Status reports on actions from previous Management Reviews Identification of any strategic or operations changes that affect the System Identification of any policy issues requiring review Status reports on progress towards meeting specific improvement objectives: y Customer Satisfaction y Supplier Performance y Overall System effectiveness including evidence of repeat audit findings or other repeat problems y Overall operational efficiency including an evaluation of the cost of poor quality y Manufacturing process effectiveness and efficiency including performance against customer specified (or other targets for productivity, process capability and cost y Overall product performance including an analysis of actual and potential field failures and their impact on quality, safety, or the environment y Overall product quality including performance against customer specified (or other) targets related to product quality y Overall effectiveness of training completed including skills training, on-the-job training, and employee awareness and effectiveness of employee motivation y Recommendations for improvement and plans By Wes Westberg

Page: 2

Page: 111

Assess Overall System Effectiveness Monitor Objectives and Operations

Quality/Environmental Manual ................................................... 5
SOP 4.2.2 ......................................................................................... 5 Scope ............................................................................................ 5 Procedures ......................................................................................... 78 Documentation Requirements ....................................................... 79 SOP 4.2 .......................................................................................... 79 Control of Documents .................................................................... 82 SOP 4.2.3 ....................................................................................... 82 Control of Records .......................................................................... 85 SOP 4.2.4 ....................................................................................... 85

Plan & Schedule Management Review Meeting

Significant Impact on System

Analyze Results & Trends

Management Review ........................................................................ 88 SOP 5.6 .......................................................................................... 88 Competence Awareness & Training .............................................. 94 SOP 6.2.2 ....................................................................................... 94 Control of Nonconforming Product............................................. 98 SOP 8.3 .......................................................................................... 98

Issue Management Review Agenda

Prepare Management Review Inputs

Issue Management Review Minutes

Review Inputs & Develop Outputs Action to improve Effectiveness of the System & its processes Actions to improve products Actions to provide needed resources New or revised improvements of objectives

Corrective and Preventive Action................................................ 101 SOP 8.5.2/8.5.3 .......................................................................... 101 Work Instructions .......................................................................... 105 WI-SB-5.2.2 ................................................................................. 105 Work Instructions .......................................................................... 107 WI-DL-6.2.2 ................................................................................ 107 Management Review FC-MR-5.6................................................. 110

Monitor Implementation of Actions Resulting from Management Review

Assess Process for Effectiveness

Page: 110

Page: 3

13. The quality inspector performs part inspection and looks for (see boundary sample): Correct Color No Forming Flaws (I.E., Excess Carpet, Carpet Wrinkles) y Clean Trim Edge ² No Fuzz Or Debris y Hole Clean ² No Slugs y Cut or punched clean Slots and any additional cutouts. y Overall Appearance Good 14. The quality inspector records the findings (If needed follow SOP 8.3 ² Nonconforming product) 15. The quality inspector also checks for container quantity and correct label y y Rework Instructions: If the tool in the press does not punch the required holes in the S197 Deck Lid remove the part to designated rework area. Rework the part by manually punching the holes using correct size punch 3/16 for the two holes on each side of the release trunk slot and 5/16 for the remaining holes. Revision History

Page: 4

Page: 109

y Process:

Provides shipping containers as required during the shift


SOP 4.2.2 SCOPE GENERAL The Company is a design-responsible supplier of (name your product here). Our products (name your market here) and therefore the quality and environmental management system adhere to the current ISO/TS 16949 and ISO 14001 standards, and The Company·s quality and environmental policies. The Company has based the Quality Environmental Management System described in this manual to demonstrate our capability (see Section 5) to provide products and services that meet customer and applicable regulatory requirements, and to operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction consistently. We developed Quality/Environmental Systems in accordance with the following four additional types of documents containing recommended automotive industry practices, examples, illustrations, and explanations, to smooth the progress of continual improvement by emphasizing defect prevention and the reduction of variation and waste: y International Automotive Task Force (IATF) Guidance to ISO 9001 and all related documents Quality System Assessment Checklist to ISO 9001 and all related documents

1. The operator uses pre-cut carpet and the operator attaches the tenor frame to the carpet 2. The operator raises the carpet to the cutter and cuts the carpet just above the tenor frame 3. The operator then places the tenor frame central over the tool 4. The operator cycles the press by pressing the two black palm buttons simultaneously 5. When the press finishes its· cycle, the operator removes the parts and the left over material 6. The operator then places the waste material into the compactor 7. The operator inspects the part to verify 15 holes, one slot, and 3 additional cutouts are clean with no slugs or fabric strings or debris. If holes, slots, or cutouts are not punched clean, follow Rework Instruction. 8. The operator burnishes the part edges of extra fuzz (if necessary). 9. The quality inspector performs 1st piece inspection at beginning of shift (If needed follow SOP 8.3 ² Nonconforming product), and records the information 10. The operator then places the finished parts into a shipping container to packaging specifications 11. When the container is full, the operator has the material handler to remove the container and bring an empty one as needed 12. The material handler puts a shipping label on container and moves the container to the inspection holding area Page: 108


Page: 5

zip.2 General Safety Notes PPE: y y y y Safety Glasses Kevlar Gloves Kevlar Sleeves Knife Company Background The Company. established in XXXX. City. The following table identifies the requirements not applicable to our organization and provides a brief narrative justifying their exclusion from the scope of our Quality/Environmental Systems: Page: 6 Material Needed: y Stage Material for production: The team leader ensures that the proper tenor frames are available at the beginning of the shift and will check throughout the shift. The Company·s· Quality and Environmental Policy are available upon request. The material handler: y Brings carpet to the press and helps the operator to load the carpet onto carpet feeder Page: 107 . APPLICATION Our Quality/Environmental Systems comply with all applicable requirements contained in ISO/TS 16949:2002.y ISO/TS 16949 Automotive Certification Scheme-Rules for Achieving IATF Recognition and all related documents y y ISO 14001 Environmental Management Systems Requirements and all related documents Customer-specific requirements and guidance documents WORK INSTRUCTIONS WI-DL-6. XXXX General Notes Setup includes: y y y y Press (See Setup Sheet) Check Fixture Burnishing Table Final Pack Container Carpet ² Milliken -62 µ roll Where possible we integrated the quality system and the environmental management system to ensure that operations are cost effective and environmentally responsible. and encompasses all operations at both of our facilities.2. State. and the headquarters is located at XXX Some Street. The Company currently supplies to the following manufacturers: y y XXXX. covers the design and provision of all company products.

Advanced Product Quality Planning & Control Plan (APQP) FMEA-3. which. The operator then places the finished parts into a shipping container 11. Production Part Approval Process (PPAP Fourth Edition) Page: 7 . General Motors Customer Specific Requirements . and after the removal of the part from the over bend fixture 10. When the press finishes its· cycle. DaimlerChrysler (Chrysler Group) Customer-Specific Requirements for Use with ISO/TS 16949:2002 y y y  Customer Reference Manuals: y y y Page: 106 APQP-2. Potential Failure Mode and Effects Analysis (FMEA Third Edition) PPAP-4. the operator calls the material handler to remove the container and bring an empty one 12. Ford Motor Company Customer-Specific Requirements for Use with ISO/TS 16949:2002 CSR-GM.ISO/TS 16949:2002 CSR-DC. Quality management systems ² Guidelines for performance improvements  Customer Specific Requirements: y ISO/TS 16949:2002. The operator then places the part on over bend fixture and the waste material into the compactor and presses the green palm buttons simultaneously 9. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. Reference Documents The following external documents contain provisions.3. Quality management systems ² Fundamentals and vocabulary ISO 9001:2000. through reference in this manual. Part inspection 14. The quality inspector performs 1st piece inspection. Quality management systems ² Requirements ISO 9004:2000. Place the both tenor frames central over the cavities (one tenor frame per two cavities) 6. Pack and label Revision History 1. Raise carpet to the cutter and cut the carpet just above the tenor frames 5. constitute provisions of our Quality/Environmental Systems: y y y ISO 9000:2005. Attach both tenor frames to the carpet and cut the carpet between them 4. The operator cycles the press by pressing the two black palm buttons simultaneously 7. When the container is full. at beginning of shift. the operator removes the parts and the left over material 8. Quality management systems ² particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations CSR-Ford.

customers. Material handler brings material to conveyor and setup in proper position for conveyor load 2. IATF Guidance to ISO/TS 16949:2002 WORK INSTRUCTIONS WI-SB-5. and definitions given in ISO 9000 as supplemented by terms defined in ISO/TS 16949:2002.y y y SPC-3.2. Addresses additional control chart methods and tools MSA-3. and understood throughout the organization. and region and referenced throughout our Quality/Environmental Systems are contained in Appendix A. Two frames are required Process: 1. Reinforces the need for a systemic approach to analysis of variation in data 3. Acronyms. Quality Management System GENERAL REQUIREMENTS The responsibility belongs to Top Management for defining the organization·s quality and environmental policy and to ensure the documented. Management review meetings. Quality System Assessment Checklist. Material handler brings carpet to the press to be loaded onto carpet cutter 3. include the Quality and Environmental policies and objectives for continuing suitability. Terms and Definitions Our Quality/Environmental Systems uses the same internationally recognized terms. Terms and Definitions. Checklist to ISO/TS 16949:2002 TS-GS. has an improved flow and 2.2 Important General Safety Notes PPE: y y Safety glasses Gloves Important General Notes Setup includes: y Press Carpet Cutter Over Bend fixture Check Fixture Final Pack Container 2. Second Edition. Section 3. Statistical Process Control (SPC) Note: 1. 3. The material is automatically loaded onto conveyor and into oven while the operator prepares the carpet for insertion into the press 2. industry. Measurement Systems Analysis (MSA) TS-QSA2. vocabulary. communicated. Page: 8 y y y y Stage Material for production: 1. terms. The SPC Reference Manual. Provide shipping container 4. vocabulary. and definitions unique to our organization. The operator uses the controls to roll out the carpet long enough to place the tenor frames on the carpet Page: 105 .

including all SOPs and other key Quality/Environmental Systems documents. Specific responsibilities for and the sequence and interaction of our key Quality/Environmental Systems processes are detailed in the Standard Operating Procedures (SOPs). They are very generic in nature. many of which contain or reference deployment flow charts depicting the process or procedure described in the narrative SOP. and related processes for providing products and services. Page: 104 Page: 9 . by defining and managing: y Process inputs. We have adopted the process approach advocated by ISO 9000. which establishes documents and implements our quality policy. and satisfies Quality/ Environmental Systems requirements of ISO900/14001. Appendix A contains a List of Key Quality/ Environmental Systems Documents. GENERAL REQUIREMENTS ² SUPPLEMENTAL We also recognize the significant role that subcontractors play in achieving desired results and recognize that we must ensure proper control over outsourced Quality/ Environmental Systems processes (Section 7).Work Instructions This booklet contains sample Work Instructions. which meet or exceed customer requirements. Our Quality/Environmental Systems is part of our overall management system. and y Interfaces between interrelated processes to ensure system effectiveness. controls. and outputs to ensure desired results are achieved. Our flowcharts depict outsourced processes and procedures describe the governing of their management in documents referenced in applicable SOPs.

We review preventive actions during regular management review meetings. Each Department Manager is responsible for evaluating and adjusting resource requirements to efficiently execute assignments and accomplish goals defined in the business plan. We will make records of the analysis available upon request. We initiate Preventive Actions because of. If a corrective action is initiated because of the analysis will be tracked through the corrective action format. Lean activities. Management gives individuals total support and the necessary authority to perform the assigned tasks. lessons learned follow up. This quality manual. including the implementation and control of the Environmental Management System. We track preventive actions on the Preventive Action Log. The Company recognizes that control of any outsourced processes is necessary in order to ensure the product conforms to customer requirements. and continually improve its effectiveness. and analysis of these processes is made available and actions necessary to achieve planned results and support continuous improvement. the APQP process. and other internal and external documents and data Page: 10 We retain all forms used in the corrective and preventive action procedure for active life of the product for reference to prevent reoccurrence. Quality/Environmental Management System processes. through the Management Team. Analysis of customer returned rejects begins upon receipt of the defective material. measuring. monitoring. Quality/Environmental Systems documents and data may be in hard copy or electronic media.DOCUMENTATION REQUIREMENTS GENERAL The Management. including their sequence and interaction with other processes. or technology changes. we identify and document in this Quality/ Environmental Manual. is responsible to implement and maintain a quality and environmental management system. and managed in accordance with ISO and customer requirements. Revision History Page: 103 . SOPs. Management reviews the identified and documented indicators for measurement and analysis to assure effectiveness and efficiency. The Management ensures that adequate resources and information necessary to support the operation. TPM activities.

