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

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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

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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

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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


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established in XXXX. covers the design and provision of all company products. State.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. and encompasses all operations at both of our facilities. The Company currently supplies to the following manufacturers: y y XXXX. City.2. APPLICATION Our Quality/Environmental Systems comply with all applicable requirements contained in ISO/TS 16949:2002. The Company·s· Quality and Environmental Policy are available upon request. 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. The material handler: y Brings carpet to the press and helps the operator to load the carpet onto carpet feeder Page: 107 . 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. and the headquarters is located at XXX Some Street. zip.2 General Safety Notes PPE: y y y y Safety Glasses Kevlar Gloves Kevlar Sleeves Knife Company Background The Company.

and after the removal of the part from the over bend fixture 10.ISO/TS 16949:2002 CSR-DC. Production Part Approval Process (PPAP Fourth Edition) Page: 7 . The operator cycles the press by pressing the two black palm buttons simultaneously 7. the operator calls the material handler to remove the container and bring an empty one 12. Quality management systems ² Requirements ISO 9004:2000.3. When the press finishes its· cycle. Ford Motor Company Customer-Specific Requirements for Use with ISO/TS 16949:2002 CSR-GM. Attach both tenor frames to the carpet and cut the carpet between them 4. at beginning of shift. General Motors Customer Specific Requirements . which. 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. Place the both tenor frames central over the cavities (one tenor frame per two cavities) 6. Pack and label Revision History 1. through reference in this manual. 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. Quality management systems ² Fundamentals and vocabulary ISO 9001:2000. Raise carpet to the cutter and cut the carpet just above the tenor frames 5. Advanced Product Quality Planning & Control Plan (APQP) FMEA-3. Quality management systems ² Guidelines for performance improvements  Customer Specific Requirements: y ISO/TS 16949:2002. Quality management systems ² particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations CSR-Ford. the operator removes the parts and the left over material 8. Potential Failure Mode and Effects Analysis (FMEA Third Edition) PPAP-4. The quality inspector performs 1st piece inspection. The operator then places the finished parts into a shipping container 11. Reference Documents The following external documents contain provisions. When the container is full. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. Part inspection 14. constitute provisions of our Quality/Environmental Systems: y y y ISO 9000:2005.

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

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

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

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

2/8.3).2 FOMCRLOG SOP 8. readily available and retained for a specified period in Quality Record Matrix.0 Definitions Not applicable 4. When we reach retention time. 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. below includes forms used to create controlled quality records as detailed in procedure SOP 4. distribution.2. The information Quality Manager has overall responsibility for ensuring that all Quality/Environmental Systems documents. records should be disposed of accordingly. d) Ensure that relevant versions of applicable documents are available at points of use. readily identifiable.0 Application This procedure applies to all quality problems.5. and to apply suitable identification to them if they are retained for any purpose. ENGINEERING SPECIFICATIONS The Program Manager oversees our process for assuring the timely review. 3. including internal rejections. e) Ensure that documents remain legible. The Company uses a Product Data Management system to manage and control engineering records and data (see SOP 4.3: a) Approve documents for adequacy prior to issue. The format utilized will be an 8D.0 Purpose This procedure provides a systematic means in which quality problems will be eliminated. and implementation of all customer-engineering standards/ specifications and changes based on customer-required schedule. unless otherwise directed by the customer. problems from subcontractors and customer complaints. as well as ISO or TS requirements.3 1.5.0 Associated Materials FOCAR 8.0 Responsibility It is the responsibility of the Quality Manager to manage the corrective/preventative action. Page: 12 CORRECTIVE AND PREVENTIVE ACTION SOP 8. The Top Management Team is responsible for analysis of customer-rejected material. 5. and re-approve documents.5.3 FOPARLOG Concern Report (MCR) Material Concern Report Tracking Log Control of Nonconforming Product Procedure Preventative Action Log Page: 101 . c) Identify the current revision status of documents. b) Review. 2.Quality and Environmental records are legible.2. Record retention must satisfy both regulatory and customer requirements. update as necessary.

Quality or a member of management will provide written instructions to the employee conducting these activities. Production personnel complete sort or rework. 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.2.4 details procedures necessary to control Quality/Environmental Systems records that. etc. date. Record Scrapped material in the Scrap Log and the Material Concern Report. b) Product/process evaluation/acceptance criteria c) Procedures. Pertinent Records from our sub-contractors are an element of this. all material shipped under a customer concession or deviation will be. A Quality representative records the results of the inspection and rework on the Material Concern Report listing the method of rework. drawings. (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. Records may be in the form of hard copy or electronic media. employee responsible for reprocessing. as a minimum.some rework necessary with written instructions & records. When a change involves standards or specs that are reference on design records. or instructions used to perform an activity. or they affect PPAP documents. 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. The designated Quality Representative re-inspects the material. are prepared to document: a) Results of processes performed. d) Identification of material. or equipment used in the making of the product e) Personnel. parts.2. Identify. we submit an updated PPAP. Scrap Nonconforming materials or reworked accordingly. number of acceptable/ unacceptable parts.The Production Supervision and Quality Manager determine the disposition of the non-conforming material and record it on the Quarantine Area Record. Revision History Page: 100 . Maintain Records of the quantity and expiration date. No rework shall be visible on the exterior of the product. There are four possible determinations of inspected product: y y y y Acceptable Product ² green check mark Acceptable Product . 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. including identification of the individual performing the activity. Remove Conforming materials from the container and returned to production flow. as required by the customer.3. SOP 4. including revision or date of document.

