Page: 2

TABLE OF CONTENTS
Quality/Environmental Manual ......... 4 Documentation Requirements .......... 93 Control of Documents ...................... 96 Control of Records ......................... 100 Management Review ...................... 103 Competence Awareness & Training 111 Control of Nonconforming Product . 116 Corrective and Preventive Action .... 120 Work Instructions ......................... 124 Work Instructions ......................... 127 Management Review FC-MR-5.6 .... 131

Page: 134

Page: 3

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 Page: 4 Page: 133 . We developed Quality/Environmental Systems in accordance with the following four additional types of documents containing recommended automotive industry practices.QUALITY/ENVIRONMENTAL MANUAL SOP 4. 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.2. examples. and explanations. and to operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction consistently. 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.2 1. illustrations. Scope General The Company is a design-responsible supplier of (name your product here).

and employee awareness and effectiveness of employee motivation Recommendations for improvement and plans y Quality System Assessment Checklist to ISO 9001 and all related documents ISO/TS 16949 Automotive Certification SchemeRules 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 y Company Background The Company. established in XXXX. XXXX Where possible we integrated the quality system and the environmental management system to ensure that operations are cost effective and environmentally responsible. or the environment y Oerall product qualtiy including performance against customer spcified (or other) targets related to product quality Overall effectiveness of training completed including skills training. The Company·s· Quality and Environmental Policy are available upon request. The Company currently supplies to the following manufacturers: y y XXXX. process capability and cost y Overall product performance including an analysis of actual and potential field failures and their impacton on quality. safety. City. State. and the headquarters is located at XXX Some Street. y Page: 132 Page: 5 .y Status reports on actions from previous Management Reveiws Identification of any stratigic or operations changes that could 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 effedciency including an evaluation of the cost of poor quality y Manufacturing process effectivness and efficiency including performance against customer specified (or other targets for productivity. zip. on-the-job training.

Quality management systems ² Requirements ISO 9004:2000. which. Quality management systems ² Guidelines for performance improvements Issue Management Review Agenda Prepare Management Review Inputs Issue Management Rewview Minutes Review Inputs & Develop Outputs Action to improve Effectiveness of the System & its processes Monitor Implementation of Actions Resulting from Management Review Actionss to improve products Actions to provide nedded resources New or revised improment of objectives Assess Process for Effectiveness Page: 6 Page: 131 .6 Assess Overall System Effectiveness Monitor Objedctives and Operations Plan & Schedule Managament Review Meeting Significant Impact on System Exclusion Table Clause Exclusion Justification Analyze Results & Trends 2. covers the design and provision of all company products. constitute provisions of our Quality/Environmental Systems: y y y ISO 9000:2005.Application Our Quality/Environmental Systems comply with all applicable requirements contained in ISO/TS 16949:2002. and encompasses all operations at both of our facilities. Quality management systems ² Fundamentals and vocabulary ISO 9001:2000. 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: MANAGEMENT REVIEW FC-MR-5. Reference Documents The following external documents contain provisions. through reference in this manual.

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. Second Edition. Statistical Process Control (SPC) Note: 1. Potential Failure Mode and Effects Analysis (FMEA Third Edition) PPAP-4. Ford Motor Company CustomerSpecific Requirements for Use with ISO/TS 16949:2002 CSR-GM. The SPC Reference Manual. Production Part Approval Process (PPAP Fourth Edition) SPC-3.ISO/TS 16949:2002 CSR-DC. DaimlerChrysler (Chrysler Group) Customer-Specific Requirements for Use with ISO/TS 16949:2002 y y y  Customer Reference Manuals: y y y y APQP-2. has an improved flow and 2. Quality management systems ² particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations CSR-Ford. Advanced Product Quality Planning & Control Plan (APQP) FMEA-3. Revision History  Customer Specific Requirements: y ISO/TS 16949:2002. Reinforces the need for a systemic approach to analysis of variation in data Page: 130 Page: 7 . General Motors Customer Specific Requirements . 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.

3 ² Nonconforming product). 4. The operator then places the finished parts into a shipping container to packaging specifications 11. Section 3. Management review meetings. Excess Carpet. The quality inspector performs 1st piece inspection at beginning of shift (If needed follow SOP 8. Quality Management System General Requirements Top Management is responsible to define the organization·s quality and environmental policy and ensure that it is documented. Checklist to ISO/TS 16949:2002 TS-GS. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. Addresses additional control chart methods and tools MSA-3. and region and referenced throughout our Quality/Environmental Systems are contained in Appendix A. The quality inspector performs part inspection and looks for (see boundary sample): y y y y y y Correct Color No Forming Flaws (I. Terms and Definitions. and definitions unique to our organization. and understood throughout the organization. Page: 8 14. The quality inspector also checks for container quantity and correct label Page: 129 . customers. include the Quality and Environmental policies and objectives for continuing suitability. the operator has the material handler to remove the container and bring an empty one as needed 12.. Quality System Assessment Checklist. Carpet Wrinkles) Clean Trim Edge ² No Fuzz Or Debris Hole Clean ² No Slugs Slots and additional cutouts are cut or punched clean. and records the information 10. vocabulary.E. Overall Appearance Good 3. terms. When the container is full. IATF Guidance to ISO/TS 16949:2002 9.3 ² Nonconforming product) 15. Measurement Systems Analysis (MSA) TS-QSA2. Acronyms. vocabulary.y y 3. and definitions given in ISO 9000 as supplemented by terms defined in ISO/TS 16949:2002. communicated. The quality inspector records the findings (If needed follow SOP 8. industry. Terms and Definitions Our Quality/Environmental Systems uses the same internationally recognized terms.

and satisfies Quality/ Environmental Systems requirements of ISO9001/ 14001. which meet or exceed customer requirements. The operator then places the waste material into the compactor 7. The operator inspects the part to verify 15 holes. 8. and outputs to ensure 1. Specific responsibilities for and the sequence and interaction of our key Quality/Environmental Systems processes are detailed in the Standard Operating Procedures (SOPs). including all SOPs and other key Quality/Environmental Systems documents. which establishes documents and implements our quality policy. 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 Page: 9 . The operator raises the carpet to the cutter and cuts the carpet just above the tenor frame 3. Appendix A contains a List of Key Quality/ Environmental Systems Documents. many of which contain or reference deployment flow charts depicting the process or procedure described in the narrative SOP. the operator removes the parts and the left over material 6. If holes. When the press finishes its· cycle. and y Interfaces between interrelated processes to ensure system effectiveness is achieved. The operator burnishes the part edges of extra fuzz (if necessary).The material handler: y Brings carpet to the press and helps the operator to load the carpet onto carpet feeder Provides shipping containers as required during the shift y Process: Our Quality/Environmental Systems is part of our overall management system. follow Rework Instruction. or cutouts are not punched clean. and 3 additional cutouts are clean with no slugs or fabric strings or debris. by defining and managing: y Process inputs. The operator uses pre-cut carpet and the operator attaches the tenor frame to the carpet 2. Page: 128 desired results are achieved. controls. 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. one slot. and related processes for providing products and services. We have adopted the process approach advocated by ISO 9000. slots.

WORK INSTRUCTIONS WI-DL-6. monitoring. and continually improve its effectiveness. Management reviews the identified and documented indicators for measurement and analysis to assure effectiveness and efficiency. through the Management Team. and are managed in accordance with ISO and customer requirements. including their sequence and interaction with other processes. Outsourced processes are also depicted in our flowcharts. measuring.2. Page: 127 Page: 10 . have been identified and documented in this Quality/ Environmental Manual.outsourced Quality/ Environmental Systems processes (Section 7).2 General Safety Notes PPE: y y y y Safety Glasses Kevlar Gloves Kevlar Sleeves Knife General Notes Setup includes: y y y y Press (See Setup Sheet) Check Fixture Burnishing Table Final Pack Container Material Needed: y Carpet ² Milliken -62 µ roll Stage Material for production: The team leader ensures that the proper tenor frames are available at the beginning of the shift and will check throughout the shift. The Management ensures that adequate resources and information necessary to support the operation. Documentation requirements General The Management. and analysis of these processes is made available and actions necessary to achieve planned results and support continuous improvement. procedures governing their management are described in documents referenced in applicable SOPs. is responsible to implement and maintain a quality and environmental management system. Quality/Environmental Management System processes.

The material handler puts a shipping label on container and moves the container to the inspection holding area 13. job descriptions. perform. The Company recognizes that control of any outsourced processes is necessary in order to ensure the product conforms to customer requirements. SOPs. We use SOPs and flow charts to document and define the key Quality/Environmental Systems processes. Quality manual This manual is that part of our Quality/Environmental Systems defines the scope of our Quality/Environmental Systems and documents the policy. Pack and label Revision History Each Department Manager is responsible for evaluating and adjusting resource requirements to efficiently execute assignments and accomplish goals defined in the business plan. Part inspection 14. including the implementation and control of the Environmental Management System. and other internal and external documents and data needed to manage. When the container is full. or verify work affecting product quality. procedures. We also issue and control work instructions.11. the operator calls the material handler to remove the container and bring an empty one 12. and other internal and external documents and data as appropriate and needed to manage our systems (Section 4). Management gives individuals total support and the necessary authority to perform the assigned tasks. Quality/Environmental Systems documents and data may be in hard copy or electronic media. This quality manual. and processes needed to implement our quality policy and achieve our quality Page: 126 Page: 11 .

Record retention must satisfy both regulatory and customer requirements. storage. retrieval. The operator cycles the press by pressing the two black palm buttons simultaneously 7. The material is automatically loaded onto conveyor and into oven while the operator prepares the carpet for insertion into the press 2. records should be disposed of accordingly. Raise carpet to the cutter and cut the carpet just above the tenor frames 5. The quality inspector performs 1st piece inspection. 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. below includes forms used to create controlled quality records as detailed in procedure SOP 4. Once retention time is met. Pertinent records from our subcontractors are an element of this. When the press finishes its· cycle. The information Quality Manager has overall responsibility for ensuring that all Quality/Environmental Systems documents. the operator removes the parts and the left over material 8. 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. Attach both tenor frames to the carpet and cut the carpet between them 4. and the retention and disposition of these records Quality/Environmental records are legible.3: Page: 12 Process: 1. The operator then places the finished parts into a shipping container Page: 125 . as well as ISO/TS requirements. and after the removal of the part from the over bend fixture 10. Control of documents Quality/Environmental records represent information that demonstrates conformity to Quality/Environmental Systems requirements and effective operation of The Company·s· Quality and Environmental system. The operator uses the controls to roll out the carpet long enough to place the tenor frames on the carpet 3.2. protection. Each Process Owner is responsible for identifying which records they consider quality/environmental records and for collection. Place the both tenor frames central over the cavities (one tenor frame per two cavities) 6.objectives. readily available and retained for a specified period in Quality Record Matrix. at beginning of shift.

