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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MANAGEMENT REVIEW FC-MR-5.6
Assess Overall System Effectiveness Monitor Objectives and Operations

CONTENTS
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

QUALITY /ENVIRONMENTAL

MANUAL
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

y

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The material handler: y Brings carpet to the press and helps the operator to load the carpet onto carpet feeder Page: 107 .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. The Company·s· Quality and Environmental Policy are available upon request. established in XXXX. 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. State. APPLICATION Our Quality/Environmental Systems comply with all applicable requirements contained in ISO/TS 16949:2002.2 General Safety Notes PPE: y y y y Safety Glasses Kevlar Gloves Kevlar Sleeves Knife Company Background The Company. and the headquarters is located at XXX Some Street. zip. 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. City. and encompasses all operations at both of our facilities.2. The Company currently supplies to the following manufacturers: y y XXXX. covers the design and provision of all company products.

Potential Failure Mode and Effects Analysis (FMEA Third Edition) PPAP-4. The quality inspector performs 1st piece inspection. When the press finishes its· cycle. Quality management systems ² Guidelines for performance improvements  Customer Specific Requirements: y ISO/TS 16949:2002. When the container is full. Pack and label Revision History 1. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. and after the removal of the part from the over bend fixture 10. The operator cycles the press by pressing the two black palm buttons simultaneously 7. 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. Place the both tenor frames central over the cavities (one tenor frame per two cavities) 6. Quality management systems ² particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations CSR-Ford. Reference Documents The following external documents contain provisions. the operator removes the parts and the left over material 8. Production Part Approval Process (PPAP Fourth Edition) Page: 7 . Part inspection 14. Attach both tenor frames to the carpet and cut the carpet between them 4. the operator calls the material handler to remove the container and bring an empty one 12. Advanced Product Quality Planning & Control Plan (APQP) FMEA-3. Quality management systems ² Fundamentals and vocabulary ISO 9001:2000. constitute provisions of our Quality/Environmental Systems: y y y ISO 9000:2005. which. through reference in this manual. 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-2.3. Ford Motor Company Customer-Specific Requirements for Use with ISO/TS 16949:2002 CSR-GM. Raise carpet to the cutter and cut the carpet just above the tenor frames 5. The operator then places the finished parts into a shipping container 11.ISO/TS 16949:2002 CSR-DC. Quality management systems ² Requirements ISO 9004:2000. at beginning of shift. General Motors Customer Specific Requirements .

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

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

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

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

3 1.0 Purpose This procedure provides a systematic means in which quality problems will be eliminated. distribution. problems from subcontractors and customer complaints. and implementation of all customer-engineering standards/ specifications and changes based on customer-required schedule. including internal rejections.2/8.3 FOPARLOG Concern Report (MCR) Material Concern Report Tracking Log Control of Nonconforming Product Procedure Preventative Action Log Page: 101 . The format utilized will be an 8D. ENGINEERING SPECIFICATIONS The Program Manager oversees our process for assuring the timely review. and to apply suitable identification to them if they are retained for any purpose.5. Record retention must satisfy both regulatory and customer requirements. unless otherwise directed by the customer.0 Definitions Not applicable 4.0 Responsibility It is the responsibility of the Quality Manager to manage the corrective/preventative action. records should be disposed of accordingly. c) Identify the current revision status of documents.0 Associated Materials FOCAR 8. and re-approve documents. The Company uses a Product Data Management system to manage and control engineering records and data (see SOP 4.5. readily identifiable. The information Quality Manager has overall responsibility for ensuring that all Quality/Environmental Systems documents. The Top Management Team is responsible for analysis of customer-rejected material.3). Page: 12 CORRECTIVE AND PREVENTIVE ACTION SOP 8.2. as well as ISO or TS requirements. 2.0 Application This procedure applies to all quality problems.Quality and Environmental records are legible.2.2 FOMCRLOG SOP 8.5. When we reach retention time.3: a) Approve documents for adequacy prior to issue. below includes forms used to create controlled quality records as detailed in procedure SOP 4. 3. readily available and retained for a specified period in Quality Record Matrix. d) Ensure that relevant versions of applicable documents are available at points of use. e) Ensure that documents remain legible. 5. update as necessary. 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. b) Review.

