16949 Manual Procedures | Quality Management System | Quality (Business)

Page: 2

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

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

The Company·s· Quality and Environmental Policy are available upon request. 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. y Page: 132 Page: 5 . on-the-job training. The Company currently supplies to the following manufacturers: y y XXXX. safety.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. City. and the headquarters is located at XXX Some Street. process capability and cost y Overall product performance including an analysis of actual and potential field failures and their impacton on quality. zip. 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. State. 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.

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. 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.Application Our Quality/Environmental Systems comply with all applicable requirements contained in ISO/TS 16949:2002. which. constitute provisions of our Quality/Environmental Systems: y y y ISO 9000:2005. Quality management systems ² Fundamentals and vocabulary ISO 9001:2000. through reference in this manual. and encompasses all operations at both of our facilities. covers the design and provision of all company products. 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 . Quality management systems ² Requirements ISO 9004:2000. Reference Documents The following external documents contain provisions.

Statistical Process Control (SPC) Note: 1. has an improved flow and 2. Second Edition. Production Part Approval Process (PPAP Fourth Edition) SPC-3. General Motors Customer Specific Requirements .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. Ford Motor Company CustomerSpecific Requirements for Use with ISO/TS 16949:2002 CSR-GM. 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. Potential Failure Mode and Effects Analysis (FMEA Third Edition) PPAP-4. 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 . The SPC Reference Manual. 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.ISO/TS 16949:2002 CSR-DC. Advanced Product Quality Planning & Control Plan (APQP) FMEA-3. Quality management systems ² particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations CSR-Ford.

Excess Carpet. The operator then places the finished parts into a shipping container to packaging specifications 11. Addresses additional control chart methods and tools MSA-3. communicated. the operator has the material handler to remove the container and bring an empty one as needed 12.E. Overall Appearance Good 3.3 ² Nonconforming product).3 ² Nonconforming product) 15. industry. customers. Page: 8 14. The quality inspector performs part inspection and looks for (see boundary sample): y y y y y y Correct Color No Forming Flaws (I. and definitions given in ISO 9000 as supplemented by terms defined in ISO/TS 16949:2002. Quality Management System General Requirements Top Management is responsible to define the organization·s quality and environmental policy and ensure that it is documented.y y 3. When the container is full. and definitions unique to our organization. The quality inspector records the findings (If needed follow SOP 8. vocabulary. Checklist to ISO/TS 16949:2002 TS-GS. 4. and region and referenced throughout our Quality/Environmental Systems are contained in Appendix A.. Measurement Systems Analysis (MSA) TS-QSA2. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. The quality inspector also checks for container quantity and correct label Page: 129 . include the Quality and Environmental policies and objectives for continuing suitability. and records the information 10. Management review meetings. and understood throughout the organization. Quality System Assessment Checklist. Section 3. Acronyms. Terms and Definitions Our Quality/Environmental Systems uses the same internationally recognized terms. vocabulary. Carpet Wrinkles) Clean Trim Edge ² No Fuzz Or Debris Hole Clean ² No Slugs Slots and additional cutouts are cut or punched clean. IATF Guidance to ISO/TS 16949:2002 9. Terms and Definitions. terms. The quality inspector performs 1st piece inspection at beginning of shift (If needed follow SOP 8.

Page: 128 desired results are achieved. We have adopted the process approach advocated by ISO 9000. slots. controls. Appendix A contains a List of Key Quality/ Environmental Systems Documents. or cutouts are not punched clean. 8. The operator then places the tenor frame central over the tool 4. which meet or exceed customer requirements. The operator burnishes the part edges of extra fuzz (if necessary). The operator inspects the part to verify 15 holes.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. which establishes documents and implements our quality policy. by defining and managing: y Process inputs. including all SOPs and other key Quality/Environmental Systems documents. many of which contain or reference deployment flow charts depicting the process or procedure described in the narrative SOP. follow Rework Instruction. 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 . and satisfies Quality/ Environmental Systems requirements of ISO9001/ 14001. and related processes for providing products and services. When the press finishes its· cycle. If holes. and 3 additional cutouts are clean with no slugs or fabric strings or debris. The operator cycles the press by pressing the two black palm buttons simultaneously 5. one slot. The operator raises the carpet to the cutter and cuts the carpet just above the tenor frame 3. and y Interfaces between interrelated processes to ensure system effectiveness is achieved. The operator uses pre-cut carpet and the operator attaches the tenor frame to the carpet 2. 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). the operator removes the parts and the left over material 6. The operator then places the waste material into the compactor 7.

Management reviews the identified and documented indicators for measurement and analysis to assure effectiveness and efficiency. and are managed in accordance with ISO and customer requirements. Documentation requirements General The Management. including their sequence and interaction with other processes. procedures governing their management are described in documents referenced in applicable SOPs. and continually improve its effectiveness. WORK INSTRUCTIONS WI-DL-6. Page: 127 Page: 10 . Quality/Environmental Management System processes.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. is responsible to implement and maintain a quality and environmental management system. monitoring. Outsourced processes are also depicted in our flowcharts.2. and analysis of these processes is made available and actions necessary to achieve planned results and support continuous improvement. through the Management Team.outsourced Quality/ Environmental Systems processes (Section 7). have been identified and documented in this Quality/ Environmental Manual. The Management ensures that adequate resources and information necessary to support the operation. measuring.

Quality/Environmental Systems documents and data may be in hard copy or electronic media. job descriptions. Management gives individuals total support and the necessary authority to perform the assigned tasks. procedures. The Company recognizes that control of any outsourced processes is necessary in order to ensure the product conforms to customer requirements. 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. perform. or verify work affecting product quality. and other internal and external documents and data as appropriate and needed to manage our systems (Section 4). This quality manual. including the implementation and control of the Environmental Management System. We use SOPs and flow charts to document and define the key Quality/Environmental Systems processes. The material handler puts a shipping label on container and moves the container to the inspection holding area 13. We also issue and control work instructions.11. Quality manual This manual is that part of our Quality/Environmental Systems defines the scope of our Quality/Environmental Systems and documents the policy. SOPs. When the container is full. and processes needed to implement our quality policy and achieve our quality Page: 126 Page: 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 needed to manage. Part inspection 14.

