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Instructor / Lecturer:
Audience Acquaintance / Ice Breaker:
Introduce yourself What Company do you work for? Any previous Quality Management or auditing experience? Define a process in your company which has a direct impact on the customer (External)
Switch mobile phones to the silent mode. Toilets. Break. Material provided. A written open book final exam
Switzerland. 42’000 employees -1000 Offices and 320 Laboratories in more than 120 Countries. 4 . quality and integrity. SGS is recognized as the global benchmark for the highest standards of expertise.Is THE Global Group Established in 1878 .Head Office in Geneva.
We provide leading & innovative services to all industries Certification Inspection & Verification Outsourcing In the areas of: Risk Management Technical Consulting Testing & Analysis Trainings ®: ISO/TS 16949: 2002 3 Days Internal Auditor Certification Course 5 .
Understand the structure and content of ISO/TS 16949: 2002.Course Objectives: Understand and apply the automotive process approach to auditing. the support documents and the automotive core tools. Demonstrated personnel attributes and demonstrated ability to apply knowledge and skills. 6 . Who should attend? A person who has the competence to conduct an audit.
Goal of ISO/TS 16949: 2002 The goal of this Technical Specification is the development of a quality management system that provides for: • Continual improvement • Emphasizing defect prevention and • The reduction of variation and waste in the supply chain. 7 .
Course Outline: Session 1 Background & Development of ISO/TS & Automotive Process Approach Internal Auditor Qualification & Customer Specific requirements APQP & Control Plan Statistical Process Control (SPC) Failure Mode & Effect Analysis (FMEA) Measurement System Analysis (MSA) Rules For Achieving IATF Recognition Written Exam (Open Book) Session 2 Day 1 Session 3 Session 4 Session 5 Session 6 Session 7 Day 2 Day 3 8 .
Session 1: Background & Development of ISO/TS 16949: 2002 & Automotive Process Approach 9 .
History of Quality Standards 1979 BS 5750 1987 ISO 9000 series 1994 ISO 9000 revision / QS 9000 issued 10 .
11 .Automotive migration to International Standards EAQF France AVSQ Italy VDA 6 Germany QS 9000 USA Automotive sector Quality requirements (With registration variation) ISO/TS 1st edition ISO 9001: 1994 Based document ISO/TS 2002 edition ISO 9001: 2000 Based document 1994 1997 1998 1999 2000 2002 The plan is to have no change before 2008 at the earliest due to alignment with ISO 9001: 2000 update.
IATF Representatives France Car Makers PSA Renault Liaison (Europe / US) FIEV National Super Organization VDA ANFIA Germany Italy VW BMW Daimler Opel Fiat USA Chrysler Ford GM VW of USA AIAG / IAOB SMMT JAMA Nissan Toyota Honda Suppliers Faurecia Bosch Magneti Marelli Bosch USA GKN UK Japan 12 .
13 .Scope of ISO/TS 16949: 2002 This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured. Also applicable to vehicle manufacturers. This technical specification can be applied throughout the automotive supply chain.
Business Planning Business Plan Policy Imp act Objectives Planning In e c n e flu Employee Motivation & Empowerment 14 .
Terminology ISO/TS 16949: 2002 Process Customer Procedure ISO 9001: 1994 15 .
8 Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach to management Continual Improvement Factual Approach to decision making Mutually beneficial supplier relationship Please find a requirement in ISO/TS which relates to each of the above principles. 16 .
Process Approach 5 6 4 8 7 17 .
Process Any Activity or set of activities that uses resources to transform inputs to outputs 18 .
INPUT Customer who has a need OUTPUT Customer who has a need met And a chain of activities between these two limits Input Step 1 Step 2 Step “N” Output 19 .A process A process has a start and an end defined by two limits.
20 .Identification of processes ISO/TS 16949: 2002 requires: The organization shall identify processes needed for the quality management system and their application throughout the organization. Measure. monitor and improve these processes. Determine the sequence and interaction of these processes.
