corresponding graphic representations FMEA review. all related processes/work stages (equipment. tools). the actual root cause must be determined by analysis before corrective actions are planned.3 Are there procedures for the analysis of nonconformity causes? Requirements/Explanation: The following quality methods. the supplier and/or customer must be involved in the analysis of the root causes of the nonconformities. Often the root cause is not obvious. for example. installations.18. actions for elimination must be derived from the results of the root cause analysis and their performance evidenced. 166 . customer service reports and customer complaints As far as is appropriate. Within the scope of preventing nonconformities. which necessitates a thorough analysis of. quality records.: product specifications (including materials etc.). for example. When a quality problem occurs.
4. Requirements/Explanation: In order to prevent a problem reoccurring. Describe the problem. Note: Clarify the problem for yourself. special preventive actions must be implemented. Work on the problem in a team. Define measures that will prevent a recurrence of the problem. Indications of the effectiveness can also come from customer services/ service department. Problem solving in teams: 0. 8.4* Are there procedures to prevent recurrent nonconformities? Explanation of Terms: "Recurrent nonconformities" are those nonconformities which reoccur because their root cause was not correctly identified and remedied in previous corrective actions. See also Question 17. 3. 6. Define measures for the elimination of the problem and check their effectiveness through experiments/trials. 2. 1. Initiate temporary actions to limit damage and check their effectiveness. their effectiveness must be monitored to ensure that the desired objective is achieved. 167 . Determine the root cause(s) and check that it is (they are) really the root cause(s). Praise the performance and success of the team. 5. When measures to eliminate nonconformities have been realized.18. 7. Implement the measures for elimination and check their effectiveness. 4. Changes and the experiences resulting from them must be documented.
preservation and transport of the products are included in the terms stated in the heading.15.15. storage.1 4.5 19. Packaging.3 4.15.1 4.1 16. rectify and initiate corrective actions on packaging nonconformities and transport related damage? Is the identification of products during transport and storage ensured? 4. Preservation and Delivery DIN EN ISO 9001.4) 19.4 (10.19 Handling.6 * Is there a procedure which documents delivery -reliability? 169 .2 16. Section 4.15.1 Are there instructions for the handling of products? Is the packing and identification process prior to delivery defined and monitored? Is it ensured that damage or deterioration in quality during storage and transport is prevented? Is there a procedure to record.15. Reference DIN EN ISO 9001 9004-1 19.2 4.2 -- 19.5 4.4 4.4 4. Storage.2 16.15. They encompass the entire logistical chain of product manufacturing from beginning to end.1 4.15.1 16.15.6 4.15 DIN EN ISO 9004-1 Section 16 Measures to prevent quality shortcomings arising from incorrect handling.2 19.4 16. packing.3 184.108.40.206 19.
Requirements/Explanation: The instructions must contain orderly planning and control for incoming materials. internal and external transport planning and inspection of packaging storage of only clearly identified products appropriate storage conditions first in / first out (stock control system) monitoring of limited storage-life products shipping operations orderliness and cleanliness implementation of customer instructions cleaning and preservation informing the customer about handling disposal. and for end products up to the point of use by the final customer.: handling.19. storage. The methods and responsibilities must be defined for. e.g. their further processing.1 Are there instructions for the handling of products? Explanation of Terms: „Handling of products“ is viewed as all transport and handling methods and operations in the complete logistical chain. 170 .
19. as well as the materials themselves which are necessary for this. Customer requirements regarding packing must be observed and must be accessible on site. The packing must ensure that products arrive at their place of use complete and undamaged.2 Is the packing and identification process prior to delivery defined and monitored? Requirements/Explanation: Procedures/work instructions must describe all steps which guarantee appropriate packing. 171 . Product packing includes the following: initial packing final packaging / repackaging for shipment container identification. Adherence to requirements can be proven through dispatch audits. Training and instructions are necessary for this.
chemical reaction) written instructions for product handling are to be raised (see Question 19.19.g. 172 . for example: condition of containers cleaning and preservation filling of containers methods of transport (temperature. corrosion. if necessary. rectify and initiate corrective actions on packaging nonconformities and transport related damage? Requirements/Explanation: Reporting routes and processing of incidents of both internal and external transport-related damage are to be defined in writing and the responsible circle of people informed. in the context of audits). vibrations.g. Special attention should be paid to. The responsibilities for corrective actions are to be determined (if necessary.) protective measures for products and personnel effects of humidity padding secure fixing collective packaging instructions for handling (e. 19.g. delivery).3 Is it ensured that damage or deterioration in quality during storage and transport is prevented? Requirements/Explanation: In order to avoid damage or deterioration in quality (e. through dirt. the customer must be involved). The measures implemented are to be checked for their effectiveness.4 Is there a procedure to record.1). etc. by regular plant inspections. Conformance to the requirements is to be ensured (e. assembly.
the system should be structured so that: the customer is informed in advance about delivery shipments an emergency strategy can be operated if a bottleneck in supply occurs. Customer requirements must be taken into account. Furthermore. Requirements/Explanation: The information system should continuously serve to: optimize the throughput time adjust the stock turnover to the needs of the customer minimize stock levels. inspection status) expiry date removal of invalid identification.: identification in accordance with specification requirements revision status clear and permanent referencing of identification and/or accompanying documents to the product (processing stage.g. if a recall or a special inspection is necessary. corrective measures are to be introduced.6* Is there a procedure which documents delivery reliability? Explanation of Terms: Under „delivery reliability“ one understands the adherence to promised delivery deadlines and delivery quantities for products within a defined delivery period. 173 . The identification should be sufficient to allow for the identification of an individual product.19. Note: 19.5 Is the identification of products during transport and storage ensured? Requirements/Explanation: It must be ensured that products are identifiable at all times during transport and storage. If deviations from the delivery obligations are recognized or reported. The identification refers to e.
review and approval of quality records? Are there procedures and responsibilities defined for the evaluation and distribution of quality records? Is it defined where. how and for how long quality records are retained? Is the manner in which quality records are made accessible to the customer defined. if this has been contractually agreed? 4. collection.16 the identification.16 4.3 20.16 17. compilation.4 4.2 17.3 20. deterioration or loss and must be kept in order so that they are easily retrievable. Their identification.16 DIN EN ISO 9004-1. archiving and updating must be ensured.16 17. Note: For this element VDA Volume 1 and 7 are also valid.1 20. Quality records from suppliers must be taken into account in the same manner.4 4. Reference DIN EN ISO 9001 9004-1 20.3.3 - 175 .1 Are procedures and responsibilities defined for 4. Section 17 Quality management need records of quality-relevant data in order to be able to demonstrate compliance with the defined quality requirements and the effectiveness of the quality system. The ability to retrieve records and their hierarchical order must be guaranteed at all times. The same applies to records on electronic media. distribution.20 Control of Quality Records DIN EN ISO 9001. All quality records must be legible and stored in facilities under suitable conditions which avoid damage. Section 4.
