Quality Manual - QS9000(doc 40)英文

Quality Manual - QS9000(doc 40)英文 Quality Manual REVISION RELEASED REVISION CHANGES REV 01 Aug 2, 1996 Initial REV 02 Sept 24, 1996 General Changes REV 03 June 20, 1997 Revised and Rewritten REV D September 24, Revised per QS-9000 requirements and Pilgrim 1997 implementation; chg. “rev” to alpha REV E Oct. 22, 97 Incorporate additional QS requirements APPROVED BY: Date: Christ Zomaya, President APPROVED BY: Date: Jack Davis, Director of Quality Assurance Page 1 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E Table of Contents Introduction 3 1.0 Scope 4 2.0 Definition 5 3.0 Quality System Requirements 6 4.0 Management Responsibility 6 4.1 Quality System 8 4.2 Contract Review 10 4.3 Design Review 11 4.4 Document and Data Control 13 4.5 Purchasing 15 4.6 Control of Customer Supplier Product 17 4.7 Product Identification and Traceability 18 4.8 Process Control 19 4.9 Inspection and Testing 21 4.10 Control of Inspection Measuring Test Equipment 23 4.11 Inspection and Test Status 24 4.12 Control of Non-Conforming Product 25 4.13 Corrective and Preventive Action 26 4.14 Handling, Storage, Packaging, Preservation and Delivery 28 4.15 Control of Quality Records 30 4.16 Internal Quality Audits 31 4.17 Training 32 4.18 Servicing 33 4.19 Statistical Techniques 34 4.20 Production Part Approval Process 35 4.21 Continuous Improvement 36 4.22 Manufacturing Capabilities 37 4.23 4.24 Customer Specific Requirements 38 Appendix 1 Organization Chart 39 Appendix 2 QS/ISO Element/Procedure Matrix 40 Page 2 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 1.0 Introduction 1.1 Company Background Zomaya Group Inc., (dba) GOLDENRAM, was founded in 1988 by Christ J. Zomaya. GOLDENRAM is a worldwide supplier of computer memory enhancements. Since its inception, GOLDENRAM has achieved remarkable growth and success. Its name has become synonymous with product dependability and is a recognized leader in the development and implementation of valued-added services. Today, the Company is the proud manufacturer of GOLDENRAM brand premium high performance memory upgrades and other enhancements for all major brand computers and laser printers. GOLDENRAM manufactures hundreds of different upgrade products, including cache memory, video RAM, and fully kitted mass storage solutions. To meet the increasing demand in market change and satisfy customer needs, GOLDENRAM implemented a combination of a functional and product/market organizational structure. Through strategic market planning and development, GOLDENRAM is now one of the fastest growing privately held corporations in the United States. 1.2 Mission Statement GOLDENRAM is committed to professionalism, understanding, and fulfillment of customer requirements. Our goal is to grow aggressively, but plan conservatively in the financial aspect of the business. Financial strength will provide security to employees, vendors, and ultimately the customer. GOLDENRAM's vision is to be recognized by its customers, employees, suppliers and competitors as the world's preeminent supplier of computer enhancements. GOLDENRAM is committed to getting ideas aggressively into production enabling fulfillment of customer requirements faster than anyone else while maintaining quality and financial stability. GOLDENRAM's Quality System supports this vision ensuring ongoing quality, commitment, and valued relationships with customers and vendors. Page 3 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 2.0 Scope 2.1 Structure This manual describes the Quality Management System in operation at GOLDENRAM (the Company). This manual is the primary reference document within the Company for all quality related activities and is used for the purpose of auditing the effectiveness of the Quality Management System; where appropriate, more detail is provided in operating procedures which are in turn supplemented by work instructions. GOLDENRAM’s quality management system is structured to provide for continuous improvement, emphasizing defect prevention and reduction of variation and waste. Besides the ISO-9001 requirements, the supplemental requirements of Section I & Sector and Customer specific requirements, Section II & III are only applicable to contracts from customers who require compliance to QS-9000. 2.2 Distribution The Quality Manual and its subsequent revisions are approved by the President and the Quality Management Representative prior to release. Manuals are issued as controlled and uncontrolled copies; controlled copies are uniquely numbered and provided with a revision update service. Uncontrolled copies are current revisions issued as information only and are not supported with revision update services. The Document Control Department is responsible for issuing controlled copies and maintaining a distribution list. 2.3 Change Control The Document Control Department circulates draft revision copies to appropriate parties and, upon approval, issues new controlled copies and updates the electronic media. Change Control is detailed in section 4.5 of this manual. Page 4 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 3.0 Definition This section of the Quality Manual is to define terms that pertain to specific processes documented herein. Beta Site A customer or test site in the true application of a product to confirm there are no problems with the product. This is a done after initial tests are done at the manufacture site. Contract Agreed requirements between a supplier and customer transmitted by any means. ISO 9001 Quality System A model for quality assurance in design development, production, installation and servicing. Manager Used as generic title for any level of management (Manager, Director, and VP) with direct responsibility. Product Result of activities or processes. QS-9000 Quality System Quality System requirements to meet automotive customer needs. Page 5 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E GOLDENRAM QUALITY MANUAL 4.0 Quality System Requirement The purpose of the GoldenRAM Quality Manual is to provide guidelines to meet the goals of the company’s mission statement. The Quality Manual defines a framework that is in compliance with both the ISO 9001 and QS 9000 standard requirements. The ISO 9001 requirements are the foundation of this quality manual and are printed in normal type with the QS 9000 interpretations and supplemental quality system requirements printed in italic type. The QS 9000 requirements have been included in this Quality Manual to address the requirements of automotive customer needs as applicable, and are implemented for contracts from customers who subscribe to QS 9000. This Quality Manual establishes standards for addressing all quality system processes within the company. 