3). and re-approve documents. Material handler brings material to conveyor and setup in proper position for conveyor load 2. and implementation of all customer-engineering standards/ specifications and changes based on customer-required schedule. Material handler brings carpet to the press to be loaded onto carpet cutter 3. Provide shipping container 4. 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. c) Identify the current revision status of documents.WORK INSTRUCTIONS a) Approve documents for adequacy prior to issue. WI-SB-5. readily identifiable. Important General Notes Setup includes: y y y y y Press Carpet Cutter Over Bend fixture Check Fixture Final Pack Container Stage Material for production: 1. Engineering specifications The Program Manager oversees our process for assuring the timely review.2 Important General Safety Notes PPE: y y Safety glasses Gloves d) Ensure that relevant versions of applicable documents are available at points of use.2. b) Review. The Company uses a Product Data Management system to manage and control engineering records and data (see SOP 4. Two frames are required Page: 124 Page: 13 . and to apply suitable identification to them if they are retained for any purpose.2. distribution. update as necessary. e) Ensure that documents remain legible.

b) Product/process evaluation/acceptance criteria Work Instructions This booklet contains sample Work Instructions.3.4 details procedures necessary to control Quality/Environmental Systems records that. including identification of the individual performing the activity. Pertinent Records from our sub-contractors are an element of this. we submit an updated PPAP. Page: 14 Page: 123 . When a change involves standards or specs that are reference on design records.2. or they affect PPAP documents. SOP 4. They are very generic in nature and would need to be added to or changed for a real company. are prepared to document: a) Results of processes performed.2. 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.The Company considers reviews timely if performed within two working weeks of receipt. (Section 7) Master Lists Requirements for the establishment and maintenance of Master Lists of internal and external Quality/Environmental Systems documents are defined in SOP 4. as a minimum. Records may be in the form of hard copy or electronic media.

x-bar and r charts. work instructions. Disposition of records also includes their disposal. We provide evidence of commitment to the development. implementation.The corrective action is monitored for thirty days to assure that the action taken has been successful. the APQP process. including revision or date of document. If the action is successful. Statistical methods (i. etc. Records of the analysis will be made available upon request. or instructions used to perform an activity. Preventive Actions may be initiated because of. Preventive actions will be tracked on the Preventive Action Log. Revision History c) Procedures. All forms used in the corrective and preventive action procedure are retained for active life of the product for reference to prevent reoccurrence. along with the management team. Management Responsibility Management commitment The Managing Director.) are used when applicable.) are updated to permanently implement the changes required by the corrective or preventive action. All corrective actions are to be reviewed during management review meeting. drawings. lessons learned follow up. and improvement of our Quality/ Environmental Systems in very tangible ways: Page: 122 Page: 15 . Preventive actions will be reviewed during regular management review meetings. diagrams. etc.2. Records controlled include customer-specified records. material or equipment qualifications f) Pertinent technical records from sub-contractors Records Retention SOP 4. If a corrective action is initiated because of the analysis will be tracked through the corrective action format. appropriate documents (procedures. or equipment used in the making of the product e) Personnel. d) Identification of material. is responsible to communicate the importance of meeting customer as well as statutory and regulatory requirements.4 contains related procedures and responsibilities to ensure: y y y y y Record controls established satisfy all regulatory and customer requirements. parts. Analysis of customer returned rejects will begin upon receipt of the defective material. TPM activities. Lean activities or technology changes.e.

All suspect parts are inspected and inventoried. Corrective/Preventative action reports must be complete through interim corrective action within three days of issuance. The root cause of the problem is established and documented after the initial write up. Permanent corrective action is to be determined by the team within 7 days of issuance. Page: 16 Page: 121 .3 FOPARLOG 6. through periodic management review of the quality policy statement. The team will utilize mistake-proofing methodology to the degree appropriate to the magnitude of the problems and commensurate with the risks encountered.If future shipments are to be certified a method and duration must be established by Manufacturing. implementation. The quantity checked. and corporate level improvement objectives.Our quality policy statement (Section 5) documents and communicates the importance of meeting or exceeding all applicable requirements (including customer. SOP 8. We communicate and deploy our quality policy and objectives throughout the organization through individual performance objectives established and reviewed during employee performance reviews (Section 5 and 6). the quantity defective. products. We ensure understanding. and disposition of stock are determined and recorded. within twenty-four hours of the receipt of the notice of concern. y All managers demonstrate their commitment to the development and improvement of the Quality/ Environmental Systems through the provision of necessary resources (Section 6). and through their proactive involvement in our continual improvement activities (Section 8). Emphasis is placed on improving both effectiveness and efficiency of our key Quality/Environmental Systems processes. and maintenance of our quality policy at all levels of the organization through widespread printed distribution of our quality policy statement. through their involvement in the internal audit process. regulatory and legal requirements) through continual improvement of our processes.0 Procedure Control of Nonconforming Product Procedure Preventative Action Log An immediate (possibly temporary) fix is developed and implemented with documentation. and the customer (if applicable). Quality. The time frame to verify the effectiveness of the corrective action is to be determined by the corrective action team. and services.

the Managing Director has overall responsibility for ensuring that specified and unspecified requirements are determined. 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).2/8.5. 5.0 Definitions Not applicable 4.2 FOMCRLOG Concern Report (MCR) Material Concern Report Tracking Log Page: 120 y . 3. and converted into requirements (Section 7).0 Associated Materials FOCAR 8. The format utilized will be an 8D.0 Purpose This procedure provides a systematic means in which quality problems will be eliminated. Top Management ensures that we meet these requirements with the aim of enhancing Customer Satisfaction. The Top Management Team is responsible for analysis of customer rejected material. Customer focus Customer requirements are determined during Quoting and Contract review processes. understood. unless otherwise directed by the customer. and it prescribes the method by which we accomplish this: by continually improving Page: 17 SOP 8.CORRECTIVE AND PREVENTIVE ACTION Process efficiency Top management reviews product realization and support processes to assure both effectiveness and efficiency during management reviews (Section 5).0 Responsibility y The Quality Manager is responsible for ensuring that the corrective/preventative action is managed effectively.5. 2. These customer focused communications and interactions ultimately yield clear.5. including internal rejections. Our quality policy statement indicates our commitment and focuses on what is important to us as an organization: achieving customer satisfaction. explicit customer requirements and expectations in the form of a contractual agreement or customer order. problems from subcontractors and customer complaints.0 Application This procedure applies to all quality problems.3 1.

Conforming materials are removed from the container and returned to production flow. Scrapped material is recorded in the Scrap Log and the Material Concern Report. The material is re-inspected by the designated Quality Representative. Page: 18 Page: 119 . employee responsible for reprocessing. and along with all policies contained in this manual. number of acceptable/ unacceptable parts. regular communication. All material shipped under a customer concession or deviation will be identified as required by the customer.some rework necessary with written instructions & records. Nonconforming materials are scrapped or reworked accordingly. date. 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. y y y Acceptable Product . Revision History y Quality/Environmental Policy Management review meetings checks the Quality and Environmental policies and objectives for continuing suitability. Unacceptable Product (placed in red ´SCRAPµ container / on rack) Questionable Product (QA disposition required) Quality disposes of questionable product and records the final counts and outcomes.processes. Records of the quantity and expiration date shall be maintained. A Quality representative records the results of the inspection and rework on the Material Concern Report listing the method of rework. etc. Our quality policy statement is controlled by inclusion in this manual. and reinforcement during annual employee performance reviews (Section 6). products. Moreover. and services to ensure they consistently meet or exceed requirements. (Section 5) y We ensure that our quality policy is communicated and understood at all levels of the organization through documented training. 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). No rework shall be visible on the exterior of the product.

The quality manual documents the necessary processes that define the planning process for quality/environmental management system and objectives. Quality or a member of management will provide written instructions to the employee conducting these activities. as appropriate.3 FO 8. Production personnel complete sort or rework. Make statement 2. (If material is part of an accumulation.0 Procedure Corrective/Preventive Action Procedure Quarantine Area Record Scrap Log Quality Policy Our Objective Will Be Accomplished Through Customer Satisfaction by Providing: 1. the container(s) is identified by a Quality representative or production supervisor with an initial Material Concern Report. up to the disposition section. We also have methods to track update and revise fall under the Continuous Improvement Process. The business plan includes short and longterm goals relating to quality and environmental policy objectives. There are four possible determinations of inspected product: y Acceptable Product ² green check mark Page: 118 Page: 19 .3 6.2 FO 8.SOP 8. and defines timeframes to achieve each goal. to encourage customer satisfaction and overall growth of the organization. The Production Supervision and Quality Manager determine the disposition of the non-conforming material and record it on the Quarantine Area Record. Make another statement 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. completes the Quarantine Area Record.5. a Material Concern Report will be issued at the time of occurrence) The non-conforming material is moved to the Quarantine Area and a member of the quality department or Production Supervision. The Company·s Management Team annually reviews business plan and revises. When material is found to be nonconforming. including those needed to meet product requirements.

sorting or even sending a company representative to their site to protect their interests. Material is reviewed and disposition is determined by management and quality. We accomplished Benchmarking formally and informally via trade shows. that differ from those currently approved according to the Production Part Approval Process Manual.0 Associated Materials FO 8. It is clearly (visually) identified and quarantined or segregated to prevent inadvertent use or installation. The Program Manager/Production is responsible for managing the customer authorization of products or processes and the procurement of a deviation or concession. and charting of performance measures (Section 6). customer feedback. This managing includes the procurement of a deviation or concession from the customer if changes to the product differ. efficiency. (Section 6) Product Performance: Program Manager. including materials and services provided by vendors. Actions will be taken such as stock returns and replacement.3 The Quality Manager is responsible for notifying the customer if non-conforming material is detected after shipment has been made or use has started. 5.3 NCMR Material Concern Report y y y y y y y Page: 117 . as information is available.The Company benchmarks trends in quality. productivity. Objectives may include the following possible measures (Section 5): y Customer Satisfaction: Managing Director (Section 8) Supplier Performance: Materials Manage (Section 7) Quality/Environmental Systems Effectiveness: ISO Management Representative. reading material. The Quality Department is responsible for maintaining and analyzing data from NC material activities. (Section 7) Effectiveness of Manufacturing Processes: Production Manager (Section 7) Product Quality: Quality Manager (Section 8) Page: 20 product which does not conform to specified requirements. (Section 8) Overall Operational Efficiency and Manufacturing Process Efficiency (Section 5 and 6) Training Effectiveness and Employee Awareness: Human Resource Director (HRD) with input from the Training Manager. 4. and effectiveness are.