A clear illustration of all types of quality records is advantageous. for example: evidence to contract review evidence of inspections. Quality relevant records are. review and approval of quality records? Explanation of Terms: „Identification" serves the clear referencing to processes. 176 . operations or products. process and product audits) materials tests calibrations quality control charts complaints evidence of implemented corrective actions evidence of quality related costs evidence of process related costs evidence of quality related losses documentation of preventive maintenance. including tools/organizations) quality audits (system.20. Requirements/Explanation: The operations are to be comprehensively structured from the customer through to the company under inclusion of all relevant departments.1 Are procedures and responsibilities defined for the identification. tests and experiments product/process approvals and releases capability records (quality capability of men and machines. "Approval" is the approval of the measures noted in the records. "Review" encompasses the plausibility check. as well as the formality and correctness of the contents of the records.
20. "Responsibilities" are those functions within the company which evaluate and distribute quality records. meaningful evaluations of quality data must be available to the responsible parties.1 177 .2 Are there procedures and responsibilities defined for the evaluation and distribution of quality records? Explanation of Terms: "Procedures" describe what. Processes and responsibilities for the evaluation and distribution must be controlled. periodic projections and status reports. see Question 20. Requirements/Explanation: To control quality in the various areas of authority. This applies to individual reports. when and to what extent evaluations are to be performed. Note: For a listing of quality records. The quality records of the supplier and customer must be incorporated into this process.
microfilm. for example must be considered: protection against fire. additional back-up files (e. Minimum requirements for the archiving period are: one year after product discontinuation: Product/ process releases. longer: documents requiring special archiving (DWSpA) (See VDA Volume 1) - The destruction of quality records after defined archiving period has to be ruled. security copy etc).1 2) Copies of records concerning discontinued products which are required for approval of the new products must be archived referenced to these new products. management reviews etc. Records to internal quality audits. storage media (files. the process and the product fulfilled all the quality requirements for that particular period. Tool inspection reports.g. two years: Records on quality performance (quality control charts). whereby it must be guaranteed that all documents are retrievable. even at a later date that the quality system. Purchase contracts and supplements to them etc.g. Thereby the following. on the basis of the requirements of legislation. ppm lists etc. water etc. DP storage) if necessary. three years: Reports for the (top) management.20. customers and product liability aspects (see VDA Volume 1). among other things. double archiving. how and for how long quality records are retained? Explanation of Terms: "Retained" refers to the filing and archiving of records.: retention period filing system filing location. Note: 1) For a listing of quality records. Retaining quality records is necessary in order to be able to prove. see Question 20. Inspection results.3 Is it defined where. general guidelines.2 178 . Requirements/Explanation: This requires instruction about e. 3) See Question 06. The retention (or archiving) period must be defined.
The procedure for this must be defined.1 179 . Therefore it must be possible to refer back to the supplier’s quality records for this purpose. certain product characteristics of the finished product can no longer be inspected by the customer. In many cases. Note: For a listing of quality records.20. if this has been contractually agreed? Requirements/Explanation: Quality records must be made accessible to the customer. Direct referencing and identification of the relevant records to the defined products and associated processes must be defined as a procedure.4 Is the manner in which quality records are made accessible to the customer defined. in so far as this is contractually agreed. see Question 20.
4 181 .6 7.3 is relevant for the evaluation of this element.3 21.3 21. (7) This element summarizes all quality-relevant activities which are necessary for observing a product in the utilization phase.4 21.4. Reference DIN EN ISO 9001 9004-1 21.19 16.3 - 21. Section 4.19) 16. The knowledge gained from customer service and from maintenance activities about weaknesses must be used to improve products and processes.4.3 16.2 - 7.5 16.5 4. Note: If only the Question 21.1 16. (After Sales.1 Is the preparation of operation and assambly instruction defined and are these clear and understood? Is there a procedure for product surveillance and an early warning system for product failures in use? Is there a procedure to analyze product nonconformities during use. Post-production Activities) DIN EN ISO 9001.19 DIN EN ISO 9004-1 Section 16.5 under Element 18. as well as to implement and monitor corrective actions? Is the customer service function included in the information flow system? Is there a procedure for maintenance activities.21 Servicing. then this question can also be considered and evaluated as an additional question 18. In this case the individual evaluation of Element 21 is no longer applicable. if these are agreed? (4.
Every company must be aware of how it’s products behave in use. It must be noted that the operating and assembly instructions must be available and.2 Is there a procedure for product surveillance and an early warning system for product failures in use? Requirements/Explanation: The procedure for this must be defined and. Thereby. this question applies primarily to companies active in the accessory business sector. agreed with customers that further process delivered products. 21.21. The necessity of this question is to be agreed upon in individual cases. must be evidenced. the following must be considered: responsibility for the preparation multilingual arrangements with respect to the range of users consideration of foreseeable misuse warnings concerning incorrect use (also during commissioning).1 Is the preparation of operation and assambly instruction defined and are these clear and understood? Requirements/Explanation: The preparation of operating and assembly instructions is necessary for some products. in order to obtain information about the quality of it’s products in use. not only the warranty period but also the entire utilization period should be taken into account (e. 182 . if necessary.g. that is. also long-term evaluations). Note: Regarding products within the automotive industry. if necessary. The activities undertaken by the company. In this case. prior to the introduction of the product. agreed with the customer in good time.
An early warning system must be agreed and built up between the company and the customer. 183 . the following organizational units: Note: Development Work planning Production Quality management. e. The information must be available to. This should include. See Question 21. among others. It is especially important that systems’ suppliers and suppliers of complex products establish a quick feedback system for the introduction of new products.This includes for example: regular market observation evaluation of field returns / warranty cases customer surveys customer information/early warning system.g.: an observation and information system an organizational system for actions when necessary the definition of the responsible person / contact person.3 concerning the analysis and evaluation of nonconformities.
a procedure must be defined for the analysis.3 Is there a procedure to analyze product nonconformities during use. if necessary. for example. as well as to implement and monitor corrective actions? Requirements/Explanation: For product nonconformities during use. The following steps must. The aim is to avoid nonconformities. to the development department. The results of the analysis of the nonconformity and the corrective actions must be informed to the customer and. 184 . be understandable and documented: Procurement of the nonconforming product Analysis of nonconforming production with regard to location.21. to exclude the possibility of a recurrence of the nonconformity and to implement continuous improvements to the process. Note: The procedure for the above is to be defined with the customer. medium and long term) Implementing corrective actions Monitoring of corrective actions Evidence of the effectiveness of actions carried out. or respectively for return shipments from customers. implementation and monitoring of corrective actions. type and cause of nonconformity Definition of corrective actions (short.