Each Process Owner is responsible for identifying which records they consider quality/environmental records and for collection.2. Raise carpet to the cutter and cut the carpet just above the tenor frames 5. readily available and retained for a specified period in Quality Record Matrix. and the retention and disposition of these records Quality/Environmental records are legible. protection. the operator removes the parts and the left over material 8. The operator uses the controls to roll out the carpet long enough to place the tenor frames on the carpet 3. The operator then places the part on over bend fixture and the waste material into the compactor and presses the green palm buttons simultaneously 9. The operator then places the finished parts into a shipping container Page: 125 . Pertinent records from our subcontractors are an element of this. The material is automatically loaded onto conveyor and into oven while the operator prepares the carpet for insertion into the press 2. Attach both tenor frames to the carpet and cut the carpet between them 4. as well as ISO/TS requirements. Place the both tenor frames central over the cavities (one tenor frame per two cavities) 6.objectives. and after the removal of the part from the over bend fixture 10. When the press finishes its· cycle. The quality inspector performs 1st piece inspection. below includes forms used to create controlled quality records as detailed in procedure SOP 4. 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 cycles the press by pressing the two black palm buttons simultaneously 7. retrieval. records should be disposed of accordingly. at beginning of shift. storage. Once retention time is met. The information Quality Manager has overall responsibility for ensuring that all Quality/Environmental Systems documents.3: Page: 12 Process: 1. 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. Record retention must satisfy both regulatory and customer requirements.

and re-approve documents. Two frames are required Page: 124 Page: 13 . WI-SB-5. e) Ensure that documents remain legible. and to apply suitable identification to them if they are retained for any purpose.2. and implementation of all customer-engineering standards/ specifications and changes based on customer-required schedule. update as necessary.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. distribution. Material handler brings carpet to the press to be loaded onto carpet cutter 3. readily identifiable. The Company uses a Product Data Management system to manage and control engineering records and data (see SOP 4. b) Review. c) Identify the current revision status of documents.2.3). 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. Material handler brings material to conveyor and setup in proper position for conveyor load 2. 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. Provide shipping container 4.WORK INSTRUCTIONS a) Approve documents for adequacy prior to issue.

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. or they affect PPAP documents.4 details procedures necessary to control Quality/Environmental Systems records that.2.2. are prepared to document: a) Results of processes performed.3. (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. b) Product/process evaluation/acceptance criteria Work Instructions This booklet contains sample Work Instructions. When a change involves standards or specs that are reference on design records. we submit an updated PPAP. SOP 4. Pertinent Records from our sub-contractors are an element of this. They are very generic in nature and would need to be added to or changed for a real company.The Company considers reviews timely if performed within two working weeks of receipt. Page: 14 Page: 123 . Records may be in the form of hard copy or electronic media. including identification of the individual performing the activity.

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

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

The format utilized will be an 8D. Top Management ensures that we meet these requirements with the aim of enhancing Customer Satisfaction.5.5.5. including internal rejections. understood.0 Definitions Not applicable 4.3 1.0 Purpose This procedure provides a systematic means in which quality problems will be eliminated.0 Responsibility y The Quality Manager is responsible for ensuring that the corrective/preventative action is managed effectively. 3.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).2 FOMCRLOG Concern Report (MCR) Material Concern Report Tracking Log Page: 120 y . 2.2/8. and converted into requirements (Section 7). Our quality policy statement indicates our commitment and focuses on what is important to us as an organization: achieving customer satisfaction. Customer focus Customer requirements are determined during Quoting and Contract review processes. unless otherwise directed by the customer. The Top Management Team is responsible for analysis of customer rejected material. 5. problems from subcontractors and customer complaints.0 Associated Materials FOCAR 8. through Customer feedback and the following activities: y The Company continually monitors and measures customer complaints and other customer input/ feedback to identify opportunities for improvement (Section 8). and it prescribes the method by which we accomplish this: by continually improving Page: 17 SOP 8. explicit customer requirements and expectations in the form of a contractual agreement or customer order.0 Application This procedure applies to all quality problems. These customer focused communications and interactions ultimately yield clear. the Managing Director has overall responsibility for ensuring that specified and unspecified requirements are determined.

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

The Company·s Management Team annually reviews business plan and revises.2 FO 8. The Production Supervision and Quality Manager determine the disposition of the non-conforming material and record it on the Quarantine Area Record. We also have methods to track update and revise fall under the Continuous Improvement Process.3 6. The quality manual documents the necessary processes that define the planning process for quality/environmental management system and objectives. 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.5.0 Procedure Corrective/Preventive Action Procedure Quarantine Area Record Scrap Log Quality Policy Our Objective Will Be Accomplished Through Customer Satisfaction by Providing: 1. up to the disposition section. as appropriate.SOP 8. When material is found to be nonconforming. the container(s) is identified by a Quality representative or production supervisor with an initial Material Concern Report. (If material is part of an accumulation. The business plan includes short and longterm goals relating to quality and environmental policy objectives. and defines timeframes to achieve each goal. There are four possible determinations of inspected product: y Acceptable Product ² green check mark Page: 118 Page: 19 . completes the Quarantine Area Record.3 FO 8. Make statement 2. including those needed to meet product requirements. to encourage customer satisfaction and overall growth of the organization. Quality or a member of management will provide written instructions to the employee conducting these activities. Production personnel complete sort or rework. 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.