Management Responsibility Management commitment The Quality Department is responsible for maintaining and analyzing data from NC material activities. 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).5. the Quality representative or production supervisor identifies the container(s) with an initial Material Concern Report. Page: 14 . The Quality Manager will take Actions such as stock returns and replacement. We provide evidence of commitment to the development.3 Quarantine Area Record 6. The Quality Manager is responsible for notifying the customer of non-conforming material found after shipment or use has started. implementation. We ensure understanding.3 NCMR Material Concern Report SOP 8. The Program Manager/Production is responsible for managing the customer authorization of products or processes and the procurement of a deviation or concession. regulatory and legal requirements) through continual improvement of our processes.RECORDS RETENTION SOP 4. along with the management team. and corporate level improvement objectives.0 Associated Materials FO 8. Records controlled include customer-specified records. up to the disposition section.2 Corrective/Preventive Action Procedure FO 8. and services.2.0 Procedure When finding nonconforming material.4 contains related procedures and responsibilities to ensure: y y y y y Record controls established satisfy all regulatory and customer requirements. products. sorting or even sending a company representative to their site to protect their interests. including materials and services provided by vendors. 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. and maintenance of our quality policy at all levels of the organization through widespread printed distribution of our quality policy statement. that differ from those currently approved according to the Production Part Approval Process Manual. 5. Disposition of records also includes their disposal. This managing includes the procurement of a deviation or concession from the customer if changes to the product differ. implementation. is responsible to communicate the importance of meeting customer as well as statutory and regulatory requirements. completes the Quarantine Area Record. 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. Page: 99 The Managing Director. (If material is part of an accumulation. through periodic management review of the quality policy statement.

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

in any new or modified job. We control our quality policy statement by including it in this manual. regular communication. (Section 5) y We ensure that our quality policy is communicated and understood at all levels of the organization through documented training. QUALITY POLICY We will Accomplish Our Objective through Customer Satisfaction by Providing: 1. is reviewed for continuing suitability during management review meetings (Section 5). and along with all policies contained in this manual. and services to ensure they consistently meet or exceed requirements. products. QUALITY OBJECTIVE Our objective is to satisfy all of our customers with quality products and services. Make statement 2. 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. 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. including contract or service personnel. Moreover. y On-The-Job training is provided for all personnel.method by which we accomplish this: by continually improving processes. and reinforcement during annual employee performance reviews (Section 6). Make another statement Page: 16 Page: 97 . 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.

The quality manual documents the necessary processes that define the planning process for quality/environmental management system and objectives. 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. reading material. as information is available. and effectiveness are. 5. and give an assessment test (if applicable) upon completion of the course.0 Procedure Identify training needs.evaluation form. to encourage customer satisfaction and overall growth of the organization.0 Associated Materials Orientation Manual Job Descriptions 6. The Company benchmarks trends in quality. The Company employees and their manager/supervisor shall review the employees training status to determine training needs. We also have methods to track update and revise fall under the Continuous Improvement Process. including those needed to meet product requirements. as appropriate. efficiency. and charting of performance measures (Section 6). and defines timeframes to achieve each goal. 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 . This review occurs concurrently with the employee·s performance evaluation or upon need. customer feedback. We accomplished Benchmarking formally and informally via trade shows. The Company·s Management Team annually reviews business plan and revises. productivity. The business plan includes short and long-term goals relating to quality and environmental policy objectives. 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. 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.

We base specific measurable objectives on achievable performance within a specified period. which the Human Resource Department maintains. We inform personnel whose work affects quality about the consequences to the customer of nonconformity to quality requirements. (Section 7) d) Provide objective evidence that all supplied products and services satisfy all AIAG Production Part Approval Process (PPAP) requirements. and associated customer specific requirements documents. quality systems and personnel to consistently and cost effectively produce products and furnish services that meet customer needs (Section 7). c) Develop and implement Advanced Product Quality Planning (APQP) practices and procedures in accordance with ISO/TS 16949:2002. All employees have training in awareness. The employee·s manager/supervisor in the performance review process determines individual training needs. processes. Each salary employee has an individual training record. PPAP-4¸ (Section 7) as required including acceptable process capabilities for all Special/Control Characteristics that have been established. These records include. training matrices and copies of training certificates. Evaluating Training The Human Resource Department continually assesses the training courses offered internally. training matrices and copies of training certificates. Evaluating Training Needs All employees (salaried and hourly) must complete the specific orientation program administered by the Human Resource Department. including the AIAG ´Advanced Product Quality Planning and Control Planµ reference manual.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. (Section 7 and 8) b) Manage and control facilities. Page: 18 . 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. relevance. but are not limited to. 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. APQP-2. 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. and importance of their activities and how they contribute to the achievement of our overall quality objectives.

2 1. all applicable environmental laws and regulations of the jurisdictions in which we do business (Section 6). or to exceed. (Section 8) Conduct operations in conformance with. 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. but are not Page: 94 e) f) g) h) Note: In the absence of any specific instructions.COMPETENCE AWARENESS & TRAINING SOP 6. (Section 7). Each job description identifies the competence level/ education. as appropriate. (Section 8) Be committed to continuous process improvement by emphasising reduction of part-to-part variation and the elimination of all waste. 2. skills appropriate required for the position. 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). Meet customer requirements by controlling and using returnable packaging. 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.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. maintaining. and 8) The Quality Manager develops appropriate quality planning documents for specific products. These records include. of. we will default to a level 3 PPAP submission.0 Definitions Not applicable 4.0 Responsibility Job Description Each position has a written job description maintained by the Human Resources Department. This manual constitutes our overall plan for establishing. (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. 6.0 Application The scope of this procedure incorporates the training of all employees performing quality related activities. which the Human Resource Department maintains.2. (Sections 5. the training provided. Each hourly employee has an individual training record. and through the provision of resources needed for its effective implementation. 3. SPC-3. 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. projects. and associated customer specific requirements documents. and improving systems. Page: 19 .