21. 185 . The objective is to ensure the feedback of information from the customer to the corresponding company departments. Requirements/Explanation: Customer service is recognizable through. for example: identified responsibilities discussion notes check lists meeting reports travel reports. Evidence of customer services can be. for example: providing special tools and testing equipment for customer services technical advice (liaison engineer.see Section 4.4).1 #1. advice on processing and use) requests for quality related information support for own sales offices information flow to and from the customer qualification measures in manufacturing plants timely availability of (modified) replacement parts recall of obsolete products and evidence about this.4 Is the customer service function included in the information flow system? Explanation of Terms: „Customer service“ is the care of the products at the customer (including intangible products .
21. if these are agreed? Requirements/Explanation: Where maintenance on delivered products is a requirement of the recipient. 186 . the company must define: what belongs to the scope of maintenance how it is to be reported on how the requirements are to be fulfilled. among other things. The following must also be taken into account.5 Is there a procedure for maintenance activities. special tools inspection measuring and testing equipment work instructions for commissioning administration of spare parts The organizational procedures must be shown.
20.1 22.2 20. It is dependent on the product and on the manufacturing processes implemented and encompasses the planning. as well as the evaluation of results.20 of quality inspections on deliveries? Are statistical methods used for process optimization and for process control? 4.in production. This must be considered by the users of statistical methods.20 Section 20 The use of statistical methods is an important quality element in all areas of the quality loop.1f 20. All statistical statements are limited in that they are only valid with a certain degree of probability.4 22. Reference DIN EN ISO 9001 22.in the design phase leads to the definition of realistic tolerances and functional values . The use of statistical methods and procedures: .6 Are statistical methods used for the evaluation 4. h 20.1f 20. DIN EN ISO 9004-1 Section 4.2 Are the possibilities for using statistical 4.2 20.1c/g 20. the performance.2 187 22.1 20. h20.2 20.3 22.1b.20 Are statistical methods used for the evaluation 4. allows the evaluation of the quality of a quantity of (untested) parts based on a sample of products.5 22. correct statements to be made about quality levels and any changes to these levels.1 methods determined and is their use planned? Are statistical methods used for planning and evaluating experiments and estimating product risks during development? 4.1a. Statistical methods are based on the laws of probability calculation.20 of quality test at final inspection? Are statistical methods used for the evaluation 4.in experiments raises the meaningfulness and safety of statements using low numbers of experiment samples . Their implementation allows.20 of product failures during use? .22 Statistical Methods DIN EN ISO 9001.2 20. with economical expenditure.20 9004-1 20.
Wherever possible and economically viable. 188 . Statistical methods must be used both for product and process development in testing. which processes and characteristics have to be tested and evaluated and with which methods. FMEA). dependent on the results of the risk analysis (e. Statistical methods are planned within the framework of project planning in the form of a advanced quality plan (quality planning). design and model construction.2 Are statistical methods used for planning and evaluating experiments and estimating product risks during development? Requirements/Explanation: Typical methods are e. The results of the statistical evaluation must be considered within the scope of quality improvement programs. It is to be defined. Statistical methods allow the user to assess processes taking into account economic aspects within the process chain.: Design of Experiments / analysis of influencing variables variance and regression analysis significance studies calculation of failure probability FMEA failure tree analysis system optimization. The appropriate method must be defined and used for the particular application.1 Are the possibilities for using statistical methods determined and is their use planned? Requirements/Explanation: The need for statistical methods to determine. the statistical evaluation of process parameters must be given precedence over the evaluation of quality results on products. monitor and examine process and product within the process chain must be defined.g. 22.g.22.
g.4 Are statistical methods used for process optimization and for process control? Requirements/Explanation: Typical methods for process control and optimization. Ppk. These evaluations also serve supplier evaluations. e. The evaluation of quality evidence for deliveries also forms part of this.: Random sampling techniques Nonconformity tally cards Pareto analysis. g. are e.3 Are statistical methods used for the evaluation of quality inspections on deliveries? Requirements/Explanation: Typical methods are. 22.22. Cpk) Design of Experiments Analysis of influencing variables Variance and regression analysis Significance studies 189 .: Quality control cards /SPC Random sampling techniques Nonconformity tally cards Pareto analysis Capability studies(Cmk.
The Zero-Defect-Strategy is to be considered.: nonconformity tally cards Pareto analysis probability grids. for example.5 Are statistical methods used for the evaluation of quality test at final inspection? Requirements/Explanation: Typical methods are e. 190 . (i.g. It finds application.g. Random sampling plans are to be defined from a statistical viewpoint.: random sampling techniques nonconformity tally cards Pareto analysis. in customer services and handling of warranty cases.6 Are statistical methods used for the evaluation of product failures during use? Requirements/Explanation: Typical methods are e. 22. Keeping statistics related to a production period is in many cases of great significance. Acceptance figure c=0).22.e.
1749 Reference sources: Druckerei Henrich D-60528 Frankfurt am Main. Schwanheimer Str. The forms shown below show examples of possibilities. block of 10 sets. 5 pages each set. 110 (0 69)67 80 06-0 (0 69)67 80 06-30 191 . rationally and clearly for all parties involved. Order No. 12 pages each set. The set of forms: Quality system audit for material products in accordance with VDA 6.1 consisting of : Questionnaire (questions only) DIN A5. block of 10 sets.summary DIN A4. Both blocks belong together and are only available as a set in German/English.8 Forms for the Quality System Audit . Assessment documents Overall assessment of the quality system Overall grading Summary of results Summary of the assessed questions Corrective actions Corrective actions .tangible products - The use of forms to correctly carry out the quality system audit is advantageous because they enable the results to be gathered quickly.
..................................................... Signature of audited/certified company/Date .....................................................................................VDA 6........ Signature Auditor(s) / Date ................................................................................................................. ..................................................................................................................................................... Signature/Date 192 ............................................... ................................................................ ................................................... that the audited/certified company may communicate the audit results to other parties............................. Part 1....................................................... ............................... ............... of System Audit: Audit-period: starting ending Audited/Certified Company Area / Works Location Audited Products / Product groups Address Contact person Result Overall Compliance CTOT % from CM % and CP % Issuing of Audit Certificate is recommended yes Comments of the audited / certified company: ............ no The customer/certification body agrees................................Quality System Audit Overall Evaluation of the Quality System of the Company Customer/Certification body Area/Works Location Auditor Report No.........