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

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. The Quality Manager will take Actions such as stock returns and replacement. Records controlled include customer-specified records.0 Associated Materials FO 8.0 Procedure When finding nonconforming material. We provide evidence of commitment to the development. sorting or even sending a company representative to their site to protect their interests. Management Responsibility Management commitment The Quality Department is responsible for maintaining and analyzing data from NC material activities. implementation. products.3 Quarantine Area Record 6. 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). that differ from those currently approved according to the Production Part Approval Process Manual. and corporate level improvement objectives. through periodic management review of the quality policy statement.5. Disposition of records also includes their disposal. regulatory and legal requirements) through continual improvement of our processes.RECORDS RETENTION SOP 4.4 contains related procedures and responsibilities to ensure: y y y y y Record controls established satisfy all regulatory and customer requirements. (If material is part of an accumulation. the Quality representative or production supervisor identifies the container(s) with an initial Material Concern Report. The Quality Manager is responsible for notifying the customer of non-conforming material found after shipment or use has started. completes the Quarantine Area Record. implementation. along with the management team. and maintenance of our quality policy at all levels of the organization through widespread printed distribution of our quality policy statement. Page: 14 . 5.3 NCMR Material Concern Report SOP 8. We ensure understanding. Page: 99 The Managing Director. This managing includes the procurement of a deviation or concession from the customer if changes to the product differ. The Program Manager/Production is responsible for managing the customer authorization of products or processes and the procurement of a deviation or concession. is responsible to communicate the importance of meeting customer as well as statutory and regulatory requirements. and services.2 Corrective/Preventive Action Procedure FO 8. including materials and services provided by vendors. up to the disposition section.2. 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.

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

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

and effectiveness are. The business plan includes short and long-term goals relating to quality and environmental policy objectives. as information is available. customer feedback. 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.0 Associated Materials Orientation Manual Job Descriptions 6. This review occurs concurrently with the employee·s performance evaluation or upon need. productivity. It is the responsibility of the TS-16949 Management Representative to measure the extent to which our personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. We also have methods to track update and revise fall under the Continuous Improvement Process. The Company benchmarks trends in quality. 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. The quality manual documents the necessary processes that define the planning process for quality/environmental management system and objectives. 5. We accomplished Benchmarking formally and informally via trade shows. 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 .0 Procedure Identify training needs. The Company·s Management Team annually reviews business plan and revises. efficiency. The Company employees and their manager/supervisor shall review the employees training status to determine training needs. and defines timeframes to achieve each goal. to encourage customer satisfaction and overall growth of the organization. and charting of performance measures (Section 6). and give an assessment test (if applicable) upon completion of the course. including those needed to meet product requirements. as appropriate.evaluation form. reading material.

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

Each job description identifies the competence level/ education. or to exceed. (Section 8) Be committed to continuous process improvement by emphasising reduction of part-to-part variation and the elimination of all waste. 6. but are not Page: 94 e) f) g) h) Note: In the absence of any specific instructions. 3.2 1.0 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. all applicable environmental laws and regulations of the jurisdictions in which we do business (Section 6).COMPETENCE AWARENESS & TRAINING SOP 6. This manual constitutes our overall plan for establishing. 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). and 8) The Quality Manager develops appropriate quality planning documents for specific products. the training provided. as appropriate. which the Human Resource Department maintains. skills appropriate required for the position. projects. 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 Responsibility Job Description Each position has a written job description maintained by the Human Resources Department. we will default to a level 3 PPAP submission. and through the provision of resources needed for its effective implementation. 2. 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. and improving systems. of. Meet customer requirements by controlling and using returnable packaging. SPC-3. 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.0 Application The scope of this procedure incorporates the training of all employees performing quality related activities. (Sections 5. Each hourly employee has an individual training record.0 Definitions Not applicable 4. (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. and associated customer specific requirements documents.2. Page: 19 . These records include. (Section 7). (Section 8) Conduct operations in conformance with.