0 Associated Materials FO 8. 4. and effectiveness are. productivity. (Section 6) Product Performance: Program Manager. efficiency. (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. This managing includes the procurement of a deviation or concession from the customer if changes to the product differ. Actions will be taken such as stock returns and replacement.3 NCMR Material Concern Report y y y y y y y Page: 117 . 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). reading material. The Quality Department is responsible for maintaining and analyzing data from NC material activities. sorting or even sending a company representative to their site to protect their interests.The Company benchmarks trends in quality. customer feedback. 5. including materials and services provided by vendors.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. that differ from those currently approved according to the Production Part Approval Process Manual. 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. It is clearly (visually) identified and quarantined or segregated to prevent inadvertent use or installation. as information is available. We accomplished Benchmarking formally and informally via trade shows. Material is reviewed and disposition is determined by management and quality. (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.

g. 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. 4. etc.g. We base specific measurable objectives on achievable performance within a specified period. c) Develop and implement Advanced Product Quality Planning (APQP) practices and procedures in accordance with ISO/TS 16949:2002.0 Application This procedure applies to. (Section 7) d) Provide objective evidence that all supplied products and services satisfy all AIAG Production Part Approval Process (PPAP) requirements.0 Definitions Nonconforming Product: Material (e. quality systems and personnel to consistently and cost effectively produce products and furnish services that meet customer needs (Section 7). dimensions.. etc. visual. purchased components. and associated customer specific requirements documents. but is not limited to.) Suspect Product: All material having the same lot number as known nonconforming product. 3. processes. (Section 7 and 8) b) Manage and control facilities. PPAP-4¸ (Section 7) as required including acceptable process capabilities for all Special/Control Characteristics that have been established. resin. APQP-2.0 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. customer rejection / returns or material received from a supplier.. 2.3 1.CONTROL OF NONCONFORMING PRODUCT SOP 8. work-in-progress. in-house rejections. including the AIAG ´Advanced Product Quality Planning and Control Planµ reference manual. melt flow. unidentified or suspect material.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. Note: In the absence of any specific Page: 21 .) that does not meet established parameters (e.

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

5. 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). including contract or service personnel. and communication Responsibility and authority 6. with the help of department managers. (Sections 5. sets direction and ensures the success of our business through the clear definition and communication of Quality/Environmental Systems responsibilities and authorities. Responsibility. in any new or modified job. and 8) The Quality Manager develops appropriate quality planning documents for specific products. Responsibility for quality Overall Quality/Environmental Systems responsibility and authority is as follows: Page: 114 Page: 23 . 6. 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. projects. The Managing Director (MD). This review occurs concurrently with the employee·s performance evaluation or upon need. The Company employees and their manager/supervisor shall review the employees training status to determine training needs. authority. 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.0 Procedure Identify training needs.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.

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

Each hourly employee has an individual training record. Personnel whose work affects quality are informed about the consequences to the customer of nonconformity to quality requirements. relevance. Management representative The Company has appointed Quality and Environmental Management representatives for each system. Each salary employee has an individual training record. which is maintained by the Human Resource Department. which is maintained by the Human Resource Department. All employees have training in awareness. and maintained in accordance with their respective standards (Section 5). training matrices and copies of training certificates. job descriptions. etc. 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. work instructions. These records include.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. implemented. 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. 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. and importance of their activities and how they contribute to the achievement of our overall quality objectives. flow charts. 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. These records include. The Page: 112 y . 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. but are not limited to. training matrices and copies of training certificates. but are not limited to. Personnel responsible for product quality have the authority to stop production to correct quality problems (Section 8).

y The Environmental Management Representative is responsible for documenting and responding to relevant communication from external parties. and its policies. We communicate information regarding Quality/ Environmental Systems processes and their effectiveness through documented training (Section 6). 2. and specific training sessions to communicate internal information about the effectiveness of our quality and environmental management system. COMPETENCE AWARENESS & TRAINING SOP 6.0 Application The scope of this procedure incorporates the training of all employees performing quality related activities.2 1. including but not limited to workplace meetings. 3. and corrective/ preventive action processes (Section 8). objectives and significant environmental aspects. Each job description identifies the competence level/ education. continual improvement. 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. Page: 26 Page: 111 .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. new employee orientation. memos.0 Responsibility Job Description Each position has a written job description maintained by the Human Resources Department. from contract review through production Internal communication The Company uses a variety of tools. the internal audit process (Section 8). bulletins. as appropriate. skills appropriate required for the position. the training provided.0 Definitions Not applicable 4.2. and regular formal and informal communications as follows: y The ISO Management Representative posts information on quality bulletin boards throughout the facility to convey information regarding customer requirements.

0 Associated Records Management Review Report: Record of the management review meeting. and effectiveness of our Quality/Environmental Systems in accordance with procedures detailed in SOP 5. policies and changes. The Managing Director Page: 110 Page: 27 . 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. which we convey and reinforce during employee performance. Quality Objectives Matrix: Record of established quality objectives. Documented on the title page of the Management Review Report (MRR 5. are responsible for establishing internal communications as needed to convey to their employees the relevance and importance of their activities. adequacy. Management Review Report.6.6. and related statutory/regulatory requirements. y The Company uses internal audits (Section 8) to reinforce or communicate appropriate information to employees. programs. Management review Top Management conducts formal review meetings at least quarterly to ensure the continuing suitability.1.6). conclusions. The Human Resources Department posts information on employee bulletin boards throughout the facility to convey information regarding employee benefits.9. All managers and supervisors. and any actions initiated to implement the conclusions and policies. reviews (Section 6). Documented using form FO-MRR-5. involvement opportunities. and applicable statutory/regulatory requirements. to include presented and discussed topics and issues. Communications regarding how employees contribute to the achievement of objectives. typically this information is conveyed through production team meetings and cross-functional improvement projects (Section 8).