1) Awareness of policy/ objectives (6.5.2) Preventive maintenance (188.8.131.52.5.5) How? Control plans (7.5.2) Agency/ Contract labour (6.1) Induction/ training records (6.4) Cost of poor quality (5.2.4) Packaging/labeling (7.1) Nonconforming product procedure (8.1) Other Organizational objectives (5.3/4) (Support Processes) IT Human resource Logistics Sales Quality Preventive maintenance What Results? Analysis of data (8.6.3) Measuring equipment (7.1.1) Maintenance objectives (7.1.1) Continual improvement results (184.108.40.206.2.4) Outputs Conforming product delivered to customer schedule (8.1.5) Training effectiveness (6.5.1) Customer satisfaction (220.127.116.11.2) Personnel safety (6.5) Maintenance (7.4.6) Raw materials (7.3) Process equipment (6.3) Dispatch process (7.3) Job responsibilities/ authorities (5.5) Customer property (18.104.22.168) Management review (22.214.171.124.2) Document control/ records (4.4) Process: With Who? Competence criteria (6.2) 21 .7) Contingency plan (126.96.36.199.2.4) SPC (8.1) Manufacturing Process (188.8.131.52) Tooling (7.Audit Tool: Turtle Diagram With What? Plant and machinery (184.108.40.206.1) Process capability (8.3.4) Transportation (6.2) SPC awareness (8.3) Inputs Customer schedule (220.127.116.11.1) Work instructions (7.5) Audit records (18.104.22.168.
Turtle Diagram Workshop In your groups analyze the process allocated by the trainer and create a turtle diagram. 22 .
when. and how much? Check Check • How will you know it worked? Act • How do you plan to fully adopt? 23 .Process Improvement (Shewart Cycle) Plan • What and why? Act Plan Do Do • How.
The Dilbert Cycle Blame someone else for catastrophe Make wild guess at what is wrong ACT Adopt unproven process or technology 24 .
Plan-Do-Check-Act diagram Requirement Requirement Yes Plan Plan Do Check Conforms? No Product / Service Corrective Action Feedback Loop Continual Improvement 25 .
The << V >> Cycle and the audit P C Approach << Top Down >> A PDCA feedback system D 26 .
5. 2. information feedback. Worst case operations. Management of improvement plans (the dinamism) 27 . looking at such items as: 1. 3. Deployment of objectives. 6. Resources assigned.The << V >> Cycle and the audit – Cont. The audit plan must take into account the way the processes should be managed. 4. Indicators. Organization.
responsibilities assigned and responsibilities defined! Top Management P Management from the top management at every level! Strategy Policy Objectives Resources Strategic thinking Decisions Use information A Top Management Process Owners Risk analysis Planning the activities C D Operations & recording Reporting Improvement actions Collect and analyze Operational information Process Owners Participants Participants The organization must identify and allocate necessary resources but also ensure continual improvement 28 .The << V >> Cycle: Follow through the business strategy Responsibilities shared.
What is the actual performance? C A P Do How is performance being improved? How was the process planned. At the work station? 29 .The CAPDo Logic Start with a questions about performance. does the process design allow performance objectives to be met? Previous Performance results? Is the process being carried out as designed? Are the Methods being applied in the field? On the shop floor. what are the indicators and objectives. what is expected.
1.2.3) Job responsibilities/ authorities (22.214.171.124.1) Continual improvement results (8.2.4) Manufacturing Process (7.5) How? Control plans (7.5) Audit records (8.1.1) Maintenance objectives (7.3) Dispatch process (126.96.36.199) Management review (5.4) Process: Outputs Conforming product delivered to customer schedule (8.2.1) Induction/ training records (6.3.6) Raw materials (7.4.5) Customer property (7.1) Awareness of policy/ objectives (188.8.131.52.184.108.40.206.4) SPC (8.2.7) Contingency plan (6.1) Process capability (220.127.116.11) Other Organizational objectives (18.104.22.168) With Who? Competence criteria (6.1.2.Understand the process to audit With What? Plant and machinery (6.2.2) Preventive maintenance (7.1) Nonconforming product procedure (8.2) Agency/ Contract labour (6.4) Packaging/labeling (7.2.3) Inputs Customer schedule (7.6) Tooling (7.4) Cost of poor quality (5.2) SPC awareness (8.2) Personnel safety (22.214.171.124.126.96.36.199.1) Work instructions (7.2) 30 .2) Document control/ records (188.8.131.52) Measuring equipment (7.6.3) Process equipment (184.108.40.206) Training effectiveness (6.4) Transportation (6.3/4) (Support Processes) IT Human resource Logistics Sales Quality Preventive maintenance What Results? Analysis of data (8.3.1) Customer satisfaction (8.5) Maintenance (7.
reporting and reviewing performance against quality objectives & evaluation of the cost of poor quality 31 .Effectiveness of system Customer measures: • Delivered part quality performance • Customer disruptions including field returns • Delivery schedule performance (including incidents of premium freight) • Customer notification related to quality or delivery issues Organization measures: • Establishing.