1.2. processes. sets direction and ensures the success of our business through the clear definition and communication of Quality/Environmental Systems responsibilities and authorities. if any.6) Revision History Page: 93 . to include presented and discussed topics and issues. and systems Page: 20 9.1.2 Operational Procedure. Quality/Environmental Systems Planning including the establishment and deployment of objectives (Section 5). and retention period for management review records. Control of Records SOP 8. Control of Records The location. and concluded the review with appropriate decisions and actions.4. conclusions. Operational Procedure SOP 4. MANAGEMENT All managers are responsible for execution of the Business Plan and implementation of the policy.0 Referenced Documents 5. Other members of Top Management include: y y The Operations Managing and The Human Resource Director 7. absent participants. The interrelationship of Top Management and other key personnel is depicted our Organization Chart. Management Review Report Documented using form FO-MRR-5. development and communication of our quality policy.6.1 Management Review Report Form SOP 4. AUTHORITY.2.0 Records Management review records must be as comprehensive as possible. with the help of department managers. and any actions initiated to implement the conclusions and policies.0 8. Top Management is responsible for Business Planning. The report is prepared by the Quality Manager and is distributed to the attending and.5. policies and changes. We document the Management Review output in the Management Review Report based on form MRR 5.RESPONSIBILITY. They will be the sole evidence that the agenda of the review was completely covered.6.6. the provision of resources needed to implement and improve Quality/Environmental Systems and management reviews (Sections 5 and 6). AND COMMUNICATION The Managing Director (MD).4 Operational Procedure. Quality Objectives Matrix: We document Record of established quality objectiveson the title page of the Management Review Report (MRR 5. 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 and Preventive Action Associated Records Management Review Report: Record of the management review meeting.

Management ensures the staffing of all production shifts with personnel in charge of. Page: 21 .5. Page: 92 described in this manual. MANAGEMENT REPRESENTATIVE The Company has appointed Quality and Environmental Management representatives for each system.1) in the Actions.6. time frame. We identify resource needed for implementing improvement actions These include assignment of responsibility. Corrective. job descriptions. Management with responsibility and authority for corrective action promptly notifies employees of non-conformities (Section 8). and Preventive Actions. Managers also conduct employee performance reviews (Section 6). Quality objectives Documented on the title page of the Management Review Report (refer to Section 6 of this procedure). 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.3) and processed in accordance with procedure SOP 8. Corrective or preventive actions Documented in the Corrective Action Request (CAR) form (FO-NCCAR-8. technical knowledge. and allocation of human. or delegated responsibility for product quality (Section 7). All managers are responsible for planning and controlling Quality/ Environmental Systems processes within their area(s) of responsibility. including the establishment and deployment of operational level objectives (Section 5). We normally use CARs for improvements related to specific actual or potential product or process nonconformities.0 y y y Management review output Improvement of the quality management system. 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. and the provision of resources needed to implement and improve these processes. Personnel responsible for product quality have the authority to stop production to correct quality problems (Section 8). etc. 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. and Due Date columns.2. EMPLOYEES All employees are responsible for the quality of their work and implementation of the policy and procedures applicable to processes they perform. equipment. This method is most suitable for implementing long-term improvement goals. Improvement of quality performance. flow charts. and other necessary resources. and do not directly related to product or process conformity. Assigned to.6.2. work instructions. This type of action is most suitable for minor improvements that we can implement quickly.

Following each presentation. compare their status and performance with preceding periods. continual improvement. including but not limited to workplace meetings. new employee orientation.implemented. When an objective is not achieved. 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. or when changes within or outside the company render the policy inadequate or inappropriate. from contract review through production INTERNAL COMMUNICATION The Company uses a variety of tools. the participants decide whether to drop the objective. We communicate information regarding Quality/ Environmental Systems processes and their effectiveness through documented training (Section 6). and records their status in the Status Next Management Review column. and specific training sessions to communicate internal information about the effectiveness of our quality and environmental management system. and its policies. 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. At the end of the meeting. Page: 91 y CUSTOMER REPRESENTATIVE The Program Manager will ensure and address customer requirements and will represent the needs of the customer internal functions. 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. or extend the target due date. and identify areas where improvement is required. 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). memos.0 other operations and activities. We review the principal quality policy to ensure its continuing suitability. bulletins. and any other such issues related to the quality management system. 5. and corrective/ preventive action processes (Section 8). the internal audit process (Section 8). the participants discuss the issues. reduce its target value. and maintained in accordance with their respective standards (Section 5). and the status and importance of quality activities. market and customer response to the quality effort. 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. The policy is changed when the goals expressed in the policy have been achieved. objectives and significant environmental aspects. Quality objectives are established to improve performance and/or the quality system and thus fulfill the quality policy and other organizational goals and aspirations. Page: 22 .

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

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

0 Procedure Frequency and Scheduling Quality performance and the quality management system and reviewed at least once a year. We conduct the additional review in September. 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. In addition.0 Purpose The purpose of this procedure is to provide for a system and instructions. conducting. of this procedure. those named in Section 4. through the maturation phase of the quality system). as well as through the results of internal audits of the quality and environmental Page: 25 Page: 88 . We conduct the annual review in March. through the Management team. 3. Review Input.6 1.6. improvement of product related to customer requirements.MANAGEMENT REVIEW SOP 5.. safety or the environment as an input to the management review process. the Operations Manager may call for unscheduled extraordinary reviews. REVIEW OUTPUT At a minimum. determines its resource needs and provides the resources to implement and maintain the quality management system and continually improve its effectiveness. management reviews (and/or specified in our Business Plan) and reviewed for status and continuing suitability. In response to changing or special conditions and events.0 Application This procedure applies to all activities comprising the quality system. and to assign responsibilities for scheduling. 2. Quoting process. and recording management reviews of the quality management system. management reviews are conducted twice a year. we record the results of management review meetings and the ISO Management Representative maintains the records. capital expenditure review. The Program Manager provides an analysis of actual and potential field-failures and their impact on quality. and provision of resource needs. RESOURCE MANAGEMENT PROVISION OF RESOURCES The Company. We accomplish verification of work through budget comparisons. Per SOP 5. and in particular. performance measurements. and advanced Quality/ Environmental Planning. and to enhance customer satisfaction by meeting customer requirements. Resource requirements identified during the Business Plan Process.0 Definitions None 4. REVIEW INPUT ² SUPPLEMENTAL. For the first two years (i.e.

and Service Provision Planning Measurement Systems Planning (including the conduct of MSA) Measurement. other than production part approvals. purchase orders and amendments. tooling records. 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.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. Revision History The MD. and Improvement Planning (including the use of SPC) Organizational Continual Improvement Planning Manufacturing Process Continual Improvement Planning Obsolete documents. 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. 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. Equipment and other Infrastructure Planning Contingency Planning Work Environment. Facility. Analysis. with input from other responsible managers. (Section 5) Page: 26 Page: 87 .