Page: 28 Resource needs for implementing improvement actions are identified. Management review output is documented in the Management Review Report based on form MRR 5. The location and retention period for management review records are specified in Operational Procedure SOP 4. Control of Records. identifying opportunities for improvement and corrective and preventative actions. facility and equipment. and environment. 7.5. plant. and an assessment of the suitability and effective of support processes (i.0 Records Management review records must be as comprehensive as possible.2. (Section 8) The Company record review results provide at a minimum. and that the review was concluded with appropriate decisions and actions. evidence of achievement of quality/environmental objectives and customer satisfaction. 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.4 Operational Procedure. These include assignment of responsibility. technical knowledge. and other necessary resources. The Company holds review meetings at least monthly to review plant specific data and process effectiveness indicators. 8. Quality system performance Each management review includes all requirements of the Quality/Environmental Systems including monitoring of quality objectives (Section 5).or designee chairs the corporate reviews and top management from all relevant functions attends.6.1 Management Review Report Form SOP 4.1. Corrective and Preventive Action Page: 109 . They will be the sole evidence that the agenda of the review was completely covered.4. (Section 5) The Quality Manager ensures that review includes analysis of actual and potential field failure and their impact on quality. regular evaluation of the cost of poor quality (Section 8) . We retain meeting records.e. equipment.6. safety. Section 6) as an essential part of our continual improvement process (Section 8).0 Referenced Documents 5.2. if any. time frame. Control of Records SOP 8. absent participants. and allocation of human. The report is prepared by the Quality Manager and is distributed to the attending and.2 Operational Procedure.

CARs are normally used for improvements related to specific actual or potential product or process nonconformities. Review output These improvement actions are defined implemented as: Management review actions Documented in the Management Review Report (FO-MRR-5. and strategic or operational changes that could affect the QEMS. related performance trends. and Due Date columns. Page: 108 At a minimum.3) and processed in accordance with procedure SOP 8. improvement of product related to Page: 29 .2.0 y y y Management review output Improvement of the quality management system. Review input ² Supplemental. The Program Manager provides an analysis of actual and potential field-failures and their impact on quality. we use these results to demonstrate achievement of the quality objectives in our Business Plan and customer satisfaction with supplied product. and opportunities for improvement. Assigned to. 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.6. Improvement of quality performance. Corrective and Preventive Actions. This type of action is most suitable for minor improvements that can be quickly implemented.1) in the Actions. safety or the environment as an input to the management review process. This method is most suitable for implementing long-term improvement goals. follow-up actions from earlier management reviews. and which are not directly related to product or process conformity. Quality objectives Documented on the title page of the Management Review Report (refer to Section 6 of this procedure). all applicable requirements of the QEMS. Review input The management review meeting includes a review of our quality policy (Section 5). corporate level.2.5. 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. results of self-assessments (Section 8). At a minimum.6. In addition. Corrective or preventive actions Documented in the Corrective Action Request (CAR) form (FO-NCCAR-8. and Improvement of products and/or services to better meet customer requirements and increase customer satisfaction At a minimum.

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. and to enhance customer satisfaction by meeting customer requirements. through the Management team.6. The principal quality policy is reviewed to ensure its continuing suitability. The policy is changed when the goals expressed in the policy have been achieved. performance measurements. or when changes within or outside the company render the policy inadequate or inappropriate. 5. we record the results of management review meetings and the ISO Management Representative maintains the records. determines its resource needs and provides the resources to implement and maintain the quality management system and continually improve its effectiveness. Resource requirements identified during the Business Plan Process. Per SOP 5. Quoting process. Page: 30 Page: 107 . We accomplish verification of work through budget comparisons. reduce its target value. and provision of resource needs. capital expenditure review. 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 records their status in the Status Next Management Review column. Resource Management Provision of resources The Company. At the end of the meeting. Objectives that have been achieved may be discontinued or be retained with a higher target value.customer requirements. When an objective is not achieved. and advanced Quality/ Environmental Planning. 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). the participants decide whether to drop the objective. or extend the target due date.

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

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

including on-the-job-training (OJT).Manager may call for unscheduled extraordinary reviews. reassigned to another person/function. Production. changed. as Page: 33 . Agenda The agenda for management review meetings covers at least all items listed in Section 4 of this procedure. Management review input At a minimum. Where possible. and update of hourly employee Training/Competence Matrix records. Personnel performing specific assigned tasks are qualified. with input from responsible managers. No more than one manager may be absent from the meeting. after reviewing the minutes. and Purchasing. 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. Attendance Management reviews are chaired by the Quality Manager and are attended by Management. Those managers who are unable to attend shall receive minutes of the review meeting and. At a minimum. Training Responsible managers identify training needs for their employees and achieve competence of all personnel performing activities affecting product quality. Engineering. The Operations Manager and Quality Manager must always attend. Our Training Coordinator is responsible to analyze effectiveness of training and competence. The agenda is documented on the cover page of the Management Review Report. Actions which are not completed may be extended with a new due date. we help existing employees qualify for new/changed jobs through the provision of appropriate education and training. The Human Resource Department. may submit their input and comments to the Quality Manager. 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. 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.

g. the Operations Page: 103 Page: 34 . Responsible managers ensure that employees are aware of the relevance and importance of their activities and contributions to the achievement of our objectives.). with particular attention to the satisfaction of customer requirements (application of digitized mathematically based data. and in particular those named in Section 4. Review Input. The annual review is conducted in March.0 Purpose The purpose of this procedure is to provide for a system and instructions. and to assign responsibilities for scheduling. through the maturation phase of the quality system). MANAGEMENT REVIEW SOP 5.6 1. conducting. For the first two years (i. including agency or contract employees.e.. We conduct Annual employee reviews to give one on one interaction of communication employee with The Company Management.0 Application This procedure applies to all activities comprising the quality system.0 Definitions None 4. e. and recording management reviews of the quality management system. In response to changing or special conditions and events. 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. 3. Employee motivation and empowerment The management team is responsible to motivate employees to achieve quality objectives. to make continual improvements and to create an environment to promote innovation. The additional review is conducted in September. 2.required. management reviews are conducted twice a year. of this procedure.0 Procedure Frequency and Scheduling Quality performance and the quality management system are reviewed at least once a year. The Company carries out periodic audits with employees to determine their awareness of the relevance and importance of their activities and contribute to the achievement of the quality and environmental objectives.