32 . • Realistic • Time-phased. An effective quality planning goal has five characteristics (SMART): • Specific. • Agreed upon/Achievable.SMART The more the goals reflects the customers needs and expectations. • Measurable. the more successful the project will be.
Audits parties’ levels Accreditation Body Certification Body S U P P L I E R 2nd p 2nd p 2nd p 33 4th p 3rd p 3rd p 1st p O R G A N I Z A T I O N 3rd p 1st p C U S T U M E R 1st p .
34 .Why conduct Internal Audits? To comply with quality management system standards! To help facilitate continuous improvement of the quality management system Help in sharing best practices between departments Provides management information about the state of the business Helps focus attention on need for system compliance.
Phases of an audit Audit planning and scope Preparation • Documentation • Checklist Executing the audit • Opening meeting • Collecting evidence • Closing meeting Audit report preparation / distribution Corrective action follow up / Close out. 35 .
activities and shifts in accordance with an annual plan. Prepare an audit plan to satisfy the system and process audit requirements in ISO/TS 16949: 2002 36 . the audit frequency shall be appropriately increased. • Cover all processes. • When internal / external non conformities or customer complaints occur.Audit Planning The audit program shall be planned taking into consideration: • Status and importance of the processes and areas to be audited. • Results of previous audits.
Manufacturing process audit: Audit of each manufacturing process to determine its effectiveness Product Audit: Audit of product at appropriate stages of production and delivery to verify conformance to all specified requirements.The audit approach Quality management system audit: Verify compliance with ISO/TS 16949 + any additional quality management system requirements. 37 .
Can be extended to apply to any company business processes. ISO 9001.2: The organization shall audit each manufacturing process to determine its effectiveness. 2000 requires a process approach 38 .Manufacturing Process Audit ISO/TS requirement 8.2.2.
3 Audit product at appropriate stages of production and delivery to verify conformance to all specified requirements such as product dimensions. at a defined frequency. labeling. packaging. functionality. 39 .2.Product Audits Known in QS-9000 as final product audit (Applied to final packaged product only) ISO/TS requirement 8.2.
on after by by .an independent auditor 40 .completion of a production stage .Product Audits A product audit is the planning.comparison with reference values .Quantitative and qualitative characteristics.material products . evaluation and documentation of examinations of . performance.
5 for guidance 41 .Product audit planning Link to production process audits or run as an independent audit program? Base frequency on results! Immediate action required if problems found Refer to VDA6.
Session 2: Internal Auditor Qualification & Customer Specific Requirement 42 .
Competence: Demonstrated personal attributes and demonstrated ability to apply knowledge and skills.Internal Auditor Qualification ISO 19011 Auditor: a person who has the competence to conduct an audit. 43 .
Auditor Competence defined in ISO 19011 Quality system knowledge Generic Knowledge Environment System knowledge Education Work Experience Auditor training Audit Experience Personnel attributes 44 .
Current techniques What is your organizations current process for qualifying internal auditors? How is competence maintained? 45 .
2.2 Training) Ensure that your understand your Customer specific requirements for auditor qualification • E. Ford / GM / Peugeot 46 .Internal Auditor Qualification Auditor Qualification: “The organization shall have internal auditors who are qualified to audit the requirements of this technical specification” (See 6.g.2.
core tools.Examples of Customer Specific qualification requirements Ford (requirement 4.39) • Trained in ISO/TS 16949: 2002. • Participate in practice sessions equivalent to one day. • Training delivered by a trainer qualified under the above criteria Or • Conduct at least 5 internal audits in 24 months. customer specific requirements and the automotive process approach. under supervision of an auditor trained as above 47 .
FMEA) • Understand GM customer specific requirements 48 .10) • Qualified as recommended in ISO 19011 sections 7. MSA. APQP. SPC.17.5 • Understand the process approach • Understand core tools (PPAP.1.Examples of Customer Specific qualification requirements General Motors (Requirement 4.