Some persons may move on to the fourth stage and we deem them an ´expertµ allowing them to train others or assume other responsibilities. The retention duration listed is a minimum retention. 5. 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. We might retain the records longer for reference at the discretion of the responsible party. experience and competence. (SOP 6) Page: 27 . The Quality Department retains superseded part documents used for new part qualification. 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 Materials Manager and Accounting department are responsible for ensuring the proper retention of customer related purchase orders and amendments. It is which visually displays the capabilities of the person according to which of the quadrants have been achieved. AND TRAINING The Company maintains a Training/Competence Matrix for personnel by job description. All personnel understand the importance of their activities and their contribution to the achievement of the quality and environmental objectives.2 SOP 8. COMPETENCE. It is a four-quadrant system. AWARENESS. skills.2 FO 4. The Quality Department ensures quality records are available for evaluation by the customer for the stated period.0 Associated Materials AIAG APQP AIAG FMEA AIAG MSA AIAG SPC AIAG PPAP SOP 5. In the second phase.6 SOP 7. we deem the new person ´competentµ to work on his or her own.0 Procedure The responsible personnel and/or departments ensure the validity and completeness. This Competency Matrix is available to persons assigning work. The status of archived records is determined and appropriate records are disposed of annually. In the third phase.2.4 QR 6.2. and determine the filing and storage method (for retrieving and preventing damage) and the retention duration (conforming to TS16949 requirements) for quality records.

filing. availability. and update of hourly employee Training/Competence Matrix records. including on-the-job-training (OJT). 2. Personnel performing specific assigned tasks are qualified.0 Definitions None 4. quality performance records. The Human Resource Department. collection.g. This is inclusive of all prints. evaluates and qualifies applicants for specific job openings based on documented or demonstrated competencies. The Quality Manager is responsible for ensuring the proper retention of production part approvals. Page: 85 . as required.).2. 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. we help existing employees qualify for new/changed jobs through the provision of appropriate education and training. with input from responsible managers. internal quality system audits. and disposal. storage. indexing. Our Training Coordinator is responsible to analyze effectiveness of training and competence.0 Purpose This procedure provides a method of maintaining quality records consisting of identification. 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. e.0 Application This procedure applies to all departments responsible for the maintenance of quality records.0 Responsibility Each Department Manager is responsible for records their department creates and for their maintenance. 3. Where possible. and disposal. The Program Manager and/or designee are responsible for ensuring the proper retention of appropriate tooling records. protection. Accounting department and the Materials Manager are responsible for ensuring the proper retention of subcontractor purchase orders and amendments.4 1. TRAINING Responsible managers identify training needs for their employees and achieve competence of all personnel performing activities affecting product quality.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. with particular attention to the satisfaction of customer requirements (application of digitized mathematically based data. and management review.

4 Control of Quality Records Procedure SOP 7.3 WI 4. Responsible managers. Responsible managers ensure that employees are aware of the relevance and importance of their activities and contributions to the achievement of our objectives. 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). first piece. The Plant Supervisor is responsible for ensuring the maintenance of records for Total Preventive Maintenance activities. The Program Manager is responsible for ensuring all levels of documents and subordinate documents (such as control plan.2. officers. Department Managers are responsible for reviewing all of their applicable documents within their departments at a minimum of annually to insure relevance and conformance.3 Revision History Advanced Quality-Planning Procedure Documentation ² Writing Procedures and Work Instructions product quality. including agency or contract employees. 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. 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. and in-process and operator instructions) and that they agree with each other. to make continual improvements and to create an environment to promote innovation. 5.2.ensuring the identification and/or disposition of obsolete copies. Page: 84 Page: 29 .0 Associated Materials SOP 4. 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. EMPLOYEE MOTIVATION AND EMPOWERMENT The management team is responsible to motivate employees to achieve quality objectives.

or supervisor who identified the training requirement. ISO 14001 The Program Manager is responsible for a timely review of customer drawings and specifications. and importance achieving our quality policy (Section 5) and objectives (Section 5). The responsible manager collects the documents for each training event. workspace and associated utilities. and experience in accordance with provision of Section 4. including buildings. Department Managers are responsible for creating. training. Both the person receiving a copy of a new or revised document and the person distributing the document are responsible for Page: 83 . and maintaining their individual department work instructions. 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). We evaluate provided training through immediate feedback from the employee and the manager. Instructions and Test Procedures are available. The Program Manager is responsible for receiving. 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. The Training Manager maintains records of all training completed. approving. All Department Managers listed above are also responsible for making sure distributed and or retrieving and replacing obsolete copies with the latest revision. INFRASTRUCTURE The Company provides and maintains the infrastructure needed to achieve conformity to product requirements. the relevance. skills. System. The Human Resources Department maintains employee qualification and competency review records and annual performance review results. 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. we ensure that our employees are aware of customer requirements (Section 5 and Section 5). We accomplished this through awareness training. RECORDS We maintain appropriate records of education. EMPLOYEE AWARENESS Through their activities and contributions. The Plant Supervisor is responsible for ensuring current instructions are available at all work instructions. employee performance reviews (Section 6). reviewing and retaining CAD/ Math data.EFFECTIVENESS The Company evaluates the effectiveness of all actions taken to meet competency needs.