4.1 Management Responsibility The purpose of this section is to outline management’s responsibilities to achieve the Company’s Quality Policy and ensure that all policies and procedures are thoroughly examined with the consideration of all affected 4.1.1 Quality Policy Quality policy statement: “GOLDENRAM is committed to being Simply The Best by providing quality products and services which meet the needs of its employees, customers and suppliers.” GOLDENRAM Quality Policy is based on proper planning to ensure that all policies and procedures are understood, implemented and maintained at all levels. The management of the Company shall commit themselves to meet the expectations of internal and external customers. 4.1.2 Organization 4.1.2.1 Responsibility and Authority An organization chart is maintained for all personnel who manage and perform work affecting quality (See Appendix 1 to this manual). 4.1.2.2 Resources GOLDENRAM shall identify required resources through process planning, quality planning, product audit, and process audit. The Company shall provide all necessary resources (internal or external) including trained personnel, manpower, equipment, and other resources to achieve the Company’s quality goals. Page 6 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.1.2.3 Management Representative The Director of Quality at GOLDENRAM is designated as the QS/ISO 9001 Management Representative who, irrespective of other responsibilities, has the authority and responsibility to ensure that the Quality System is maintained and continuously improved. In the absence of the Director of Quality, the deputy management representative will assume responsibility for maintaining the quality system. Organizational Interfaces GOLDENRAM uses multi-disciplinary approach for decision making. Systems are in place to ensure management of appropriate activities during concept development, prototype and production per Advanced Product Quality Planning and Control Plan. 4.1.3 Management Review The GOLDENRAM quality system is reviewed by top management as needed, at least twice yearly, to assure its effectiveness. These reviews will take place in scheduled Management Review meetings that are chaired by the Director of Quality. Meeting minutes will be kept for three years to document these Quality system reviews. These reviews will include all elements of the Quality System. 4.1.4 Business Plan GOLDENRAM believes in strategic business planning. Our business plan covers goals and plans for both short and long term, with emphasis placed on determining current and future customer expectations. The business plan is tracked, updated, revised if necessary and reviewed periodically to ensure effective implementation and communication through the organization as appropriate. 4.1.5 Analysis and Use of Company Level Data Appropriate trends in company level data are documented for key indicators. For comparison purposes and to set objectives, whenever possible, appropriate benchmarks are used. Key customer related trends and priorities for customer related problems are supported by this activity. 4.1.6 Customer Satisfaction GOLDENRAM is committed to objectively determining customer satisfaction and dissatisfaction. This information is periodically reviewed by management for continuous improvement. Page 7 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.2 Quality System 4.2.1 General In this section of the Quality Manual, an outline is presented which identifies, defines, and documents the quality system. This documented system conforms to the QS-9000/ISO-9001 standards to ensure that product and processes meet the specified requirements. 4.2.2 Quality System Procedures GOLDENRAM structures its documentation in the following format: Level 1 - Quality Manual Level 2 - Procedures/Flow Charts Level 3 - Work Instructions Level 4 – Records Other external documents such as AIAG’s, APQP, PPAP, FMEA, MSA, SPC also form an integral part of GoldenRAM’s Quality System The QS/ISO Element/Procedure Matrix (Appendix 2) provides a cross-reference between the QS-9000/ISO-9001 Standard Elements and supporting procedures. Each individual in the Company will have access to the Quality System procedures that effect them, via electronic media and/or hard copy. 4.2.3 Quality Planning Requirements for quality planning are met through documented procedures and, where applicable, the APQP and Control Plan Manual that form an integral part of GOLDENRAM’s quality system. These may include but are not limited to: a) Preparation of quality procedures, Control Plans, FMEA’s including flow charts when required. b) Identification and acquisition of required resources. c) Identification of training needs and provision for necessary training. d) Updating quality inspection and testing techniques. e) Clarification of the standards and acceptance criteria. Page 8 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E f) Identification of the appropriate stages for inspection and testing. g) Identification and preparation of quality records. Special Characteristics Special characteristics are finalized during the APQP/FMEA and Control Plan exercise, and appropriate process controls are established for all special characteristics. Use of Cross Functional Teams The advanced product quality planning process at GOLDENRAM requires internal cross-functional teams to prepare for production, new or changed products. Feasibility Review GOLDENRAM investigates and confirms the manufacturing feasibility of proposed products prior to contracting for QS-9000 contracts. Process Failure Mode & Effect Analysis (Process FMEA) Process FMEA’s are used to improve the process with a focus on defect prevention. The Control Plan Control Plans will be developed at the system, sub-system, component and/or material level as appropriate and required. These may cover Prototype, Pre-launch and Product phase as appropriate. Use of cross-functional teams, reviews and updates are performed per APQP and Control Plan Manual guidelines. Page 9 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.3 Contract Review 4.3.1 General The purpose of this section of the Quality Manual is to outline the system in place for contract review. 