Internal Auditor Qualification What do you think an organization should take into account when selecting and qualifying internal auditors? Define what you think a “Competency profile” should be? 49 .
focused on achieving objectives Decisive: Reaches timely conclusions based upon logical reasoning and analysis Self – reliant: Acts and functions independently while interacting effectively with others 50 . honest. truthful. discreet Open minded: Willing to consider other points of view Diplomatic: Tactful in dealing with people Observant: Actively aware of physical surroundings and activities Perceptive: Instinctively aware of and able to understand situations Versatile: Adjusts readily to different situations Tenacious: Persistent.Personnel Attributes Ethical: Fair. sincere.
Auditor Qualification Criteria Education Training in ISO/TS 16949: 2002 Work Experience Quality management experience Demonstrated ability to apply knowledge and skills 51 .
and amendments maintained for the length of time for the part plus one year – Production inspection and test results retained for one year after the year when they are created – Internal audit and management review records retained for three years • 4.Customer Specific Requirements Overview of Ford Motor Company: • 4. purchase orders.4 Control of records: – PPAP. tooling records.6 Customer representative: – Inform Ford within 10 days of any change to senior management responsible for quality 52 .
Process Approach to auditing methodology What are the objective(s) for the process? How do they link to business objective? What activities are carried out in the process? What are the applicable support processes? How is achievement measured? What results are actually being achieved? What actions are planned to ensure achievement of defined objectives? What improvement efforts are being made? 53 .
agenda. where to start and finish!) Make logistical arrangements with auditee (timings.e. audit scope) Identify any objectives / measures related to the process and documents used to control the process (may be done by discussion with auditee) 54 .Preparing to audit a process Ensured scope of audit is clearly defined (i.
Preparing to audit a process Prepare for a process audit by review of key information gathered which may include: • • • • • • Relevant performance indicators / objectives Management review minutes Previous audit records Continuous improvement plans ISO/TS 16949: 2002 Customer specific requirements Planning is essential for an effective audit 55 .
Checklist Preparation ISO/TS 16949: 2002.2.4 note states: “Specific checklists should be used for each audit” Create your own generic checklists or an individual turtle diagram / checklists for each audit Use turtle / checklist as a guide and not the only questions to be asked! 56 . 8.2.
e.Undertaking the audit (What. Outline the objective of the audit to the auditee. Why. Set the Scene: Opening meeting. Analyse the process: Review what actually happens. 57 . How. 3. 2. Establish responsibilities: Confirm responsibilities and what happens in the process / area.g. Show me?) 1. follow an audit trail. When. Who. Where.
When. not just procedure compliance! Look for opportunities for Improvement 58 . Show me?) 4. Search for objective evidence & records Interview relevant employees (Include management) Look for the evidence of implementation and effectiveness of process. Why. Where. How. Who.Undertaking the audit (What.
Why. How. Show me?) 4. Who. Where.Undertaking the audit (What. Search for objective evidence & records • • • • Follow process flow Do not get distracted Take notes on items to follow up on Manage time effectively Open questions may take minutes Closed questions may take seconds It takes time to study data Allow for the unexpected 59 . When.
Why. Show me?) 5. Where. Check back Confirm understanding & link findings (e. to ISO/TS 16949: 2002 requirement) 6.g. How. When.Undertaking the audit (What. Who. Close out Explain audit findings to auditee and agree actions required 60 .
customer requirements.Reporting Findings Evidence gathered should be evaluated against requirements defined in ISO/TS 16949: 2002. (Conformity. prepare written nonconformities / opportunity for improvement 61 . and organizations management system Confirm decisions. Non conformity or opportunity for improvement) Where found.
ISO 9000: 2000 definitions Conformity: Fulfillment of requirement Nonconformity: Non fulfillment of a requirement 62 .
ISO/TS 16949 Definitions Major Nonconformity: • Absence of or total breakdown of a system to meet an ISO/TS 16949 requirement • Any noncompliance that would result in the probable shipment of nonconforming product. A condition that may result in the failure or materially reduce the usability of the product or services for their intended purpose. • A noncompliance that judgement and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes and products 63 .
64 .ISO/TS 16949 Definitions Minor Nonconformity: • A failure to comply with ISO/TS 16949 which based on judgement and experience is not likely to result in the failure of the quality system or reduce its ability to assure controlled processes or products.
e.Opportunities for Improvement Auditors should identify opportunities for improvement as these become evident. Where the situation is compliant but could be undertaken more efficiently. 65 .g.