Note: In the absence of any specific Page: 21 . purchased components.CONTROL OF NONCONFORMING PRODUCT SOP 8. in-house rejections. 4. processes. (Section 7 and 8) b) Manage and control facilities.g. 2. and associated customer specific requirements documents.g. 3. work-in-progress. We base specific measurable objectives on achievable performance within a specified period. 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.. customer rejection / returns or material received from a supplier. resin. melt flow.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. but is not limited to. etc. visual. unidentified or suspect material.0 Definitions Nonconforming Product: Material (e. PPAP-4¸ (Section 7) as required including acceptable process capabilities for all Special/Control Characteristics that have been established.0 Application This procedure applies to. etc. APQP-2. including the AIAG ´Advanced Product Quality Planning and Control Planµ reference manual. (Section 7) d) Provide objective evidence that all supplied products and services satisfy all AIAG Production Part Approval Process (PPAP) requirements.. quality systems and personnel to consistently and cost effectively produce products and furnish services that meet customer needs (Section 7). c) Develop and implement Advanced Product Quality Planning (APQP) practices and procedures in accordance with ISO/TS 16949:2002.) that does not meet established parameters (e.3 1.0 Responsibility The Production Supervision and Quality Department are responsible for following documented procedures and work instructions for Page: 116 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.) Suspect Product: All material having the same lot number as known nonconforming product. dimensions.

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. (Section 8) g) Conduct operations in conformance with. or to exceed. (Section 7). 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. when applicable Employee on the job performance Revision History Page: 22 Page: 115 . (Section 7) e) Utilize appropriate statistical techniques for ongoing process control and improvement as established in the AIAG ´Statistical Process Control (SPC)µ reference manual. maintaining. and associated customer specific requirements documents. of. and improving systems. and through the provision of resources needed for its effective implementation. (Section 8) f) Be committed to continuous process improvement by emphasising reduction of part-to-part variation and the elimination of all waste. This manual constitutes our overall plan for establishing. we will default to a level 3 PPAP submission. h) Meet customer requirements by controlling and using returnable packaging. SPC-3. all applicable environmental laws and regulations of the jurisdictions in which we do business (Section 6).instructions.

The Managing Director (MD). This review occurs concurrently with the employee·s performance evaluation or upon need. 6.0 Procedure Identify training needs.5.0 Associated Materials Orientation Manual Job Descriptions Our management review process and internal audit process ensure the integrity of our System is maintained when significant changes are planned and implemented that affect our key Systems. in any new or modified job. with the help of department managers. sets direction and ensures the success of our business through the clear definition and communication of Quality/Environmental Systems responsibilities and authorities. Other members of Top Management include: y y The Operations Managing and The Human Resource Director y y y The interrelationship of Top Management and other key personnel is depicted our Organization Chart. authority. and communication Responsibility and authority 6. Provide Training One or more of the following provides formal training: y y Identified The Company Trainers Professional / Industry Organizations or Societies Local Community and Trade Schools College and University Sponsored Classes On-The-Job training is provided for all personnel. and 8) The Quality Manager develops appropriate quality planning documents for specific products. projects. including contract or service personnel. (Sections 5. Responsibility. The Company employees and their manager/supervisor shall review the employees training status to determine training needs. Responsibility for quality Overall Quality/Environmental Systems responsibility and authority is as follows: Page: 114 Page: 23 . 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).

the provision of resources needed to implement and improve Quality/Environmental Systems and management reviews (Sections 5 and 6). and the provision of resources needed to implement and improve these processes. Quality/Environmental Systems Planning including the establishment and deployment of objectives (Section 5). Management ensures the staffing of all production shifts with personnel in charge of. Top Management is responsible for Business Planning. 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. or delegated responsibility for product quality (Section 7). 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. development and communication of our quality policy. All managers are responsible for planning and controlling Quality/ Environmental Systems processes within their area(s) of responsibility. Page: 113 Page: 24 . Managers also conduct employee performance reviews (Section 6). Evaluating Training The training courses offered internally are continually assessed by the Human Resource Department. processes. including the establishment and deployment of operational level objectives (Section 5). Management All managers are responsible for execution of the Business Plan and implementation of the policy. 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. Management with responsibility and authority for corrective action promptly notifies employees of non-conformities (Section 8). and systems described in this manual. and an assessment test (if applicable) is given upon completion of the course.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. employee·s manager/supervisor in the performance review process determines individual training needs. The content of the courses are evaluated through a training feedback and evaluation form.

The management representatives have the responsibility and authority to: y Ensuring that the ISO/TS 16949:2002 processes needed for quality and environmental management systems are established. Management representative The Company has appointed Quality and Environmental Management representatives for each system. Ensuring the promotion of awareness of customer and environmental requirements throughout the organization (Section 5) Page: 25 All employees (salaried and hourly) must complete the specific orientation program administered by the Human Resource Department. Personnel responsible for product quality have the authority to stop production to correct quality problems (Section 8). flow charts. Evaluating Training Needs Employees All employees are responsible for the quality of their work and implementation of the policy and procedures applicable to processes they perform. training matrices and copies of training certificates. implemented. which is maintained by the Human Resource Department. Salary Employees: Records of salary training needs and training received by active employees performing activities affecting quality shall be maintained by the Human Resource Department. These records include. and importance of their activities and how they contribute to the achievement of our overall quality objectives. The Page: 112 y . and maintained in accordance with their respective standards (Section 5).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. but are not limited to. job descriptions. 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. Each hourly employee has an individual training record. which is maintained by the Human Resource Department. Personnel whose work affects quality are informed about the consequences to the customer of nonconformity to quality requirements. training matrices and copies of training certificates. Each salary employee has an individual training record. work instructions. etc. All employees have training in awareness. relevance. These records include. but are not limited to.

COMPETENCE AWARENESS & TRAINING SOP 6. Each job description identifies the competence level/ education. bulletins. 3. continual improvement. including but not limited to workplace meetings. We communicate information regarding Quality/ Environmental Systems processes and their effectiveness through documented training (Section 6). and its policies. and corrective/ preventive action processes (Section 8).0 Definitions Not applicable 4. from contract review through production Internal communication The Company uses a variety of tools. 2. as appropriate. the internal audit process (Section 8).0 Responsibility Job Description Each position has a written job description maintained by the Human Resources Department. Page: 26 Page: 111 . Customer representative The Program Manager will ensure and address customer requirements and will represent the needs of the customer internal functions. and the status and importance of quality activities. and specific training sessions to communicate internal information about the effectiveness of our quality and environmental management system. objectives and significant environmental aspects. and regular formal and informal communications as follows: y The ISO Management Representative posts information on quality bulletin boards throughout the facility to convey information regarding customer requirements. the training provided.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.0 Application The scope of this procedure incorporates the training of all employees performing quality related activities. new employee orientation.2.2 1. skills appropriate required for the position.y The Environmental Management Representative is responsible for documenting and responding to relevant communication from external parties. memos.

programs. and effectiveness of our Quality/Environmental Systems in accordance with procedures detailed in SOP 5.1. y The Company uses internal audits (Section 8) to reinforce or communicate appropriate information to employees. to include presented and discussed topics and issues. typically this information is conveyed through production team meetings and cross-functional improvement projects (Section 8). Documented on the title page of the Management Review Report (MRR 5.9. which we convey and reinforce during employee performance. are responsible for establishing internal communications as needed to convey to their employees the relevance and importance of their activities. involvement opportunities. The Human Resources Department posts information on employee bulletin boards throughout the facility to convey information regarding employee benefits. Management review Top Management conducts formal review meetings at least quarterly to ensure the continuing suitability. and applicable statutory/regulatory requirements. and related statutory/regulatory requirements. Communications regarding how employees contribute to the achievement of objectives. Quality Objectives Matrix: Record of established quality objectives. All managers and supervisors.6. conclusions.0 Associated Records Management Review Report: Record of the management review meeting.6). and any actions initiated to implement the conclusions and policies. Revision History 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.6. policies and changes. reviews (Section 6). adequacy. The Managing Director Page: 110 Page: 27 . Management Review Report. Documented using form FO-MRR-5.

The location and retention period for management review records are specified in Operational Procedure SOP 4. and that the review was concluded with appropriate decisions and actions.2. time frame. These include assignment of responsibility.5.1. Control of Records. and environment.e. They will be the sole evidence that the agenda of the review was completely covered. We retain meeting records. and other necessary resources.or designee chairs the corporate reviews and top management from all relevant functions attends.2.0 Records Management review records must be as comprehensive as possible. technical knowledge. and an assessment of the suitability and effective of support processes (i. Quality system performance Each management review includes all requirements of the Quality/Environmental Systems including monitoring of quality objectives (Section 5). 8.1 Management Review Report Form SOP 4.2 Operational Procedure. The Company holds review meetings at least monthly to review plant specific data and process effectiveness indicators.6. facility and equipment.4 Operational Procedure. 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. evidence of achievement of quality/environmental objectives and customer satisfaction. equipment. and allocation of human. absent participants. The report is prepared by the Quality Manager and is distributed to the attending and.6. (Section 8) The Company record review results provide at a minimum. Page: 28 Resource needs for implementing improvement actions are identified. 7. safety. Section 6) as an essential part of our continual improvement process (Section 8). Corrective and Preventive Action Page: 109 .4. regular evaluation of the cost of poor quality (Section 8) . if any. (Section 5) The Quality Manager ensures that review includes analysis of actual and potential field failure and their impact on quality. plant.0 Referenced Documents 5. Management review output is documented in the Management Review Report based on form MRR 5. identifying opportunities for improvement and corrective and preventative actions. Control of Records SOP 8.

Quality objectives Documented on the title page of the Management Review Report (refer to Section 6 of this procedure). follow-up actions from earlier management reviews.6. results of self-assessments (Section 8). all applicable requirements of the QEMS.3) and processed in accordance with procedure SOP 8. Review input ² Supplemental. Page: 108 At a minimum. Review input The management review meeting includes a review of our quality policy (Section 5). Assigned to. we use these results to demonstrate achievement of the quality objectives in our Business Plan and customer satisfaction with supplied product. and which are not directly related to product or process conformity.5. and Improvement of products and/or services to better meet customer requirements and increase customer satisfaction At a minimum.1) in the Actions.0 y y y Management review output Improvement of the quality management system. At a minimum. In addition. and strategic or operational changes that could affect the QEMS. This method is most suitable for implementing long-term improvement goals. improvement of product related to Page: 29 . 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. The Program Manager provides an analysis of actual and potential field-failures and their impact on quality. related performance trends. Corrective and Preventive Actions. Corrective or preventive actions Documented in the Corrective Action Request (CAR) form (FO-NCCAR-8. corporate level. and opportunities for improvement.6. Improvement of quality performance. safety or the environment as an input to the management review process. effectiveness and/or efficiency improvement objectives (Section 5) documented in prior management reviews (and/or specified in our Business Plan) and reviewed for status and continuing suitability. Review output These improvement actions are defined implemented as: Management review actions Documented in the Management Review Report (FO-MRR-5. This type of action is most suitable for minor improvements that can be quickly implemented. CARs are normally used for improvements related to specific actual or potential product or process nonconformities. and Due Date columns.2.2.