4.3.2 Review GOLDENRAM understands that a contract exists whether verbal, written, or implied between itself and its customers and vendors. In order to ensure contracts are properly reviewed, a Contract Review Process is established with departmental representatives to review orders per established procedures. Before submission of a tender, or at contract acceptance, each of these contracts shall be reviewed to ensure: a) Requirements are adequately defined and documented including the verification of any verbal orders. b) Any differences are resolved, communicated, and documented. c) Verification of the Company's capability to meet contractual requirements. d) All customer requirements, including those in Section III of QS-9000, if applicable, can be met. 4.3.3 Amendment to Contract When contract amendments are required, the amendments are made per established procedures and communicated to all concerned. 4.3.4 Records Records of contract reviews and their amendments will be maintained. Page 10 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.4 Design Control 4.4.1 General GOLDENRAM shall define and maintain procedures to control and verify the product design to ensure that the design is meeting the customers' and manufacturers' requirements. 4.4.2 Design and Development Planning The Engineering Department prepares product development plans for critical design and development activities. The plan describes or references these activities and defines responsibility for their implementation to meet the delivery requirements of internal and external customers. GOLDENRAM ensures that required skills such as FMEA’s, CAD/CAE are available as appropriate. 4.4.3 Organizational and Technical Interfaces GOLDENRAM uses organizational and technical interface during the design development process, particularly for design input and design review/revision. 4.4.4 Design Input GOLDENRAM shall identify and document design input which may include requirements relating to the product, such as the platform in which the product will be installed, manufacturers' like designs, marketing data and manufacturers' technical data of sub-components. Contract review activities shall also be evaluated for its relevance to design input. GOLDENRAM is equipped with appropriate resources for CAD/CAE and two-way interface with customers. 4.4.5 Design Output GOLDENRAM shall verify that the design output meets all the design-input requirements including industrial acceptance criteria. Design output will be made available to facilitate the verification and validation of the input requirements. The design output will identify those characteristics of the design that are critical to the safe and proper functioning of the product. Design output will be reviewed prior to release. Efforts to simplify, optimize, innovate, and reduce waste, are an integral part of this process. When appropriate, the design output process shall include cost/performance/risk trade-offs, design FMEA’s, feedbacks from testing, production and the field. Page 11 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.4.6 Design Review At appropriate stages of design, formal documented reviews of the design results are planned and conducted. Participants at each design review will include representatives of functions concerned, as well as other external specialists, as required. Records of these reviews are maintained electronically. 4.4.7 Design Verification GOLDENRAM shall establish techniques to verify that the product’s input design matches that of the product’s output design at appropriate stages of design as defined by the Project Engineer. Design verification includes conducting design reviews, and may also include performing analyses, comparison of the new design with a similar proven design, undertaking tests, and reviewing the design stage documents before release. Records of the design verification are maintained. A comprehensive prototype program that includes performance testing is in place and used when required. GoldenRAM will use the same sub-contractors, tooling and processes, as will be used in production wherever possible. 4.4.8 Design Validation GOLDENRAM will validate design configuration and systems compatibility and the information will be made available for reference to the appropriate departments. Where applicable, GOLDENRAM will establish relationships with equipment manufacturers and customers to be beta sites for our design validation. Design validation includes qualification tests. 4.4.9 Design Changes All design changes and modifications are identified, documented, reviewed and approved by the program's authorized personnel and/or the customer as required. For QS9000 contracts the PPAP procedure is followed as applicable before design changes are implemented. For proprietary designs, impact on form, fit, function, performance, and/or durability shall be determined with the customer so that all effects can be properly evaluated. Page 12 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.5 Document and Data Control 4.5.1 General The purpose of this section of the Quality Manual is to define the system in place for the control of all released external standards, customer drawings and documents pertaining to QS-9000/ISO 9001 standards, including form, approval, issuance, and updates. Reference Documents As appropriate, GOLDENRAM shall acquire & maintain currently released editions of documents that are referenced in customer drawings or specifications. These reference documents will be made available at appropriate manufacturing locations. Document Identification for Special Characteristics GOLDENRAM’s process control guidelines/documents shall be marked with the customer’s special characteristic symbols to indicate those process steps that affect special characteristics, as required by the customer. 