3....................... .....................................................................................Only for Customer / Supplier Audits (2 Party) Customer: Report No... ................................. of System Audit: Ranking: Supplier: Date: Overall Compliance CTOT % from CM % and CP % Auditor Ranking (for downgrading acc.................................... to.........................................................3............... ........................ Par.........................3 Notes 1 and 2) Comments on Ranking (Auditor): ..................................................................... System evaluation: Overall Compliance in percent 90 to 100 80 to less than 90 60 to less than 80 less than 60 Evaluation of Quality System full compliance mainly compliant conditionally compliant not compliant Designation of Evaluation A *) AB*) B C *) see notes under Par.......................................................................................... ............................................... ...................................................................................................................................................................................... Part 1.........................................................3..................................................................................................................................3 193 .3.......... ........Quality System Overall Compliance nd ............................................................ .VDA 6..................
Pack. Storage.Z1 No. Personnel Fin.-System.. ved Compl. Quality in Marketing 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 CP Design Control (Product design) Process Planning. etc. Identification.) Document and Data Control Purchasing Control of customer supplied Prod. Handling. Traceability. Process Control Inspection + Test (for Products) Control of Insp. Product Safety Company Strategy X Compliance level 1 . archieposs. consideration on Q.22 194 . Part M: Management 01 Management Responsibility 02 03 04 05 06 Z1 CM Quality System Internal Audits Training. level CE % Compliance Profile % 20 40 60 80 Part P: Product and Process 07 Contract Review. sed poss. Asses max. Of Scoree Questions max.. Corrective + Preventive Actions. Control of Quality records Servicing (Post-Production Activity) Statistical Methods X Compliance level 7 .(Process dev. of System Audit: Company: Date: VDA Element No.Quality System Audit: Summary of Results Customer/Certification body: Report N°. Part 1 .VDA 6..+Test Equipment Control of non-conforming Prod. etc.
4 15.3 13.2 12.3 10.2 02.2 17.1 18.3 09.6 09. process and Quality system 195 . of System Audit: Certificate N°.5 22.3 Z1.1 15. reasons to be given on a separate sheet.4 21.Questions with particular relevance for product-.6 = Question not applicable thus not evaluated.7 08.3 15.1 10.3 06.2 21.6 11.2 18.1 07.4 05.2 22.2 09.4 14.4 02.2 11.5 04.1 21.4 06.4 07.3 14.4 09.6 02.1 03.5 01.1 09.3 05.1 16.1 06.6 19.2 16.4 22.5 14.4 04.1 20.4 18.5 08.1 19.4 19.7 Audited/Certified company: Date: DIN EN ISO: Valid to: 01.1 04.1 Note: 01.2 na 01.3 18.2 13.4 21.3 22.: 01.2 Z1.3 19.4 10.6 15.4 13.5 09.1 14.4 Z1.4 11.2 05.5 10.3 02.4 12.4 16.5 22.2 20.1 08.2 10.Quality System Audit: Summary of Evaluated questions Customer / Certification body: Report N°.4 17.3 21.6 13.3 03.7 Z1.2 04.6 13.7 04.3 17.5 15.3 12.3 08.5 11.4 20.3 04.5 02.5 13.2 08.3 01.7 09.1 11.2 14.1 17.2 03.2 06.5 16.6 14.2 07.1 02.2 19.3 11. = *.3 20.3 07.1 12.4 08.VDA 6.1 Z1.5 11.5 19.7 14.2 15.1 22.4 03.3 16.1 05.6 04. Part 1.6 08.1 13.5 07.
VDA 6. to Quality Element ________ / Question _______/Page N°. 196 . Part 1.Quality System Audit: Remarks on Status Customer / Certification body: Report No. of System Audit: Audited/Certified company: Date: Ref.
No.Quality System Audit: Corrective Actions Customer / Certification body: Report N°. 197 .VDA 6. proposed corrective actions Audited/Certified Company: Date: Response and actions of the audited / certified company deadline .Part 1. Deviations. of System Audit: Q-Element seq.
VDA 6, Part 1- Quality System Audit: Corrective action - Summary
Customer / Certification body: Report N°. of System Audit:
Audited/Certified Company: Date:
further Information on page No.
J F M A M J J A S O
Part M: Management 01 Management Responsibility 02 03 04 05 06 Z1 Quality System Internal Audits Training, Personnel Fin. consideration on Q.-System. Product Safety Company Strategy
Part P: Product and Process 07 Contract Review, Quality in Marketing 08 Design Control (Product design) 09 10 11 12 13 14 15 16 17 18 19 20 21 22 Process Planning,(Process dev.) Document and Data Control Purchasing Control of custom-supplied Prod. Identification, Traceability, etc.. Process Control Inspection + Test (Product testing) Control of Insp.+Test Equipment Control of non-conforming Prod. Corrective + Preventive Actions. Handling., Storage, Pack., etc. Control of Quality records Servicing (Post-Production Activity) Statistical Methods
VDA-Series "Quality Management in the Automotive Industry": Volume 1 Quality Evidence - Guidelines for Documenting and Archiving Quality RequirementsQuality Assurance of Supplies - Supplier Selection, Quality Agreements, Production Process and Product Approval, Quality Performance in the SeriesEnsuring Reliability of Car Suppliers – Procedures and Examples Manufacturers and
Quality Assurance prior to Serial Application Part 1: Partnerships, Processes, MethodsPart 2: System FMEA Part 3: Project Planning Basics: Quality Audit, Fundamentals Part 1: Quality System Audit Part 2: System Audit – Services Part 3: Process Audit Part 4: Quality System Audit, Production Means Part 5: Product Audit Part 6: Product Audit, Services Basics for Interchange of Quality Data – Electronic Transfer of Quality Data Guidelines for Quality Assurance of Trailer, Superstructure and Container Manufacturers Quality Assurance Emissionen and Consumption
Masing, Walter (Hrsg.), Handbuch des Qualitätsmanagement, 3. Auflage, 1994 DGQ-Schrift 11 - 04 (Stand 1995) Begriffe zum Qualitätsmanagement DGQ-Schrift 12 - 62 (Stand 1991) Qualitätssicherungs-Handbuch und Verfahrensanweisung, Leitfaden für die Erstellung DGQ-Schrift 12 - 63 (Stand 1993) Systemaudit DIN EN ISO 8402 (1995) Qualitätsmanagement und Qualitätssicherung – Begriffe DIN EN ISO 9000, Teil 1 (08/94) Qualitätsmanagement- und Qualitätssicherungsnormen; Leitfaden zur Auswahl und Anwendung DIN EN ISO 9000 Teil 2 (03/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Allgemeiner Leitfaden zur Anwend. von ISO 9001, ISO 9002 und ISO 9003 DIN EN ISO 9000 Teil 3 (06/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Leitfaden für die Anwendung von ISO 9001 auf die Entwicklung, Lieferung und Wartung von Software DIN EN ISO 9000 Teil 4 (05/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Anwendung auf das Zuverlässigkeitsmanagement DIN EN ISO 9001 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung in Design/Entwicklung, Produktion, Montage und Kundendienst DIN EN ISO 9002 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung in Produktion und Montage
DIN EN ISO 9003 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung bei der Endprüfung DIN EN ISO 9004, Teil 1 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden DIN EN ISO 9004, Teil 2 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für Dienstleistungen DIN EN ISO 9004 Teil 3 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für verfahrenstechnische Produkte DIN EN ISO 9004 Teil 4 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für Qualitätsverbesserung DIN ISO 10011 Teil 1 (06/92) Leitfaden für das Audit von Qualitätssicherungssystemen; Auditdurchführung DIN ISO 10011 Teil 2 (06/92) - Qualifikationskriterien für Auditoren DIN ISO 10011 Teil 3 (06/92) - Management von Auditprogrammen DIN ISO 10012 Teil 1 (08/92) Forderung an die Darlegung der Qualitätssicherung von Prüfmitteln - Management von Prüfmitteln VDI-Richtlinie 2890 (1986) Planmäßige Instandhaltung: Anleitung zur Erstellung von Wartungs- und Inspektionsplänen VDI/VDE/DGQ-Richtlinie 2618 (Teil 1 - 17): Prüfanweisung zur Prüfmittelüberwachung
2 9.25 Beuth-Verlag. Burggrafenstraße. 81631 München 9. Postfach 86 04 20.1 Verband der Automobilindustrie e. 60325 Frankfurt Carl Hanser Verlag.9. 10787 Berlin 202 . (VDA) Qualitätsmanagement Center (QMC) Lindenstraße 5.25 References 9.24 VDI/VDE/DGQ-Richtlinie 2619: Prüfplanung DGQ-Schrift 14-18 (1995) Wirtschaftlichkeit durch Qualitätsmanagement 9.3 . V.