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

Employee qualification/competency review records and annual performance review results are maintained by the Human Resources Department. skills. and any supporting services that are needed. In addition.2.2 FO 4. The Materials Manager and Accounting department are responsible for ensuring the proper retention of customer related purchase orders and amendments.4 DD FO 4. facility. Infrastructure The Company provides and maintains the infrastructure needed to achieve conformity to product requirements. training. employee performance reviews (Section 6). process equipment (hardware and software as necessary). such as transportation or communication.0 Accounting department and the Materials Manager are responsible for ensuring the proper retention of subcontractor purchase orders and amendments.6 SOP 7.6. We use a multi-disciplinary approach to develop plant. and experience in accordance with provision of Section 4.1. Associated Materials AIAG APQP AIAG FMEA AIAG MSA AIAG SPC AIAG PPAP SOP 5. The Training Manager maintains records of all training completed. we detail methods to evaluate and monitor the effectiveness of existing operations in SOP 7.achieving our quality policy (Section 5) and objectives (Section 5). including buildings. workspace and associated utilities.5. Records We maintain appropriate records of education.2 SOP 8.4 and SOP 5. processes. This is accomplished through awareness training. and equipment.2. The Company prepared contingency plans to satisfy customer requirements in event of an emergency such as 5.2.4 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 employee participation in our internal audit (Section 8) and improvement (Section 8) processes.

maintenance. and Transportation and material handling equipment management. facility. and repair y y Plant. 3. and disposal. The Information Systems Manager has Page: 37 .CONTROL OF RECORDS utility interruptions. The Plant Supervisor develops and implements an effective preventive maintenance program utilizing predictive maintenance methods (Section 7) as appropriate. internal quality system audits. labor shortages. handling and value-added use of floor space and facilitate synchronous material flow.3. these programs include: y y y SOP 4. and equipment planning The MD uses a multidisciplinary approach for developing plant. collection. 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. storage. and management review. availability. and disposal. filing. indexing.0 Purpose This procedure provides a method of maintaining quality records consisting of identification. The Quality Manager is responsible for ensuring the proper retention of production part approvals. (SOP 6. quality performance records.2) The Plant Supervisor has overall responsibility for managing our Facilities and Equipment Maintenance programs in accordance with SOP 6. and equipment plans. The Program Manager and/or designee is responsible for ensuring the proper retention of appropriate tooling records. Page: 100 Facilities management. protection. facility.2. maintenance and repair Housekeeping/custodial services management Process equipment management.4 1.0 Responsibility Each Department Manager is responsible for records their department creates and for their maintenance. 2. and key equipment failure and quality issues.0 Application This procedure applies to all departments responsible for the maintenance of quality records.3. This is inclusive of all prints. maintenance and repair Production tooling management.0 Definitions None 4.

We engender total participation by involving employees in internal audit (Section 8) and improvement (Section 8) activities. in conjunction with the Information Systems Manager and other appropriate managers. and key equipment failure and field returns.overall responsibility for managing our automated data processing and communications systems.2.4 Control of Quality Records Procedure SOP 7. and maintaining safety and environmental management systems. Management reviews the effectiveness of these efforts during management review meetings (Section 5). We monitor and improve workplace safety.0 Associated Materials SOP 4. and ergonomics by following proper manufacturing practices. statutory or regulatory requirements. 5. interesting work. and maintaining effective employee benefit and workforce involvement programs. The Quality Manager. Work environment We provide employee benefits. ensures contingency plans are documented in the Business Plan and implemented as needed to satisfy customer requirements in the event of an emergency such as utility interruptions. implementing. 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. The Operations Manager has overall responsibility for identifying. The Human Resources Department has overall responsibility for identifying. Contingency plans.3 WI 4. job and schedule flexibility. implementing. and involvement of our employees in an empowered environment of continual improvement (Section 6). health.3 Advanced Quality Planning Procedure Documentation ² Writing Procedures and Work Instructions Revision History Page: 99 . processes and controls needed to ensure product conformance and meet customer.2. labor shortages.

The Program Manager is responsible for receiving. 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.Control Procedure and Engineering Change Process. and through safety team meetings and training (Section 6). but not limited to. Product Realization Planning of product realization 1. The Company has implemented a Quality and Environmental-planning process to define and document how the respective requirements will be met (See SOP 7. Cleanliness of premises We provide and maintain a work environment in a state of order. and in-process and operator instructions) are in agreement. reviewing and retaining CAD/ Math data. Instructions and Test Procedures are available. and repair consistent with the product and manufacturing process needs (Section 6) 6.1 & SOP 7. For new projects. 2. The Plant Supervisor is responsible for ensuring records of Total Preventive Maintenance activities are maintained. cleanliness. 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. first piece. a cross functional team plans the processes with consideration given to. Department Managers are responsible for creating. 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. 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).2). the following: Page: 39 Page: 98 . approving. and maintaining their individual department work instructions.

equipment. The quality/environmental objectives and requirements for the product b. processes. fixtures. Customer requirements and references to technical specifications are to be included in the quality plan 3. 4. and tooling e. monitoring. SPC PFMEA. documentation. Product special characteristics. 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. PPAP. 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 . facilities. inspection and test activities g. training and skills needed to achieve the required quality and environmental objectives and targets. The identification of any controls. and Control Plan manuals as required. MSA. System. including safety characteristics d. ISO 14001 y y y y y y The Program Manager is responsible for a timely review of customer drawings and specifications. 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 (including inspection and test equipment). Error proofing for processes. including the prevention of pollution f.a. Identification of required verification.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. measuring. The Company uses the methods in the APQP. Environmental aspects/impacts c.