QUALITY MANUAL This manual is that part of our Quality/Environmental Systems defines the scope of our Quality/Environmental Systems and documents the policy. and processes needed to implement our quality policy and achieve our quality objectives. and the retention and disposition of these records Page: 102 Page: 11 .) when applicable. protection. and other internal and external documents and data as appropriate and needed to manage our systems (Section 4). appropriate documents (procedures.0 Procedure An immediate (possibly temporary) fix is developed and implemented with documentation. storage. We use SOPs and flow charts to document and define the key Quality/Environmental Systems processes. Each Process Owner is responsible for identifying which records they consider quality and environmental records and for collection. procedures. The team will utilize mistake-proofing methodology to the degree appropriate to the magnitude of the problems and commensurate with the risks encountered. needed to manage. We use Statistical methods (i. job descriptions. We inspect and inventory all suspect parts. work instructions.) are updated to permanently implement the changes required by the corrective or preventive action. The corrective action team determines the period to verify the effectiveness of the corrective action is to be by. This manual also shows our justification for any exclusion from ISO/TS 16949:2002 requirements (Section 1) and defines the overall sequence of between our key Quality/Environmental Systems processes. A team will determine permanent corrective action within 7 days of issuance. We review all corrective actions during management review meeting. Manufacturing.If future shipments are to be certified. diagrams. Corrective/Preventative action reports must be complete through interim corrective action within three days of issuance. Pertinent records from our subcontractors are an element of this.e. Quality. or verify work affecting product quality. etc. within twenty-four hours of the receipt of the notice of concern. and the customer (if applicable) must establish a method and duration. and disposition of stock are determined and recorded. x-bar and r charts. We monitor the corrective action for thirty days to assure that the action taken has been successful. etc. The quantity checked. CONTROL OF DOCUMENTS Quality/Environmental records represent information that demonstrates conformity to Quality/Environmental Systems requirements and effective operation of The Company·s· Quality and Environmental system. the quantity defective. The root cause of the problem is established and documented after the initial write up. If the action is successful.6. retrieval. perform. We also issue and control work instructions.

d) Ensure that relevant versions of applicable documents are available at points of use. 5. The Top Management Team is responsible for analysis of customer-rejected material.2. including internal rejections. b) Review. unless otherwise directed by the customer. 3. The Company uses a Product Data Management system to manage and control engineering records and data (see SOP 4. 2. below includes forms used to create controlled quality records as detailed in procedure SOP 4. readily available and retained for a specified period in Quality Record Matrix.3).3 1.3: a) Approve documents for adequacy prior to issue.0 Definitions Not applicable 4.0 Purpose This procedure provides a systematic means in which quality problems will be eliminated. as well as ISO or TS requirements. Record retention must satisfy both regulatory and customer requirements. The format utilized will be an 8D. update as necessary. When we reach retention time.5.2 FOMCRLOG SOP 8. problems from subcontractors and customer complaints. c) Identify the current revision status of documents. and re-approve documents. distribution. and retrievable f) Ensure that identified external documents (including customer-engineering standards/specifications) have controlled distribution g) Prevent the unintended the use of obsolete documents.0 Application This procedure applies to all quality problems. and implementation of all customer-engineering standards/ specifications and changes based on customer-required schedule.5.0 Associated Materials FOCAR 8. e) Ensure that documents remain legible.2/8. ENGINEERING SPECIFICATIONS The Program Manager oversees our process for assuring the timely review. Page: 12 CORRECTIVE AND PREVENTIVE ACTION SOP 8.3 FOPARLOG Concern Report (MCR) Material Concern Report Tracking Log Control of Nonconforming Product Procedure Preventative Action Log Page: 101 .2. and to apply suitable identification to them if they are retained for any purpose. records should be disposed of accordingly. The information Quality Manager has overall responsibility for ensuring that all Quality/Environmental Systems documents.0 Responsibility It is the responsibility of the Quality Manager to manage the corrective/preventative action.Quality and Environmental records are legible. readily identifiable.5.

There are four possible determinations of inspected product: y y y y Acceptable Product ² green check mark Acceptable Product . as a minimum. Quality or a member of management will provide written instructions to the employee conducting these activities. Production personnel complete sort or rework.4 details procedures necessary to control Quality/Environmental Systems records that. When a change involves standards or specs that are reference on design records.The Production Supervision and Quality Manager determine the disposition of the non-conforming material and record it on the Quarantine Area Record. SOP 4. are prepared to document: a) Results of processes performed. parts. as required by the customer. b) Product/process evaluation/acceptance criteria c) Procedures. or they affect PPAP documents. Identify. d) Identification of material. Scrap Nonconforming materials or reworked accordingly. etc. we submit an updated PPAP.2. Pertinent Records from our sub-contractors are an element of this.3. CONTROL OF RECORDS Quality/Environmental records represent information that demonstrates conformity to Quality/Environmental Systems requirements and effective operation of The Company·s· Quality and Environmental system. A Quality representative records the results of the inspection and rework on the Material Concern Report listing the method of rework.2. drawings. date. including identification of the individual performing the activity. Records may be in the form of hard copy or electronic media. employee responsible for reprocessing. Remove Conforming materials from the container and returned to production flow. (Section 7) MASTER LISTS We define requirements for the establishment and maintenance of Master Lists of internal and external Quality and Environmental Systems documents in SOP 4. The designated Quality Representative re-inspects the material. Unacceptable Product (placed in red ´SCRAPµ container / on rack) Questionable Product (QA disposition required) The Company considers reviews timely if performed within two working weeks of receipt.some rework necessary with written instructions & records. all material shipped under a customer concession or deviation will be. Maintain Records of the quantity and expiration date. Record Scrapped material in the Scrap Log and the Material Concern Report. including revision or date of document. material or equipment qualifications f) Pertinent technical records from sub-contractors Page: 13 Quality disposes of questionable product and records the final counts and outcomes. Revision History Page: 100 . No rework shall be visible on the exterior of the product. or instructions used to perform an activity. or equipment used in the making of the product e) Personnel. number of acceptable/ unacceptable parts.

We provide evidence of commitment to the development. regulatory and legal requirements) through continual improvement of our processes. that differ from those currently approved according to the Production Part Approval Process Manual. This managing includes the procurement of a deviation or concession from the customer if changes to the product differ. and services. the Quality representative or production supervisor identifies the container(s) with an initial Material Concern Report. (If material is part of an accumulation.3 Quarantine Area Record 6. completes the Quarantine Area Record.0 Procedure When finding nonconforming material. and maintenance of our quality policy at all levels of the organization through widespread printed distribution of our quality policy statement. implementation.2. along with the management team. including materials and services provided by vendors. We ensure understanding. issue a Material Concern Report at the time of occurrence) We move non-conforming material to the Quarantine Area and a member of the quality department or Production Supervision. Page: 14 . Records controlled include customer-specified records. is responsible to communicate the importance of meeting customer as well as statutory and regulatory requirements. and improvement of our Quality/ Environmental Systems in very tangible ways: Our quality policy statement (Section 5) documents and communicates the importance of meeting or exceeding all applicable requirements (including customer. 5.3 NCMR Material Concern Report SOP 8. Disposition of records also includes their disposal. products. and corporate level improvement objectives.5. through periodic management review of the quality policy statement. Page: 99 The Managing Director. The Quality Manager is responsible for notifying the customer of non-conforming material found after shipment or use has started.0 Associated Materials FO 8. We communicate and deploy our quality policy and objectives throughout the organization through individual performance objectives established and reviewed during employee performance reviews (Section 5 and 6). The Program Manager/Production is responsible for managing the customer authorization of products or processes and the procurement of a deviation or concession.RECORDS RETENTION SOP 4. implementation.2 Corrective/Preventive Action Procedure FO 8. sorting or even sending a company representative to their site to protect their interests.4 contains related procedures and responsibilities to ensure: y y y y y Record controls established satisfy all regulatory and customer requirements. up to the disposition section. Management Responsibility Management commitment The Quality Department is responsible for maintaining and analyzing data from NC material activities. The Quality Manager will take Actions such as stock returns and replacement.

and through their proactive involvement in our continual improvement activities (Section 8).0 Application This procedure applies to. and it prescribes the Page: 15 y y . explicit customer requirements and expectations in the form of a contractual agreement or customer order.g. 3. dimensions. 4. Our quality policy statement indicates our commitment and focuses on what is important to us as an organization: achieving customer satisfaction.) that does not meet established parameters (e. purchased components. CUSTOMER FOCUS Customer requirements are determined during Quoting and Contract review processes. resin. visual.0 Definitions Nonconforming Product: Material (e. work-in-progress. 2.CONTROL OF NONCONFORMING PRODUCT SOP 8. PROCESS EFFICIENCY Top management reviews product realization and support processes to assure both effectiveness and efficiency during management reviews (Section 5). understood. These customer focused communications and interactions ultimately yield clear. customer rejection / returns or material received from a supplier. melt flow. the Managing Director has overall responsibility for ensuring that specified and unspecified requirements are determined.0 Purpose This procedure provides a method to control nonconforming material at any location in the S Group and to eliminate its potential for unintended use or delivery.0 Responsibility The Production Supervision and Quality Department are responsible for following documented procedures and work instructions for product that does not conform to specified requirements. We place emphasis on improving both effectiveness and efficiency of our key Quality/Environmental Systems processes.. unidentified or suspect material. through their involvement in the internal audit process.3 1.g. Top Management ensures that we meet these requirements with the aim of enhancing Customer Satisfaction. Page: 98 All managers demonstrate their commitment to the development and improvement of the Quality/ Environmental Systems through the provision of necessary resources (Section 6). It is clearly (visually) identified and quarantined or segregated to prevent inadvertent use or installation.) Suspect Product: All material having the same lot number as known nonconforming product. Material is reviewed and disposition is determined by management and quality.. through Customer feedback and the following activities: y The Company continually monitors and measures customer complaints and other customer input/ feedback to identify opportunities for improvement (Section 8). in-house rejections. and converted into requirements (Section 7). but is not limited to. etc. etc.

method by which we accomplish this: by continually improving processes. QUALITY OBJECTIVE Our objective is to satisfy all of our customers with quality products and services. y On-The-Job training is provided for all personnel. and services to ensure they consistently meet or exceed requirements. including contract or service personnel. Make another statement Page: 16 Page: 97 . in any new or modified job. and reinforcement during annual employee performance reviews (Section 6). Make statement 2. We control our quality policy statement by including it in this manual. QUALITY POLICY We will Accomplish Our Objective through Customer Satisfaction by Providing: 1. regular communication. products. and along with all policies contained in this manual. Moreover. Determine Effectiveness of Training One or more of the following determines training effectiveness: y y y Review of Salaried and Hourly Evaluations Post-training tests. (Section 5) y We ensure that our quality policy is communicated and understood at all levels of the organization through documented training. is reviewed for continuing suitability during management review meetings (Section 5). our quality policy statement acts as a compass in providing the direction and a framework for establishing key corporate level performance measures and related improvement objectives. when applicable Employee on the job performance y Revision History QUALITY/ENVIRONMENTAL POLICY Management review meetings checks the Quality and Environmental policies and objectives for continuing suitability.

We also have methods to track update and revise fall under the Continuous Improvement Process. The Company·s Management Team annually reviews business plan and revises. The Company benchmarks trends in quality. 5.0 Procedure Identify training needs. as appropriate. The quality manual documents the necessary processes that define the planning process for quality/environmental management system and objectives. productivity. It is the responsibility of the TS-16949 Management Representative to measure the extent to which our personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. The Company employees and their manager/supervisor shall review the employees training status to determine training needs. Provide Training One or more of the following provides formal training: y y y y Identified The Company Trainers Professional / Industry Organizations or Societies Local Community and Trade Schools College and University Sponsored Classes Page: 96 PLANNING QUALITY OBJECTIVES The Managing Director and Operations Manager ensures (established at relevant functions and levels within the organization) that quality and environmental objectives and measures are documented in a business plan. as information is available.0 Associated Materials Orientation Manual Job Descriptions 6. reading material. Objectives may include the following possible measures (Section 5): y y y y Customer Satisfaction: Managing Director (Section 8) Supplier Performance: Materials Manage (Section 7) Quality/Environmental Systems Effectiveness: ISO Management Representative (Section 8) Overall Operational Efficiency and Manufacturing Process Efficiency (Section 5 and 6) Page: 17 . efficiency. customer feedback.evaluation form. and give an assessment test (if applicable) upon completion of the course. It is the responsibility of the Manufacturing Supervisor to inform personnel whose work affect quality of the consequences to the customer of nonconformity to quality requirements. to encourage customer satisfaction and overall growth of the organization. and charting of performance measures (Section 6). This review occurs concurrently with the employee·s performance evaluation or upon need. The business plan includes short and long-term goals relating to quality and environmental policy objectives. and effectiveness are. including those needed to meet product requirements. and defines timeframes to achieve each goal. We accomplished Benchmarking formally and informally via trade shows.