review. and key equipment failure and quality issues. The Company prepared contingency plans to satisfy customer requirements in event of an emergency such as utility interruptions. AND EQUIPMENT PLANNING The MD uses a multidisciplinary approach for developing plant. manufacturing processes. We use a multi-disciplinary approach to develop plant. FACILITY.2) The Plant Supervisor has overall responsibility for managing our Facilities and Equipment Maintenance programs in accordance with SOP 6. and equipment plans. labor shortages.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. In addition. and Transportation and material handling equipment management. maintenance. 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). 2.CONTROL OF DOCUMENTS SOP 4. Application This procedure applies to statutory & regulatory requirements the drawings specifications and documents that explain the engineering requirements. and distribution of drawings and documents. including documents of external origin. (SOP 6. and repair PLANT. and any supporting services that are needed. Purpose This procedure describes the responsibilities for receipt. 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.4 and SOP 5. facility.2. Page: 82 Page: 31 . 3.3. handling and valueadded use of floor space and facilitate synchronous material flow. y 4. maintenance and repair Production tooling management. assembly methods.1. we detail methods to evaluate and monitor the effectiveness of existing operations in SOP 7. facility. work instructions and inspection instructions related to deliverable goods and our processes. such as transportation or communication. test procedures. these programs include: y y y y y Facilities management. and equipment. maintenance and repair Housekeeping/custodial services management Process equipment management. processes.6.5.3 1.3.

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

If a Quality System procedure needs to be changed. Product special characteristics. a cross functional team plans the processes with consideration given to.manuals and data within their area of responsibility as required. The responsible Department ensures that designated personnel receive approval. the revision history identifies the changes. 2. The quality department distributes a copy of the new or revised policy.3 SOP4. 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. The Company has implemented a Quality and Environmental-planning process to define and document how the respective requirements will be met (See SOP 7. The changes become part of the revision history. Procedure Manual. procedure. may request document changes. The Quality Department files original form. or instruction according to the Quality Policy Manual. and tooling Page: 33 . For new projects. and Operator Instructions Distribution List. Error proofing for processes. If not approved. 5. The quality/environmental objectives and requirements for the product b.2. but not limited to. and repair consistent with the product and manufacturing process needs (Section 6) PRODUCT REALIZATION PLANNING OF PRODUCT REALIZATION 1. Reference 6.0 Procedure Any member of staff. 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). the following: a. including safety characteristics d.0 Associated Materials SOP 4. cleanliness. CLEANLINESS OF PREMISES We provide and maintain a work environment in a state of order.2). equipment. The Administrator will maintain a master list of qualityrelated documents.2. The responsible Department ensures availability of appropriate documents at all locations where the performance of operations affect the quality system. Where practical. Environmental aspects/impacts c.4 FO 4.2.3 6.1 & SOP 7. and for the recall of obsolete documents. the request form gives an explanation and a copy returned to the originator. facilities.0. send a Quality Manual Change Request Form to the Quality Manager describing the proposed change. and amendments of all documents and data relating to the requirements of the quality system. through their department manager. initial issue.

When we receive the approval for any changes affecting customer requirements. and operator instructions. measuring. monitoring. we notify the customer and validate changes before implementation. One level above the author will be an approver for reviewing and approving companywide policies. The Company assesses product and manufacturing process changes that affect product realization. 3. revises. prepares. procedure.0 Application To maintain designated secured locations for original policy. Quality receives. fixtures. and systematically issues documents in a controlled manner. reviews. DOCUMENTATION REQUIREMENTS SOP 4. and specifications. The identification of any controls. MSA. procedures. Customer requirements and references to technical specifications are to be included in the quality plan The Company uses the methods in the APQP. 5. approves. We confirm defined activities to ensure compliance with customer requirements. e. including the prevention of pollution f. procedures. equipment (including inspection and test equipment). 2. including electronic data. processes. training and skills needed to achieve the required quality and environmental objectives and targets. documentation.0 Responsibility The Process Owners/Area Managers are responsible for controlling issuance and maintenance of quality/and environmental-related policies. SPC PFMEA. drawings. and PPAP.2 1. 4. and operator instructions for original release and the release of changes. inspection and test activities g. We maintain customer confidentiality for all products and projects under development. 6. and instruction elements. Department/Plant Supervisor are responsible for controlling issuance and maintenance of associated Page: 34 Page: 79 .0 Purpose This procedure addresses the maintenance of quality documents pertaining to customer requirements. and related product information.3.0 Definitions Not applicable 4. Identification of required verification. and Control Plan manuals as required. The quality plan and relevant work instructions clearly define acceptance criteria and approved by the customer. 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. The Program Manager and/or designee are responsible for controlling issuance and maintenance of drawings.

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

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

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

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

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

fixed design reviews. customer feedback. We apply corrective actions and controls to similar processes and products. We consider our preventive action system effective if we avoid potential losses.1 in accordance with customer specific requirements (see APQP and serves as the overall APQP Team Leader (as referenced throughout this section). FMEA. 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. manufacturing. 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. (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. When we implement a process change. 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.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. (Section 5) PREVENTIVE ACTION Data from internal audits. quality. procedures. employee suggestions. (Section 7) DESIGN PLANNING The Program Manager serves as Design Team Leader for tooling design projects for new/changed non-automotive products. The Company responds in the problem-solving format prescribed by the customer. Investigating and eliminating the root cause of potential failures is a critical part of our continual improvement process. we change work instructions as appropriate. Results of this analysis and related recommendations presented to Top Management for review and action during management reviews. The Design (or APQP) Team Leader uses project management planning tools (available software etc. and requirements Development and review of control plans Page: 40 Page: 73 . through: y y We consider the size and effects of the nonconformities when corrective/preventative actions are taken. scheduled verification and validation activities. engineering. production and other appropriate qualified personnel to prepare for product realization.) to establish a Design Plan that identifies design stages. Results of this analysis and related recommendations and present them to Top Management for review and action during management reviews. When external non-conformances occur. policies. MULTIDISCIPLINARY APPROACH The Design (or APQP) Team Leader forms a Design (or APQP) Team composed of design. There is a defined problem-solving process used in all plants. when appropriate.