The final determination of the which questions are or are not used in the audit/certification process is subject to agreement between the company to be audited and the customer or certification body under consideration of risk aspects. V. This may vary when comparing different associations and suppliers. supplementing explanations for some questions of the VDA questionnaire were established from a chemistry-specific viewpoint. (DGM) Oberursel/Ts. Thereby. These questions not pertinent to this industry sector should not be used in audits/certification and evaluation. Part 1 and DIN EN ISO 9001 has since the publication of the st 1 Edition in January 1991 received great attention even beyond the sector of the automotive industry. Therefore. German Association for Material Science) For the committees: Strangpressen und Walzen von NE-Metallen (Extrusion Molding and Rolling) Deutscher Schraubenverband e. This was the reason why quality management working groups from several expert and industrial associations have discussed the content and formulation of this document.1 Introduction The current publication on the auditing of quality systems according to DIN EN ISO 9004. V Hagen (German Association of Fasteners) • Verband der Chemischen Industrie e. however. V. 10. 203 .2 Summary of the National Associations • Deutsche Gesellschaft für Materialkunde e. The comparison and explanations are contained in a VCI brochure which is available from the VCI.10 Agreement with Industrial Associations 10. the production processes in the chemical industry are partially structured different to other industrial branches. it was established that the questionnaire could be adapted apart from some questions not pertinent to this industry sector. (VCI) Frankfurt/Main (Association of the Chemical Industry) The VCI regards all questions as applicable.
The wording of the agreement in the German language is printed on the following page. . Düsseldorf (Drawing and Cold Rolling Works Industrial Association) For the member associations: .FF – (Vehicle Springs) . V. V.Fachvereinigung Präzisionsrohrwerke e.KF – (Cold Formed Springs) .Eisen.V.Verein Deutscher Eisenhüttenleute e.Stabziehereien-Vereinigung e. (Steel Wire Organization) . V.3 International Agreement on Mutual Recognition In March 1994. (Bar Drawing Association) 10. V.und Stahldrahtvereinigung e. This was realized after an intensive comparison of the two existing questionnaires and after a corresponding alignment of the requirements.VDFI Kaltgeformte Federn .VDFI Fahrzeugfedern e.• Verband der Deutschen Federnindustrie (VDFI) Hagen (Association of the German Spring Industry) For the member associations: .Fachvereinigung Kaltwalzwerke e. as well as after joint audits at German and French suppliers. V. (Association of Precision Tube Works) . (Cold Rolling Works) Kaltbund und Kaltprofile (Cold Strip and Cold Profile) .V.Industrieverband Deutscher Schmieden e. (IDS) Hagen (German Forging Industry Association) • Wirtschaftsvereinigung Ziehereien und Kaltwalzwerke e. the agreement on the mutual recognition of results of quality system audits between the French and German Automotive Industry was concluded. 204 . V. (VDEH) Düsseldorf (Association of German Iron Foundry Workers) .
nine signatures . FIEV and Verband der Automobilindustrie (VDA) The car manufacturers PSA PEUGEOT CITROËN and RENAULT evaluate the quality capability of their suppliers according to a procedure that is described in the publication „REFERENTIEL D’EVALUATION D’APTITUDE QUALITÉ FOURNISSEURS“ (Evaluation of the quality capability of suppliers) Edition 94. based on the standard series EN29000.AGREEMENT on mutual recognition PSA Peugeot Citroën. Specific elements of the respective partner may be subject of a supplementing audit. Renault.End of the agreement – 205 . members of the VDA (Verband der Automobilindustrie e. This requires. The German car and component manufacturers. Association of the German Automotive Industry) have established an audit procedure for the evaluation of the quality systems of their suppliers that is described in Volume 6 of the series „QUALITÄTSMANAGEMENT IN DER AUTOMOBILINDUSTRIE – QUALIÄTSSICHERUNGSSYSTE MAUDIT“ and which is also based on the standard series EN 29000. that the audited company provides the result and audit report of a preceding audit. In an effort to raise the efficiency when auditing quality systems and after establishing the comparability of both evaluation procedures • The car manufacturers PSA PEUGEOT CITROËN and RENAULT. as well as the component manufacturers of the FIEV on the one side and • The car and component manufacturers of the VDA on the other side have decided TO MUTUALLY RECOGNIZE AUDITS WHICH HAVE BEEN CARRIED OUT BY ONE OF THE CONTRACT PARTNERS FOLLOWING ONE OF THE ABOVE PROCEDURES AND THEIR RESULTS. It forms the basis for evaluating the quality capability of their own suppliers. The French component manufacturers.V. members of the FIEV (Fédération des Industries des Equipements pour Véhicules). have participated in the development of this procedure.