4.5.2 Document and Data Approval and Issue a) All documents and data shall be reviewed and approved for adequacy by authorized personnel prior to release. b) The Document Control Department controls all released documents. c) A master list of released documents, indicating the current revision level, is maintained by the Document Control Department. d) Current revisions of all appropriate documents are available in the work area for all operations essential to the effective functioning of the quality system. e) Document Control is responsible to remove all obsolete copies of controlled documents and archive obsolete master copies. f) Manufacturing documents governing production and process shall be generated, approved, and released as per documented procedures. g) All procedures and forms are saved in an electronic media, in a "read only" format with restricted access. Page 13 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E Engineering Specifications GOLDENRAM has systems in place to assure the timely review, distribution, and implementation of all customer engineering standards/specifications and changes. GOLDENRAM shall maintain production records to show the date(s) each change is implemented, including all appropriate documents. 4.5.3 Document and Data Changes Changes to controlled documents shall be reviewed and approved by the same departmental personnel that performed the original approval. When the original approving personnel are not available the alternate approver will have access to all pertinent background information/documentation. The Document Control Department is responsible for revising controlled documents and their distribution. Changes made will be indicated in the document where appropriate. The master list of released documents will be revised and re-issued as required. Page 14 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.6 Purchasing 4.6.1 General The purpose of this section of the Quality Manual is to outline the system in place for approving suppliers, reviewing purchase documents, and verification of purchased products. A master Approved Vendor List will be maintained and reviewed by the Purchasing and Quality Assurance Departments. Approved Materials for Ongoing Production When required GOLDENRAM shall purchase the relevant materials from subcontractors on the customers approved subcontractor list. GOLDENRAM will ensure that all material used in part manufacture satisfy all applicable regulations for the country of manufacture. 4.6.2 Evaluation of Subcontractors a) Sub-contractors shall be selected based on their ability to meet contract and quality requirements, such as manufacturing capabilities, quality system, pricing, delivery schedules, and work environments. b) Sub-contractors' quality is continually monitored via the receiving inspection and test function. c) As required, sub-contractors will be notified about quality issues either verbally or through a formal "Corrective Action Request". d) Site visits are performed as required in the event that additional clarification or verification is necessary. e) As with subcontract supplied material, the quality of electronic components and process related material is inspected using documented procedures. Subcontractor Development Where applicable, GOLDENRAM will perform subcontractor quality system development using Sections I & II of QS-9000. Scheduling Subcontractors To meet QS-9000 customer requirements GOLDENRAM will require 100% on-time delivery performance from subcontractors. GOLDENRAM provides appropriate planning information to subcontractors to help them meet this requirement. Page 15 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E Subcontractor’s delivery performance is monitored, including tracking of premium or excessive freight. 4.6.3 Purchasing Data The Purchasing Department assures that all purchase orders contain sufficient information to deliver the required product. When applicable, the purchase order or associated drawings shall contain quality characteristics, dimensions, materials and technical features of the product being purchased. Restricted Substances GOLDENRAM ensures that governmental and safety constrains on restricted toxic and hazardous substances are complied with relative to purchased product and the manufacturing processes. 4.6.4 Verification of Purchase Product 4.6.4.1 Supplier Verification at Subcontractors’ Premises When specified by contract or purchase order, GOLDENRAM has the option of source inspection prior to shipment of product from subcontractors. Source verification does not absolve subcontractors' responsibility to furnish acceptable products nor shall it preclude subsequent rejection of unacceptable products. 4.6.4.2 Customer Verification of Subcontracted Product When specified by contract, GOLDENRAM customers or its representatives shall be afforded the right to verify, at GOLDENRAM's or subcontractors' premises, that product conform to specified requirements. This verification shall not be used by GOLDENRAM as evidence of effective control of quality by GOLDENRAM and the subcontractor. Page 16 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.7 Control of Customer Supplied Product The purpose of this section of the Quality Manual is to outline the policy for the management of consigned material. In the event of customer supplied product, the material supplied will be checked to verify that the correct material, including customer owned tooling and returnable packaging has been received and that the material has not been damaged in transit. Any part that is lost, damaged, or otherwise unsuitable for use shall be recorded and reported to the customer. Consignment material is stocked and maintained, segregated from normal inventory. Verification or inspection by GOLDENRAM does not absolve the customer of the responsibility to provide acceptable product. Page 17 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.8 Product Identification and Traceability The purpose of this section of the Quality Manual is to outline the procedures used for identification and traceability of product where the product identify is not inherently obvious. 4.8.1 GOLDENRAM has established traceability via the maintenance of the receiving log to note any batch numbers, serial numbers, or any other identification of the product that will associate it with a specific purchase order. 4.8.2 Purchased product/components are identified by a "receiving" log, which is generated by receiving personnel. This document remains with the material until it is stocked in the Warehouse. The receiver includes a unique part number and a brief description. 