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

We use inputs to the management review process to establish new or changed improvement objectives and to initiate/prioritize additional improvement actions. 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 processoriented audits (Section 8) of key manufacturing processes at least once annually.5) which includes improvement actions and corrective and preventive actions as outlined in Section 8. The Program Manager summarizes and reports results of manufacturing process improvement activities to Management for review. 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. and other improvement actions accomplish the desired results or objectives. product monitoring and measurement activities (Section 8). (Section 5) MANUFACTURING PROCESS IMPROVEMENT The Program Manager plans and implements continual improvement of manufacturing processes that are capable and stable. Product error-proofing Product definition including drawings or mathematically based data Product design review results. (Section 5) The Quality Manager has overall responsibility for establishing and implementing an effective continual improvement system (SOP 8. indicate design characteristics critical to the safe and proper operation of the product. and other process documents as appropriate. The overall objective of manufacturing process improvement is to reduce part-to-part variation and eliminate all waste. Control Plans.d. 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 information needed for production and service provision. potential problems identified do not occur. We identify such opportunities through analysis of manufacturing process monitoring. include or reference acceptance criteria. or where product characteristics are predictable and meet customer requirements. including: Page: 42 Page: 71 . such actions are effective if the problems corrected do not reoccur. and diagnostic guidelines Essentially. DESIGN OUTPUTS The Design (or APQP) Team Leader ensures that design outputs comply with the design input requirements. As warranted. 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).

Measurements may include quality risks. decisionmaking. Form 8. customer feedback. MONITORING The Design (or APQP) Team Leader monitors the design project by defining. we may initiate corrective/preventative action. corrective and preventive actions. and critical paths. support status review. We implement computerized information systems for timely reporting of data related to product usage. analyzing and recording measurements at specified stages of design and reports summary results as an input to management review (Section 5). lead-times. costs. and compare with competitors and/or appropriate benchmarks. and longer term planning. quality and environmental objectives. (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. 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. Management Action Requests (MARs). Page: 43 Page: 70 . work instructions Manufacturing process FMEAs Specifications and drawings Tool designs DESIGN REVIEW During the evolution of each design project.5-1. When we notice negative trends during data analysis. corrective and preventive actions and management review. (Section 5) CONTINUAL IMPROVEMENT We implement Continual Improvement with the goal of continually improving the quality/environmental management system using the quality policy. the Design (or APQP) Team Leader conducts design reviews as planned and records results and any necessary actions. trends in data and information. DESIGN VERIFICATION We conduct design verification to ensure that the design and development outputs have met the specified input requirements. Records of verification results and any necessary actions which we record on the DVP & R and Program Open Issues. audit results. We use this information to develop priorities for prompt solutions to customer-related problems. 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. (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.We report and compare with progress towards the overall business objectives During Business Planning and Management Review processes. Our Management Review Process assesses the overall effectiveness of continual improvement program. is used to document improvement.

Wherever practicable. and process.Design Validation includes a review of field reports for similar products. If placed on ´containment statusµ (due to continued poor performance and/or failure to achieve goals and objectives). Suppliers are required to follow The Company product and manufacturing process approval procedures and requirements. and appearance specifications as required by the customer. We perform Validation in accordance with customer requirements. 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. if applicable. We conduct final validation testing to validate the final product. Production Part Approval Process (PPAP) for customers requiring this program or other sample submission programs as required. these we document these changes and keep them in the ECN documentation. The Company will take all actions required by the customer.3. and suppliers. 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. We perform design validation on products that we produced from production equipment and tooling wherever and to the extent possible. ANALYSIS OF DATA We collect and analyze data from quality and environmental system processes evaluate the effectiveness of the quality/environmental management system. 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 8.3. We maintain Engineering Approved Product Authorization (EAPA) records. material. including program timing. As applicable. characteristics and trends of processes and products. we complete validation prior to the delivery or implementation of the product. the Design (or APQP) Team Leader plans and carries out or oversees design validation to ensure it is performed in accordance with customer requirements. It is the responsibility of the Program Manager in cooperation with the Quality Manager to ensure The Company submissions meet functional. Page: 69 . and label the carton of parts. If there needs to be corrective actions. including program timing. Analysis of this data provides information relating to customer satisfaction. design. after process verification we submit the Product approval. The original or superseding specs and requirements are complied with when the authorization expires. CUSTOMER WAIVER According to the production Part Approval Process (PPAP) manual. 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. product conformity. This helps us to find opportunities for continual improvement of the effectiveness of the quality/environmental management system. including expiration date or quantity authorized. The Program Manager keeps records of required tests in the APQP documentation. and guidelines contained in SOP 8.