Resource Management Provision of resources The Company. and advanced Quality/ Environmental Planning. we record the results of management review meetings and the ISO Management Representative maintains the records.customer requirements. performance measurements. When an objective is not achieved. determines its resource needs and provides the resources to implement and maintain the quality management system and continually improve its effectiveness. Any quality objectives that are carried on into the next period and any new objectives established by the review meeting are documented in the Quality Objectives Matrix on the title page of the Management Review Report. and provision of resource needs. or extend the target due date. as well as through the results of internal audits of the quality and environmental provided through our budgeting and other business management processes including: and thus fulfill the quality policy and other organizational goals and aspirations. At the end of the meeting. Page: 30 Page: 107 . and to enhance customer satisfaction by meeting customer requirements. Per SOP 5. The policy is changed when the goals expressed in the policy have been achieved.6. Resource requirements identified during the Business Plan Process. reduce its target value. Quoting process. through the Management team. and records their status in the Status Next Management Review column. The principal quality policy is reviewed to ensure its continuing suitability. 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). capital expenditure review. or when changes within or outside the company render the policy inadequate or inappropriate. Objectives that have been achieved may be discontinued or be retained with a higher target value. the participants decide whether to drop the objective. We accomplish verification of work through budget comparisons. 5.

Facility. 5. 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 (Section 5). 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. Following each presentation. and Improvement Planning (including the use of SPC) Organizational Continual Improvement Planning Manufacturing Process Continual Improvement Planning The MD. capacity. market and customer response to the quality effort.Changes and quality system planning Quality highlights any product. Recommendations for improvement Quality concludes the input phase of the review with recommendations for improvement. process. and Service Provision Planning Measurement Systems Planning (including the conduct of MSA) Measurement.0 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. 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. and any other such issues related to the quality management system. compare their status and performance with preceding periods. Services and Vendors) Production. In addition to the topics listed above. the management review may also consider such issues as cost of quality and non-quality. the participants discuss the issues. integration of the quality system with other operations and activities. Equipment and other Infrastructure Planning Contingency Planning Work Environment. Analysis. and identify areas where improvement is required. with input from other responsible managers. Quality objectives are established to improve performance and/or the quality system 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. Page: 31 Page: 106 .

supplier quality performance. on-time delivery performance. Process performance and product conformity Quality presents quality performance data. (SOP 6) abandoned. the experienced person or member of management continues to observe the new person. Page: 105 Page: 32 . It is a four-quadrant system. This Competency Matrix is available to persons assigning work.Analysis of Data. Customer feedback and complaints Customer Service presents summaries of customer feedback and customer complaints.4. In the third phase. It is which visually displays the capabilities of the person according to which of the quadrants have been achieved. Internal quality audits Quality presents results of internal quality system audits. the frequency of audit findings against particular elements of the quality system and discussion of significant findings. and Training The Company maintains a Training/Competence Matrix for personnel by job description. and coordinate with ISO/TS 16949 Element 8. Awareness.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. Corrective and preventive actions: Quality presents the most important corrective and preventive actions implemented through the period. Competence. This includes rates of process and product nonconformities. This includes summaries of results for the cycle. including analysis of trends. Some persons may move on to the fourth stage and we deem them an ´expertµ allowing them to train others or assume other responsibilities. All personnel understand the importance of their activities and their contribution to the achievement of the quality and environmental objectives. Edit the scope of the quality performance data as appropriate. 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. Reasons for the failure to implement the action and any decisions regarding continuation of the action are recorded in the Management Review Report. experience and competence. and productivity data. and the status of pending actions. we deem the new person ´competentµ to work on his or her own. skills. In the second phase.

evaluates and qualifies applicants for specific job openings based on documented or demonstrated competencies. or Page: 104 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. No more than one manager may be absent from the meeting. The Operations Manager and Quality Manager must always attend. Attendance Management reviews are chaired by the Quality Manager and are attended by Management. Agenda The agenda for management review meetings covers at least all items listed in Section 4 of this procedure. Those managers who are unable to attend shall receive minutes of the review meeting and. the following information and data are presented for review: Follow-up actions from previous reviews Quality reports on the status of action items from the previous meetings. The agenda is documented on the cover page of the Management Review Report. these include: 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. Actions which are not completed may be extended with a new due date. Our Training Coordinator is responsible to analyze effectiveness of training and competence. 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. Management review input At a minimum. changed. as Page: 33 . with input from responsible managers. after reviewing the minutes. At a minimum. Engineering. reassigned to another person/function. The Human Resource Department. Personnel performing specific assigned tasks are qualified.Manager may call for unscheduled extraordinary reviews. including on-the-job-training (OJT). Production. may submit their input and comments to the Quality Manager. and Purchasing. and update of hourly employee Training/Competence Matrix records. Where possible.

MANAGEMENT REVIEW SOP 5.0 Definitions None 4. 2. We conduct Annual employee reviews to give one on one interaction of communication employee with The Company Management. and to assign responsibilities for scheduling. For the first two years (i.required. Review Input. e. including agency or contract employees.e. The additional review is conducted in September. On-the-job-training Responsible managers ensure on the job training (OJT) is provided for personnel in any new or modified job affecting product quality. The Company carries out periodic audits with employees to determine their awareness of the relevance and importance of their activities and contribute to the achievement of the quality and environmental objectives. Employee motivation and empowerment The management team is responsible to motivate employees to achieve quality objectives.0 Application This procedure applies to all activities comprising the quality system.0 Procedure Frequency and Scheduling Quality performance and the quality management system are reviewed at least once a year.. Responsible managers ensure that employees are aware of the relevance and importance of their activities and contributions to the achievement of our objectives. conducting. The annual review is conducted in March. 3. and recording management reviews of the quality management system.). of this procedure.6 1.0 Purpose The purpose of this procedure is to provide for a system and instructions. to make continual improvements and to create an environment to promote innovation. In response to changing or special conditions and events. and in particular those named in Section 4. the Operations Page: 103 Page: 34 .g. management reviews are conducted twice a year. with particular attention to the satisfaction of customer requirements (application of digitized mathematically based data. through the maturation phase of the quality system).

Provision. purchase orders and amendments. 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). The Quality Department ensures quality records are available for evaluation by the customer for the stated period. shall be maintained for the length of time established by the corresponding Department Manager and in accordance with minimum customer requirements. Responsible managers monitor and measure the overall training effectiveness and to meet competency needs and provides related recommendations to Top Management for review and action (Section 5). We evaluate provided training through immediate feedback from the employee and the manager. tooling records. The records may be retained longer for reference at the discretion of the responsible party. or supervisor who identified the training requirement. 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 status of archived records is determined and appropriate records are disposed of annually.6. and supervisors reevaluate employee competencies and evaluate employee performance against established objectives through our employee performance review process.0 Procedure The responsible personnel and/or departments ensures the validity and completeness. The responsible manager collects the documents for each training event. The Quality Department retains superseded part documents used for new part qualification. Responsible managers. the relevance. The retention duration listed is a minimum retention. officers. and importance Page: 102 Page: 35 Revision History . Employee Awareness Through their activities and contributions. and determines the filing and storage method (for retrievability and preventing damage) and the retention duration (conforming to TS-16949 requirements) for quality records. Effectiveness The Company evaluates the effectiveness of all actions taken to meet competency needs. other than production part approvals. Obsolete documents. we ensure that our employees are aware of customer requirements (Section 5 and Section 5).

The Training Manager maintains records of all training completed.6 SOP 7. such as transportation or communication. employee performance reviews (Section 6). and any supporting services that are needed. including buildings. In addition. and employee participation in our internal audit (Section 8) and improvement (Section 8) processes. The Materials Manager and Accounting department are responsible for ensuring the proper retention of customer related purchase orders and amendments. processes. we detail methods to evaluate and monitor the effectiveness of existing operations in SOP 7.4 DD FO 4.2. Associated Materials AIAG APQP AIAG FMEA AIAG MSA AIAG SPC AIAG PPAP SOP 5. facility.5. Employee qualification/competency review records and annual performance review results are maintained by the Human Resources Department. process equipment (hardware and software as necessary). We use a multi-disciplinary approach to develop plant.2 FO 4.2 SOP 8.4 and SOP 5.6. Records We maintain appropriate records of education. This is accomplished through awareness training. Infrastructure The Company provides and maintains the infrastructure needed to achieve conformity to product requirements.achieving our quality policy (Section 5) and objectives (Section 5).2. skills. The Company prepared contingency plans to satisfy customer requirements in event of an emergency such as 5. workspace and associated utilities.4 QR Advanced Product Quality Planning Manual Failure Mode Effect Analysis Manual Measurement Systems Analysis Manual Statistical Process Control Manual Production Part Approval Process Management Review Procedure Contract Review Procedure Internal Audit Procedure Destroyed Documents List Quality Records List Page: 36 Page: 101 . and experience in accordance with provision of Section 4.2.0 Accounting department and the Materials Manager are responsible for ensuring the proper retention of subcontractor purchase orders and amendments. training. and equipment.1.

these programs include: y y y SOP 4. The Program Manager and/or designee is responsible for ensuring the proper retention of appropriate tooling records. maintenance and repair Housekeeping/custodial services management Process equipment management. This is inclusive of all prints. collection. 2. filing. The Information Systems Manager has Page: 37 .4 1.3. storage. maintenance and repair Production tooling management. Page: 100 Facilities management. and equipment plans. and disposal. facility.2. and Transportation and material handling equipment management. 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.CONTROL OF RECORDS utility interruptions. internal quality system audits. The Quality Manager is responsible for ensuring the proper retention of production part approvals. facility. handling and value-added use of floor space and facilitate synchronous material flow. quality performance records.0 Purpose This procedure provides a method of maintaining quality records consisting of identification. (SOP 6. indexing. maintenance. availability.0 Definitions None 4. 3. and equipment planning The MD uses a multidisciplinary approach for developing plant. labor shortages. and disposal. and repair y y Plant.0 Application This procedure applies to all departments responsible for the maintenance of quality records. protection.0 Responsibility Each Department Manager is responsible for records their department creates and for their maintenance.3. and management review. and key equipment failure and quality issues. The Plant Supervisor develops and implements an effective preventive maintenance program utilizing predictive maintenance methods (Section 7) as appropriate.2) The Plant Supervisor has overall responsibility for managing our Facilities and Equipment Maintenance programs in accordance with SOP 6.