4.8.3 Work-in-progress product is identified by PO/work order number and build status, by a shop traveler/documentation, which accompanies each lot. 4.8.4 All assemblies are identified after final test with a GOLDENRAM label that provides product traceability. 4.8.5 In case any additional requirements are agreed to between GOLDENRAM and its customer, we will ensure its compliance. Page 18 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.9 Process Control The purpose of this section of the Quality Manual is to describe process control activities required to achieve quality results. All processes affecting product and service at GOLDENRAM are carried out under controlled conditions. Controlled conditions include: a) Documented procedures in the Production Department defining the manner of production and process characteristics. b) Suitable working environment (ESD, temperature, and humidity) will be facilitated to ensure that they are appropriate to meet the desired quality requirements. Governmental Safety & Environmental Regulations GOLDENRAM is committed to compliance with all applicable governmental safety and environmental regulations including those applicable to hazardous materials. Appropriate documents for compliance are kept on record. c) Quality audits will be performed randomly to check the in-process work centers to ensure compliance with documented requirements. d) Statistical Process Control (SPC) charts are maintained at process points, which are selected by Quality, Engineering and Manufacturing. Designation of Special Characteristics GOLDENRAM shall comply with all customer requirements for designation, documentation and control of special characteristics. e) Documented test and inspection procedures are followed. f) Workmanship criteria are specified. g) Suitable manufacturing equipment is used and maintained in accordance with Preventative Maintenance and Equipment Calibration procedures to ensure continuing process capability. Preventive Maintenance Key process equipment is identified and appropriate resources are provided to develop an effective planned total preventive maintenance system. Page 19 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.9.1 Process Monitoring and Operator Instructions Appropriate documented process monitoring and operation instructions are available where required at the work station areas. These are devised based on APQP and Control Plan where applicable. 4.9.2 Preliminary Process Capability Requirements Preliminary process capability studies will be performed for each GOLDENRAM or customer designated special characteristic for new processes to meet either customer requirements or for default values per QS-9000 as applicable. PPAP process will be followed as appropriate. Mistake proofing actives will be evaluated for unacceptable results. When available, applicable attribute data from early production runs may be used to prioritize process improvements and to begin control charts. 4.9.3 Ongoing and Modified Process Performance Requirements GOLDENRAM is committed to meet ongoing process requirements as defined by the customer or otherwise the default values per QS-9000. Control Plans will address reaction plans for unstable or non-capable characteristics, when required these plans will be submitted for customers review and approval regardless of capability requirement or the demonstrated process capability. Continuous improvement will be required with priority on special characteristics. 4.9.4 Modified Preliminary or Ongoing Capability Requirements In some cases, the customer may require either higher or lower capability requirements than the previously stated default requirements. In these cases, the Control Plan shall be annotated accordingly. 4.9.5 Verification of Job Set-Ups Set-ups are done and verified as per documented procedures. Last off part comparisons and/or statistical verifications are done where appropriate. 4.9.6 Process Changes Records are maintained of process change effective dates. PPAP Manual guidelines are followed for customer’s approval as applicable. 4.9.7 Appearance Items QS-9000 appearance item requirements are not applicable to GoldenRAM’s products. Page 20 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.10 Inspection and Testing 4.10.1 General The purpose of this section of the Quality Manual is to outline the system in place for ensuring all material and products undergo inspection as per customer requirements defined during the product inception phase. GOLDENRAM shall establish and maintain documented procedures in all departments that involve inspection and testing of the Company’s product. The objective of these documented inspecting and testing procedures is to ensure that products, at all stages, will be inspected and tested to the Company’s Quality standards or customer requirements. These records of documented inspections and tests will be maintained and made available to all appropriate personnel. Acceptance Criteria For attribute data for QS-9000 contracts, the sampling plan shall be zero defects. For other situations, acceptance criteria will be per customer requirements, as appropriate. Accredited Laboratories Accredited Laboratories shall be used when required by the customer. 4.10.2 Receiving Inspection and Testing 4.10.2.1 Incoming material to be used on deliverable product is inspected and tested in accordance with documented procedures/Control Plan. 4.10.2.2 The amount and type of inspection is set according to procedure, unless otherwise directed by Quality Management, and can be adjusted based on supplier performance. 4.10.2.3 Material, which is waived through inspection, shall be identified and documented to provide traceability in case of recall. Page 21 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E Incoming Product Quality One or more of the following methods are used: Statistical data, inspection and/or testing, assessments, evaluation by accredited labs, subcontractors warrants or certifications in conjunction with one of the above. 4.10.3 In-process Inspection and Testing Verification of product through appropriate inspection/test is performed in accordance with the established Control Plan/procedures. Products shall not be released until the required inspections and tests have been received, verified, and/or completed. Process activities are directed towards defect prevention methods rather than defect detection. 