The processes applicable to the planning. and rework and calibration services) are defined in accordance with the policies outlined in this section. We maintain records of the review and any necessary actions. Therefore. 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. along with the PPAP process. The Quality Control Manager has the responsibility to ensure disposition of all suspect or nonconforming material within an appropriate timeframe. PURCHASING We work in partnership with our suppliers to ensure that purchased products and services meet all applicable requirements. sorting. (Section 4) CONTROL OF NONCONFORMING PRODUCT ² SUPPLEMENTAL We classify and process product with unidentified (Section 7) or suspect status as nonconforming. Sales. or potential effects. 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. design changes with Engineering. Because we perform rework/repair for minor defect problems.Suspect or rejected material is either clearly identified with yellow Quality Hold tape or is stored in clearly marked designated areas. PRODUCT RECALL In the event we detect nonconforming product after delivery or use has started. of the nonconformity. as appropriate. Page: 45 Page: 68 . Where appropriate. verify. Note: In the absence of any specific instructions. the operations are a repetition of one or more original production processes. and the APQP processes. the Quality Manager notifies the customer and initiates action appropriate to the effects. depending on the nonconformity. The review of a change includes an evaluation of the effect of the changes on component parts and product already delivered. including concessions obtained. we will default to a level 3 PPAP submission (Section 7). and approve. we use our Standard Operating Procedure 7. The customer will authorize design changes before implementation. The Company will validate all productionengineering changes to PPAP requirements. acquisition and verification of all products and services that affect customer requirements (such as sub-assembly. CONTROL OF DESIGN CHANGES We review. sequencing. and Manufacturing before their implementation. PRODUCT APPROVAL PROCESS To ensure proper employee understanding. we use the original process instructions and rework material and we verify activities specified on the control plan. validate. We distribute an internal work order for changes as is detailed in the Design Release and Change Procedure.1 Details in. and maintain them according to SOP applicable inspection and test procedures. 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.

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

and quality management system requirements. We then recorded the results of evaluations and follow/up actions. or specification) we purchase products. Page: 66 CUSTOMER-APPROVED SOURCES Where specified (by contract. Personnel responsible for making appearance evaluations are qualified and competent to do so. We maintain Masters for color. (SOP 8.4. which is product with unidentified status.4. and special status customer notifications related to quality or delivery issues.2. The Materials Manager monitors Supplier performance per SOP 7.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. requirements for approval/qualification of product. 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. & texture and evaluation equipment in the QC laboratory. Page: 47 . materials. APPEARANCE ITEMS For parts designated by the customer as ´appearance itemsµ The Company provides. (Section 6) CONTROL OF NONCONFORMING PRODUCT The Company procures raw materials and manufacture products that are defect free.e. We maintain a master list of approved suppliers to ensure we only purchase product from The Company qualified sources or customer-approved sources. customer engineering drawing. product audits or customer complaints. procedures. the applicable control plan and design records (i. equipment. appropriate resources. We consider suspect product. qualification of personnel.2 and the following policies. where appropriate. Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services. IDENTIFICATION Identification of nonconforming product originates from inspection.1 through one or more of the following indicators: delivered product quality. gloss. or services from customer-approved sources. customer disruptions including field returns. delivery schedule performance (including incidents of premium freight). nonconforming product until status can be confirmed. 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. drawings). processes/systems. including. grain. for evaluation areas for appearance items.4) Results are retained and available for customer review. Employees clearly mark or otherwise identify nonconforming product or suspect material. including performance of color eyesight testing. including lighting. including suspect products.3). internal testing. Documented procedures are available for the control of non-conforming materials and product. to prevent their use or delivery to the customer (SOP 8.

and processes must be measured. Production personnel in accordance with the applicable control plan perform manufacturing process monitoring (Section 7 and 8). and certification.that is. the Quality Manager documents and communicates the intended verification arrangements and method of product release related to verification activities performed at our suppliers· premises. EVIDENCE OF CONFORMITY We maintain test and inspection records for a minimum of three years. facilities and equipment. Our initial focus is to assure the quality of process inputs . Equipment and facilities must be adequate. monitored. We have Inspection procedures in the Receiving Inspection Process and on Incoming Inspection Form. and properly utilized the suitability of the fundamental process inputs must be assured. (Section 8) Page: 48 Page: 65 . IN-PROCESS INSPECTION Quality Control personnel perform formal in-process inspections in accordance with the control plan and SOP 8. material. FINAL INSPECTION AND TEST: We verify all finished products and completed services by final inspections/tests specified in the control plan and SOP 8.2. and issued. and methods. These records include final inspection authority. The Quality Manager plans and implements appropriate sampling plans and other statistical techniques to verify purchased product per Section 8. available. As applicable. PRODUCT RELEASE AND DELIVERY: We do not release product or deliver until we complete all planned inspections and. and confirm that all critical parameters are in accordance with established requirements and specifications. We try to identify and control Nonconforming (or suspect) product to prevent its inadvertent use. and records have been maintained providing evidence of conformity with acceptance criteria and identifying the person(s) authorizing release. identify. Material must meet specified requirements and be properly identified. and controlled to assure effectiveness and/or to identify opportunities for improvement.4. training. 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.2. Employees must be equipped to perform the process properly through appropriate education. product samples are stored for a minimum of 3 years. Additionally. accurate.4. employees. RELEASE We do not release products for further processing or delivery until we have objective evidence that meet all requirements.INCOMING PRODUCT QUALITY Quality Control is responsible for conducting verification inspections to ensure incoming materials meet customer specifications. stored.

When selecting product parameters to monitor compliance to internal and external requirements. layout inspection and functional test. (Section 7) JOB SET UP VERIFICATION Job set ups are verified per SOP 8. Page: 49 Page: 64 . and special consideration regarding monitoring and measurement of appearance items. 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. including processes producing bulk materials. subsystem. as well as parts. in-process inspection. (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. and material level for the product supplied.4 prior to commencing each new production run and/or when process changes are made. Methods used to verify incoming product from the supplier. This is responsibility if Program Manager. CONTROL PLAN The Quality Manager develops control plans at the system.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.4). evaluation by accredited laboratories. or source inspections. and the required capability and inspection/test skills needed.2. final inspection and test. (Section 7) The scope of our product monitoring and measurement system (SOP 8. manufacturing process.4) includes receiving inspection. 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.2. such as receiving inspection or (SOP 8. job set up verification. 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. product characteristics are determined leading to the types of measurement. suitable measurement means. 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). 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.2. measurement logistics. or delegated responsibility for product quality Tooling Management: The Company personnel maintain control over any work that is outsourced. component.