1 is limited. may. no element lies below 75% compliance. It is supplemented by VDA 6. A certificate supplement VDA 6. 3.11 Notes on a Certification according to VDA 6.1 an existing certificate according to DIN EN ISO 9001 or 9002 may be taken into account so that the expenditure for upgrading to VDA 6.3).1 Certification bodies. no question identified with a * is marked with less then eight points and no question without marking reaches zero points (compare Para. Basics.1 (for the certificate according to DIN EN ISO 9001/ 9002) may be issued by the certification body if an overall compliance of at least 90% has been reached. This certification is based on a certificate according to DIN EN ISO 9001 or 9002.1 auditors„ with the corresponding branch expertise.3. Certification audits must only be carried out by „certified VDA 6.1-specific elements and questions whereby all appropriate questions of the VDA 6. contractually accredited by VDA. Part 1. certify the quality system of a company on the basis of VDA Volume 6. 206 . More details are given in VDA Volume 6. upon request. When certifying according to VDA 6.1 questionnaire must be evaluated.
Changes have been made in: Foreword "Quality Standards of the German Automotive Industry" updated 3.1 Changes of the 4 Edition compared to the 3 Edition Further corrections and updating have been incorporated. 3. elements and questions has widely remained unchanged.3 Rating during Customer/Supplier Audits (2 Party) The classification for customer/supplier audits (2 –party) has been revised taking into account the questions with special influence (*-questions). Quality System Audit Scope of application for all 3 audit types (1 -. 3.3. 3. The audited organization is from now on generally referred to as „the company„. rd nd nd st nd rd 207 . 3.1 Individual Rating of Questions and Quality Elements The definition of „mainly„ has been extended. The factual content of the chapters. The definition of 41 questions as being of special influence to product and process quality or the quality system (*-questions) has been newly introduced.4 Awarding of the VDA 6.3.2 Selection of the Quality elements and Relevant Questions The possibility regarding the omission or addition of elements or questions have been defined more precisely.1 Certificate Supplement (3 –party) Rules for the issue of certificate. An additional downgrading from A to AB has been introduced when questions are marked with 0 points. and for follow-up or re-audits have been newly included.12 Appendix th rd 12.3. 2 – and 3 -party) determined.
VDA 6.1 Certificate The text of the certificate has been changed. The statement of the level of compliance has been dropped.
Questionnaire Question 01.6: Management review "with all elements" dropped Question 03.1: Qualification requirements for internal auditors updated. External auditors now defined under 04.5. Question 04.5 Qualification requirements for external auditors newly included. Question 06 The circle of persons to be informed has been newly formulated.
Question 06.4 Definition for „Emergency Plans„ revised. Element Z1 Is now generally to be taken into account during audits/certification.
Question Z1.3 Examples for data have been supplemented. Question 07.5 Formulation: „early„ has been added. Question 09.4 Quality evaluation „at least three times„ has been dropped. Element 10 Element 11 VDA Volume 1 has been added as being applicable. „Supplier„ is generally used instead of „Subsupplier„. The note was added that the element is also applicable for internal customer/supplier relationships.
Question 11.6 „inspected“ and „not inspected„ has been replaced by „released„ and „not released„. Question 13.2 „Inspection and test plan„ has been replaced by „inspection and test instruction„. Question 13.3 Formulation: „Production parameters of the process“ has been replaced with „process parameters“. Question 13.4 Formulation: „Manufacturing means„ has been replaced by „production means„. Question 14.1 Explanation to „Process Capability„ added. Question 14.2 PPA Process according to VDA Volume 2 and note on process changes added. 208
Question 14.7 Note on applicable methods added. Question 15.1 „Destructive testing„ added. Question 15.2 Procedure for rework added. Question 15.6 „Durability test„ added, „Product audit„ dropped (compare 03.4). Element 20 „Quality-relevant records„ changed into „Quality records„. Note on VDA Volume 1 added.
Question 20.1 Formulation: „maintenance„ has been dropped. Question 20.3 Definition for DwSpA added (compare VDA 1). Element 21 8 Forms Note on procedure when only Question 21.3 is relevant.
Generally, the term „supplier“ has been dropped. In the form ‚Corrective actions‘ the word „deviations„ has been added. 11 Notes on Certification
This section has been updated. VDA Volume 6, Basics for Quality Audits is referenced. 12 Appendix
The notes on changes made from 2 dropped.
Edition to the 3 Edition have been
In the following, the comparison tables to DIN EN ISO 9001 are shown.
VDA 6 M 01. 01.1 01.2 01.3 01.4 01.5 01.6 02. 02.1 02.2 02.3 02.5 02.4 02.6 03. 03.1 03.2 03.3 03.4 04. 04.1 04.2 04.3 04.4 04.5 04.6 04.7 05. 05.1 05.2 05.3 05.4 06. 06.1 06.2 06.3 06.4
Comparison Matrix VDA 6.1 / DIN EN ISO 900194
Subject of the Question Company Management Management Responsibility Quality policy Quality objectives Continual improvement Quality system, resources for personnel and material costs Management representative Management review Quality System Quality manual Scope of quality system Responsibility and authority Project management Quality planning Quality plans Internal Audits Auditor qualification Internal quality audits Corrective actions and their documentation Product and process audits Training Training program Further training in quality techniques Further training - Executives New appointments, realization Qualification Promotion of quality awareness Presentation of the quality achieved Financial Considerations to Quality Systems Methods of reporting Regularity of reporting Nonconformity costs internal Nonconformity costs external Product Safety Product liability - Basics Products requiring documentation Identification of product risks Localization of nonconforming units DIN EN ISO 9001 4.1 4.1.1 4.1.1 -220.127.116.11 18.104.22.168, 22.214.171.124 4.1.3 4.2 4.2.1, 4.2.2 4.1.2 126.96.36.199 (4.4.3) 4.2.3 4.2.3 4.17 4.17.2 4.17.1, 4.17.3 --4.18 4.18 4.18 4.18, 188.8.131.52 4.18 4.18 ---(4.1.3) ---(4.2.3a, -g) -(4.8)