4.10.4 Final Inspection and Testing All products are inspected and tested in accordance with the established control plan/procedures. All products are verified as having successfully passed all required inspection and test. Layout Inspection and Functional Testing Layout inspection and functional testing will be performed when required by the customer at a frequency established by the customer. Results will be made available for customer review upon request. 4.10.5 Inspection and Test Records Signatures and/or stamps shall be required in all phases of the product's cycle. Records of product conformity to specified requirements are reviewed and maintained. All records shall indicate the nature of such inspection and tests as well as the acceptance criteria. Page 22 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.11 Control of Inspection Measuring Test Equipment 4.11.1 General The purpose of this section of the Quality manual is to outline the systems and controls pertaining to inspection, measuring and test equipment. GOLDENRAM shall establish documented procedures to control inspection, measuring and test equipment which is used to demonstrate product conformance. All of the Company’s test equipment shall be properly maintained and tested. There shall be records documenting the equipment, usage, and source of purchase and service schedules. 4.11.2 Control Procedures GOLDENRAM's calibration system shall ensure the accuracy of all its measuring and testing equipment. Any equipment that is used in product development and/or testing shall be calibrated according to the manufacturers or other established specifications. Procedures shall be established to safeguard against adjustments, which would invalidate calibration settings. 4.11.3 Inspection, Measuring and Test Equipment Records Such records shall include appropriate revisions following engineering changes, gauge conditions and actual as received readings, and notification to customer if suspect material has been shipped. 4.11.4 Measurement System Analysis Where appropriate and required, statistical studies are conducted to analyze the variations in the measuring and test equipment. Methods used will be in conformance to the Control Plan and MSA Manual. Page 23 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.12 Inspection and Test Status The purpose of this section of the Quality manual is to describe the methods used to identify the inspection and test status of product. GOLDENRAM shall maintain inspection and test records that show the stamp markings, and/or authorized signatures for its product testing. The standards that the Company establishes for the inspection and test status shall be effective in preventing the inadvertent release of un-inspected product to GOLDENRAM customers. The inspection stamping system is used at the Company to indicate that materials, parts, or assemblies have been accepted by the Inspection Department. The materials used in manufacturing, in stock, on the line, or in process, are identified with acceptance data. Product Location Location of product in normal production flow does not constitute suitable indication of inspection and test status unless inherently obvious. Supplemental Verification When required by the customer, additional verification identification requirements shall be met. Page 24 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.13 Control of Non conforming Product 4.13.1 General The purpose of this section of the Quality Manual is to describe the control of suspect as well as non-conforming product upon receipt and at various stages of production. Procedures shall be established to provide for identification, documentation, evaluation, segregation, disposition, and notification of non-conformities. 4.13.2 Review and Dispositioning of Nonconforming Product The MRB, with members from appropriate departments shall review and disposition material per established criteria, for example; use as is, re-work, scrap, or return to vendor. Repaired and/or reworked product shall be re-inspected in accordance with the Control Plan/documented procedures. 4.13.3 Control of Reworked Product Rework instructions/procedures are available and utilized by appropriate personnel in the work areas. Prioritized reduction plans will be implemented based on the analysis of non- conforming product. 4.13.4 Engineering Approved Product Authorization Guidelines of PPAP Manual will be followed when customer authorization is required. Records of quantity approved or expiration date are maintained where applicable. After expiration of authorization, compliance to original or superseding specification is ensured. Material shipped on an authorization will be properly identified, as required by the customer, on the shipping container. Page 25 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.14 Corrective and Preventive Action 4.14.1 General The purpose of this section of the Quality Manual is to outline the Corrective and Preventive Action systems used for correcting and preventing non- conforming situations as they pertain to product and services. GOLDENRAM shall establish and maintain documented procedures for implementing corrective and preventive action. Any action taken to eliminate the causes of actual or potential non-conformities shall be appropriate to the magnitude of the problems. GOLDENRAM shall implement and record any changes to the documented procedures resulting from corrective and preventive action. Problem Solving Methods GOLDENRAM uses disciplined problem solving methods. GOLDENRAM shall respond in a manner prescribed by the customer in case of external non- conformance. 