and concluded the review with appropriate decisions and actions. processes. to include presented and discussed topics and issues. MANAGEMENT All managers are responsible for execution of the Business Plan and implementation of the policy.6) Revision History Page: 93 .0 8.6. the provision of resources needed to implement and improve Quality/Environmental Systems and management reviews (Sections 5 and 6). AUTHORITY.1 Management Review Report Form SOP 4. and systems Page: 20 9.4 Operational Procedure. Quality Objectives Matrix: We document Record of established quality objectiveson the title page of the Management Review Report (MRR 5. policies and changes. Top Management is responsible for Business Planning. if any.6. with the help of department managers. Other members of Top Management include: y y The Operations Managing and The Human Resource Director 7. development and communication of our quality policy.RESPONSIBILITY.2. Management Review Report Documented using form FO-MRR-5. sets direction and ensures the success of our business through the clear definition and communication of Quality/Environmental Systems responsibilities and authorities. The report is prepared by the Quality Manager and is distributed to the attending and.1. absent participants.2 Operational Procedure. Control of Records The location. The interrelationship of Top Management and other key personnel is depicted our Organization Chart. conclusions. We document the Management Review output in the Management Review Report based on form MRR 5. Operational Procedure SOP 4. and retention period for management review records.4.2. Control of Records SOP 8.0 Referenced Documents 5.0 Records Management review records must be as comprehensive as possible. 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. Quality/Environmental Systems Planning including the establishment and deployment of objectives (Section 5).5. They will be the sole evidence that the agenda of the review was completely covered. AND COMMUNICATION The Managing Director (MD).6.1. and any actions initiated to implement the conclusions and policies. Corrective and Preventive Action Associated Records Management Review Report: Record of the management review meeting.

and allocation of human. time frame. Assigned to.6. Management ensures the staffing of all production shifts with personnel in charge of. and Due Date columns. and other necessary resources. and do not directly related to product or process conformity.1) in the Actions. etc. Management with responsibility and authority for corrective action promptly notifies employees of non-conformities (Section 8). Corrective or preventive actions Documented in the Corrective Action Request (CAR) form (FO-NCCAR-8. flow charts.5. 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.2. or delegated responsibility for product quality (Section 7).2. MANAGEMENT REPRESENTATIVE The Company has appointed Quality and Environmental Management representatives for each system. 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. Page: 21 .6.0 y y y Management review output Improvement of the quality management system. including the establishment and deployment of operational level objectives (Section 5). EMPLOYEES All employees are responsible for the quality of their work and implementation of the policy and procedures applicable to processes they perform. Managers also conduct employee performance reviews (Section 6). equipment. and the provision of resources needed to implement and improve these processes. This method is most suitable for implementing long-term improvement goals. This type of action is most suitable for minor improvements that we can implement quickly. and Preventive Actions. Page: 92 described in this manual.3) and processed in accordance with procedure SOP 8. work instructions. All managers are responsible for planning and controlling Quality/ Environmental Systems processes within their area(s) of responsibility. We identify resource needed for implementing improvement actions These include assignment of responsibility. technical knowledge. 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. We normally use CARs for improvements related to specific actual or potential product or process nonconformities. Quality objectives Documented on the title page of the Management Review Report (refer to Section 6 of this procedure). Personnel responsible for product quality have the authority to stop production to correct quality problems (Section 8). Corrective. Improvement of quality performance. job descriptions.

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

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

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

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

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. we shall maintain them for the length of time established by the corresponding Department Manager and in accordance with minimum customer requirements. and Improvement Planning (including the use of SPC) Organizational Continual Improvement Planning Manufacturing Process Continual Improvement Planning Obsolete documents. Equipment and other Infrastructure Planning Contingency Planning Work Environment. 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. tooling records. purchase orders and amendments. Facility.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. Analysis. and Service Provision Planning Measurement Systems Planning (including the conduct of MSA) Measurement. Services and Vendors) Production. other than production part approvals. (Section 5) Page: 26 Page: 87 . Revision History The MD. with input from other responsible managers.