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

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

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

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). and delivery.5. through Production Shift Supervisors. this includes any processes where deficiencies may become apparent only after the product is in use or the delivery of services. As applicable. shipping. ISO 14001. DELIVERY. QUALITY/ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT The Company conducts system audits. MONITORING ACTIVITIES The Production Manager.5. as identified in the contract.Director periodically reviews customer satisfaction survey data and other customer feedback (including complaints). (Section 5) INTERNAL AUDIT The Company·s internal audit results are critical inputs to aid in assessing the effectiveness of our QEMS. 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 . and in promoting awareness of customer requirements and effectiveness of the Quality/ Environmental Systems. (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.1) The Quality Manager is responsible for planning and implementing in-process inspections needed to ensure process control and product quality. 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. AND POST-DELIVERY PROCESSES Release of product is dependent on its compliance with all specifications and its ability to meet customer requirements including packaging. (Section 8) RELEASE. ensures that production personnel monitor the quality of the work and that employees understand the procedures for reporting related problems and suspected nonconforming conditions. (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. as well as progress towards achievement of corporate level customer satisfaction improvement objectives (Section 5) and provides related recommendations for review by Top Management.2.( SOP 7. 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.

including inspection and testing activities.3. appropriate controls and records are established.1: CUSTOMER SATISFACTION ² SUPPLEMENTAL Customer Satisfaction is a critical measurement of the performance of the quality management system. This drives our quality policy ´to meet or exceed customer requirementsµ. incoming product received without part numbers in Receiving.5.1 and the AIAG ´Statistical Process Controlµ (SPC) reference manual. We analyze Customer satisfaction data and report it in management review meetings. See Management Review Process. and delivery in accord with procedures defined in SOP 7.1. or perform work will attend a Basic Statistics course containing an overview on basic concepts such as variation. IDENTIFICATION AND TRACEABILITY ² SUPPLEMENTAL The identification and status of product is established and maintained during all product and service provision processes. IDENTIFICATION AND TRACEABILITY The Program Manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. We must receive incoming material with labels indicating the assigned part numbers. 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. (Section 7) KNOWLEDGE OF BASIC STATISTICAL CONCEPTS Employees using statistical tools to manage. We assign Incoming material part numbers. verify.2. QC Receiving personnel are Page: 54 . Measurements of customer satisfaction include evaluation of Customer feedback such as complaints. 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. production. returned goods. installation. and revalidation Use of specific methods and procedures improvement when established per SOP 8. We tag or label. control (stability) process capability. 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. Where product traceability is a customer-specified requirement. warranty reviews. We monitor the manufacturing process performance to demonstrate compliance with customer requirements for product quality and efficiency of the process.y y Requirements for records. SPC. customer performance ratings and delivered part quality. (Section 6) MONITORING AND MEASUREMENT CUSTOMER SATISFACTION Customer satisfaction is the reason we exist.

handling. storage. or unsuitable customer property and immediately reported to the customer. The Company identifies. (See SOP 7. test. Statistical techniques for on-going process control and Page: 58 . deterioration. verifies. and improvement activities needed to assure product and Quality/Environmental Systems conformity and achieve continual Quality/Environmental Systems improvement. (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 maintains appropriate traceability records in accordance with customer requirements. the Quality Manager plans for. A FIFO inventory system is used and regular tracking of inventory turns. and preservation of product pending use or delivery. as applicable. process monitoring and measurement. (Section 7) CUSTOMER PROPERTY Customer property includes customer-owned material. 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. and protection. protects.6 for calibration laboratories) MEASUREMENT. measurement. 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. we report at the management meeting. and maintains customer property provided for use or incorporation into the product. damaged. analysis. We design designated storage areas to prevent damage. by applying the same process controls as we do to purchase product. tooling (including test/inspection tooling and equipment). and intellectual property. packaging. and product monitoring and measurement. These activities include assessment of customer satisfaction. The Quality Manager ensures that we record lost. tools (including returnable packaging). conduct of internal audits. Where contractually required. plan. or calibration services are either acceptable to the customer or accredited to ISO 17025. (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. ANALYSIS AND IMPROVEMENT GENERAL These sections describes how we define. EXTERNAL LABORATORY The Quality Manager ensures external laboratories used for inspection. and implement the monitoring.

STORAGE AND INVENTORY In order to detect deterioration. and test equipment needed to provide evidence of product conformity to determined requirements. we periodically assess the condition of stock. We used a number or other identifier to provide traceability to the device calibration record. In addition.) is controlled as nonconforming product. actions taken are documented. obsolete product (including expired age dated material. (Section 4 & 7) MEASUREMENT SYSTEMS ANALYSIS The Quality Manager is responsible for selecting appropriate analytical methods and acceptance criteria. Further. (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. CALIBRATION/VERIFICATION RECORDS Records of the calibration verification activity for all gauges. Obsolete product is treated the same as nonconforming product and is appropriately identified and segregated to avoid using it for production.Inventory turns and levels are goals defined within the business plan.g. 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. frequency/method of checks. Verify and receive products into their system. including their identification. measuring. (Section 8) We maintain appropriate calibration records to document results of calibration activities and suitable indicators are used to show current calibration status. which conform to the Measurement Systems Analysis manual. 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. 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. Create an electronic invoice that will generate payment. including employee and customer owned equipment. 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. and maintenance of monitoring and measuring devices Page: 56 . including appropriate corrective actions to remedy the situation and preclude its recurrence. e. such as gage R & R studies. include: y Equipment identification. When we find monitoring and measuring devices out of calibration (or when we do not know the calibration status). We identify and select monitoring and measuring devices and verify their capability of meeting such requirements prior to use. control. uses/acceptance criteria and what actions to take when results are unsatisfactory. we adjust or re-adjust as necessary and the validity of previous measuring results and document. location.

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