Each salary employee has an individual training record. c) Develop and implement Advanced Product Quality Planning (APQP) practices and procedures in accordance with ISO/TS 16949:2002. These records include. Evaluating Training Needs All employees (salaried and hourly) must complete the specific orientation program administered by the Human Resource Department.y y y y Training Effectiveness and Employee Awareness: Human Resource Director (HRD) with input from the Training Manager (Section 6) Product Performance: Program Manager (Section 7) Effectiveness of Manufacturing Processes: Production Manager (Section 7) Product Quality: Quality Manager (Section 8) limited to. Salary Employees: Human Resource Department shall maintained records of salary training needs and training received by active employees performing activities affecting quality. including the AIAG ´Advanced Product Quality Planning and Control Planµ reference manual. Page: 18 . and importance of their activities and how they contribute to the achievement of our overall quality objectives. All employees have training in awareness. driven by the following objectives we strive to achieve as a Full Service Supplier (FSS) to the automotive industry: a) Achievement of Zero Defects and 100% on time delivery performance. processes. APQP-2. PPAP-4¸ (Section 7) as required including acceptable process capabilities for all Special/Control Characteristics that have been established. (Section 7 and 8) b) Manage and control facilities. training matrices and copies of training certificates. relevance. The employee·s manager/supervisor in the performance review process determines individual training needs. Safety Training All employees receive safety training Specialized Training Employees requiring specialized training in areas affecting quality shall receive the training needed per job description. and associated customer specific requirements documents. which the Human Resource Department maintains. quality systems and personnel to consistently and cost effectively produce products and furnish services that meet customer needs (Section 7). (Section 7) d) Provide objective evidence that all supplied products and services satisfy all AIAG Production Part Approval Process (PPAP) requirements. We base specific measurable objectives on achievable performance within a specified period. They evaluate content of the courses through a training feedback and Page: 95 Quality objectives ² Supplemental: Top management utilizes the management review process (Section 5) to define quality objectives and measurements to include in our Business Plan and used to deploy our quality policy. but are not limited to. training matrices and copies of training certificates. Evaluating Training The Human Resource Department continually assesses the training courses offered internally. We inform personnel whose work affects quality about the consequences to the customer of nonconformity to quality requirements.

2 1. Page: 19 . 2. Each hourly employee has an individual training record. (Section 8) Conduct operations in conformance with. or to exceed. Meet customer requirements by controlling and using returnable packaging. and through the provision of resources needed for its effective implementation. 6. all applicable environmental laws and regulations of the jurisdictions in which we do business (Section 6).0 Application The scope of this procedure incorporates the training of all employees performing quality related activities. we will default to a level 3 PPAP submission. the training provided. and improving systems. QUALITY MANAGEMENT SYSTEM PLANNING The Quality/Environmental Systems planning process involves the establishment and communication of our quality policy and objectives through issuance of this manual and its associated procedures. and associated customer specific requirements documents.0 Purpose The system described in this section is used to ensure that all personnel performing activities affecting quality shall have their training needs identified and. 3.0 Responsibility Job Description Each position has a written job description maintained by the Human Resources Department. (Sections 5. SPC-3.2. We maintain our management review process and internal audit process ensure the integrity of our System when we plan significant changes and implemented that affect our key Systems. (Section 7). and 8) The Quality Manager develops appropriate quality planning documents for specific products. as appropriate. Training Records Hourly Employees: Records of hourly training needs and training received by active employees performing activities affecting quality shall be maintained by the Human Resource Department. or contracts whenever customer requirements exceed the capability or intent of the product/service realization and support processes described in our Quality/Environmental Systems (Section 7). of. This manual constitutes our overall plan for establishing. projects. (Section 7) Utilize appropriate statistical techniques for on-going process control and improvement as established in the AIAG ´Statistical Process Control (SPC)µ reference manual. These records include. but are not Page: 94 e) f) g) h) Note: In the absence of any specific instructions. maintaining. which the Human Resource Department maintains. skills appropriate required for the position. Each job description identifies the competence level/ education. (Section 8) Be committed to continuous process improvement by emphasising reduction of part-to-part variation and the elimination of all waste.COMPETENCE AWARENESS & TRAINING SOP 6.0 Definitions Not applicable 4.

and any actions initiated to implement the conclusions and policies. and systems Page: 20 9. Quality Objectives Matrix: We document Record of established quality objectiveson the title page of the Management Review Report (MRR 5. AND COMMUNICATION The Managing Director (MD).0 Referenced Documents 5. Management Review Report Documented using form FO-MRR-5. The interrelationship of Top Management and other key personnel is depicted our Organization Chart. Operational Procedure SOP 4.4 Operational Procedure.2.0 8. Control of Records SOP 8. and retention period for management review records. Top Management is responsible for Business Planning. Quality/Environmental Systems Planning including the establishment and deployment of objectives (Section 5). The report is prepared by the Quality Manager and is distributed to the attending and. policies and changes. and concluded the review with appropriate decisions and actions. Operational Procedure. with the help of department managers.6.6) Revision History Page: 93 .4. Corrective and Preventive Action Associated Records Management Review Report: Record of the management review meeting. Control of Records The location. conclusions. They will be the sole evidence that the agenda of the review was completely covered.1. the provision of resources needed to implement and improve Quality/Environmental Systems and management reviews (Sections 5 and 6).2. AUTHORITY. to include presented and discussed topics and issues. sets direction and ensures the success of our business through the clear definition and communication of Quality/Environmental Systems responsibilities and authorities.0 Records Management review records must be as comprehensive as possible.1 Management Review Report Form SOP 4. MANAGEMENT All managers are responsible for execution of the Business Plan and implementation of the policy. development and communication of our quality policy. Other members of Top Management include: y y The Operations Managing and The Human Resource Director 7. if any. We document the Management Review output in the Management Review Report based on form MRR 5. absent participants.6. processes.RESPONSIBILITY. RESPONSIBILITY FOR QUALITY Overall Quality/Environmental Systems responsibility and authority is as follows: TOP MANAGEMENT Members of Top Management are ultimately responsible for the quality of The Company·s· products and services since they control the systems and processes accomplished work.

Corrective or preventive actions Documented in the Corrective Action Request (CAR) form (FO-NCCAR-8.6.2. equipment. Corrective. work instructions. We normally use CARs for improvements related to specific actual or potential product or process nonconformities. Page: 21 . Assigned to. This type of action is most suitable for minor improvements that we can implement quickly. and Due Date columns.6. EMPLOYEES All employees are responsible for the quality of their work and implementation of the policy and procedures applicable to processes they perform. Quality objectives Documented on the title page of the Management Review Report (refer to Section 6 of this procedure). and do not directly related to product or process conformity. and Preventive Actions. Detailed responsibilities and authorities for Quality/ Environmental Systems implementation and improvement are contained in lower level documents referenced throughout this manual and other Quality/Environmental Systems documents including procedures. We identify resource needed for implementing improvement actions These include assignment of responsibility. MANAGEMENT REPRESENTATIVE The Company has appointed Quality and Environmental Management representatives for each system. and other necessary resources. etc. The management representatives have the responsibility and authority to: y Ensuring that the ISO system processes needed for quality and environmental management systems are established. and allocation of human. Page: 92 described in this manual. time frame. and Improvement of products and/or services to better meet customer requirements and increase customer satisfaction We define these improvement actions implemented as: Management review actions Documented in the Management Review Report (FOMRR-5. flow charts.3) and processed in accordance with procedure SOP 8.5. Management with responsibility and authority for corrective action promptly notifies employees of non-conformities (Section 8). Personnel responsible for product quality have the authority to stop production to correct quality problems (Section 8). Improvement of quality performance. and the provision of resources needed to implement and improve these processes. This method is most suitable for implementing long-term improvement goals.0 y y y Management review output Improvement of the quality management system. All managers are responsible for planning and controlling Quality/ Environmental Systems processes within their area(s) of responsibility. technical knowledge. Management ensures the staffing of all production shifts with personnel in charge of. Managers also conduct employee performance reviews (Section 6). job descriptions.2. including the establishment and deployment of operational level objectives (Section 5).1) in the Actions. or delegated responsibility for product quality (Section 7).

Following each presentation. the internal audit process (Section 8). and records their status in the Status Next Management Review column. and any other such issues related to the quality management system. the participants discuss the issues. bulletins. from contract review through production INTERNAL COMMUNICATION The Company uses a variety of tools. and specific training sessions to communicate internal information about the effectiveness of our quality and environmental management system. continual improvement. The policy is changed when the goals expressed in the policy have been achieved. Page: 22 . We carry any quality objectives into the next period and any new objectives established by the review meeting and document in the Quality Objectives Matrix on the title page of the Management Review Report. new employee orientation. and identify areas where improvement is required. and its policies. Quality objectives are established to improve performance and/or the quality system and thus fulfill the quality policy and other organizational goals and aspirations. Quality objectives and quality policy An important role of management reviews is to establish quality objectives and to review progress toward achieving the objectives and fulfilling the quality policy. and corrective/ preventive action processes (Section 8). and the status and importance of quality activities. We review the principal quality policy to ensure its continuing suitability. When an objective is not achieved. market and customer response to the quality effort. objectives and significant environmental aspects.implemented. or extend the target due date. and maintained in accordance with their respective standards (Section 5). At the end of the meeting. We communicate information regarding Quality/ Environmental Systems processes and their effectiveness through documented training (Section 6). or when changes within or outside the company render the policy inadequate or inappropriate. compare their status and performance with preceding periods. and regular formal and informal communications as follows: y The ISO Management Representative posts information on quality bulletin boards throughout the facility to convey information regarding customer requirements. the participants decide whether to drop the objective. 5. y Ensuring the promotion of awareness of customer and environmental requirements throughout the organization (Section 5) The Environmental Management Representative is responsible for documenting and responding to relevant communication from external parties. memos. Page: 91 y CUSTOMER REPRESENTATIVE The Program Manager will ensure and address customer requirements and will represent the needs of the customer internal functions. Quality presents the status of quality objectives established by the previous review (those objectives are documented on the title page of the Management Review Report).0 other operations and activities. including but not limited to workplace meetings. reduce its target value.

Analysis of Data. and applicable statutory/regulatory requirements. involvement opportunities. The Managing Director or designee chairs the corporate reviews and top management from all relevant functions attends. Internal quality audits Quality presents results of internal quality system audits. capacity. MANAGEMENT REVIEW Top Management conducts formal review meetings at least quarterly to ensure the continuing suitability. programs. (Section 5) Page: 23 .6. Recommendations for improvement Quality concludes the input phase of the review with recommendations for improvement. including analysis of trends. All managers and supervisors. or other operational or organizational changes that affect the quality system and proposes specific actions to update or modify the system in response to these changing circumstances. In addition to the topics listed above. Communications regarding how employees contribute to the achievement of objectives. The Operations Manager posts information on safety bulletin boards throughout the facility to convey information regarding the status of the Safety and Environmental Management Program. This includes summaries of results for the cycle.4. typically this information is conveyed through production team meetings and cross-functional improvement projects (Section 8). and effectiveness of our Quality/Environmental Systems in accordance with procedures detailed in SOP 5. We retain meeting records. adequacy. Corrective and preventive actions: Quality presents the most important corrective and preventive actions implemented through the period. process. the management review may also consider such issues as cost of quality and non-quality. integration of the quality system with Page: 90 y The Company uses internal audits (Section 8) to reinforce or communicate appropriate information to employees. Changes and quality system planning Quality highlights any product. Customer feedback and complaints Customer Service presents summaries of customer feedback and customer complaints. reviews (Section 6). are responsible for establishing internal communications as needed to convey to their employees the relevance and importance of their activities. evidence of achievement of quality/environmental objectives and customer satisfaction. and productivity data. Edit the scope of the quality performance data as appropriate. and related statutory/regulatory requirements. the frequency of audit findings against particular elements of the quality system and discussion of significant performance. which we convey and reinforce during employee performance. The Human Resources Department posts information on employee bulletin boards throughout the facility to convey information regarding employee benefits. supplier quality performance. (Section 8) The Company record review results provide at a minimum. and the status of pending actions. and coordinate with ISO/TS 16949 Element 8.