and determine the filing and storage method (for retrieving and preventing damage) and the retention duration (conforming to TS16949 requirements) for quality records. AND TRAINING The Company maintains a Training/Competence Matrix for personnel by job description.0 Procedure The responsible personnel and/or departments ensure the validity and completeness. we deem the new person ´competentµ to work on his or her own. In the third phase. COMPETENCE. The Quality Department retains superseded part documents used for new part qualification. AWARENESS. Some persons may move on to the fourth stage and we deem them an ´expertµ allowing them to train others or assume other responsibilities.4 QR 6.2 FO 4.2 SOP 8. It is which visually displays the capabilities of the person according to which of the quadrants have been achieved. It is a four-quadrant system. skills. (SOP 6) Page: 27 . In the second phase. All personnel understand the importance of their activities and their contribution to the achievement of the quality and environmental objectives. 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. experience and competence.2. This Competency Matrix is available to persons assigning work.The Materials Manager and Accounting department are responsible for ensuring the proper retention of customer related purchase orders and amendments. The retention duration listed is a minimum retention. 5. The Quality Department ensures quality records are available for evaluation by the customer for the stated period. 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.2. the experienced person or member of management continues to observe the new person.0 Associated Materials AIAG APQP AIAG FMEA AIAG MSA AIAG SPC AIAG PPAP SOP 5.6 SOP 7. We might retain the records longer for reference at the discretion of the responsible party. The status of archived records is determined and appropriate records are disposed of annually.

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

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

workspace and associated utilities. ISO 14001 The Program Manager is responsible for a timely review of customer drawings and specifications. Both the person receiving a copy of a new or revised document and the person distributing the document are responsible for Page: 83 . The Human Resources Department maintains employee qualification and competency review records and annual performance review results. employee performance reviews (Section 6). 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. System. reviewing and retaining CAD/ Math data. we ensure that our employees are aware of customer requirements (Section 5 and Section 5). Instructions and Test Procedures are available. The Training Manager maintains records of all training completed. EMPLOYEE AWARENESS Through their activities and contributions. and experience in accordance with provision of Section 4. Department Managers are responsible for creating. All Department Managers listed above are also responsible for making sure distributed and or retrieving and replacing obsolete copies with the latest revision. We accomplished this through awareness training. and employee participation in our internal audit (Section 8) and improvement (Section 8) processes. The Plant Supervisor is responsible for ensuring current instructions are available at all 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). The Program Manager is responsible for receiving. approving. or supervisor who identified the training requirement. and importance achieving our quality policy (Section 5) and objectives (Section 5). INFRASTRUCTURE The Company provides and maintains the infrastructure needed to achieve conformity to product requirements. training. We evaluate provided training through immediate feedback from the employee and the manager. 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 responsible manager collects the documents for each training event. and maintaining their individual department work instructions. RECORDS We maintain appropriate records of education.EFFECTIVENESS The Company evaluates the effectiveness of all actions taken to meet competency needs. skills. the relevance. including buildings.

AND EQUIPMENT PLANNING The MD uses a multidisciplinary approach for developing plant.3 1. maintenance and repair Housekeeping/custodial services management Process equipment management. facility.6. and any supporting services that are needed.4 and SOP 5. labor shortages.2) The Plant Supervisor has overall responsibility for managing our Facilities and Equipment Maintenance programs in accordance with SOP 6. test procedures. Application This procedure applies to statutory & regulatory requirements the drawings specifications and documents that explain the engineering requirements. processes. Purpose This procedure describes the responsibilities for receipt. 2. review. 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.1. facility.CONTROL OF DOCUMENTS SOP 4. y 4.2. We use a multi-disciplinary approach to develop plant. including documents of external origin. and distribution of drawings and documents. In addition. manufacturing processes. The Company prepared contingency plans to satisfy customer requirements in event of an emergency such as utility interruptions.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. 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). and key equipment failure and quality issues. such as transportation or communication. 3. and Transportation and material handling equipment management. work instructions and inspection instructions related to deliverable goods and our processes. and repair PLANT. and equipment.3.5. maintenance and repair Production tooling management. these programs include: y y y y y Facilities management. FACILITY. Page: 82 Page: 31 . and equipment plans. we detail methods to evaluate and monitor the effectiveness of existing operations in SOP 7. assembly methods. (SOP 6. maintenance.3. handling and valueadded use of floor space and facilitate synchronous material flow.