2. manufacturing processes. we notify the customer and validate changes before implementation. 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. impact use with the customer. work instructions and inspection instructions related to deliverable goods and our processes. Purpose This procedure describes the responsibilities for receipt. as detailed in SOP 7. including electronic data. PPAP. We maintain customer confidentiality for all products and projects under development. When we receive the approval for any changes affecting customer requirements. review. PFMEA. 5.) Page: 41 y Page: 96 . clearly define acceptance criteria and approved by the customer. Tooling. 2. The quality plan and relevant work instructions.. Fixtures. Application This procedure applies to statutory & regulatory requirements the drawings specifications and documents that explain the engineering requirements.CONTROL OF DOCUMENTS SOP 4. 3.3 1. (Section 7) Our APQP/PPAP process. Control Plans.e. We confirm defined activities to ensure compliance with customer requirements. including documents of external origin. and related product information. 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. test procedures. etc.1 provides a consistent advanced product quality planning process acceptable to all of our customers. assembly methods. and distribution of drawings and documents. Planning of product realization ² Supplemental We review proprietary designs. 6. Run @ Rate.

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

(Section 8) Page: 94 Page: 43 . and amendments of all documents and data relating to the requirements of the quality system.0. and all related changes that may affect product realization. (Section 7) Customer-related processes Achieving our quality policy ´to meet or exceed customer requirementsµ requires that we determine. 5. and SOP 7. acceptance criteria.3 SOP4. impact of form. Department/Plant Supervisor are responsible for controlling issuance and maintenance of associated manuals and data within their area of responsibility as required. and that we establish effective communication systems with our customers with regards to product information.0 Associated Materials SOP 4.4 FO 4. For propriety designs. When required by the customer.2. inquiries. fit. such as required for new product introduction.2.The Program Manager and/or designee are responsible for controlling issuance and maintenance of drawings.2. additional verification and identification requirements are performed. and for the recall of obsolete documents. and customer feedback. initial issue. and consistently meet or exceed our customers· requirements and expectations. The Administrator will maintain a master list of quality-related documents.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). Reference 6. understand. The responsible Department ensures availability of appropriate documents at all locations where the performance of operations affect the quality system. and/or manufacturing process. including complaints. validation. and function (including performance and durability) are reviewed with the customer. so all effects can be properly.1. contract or order handling and related changes. The responsible Department ensures that designated personnel receive approval. Change control The Quality Manager obtains necessary customer approval of quality plans. product.

requirements related to the product are reviewed to ensure that product requirements are defined. elimination. safety and environmental regulations and requirements.0 Purpose This procedure addresses the maintenance of quality documents pertaining to customer requirements. Quality receives. reviews. revises. procedures.0 Definitions Not applicable 4. approves. and operator instructions. government. and instruction elements. procedure. applicable statutory.2 1. All applicable government. recycling.Determination of requirements related to the product The Company maintains documented procedures for quoting and contract review and the coordination of these activities. Review of requirements related to the product During Quoting and Contract Review. One level above the author will be an approver for reviewing and approving company wide policies. and operator instructions for original release and the release of changes. documentation. and specifications. The Company conforms to customer requirements for designation. or disposal of materials. requirements not stated by customer but are necessary for specified or intended use. and systematically issues documents in a controlled manner. and control of special characteristics that are indentified during the planning phase. drawings. 3. environmental impact. Page: 93 . handling. prepares.0 Application To maintain designated secured locations for original policy. safety. contract or order requirements Page: 44 DOCUMENTATION REQUIREMENTS SOP 4. and identified characteristics (Section 7). and any additional requirements determined by the Company. and environmental regulations applied to the acquisition. When a request for quote is received. storage. it is processed according to the Quoting Process to ensure that quality and environmental requirements adequately define and document considerations for recycling. Requirements include those specified by the customer (including delivery and post delivery requirements). 2.0 Responsibility The Process Owners/Area Managers are responsible for controlling issuance and maintenance of quality/and environmental-related policies. procedures.

Records of feasibility reviews are maintained as in noted in the Quality and Environmental Records. and product design input and manufacturing process design input in accordance with customer-specific requirements governing the APQP/PPAP process detailed in SOP 7. Procedures This booklet contains sample procedures. including risk analysis.1 in accordance with APQP. Organization manufacturing feasibility The Program Manager confirms and documents the manufacturing feasibility of proposed automotive products.differing from those previously expressed are resolved. They are very generic in nature and would need to be added to or changed for a real company. verification. During Quoting. and The Company can meet the defined requirements. Where product requirements are changed. This review is conducted before the purchase contract is accepted. Page: 92 Page: 45 .2) Customer communication During the design and development planning the following are determined and controlled: the design and development stages. unless customer waives review requirement. and validation that are appropriate to each design and development stage and the responsibilities and authorities for design and development. review.2. we ensure relevant documents are amended and relevant personnel are made aware of the changed requirements (SOP 7. (Section 7). feasibility reviews and risk analysis are carried out and documented to determine the manufacturing feasibility of the product.

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

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

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

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

These records are available to the customer upon request. policies. When external non-conformances occur. Design outputs The Design (or APQP) Team Leader ensures that design outputs comply with the design input requirements.5. and other process documents as appropriate. engineering facilities. procedures. When a process change is implemented. The size and effects of the nonconformities are considered when corrective/preventative actions are taken. and work instructions are changed as appropriate. The Company responds in the problem-solving format prescribed by the customer. including error proofing Documenting results of action taken and reviewing action taken SOP 8. indicate design characteristics critical to the safe and proper operation of the product. Results of this analysis and related recommendations are presented to Top Management for y Page: 50 Page: 87 . y Non-conformities relating to customer returns from assembly 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.Advanced Product Quality Planning is used to indentify Customer product and process special characteristics and symbols to be included on FMEAS.2. 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. and diagnostic guidelines y Determining and implementing action needed. include information needed for production and service provision. Corrective action procedures are followed to prevent recurrence. and dealerships are analyzed in a timely manner and the results are. when appropriate. There is a defined problem-solving process used in all plants. Corrective actions and controls are applied to similar processes and products. Product error-proofing Product definition including drawings or mathematically based data Product design review results. Control Plans. include or reference acceptance criteria.