Preparing nonconformities Typical reporting structure • • • • • • • • • Report number Date Auditor / audit team name and auditee Process / area audited ISO/TS requirement / related procedure Failure observed Evidence found Nonconformity grade (Where applicable) Agreement / signature of auditee 66 .
Audit reporting Report content: • Scope & objectives of audit • Details of auditors / auditees • Reference documents against which audit was conducted • Nonconformities and opportunities for improvement • The systems ability to achieve defined quality objectives • Distribution list 67 .
Corrective action follow up Auditee is responsible for determining root cause. and initiating corrective and preventive action needed to address nonconformities Auditors responsibility is to verify corrective and preventive action is effectively implemented within the agreed timescale 68 .
IBW1 “Temporary employee trained and leak test now being undertaken at the required frequency” Is this acceptable to close the nonconformance? 69 .Audit situation “Work shop” Following submission of the nonconformity report to the manufacturing manager. the following response was received by the auditor. within the agreed timescale: Report no.
2. specified on the control plan for product A1246.2.B.B. Wright Auditee: U.: 8.3 Nonconformity: The leak test.Nonconformity report Report #: IBW1 Auditor: I.1.2. was not being undertaken at the defined frequency & failures were found at customer. Evidence of competency was not seen for other temporary staff. No evidence was available to demonstrate the temporary employee operating the process was competent to undertake the leak test. Wright Process / support: Manufacturing / HR Management ISO/TS req. Nhad 70 Date raised: May 2004 .3. Grade: Major Signed: Auditor: I. 6.B.
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Session 3: Advanced Product Quality Planning (APQP) & Control Plan 72 .
Product Quality Planning Timing Chart 73 .
Preliminary listing of special product & process characteristics. Plan & Define Program Outputs: Design goals. Reliability & Quality goals. 74 . Preliminary bill of Material. Preliminary process flow chart.1. Product Assurance plan. Management Support.
Gages / Testing equipment requirements. 75 .2. Special product & process characteristics. Product design & development Outputs: New equipment. Team feasibility commitment and management support. tooling & facilities requirements. Prototype Control Plan.
3. Process Design & Development
Outputs: Packaging Standard. Product / process quality system review. Process flow chart. Floor plan layout. Characteristics matrix. PFMEA. Pre-launch Control Plan. Process instructions. Measurement systems analysis plan. Preliminary process capability study plan. Packaging specifications. Management support.
4. Product & Process Validation
Outputs: Production Trial run. Measurement system evaluation. Preliminary process capability study. Production part approval. Production validation testing. Packaging evaluation. Production control plan. Quality planning sign off & management support.
5. Feedback, Assessment & Corrective Action
Outputs: Reduced variation. Customer satisfaction. Delivery & Service.
Process analysis 79 .
Control plan methodology What: is a formal document that provides a written summary description of the systems. selection and implementation of value added control methods for the whole product manufacturing processes Where: all actions required at each phase of processes including receiving. in-process . and periodic requirements to assure that all process outputs will be in a state of control 80 . methods and documents used in controlling parts and processes in order to minimize process and product variations Why: to aid in the manufacture of quality products according to customer requirements How: by providing a structured approach for the design.outgoing .
size and complexity of its manufacturing processes . A single control plan may apply to a group or family of products that are produced by the same processes at same source. 81 .CP – Important notes The control plan does not replace the information contained in detailed operator instructions but may make reference to. The control plan should provide the processes monitoring and control methods that will be used to control both product characteristics and process parameters The control plan represents an integral part of an overall quality system and should be used in conjunction with other related documents The control plan should be utilized as a living document that responds to continual updating and improvements of processes Organization should use the control plan format that is most suitable to its type.
such as: • • • • • • Process flow diagram PFMEA Special product characteristics Lessons learned from similar parts Team knowledge of the process and experience Design reviews 82 . Utilize all the available information to gain a better understanding of the process. design. manufacturing. quality functions and others as appropriate. customer services.While establishing control plans use a cross functional (multidisciplinary) team that comprises engineering.
it identifies and communicates changes in product/process characteristics.ultimately enhancing customer satisfaction As a living document . control methods and corrective actions. manufacturing and assembly .Benefits of developing and implementing control plans includes It’s an aid to reduce waste and improve the quality of the products during design. 83 . this will help to reduce costs without sacrificing quality . It’s a structured discipline that provides a thorough evaluation of the product and process It helps to identify source of variations (input variables) that cause variation in product characteristics (output variables) It focus resources on processes and products related to characteristics that are important to the customer .