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

5. and for the recall of obsolete documents. the following: a. The quality department distributes a copy of the new or revised policy. The Company has implemented a Quality and Environmental-planning process to define and document how the respective requirements will be met (See SOP 7.3 6. 2. procedure. but not limited to.1 & SOP 7. or instruction according to the Quality Policy Manual. through their department manager. For new projects. a cross functional team plans the processes with consideration given to. may request document changes.0 Associated Materials SOP 4. The responsible Department ensures availability of appropriate documents at all locations where the performance of operations affect the quality system. 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. If a Quality System procedure needs to be changed. CLEANLINESS OF PREMISES We provide and maintain a work environment in a state of order. and repair consistent with the product and manufacturing process needs (Section 6) PRODUCT REALIZATION PLANNING OF PRODUCT REALIZATION 1. Error proofing for processes.0. The quality/environmental objectives and requirements for the product b. The Administrator will maintain a master list of qualityrelated documents.3 SOP4. Product special characteristics. the request form gives an explanation and a copy returned to the originator. the revision history identifies the changes.2).2. Environmental aspects/impacts c. The changes become part of the revision history. cleanliness.0 Procedure Any member of staff. facilities. The responsible Department ensures that designated personnel receive approval. Reference 6. The Quality Department files original form. equipment.2.2. and tooling Page: 33 . including safety characteristics d. 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).manuals and data within their area of responsibility as required. If not approved.4 FO 4. Procedure Manual. initial issue. send a Quality Manual Change Request Form to the Quality Manager describing the proposed change. and Operator Instructions Distribution List. and amendments of all documents and data relating to the requirements of the quality system. Where practical.

2. monitoring. approves. 4. The identification of any controls. reviews. we notify the customer and validate changes before implementation. and systematically issues documents in a controlled manner. The quality plan and relevant work instructions clearly define acceptance criteria and approved by the customer. Customer requirements and references to technical specifications are to be included in the quality plan The Company uses the methods in the APQP. and specifications. processes. drawings. We confirm defined activities to ensure compliance with customer requirements.0 Purpose This procedure addresses the maintenance of quality documents pertaining to customer requirements. and instruction elements. and Control Plan manuals as required. inspection and test activities g. SPC PFMEA. Identification of required verification. and PPAP. and operator instructions. procedure. procedures. fixtures.2 1. Quality receives. and related product information.0 Responsibility The Process Owners/Area Managers are responsible for controlling issuance and maintenance of quality/and environmental-related policies. 5.0 Application To maintain designated secured locations for original policy. prepares. and operator instructions for original release and the release of changes. equipment (including inspection and test equipment).0 Definitions Not applicable 4. 3. documentation. procedures. measuring. MSA.3. 6. including electronic data. We maintain customer confidentiality for all products and projects under development. 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. DOCUMENTATION REQUIREMENTS SOP 4. e. including the prevention of pollution f. The Program Manager and/or designee are responsible for controlling issuance and maintenance of drawings. The Company assesses product and manufacturing process changes that affect product realization. Department/Plant Supervisor are responsible for controlling issuance and maintenance of associated Page: 34 Page: 79 . One level above the author will be an approver for reviewing and approving companywide policies. training and skills needed to achieve the required quality and environmental objectives and targets. revises. When we receive the approval for any changes affecting customer requirements.