e. reassigned to another person/function. and Purchasing. and strategic or operational changes that could affect the QEMS. QUALITY SYSTEM PERFORMANCE Each management review includes all requirements of the Quality/Environmental Systems including monitoring of quality objectives (Section 5). Management review input At a minimum. after reviewing the minutes. Process performance and product conformity Quality presents quality performance data. plant. follow-up actions from earlier management reviews. The Operations Manager and Quality Manager must always attend. or abandoned. effectiveness and/or efficiency improvement objectives (Section 5) documented in prior Page: 24 Attendance The Quality Manager chairs the Management Reviews attended by Management. corporate level. No more than one manager may be absent from the meeting. REVIEW INPUT The management review meeting includes a review of our quality policy (Section 5). on-time Page: 89 . The Company holds review meetings at least monthly to review plant specific data and process effectiveness indicators. and environment. results of self-assessments (Section 8). and an assessment of the suitability and effective of support processes (i. changed. Actions which are not completed may be extended with a new due date. safety. Those managers who are unable to attend shall receive minutes of the review meeting and. facility and equipment. and opportunities for improvement. regular evaluation of the cost of poor quality (Section 8) . Production.The Quality Manager ensures that review includes analysis of actual and potential field failure and their impact on quality. we present the following information and data for review: Follow-up actions from previous reviews Quality reports on the status of action items from the previous meetings. Agenda The agenda for management review meetings covers at least all items listed in Section 4 of this procedure. we use these results to demonstrate achievement of the quality objectives in our Business Plan and customer satisfaction with supplied product. all applicable requirements of the QEMS. At a minimum. At a minimum. related performance trends. Section 6) as an essential part of our continual improvement process (Section 8). Engineering. identifying opportunities for improvement and corrective and preventative actions. The primary output of management review meetings are management actions taken (Section 8) to make changes or improvements to our Quality/Environmental Systems and the provision of resources needed to implement these actions. This includes rates of process and product nonconformities. We record reasons for the failure to implement the action and any decisions regarding continuation of the action in the Management Review Report. may submit their input and comments to the Quality Manager. We document the agenda on the cover page of the Management Review Report.

We conduct the additional review in September.0 Application This procedure applies to all activities comprising the quality system. we record the results of management review meetings and the ISO Management Representative maintains the records. safety or the environment as an input to the management review process.0 Definitions None 4. We accomplish verification of work through budget comparisons. those named in Section 4. REVIEW OUTPUT At a minimum. the Operations Manager may call for unscheduled extraordinary reviews. 3. The Program Manager provides an analysis of actual and potential field-failures and their impact on quality. determines its resource needs and provides the resources to implement and maintain the quality management system and continually improve its effectiveness. and to enhance customer satisfaction by meeting customer requirements. conducting.MANAGEMENT REVIEW SOP 5. through the Management team. Quoting process. and advanced Quality/ Environmental Planning. performance measurements.6. Review Input. We conduct the annual review in March. Resource requirements identified during the Business Plan Process. management reviews (and/or specified in our Business Plan) and reviewed for status and continuing suitability. RESOURCE MANAGEMENT PROVISION OF RESOURCES The Company. management reviews are conducted twice a year. For the first two years (i.6 1. outputs from management review meetings include new/revised corporate level improvement objectives and any related actions required for improvement of the Quality/Environmental Systems and its processes.0 Procedure Frequency and Scheduling Quality performance and the quality management system and reviewed at least once a year. capital expenditure review. and to assign responsibilities for scheduling. as well as through the results of internal audits of the quality and environmental Page: 25 Page: 88 . improvement of product related to customer requirements. 2.0 Purpose The purpose of this procedure is to provide for a system and instructions. and in particular.e.. Per SOP 5. of this procedure. through the maturation phase of the quality system). In addition. and recording management reviews of the quality management system. In response to changing or special conditions and events. REVIEW INPUT ² SUPPLEMENTAL. and provision of resource needs.

with input from other responsible managers. and Safety Planning Product Quality Planning (including Advance Product Quality Planning) Planning of Customer-related Processes Product and Manufacturing Process Design and Development Planning Planning of Purchased Product (Materials. Revision History The MD. other than production part approvals. Analysis. Equipment and other Infrastructure Planning Contingency Planning Work Environment.provided through our budgeting and other business management processes including: SUBJECT y y y y y y y y y y y y y y y y Quality/Environmental Planning Business Planning Human Resource Planning Plant. and Improvement Planning (including the use of SPC) Organizational Continual Improvement Planning Manufacturing Process Continual Improvement Planning Obsolete documents. Facility. monitors and measures overall operational efficiency (including the cost of poor quality) and provides related input and recommendations that may affect Quality/ Environmental Systems effectiveness to Top Management for review and action. and Service Provision Planning Measurement Systems Planning (including the conduct of MSA) Measurement. tooling records. we shall maintain them for the length of time established by the corresponding Department Manager and in accordance with minimum customer requirements. Services and Vendors) Production. purchase orders and amendments. (Section 5) Page: 26 Page: 87 .

5. The Quality Department ensures quality records are available for evaluation by the customer for the stated period. This Competency Matrix is available to persons assigning work. AWARENESS.2.0 Procedure The responsible personnel and/or departments ensure the validity and completeness.4 QR 6.2 SOP 8. (SOP 6) Page: 27 . COMPETENCE.0 Associated Materials AIAG APQP AIAG FMEA AIAG MSA AIAG SPC AIAG PPAP SOP 5. All personnel understand the importance of their activities and their contribution to the achievement of the quality and environmental objectives. AND TRAINING The Company maintains a Training/Competence Matrix for personnel by job description.The Materials Manager and Accounting department are responsible for ensuring the proper retention of customer related purchase orders and amendments. we deem the new person ´competentµ to work on his or her own. skills. In the second phase. It is which visually displays the capabilities of the person according to which of the quadrants have been achieved. The retention duration listed is a minimum retention.6 SOP 7. experience and competence. We might retain the records longer for reference at the discretion of the responsible party. In the third phase.2 FO 4.2. and determine the filing and storage method (for retrieving and preventing damage) and the retention duration (conforming to TS16949 requirements) for quality records. We utilize a ´mentorµ system for the first of four phases with an experienced operator working with a new person and the work instructions of the particular process. It is a four-quadrant system. The status of archived records is determined and appropriate records are disposed of annually. Page: 86 Advanced Product Quality Planning Manual Failure Mode Effect Analysis Manual Measurement Systems Analysis Manual Statistical Process Control Manual Production Part Approval Process Management Review Procedures Contract Review Procedures Internal Audit Procedure Quality Records List HUMAN RESOURCES GENERAL The Company ensures that all employees who perform activities that may affect product quality or have significant impact on the environment have the appropriate training. the experienced person or member of management continues to observe the new person. The Quality Department retains superseded part documents used for new part qualification. Some persons may move on to the fourth stage and we deem them an ´expertµ allowing them to train others or assume other responsibilities.

filing. and management review. TRAINING Responsible managers identify training needs for their employees and achieve competence of all personnel performing activities affecting product quality. with input from responsible managers.0 Definitions None 4.g.4 1. including on-the-job-training (OJT). PRODUCT DESIGN SKILLS The Program Manager ensures that personnel with product or manufacturing process design responsibility (Section 7) are competent to achieve design requirements and are skilled in design methods (Section 7) needed to achieve desired results. storage. Where possible.0 Application This procedure applies to all departments responsible for the maintenance of quality records. Our Training Coordinator is responsible to analyze effectiveness of training and competence. ON-THE-JOB-TRAINING Responsible managers ensure on the job training (OJT) is provided for personnel in any new or modified job affecting Page: 28 CONTROL OF RECORDS SOP 4. protection. This is inclusive of all prints. and disposal.2. e. 3. Page: 85 . evaluates and qualifies applicants for specific job openings based on documented or demonstrated competencies. availability. quality performance records.NEED DETERMINATION Department managers and supervisors are responsible to identify required training and competency for personnel in their respective areas and to coordinate training and follow through with evaluations for competencies. indexing. The Program Manager and/or designee are responsible for ensuring the proper retention of appropriate tooling records. we help existing employees qualify for new/changed jobs through the provision of appropriate education and training. as required. The Human Resource Department. and update of hourly employee Training/Competence Matrix records. Accounting department and the Materials Manager are responsible for ensuring the proper retention of subcontractor purchase orders and amendments.). The Quality Manager is responsible for ensuring the proper retention of production part approvals. internal quality system audits.0 Purpose This procedure provides a method of maintaining quality records consisting of identification.0 Responsibility Each Department Manager is responsible for records their department creates and for their maintenance. Personnel performing specific assigned tasks are qualified. 2. with particular attention to the satisfaction of customer requirements (application of digitized mathematically based data. collection. and disposal.

The Company carries out periodic audits with employees to determine their awareness of the relevance and importance of their activities and contribute to the achievement of the quality and environmental objectives. The Program Manager is responsible for ensuring all levels of documents and subordinate documents (such as control plan.3 WI 4. EMPLOYEE MOTIVATION AND EMPOWERMENT The management team is responsible to motivate employees to achieve quality objectives.4 Control of Quality Records Procedure SOP 7. We conduct Annual employee reviews to give one on one interaction of communication employee with The Company Management. and supervisors re-evaluate employee competencies and evaluate employee performance against established objectives through our employee performance review process.2.3 Revision History Advanced Quality-Planning Procedure Documentation ² Writing Procedures and Work Instructions product quality. Page: 84 Page: 29 . and in-process and operator instructions) and that they agree with each other. We use employee performance reviews and the internal audit process (Section 8) to promote and assess the extent of quality and technological awareness throughout our organization. Department Managers are responsible for reviewing all of their applicable documents within their departments at a minimum of annually to insure relevance and conformance.2.ensuring the identification and/or disposition of obsolete copies. The Plant Supervisor is responsible for ensuring the maintenance of records for Total Preventive Maintenance activities. first piece. to make continual improvements and to create an environment to promote innovation.0 Associated Materials SOP 4. PROVISION We utilize the ´employee performance review processµ to motivate employees to achieve individual or functional performance objectives that support achievement of our corporate objectives (Section 5). officers. Responsible managers ensure that employees are aware of the relevance and importance of their activities and contributions to the achievement of our objectives. Responsible managers. including agency or contract employees. 5.

Both the person receiving a copy of a new or revised document and the person distributing the document are responsible for Page: 83 . and employee participation in our internal audit (Section 8) and improvement (Section 8) processes. process Page: 30 The Quality Manager and/or designee is responsible for retaining master copies and assuring current revision level of the AIAG reference manuals: y y y y y y y Advanced Product Quality Planning & Control Plan Fundamental Statistical Process Control Measurement Systems Analysis Potential Failure Mode and Effects Analysis Product Part Approval Process Quality System Requirements ISO 9000 or TS 16949 Environmental Mgmt. Responsible managers monitor and measure the overall training effectiveness and to meet competency needs and provides related recommendations to Top Management for review and action (Section 5). The Training Manager maintains records of all training completed. skills. The Human Resources Department maintains employee qualification and competency review records and annual performance review results. We accomplished this through awareness training. including buildings. and importance achieving our quality policy (Section 5) and objectives (Section 5). All Department Managers listed above are also responsible for making sure distributed and or retrieving and replacing obsolete copies with the latest revision. RECORDS We maintain appropriate records of education. we ensure that our employees are aware of customer requirements (Section 5 and Section 5). EMPLOYEE AWARENESS Through their activities and contributions. the relevance. System. ISO 14001 The Program Manager is responsible for a timely review of customer drawings and specifications. approving. The responsible manager collects the documents for each training event. employee performance reviews (Section 6). The Program Manager is responsible for receiving. Instructions and Test Procedures are available. INFRASTRUCTURE The Company provides and maintains the infrastructure needed to achieve conformity to product requirements. We evaluate provided training through immediate feedback from the employee and the manager. or supervisor who identified the training requirement. training. and maintaining their individual department work instructions.EFFECTIVENESS The Company evaluates the effectiveness of all actions taken to meet competency needs. Department Managers are responsible for creating. and experience in accordance with provision of Section 4. The Plant Supervisor is responsible for ensuring current instructions are available at all work instructions. reviewing and retaining CAD/ Math data. workspace and associated utilities. The PM has 10 business days of receipt to document the receipt of drawings and maintain the engineering standards according to the Drawing Control Procedure and Engineering Change Process.