Types of control plans Prototype CP: it is a description of dimensional measurements and material and performance tests that will occur during prototype build Pre launch CP: it is a description of dimensional measurements and material and performance tests that will occur after prototype and before full production Production CP: it is a description of dimensional measurements and material and performance tests that will occur during mass production 84 .
/Tolerance 10 Size Sample Frequency 11 Respo nsible 12 Reaction Plan 13 Documents 14 Records 85 .Control Plan Table: 1 Serial 2 Operation # 3 Material Operation Description 4 5 Characteristics 6 Measurement Technique 7 Clas s 8 Machines / Device / Equipments / Tools 9 Spec.
Session 4: Statistical Process Control (SPC) 86 .
calculating control limits and interpreting data Understand the term process capability 87 .Objectives Understand the purpose of statistical process control (SPC) and link to ISO/TS 16949: 2002 Understand variable and attribute data and the types of charts used for each Understand methods of constructing control charts.
1: 8.1.Link to ISO/TS 16949: 2002 7.2: Control Plan Verification of Job setup Measurement system analysis Identification of statistical tools Knowledge of basic statistical concepts Monitoring and measuring of manufacturing processes Manufacturing process improvement 88 .1.3: 7.2: 8.1: 8.5.1: 220.127.116.11.18.104.22.168: 8.3.1.
What is Statistical Process Control The use of statistical techniques such as Control Charts to analyze a process or its outputs so as to take appropriate actions to achieve and maintain a state of statistical control and to improve process capability” 89 .
Quality Loss Function. Distribution of Products produced 90 .
Types of Statistical Quality Control 91 .
Quality Characteristics 92 .
All process are subject to variability: • Natural causes: random variations. • Assignable causes: correctable problems. Uses process control charts.Statistical Process Control Statistical technique used to ensure process is making product to standard. unskilled workers. poor material. – Machine wear. 93 . Objective: Identify assignable causes.
Process Control: Three Types of Process Outputs 94 .
Has many uses: • • • • Identify data collection points. Identify where travel distances can be reduced. Identify places for improvement. 95 .Process Chart Shows sequence of events in process. Depicts activity relation ships. Find problem sources.
Statistical Process Control (SPC)
Uses statistics & control charts to tell when to adjust process. Developed by Shewhart in 1920’s. Involves:
• Creating standards (Upper & Lower limits). • Measuring sample output (e.g. mean wgt.). • Taking Corrective actions (if necessary).
Done while product is being produced.
Statistical Process Control Steps
Process Control Chart
Patterns to look for in Control Charts 99 .
Process Capability Cpk 100 .
Meaning of Cpk Measures 101 .
000.00 1.000 233 / 1.Capability Indices If the process data have a normal (bell shape) distribution the following can be used as a guide to interpret Cpk: Cpk 1.33 1.000 / 1.000 Customer will often specify minimum Cpk 102 .4 / 1.00 Approx.67 2.000. % out of Spec 66.000 6.000 / 1.000.000.000 3.
Session 5: Failure Mode & Effect Analysis 103 .
3.2: 7.Requirement for FMEA in ISO/TS 16949 0.1.3.3: 22.214.171.124.5: 126.96.36.199: 7.1: Goal Engineering specifications Multidisciplinary approach Special Characteristics Product Design Output Manufacturing process design outputs Control Plan 104 .1: 7.3.1: 188.8.131.52.
Definition of FMEA A systematic group of activities intended to: Recognize and evaluate the potential failure of a product / process and the effects of failure Identify actions that could eliminate or reduce the chance of the potential failure occuring Document the entire process 105 .
Vehicle Manufacturing View Evidence from vehicle campaigns / recalls have shown a fully implemented FMEA could have prevented many cases Act “before the event” (Prevention) not after (Detection) 106 .
Interaction with ISO/TS 16949: 2002 Product Realization Continual Improvement Design Control Design & Process FMEA Competence / Training Process Control Corrective / Preventive Action 107 .