The Quality Manager. health. and ergonomics by following proper manufacturing practices. processes and controls needed to ensure product conformance and meet customer. Page: 38 Department Managers are responsible for reviewing all of their applicable documents within their departments at a minimum of annually to insure relevance and conformance. We monitor and improve workplace safety.3 Advanced Quality Planning Procedure Documentation ² Writing Procedures and Work Instructions Revision History Page: 99 . and maintaining safety and environmental management systems. in conjunction with the Information Systems Manager and other appropriate managers. statutory or regulatory requirements. Contingency plans. 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.0 Associated Materials SOP 4. implementing.overall responsibility for managing our automated data processing and communications systems. job and schedule flexibility. Management reviews the effectiveness of these efforts during management review meetings (Section 5).3 WI 4. The Human Resources Department has overall responsibility for identifying. labor shortages. Work environment We provide employee benefits. 5. The Operations Manager has overall responsibility for identifying.2. and involvement of our employees in an empowered environment of continual improvement (Section 6).2. interesting work.4 Control of Quality Records Procedure SOP 7. We engender total participation by involving employees in internal audit (Section 8) and improvement (Section 8) activities. and key equipment failure and field returns. and maintaining effective employee benefit and workforce involvement programs. implementing.

approving. The Program Manager is responsible for receiving. Instructions and Test Procedures are available. and maintaining their individual department work instructions.1 & SOP 7. a cross functional team plans the processes with consideration given to. Product Realization Planning of product realization 1. and in-process and operator instructions) are in agreement. 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). cleanliness. 2. the following: Page: 39 Page: 98 . first piece. reviewing and retaining CAD/ Math data. For new projects.Control Procedure and Engineering Change Process. The Plant Supervisor is responsible for ensuring current instructions are available at all work instructions. The Program Manager is responsible for ensuring all levels of documents and subordinate documents (such as control plan. and repair consistent with the product and manufacturing process needs (Section 6) 6. All Department Managers listed above are also responsible for making sure distributed and or obsolete copies are retrieved and replaced with the latest revision. Both the person receiving a copy of a new or revised document and the person distributing the document are responsible for ensuring that obsolete copies are identified and/or disposed of. Cleanliness of premises We provide and maintain a work environment in a state of order. The Plant Supervisor is responsible for ensuring records of Total Preventive Maintenance activities are maintained. The Company has implemented a Quality and Environmental-planning process to define and document how the respective requirements will be met (See SOP 7. but not limited to.2). Department Managers are responsible for creating. and through safety team meetings and training (Section 6). This planning process is consistent with the requirements of the ISO/ TS16949 standard and sets the framework for all Company processes of the quality/environmental management systems.

Product special characteristics. monitoring. including the prevention of pollution f. MSA. Customer requirements and references to technical specifications are to be included in the quality plan 3. Error proofing for processes. 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. equipment. The Quality Manager and/or designee is responsible for retaining master copies and assuring current revision level of the AIAG reference manuals: 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 TS 16949 Environmental Mgmt. documentation. Environmental aspects/impacts c. measuring. processes. The identification of any controls. ISO 14001 y y y y y y The Program Manager is responsible for a timely review of customer drawings and specifications. and Control Plan manuals as required.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.a. The PM has 10 business days of receipt to document the receipt of drawings and maintain the engineering standards according to the Drawing Page: 97 Page: 40 . equipment (including inspection and test equipment). PPAP. inspection and test activities g. fixtures. Identification of required verification. System. The quality/environmental objectives and requirements for the product b. including safety characteristics d. 4. SPC PFMEA. training and skills needed to achieve the required quality and environmental objectives and targets. facilities. The Company uses the methods in the APQP. and tooling e.

Run @ Rate. Planning of product realization ² Supplemental We review proprietary designs. 6.CONTROL OF DOCUMENTS SOP 4. PFMEA.2. The quality plan and relevant work instructions. test procedures. Purpose This procedure describes the responsibilities for receipt. We maintain customer confidentiality for all products and projects under development. Fixtures. Tooling. 3. When we receive the approval for any changes affecting customer requirements. and related product information. including documents of external origin.e. (Section 7) Our APQP/PPAP process. PPAP. we notify the customer and validate changes before implementation. impact use with the customer. work instructions and inspection instructions related to deliverable goods and our processes. including electronic data.1 provides a consistent advanced product quality planning process acceptable to all of our customers. Application This procedure applies to statutory & regulatory requirements the drawings specifications and documents that explain the engineering requirements.3 1. 2. clearly define acceptance criteria and approved by the customer.. 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 4. We confirm defined activities to ensure compliance with customer requirements. as detailed in SOP 7. review.) Page: 41 y Page: 96 . and distribution of drawings and documents. manufacturing processes. The Company assesses product and manufacturing process changes that affect product realization. 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. Control Plans. 5. assembly methods. etc.

Procedure Manual. or services (e.g. Page: 42 Revision History Page: 95 .) Production following any change in process or method of manufacture Change of source for subcontracted parts.) that affect product characteristics and process parameters. or instruction. etc.1) in the absence of any specific instructions. 6. the recipient updates the manual. PPAP-4. Production Part Approval Process (PPAP) (Section 7). to determine the type of quality re-certification required (PPAP documentation. procedure. The APQP Team Leader ensures: y Submissions for part approval prior to the implementation of changes. The APQP Team Leader implements the PPAP recognized by our customers. send a Quality Manual Change Request Form to the Quality Manager describing the proposed change. operator instructions. For attribute data sampling. All documents used during. heat treating or plating) Product re-released after the tooling has been inactive from volume production for twelve months or more. FMEAs. Upon receipt of the new or revised policy. The changes become part of the revision history. the revision history identifies the changes.0 Procedure Any member of staff. or instruction according to the Quality Policy Manual. acceptable to use ¶as is· due to unavailability of revised forms or unacceptable costs which would be incurred by disposing of unused forms.Special Characteristics for inclusion in the control plan comply with customer specifications (including drawings. may request document changes. If not approved. If a Quality System procedure needs to be changed. The Quality Department files original form. where required. materials. The quality department distributes a copy of the new or revised policy. or forms generated before the revision process shall be considered ¶grandfathered·. the acceptance level is zero defects (Section 8). the request form gives an explanation and a copy returned to the originator. Where practical. see SOP 7. we will default to a level 3 PPAP submission. through their department manager. and Operator Instructions Distribution List. PPAP approval is obtained prior to the first production shipment of product (unless specifically waived by the customer). y y y Acceptance criteria Acceptance criteria is approved by the customer. procedure.

validation. (Section 7) Customer-related processes Achieving our quality policy ´to meet or exceed customer requirementsµ requires that we determine. The responsible Department ensures that designated personnel receive approval. and function (including performance and durability) are reviewed with the customer. and/or manufacturing process. and consistently meet or exceed our customers· requirements and expectations. The responsible Department ensures availability of appropriate documents at all locations where the performance of operations affect the quality system. (Section 8) Page: 94 Page: 43 .2. understand. impact of form. and SOP 7. When required by the customer. inquiries. For propriety designs.2. contract or order handling and related changes. and for the recall of obsolete documents.1. acceptance criteria. product. and amendments of all documents and data relating to the requirements of the quality system. such as required for new product introduction. initial issue.0.3 Document Control Control of Quality/Environmental Records Quality Manual Change Request Department Specific Manuals Confidentiality We ensure the confidentiality of customer-contracted products and projects under development and related product information (Section 7). additional verification and identification requirements are performed. Change control The Quality Manager obtains necessary customer approval of quality plans. and that we establish effective communication systems with our customers with regards to product information. so all effects can be properly.2. 5. Reference 6.0 Associated Materials SOP 4.4 FO 4. The Administrator will maintain a master list of quality-related documents. including complaints.3 SOP4. Department/Plant Supervisor are responsible for controlling issuance and maintenance of associated manuals and data within their area of responsibility as required.The Program Manager and/or designee are responsible for controlling issuance and maintenance of drawings. and customer feedback. fit. and all related changes that may affect product realization.

approves.2 1. and instruction elements. environmental impact. One level above the author will be an approver for reviewing and approving company wide policies. and environmental regulations applied to the acquisition. drawings. and systematically issues documents in a controlled manner. storage. and control of special characteristics that are indentified during the planning phase.0 Definitions Not applicable 4. recycling. Requirements include those specified by the customer (including delivery and post delivery requirements). Review of requirements related to the product During Quoting and Contract Review. reviews. revises. handling. procedures. requirements related to the product are reviewed to ensure that product requirements are defined.0 Purpose This procedure addresses the maintenance of quality documents pertaining to customer requirements. procedures. 3. Quality receives.0 Application To maintain designated secured locations for original policy. and any additional requirements determined by the Company. or disposal of materials.Determination of requirements related to the product The Company maintains documented procedures for quoting and contract review and the coordination of these activities. contract or order requirements Page: 44 DOCUMENTATION REQUIREMENTS SOP 4. prepares. procedure. it is processed according to the Quoting Process to ensure that quality and environmental requirements adequately define and document considerations for recycling. Page: 93 . applicable statutory. safety and environmental regulations and requirements. 2. The Company conforms to customer requirements for designation. and operator instructions for original release and the release of changes. requirements not stated by customer but are necessary for specified or intended use. documentation. and identified characteristics (Section 7). government. All applicable government. elimination.0 Responsibility The Process Owners/Area Managers are responsible for controlling issuance and maintenance of quality/and environmental-related policies. When a request for quote is received. and specifications. safety. and operator instructions.

including risk analysis. review. (Section 7). Organization manufacturing feasibility The Program Manager confirms and documents the manufacturing feasibility of proposed automotive products. verification.differing from those previously expressed are resolved. feasibility reviews and risk analysis are carried out and documented to determine the manufacturing feasibility of the product. They are very generic in nature and would need to be added to or changed for a real company. This review is conducted before the purchase contract is accepted. During Quoting. Where product requirements are changed. Records of feasibility reviews are maintained as in noted in the Quality and Environmental Records. we ensure relevant documents are amended and relevant personnel are made aware of the changed requirements (SOP 7.2) Customer communication During the design and development planning the following are determined and controlled: the design and development stages. Procedures This booklet contains sample procedures. Page: 92 Page: 45 . and product design input and manufacturing process design input in accordance with customer-specific requirements governing the APQP/PPAP process detailed in SOP 7.1 in accordance with APQP.2. unless customer waives review requirement. and The Company can meet the defined requirements. and validation that are appropriate to each design and development stage and the responsibilities and authorities for design and development.

products. This will include the recording of information to track performance. including but not limited to computer-aided design (CAD) data and electronic data interchange (EDI). the key characteristics of the operations and activities that can have significant impact on the environment. Page: 91 . relevant operations controls. The Company and our customers require EDI methods to be employed by all partner suppliers throughout the supply chain. processes. development. or Page: 46 Monitoring and Measurement The Company shall establish and maintain documented procedures to monitor and measure. Design and development Design and development processes for tooling is employed by The Company to transform customer requirements into specifications. on a regular basis. i. All of our EDI initiatives. and conformance with objectives and targets. The Program Manager maintains a list of products for which The Company has design responsibility. the authority to establish a new.e. in a customer specified language and format.To prepare for product realization. or systems. activities are carried out using a multidisciplinary approach including identification and monitoring of special characteristics. including data. and review of FMEAs and control plans. policies. Electronic Data Interchange (EDI) The Company believes that the most effective and efficient way to communicate throughout our supply chain is to utilize a common industry practice for EDI. Customer communication ² Supplemental The Information Systems Manager establishes/maintains an ability to communicate necessary information. and transaction sets comply with the guidelines set forth by the AIAG and our key suppliers are mandated to have the capability to interface with us electronically.