4.14.2 Corrective Action GOLDENRAM shall establish a system for handling customer complaints and internal non-conformities. This system shall include the investigation of the root cause of the non-conformities related to product, process and service. Appropriate corrective action shall be taken in the most expeditious manner and in accordance with the documented procedures. The Quality Assurance Department shall monitor the effectiveness of its implementation. Returned Product Test Analysis (QS-9000 Contracts) GOLDENRAM shall analyze parts for QS-9000 contracts returned from the customer’s manufacturing plant, engineering facilities and dealerships. This excludes any non-defective unopened parts returned under over-stock rotation or such promotional sales policies. Records of such analysis are kept and used to initiate corrective action and process changes to prevent re-occurrence. Page 26 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.14.3 Preventive Action GOLDENRAM will emphasize preventive action in its Quality System. The internal audit process and Management Review process shall be used to determine the appropriate actions including design changes, changes of supplier, review of SPC data during in-process manufacturing and testing, as well as training. Preventive action will be monitored for its effectiveness. As a value added service GOLDENRAM provides Technical Support to its customers and end users to help resolve technical and related issues. Page 27 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.15 Handling, Storage, Packaging, Preservation, and Delivery 4.15.1 General The purpose of this section of the Quality Manual is to outline controls in place for handling, storage, packaging, and delivery of product. 4.15.2 Handling a) Assemblies and sensitive components are handled in accordance with all precautions as specified in the Electro Static Discharge (ESD) and Material Handling procedures. b) All materials used in manufacturing are handled and stored in such a manner as to prevent damage or deterioration. 4.15.3 Storage a) Secured designated areas are used for storage of materials to prevent damage. The receipt and dispatching of stored materials is controlled by established procedures. Designated areas are ESD protected and some areas are climate controlled when required to prevent deterioration of materials. b) Incoming material is received in accordance with the "Receiving” and “Receiving Inspection” Procedures. Inventory GOLDENRAM’s inventory management system strives to continuously optimize inventory turnover time, assure stock rotations and minimize inventory levels. 4.15.4 Packaging a) All products shipped from GOLDENRAM, regardless of their origin, shall be packaged and labeled in accordance with GOLDENRAM's established procedures. b) Finished goods are packaged in a manner so as to protect the product during shipping in accordance with established procedures. In the event customer-packaging standards/guidelines, including applicable service parts packaging are required; GOLDENRAM will ensure compliance to the specification. Page 28 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E c) Packaging will be appropriate to meet customer and marketing requirements. GOLDENRAM ensures all materials shipped to QS customers are labeled according to customers requirements where specified (Section III of QS-9000). 4.15.5 Preservation All products shall be maintained and segregated in accordance with the specified requirements established by the Company. Preservation methods shall include but not be limited to segregation of the product, controlled environment, and proper inventory method. 4.15.6 Delivery Finished goods are typically delivered to the customers via common carriers selected by GOLDENRAM. In the event that a customer specifies special delivery/transportation requirements, this will be coordinated by the GOLDENRAM Warehouse Manager. All deliveries to customers are packaged in a manner that will provide safe transport to the destination. In the event of emergency deliveries, the most appropriate mode of transportation/carrier will be used to meet customer delivery requirements. GOLDENRAM’s Delivery Performance Monitoring GOLDENRAM has established systems to support 100% on-time shipments to meet QS-9000 customer’s production and service requirements. In case of any default, GOLDENRAM shall implement appropriate corrective action including communication of delivery problem information to the customer. GOLDENRAM has a systematic approach to meeting established lead time requirements and shall track performance to the customer’s delivery requirements including transportation mode, routings and containers for QS- 9000 contracts. Production Scheduling GoldenRAM’s production scheduling activity shall be order-driven. Shipment Notification System GOLDENRAM has a computerized system for on-line transmittal of advanced shipment notification (ASN), transmittal at the time of shipment unless waived by the customer. GOLDENRAM also has a back-up method in the event on- line system fails. GOLDENRAM ensures that shipping documents and labels match the ASN information. The ASN system is used only when required by the customer. Page 29 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.16 Control of Quality Records The purpose of this section of the Quality Manual is to outline the system in place for data collection and analysis, including record retention. 4.16.1 Quality records are maintained to demonstrate conformance to specified requirements and the effective operation of the Quality System. The system provides for the identification, collection, indexing, filing, storage, maintenance, retrieval and disposition of quality documentation and records. 4.16.2 Quality Assurance data from the manufacturing process is collected using applicable inspection methods. Reports formatted from this database are analyzed by management for trends. This quality data shall include the pertinent quality records of subcontractors. 4.16.3 The maintenance of accurate quality records and reports are the responsibility of the Document Control Department. 4.16.4 Quality Records are maintained per documented procedures at the GOLDENRAM facility in either hard copy or electronic media. 4.16.5 When required by contract, quality records will be made available for review by the customer or their representative. Record Retention For records pertaining to QS-9000 contracts, requirements specified in QS-9000 standard and associated manuals will be followed unless required otherwise by the customer. Superseded Parts Copies of documents from superseded parts required for new part qualification will be retained in the new part file. Page 30 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.17 Internal Quality Audits The purpose of this section of the Quality Manual is to outline the system for Quality System Audits. 4.17.1 Internal audits provide detailed information to determine the effectiveness of a process and its procedures, and are used as management tools to examine and verify the overall effectiveness of the Quality System. Internal audits are performed in accordance with an established schedule in the order of their importance and are conducted by personnel independent of the area being audited. 