Severity is the rank associated with the most serious effect for a given failure mode Severity can only be reduced by design change Team should establish criteria and ranking system
Occurrence is the likelihood that a specific cause / mechanism of failure will occur Rank from 1 to 10 The ranking number has a relative meaning rather absolute value
Detection is the rank associated with the best detection control listed in the process control column
Occurrence and detection ranking S X O X D = RPN This value can be between 1 and 1000 Customers may define trigger points for action (e. RPN > 100 Severity > 8) 111 .Risk Priority Number – RPN RPN is the product of severity.g.
FMEA Flow Chart Assign a label to each process or system component List the function of each component List potential failure modes Describe effects of the failures Determine failure severity Determine probability of failure Determine detection rate of failure Assign RPN Take action to reduce the highest risk 112 .
R esp o n sib ility A ctio n s e Pm en d ed &C o m p letio n T aken t NA ctio n D ate S O D R e c e P v c t N ItemF u n ctio no r P u rp o se P o ten tial P o ten tial F ailu reM o d eE ffect o f F ailu re 113 .FMEA Worksheet F ailu reM o d ean dE ffectsA n aly sis P roduct or P rocessN am e: C om ponent: M odel N um ber: D esignR esponsibility: C om pletionD ate: F M E AN um ber: P reparedB y: S CP o ten tial OC u rren t e l C au seo f c C o n tro ls v aF ailu re c s u s r r A ctio nR esu lts D RR eco m .
recorded and closed 114 .Recommended Actions Actions should be targeted toward high RPN / high severity Intent is to reduce ranking by actions Actions taken should be tracked.
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Documentation Linkages within the FMEA process DFMEA PFMEA & Flow Chart Control Plan Work Instruction & Standard Operations 125 .
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Session 6: Measurement System Analysis (MSA) 127 .
6.Requirement for MSA in ISO/TS 16949.1: Measurement System Analysis “Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. 2002 7. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement system analysis. This requirement shall apply to measurement systems referenced in the control plan. Other analytical methods of acceptance criteria may be used if approved by the customer” 128 .
The complete process used to obtain measurements. software. personnel. standards.MSA (Definition) A collection of instruments or gages. methods. environment & assumptions used to quantify a unit of measure or fix assessment to the feature characteristic being measured. operations. 129 . fixtures.
Calibration A set of operations that establish. 130 . the relation ship between a measuring device and a traceable standard of a known reference and uncertainty. under specified operating conditions.
Calibration Linkages National Standard Reference Standard Working Standard Production /gauge 131 .
Measurement System Analysis Material Man Method Input need to measure MEASUREMENT SYSTEM Output Data Machine (Time) Environment 132 .
Measurement system Analysis
“The purpose of any analysis of a measurement system should be to better understand the sources of variation that can influence the results produced by the system”.
This will allow us to quantify and communicate the limitations of specific measurement systems.
Quality of Measurement Data
Reference value: “A reference for comparison, normally determined under laboratory conditions or using a more accurate instrument”. Accuracy: How close measurements are to the reference value
Measurement System Properties
Discrimination: The smallest detectable unit of a measurement device. Should be 1/10 of the tolerance to be measured. Resolution: Capability of measurement system to detect & faithfully indicate even small changes.
Measurement system variation Location (Mean) Linearity Reference Value Bias Reference Value Smaller Bias Reference Value Larger Bias Stability Time 2 Time 1 136 .
137 . Reproducibility (AV): When 2 or more people measure the same parts or items using the same measuring technique.Measurement system variation Spread (Mean) Repeatability Reproducibility Operator B Operator C Operator A Repeatability (EV): Common cause random variables resulting from successive trials under defined conditions of measure.
Average & Range Method.Gauge R & R Studies There are 3 principle methods: Range Method. 138 . ANOVA (Analysis Of Variance) Method.
e.Gauge R & R Studies Range Method Quick Approximation of overall measurement variability. Typically uses 2 appraisers & 5 parts for study.g. % Gauge R&R = ( Gauge R&R (Process Standard Deviation) ) X 100% 139 . This has a defined confidence level. 80% with sample of 5.
140 .Gauge R & R Studies Average & Range Method Summarizes the data gathered in a measurement study. Equipment / appraiser combined & Part variation. to provide information on the total variation and its components of: • • • • Equipment. Appraiser.