6. AND EQUIPMENT PLANNING The MD uses a multidisciplinary approach for developing plant.3 1. labor shortages. maintenance and repair Production tooling management. y 4.5. FACILITY. We use a multi-disciplinary approach to develop plant. and key equipment failure and quality issues. and distribution of drawings and documents. these programs include: y y y y y Facilities management. facility. and equipment. The Company prepared contingency plans to satisfy customer requirements in event of an emergency such as utility interruptions. 3. manufacturing processes. we detail methods to evaluate and monitor the effectiveness of existing operations in SOP 7.0 Responsibility The Department Managers are responsible for ensuring that the Quality System Procedures have the appropriate controls in place to ensure that current issues are available in all locations as required. maintenance and repair Housekeeping/custodial services management Process equipment management. Page: 82 Page: 31 . and Transportation and material handling equipment management. including documents of external origin.2) The Plant Supervisor has overall responsibility for managing our Facilities and Equipment Maintenance programs in accordance with SOP 6. Application This procedure applies to statutory & regulatory requirements the drawings specifications and documents that explain the engineering requirements. In addition. processes. facility. maintenance. assembly methods. Purpose This procedure describes the responsibilities for receipt. (SOP 6. Definitions y y Quality Manager is the Document Control Specialist Controlled Customer owned product related prints & specifications are located on the ´Xµ drive and are available to Engineering Quality &Manufacturing personnel AIAG ² Automotive Industry Action Group equipment (hardware and software as necessary). review. such as transportation or communication.2. 2. and equipment plans. and any supporting services that are needed.3. and repair PLANT. work instructions and inspection instructions related to deliverable goods and our processes. handling and valueadded use of floor space and facilitate synchronous material flow.4 and SOP 5.CONTROL OF DOCUMENTS SOP 4.3. The Program Manager ensures plant layouts are designed and continually evaluated through the application of lean manufacturing principles (state your approach here) to minimize material travel. test procedures.1.

and involvement of our employees in an empowered environment of continual improvement (Section 6). and through safety team meetings and training (Section 6). Page: 32 revised policy. health. and maintaining effective employee benefit and workforce involvement programs. The Information Systems Manager has overall responsibility for managing our automated data processing and communications systems.The Plant Supervisor develops and implements an effective preventive maintenance program utilizing predictive maintenance methods (Section 7) as appropriate. The Operations Manager has overall responsibility for identifying. statutory or regulatory requirements. WORK ENVIRONMENT We provide employee benefits. or instruction. implementing. procedure. The Human Resources Department has overall responsibility for identifying. Management reviews the effectiveness of these efforts during management review meetings (Section 5). All documents used during. ensures contingency plans are documented in the Business Plan and implemented as needed to satisfy customer requirements in the event of an emergency such as utility interruptions. the recipient updates the manual. and maintaining safety and environmental management systems. and ergonomics by following proper manufacturing practices. job and schedule flexibility. We monitor and improve workplace safety. The Quality Manager. Revision History Page: 81 . in conjunction with the Information Systems Manager and other appropriate managers. and key equipment failure and field returns. We engender total participation by involving employees in internal audit (Section 8) and improvement (Section 8) activities. labor shortages. or forms generated before the revision process shall be considered ¶grandfathered·. processes and controls needed to ensure product conformance and meet customer. implementing. acceptable to use ¶as is· due to unavailability of revised forms or unacceptable costs which would be incurred by disposing of unused forms. Contingency plans. interesting work.

2. 5. Procedure Manual. cleanliness. The responsible Department ensures availability of appropriate documents at all locations where the performance of operations affect the quality system. including safety characteristics d.0.0 Associated Materials SOP 4. The changes become part of the revision history. Environmental aspects/impacts c. The responsible Department ensures that designated personnel receive approval. or instruction according to the Quality Policy Manual. The quality department distributes a copy of the new or revised policy.2).4 FO 4.1 & SOP 7. may request document changes. If not approved. a cross functional team plans the processes with consideration given to. and for the recall of obsolete documents.0 Procedure Any member of staff.2. the revision history identifies the changes. 2. facilities. the request form gives an explanation and a copy returned to the originator. Where practical. initial issue. The quality/environmental objectives and requirements for the product b. The Administrator will maintain a master list of qualityrelated documents. but not limited to. the following: a. Product special characteristics. For new projects. The Company has implemented a Quality and Environmental-planning process to define and document how the respective requirements will be met (See SOP 7.3 6. Reference 6. Error proofing for processes. and Operator Instructions Distribution List.manuals and data within their area of responsibility as required. send a Quality Manual Change Request Form to the Quality Manager describing the proposed change. and repair consistent with the product and manufacturing process needs (Section 6) PRODUCT REALIZATION PLANNING OF PRODUCT REALIZATION 1. CLEANLINESS OF PREMISES We provide and maintain a work environment in a state of order. If a Quality System procedure needs to be changed.3 SOP4. and amendments of all documents and data relating to the requirements of the quality system. The Quality Department files original form. This planning process is consistent with the requirements of the ISO standards and sets the framework for all Company processes of the quality/environmental management systems. and tooling Page: 33 . Upon receipt of the new or Page: 80 Document Control Control of Quality/Environmental Records Quality Manual Change Request Department Specific Manuals Personnel safety to achieve product quality: We design and carry out production processes to ensure product safety and minimize potential risks to employees as may be identified during development of design FMEAs (Section 7) and/or process FMEAs (Section 7) and documented in work instructions located in process areas (Section 7). equipment.2. through their department manager. procedure.

2. 4. and operator instructions. including the prevention of pollution f. and operator instructions for original release and the release of changes. procedures. revises. training and skills needed to achieve the required quality and environmental objectives and targets. Identification of required verification. SPC PFMEA. We maintain customer confidentiality for all products and projects under development. equipment (including inspection and test equipment). prepares. Records are identified and kept as evidence that the realization processes and resulting product meet company and customer requirements per the quality and environmental plans h. MSA. The Company assesses product and manufacturing process changes that affect product realization. procedures. documentation. and related product information. Customer requirements and references to technical specifications are to be included in the quality plan The Company uses the methods in the APQP. and systematically issues documents in a controlled manner. The identification of any controls.3. measuring. and specifications.0 Definitions Not applicable 4. We confirm defined activities to ensure compliance with customer requirements. and PPAP. When we receive the approval for any changes affecting customer requirements.0 Responsibility The Process Owners/Area Managers are responsible for controlling issuance and maintenance of quality/and environmental-related policies. e. procedure. approves. including electronic data. DOCUMENTATION REQUIREMENTS SOP 4. we notify the customer and validate changes before implementation. and instruction elements. inspection and test activities g. One level above the author will be an approver for reviewing and approving companywide policies.0 Application To maintain designated secured locations for original policy.2 1. 3. processes.0 Purpose This procedure addresses the maintenance of quality documents pertaining to customer requirements. and Control Plan manuals as required. Department/Plant Supervisor are responsible for controlling issuance and maintenance of associated Page: 34 Page: 79 . drawings. 6. 5. The Program Manager and/or designee are responsible for controlling issuance and maintenance of drawings. Quality receives. monitoring. reviews. fixtures. The quality plan and relevant work instructions clearly define acceptance criteria and approved by the customer.

PPAP. Control Plans.) Special Characteristics for inclusion in the control plan comply with customer specifications (including drawings.) Production following any change in process or method of manufacture Page: 35 y Page: 78 . Run @ Rate. etc. Fixtures. see SOP 7. Tooling. impact use with the customer. to determine the type of quality re-certification required (PPAP documentation. PLANNING OF PRODUCT REALIZATION ² SUPPLEMENTAL We review proprietary designs. The APQP Team uses the APQP process: y y y y Develop a control plan Develop/review failure modes and effects analysis Setup actions to reduce potential failure modes with high risk Report required deliverables (i.1 provides a consistent advanced product quality planning process acceptable to all of our customers. We obtain PPAP approval prior to the first production shipment of product (unless specifically waived by the customer). Production Part Approval Process (PPAP) (Section 7). operator instructions. The APQP Team Leader ensures: y Submissions for part approval prior to the implementation of changes.PROCEDURES This booklet contains sample procedures.e.) that affect product characteristics and process parameters. (Section 7) Our APQP/PPAP process. FMEAs. The APQP Team Leader implements the PPAP recognized by our customers. we will default to a level 3 PPAP submission.1) in the absence of any specific instructions. etc. as detailed in SOP 7. PPAP-4. PFMEA. They are very generic in nature.

For attribute data sampling. heat treating or plating) Product re-released after the tooling has been inactive from volume production for twelve months or more. CHANGE CONTROL The Quality Manager obtains necessary customer approval of quality plans. and all related changes that may affect product realization. such as required for new product introduction. we perform additional verification and identification requirements. impact of form.y y Change of source for subcontracted parts. so all effects can be properly. ACCEPTANCE CRITERIA Acceptance criteria is approved by the customer. materials. understand. and function (including performance and durability) and reviewed with the customer. where required. For propriety designs. product.g. validation. CONFIDENTIALITY We ensure the confidentiality of customer-contracted products and projects under development and related product information (Section 7). or services (e. When required by the customer.1. fit. the acceptance level is zero defects (Section 8). and SOP 7. and/or manufacturing process. and that we establish effective communication systems with our customers with regards to product Page: 36 Page: 77 . acceptance criteria. (Section 7) CUSTOMER-RELATED PROCESSES Achieving our quality policy ´to meet or exceed customer requirementsµ requires that we determine. and consistently meet or exceed our customers· requirements and expectations.

applicable statutory. The Company conforms to customer requirements for designation. REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT During Quoting and Contract Review. safety and environmental regulations and requirements. We conduct emergency response drills.EMERGENCY RESPONSE When appropriate. information. We review and revise procedures and instructions after drills and after the occurrence of accidents or emergencies. (Section 8) DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT The Company maintains documented procedures for quoting and contract review and the coordination of these activities. Requirements include those specified by the customer (including delivery and post delivery requirements). This will include the recording of information to track performance. specific emergency response instructions are prepared to allow rapid and effective response to environmental incidents. and conformance with objectives and targets. Procedures provide general guidelines to follow in the event of an environmental accident or incident and references appropriate emergency response instructions. documentation. safety. requirements not stated by customer but are necessary for specified or intended use. environmental impact. and identified characteristics (Section 7). MONITORING AND MEASUREMENT The Company shall establish and maintain documented procedures to monitor and measure. handling. government. inquiries. storage. and customer feedback. on a regular basis. the key characteristics of the operations and activities that can have significant impact on the environment. contract or order requirements differing from those Page: 76 Page: 37 . elimination. and any additional requirements determined by the Company. and environmental regulations applied to the acquisition. we review requirements related to the product to ensure that product requirements are defined. recycling. When a request for quote is received. as a minimum. including complaints. or disposal of materials. and control of indentified special characteristics that occur during the planning phase. contract or order handling and related changes. All applicable government. relevant operations controls. annually. where they exist. it is processed according to the Quoting Process to ensure that quality and environmental requirements adequately define and document considerations for recycling.

its technological options and its financial. Environmental objectives and targets are consistent with The Company environmental policy. review. This review is conducted before the purchase contract is accepted. when establishing its environmental objectives and targets. The Company has also established procedures related to the identifiable significant environmental aspects of the goods and services used by the company.2.previously expressed are resolved. See Procedure the Company Supplier Manual located on The Company website. and establishes action plans and programs for achieving these objectives. as described in the objectives. (Section 7) Where product requirements are changed. including risk analysis. ORGANIZATION MANUFACTURING FEASIBILITY The Program Manager confirms and documents the manufacturing feasibility of proposed automotive products. as well as the views of interested parties. objectives. and The Company can meet the defined requirements. operational. We maintain records of feasibility reviews as noted in the Quality and Environmental Records. verification.2) CUSTOMER COMMUNICATION During the design and development planning the following are determined and controlled: the design and development stages. including its commitment to the prevention of pollution. The Company considers its· legal and other voluntary requirements. To prepare for product realization. and validation that are appropriate to each design and development stage and the responsibilities and authorities for design and development. and communicates relevant procedures and requirements to suppliers and contractors. ENVIRONMENTAL OPERATIONAL CONTROL The Company has identified those operations and activities that are associated with the identified significant environmental aspects in line with its policy. we make amendments to ensure relevant documents and make relevant personnel aware of the changed requirements (SOP 7. its significant environmental aspects. feasibility reviews and risk analysis we carry out and document to determine the manufacturing feasibility of the product. and product design input and manufacturing process design input in accordance with customer-specific requirements governing the APQP/PPAP process detailed in SOP 7. we carry out activities using a multidisciplinary approach including identification and Page: 38 OBJECTIVES/TARGETS AND ENVIRONMENTAL MANAGEMENT PROGRAMS The Company identifies environmental objectives and targets. targets and action plans establish them at each relevant function and level within the organization. Page: 75 . unless customer waives review requirement. The Company shall document procedures to cover situations where the absence of such procedures could adversely affect quality or have a significant environmental impact. During Quoting. and business requirements. and targets.1 in accordance with APQP.