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

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

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

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

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

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

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

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

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

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

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

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

Page: 47 . procedures. 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. including lighting. materials. and special status customer notifications related to quality or delivery issues. nonconforming product until status can be confirmed. where appropriate. drawings). grain.e. qualification of personnel. Employees clearly mark or otherwise identify nonconforming product or suspect material. (SOP 8. (Section 6) CONTROL OF NONCONFORMING PRODUCT The Company procures raw materials and manufacture products that are defect free. Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services. for evaluation areas for appearance items. IDENTIFICATION Identification of nonconforming product originates from inspection.2. 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. gloss. requirements for approval/qualification of product.4. product audits or customer complaints. or services from customer-approved sources. Page: 66 CUSTOMER-APPROVED SOURCES Where specified (by contract. Personnel responsible for making appearance evaluations are qualified and competent to do so. internal testing. customer engineering drawing.2 and the following policies. including. delivery schedule performance (including incidents of premium freight). equipment. including suspect products. We maintain a master list of approved suppliers to ensure we only purchase product from The Company qualified sources or customer-approved sources.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. processes/systems.1 through one or more of the following indicators: delivered product quality. & texture and evaluation equipment in the QC laboratory. We consider suspect product. appropriate resources. or specification) we purchase products. Documented procedures are available for the control of non-conforming materials and product. and quality management system requirements. APPEARANCE ITEMS For parts designated by the customer as ´appearance itemsµ The Company provides. The Materials Manager monitors Supplier performance per SOP 7. including performance of color eyesight testing. We maintain Masters for color.4) Results are retained and available for customer review. to prevent their use or delivery to the customer (SOP 8. customer disruptions including field returns.4.3). the applicable control plan and design records (i. We then recorded the results of evaluations and follow/up actions. which is product with unidentified status.

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

4). (Section 7) The scope of our product monitoring and measurement system (SOP 8.2. 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). 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. and the required capability and inspection/test skills needed. component. in-process inspection. evaluation by accredited laboratories. such as receiving inspection or (SOP 8.4 prior to commencing each new production run and/or when process changes are made. or delegated responsibility for product quality Tooling Management: The Company personnel maintain control over any work that is outsourced. including processes producing bulk materials. or source inspections. This is responsibility if Program Manager.4) includes receiving inspection. When selecting product parameters to monitor compliance to internal and external requirements. product characteristics are determined leading to the types of measurement. 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. (Section 7) JOB SET UP VERIFICATION Job set ups are verified per SOP 8. Page: 49 Page: 64 . layout inspection and functional test. 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. and special consideration regarding monitoring and measurement of appearance items. (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.2. measurement logistics. 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. as well as parts.2. and material level for the product supplied. final inspection and test. subsystem. manufacturing process. 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. suitable measurement means. Methods used to verify incoming product from the supplier.

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

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

work instructions posted in areas as needed.2 defines the criteria. Responsible managers may also request that the audit be used to gather ´value addedµ data serving as input to aid in monitoring. scope. plans. AUDITOR QUALIFICATION Internal auditors are qualified to audit to ISO/TS 16949:2002 requirements (Section 6). is provided to production personnel throughout the product and service provision process. and abilities of our employees and the complexity of their assigned work process. and for reporting results and maintaining records. raw material characteristics and the required product parameters. skills. Management is responsible for the area-audited implement and timely corrective action to eliminate detected non-conformances and their causes. function. Page: 52 Page: 61 . Engineering. facilities. (Section 8) The Quality/Environmental Systems process. frequency and methods used for internal audits and define the responsibilities and requirements for planning and conducting audits. 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. and reviewed at least once annually to determine effectiveness.including process monitoring and verification instructions and criteria developed during product quality planning and manufacturing process development (Section 7). with a special emphasis on our ¶core· customer oriented processes and our unique product realization processes. or quality system element under review is effective if it is achieving the desired results or established objectives.2. Audit checklists are prepared and used to aid in ensuring audit consistency and comprehensiveness. and initiate other appropriate action in response to opportunities for improvement identified by process participants or managers. measurement. 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. We provided such information through job schedules. (Section 8) SOP 8. The Production Manager ensures that all appropriate information including final product specifications. and improvement of Quality/Environmental Systems processes and systems. 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. We conduct follow-up audits to verify timely and effective implementation of the proposed action. WORK INSTRUCTIONS The need for work instructions is dependent upon the knowledge. team meetings. EQUIPMENT The Plant Supervisor ensures the suitability and availability of all equipment.