01 mm the gauge should be able to read 0. from several days production. number each part. Select parts. Select measurement tool. from the process that represent entire operating range.001mm. Select appraisers.Gauge R & R Studies Average & Range Method – Cont. should be the same people using the instrument. if the characteristic variation is 0. has the gauge the required discrimination?. 141 .
Measurements should be made in a random order. Somebody should facilitate the study. 142 .Gauge R & R Studies Average & Range Method – Cont. Ensure each appraiser uses the same procedure. Readings should estimate the nearest number to that which can be obtained.
Numerical analysis of the study. • Part to Part variation. 143 . • Reproducibility. the variation and percent of process variation for the measurement system and its components.g.Gauge R & R Studies Average & Range Method – Cont. e. • Repeatability. “Minitab”. The study estimates. Gauge repeatability and reproducibility data sheet or specific software.
Every effort should be made to improve. 144 Over 30% . cost of repairs. Under 10% 10% .30% May be acceptable based on importance of application. etc. Not acceptable.Guidelines for Acceptance of Gauge Repeatability & Reproducibility Generally considered to be acceptable.
Excessive within part variation. Gauge fixture need to improve. AV > EV reasons: • Training appraiser. 145 .R & R – Analysis of results EV > AV reasons: • • • • Gauge need maintenance. • Gauge dial / indicator is difficult to read (Parallex). Gauge need redesigning.
41 * (PV / GRR) >5 Accepted 146 .Gauge Discrimination (NDC) <2 Not Accepted NDC = 1.
Example: See next attached work sheets. 147 .
2nd edition 150 .Session 7: The registration Process Rules for Achieving IATF recognition.
Scope of ISO/TS 16949: 2002 “This technical specification is applicable to sites of the organization where production and / or service parts specified by the customer are manufactured” “This technical specification can be applied throughout the automotive supply chain” Site: Where value added manufacturing processes occur 151 .
Medium and Heavy). Motorcycles Automotive shall be understood to exclude the following: Industrial. 152 . Forestry.Definitions (FAQ 1) Automotive shall be understood as including the following: Cars. Off-highway (Mining. Agriculture. Buses.org for latest FAQ’s and sanctioned interpretations.iaob. Construction. Trucks (Light. etc…) See www.
manufacturing meeting the applicability to ISO/TS supplied to customers non subscribing. purchasing.Scope Scope of registration must include all products / services provided to subscribing customers. sales) 153 . Scope of registration may also include at the decision of the organization. Support functions onsite or remote must be included (design.
1 & ISO 9001: 2000 QS9000 Max 50% reduction Max 30% reduction 154 Audit days of recert.Registration Process Audit days for ISO/TS 16949: 2002 defined in Annex 3 of Scheme rules ISO 9001: 2000 QS9000 / VDA 6. Audit .
Registration Process Select an IATF recognized Certification Body Contract with Certification Body Optional pre-audit / assessment Stage 1 Readiness Review Audit Planning for Stage 2 Stage 2 site audit (Within 90 days of stage 1) Nonconformance closure (90 days max) Certification decision / certificate issue Surveillance audits (years 1 and 2) Recertification (year 3) 155 .
Stage 1 Readiness Review Scheme rules require the following documents are submitted for review: • Description of processes showing sequence and interaction. minimum • Evidence that all the requirements of ISO/TS 16949: 2002 are addressed by the organization’s processes • Quality Manual (for each site to be audited) 156 . including key indicators of performance trends for the previous 12 months.
including customer reports and score cards 157 .Stage 1 Readiness Review • Internal audit and management review planning and results from previous 12 months • List of Qualified internal auditors • List of customer specific requirements • Customer satisfaction & complaints status.
Stage 2 Site Audit Audit will start with “Top Management” Auditors will look for evidence of implementation and effectiveness of processes Audit will cover all shifts Evidence must include the results of at least one complete internal audit and management review cycle. 158 .
Stage 2 Audit Findings Certificate cannot be issued with any open nonconformances Any nonconformance must be 100% resolved within 90 days of the end of stage 2 site audit Any nonconformity identified at registration assessment will require re-audit Any nonconformity identified on surveillance will result in suspension process being instigated 159 .
com 160 .The End of Day 3 & the Course Mohamed Ghorab Mohamed.ghorab@sgs.
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