ENVIRONMENTAL MANAGEMENT SYSTEM ENVIRONMENTAL ASPECTS The Company has identified the environmental aspects of its activities. Targets. legal and other voluntary requirements that are applicable to its activities. i. state. associated work instructions. Page: 74 Page: 39 . and Action Plans.3. All of our EDI initiatives. LEGAL AND OTHER REQUIREMENTS The Company has identified. CUSTOMER COMMUNICATION ² SUPPLEMENTAL The Information Systems Manager establishes/maintains an ability to communicate necessary information. and has access to. We maintain the Environmental Laws and Regulations by the Corporate EMS Coordinator thru periodic contact with local. The Company and our customers require we employ EDI methods by all partner suppliers throughout the supply chain. products. DESIGN AND DEVELOPMENT Design and development processes for tooling is employed by The Company to transform customer requirements into specifications. this responsibility includes testing and verification of design performance within customer specified applications. or systems. tooling specification. ELECTRONIC DATA INTERCHANGE (EDI) The Company believes that the most effective and efficient way to communicate throughout our supply chain is to utilize a common industry practice for EDI. Customer environmental requirements and identify them during the Quoting Process and are documented in specific contracts. We conduct ongoing determination of environmental aspects and impacts during Advanced Quality/ Environmental Planning The Company considers these significant environmental impacts and aspects when establishing environmental objectives as described in Environmental Objectives. The Program Manager maintains a list of products for which The Company has design responsibility. and federal agencies and review of environmental publications. or change an existing. We identified these significant environmental aspects and their associated impacts during the Initial Environmental Aspects Review. monitoring of special characteristics.e. the authority to establish a new. policies. The Program Manager has overall responsibility for managing tooling design and development activities in accordance with SOP 7. products. We have developed a list of applicable Environmental Requirements and maintained by the EMS Department. and production documents. and transaction sets comply with the guidelines set forth by the AIAG and our key suppliers mandate we have the capability to interface with us electronically. and services. products and services that it can control and influence and has determined those that have. including data. and review of FMEAs and control plans. development. including but not limited to computer-aided design (CAD) data and electronic data interchange (EDI). or could have. in a customer specified language and format. a significant environmental impact. processes.

Results of this analysis and related recommendations presented to Top Management for review and action during management reviews. (Section 7) DESIGN PLANNING The Program Manager serves as Design Team Leader for tooling design projects for new/changed non-automotive products. When we implement a process change. (Section 5) PREVENTIVE ACTION Data from internal audits. procedures. scheduled verification and validation activities.) to establish a Design Plan that identifies design stages. employee suggestions. Results of this analysis and related recommendations and present them to Top Management for review and action during management reviews. policies. Investigating and eliminating the root cause of potential failures is a critical part of our continual improvement process. We consider our preventive action system effective if we avoid potential losses. production and other appropriate qualified personnel to prepare for product realization.The Quality Manager has overall responsibility for managing manufacturing process design and development activities (for automotive products) in accordance with our APQP/PPAP process detailed in SOP 7. when appropriate. engineering. we change work instructions as appropriate. MULTIDISCIPLINARY APPROACH The Design (or APQP) Team Leader forms a Design (or APQP) Team composed of design. FMEA. and requirements Development and review of control plans Page: 40 Page: 73 . The Quality Manager assigns a qualified Quality Engineer to service as APQP Team Leader for design projects involving new/changed automotive products and related manufacturing processes. We apply corrective actions and controls to similar processes and products. manufacturing. When external non-conformances occur.1 in accordance with customer specific requirements (see APQP and serves as the overall APQP Team Leader (as referenced throughout this section). The Design (or APQP) Team Leader uses project management planning tools (available software etc. The Company responds in the problem-solving format prescribed by the customer. We conduct follow-ups (through the internal audit process (Section 8) to ensure that we take effective corrective action appropriate to the impact of the problem encountered. customer feedback. fixed design reviews. quality. There is a defined problem-solving process used in all plants. through: y y We consider the size and effects of the nonconformities when corrective/preventative actions are taken. and other appropriate data is collected and analyzed (Section 8) to identify the actions needed to eliminate the causes of potential problems and thereby prevent their occurrence. (Section 5) y Development/finalization and monitoring of special characteristics Development and review of Potential Failure Mode Effects Analysis (FMEA) including actions to reduce potential risks per customer guidance.

and elimination of the cause of quality and environmental problems in order to prevent recurrence. Information from similar product experience including field data and internal input and Competitor Analysis c. See SOP 8.5. DESIGN INPUTS The Product Engineer or Program Manager is responsible for identification. As designs and processes are developed. including external party communications. internal. The procedures also define requirements for determining: y y y y The causes of non-conformities and potential nonconformities Evaluating the need for action to prevent occurrence or recurrence Determining and implementing action needed. which define requirements for the review and handling of customer complaints. documented. Targets for productivity. Targets for product quality. and reviewed. non-conforming material from suppliers. timing and cost We identify process design inputs. returned products. documented. maintainability.2. where applicable. Customer requirements Page: 41 We analyze Non-conformities relating to customer returns from assembly plants. The corrective/preventive action system utilizes documented procedures. process capability and cost c. We identify product design inputs. (See APQP Workbook Master) (Section 7) The Product Engineer or Program Manager is responsible for ensuring that we identify..2 which describes the 8D methodology we use internally. analysis. applicable legal and regulatory requirements and other requirements essential for design and development. These inputs include functional and performance requirements. document and review all valid design inputs. and environmental non-conformities. applicable statutory and regulatory requirements and other requirements essential for design and development. Page: 72 .5. The Company maintains a corrective action system that provides for the identification. unclear.CORRECTIVE ACTION It is the policy of The Company to strive to prevent problems before they occur. and dealerships in a timely manner and the results are. a document for lessons learned is maintained which documents information derived from previous similar designs. This information is also reviewed as an input to new designs. documentation and reviewing all applicable design inputs are for adequacy. Incomplete. and reviewed including: a. or conflicting requirements are resolved prior to the release of the final design. customer or third Party Audit nonconformities.e. Customer requirements such as special characteristics. DFMEA) b. we do as they wish. These inputs include functional performance requirements. Product design output data (i. durability. engineering facilities. including: a. If a customer requires another format. internally recognized product or process non-conformities or potential non-conformities. life reliability. identification. including error proofing Documenting results of action taken and reviewing action taken SOP 8. These records are available to the customer upon request and we follow corrective action procedures to prevent recurrence. traceability and packaging b.

and diagnostic guidelines Essentially. We use inputs to the management review process to establish new or changed improvement objectives and to initiate/prioritize additional improvement actions. We identify such opportunities through analysis of manufacturing process monitoring. improved controls and/or to methods to reduce variation in product characteristics and manufacturing process parameters are instituted using the same methodology as prescribed for manufacturing process design and validation (Section 7). Process design includes the use of error proofing We use Advanced Product Quality Planning to indentify Customer product and process special characteristics and symbols to be included on FMEAS. and other improvement actions accomplish the desired results or objectives. potential problems identified do not occur. indicate design characteristics critical to the safe and proper operation of the product. and other process documents as appropriate. DESIGN OUTPUTS The Design (or APQP) Team Leader ensures that design outputs comply with the design input requirements. or where product characteristics are predictable and meet customer requirements. include information needed for production and service provision.5) which includes improvement actions and corrective and preventive actions as outlined in Section 8. and processoriented audits (Section 8) of key manufacturing processes at least once annually. The Program Manager summarizes and reports results of manufacturing process improvement activities to Management for review. The overall objective of manufacturing process improvement is to reduce part-to-part variation and eliminate all waste.d. Control Plans. Product error-proofing Product definition including drawings or mathematically based data Product design review results. As warranted. including: Page: 42 Page: 71 . and are approved before issuance: PRODUCT DESIGN OUTPUTS ² SUPPLEMENTAL We verify and validate product design requirements outputs against product design input using: y y y y y Design FMEAs and reliability results Product special characteristics and specifications. (Section 5) MANUFACTURING PROCESS IMPROVEMENT The Program Manager plans and implements continual improvement of manufacturing processes that are capable and stable. product monitoring and measurement activities (Section 8). such actions are effective if the problems corrected do not reoccur. MANUFACTURING PROCESS DESIGN OUTPUT Manufacturing process design outputs expressed in terms that can be verified against manufacturing process design input requirements and validated (Section 7). include or reference acceptance criteria. (Section 5) The Quality Manager has overall responsibility for establishing and implementing an effective continual improvement system (SOP 8.

We prioritize and implement all management an action based on data analysis (Section 8) and performs cost/benefit analyses to identify and prioritize improvement actions. analyzing and recording measurements at specified stages of design and reports summary results as an input to management review (Section 5). Form 8. customer feedback. When we notice negative trends during data analysis.5-1. Our Management Review Process assesses the overall effectiveness of continual improvement program. quality and environmental objectives. We use this information to develop priorities for prompt solutions to customer-related problems. costs. We implement computerized information systems for timely reporting of data related to product usage. support status review. and critical paths. is used to document improvement. MONITORING The Design (or APQP) Team Leader monitors the design project by defining. DESIGN VERIFICATION We conduct design verification to ensure that the design and development outputs have met the specified input requirements. corrective and preventive actions and management review. Measurements may include quality risks. Page: 43 Page: 70 . (Section 5) CONTINUAL IMPROVEMENT We implement Continual Improvement with the goal of continually improving the quality/environmental management system using the quality policy. trends in data and information. audit results. analysis of data. The Design (or APQP) Team Leader uses input from those involved in the review to propose a remedy for each identified problem. the Design (or APQP) Team Leader conducts design reviews as planned and records results and any necessary actions. and compare with competitors and/or appropriate benchmarks. and longer term planning. Records of verification results and any necessary actions which we record on the DVP & R and Program Open Issues. decisionmaking. work instructions Manufacturing process FMEAs Specifications and drawings Tool designs DESIGN REVIEW During the evolution of each design project. Management Action Requests (MARs). we may initiate corrective/preventative action. (Section 5) y y y y y y y y y Methods of rapid detection and feedback of product/mfg process nonconformities Manufacturing process flow chart/layout Process approval acceptance criteria Maintainability and Measurability Results of error-proofing activities Control plans. lead-times. (Section 5) We use comparative Analysis and Use of Data Trends in quality and operational performance with progress toward objectives and we develop recommendations for improvement and present them to Top Management for review and action during management reviews.We report and compare with progress towards the overall business objectives During Business Planning and Management Review processes. corrective and preventive actions.

and guidelines contained in SOP 8. after process verification we submit the Product approval. The original or superseding specs and requirements are complied with when the authorization expires. The Program Manager keeps records of required tests in the APQP documentation. Page: 44 CUSTOMER INFORMATION It is the responsibility of the Quality Control Manager to ensure that the customer is promptly informed in the event that nonconforming product has been shipped. we obtain prior written customer approval whenever the product or process is different from currently approved. Non-conformance reports requested by the customer (usually if/when a customer receives material or service that fails to conform to applicable quality and delivery specifications) are processed per customer requirements and the procedures defined in SOP 8. and suppliers. The Company will take all actions required by the customer.Design Validation includes a review of field reports for similar products. Wherever practicable. DESIGN VALIDATION The Design (or APQP) Team Leader ensures design validation is carried out as planned (per the Design Plan) and records results and any necessary actions. Analysis of this data provides information relating to customer satisfaction. CUSTOMER WAIVER According to the production Part Approval Process (PPAP) manual. including program timing. We perform Validation in accordance with customer requirements. ANALYSIS OF DATA We collect and analyze data from quality and environmental system processes evaluate the effectiveness of the quality/environmental management system. It is the responsibility of the Program Manager in cooperation with the Quality Manager to ensure The Company submissions meet functional. We perform design validation on products that we produced from production equipment and tooling wherever and to the extent possible. material. and label the carton of parts. We conduct final validation testing to validate the final product. Page: 69 . including program timing.3. we complete validation prior to the delivery or implementation of the product. and appearance specifications as required by the customer. characteristics and trends of processes and products. Suppliers are required to follow The Company product and manufacturing process approval procedures and requirements. Production Part Approval Process (PPAP) for customers requiring this program or other sample submission programs as required.3. We perform design validation to ensure the product or service resulting from design efforts performs as intended for all specified or known uses and applications. and process. We maintain Engineering Approved Product Authorization (EAPA) records. design. if applicable. including expiration date or quantity authorized. these we document these changes and keep them in the ECN documentation. the Design (or APQP) Team Leader plans and carries out or oversees design validation to ensure it is performed in accordance with customer requirements. As applicable. If there needs to be corrective actions. If placed on ´containment statusµ (due to continued poor performance and/or failure to achieve goals and objectives). This helps us to find opportunities for continual improvement of the effectiveness of the quality/environmental management system. product conformity.