VDA 6 Z1. Z1.1 Z1.2 Z1.3 Z1.4 Z1.5 P 07. 07.1 07.2 07.3 07.4 07.5 08. 08.1 08.2 08.3 08.4 08.5 08.6 08.7 09 09.1 09.2 09.3 09.4 09.5 09.6 09.7 10. 10.1 10.2 10.3 10.4 10.5
Subject of the Question Corporate Strategy Business plan on costs, sales, quality etc. Measuring methods for business results and CIP use Performance data, company-wide / comparison Customer satisfaction, measurement and modification Personnel satisfaction Product and Process Contract Review / Quality in Marketing Marketing function Contract review Structure quotation Quality requirements of the customer Requirements and performance specification known Design Control Product/process development plan Quality requirements fully considered Product/process trial Management review Design approval Result of design work Transfer of development experience Process Planning (Process Development) Process development Plan for new/modified products Production plans, work instructions Quality requirements fully considered Management review of processes and procedures Approval of processes and procedures Result of process planning and development work Transfer of experiences from process planning Document and Data Control Quality-relevant documents, responsibility, procedures, .. Approval and revision Archiving Appropriately times introduction of customer documents Non-use of invalid documents ------
DIN EN ISO 9001
4.3 -4.3.1, 4.3.2 -4.2.3, 4.3.2a, 4.3.2c 4.4 4.4.1, 4.4.2, 4.4.4, 4.4.5 4.4.4, 4.3.2c 4.4.7, 4.4.8 4.4.6 4.4.8, 4.4.3, 4.4.5 4.4.5 4.4.3, 4.4.5 4.4, (4.9) 4.4.1, 4.4.2, 4.4.4, 4.4.5 4.9 Abs.1, 4.9a 4.4.4, 4.3.2c 4.4.6 4.4.8, 4.4.3, 4.4.5 4.4.5 4.4.3, 4.4.5
4.5, 4.5.1 to -3
4.5.2, 4.5.3 4.3.4 4.5.2 4.5.3
4. 4.1 4.9b 4.10.7 15.4 15.16 4.9 Para. 4.6. (4.2 15.1.5 15.12 4.9c.6.4 (4.6.9f 4. (4.3 12.6 14.12 4.3 184.108.40.206) 4.2b 4.9d 4.12 4.9 (Para.3 11.1.2a 4.2 12. 4.7 14. 4.2. 4.4.6. 4. 4.8 4.1.-e 4. 4.10. 14.9d. Purchasing Order documents Subject of the Question Supplier selection Sample test Supplier quality performance Agreements on quality inspections Material receiving inspection Traceability Control of customer-supplied Products Agreed quality measures Minimum scope of inspection and testing Reporting of nonconformities Quality history Process Control/Identification and Traceability/Inspection and Test Status Product identification Process control measures Records of process parameters Production means – Storage Quality objective/subsequent process.2 4.7 4.1 15.7 12 12.2 11.4. -e 4.9b.3 13.3.2 220.127.116.11 4.19´6) 4. preventive servicing Special processes Environmental conditions specified/complied with Evaluation of the effectiveness of production processes Inspection and Testing Inspection and test plans Inspection and test plans and instructions Quality evidence for external purchases Quality evidence according to work steps Quality evidence on the final product Periodic inspections and tests 13.6. (4.6 11.-c.18.104.22.168 4. 2.9g 4. 4.8.9e 22.214.171.124.5 14. 4.1 11.4 13. 15.6.7 4.2h 126.96.36.199 4.4 13.11. 3 4.2) 4.3) 4. -d.1 12.1 14.-d.2 13.3b.2.5 13. dispatch Traceability Release on restart Process Control Machine/process capability tests Production release Control of relevant process parameters Maintenance.1 13.10.11. 188.8.131.52) 212 .4. 4.2c 4. 4.9.6 184.108.40.206.1.4) 4.6.10. 4.6 DIN EN ISO 9001 4.6.2b.12.7 4.9 4.4 14.7 4.4 11. 11.VDA 6 11.8 (Para. 4.2g -4.3.6 13.3 14.6.5 11.
2 4. 18.4 22.4 -4.14. 22.2a) 4.4.1 with 4.14.3 18.5 22.1 17.2d 4.11.2b 4.15.4 19.16 4.13.-d.13.2 19.14.3 20.15.2 21.1 18.19 4.13.4 18.11. 4.1 16. Measuring and Test Equipment Control and calibration system Connection to national/international standards Measurement uncertainty of inspection.2 17.1.3 21.2a (4.2 22. 16.15 220.127.116.11.3.11. 4.16.VDA 6 16.4 16. 4.20 4.1 19.1.-c.19) -(4. 20.1 22.4.2f 4.2 4.4 19.2 4.2b) -4.1 20.15. Preservation and Delivery Product handling Packaging and identification process Prevention of transport damage Correction of packaging errors Product identification Delivery reliability Control of Quality Records Quality-relevant documents Evaluation of quality records Archiving Customer access to quality records Quality in the application phase/Servicing/Customer Service Users manual and installation instructions Product observation/Field failure-early warning system Field failure analysis Customer service information Servicing Statistical Techniques (at) Method planning Development/Trial External sources Process development and control Final inspection Evaluation of field failures DIN EN ISO 9001 4.-i 4.2b 4.1 4.14.6 4.14. measuring and test equipment capability Measures to be taken in case of nonconforming inspection.5 19.1. 17. 4.2 18.104.22.168 4.5 22.20 4.15.19) (4.6 Subject of the Question Control of Inspection.1 21. measuring and test equipment Control of Nonconforming Products Treatment of nonconforming units Concessions Carrying out of corrective actions Identification of reoccurring nonconformities Corrective and Preventive Actions Initiation of corrective actions Estimating the nonconformity risk Analysis of the cause of nonconformities Prevention of nonconformity reoccurrence Handling.2 16.14.6 20.3 16. 19.5 17.16 4.2 4.3 4.2 b.15.11 4.16 (4.3 17. 4.4.-g.15.3 22.11.2a 4.4 4.20 213 .11.15.13 4.20 4.3 22.214.171.124 4. Storage.4 4.4 21 21.1 4.20 4.14.20.-e.3 19. measuring and test equipment Inspection.11. Packaging.20 4.4 21.1.2 20.
6. 09.2 01.2 .4).126.96.36.199 08. 07.1.2.3 .12.2. 09.1 07 07. 08. 09.4.2.5.5.7.1. 08. 09. 08.2.5.2. 02. 08.6 . [06. 07. 02.1 (02.6.2 Comparison Matrix DIN EN ISO 900494 / VDA6.09.2. responsibility and authority .2 . 09.4.5. 09. nonconformities quotation/order Capability to meet the requirements Amendment Records Design Control General Design and development plan Organizational and technical interfaces . 09.3 .2.2 07. 09. 02. 01.1. 08.2. 4.1 08. 09.3.1. resources Organization. 01.3 01.1 Quality policy .2. 20.1 Organization. 09. 02. 08. 08.1.1 .7 08.3 See introductory comment.5.7 08.2c . 01. 04.7. 09. management representative Management review Quality System General Documented quality procedures Quality planning VDA6 01 01.1 Management Responsibility .8 .5 Design input Design result .5).3. 15.3 .1 (04.4 4.3 4.3].2) 02 02. 09.9 Design review Design verification Design validation Design modifications 214 .7.2 .2a .1.2.4 . (05.2b .4.2.08. ].3 Contract Review General Review.6.3.1. 07. 09.4 08.3 08. 09 08.5. 08.2 02. 09.2. 02.7] See introductory comment.1 . [09. 08.6.1 .5 [08.4 .2 07.1.4 07. 02.3 Organization.7 .2 . requirements documented and understood P.1 .1 DIN EN Element according to DIN EN ISO 9001 ISO 9001 4. 02.5.1 .