The Company shall document procedures to cover situations where the absence of such procedures could adversely affect quality or have a significant environmental impact. The Company has also established procedures related to the identifiable significant environmental aspects of the goods and services used by the company. Page: 47 . Procedures provide general guidelines to follow in the event of an environmental accident or incident and references appropriate emergency response instructions. and targets. this responsibility includes testing and verification of design performance within customer specified applications. objectives. Page: 90 change an existing. scheduled verification and validation activities.Environmental objectives and targets are consistent with The Company environmental policy. 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.1 in accordance with customer specific requirements (see APQP and serves as the overall APQP Team Leader (as referenced throughout this section). tooling specification.3. Procedures and instructions are reviewed and revised after drills and after the occurrence of accidents or emergencies. 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. The Program Manager has overall responsibility for managing tooling design and development activities in accordance with SOP 7. fixed design reviews. specific emergency response instructions are prepared to allow rapid and effective response to environmental incidents. and communicates relevant procedures and requirements to suppliers and contractors. Emergency response drills are conducted. annually. See Procedure The Company Supplier Manual located on The Company website. including its commitment to the prevention of pollution. where they exist. as a minimum.) to establish a Design Plan that identifies design stages. The Design (or APQP) Team Leader uses project management planning tools (available software etc. (Section 7) Design planning The Program Manager serves as Design Team Leader for tooling design projects for new/changed non-automotive products. 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. Emergency Response When appropriate.

Page: 89 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. operational. The Environmental Laws and Regulations are maintained by the Corporate EMS Coordinator thru periodic contact with local. (See APQP Workbook Master) (Section 7). its significant environmental aspects. when establishing its environmental objectives and targets. and Action Plans. documented and reviewed for adequacy. and business requirements. manufacturing. and production documents. The Product Engineer or Program Manager is responsible for ensuring that all valid design inputs are identified. The Company considers it·s legal and other voluntary requirements. Legal and Other Requirements The Company has identified. targets and action plans are established at each relevant function and level within the organization.Multidisciplinary approach The Design (or APQP) Team Leader forms a Design (or APQP) Team composed of design. A list of applicable Environmental Requirements has been developed and is maintained by the EMS Department. as well as the views of interested parties. These inputs include functional performance requirements. and establishes action plans and programs for achieving these objectives. and requirements Development and review of control plans y y Design inputs The Product Engineer or Program Manager is responsible for ensuring that all applicable design inputs are identified. products. and services. applicable legal and regulatory requirements and other requirements essential for design and development. These inputs include functional and performance requirements. as described in the Objectives. FMEA. legal and other voluntary equirements that are applicable to its activities. Customer environmental requirements are identified during the Quoting Process and are documented in specific contracts. and federal agencies and review of environmental publications. quality. and has access to. documented and reviewed. Targets. production and other appropriate qualified personnel to prepare for product realization. state. Page: 48 . applicable statutory and regulatory requirements and other requirements essential for design and development. its technological options and its financial. through: y The Company considers these significant environmental impacts and aspects when establishing environmental objectives as described in Environmental Objectives. engineering. Objectives/Targets and Environmental Management Programs The Company identifies environmental objectives and targets. associated work instructions.

e. or could have. The preventive action system is considered effective if potential losses were avoided.review and action during management reviews. (Section 5) Preventive action Data from internal audits. a significant environmental impact. Customer requirements such as special characteristics. Environmental Management System Environmental Aspects The Company has identified the environmental aspects of its activities. 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. These significant environmental aspects and their associated impacts were identified during the Initial Environmental Aspects Review. and reviewed including: a. Results of this analysis and related recommendations are presented to Top Management for review and action during management reviews. timing and cost Process design inputs are identified. traceability and packaging b. This information is also reviewed as an input to new designs. life reliability. including: a. Investigating and eliminating the root cause of potential failures is a critical part of our continual improvement process. products and services that it can control and influence and has determined those that have. documented. where applicable. a document for lessons learned is maintained which documents information derived from previous similar designs. (Section 5) 8. Incomplete. durability. customer feedback. Ongoing determination of environmental aspects and impacts is conducted during Advanced Quality/ Environmental Planning As designs and processes are developed. Targets for productivity. Product design inputs are identified. Process design includes the use of error-proofing Page: 88 Page: 49 . and reviewed. process capability and cost c. unclear. Customer requirements d. Product design output data (i. DFMEA) b. identification.. Information from similar product experience including field data and internal input and Competitor Analysis c. documented. employee suggestions. Targets for product quality. maintainability. or conflicting requirements are resolved prior to the release of the final design.

Follow-ups are conducted (through the internal audit process (Section 8) to ensure that effective corrective action is taken appropriate to the impact of the problem encountered.2.5. Corrective actions and controls are applied to similar processes and products. Corrective action procedures are followed to prevent recurrence. The Company responds in the problem-solving format prescribed by the customer. There is a defined problem-solving process used in all plants. and are approved before issuance: Product Design Outputs ² Supplemental Product design requirements outputs can be verified and validated against product design input using: y y y y Design FMEAs and reliability results Product special characteristics and specifications. Product error-proofing Product definition including drawings or mathematically based data Product design review results. When a process change is implemented. Results of this analysis and related recommendations are presented to Top Management for y Page: 50 Page: 87 . policies. and other process documents as appropriate. include or reference acceptance criteria. and work instructions are changed as appropriate. engineering facilities. The size and effects of the nonconformities are considered when corrective/preventative actions are taken. y Non-conformities relating to customer returns from assembly plants. and diagnostic guidelines y Determining and implementing action needed. When external non-conformances occur. Control Plans. when appropriate.Advanced Product Quality Planning is used to indentify Customer product and process special characteristics and symbols to be included on FMEAS. indicate design characteristics critical to the safe and proper operation of the product. procedures. Design outputs The Design (or APQP) Team Leader ensures that design outputs comply with the design input requirements. and dealerships are analyzed in a timely manner and the results are. include information needed for production and service provision. including error proofing Documenting results of action taken and reviewing action taken SOP 8. These records are available to the customer upon request.

The Design (or APQP) Team Leader uses input from those involved in the review to propose a remedy for each identified problem. customer or third Party Audit non-conformities. we do as they wish. work instructions Manufacturing process FMEAs Specifications and drawings Tool designs y y y y y y y y Design review During the evolution of each design project. which define requirements for the review and handling of customer complaints. nonconforming material from suppliers. The procedures also define requirements for determining: y The causes of non-conformities and potential nonconformities Evaluating the need for action to prevent occurrence or recurrence 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). y Page: 86 Page: 51 . The Company maintains a corrective action system that provides for the identification. including: 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. The corrective/preventive action system utilizes documented procedures. internal. analysis. See SOP 8. Corrective action It is the policy of The Company to strive to prevent problems before they occur. including external party communications.5) which includes improvement actions and corrective and preventive actions as outlined in Section 8. If a customer requires another format.2 which describes the 8D methodology we use internally.improvement system (SOP 8. and elimination of the cause of quality and environmental problems in order to prevent recurrence. internally recognized product or process nonconformities or potential non-conformities.5. returned products. the Design (or APQP) Team Leader conducts design reviews as planned and records results and any necessary actions. and environmental non-conformities.

and other improvement actions accomplish the desired results or objectives.Monitoring The Design (or APQP) Team Leader monitors the design project by defining. 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). Wherever practicable. Validation records and any necessary actions are documented and maintained per Quality Record. Production Part Approval Process (PPAP) for customers requiring this program or other sample submission programs as required. lead-times. validation is completed prior to the delivery or implementation of the product. analyzing and recording measurements at specified stages of design and reports summary results as an input to management review (Section 5). We identify such opportunities through analysis of manufacturing process monitoring. and critical paths. Design verification Design verification is conducted to ensure that the design and development outputs have met the specified input requirements. product monitoring and measurement activities (Section 8). design. or where product characteristics are predictable and meet customer requirements. potential problems identified do not occur. The overall objective of manufacturing process improvement is to reduce part-to-part variation and eliminate all waste. Measurements may include quality risks. if applicable. Essentially. Validation is performed in accordance with customer requirements. (Section 5). The Quality Manager has overall responsibility for establishing and implementing an effective continual Page: 52 Page: 85 . costs. and process-oriented audits (Section 8) of key manufacturing processes at least once annually. including program timing. (Section 5) Manufacturing process improvement The Program Manager plans and implements continual improvement of manufacturing processes that are capable and stable. Design Validation includes a review of field reports for similar products. Inputs to the management review process are used to establish new or changed improvement objectives and to initiate/prioritize additional improvement actions. and process. such actions are effective if the problems corrected do not reoccur. The Program Manager summarizes and reports results of manufacturing process improvement activities to Management for review. As warranted. Records of verification results and any necessary actions are recorded on the DVP & R and Program Open Issues. Final validation testing is conducted to validate the final product.

Design validation is performed to ensure the product or service resulting from design efforts performs as intended for all specified or known uses/applications. these are documented as changes and kept in the ECN documentation. (Section 5) Continual improvement Continual Improvement is implemented with the goal of continually improving the quality/environmental management system using the quality policy. audit results. Suppliers are required to follow The Company product and manufacturing process approval procedures and requirements. corrective and preventive actions. As applicable. the Design (or APQP) Team Leader plans and carries out or oversees design validation to ensure it is performed in accordance with customer requirements. It is the responsibility of the Program Manager in cooperation with the Quality Manager to ensure The Company submissions meet functional. (Section 5). including program timing. If there needs to be corrective actions. material. Analysis and Use of Data: Trends in quality and operational performance are compared with progress toward objectives and related recommendations for improvement are developed and are presented to Top Management for review and action during management reviews.5-1. 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. Management Action Requests (MARs). is used to document improvement. Design validation is performed on products that have been produced from production equipment and tooling wherever and to the extent possible.Computerized information systems are implemented for timely reporting of data related to product usage. Records of required tests are kept in the APQP documentation by the Program Manager. quality and environmental objectives. corrective and preventive actions and management review. Page: 84 Page: 53 . Form 8. (Section 5) Product approval is submitted after process verification. analysis of data. Our Management Review Process assesses the overall effectiveness of continual improvement program. and appearance specifications as required by the customer. All management actions are prioritized and implemented on the basis of data analysis (Section 8) and perform cost/ benefit analyses to identify and prioritize improvement actions. customer feedback.

Product Approval Process Detailed in SOP 7.1, per PPAP, through the APQP Team Leader, to ensure all customer engineering design record and specification requirements are properly understood and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate. Note: In the absence of any specific instructions, we will default to a level 3 PPAP submission (Section 7). Control of design changes Design changes throughout the life of the program are reviewed, verified, validated, and approved, as appropriate, by Engineering, Sales, and Manufacturing before their implementation. The review of a change includes an evaluation of the effect of the changes on component parts and product already delivered. The customer will authorize design changes before implementation. Records of the review and any necessary actions are maintained. An internal work order is distributed for changes as is detailed in the Design Release and Change Procedure. The Company will validate all production-engineering changes to PPAP requirements.