All customer engineering design records and specification requirements and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate. acquisition and verification of all products and services that affect customer requirements (such as sub-assembly. We also rework or segregate any material or product that is suspect or does not conform to the appropriate specifications and will be disposed of as detailed in the Nonconforming Product Procedure. Sales. we use our Standard Operating Procedure 7. of the nonconformity. validate. We distribute an internal work order for changes as is detailed in the Design Release and Change Procedure. and approve. PRODUCT RECALL In the event we detect nonconforming product after delivery or use has started. PURCHASING We work in partnership with our suppliers to ensure that purchased products and services meet all applicable requirements. Where appropriate. and rework and calibration services) are defined in accordance with the policies outlined in this section. Because we perform rework/repair for minor defect problems. or potential effects. The review of a change includes an evaluation of the effect of the changes on component parts and product already delivered. The customer will authorize design changes before implementation. along with the PPAP process. product recall is initiated based on trace and recall data and records (Section 7) NONCONFORMANCE REPORTING Records of the nature of nonconformities and any subsequent actions taken. and maintain them according to SOP applicable inspection and test procedures. verify. we will default to a level 3 PPAP submission (Section 7). design changes with Engineering. The processes applicable to the planning. sequencing. The Company will validate all productionengineering changes to PPAP requirements. PRODUCT APPROVAL PROCESS To ensure proper employee understanding.1 Details in. including concessions obtained. We maintain records of the review and any necessary actions. Therefore. as appropriate. the operations are a repetition of one or more original production processes. depending on the nonconformity. the Quality Manager notifies the customer and initiates action appropriate to the effects. CONTROL OF DESIGN CHANGES We review.Suspect or rejected material is either clearly identified with yellow Quality Hold tape or is stored in clearly marked designated areas. The Quality Control Manager has the responsibility to ensure disposition of all suspect or nonconforming material within an appropriate timeframe. sorting. (Section 4) CONTROL OF NONCONFORMING PRODUCT ² SUPPLEMENTAL We classify and process product with unidentified (Section 7) or suspect status as nonconforming. Page: 45 Page: 68 . we use the original process instructions and rework material and we verify activities specified on the control plan. and Manufacturing before their implementation. Note: In the absence of any specific instructions. and the APQP processes.

re-grade for an alternative application.PURCHASING PROCESS The type and extent of control applied to our suppliers and purchased product is dependent upon the effect on subsequent realization processes and their output. return to supplier. scrap or other disposal. Purchasing. the results of supplier evaluations. we have established systems to manage the parts and materials received from our supply base and initiate supplier development based on importance of the supplied product and supplier quality performance in accordance with supplier expectations and monitoring procedures defined in SOP 7. and engineering work together to ensure purchased products and /or services conform to all specified requirements. DISPOSITION The results of the evaluation and resultant disposition determinations are documented. the potential impact of the product on our processes.4. DOCUMENTATION The Quality Manager or authorized Quality Control personnel enter the nonconformance into the corrective action system identifying the nonconforming product and lot number if applicable. Where needed. Engineering. and location where the nonconforming product is being held pending further review or disposition. (Section 8) SEGREGATION Nonconforming product is segregated pending evaluation and disposition. description of nonconformance. use as is (under customer concession or other required approval authority). REGULATORY CONFORMITY We also verified purchased products or materials to ensure conformity to applicable regulatory requirements. Production and other technical personnel may become involved in the evaluation and recommendation for disposition. including those from the customer. EVALUATION The Quality Manager through authorized Quality Control personnel. In order to ensure the quality of the parts shipped by The Company. We have documented Purchasing procedures. as well as consideration of other characteristics including the type of product.1. Dispositions resulting from the evaluation of nonconforming product may include rework to meet specified requirements. products. or services. perform the initial evaluation of nonconforming product in accordance with approved test and inspection procedures. and past performance. the same requirements imposed on The Company are cascaded down to our supply base. SUPPLIER QUALITY MANAGEMENT SYSTEM DEVELOPMENT Essentially. Page: 46 Page: 67 . Purchased products are verified (Section 7 and 8) to ensure conformity to specified purchase requirements. Quality Control. obtain (from relevant authority) a waiver of or deviation from requirements.

Employees clearly mark or otherwise identify nonconforming product or suspect material.2. internal testing. APPEARANCE ITEMS For parts designated by the customer as ´appearance itemsµ The Company provides. Documented procedures are available for the control of non-conforming materials and product. for evaluation areas for appearance items.2 and the following policies. or services from customer-approved sources.3). PURCHASING INFORMATION The Materials Planning and Logistics ensure the adequacy of specified purchase requirements prior to communication to the supplier per procedures defined in SOP 7. Page: 66 CUSTOMER-APPROVED SOURCES Where specified (by contract.4.4. gloss. requirements for approval/qualification of product. customer engineering drawing. the applicable control plan and design records (i. (Section 6) CONTROL OF NONCONFORMING PRODUCT The Company procures raw materials and manufacture products that are defect free. & texture and evaluation equipment in the QC laboratory. materials. including performance of color eyesight testing. where appropriate.1 through one or more of the following indicators: delivered product quality. including suspect products. The Materials Manager monitors Supplier performance per SOP 7. delivery schedule performance (including incidents of premium freight).4) Results are retained and available for customer review. Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services. and quality management system requirements. equipment. or specification) we purchase products. including. customer disruptions including field returns. nonconforming product until status can be confirmed. grain. We then recorded the results of evaluations and follow/up actions. and special status customer notifications related to quality or delivery issues. processes/systems. Page: 47 . Personnel responsible for making appearance evaluations are qualified and competent to do so. VERIFICATION OF PURCHASED PRODUCT The Quality Manager ensures and verifies that purchased product prior to use or release in accordance with provision of this section. We maintain a master list of approved suppliers to ensure we only purchase product from The Company qualified sources or customer-approved sources.e. procedures. including lighting. (SOP 8. We consider suspect product. IDENTIFICATION Identification of nonconforming product originates from inspection. drawings). to prevent their use or delivery to the customer (SOP 8.LAYOUT INSPECTION AND FUNCTIONAL TESTING Layout Inspection and Functional Testing is the responsibility of the Test Technician and Submissions Coordinator and is conducted according to customer requirements. product audits or customer complaints. appropriate resources. which is product with unidentified status. qualification of personnel. We maintain Masters for color.

EVIDENCE OF CONFORMITY We maintain test and inspection records for a minimum of three years.2. We have Inspection procedures in the Receiving Inspection Process and on Incoming Inspection Form. identify. the Quality Manager documents and communicates the intended verification arrangements and method of product release related to verification activities performed at our suppliers· premises.4. employees. and processes must be measured. PRODUCTION AND SERVICE PROVISION CONTROL OF PRODUCTION AND SERVICE PROVISION We use a process-focused approach to plan and control operations and support services related to production and service provision. IN-PROCESS INSPECTION Quality Control personnel perform formal in-process inspections in accordance with the control plan and SOP 8.4. stored. These records include final inspection authority. Material must meet specified requirements and be properly identified.that is. accurate. PRODUCT RELEASE AND DELIVERY: We do not release product or deliver until we complete all planned inspections and. Additionally. material. Employees must be equipped to perform the process properly through appropriate education. RELEASE We do not release products for further processing or delivery until we have objective evidence that meet all requirements. and certification. and records have been maintained providing evidence of conformity with acceptance criteria and identifying the person(s) authorizing release. Our initial focus is to assure the quality of process inputs . product samples are stored for a minimum of 3 years. and methods. (Section 8) Page: 48 Page: 65 .2. facilities and equipment. Production personnel in accordance with the applicable control plan perform manufacturing process monitoring (Section 7 and 8). As applicable. available. and properly utilized the suitability of the fundamental process inputs must be assured. FINAL INSPECTION AND TEST: We verify all finished products and completed services by final inspections/tests specified in the control plan and SOP 8. monitored. Equipment and facilities must be adequate. and issued. and confirm that all critical parameters are in accordance with established requirements and specifications. The Quality Manager plans and implements appropriate sampling plans and other statistical techniques to verify purchased product per Section 8. and controlled to assure effectiveness and/or to identify opportunities for improvement. training. We try to identify and control Nonconforming (or suspect) product to prevent its inadvertent use.INCOMING PRODUCT QUALITY Quality Control is responsible for conducting verification inspections to ensure incoming materials meet customer specifications.

(Section 7) JOB SET UP VERIFICATION Job set ups are verified per SOP 8.2. final inspection and test. such as receiving inspection or (SOP 8. if any Initiate the specified reaction plan when the process becomes unstable or not statistically capable Are reviewed and updated when any change occurs affecting product. and the required capability and inspection/test skills needed. This is responsibility if Program Manager. Methods used to verify incoming product from the supplier. job set up verification. When selecting product parameters to monitor compliance to internal and external requirements. (Section 7): y y For pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs Ensures that productions across all shifts are staffed with personnel in charge of. layout inspection and functional test.4) includes receiving inspection. and material level for the product supplied. (Section 7) The scope of our product monitoring and measurement system (SOP 8. RECEIVING INSPECTION Incoming product is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements in accordance with the control plan and/or documented procedures.MONITORING AND MEASUREMENT OF PRODUCT The Company has overall responsibility for planning and implementing inspection and test activities needed to verify product requirements are met at appropriate stages of the product realization process in accordance with the applicable control plan. CONTROL PLAN The Quality Manager develops control plans at the system. and special consideration regarding monitoring and measurement of appearance items. evaluation by accredited laboratories. as well as parts.2. suitable measurement means. component.2. subsystem. or delegated responsibility for product quality Tooling Management: The Company personnel maintain control over any work that is outsourced.4 prior to commencing each new production run and/or when process changes are made. measurement logistics. List the controls used for manufacturing process control Include methods for monitoring of control exercised over special characteristics defined by both The Company and the customer Include customer-required information. in-process inspection. supply sources or FMEA y The Quality Manager further ensures that control plans: y y y y y WORK INSTRUCTIONS The Production Manager prepares appropriate work instructions for all employees having responsibility for processes that impact product quality and employee safety (Section 6). manufacturing process. product characteristics are determined leading to the types of measurement. or source inspections. including processes producing bulk materials. The instructions are derived from sources such as the control plan and the product realization process and are accessible to the work areas where they are needed.4). Page: 49 Page: 64 .

and improving maintenance objectives. Work instructions governing set ups and related verifications are developed and available. provides resources for their maintenance. evaluating. MONITORING AND MEASUREMENT OF MANUFACTURING PROCESSES As part of manufacturing process design. Acceptance criteria (as well as objectives for process capability. (Section 7) PROCESS MONITORING Process operators per applicable instructions monitor processes. (Section 8). The Quality Manager then initiates a corrective action plan indicating the timing and assigned responsibilities to assure the process becomes stable and capable. the Plant Supervisor identifies key process equipment. sampling plans. For attribute data sampling. The corrective action plan is reviewed with and approved by the customer. the acceptance level shall be Zero Defects. and use statistical methods of verification where applicable. including: y y Setup Storage and recovery Page: 50 Page: 63 . Process capability study results.VERIFICATION OF JOB SET-UPS Job set ups are verified prior to commencing each new production runs and when process changes are made. and specifications (including methods of production. reliability. (Section 7). maintainability and availability) and appropriate reaction plans are included in control plans and/or job packs. acceptance criteria. the Program Manager. the Program Manager provides resources and oversees efforts related to tool and gauge design. and gauging. tooling. MANAGEMENT OF PRODUCTION TOOLING As part of manufacturing process design. Availability of replacement parts for key manufacturing equipment Documenting. and develops an effective total preventive maintenance system that at a minimum includes: y y y y Planned maintenance activities Packaging and preservation of equipment. and maintenance instructions) are documented. ensures we perform process studies on all new product realization processes to verify process capability and provide additional input for process control. (Section 7 and 8) Production personnel follow documented reaction plans when processes become unstable or no longer capable. through our APQP/PPAP process. and requires application of a customer recognized or approved problemsolving approach (Section 8). Control plans and process flow diagrams are implemented to ensure adherence to the specified measurement techniques. fabrication. PREVENTIVE AND PREDICTIVE MAINTENANCE Per Section 6. where applicable. measurement and test. and verification activities. The Production Manager establishes and implements a system for production tooling management (or monitors these activities if any work is outsourced). and reaction plans when acceptance criteria is not met.