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

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

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

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 plans and implements appropriate sampling plans and other statistical techniques to verify purchased product per Section 8. and location where the nonconforming product is being held pending further review or disposition. qualification of personnel. 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. processes/systems. requirements for approval/qualification of product. Inspection procedures are documented in the Receiving Inspection Process and on Incoming Inspection Form. 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. Engineering. product audits or customer complaints. Where needed. Employees clearly mark or otherwise identify nonconforming product or suspect material. As applicable. equipment. 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.Identification Identification of nonconforming product originates from inspection. Evaluation The Quality Manager through authorized Quality Control personnel. and quality management system requirements. perform the initial evaluation of nonconforming product in accordance with approved test and inspection procedures. Production and other technical personnel may become involved in the evaluation and recommendation for disposition. Incoming Product Quality Quality Control is responsible for conducting verification inspections to ensure incoming materials meet customer specifications. the Quality Manager documents and communicates the intended verification arrangements and method of Page: 57 Page: 80 . procedures. internal testing. description of nonconformance. Purchasing information communicated to our suppliers contains the appropriate data needed to clearly and fully describe requirements for purchased materials and services. including. (Section 8) Segregation Nonconforming product is segregated pending evaluation and disposition.4.2 and the following policies.

(Section 6) Control of nonconforming product The Company procures raw materials and manufacture products that are defect free.that is. and processes must be measured. Material must meet specified requirements and be properly identified. training. is considered non-conforming product until status can be confirmed. including suspect products. component.4) Results are retained and available for customer review. including processes producing bulk materials. available. Documented procedures are available for the control of non-conforming materials and product. and certification. including performance of color eyesight testing. 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. are provided for evaluation areas for appearance items. Suspect product. as well as parts. so that they are not used or delivered to the customer (SOP 8. facilities and equipment.2. Masters for color. Page: 58 Page: 79 . Employees must be equipped to perform the process properly through appropriate education. Appearance Items For parts designated by the customer as ´appearance itemsµ The Company provides. and controlled to assure effectiveness and/or to identify opportunities for improvement. subsystem. Personnel responsible for making appearance evaluations are qualified and competent to do so.e. and issued. (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.product release related to verification activities performed at our suppliers· premises. accurate. and properly utilized The suitability of the fundamental process inputs must be assured. including lighting. gloss. employees. and methods. material. & texture and evaluation equipment are maintained in the QC laboratory. (SOP 8. Our initial focus is to assure the quality of process inputs . drawings).3). stored. the applicable control plan and design records (i. appropriate resources. which is product with unidentified status. Equipment and facilities must be adequate. and material level for the product supplied. grain. Control plan The Quality Manager develops control plans at the system. monitored.

and confirm that all critical parameters are in accordance with established requirements and specifications. 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. identify. (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. These records include final inspection authority.4. This is responsibility if Program Manager. Release Products are not released for further processing or delivery until we have objective evidence that all requirements have been met. or delegated responsibility for product quality Tooling Management: The Company personnel maintain control over any work that is outsourced. Page: 78 Page: 59 . 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. Nonconforming (or suspect) product is identified and controlled to prevent its inadvertent use.Final Inspection and Test: All finished products and completed services are verified by final inspections/tests specified in the control plan and SOP 8. Additionally. and records have been maintained providing evidence of conformity with acceptance criteria and identifying the person(s) authorizing release. 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. 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). Evidence of Conformity Test and inspection records are maintained for a minimum of three years. Product Release and Delivery: Product is not normally released or delivered until all planned inspections and tests have been completed. measurement logistics.2. manufacturing process.

(Section 8).4) includes receiving inspection. and verification activities.2. (Section 7) The scope of our product monitoring and measurement system (SOP 8. and develops an effective total preventive maintenance system that at a minimum includes: y y Planned maintenance activities Packaging and preservation of equipment. tooling.4 prior to commencing each new production run and/or when process changes are made. Page: 77 y y Management of production tooling As part of manufacturing process design. Methods used to verify incoming product from the supplier. evaluating.Verification of job set-ups Job set ups are verified prior to commencing each new production runs and when process changes are made. and use statistical methods of verification where applicable. evaluation by accredited laboratories. and gauging. (Section 7) Job Set Up Verification Job set ups are verified per SOP 8. Production personnel in accordance with the applicable control plan perform manufacturing process monitoring (Section 7 and 8). Work instructions governing set ups and related verifications are developed and available. The Production Manager establishes and implements a system for production Page: 60 . In-process Inspection Formal in-process inspections are performed by Quality Control personnel in accordance with the control plan and SOP 8. Availability of replacement parts for key manufacturing equipment Documenting. the Plant Supervisor identifies key process equipment. and special consideration regarding monitoring and measurement of appearance items.4). or source inspections. and improving maintenance objectives.2. job set up verification. provides resources for their maintenance.2. layout inspection and functional test. Receiving Inspection Incoming product is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements in accordance with the control plan and/or documented procedures. the Program Manager provides resources and oversees efforts related to tool and gauge design. (Section 7). in-process inspection. final inspection and test. and the required capability and inspection/test skills needed. measurement means. such as receiving inspection or (SOP 8.2. fabrication. Preventive and predictive maintenance Per Section 6.4.