Non-conformance reports requested by the customer (usually if/when a customer receives material or service that fails to conform to applicable quality and delivery specifications) are processed per customer requirements and the procedures defined in SOP 8.3. If placed on ´containment statusµ (due to continued poor performance and/or failure to achieve goals and objectives), The Company will take all actions required by the customer, and guidelines contained in SOP 8.3. Analysis of data Data from quality and environmental system processes is collected and analyzed to evaluate the effectiveness of the quality/environmental management system, and to find opportunities for continual improvement of the effectiveness of the quality/environmental management system. Analysis of this data provides information relating to customer satisfaction, product conformity; characteristics and trends of processes and products, and suppliers. During Business Planning and Management Review processes, trends in data and information is reported and compared with progress towards the overall business objectives. This information is used to develop priorities for prompt solutions to customer-related problems, support status review, decision-making, and longer term planning, and is compared with competitors and/or appropriate benchmarks. When negative trends are noticed during data analysis, corrective/preventative action may be initiated.

Page: 54

Page: 83

Control of nonconforming product ² Supplemental Product with unidentified (Section 7) or suspect status is classified and processed as nonconforming. Any material or product that is suspect or does not conform to the appropriate specifications will be reworked or segregated, and disposed of as is detailed in the Nonconforming Product Procedure. Because rework/repair is only performed for minor defect problems, the operations are a repetition of one or more original production processes. Therefore, original process instructions are used and reworked material is verified by the verification activities specified on the control plan. 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. Customer Waiver According to the production Part Approval Process (PPAP) manual, prior written customer approval is obtained whenever the product or process is different from that which is currently approved. Engineering Approved Product Authorization (EAPA) records would be maintained, including expiration date or quantity authorized, and authorization is labeled on the carton of such parts. The original or superseding specs and requirements are complied with when the authorization expires.
Page: 82

Purchasing We work in partnership with our suppliers to ensure that purchased products and services meet all applicable requirements. The processes applicable to the planning, acquisition and verification of all products and services that affect customer requirements (such as sub-assembly, sequencing, sorting, and rework and calibration services) are defined in accordance with the policies outlined in this section. 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, as well as consideration of other characteristics including the type of product; the potential impact of the product on our processes, products, or services; the results of supplier evaluations; and past performance. Purchased products are verified (Section 7 and 8) to ensure conformity to specified purchase requirements. Regulatory conformity Purchased products or materials are also verified to ensure conformity to applicable regulatory requirements. Purchasing, Quality Control, and Engineering work together to ensure purchased products and /or services conform to all specified requirements, including those

Page: 55

from the customer. Purchasing procedures are documented. Supplier Quality Management System Development Essentially, the same requirements imposed on The Company are cascaded down to our supply base. In order to ensure the quality of the parts shipped by The Company, 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 7.4.1. Customer-approved sources Where specified (by contract, customer engineering drawing, or specification) we purchase products, materials, or services from customer-approved sources. A master list of approved suppliers is maintained to ensure we only purchase product from The Company qualified sources or customer-approved sources. The results of evaluations and follow/up actions are recorded. The Materials Manager monitors Supplier performance per SOP 7.4.1 through one or more of the following indicators: delivered product quality; customer disruptions including field returns; delivery schedule performance (including incidents of premium freight); and special status customer notifications related to quality or delivery issues.
Page: 56

Disposition The results of the evaluation and resultant disposition determinations are documented. Dispositions resulting from the evaluation of nonconforming product may include rework to meet specified requirements; re-grade for an alternative application; use as is (under customer concession or other required approval authority); obtain (from relevant authority) a waiver of or deviation from requirements; return to supplier; scrap or other disposal. Suspect or rejected material is either clearly identified with yellow Quality Hold tape or is stored in clearly marked designated areas, depending on the nonconformity. The Quality Control Manager is responsible to ensure disposition of all suspect or nonconforming material is made within an appropriate timeframe. Product Recall In the event nonconforming product is detected after delivery or use has started, the Quality Manager notifies the customer and initiates action appropriate to the effects, or potential effects, of the nonconformity. Where appropriate, 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, including concessions obtained, is maintained in accordance with SOP applicable inspection and test procedures, and Section 4.
Page: 81

the Quality Manager documents and communicates the intended verification arrangements and method of Page: 57 Page: 80 . processes/systems.4. procedures. including. As applicable. Where needed. Evaluation The Quality Manager through authorized Quality Control personnel. equipment. Incoming Product Quality Quality Control is responsible for conducting verification inspections to ensure incoming materials meet customer specifications. internal testing. Engineering. Production and other technical personnel may become involved in the evaluation and recommendation for disposition. and quality management system requirements.Identification Identification of nonconforming product originates from inspection. The Quality Manager plans and implements appropriate sampling plans and other statistical techniques to verify purchased product per Section 8. where appropriate. 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. (Section 8) Segregation Nonconforming product is segregated pending evaluation and disposition. Inspection procedures are documented in the Receiving Inspection Process and on Incoming Inspection Form. perform the initial evaluation of nonconforming product in accordance with approved test and inspection procedures. Verification of purchased product The Quality Manager ensures that purchased product is verified prior to use or release in accordance with provision of this section. 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. Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services.2 and the following policies. qualification of personnel. description of nonconformance. requirements for approval/qualification of product. product audits or customer complaints. and location where the nonconforming product is being held pending further review or disposition. Employees clearly mark or otherwise identify nonconforming product or suspect material.

including suspect products.4) Results are retained and available for customer review. available. as well as parts. and issued. 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. Material must meet specified requirements and be properly identified. Our initial focus is to assure the quality of process inputs . facilities and equipment. and processes must be measured. is considered non-conforming product until status can be confirmed. monitored. appropriate resources. Masters for color.3). and material level for the product supplied. Equipment and facilities must be adequate. stored.product release related to verification activities performed at our suppliers· premises. the applicable control plan and design records (i. Documented procedures are available for the control of non-conforming materials and product. are provided for evaluation areas for appearance items. and certification. subsystem. including processes producing bulk materials. (Section 6) Control of nonconforming product The Company procures raw materials and manufacture products that are defect free. drawings). material. Page: 58 Page: 79 . Employees must be equipped to perform the process properly through appropriate education. (Section 7): y For pre-launch and production that takes into account the design FMEA and manufacturing process FMEA outputs 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. Suspect product. training. and properly utilized The suitability of the fundamental process inputs must be assured. component. Personnel responsible for making appearance evaluations are qualified and competent to do so. and controlled to assure effectiveness and/or to identify opportunities for improvement. grain. (SOP 8.that is. and methods. gloss. including lighting.e. accurate. Control plan The Quality Manager develops control plans at the system. & texture and evaluation equipment are maintained in the QC laboratory. Appearance Items For parts designated by the customer as ´appearance itemsµ The Company provides. which is product with unidentified status. so that they are not used or delivered to the customer (SOP 8.2. including performance of color eyesight testing. employees.

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. This is responsibility if Program Manager.4. and confirm that all critical parameters are in accordance with established requirements and specifications. Nonconforming (or suspect) product is identified and controlled to prevent its inadvertent use. or delegated responsibility for product quality Tooling Management: The Company personnel maintain control over any work that is outsourced. measurement logistics. identify. Product Release and Delivery: Product is not normally released or delivered until all planned inspections and tests have been completed. Release Products are not released for further processing or delivery until we have objective evidence that all requirements have been met. Additionally. Page: 78 Page: 59 . Evidence of Conformity Test and inspection records are maintained for a minimum of three years. These records include final inspection authority. (Section 8) y y Ensures that productions across all shifts are staffed with personnel in charge of. product samples are stored for a minimum of 3 years. if any y Initiate the specified reaction plan when the process becomes unstable or not statistically capable y Are reviewed and updated when any change occurs affecting product. supply sources or FMEA Work instructions y The Production Manager prepares appropriate work instructions for all employees having responsibility for processes that impact product quality and employee safety (Section 6).Final Inspection and Test: All finished products and completed services are verified by final inspections/tests specified in the control plan and SOP 8. manufacturing process. The Quality Manager further ensures that control plans: List the controls used for manufacturing process control y Include methods for monitoring of control exercised over special characteristics defined by both The Company and the customer y Include customer-required information. and records have been maintained providing evidence of conformity with acceptance criteria and identifying the person(s) authorizing release.2.

Work instructions governing set ups and related verifications are developed and available. (Section 8).2. (Section 7) The scope of our product monitoring and measurement system (SOP 8.2. Production personnel in accordance with the applicable control plan perform manufacturing process monitoring (Section 7 and 8).4 prior to commencing each new production run and/or when process changes are made. measurement means. or source inspections. and gauging. layout inspection and functional test.4) includes receiving inspection. such as receiving inspection or (SOP 8. and use statistical methods of verification where applicable. Methods used to verify incoming product from the supplier. (Section 7). and improving maintenance objectives. in-process inspection. and special consideration regarding monitoring and measurement of appearance items. (Section 7) Job Set Up Verification Job set ups are verified per SOP 8. The Production Manager establishes and implements a system for production Page: 60 .4. the Plant Supervisor identifies key process equipment. job set up verification. 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. provides resources for their maintenance. fabrication. Preventive and predictive maintenance Per Section 6. In-process Inspection Formal in-process inspections are performed by Quality Control personnel in accordance with the control plan and SOP 8.2. final inspection and test. evaluating.2. evaluation by accredited laboratories. Availability of replacement parts for key manufacturing equipment Documenting. and verification activities.Verification of job set-ups Job set ups are verified prior to commencing each new production runs and when process changes are made. and develops an effective total preventive maintenance system that at a minimum includes: y y Planned maintenance activities Packaging and preservation of equipment.4). and the required capability and inspection/test skills needed. the Program Manager provides resources and oversees efforts related to tool and gauge design. tooling. Page: 77 y y Management of production tooling As part of manufacturing process design.