( SOP 7. The Program Manager has overall responsibility for ensuring ¶Special Processesµ are validated in accordance with procedures detailed in SOP 7. As applicable. this includes any processes where deficiencies may become apparent only after the product is in use or the delivery of services. DELIVERY. (Section 5) INTERNAL AUDIT The Company·s internal audit results are critical inputs to aid in assessing the effectiveness of our QEMS.1) The Quality Manager is responsible for planning and implementing in-process inspections needed to ensure process control and product quality. and in promoting awareness of customer requirements and effectiveness of the Quality/ Environmental Systems. MONITORING ACTIVITIES The Production Manager. ISO 14001. (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. AND POST-DELIVERY PROCESSES Release of product is dependent on its compliance with all specifications and its ability to meet customer requirements including packaging. QUALITY/ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT The Company conducts system audits. (Section 8) RELEASE.Director periodically reviews customer satisfaction survey data and other customer feedback (including complaints). and delivery. shipping. as well as progress towards achievement of corporate level customer satisfaction improvement objectives (Section 5) and provides related recommendations for review by Top Management. in identifying any opportunity for improvement. as identified in the contract. ensures that production personnel monitor the quality of the work and that employees understand the procedures for reporting related problems and suspected nonconforming conditions.5. The purpose of these audits is to verify that the quality/environmental system conforms to product realization arrangements and to the requirements of ISO/TS16949.2. through Production Shift Supervisors. (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. 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). 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 .5.

5.1 and the AIAG ´Statistical Process Controlµ (SPC) reference manual. Measurements of customer satisfaction include evaluation of Customer feedback such as complaints. including inspection and testing activities. SPC. and revalidation Use of specific methods and procedures improvement when established per SOP 8. We analyze Customer satisfaction data and report it in management review meetings. (Section 6) MONITORING AND MEASUREMENT CUSTOMER SATISFACTION Customer satisfaction is the reason we exist. Where product traceability is a customer-specified requirement. or perform work will attend a Basic Statistics course containing an overview on basic concepts such as variation.2. IDENTIFICATION AND TRACEABILITY The Program Manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. and delivery in accord with procedures defined in SOP 7.y y Requirements for records. returned goods. installation. We monitor the manufacturing process performance to demonstrate compliance with customer requirements for product quality and efficiency of the process. incoming product received without part numbers in Receiving. 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. This drives our quality policy ´to meet or exceed customer requirementsµ. (Section 7) KNOWLEDGE OF BASIC STATISTICAL CONCEPTS Employees using statistical tools to manage. customer performance ratings and delivered part quality.1: CUSTOMER SATISFACTION ² SUPPLEMENTAL Customer Satisfaction is a critical measurement of the performance of the quality management system. We tag or label. QC Receiving personnel are Page: 54 . 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. production. control (stability) process capability. See Management Review Process. IDENTIFICATION AND TRACEABILITY ² SUPPLEMENTAL The identification and status of product is established and maintained during all product and service provision processes. We assign Incoming material 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 8.1.3. appropriate controls and records are established. warranty reviews. We must receive incoming material with labels indicating the assigned part numbers. verify.

We design designated storage areas to prevent damage. damaged. storage. plan. A FIFO inventory system is used and regular tracking of inventory turns. The Quality Manager ensures that we record lost. protects. test. conduct of internal audits. analysis. Page: 55 LABORATORY REQUIREMENTS ² INTERNAL LABORATORY The Company does not have an internal laboratory. and product monitoring and measurement. and maintains appropriate traceability records in accordance with customer requirements.6 for calibration laboratories) MEASUREMENT. deterioration. 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. handling. Where contractually required. the Quality Manager plans for. and implement the monitoring. These activities include assessment of customer satisfaction. by applying the same process controls as we do to purchase product. and intellectual property. ANALYSIS AND IMPROVEMENT GENERAL These sections describes how we define. we report at the management meeting. Statistical techniques for on-going process control and Page: 58 .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. establishes. measurement. verifies. (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. and improvement activities needed to assure product and Quality/Environmental Systems conformity and achieve continual Quality/Environmental Systems improvement. and preservation of product pending use or delivery. process monitoring and measurement. as applicable. The Company identifies. packaging. tooling (including test/inspection tooling and equipment). or calibration services are either acceptable to the customer or accredited to ISO 17025. tools (including returnable packaging). (Section 7) CUSTOMER PROPERTY Customer property includes customer-owned material. EXTERNAL LABORATORY The Quality Manager ensures external laboratories used for inspection. and maintains customer property provided for use or incorporation into the product. (See SOP 7. and protection. or unsuitable customer property and immediately reported to the customer. (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.

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

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