3.6 .5 11 11.2 11. 13.5.4 10.6 12 (06.3 .4 9. 13.4 11.1 .1. 14.5.1 .2b .2. 9. personnel 215 .3.1.4) 9. equipment.1.1 [11.5 9. 13.2. 10.7.2a .3. . 11. (13. 11. 14. 14.2. quality plans.5 Document and Data Control . 14 9.2.6 [11. 14.2 with introductory comment].5. 11. 14. 14. 13. 11.2 4.7 4.6 9.DIN EN Element according to DIN EN ISO 9001 ISO 9001 4. documented procedure.3 14. 11.2. 11.3 Para. 13.1. 13.9 Para.2 9. 13. & D.5].3).4.2c .6. 9. 14. Inspection of purchased products (Inspection by the customer).1.5]. 11. Control of Customer-supplied Products Identification and Traceability of Products Process Control Planning of quality-influencing assembly and servicing Documented procedures Suitable equipment and environmental conditions Compliance of standards.1 General . 10.4.2. 10. 11.2. 9.6 9.7.2 9.3.2 9.7.5. 9.1 10.2 Approval and issue of D.7.3 Amendments to documents and data VDA6 10 10.2. 14.4 Approval of processes and equipment Criteria for work performance Maintenance Release Special processes Recordings of quality processes.8 188.8.131.52 11. Matching process parameters e f g e Para. 13.4.3 4.1 a b c d Purchasing General Evaluation of subcontractors Suitability: evaluate and select Monitoring: Capabilities and performance Record corresponding data Purchasing information Inspection of purchased products (Supplier at the subcontractor). 14.4 11.2. 13.4.2 9. [07.
2 16.2e . (16.1 13.3) 18.3.2a ..6.3.2 .1 .1.4 15. 18.3. 15.1 19. 15. 19.2 4.3 18 18..1.14 .4 17. measuring and test equipment Environmental conditions for measurements Handling.1 13.5 4.1 .6 Receiving inspection and testing Application after verification Scope and type of receiving inspection Pre-release and concession In-process inspection and testing Final inspection and testing Inspection and test records Control of Inspection. 18. 15.3 [07.2g . 19.2 19 19.13 .5 . 16.DIN EN Element according to DIN EN ISO 9001 ISO 9001 4. 20. system Corrective action – Determination of. 19. Preservation and Delivery General Handling Storage Packaging Preservation Delivery 216 . 19.2d . 15.5].4 [07.3 4. 17.11 .4.1 .2c .15 .3 15. Storage. 16.4. measuring and test equipment Determination of corresponding procedures Identification of calibration status Archiving of records on calibration Evaluation and recording of previous measurement results for nonconformities on inspection.1 General VDA6 15 184.108.40.206 . 19.1 . Corrective action – Monitoring of their effectiveness Preventive actions Handling. 17.1 19.5].12 4. Packaging. 15.4 17 17.3 .2b .3 .2. protection and storage of inspection.3 .1.2f .4 220.127.116.11 18.2c . inspection and testing and inspection. 19.4 16.1 17.1 .1.3 .1 18.1 14.2b .4) 16.5 14.2a .2. measuring and test equipment Protection of the calibration status Inspection and Test Status Control of Nonconforming Products General Evaluation and handling of nonconforming products Corrective and Preventive Action General Corrective actions.3.2 .6) 18.104.22.168 with 16.2.4 .4 16. 16.5 (Records always) 16 16.5. 18. 15. measuring and test equipment Determination and calibration of inspection.2i 4.1 16. (21.3 15.10 Inspection and Testing .1. process.1.6. effective treatment of nonconformities Corrective action – cause of nonconformity in relation to production.2h . Measuring and Test Equipment General Determination of control procedure. (15.1.1 .1.4 18.3 15.1 16.1.2d .
1.1 .1 03.2 03.19 4.4 21. 21.18 4.5 22 21.1 to 21.1 Para.3 04 (21.DIN EN Element according to DIN EN ISO 9001 ISO 9001 4.3.16 Control of Quality Records 4.3.17 Para.3 Para. 21.2 Internal Quality Audits Documented procedure Planning of audits and auditors Recording and distribution of results Follow-up audits – corrective actions Training Servicing Statistical Techniques Determination of demand Procedure VDA6 12. 21. 20 03 03. 21.2 Para.2.20 . 21.21. 21.4).4 217 .1.4 4.3.2 03.2.
7 copies (packed of 50 sets) First Sample Test Report – Test result. Order No. 5 copies (packed of 50 sets) Outline form for process capability verification. 769. Pad of 10 sets à 12 sheets Evaluation documents Final evaluation of the quality system Summary of results Total grading Summary of evaluated questions Individual measures Corrective Actions-Outline DIN A4. 218 . Order No. 7422.old version Order No. D-60528 Frankfurt Telephone (069) 96766-158. Pad of 10 sets of 5 sheets The two pads form a unit and are only offered as a set Order No. Pad of 50 sheets FAILURE-POSSIBILITY-AND –INFLUENCE-ANALYSIS (FMEA) . 2661 Test results. 1749 Order: DRUCKEREI HENRICH GMBH Schwanheimer Straße 110. 2662 Multipart form set. Order No. DIN A3 format.new version Order No.FMEA . Pad of 50 sheets QUALITY SYSTEM AUDIT (Material products) Questionnaire (only questions) DIN A5. DIN A3 format. 5332 Pad of 100 sheets SYSTEM . Telefax (069) 96777-159.Other VDA-FORMS FIRST SAMPLE TEST REPORT – new version • • • Cover page. 5331 Multipart form set. 2663 Pad of 50 sheets – Minimum order 1 pad FIRST SAMPLE TEST REPORT – present edition First Sample Test Report – Report result. Order No. Order No.
Methods Quality Assurance prior to Serial Application -System FMEAQuality Assurance prior to Serial Application -Project PlanningBasic for Quality Audits. Processes.Quality Management in the Automotive Industry Volume 1 Quality Evidence Guidelines for Documenting and Archiving Quality Requirements Quality Assurance of Supplies -Supplier Selection/Sampling/Quality Performance in the SeriesEnsuring Reliability of Car Manufacturers and Suppliers -Procedures and examples Quality Assurance prior to Serial Application -Partnerships. Basics DIN EN ISO 9001 and DIN EN ISO 9004 System Audit – Services Process Audit Product Audit Basics for Interchange of Quality Data -Electronic Transfer of Quality DataGuidelines for Quality Assurance of Trailer. Superstructure and Container Manufacturers Emissions and Consumption Volume 2 Volume 3 Volume 4 Part 1 Volume 4 Part 2 Volume 4 Part 3 Volume 6 Volume 6 Part 1 Volume 6 Part 2 Volume 6 Part 3 Volume 6 Part 5 Volume 7 Volume 8 Volume 9 219 . Auditing and Certification Quality System Audit.