preventive or other improvement action. such as production. including engineering change level Tool identification.(Section 8) SERVICE AGREEMENTS WITH CUSTOMER If there is a service agreement with the customer. INFORMATION Information inputs to the process include both product characteristics and appropriate work instructions containing specific work methods and other pertinent information. (Section 5) MONITORING AND MEASUREMENT OF PROCESSES We apply suitable methods for monitoring and measuring all Quality/Environmental Systems processes. or disposal PRODUCTION SCHEDULING The Production Manager schedules production to meet customer requirements and our goal to achieve 100% on-time delivery performance through a just in-time production control. managers with overall responsibility for carrying out a Quality/Environmental Systems process. We also take Corrective action. defining the status. We carry out process audits (Section 8) to monitor and. and carry out that production and service jobs in accordance with procedures detailed in SOP 7. FEEDBACK ON INFORMATION FROM SERVICES The Managing Director collects and communicates servicing concerns to Engineering. where applicable. periodically reviews internal audit results as well as progress towards achievement of corporate level objectives aimed at improving overall Quality/Environmental Systems effectiveness and provides related recommendations for review by Top Management. y y y y Maintenance and repair facilities and personnel Tool changing programs for perishable tools Tool design modification documentation. results of internal audits and related follow-ups. At a minimum. Page: 62 Page: 51 . Quality/Environmental Systems processes are documented measured. including internal auditor training records. the Quality Manager will establish and implement a plan to verify the effectiveness The Production Manager ensures we plan. controlled and evaluated (Section 8) to ensure they are effective and efficient (i. In addition. corrective or preventive action (Section 8).The ISO Management Representative maintains all internal audit records. when we do not achieve planned results. Manufacturing and other appropriate personnel for the purpose of initiating appropriate corrective. as appropriate. analyzes process performance (Section 8) and takes appropriate improvement. measure the quality and environmental management system process. repair. schedule. achieve desired results) and to identify opportunities for improvement. we monitor and measure-manufacturing processes to ensure to ensure continuing process capability and suitable performance as specified by the customer part approval process (PPAP) requirements (Section 7).e.

raw material characteristics and the required product parameters. is provided to production personnel throughout the product and service provision process. skills. team meetings. and tooling used for production and service operations-(Section 6) MONITORING AND MEASUREMENT DEVICES The Quality Manager ensures that monitoring and measurement devices capable of meeting requirements are available for use during production and service provision (Section 7) INTERNAL AUDIT PLANS Each of our key Quality/Environmental Systems processes. scope. Quality and other technical personnel identify critical production and service work will provide process sheets included in the job pack or other information included in work instructions posted in areas where needed.2. AUDITOR QUALIFICATION Internal auditors are qualified to audit to ISO/TS 16949:2002 requirements (Section 6). Page: 52 Page: 61 . plans. EQUIPMENT The Plant Supervisor ensures the suitability and availability of all equipment. The Production Manager ensures that all appropriate information including final product specifications. with a special emphasis on our ¶core· customer oriented processes and our unique product realization processes. We conduct follow-up audits to verify timely and effective implementation of the proposed action. and improvement of Quality/Environmental Systems processes and systems. We provided such information through job schedules. Management is responsible for the area-audited implement and timely corrective action to eliminate detected non-conformances and their causes. and reviewed at least once annually to determine effectiveness. WORK INSTRUCTIONS The need for work instructions is dependent upon the knowledge. Engineering. measurement. (Section 8) SOP 8. and through job specific information included in individual job packs.2 defines the criteria. and initiate other appropriate action in response to opportunities for improvement identified by process participants or managers. or quality system element under review is effective if it is achieving the desired results or established objectives. facilities.including process monitoring and verification instructions and criteria developed during product quality planning and manufacturing process development (Section 7). (Section 8) The Quality/Environmental Systems process. and for reporting results and maintaining records. and abilities of our employees and the complexity of their assigned work process. Responsible managers may also request that the audit be used to gather ´value addedµ data serving as input to aid in monitoring. function. work instructions posted in areas as needed. frequency and methods used for internal audits and define the responsibilities and requirements for planning and conducting audits. Audit checklists are prepared and used to aid in ensuring audit consistency and comprehensiveness. We use qualified personnel to audit areas for which they have no direct responsibility for the activity.

this includes any processes where deficiencies may become apparent only after the product is in use or the delivery of services.2. (Section 8) RELEASE. As applicable. as identified in the contract. The purpose of these audits is to verify that the quality/environmental system conforms to product realization arrangements and to the requirements of ISO/TS16949. and in promoting awareness of customer requirements and effectiveness of the Quality/ Environmental Systems. AND POST-DELIVERY PROCESSES Release of product is dependent on its compliance with all specifications and its ability to meet customer requirements including packaging. ISO 14001. (Section 7) The Managing Director periodically reviews operational data and progress towards achieving of corporate level performance objectives and provides recommendations for review by Top Management. shipping.1) The Quality Manager is responsible for planning and implementing in-process inspections needed to ensure process control and product quality. as well as progress towards achievement of corporate level customer satisfaction improvement objectives (Section 5) and provides related recommendations for review by Top Management. through Production Shift Supervisors.Director periodically reviews customer satisfaction survey data and other customer feedback (including complaints). ensures that production personnel monitor the quality of the work and that employees understand the procedures for reporting related problems and suspected nonconforming conditions. MONITORING ACTIVITIES The Production Manager. (Section 5) INTERNAL AUDIT The Company·s internal audit results are critical inputs to aid in assessing the effectiveness of our QEMS. (Section 5) VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION The Company defines processes in which we cannot verify results by subsequent monitoring or measurement as ´Special Processesµ. arrangements are established: y y Defining criteria for review and approval of the processes Approval of equipment and qualification of personnel Page: 53 Page: 60 . MANUFACTURING PROCESS AUDIT We conducted Audits of our key product realization processes annually to determine their effectiveness and performance and to identify opportunities for improvement (Section 8) PRODUCT AUDIT We conducted Product audits at appropriate stages of production and delivery to verify conformance to all specified requirements contained in the control plan (Section 8). QUALITY/ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT The Company conducts system audits. DELIVERY. and delivery.( SOP 7.5. in identifying any opportunity for improvement. The Program Manager has overall responsibility for ensuring ¶Special Processesµ are validated in accordance with procedures detailed in SOP 7.5.

or perform work will attend a Basic Statistics course containing an overview on basic concepts such as variation. We assign Incoming material part numbers. customer performance ratings and delivered part quality. IDENTIFICATION AND TRACEABILITY The Program Manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. verify.5. IDENTIFICATION AND TRACEABILITY ² SUPPLEMENTAL The identification and status of product is established and maintained during all product and service provision processes. including inspection and testing activities. control (stability) process capability. We tag or label. The APQP Team Leader uses a Production Part Approval Process acceptable to our customer to validate that product realization processes are capable of achieving desired results in accordance with the APQP/ PPAP process detailed in SOP 7. returned goods.3. See Management Review Process.1: CUSTOMER SATISFACTION ² SUPPLEMENTAL Customer Satisfaction is a critical measurement of the performance of the quality management system. production. Where product traceability is a customer-specified requirement.1. The Managing Director has overall responsibility for identifying and reviewing customer requirements (Section 7) and for monitoring and measuring customer satisfaction per procedures contained in SOP 8. Measurements of customer satisfaction include evaluation of Customer feedback such as complaints. We analyze Customer satisfaction data and report it in management review meetings. SPC. This drives our quality policy ´to meet or exceed customer requirementsµ. (Section 6) MONITORING AND MEASUREMENT CUSTOMER SATISFACTION Customer satisfaction is the reason we exist. incoming product received without part numbers in Receiving. appropriate controls and records are established. The Company identifies the product by suitable means throughout product realization. The Managing Page: 59 VALIDATION OF PROCESS FOR PRODUCTION AND SERVICE PROVISION ² SUPPLEMENTAL Process validation applies to all processes for production and service provision (Section 7) related to our products. and delivery in accord with procedures defined in SOP 7. and revalidation Use of specific methods and procedures improvement when established per SOP 8.y y Requirements for records. QC Receiving personnel are Page: 54 . warranty reviews. (Section 7) KNOWLEDGE OF BASIC STATISTICAL CONCEPTS Employees using statistical tools to manage. We must receive incoming material with labels indicating the assigned part numbers. installation.2. We monitor the manufacturing process performance to demonstrate compliance with customer requirements for product quality and efficiency of the process.1 and the AIAG ´Statistical Process Controlµ (SPC) reference manual.

or unsuitable customer property and immediately reported to the customer. as applicable.6 for calibration laboratories) MEASUREMENT. analysis. and improvement activities needed to assure product and Quality/Environmental Systems conformity and achieve continual Quality/Environmental Systems improvement. and maintains customer property provided for use or incorporation into the product. by applying the same process controls as we do to purchase product. plan. or calibration services are either acceptable to the customer or accredited to ISO 17025. (Section 7) CUSTOMER PROPERTY Customer property includes customer-owned material. The Quality Manager ensures that we record lost. and product monitoring and measurement. test. conduct of internal audits. establishes.y y Revisions following engineering changes Statements of conformance to specification after calibration/verification responsible for verifying incoming material part numbers and date coding as detailed in the Receiving and Inspection Process. we report at the management meeting. measurement. Where contractually required. and implement the monitoring. A FIFO inventory system is used and regular tracking of inventory turns. Statistical techniques for on-going process control and Page: 58 . deterioration. and protection. We design designated storage areas to prevent damage. The Company identifies. storage. the Quality Manager plans for. tooling (including test/inspection tooling and equipment). packaging. damaged. EXTERNAL LABORATORY The Quality Manager ensures external laboratories used for inspection. process monitoring and measurement. ANALYSIS AND IMPROVEMENT GENERAL These sections describes how we define. (Section 8) PRESERVATION OF PRODUCT The Plant Supervisor is responsible for preserving the conformity of the product during internal processing and delivery to the intended destination including identification. and preservation of product pending use or delivery. (Section 7) CUSTOMER-OWNED PRODUCTION TOOLING All customer-owned production tooling is permanently marked so the ownership of each item is visible and can be determined. handling. These activities include assessment of customer satisfaction. verifies. tools (including returnable packaging). IDENTIFICATION OF STATISTICAL TOOLS The Quality Manager ensures that statistical tools used to monitor Quality/Environmental Systems processes identified during quality planning and included control plans. Page: 55 LABORATORY REQUIREMENTS ² INTERNAL LABORATORY The Company does not have an internal laboratory. (See SOP 7. and intellectual property. and maintains appropriate traceability records in accordance with customer requirements. protects.

the Program Manager documents the method for confirming the ability of software to satisfy the intended application (Section 7) We define the processes employed for the on-going calibration. (Section 8) ADVANCED SHIPPING NOTIFICATION (ASN) The Company utilizes an ASN to facilitate the electronic transfer of data utilized by our customers to: y y y Determine and confirm goods in transit. and test equipment needed to provide evidence of product conformity to determined requirements. Verify and receive products into their system. we adjust or re-adjust as necessary and the validity of previous measuring results and document. e. Further. include: y Equipment identification. actions taken are documented. and maintenance of monitoring and measuring devices Page: 56 . All monitoring and measuring devices that can affect product quality we identify and calibrate at prescribed intervals against certified equipment having a known valid relationship to internationally or nationally known standards. CALIBRATION/VERIFICATION RECORDS Records of the calibration verification activity for all gauges. including their identification. we periodically assess the condition of stock. (Section 8) We maintain appropriate calibration records to document results of calibration activities and suitable indicators are used to show current calibration status. uses/acceptance criteria and what actions to take when results are unsatisfactory. STORAGE AND INVENTORY In order to detect deterioration. including the measurement standard against which the equipment is calibrated Page: 57 CONTROL OF MONITORING AND MEASURING DEVICES We determine what measurements we need and the accuracy required assuring conformity of our product to specified requirements.Inventory turns and levels are goals defined within the business plan. including appropriate corrective actions to remedy the situation and preclude its recurrence.) is controlled as nonconforming product. We used a number or other identifier to provide traceability to the device calibration record. When we find monitoring and measuring devices out of calibration (or when we do not know the calibration status). frequency/method of checks. such as gage R & R studies. measuring. In addition. obsolete product (including expired age dated material. which conform to the Measurement Systems Analysis manual. We identify and select monitoring and measuring devices and verify their capability of meeting such requirements prior to use. including employee and customer owned equipment. Obsolete product is treated the same as nonconforming product and is appropriately identified and segregated to avoid using it for production. control. location. Create an electronic invoice that will generate payment.g. The Company uses an automated inventory management system to optimize inventory turns over time and assure stock rotation on a ¶first-in-first-out· (FIFO) basis. (Section 4 & 7) MEASUREMENT SYSTEMS ANALYSIS The Quality Manager is responsible for selecting appropriate analytical methods and acceptance criteria.

Sign up to vote on this title
UsefulNot useful