The corrective action plan is reviewed with and approved by the customer. (Section 7) Process Monitoring Processes are monitored by process operators per applicable instructions. preventive or other improvement action. including engineering change level Tool identification. The Quality Manager then initiates a corrective action plan indicating the timing and assigned responsibilities to assure the process becomes stable and capable. Control plans and process flow diagrams are implemented to ensure adherence to the specified measurement techniques. repair. product characteristics are determined leading to the types of measurement. suitable Page: 76 tooling management (or monitors these activities if any work is outsourced). the acceptance level shall be Zero Defects. (Section 7 and 8) Production personnel follow documented reaction plans when processes become unstable or no longer capable. sampling plans. defining the status. and requires application of a customer recognized or approved problem-solving approach (Section 8). including: y y y y y Setup Storage and recovery Maintenance and repair facilities and personnel Tool changing programs for perishable tools Tool design modification documentation. Feedback on information from services The Managing Director collects and communicates servicing concerns to Engineering. When selecting product parameters to monitor compliance to internal and external requirements. and reaction plans when acceptance criteria is not met. For attribute data sampling. or disposal y Production scheduling The Production Manager schedules production to meet customer requirements and our goal to achieve 100% ontime delivery performance through a just in-time production control.(Section 8) Page: 61 . 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. such as production. acceptance criteria. Manufacturing and other appropriate personnel for the purpose of initiating appropriate corrective.control plans and/or job packs.

reliability. analyzes process performance (Section 8) and takes appropriate improvement. scheduled. measurement and test. through our APQP/PPAP process. is provided to production personnel throughout the product and service provision process. Monitoring and measurement of manufacturing processes As part of manufacturing process design. achieve desired results) and to identify opportunities for improvement. At a minimum. Process capability study results.e. In addition. Corrective action is taken. 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). where applicable. where applicable. ensures process studies are performed on all new product realization processes to verify process capability and provide additional input for process control.Service Agreements with customer If there is a service agreement with the customer. the Program Manager. The Production Manager ensures that all appropriate information including final product specifications. including process monitoring and verification instructions and criteria developed during product quality planning and manufacturing process development (Section 7). plans. and maintenance instructions) are documented. raw material characteristics and the required product parameters. and specifications (including methods of production. Information Information inputs to the process include both product characteristics and appropriate work instructions containing specific work methods and other pertinent information. Such information is provided through job schedules. as appropriate. maintainability and availability) and appropriate reaction plans are included in Page: 75 Page: 62 . work instructions posted in areas where they are needed. Acceptance criteria (as well as objectives for process capability. 8) to ensure they are effective and efficient (i. and carried out in accordance with procedures detailed in SOP 7. managers with overall responsibility for carrying out a Quality/Environmental Systems process. team meetings. measure the quality and environmental management system process. and through job specific information included in individual job packs. corrective or preventive action (Section 8). the Quality Manager will establish and implement a plan to verify the effectiveness The Production Manager ensures that production and service jobs are planned. when planned results are not achieved. Process audits (Section 8) are carried out to monitor and.

Audit checklists are prepared and used to aid in ensuring audit consistency and comprehensiveness. and abilities of our employees and the complexity of the work process they are assigned to perform. The ISO Management Representative maintains all internal audit records. through Production Shift Supervisors. Qualified personnel who do not have direct responsibility for the activity being audited carry out audits. 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. facilities 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) Monitoring Activities The Production Manager. Quality/Environmental Systems processes are documented measured. Follow-ups are conducted to verify timely and effective implementation of the proposed action. results of internal audits and related follow-ups. Management is responsible for the area audited implement and timely corrective action to eliminate detected non-conformances and their causes. Equipment The Plant Supervisor ensures the suitability and availability of all equipment.Auditor qualification Internal auditors are qualified to audit to ISO/TS 16949:2002 requirements (Section 6). 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 they are needed. skills. including internal auditor training records. and initiate other appropriate action in response to opportunities for improvement identified by process participants or managers. (Section 5) Monitoring and measurement of processes We apply suitable methods for monitoring and measuring all Quality/Environmental Systems processes.5. Engineering.( SOP 7. ensures that production personnel monitor the quality of the work and that employees understand the procedures for reporting related problems and suspected nonconforming conditions. controlled and evaluated (Section Page: 74 Work Instructions The need for work instructions is dependent upon the knowledge.1) The Quality Manager is responsible for planning and Page: 63 .

Delivery. (Section 8) The Quality/Environmental Systems process. and improvement of Quality/Environmental Systems processes and systems. and Post-Delivery Processes Release of product is dependent on its compliance with all specifications and its ability to meet customer requirements including packaging. frequency and methods used for internal audits and define the responsibilities and requirements for planning and conducting audits.2. As applicable. and delivery. scope. and for reporting results and maintaining records.implementing in-process inspections needed to ensure process control and product quality.2 defines the criteria. (Section 5) Validation of processes for production and service provision The Company defines processes in which results cannot be verified by subsequent monitoring or measurement as ´Special Processesµ. with a special emphasis on our ¶core· customer oriented processes and our unique product realization processes. (Section 8) SOP 8. Internal Audit Plans Each of our key Quality/Environmental Systems processes. and is reviewed at least once annually to determine effectiveness. measurement.5. this includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered. shipping. or quality system element under review is effective if it is achieving the desired results or established objectives. (Section 8) Release. function.2. y Page: 73 . as identified in the contract. (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. arrangements are established: y Defining criteria for review and approval of the processes Approval of equipment and qualification of personnel Page: 64 Product audit Product audits are conducted at appropriate stages of production and delivery to verify conformance to all specified requirements contained in the control plan (Section 8). The Program Manager has overall responsibility for ensuring ¶Special Processesµ are validated in accordance with procedures detailed in SOP 7. Responsible managers may also request that the audit be used to gather ´value addedµ data serving as input to aid in monitoring.

(Section 5) Internal audit The Company·s internal audit results are critical inputs to aid in assessing the effectiveness of our QEMS. Quality/Environmental Management System Audit The Company conducts system audits. ISO 14001. Identification and traceability ² Supplemental The identification and status of product is established and maintained during all product and service provision processes. as well as progress towards achievement of corporate level customer satisfaction improvement objectives (Section 5) and provides related recommendations for review by Top Management. production. Manufacturing process audit Audits of our key product realization processes are conducted annually to determine their effectiveness and performance and to identify opportunities for improvement (Section 8) y y Requirements for records. installation. Where product traceability is a customer-specified requirement. and in promoting awareness of customer requirements and effectiveness of the Quality/ Environmental Systems. Identification and traceability The Program Manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. appropriate controls and records are established. Page: 65 Page: 72 .3. The propose of these audits is to verify that the quality/environmental system conforms to product realization arrangements and to the requirements of ISO/TS16949. 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. and delivery in accord with procedures defined in SOP 7. The Company identifies the product by suitable means throughout product realization. and revalidation Use of specific methods and procedures 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.5.1. including inspection and testing activities. in identifying any opportunity for improvement. The Managing Director periodically reviews customer satisfaction survey data and other customer feedback (including complaints).Manufacturing process performance is monitored to demonstrate compliance with customer requirements for product quality and efficiency of the process.

Measurements of customer satisfaction include evaluation of Customer feedback such as complaints.2. Page: 71 Page: 66 . and maintains customer property provided for use or incorporation into the product. control (stability) process capability.1: Customer Satisfaction ² Supplemental Customer Satisfaction is a critical measurement of the performance of the quality management system. The Quality Manager ensures that lost. verify. (Section 6) Monitoring and measurement Customer Satisfaction Customer satisfaction is the reason we exist. Overadjustments will be understood and utilized throughout the organization. (Section 7) Customer property Customer property includes customer-owned material. (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. damaged. customer performance ratings and delivered part quality. (Section 8) Knowledge of Basic Statistical Concepts Employees using statistical tools to manage. returned goods. 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. protects. Incoming product received without part numbers is tagged or labeled in Receiving. tools (including returnable packaging). This drives our quality policy ´to meet or exceed customer requirementsµ. and intellectual property. tooling (including test/inspection tooling and equipment). Incoming material is received with labels indicating the assigned part numbers. by applying the same process controls as we do to purchased product. The Company identifies. warranty reviews. See Management Review Process. Where contractually required.Incoming material is assigned a part number. or perform work will attend a Basic Statistics course containing an overview on basic concepts such as variation. or unsuitable customer property is recorded and immediately reported to the customer. verifies. and maintains appropriate traceability records in accordance with customer requirements. QC Receiving personnel are responsible for verifying incoming material part numbers and date coding as detailed in the Receiving and Inspection Process. establishes. the Quality Manager plans for. Customer satisfaction data is analyzed and reported in management review meetings.

(Section 7) Page: 70 Preservation of product The Plant Supervisor is responsible for preserving the conformity of the product during internal processing and delivery to the intended destination including identification. and improvement activities needed to assure product and Quality/Environmental Systems conformity and achieve continual Quality/Environmental Systems improvement.g. Measurement. Designated storage areas are designed to prevent damage. Further. SPC. and protection. analysis. plan.1 and the AIAG ´Statistical Process Controlµ (SPC) reference manual. as applicable. test. (See SOP 7. conduct of internal audits. obsolete product (including expired age dated material. These activities include assessment of customer satisfaction. and product monitoring and measurement. e.) is controlled as nonconforming product. measurement. A FIFO inventory system is used and regular tracking of inventory turns is reported at the management meeting. Inventory turns and levels are goals defined within the business plan. storage. the condition of stock is periodically assessed. Analysis and Improvement General These sections describes how we define. (Section 8) Advanced Shipping Notification (ASN) The Company utilizes an ASN to facilitate the electronic transfer of data utilized by our customers to: Page: 67 .6 for calibration laboratories) 7. handling. The Company uses an automated inventory management system to optimize inventory turns over time and assure stock rotation on a ¶first-infirst-out· (FIFO) basis. deterioration.Laboratory Requirements ² Internal Laboratory The Company does not have an internal laboratory. and implement the monitoring. External Laboratory The Quality Manager ensures external laboratories used for inspection. Obsolete product is treated the same as nonconforming product and is appropriately identified and segregated to avoid using it for production. Storage and inventory In order to detect deterioration. Identification of Statistical Tools The Quality Manager ensures that statistical tools used to monitor Quality/ Environmental Systems processes are identified during quality planning and included control plans. or calibration services are either acceptable to the customer or accredited to ISO 17025. Statistical techniques for on-going process control and improvement are established per SOP 8. and preservation of product pending use or delivery. process monitoring and measurement. packaging.

All monitoring and measuring devices that can affect product quality are identified and calibrated at prescribed intervals against certified equipment having a known valid relationship to internationally or nationally known standards. (Section 4 & 7) Measurement systems analysis The Quality Manager is responsible for selecting appropriate analytical methods and acceptance criteria which conform to the Measurement Systems Analysis manual. including employee and customer owned equipment. In addition. Verify and receive products into their system. Calibration/verification records Records of the calibration verification activity for all gauges. actions taken are documented. including appropriate Page: 68 y y Page: 69 . We identify and select monitoring and measuring devices and verify their capability of meeting such requirements prior to use. Create an electronic invoice that will generate payment. including the measurement standard against which the equipment is calibrated Revisions following engineering changes Statements of conformance to specification after calibration/verification Control of monitoring and measuring devices We determine the measurements to be made and the accuracy required to assure conformity of our product to specified requirements. control. include: y Equipment identification. they are adjusted or re-adjusted as necessary and the validity of previous measuring results is documented. corrective actions to remedy the situation and preclude its recurrence. uses/acceptance criteria and the action to be taken when results are unsatisfactory. 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. such as gage R & R studies. frequency/method of checks. location. (Section 8) Appropriate calibration records are maintained to document results of calibration activities and suitable indicators are used to show current calibration status. When monitoring and measuring devices are found to be out of calibration (or when calibration status is not known). A number or other identifier is used to provide traceability to the device calibration record.y y y Determine and confirm goods in transit. and maintenance of monitoring and measuring devices including their identification. and test equipment needed to provide evidence of product conformity to determined requirements. measuring.

Sign up to vote on this title
UsefulNot useful