Monitoring and measurement of product The Company has overall responsibility for planning and implementing inspection and test activities needed to verify product requirements are met at appropriate stages of the product realization process in accordance with the applicable control plan.control plans and/or job packs. defining the status. Feedback on information from services The Managing Director collects and communicates servicing concerns to Engineering. Control plans and process flow diagrams are implemented to ensure adherence to the specified measurement techniques. The corrective action plan is reviewed with and approved by the customer. Manufacturing and other appropriate personnel for the purpose of initiating appropriate corrective. including engineering change level Tool identification. acceptance criteria.(Section 8) Page: 61 . product characteristics are determined leading to the types of measurement. (Section 7 and 8) Production personnel follow documented reaction plans when processes become unstable or no longer capable. suitable Page: 76 tooling management (or monitors these activities if any work is outsourced). such as production. When selecting product parameters to monitor compliance to internal and external requirements. 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. sampling plans. (Section 7) Process Monitoring Processes are monitored by process operators per applicable instructions. and requires application of a customer recognized or approved problem-solving approach (Section 8). the acceptance level shall be Zero Defects. For attribute data sampling. and reaction plans when acceptance criteria is not met. The Quality Manager then initiates a corrective action plan indicating the timing and assigned responsibilities to assure the process becomes stable and capable. preventive or other improvement action. 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. repair.

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

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

The Program Manager has overall responsibility for ensuring ¶Special Processesµ are validated in accordance with procedures detailed in SOP 7. and for reporting results and maintaining records. scope. or quality system element under review is effective if it is achieving the desired results or established objectives. As applicable. (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. and Post-Delivery Processes Release of product is dependent on its compliance with all specifications and its ability to meet customer requirements including packaging. with a special emphasis on our ¶core· customer oriented processes and our unique product realization processes.5. and delivery. measurement.2. y Page: 73 . 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). Responsible managers may also request that the audit be used to gather ´value addedµ data serving as input to aid in monitoring. (Section 8) Release. shipping. (Section 8) SOP 8. this includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered. Delivery. and is reviewed at least once annually to determine effectiveness. (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. function.implementing in-process inspections needed to ensure process control and product quality. Internal Audit Plans Each of our key Quality/Environmental Systems processes. as identified in the contract. (Section 8) The Quality/Environmental Systems process. frequency and methods used for internal audits and define the responsibilities and requirements for planning and conducting audits.2. and improvement of Quality/Environmental Systems processes and systems.2 defines the criteria.

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. 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. Where product traceability is a customer-specified requirement.5. 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. Quality/Environmental Management System Audit The Company conducts system audits. installation. ISO 14001. Identification and traceability The Program Manager has overall responsibility for establishing and maintaining product identification throughout all stages of design. and in promoting awareness of customer requirements and effectiveness of the Quality/ Environmental Systems. appropriate controls and records are established. The Company identifies the product by suitable means throughout product realization. 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. including inspection and testing activities.3. The Managing Director periodically reviews customer satisfaction survey data and other customer feedback (including complaints). Page: 65 Page: 72 . and delivery in accord with procedures defined in SOP 7. in identifying any opportunity for improvement. 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.Manufacturing process performance is monitored to demonstrate compliance with customer requirements for product quality and efficiency of the process. (Section 5) Internal audit The Company·s internal audit results are critical inputs to aid in assessing the effectiveness of our QEMS.1. Identification and traceability ² Supplemental The identification and status of product is established and maintained during all product and service provision processes.

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

conduct of internal audits. as applicable. (See SOP 7. the condition of stock is periodically assessed. and improvement activities needed to assure product and Quality/Environmental Systems conformity and achieve continual Quality/Environmental Systems improvement. A FIFO inventory system is used and regular tracking of inventory turns is reported at the management meeting. Statistical techniques for on-going process control and improvement are established per SOP 8. process monitoring and measurement. or calibration services are either acceptable to the customer or accredited to ISO 17025. Analysis and Improvement General These sections describes how we define. storage. Storage and inventory In order to detect deterioration. and protection. SPC. deterioration.Laboratory Requirements ² Internal Laboratory The Company does not have an internal laboratory. measurement. and implement the monitoring. 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. and product monitoring and measurement. packaging. Inventory turns and levels are goals defined within the business plan. and preservation of product pending use or delivery. plan. analysis.g.6 for calibration laboratories) 7. These activities include assessment of customer satisfaction. External Laboratory The Quality Manager ensures external laboratories used for inspection. Measurement. 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. obsolete product (including expired age dated material.) is controlled as nonconforming product. Obsolete product is treated the same as nonconforming product and is appropriately identified and segregated to avoid using it for production. test. e. Further. (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 . Designated storage areas are designed to prevent damage. (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.1 and the AIAG ´Statistical Process Controlµ (SPC) reference manual.

(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. include: y Equipment identification. 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. frequency/method of checks. Create an electronic invoice that will generate payment. corrective actions to remedy the situation and preclude its recurrence. uses/acceptance criteria and the action to be taken when results are unsatisfactory. (Section 8) Appropriate calibration records are maintained to document results of calibration activities and suitable indicators are used to show current calibration status. In addition. including employee and customer owned equipment. When monitoring and measuring devices are found to be out of calibration (or when calibration status is not known). actions taken are documented. control. and maintenance of monitoring and measuring devices including their identification. including appropriate Page: 68 y y Page: 69 .y y y Determine and confirm goods in transit. Calibration/verification records Records of the calibration verification activity for all gauges. 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. location. A number or other identifier is used to provide traceability to the device calibration record. 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. they are adjusted or re-adjusted as necessary and the validity of previous measuring results is documented. Verify and receive products into their system. and test equipment needed to provide evidence of product conformity to determined requirements. measuring. such as gage R & R studies. We identify and select monitoring and measuring devices and verify their capability of meeting such requirements prior to use.

Sign up to vote on this title
UsefulNot useful