4.17.2 Internal Quality Audits are performed by audit teams comprised of internal and/or external personnel for compliance to documented procedures, Quality Manual and the QS/ISO 9001 Standard. 4.17.3 The Quality Assurance Department shall establish and maintain Internal Audit procedures. 4.17.4 Audit results shall be reported to appropriate personnel. 4.17.5 Results of internal audits are an integral part of the Management Review process. 4.17.6 The implementation and effectiveness of corrective action will be verified by the Quality Assurance Department. 4.17.7 Records of audits and corrective/preventive action will be maintained for three years. Inclusion of Working Environment Suitable working environment shall be considered as part of the internal audit process. Page 31 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.18 Training The purpose of this section of the Quality Manual is to outline the system in place for operating a training program. 4.18.1 Training applies to every employee within the company and can be accomplished in a formal or informal (On the Job Training) setting as required. Employees performing tasks affecting quality during production will be qualified through methods outlined by the "Employee Training" procedures. 4.18.2 Training needs will be identified and documented in job descriptions and employee training matrix. 4.18.3 Employees may be qualified on the basis of appropriate education, training, and/or experience. 4.18.4 Documented training, policies and procedures will be established and maintained by the Quality Assurance Department. 4.18.5 Qualified and motivating trainers will be employed or contracted to perform the training process. 4.18.6 Training records, which include Operating Procedures, Work Instructions and specialized training, will be maintained and updated by each Department Manager. Training records shall be maintained and readily accessible. Training as a Strategic Issue Training is viewed as a strategic issue. Training effectiveness is periodically evaluated at the time of employee performance review or as determined by the supervisor. Page 32 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.19 Servicing , GOLDENRAM provides technical support as an after sales added value to its customers and end users (Ref. 4.14 of this manual). , Relevant feedback from technical support is provided to manufacturing, engineering and design activity for continuous improvement. , Relevant feedback is also provided to marketing/sales regarding customer satisfaction/dissatisfaction and customer complaints. , Data and information collected by technical support may also include the end user. Page 33 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.20 Statistical Techniques The purpose of this section of the Quality manual is to outline statistical techniques used to control manufacturing processes and assess product quality. 4.20.1 Identification of Need Statistical process control will be implemented on production lines as directed by the Engineering/Manufacturing Manager. Process and design FMEA’s will be used to determine those critical (special characteristics) points in the processes, which will be monitored. Whenever possible, GOLDENRAM will utilize statistical techniques to prevent non-conformities. Statistical data will be published and reviewed by appropriate personnel. 4.20.2 Procedures Procedures defining the process of data collection, reporting, and corrective action shall be established and controlled by the Manufacturing and Quality Assurance departments. Selection of Statistical Tools Appropriate statistical tools for each process, are determined during APQP process and included in the Control Plan. Knowledge of Basic Statistical Concepts GOLDENRAM ensures that basic statistical concepts are understood by appropriate employees as applicable. Page 34 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.21 Production Part Approval Process 4.21.1 General For QS-9000 contracts, GOLDENRAM will comply with the requirements set forth in the PPAP Manual including the additional approvals required in case of “Appearance Items”. 4.21.2 Engineering Change Validation GOLDENRAM will ensure and verify that changes are properly validated by the concerned parties. Page 35 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.22 Continuous Improvement 4.22.1 General GOLDENRAM has a comprehensive continuous improvement philosophy across the board. We are committed to continuous improvement in quality, service (including timely delivery) and price for all customers. Innovative improvements form an integral part of this philosophy. GOLDENRAM’s continuous improvement committee develops specific action plans for continuous improvement in processes that are most important to the customer once those processes have demonstrated stability and acceptable capability. 4.22.2 Quality and Producibility Improvement The continuous improvement committee is also responsible to identify opportunities for quality and producibility improvement projects. 4.22.3 Techniques for Continuous Improvement GOLDENRAM uses measures and methodologies such as Cp, Cpk, Control Charts, PPM, Mistake Proofing, etc. as appropriate. Page 36 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.23 Manufacturing Capabilities 4.23.1 Facilities, Equipment and Process Planning Effectiveness GOLDENRAM uses a cross-functional team approach for developing facilities, processes and equipment plans in conjunction with the APQP Process. Value added use of floor space and streamline of material flow are an integral part of this exercise. The Quality Assurance department with the support of a cross-functional team is responsible to develop methods for evaluating the effectiveness of existing operations and processes. 4.23.2 Mistake Proofing GOLDENRAM pays special attention to mistake proofing methodology during the planning processes, facilities, equipment and tooling as well as during the problem resolution. 4.23.3 Tool Design and Fabrication GOLDENRAM provides appropriate technical resources for tool and gauge design, fabrication and inspection. Customer owned tools will be permanently marked to show ownership. Production Management is responsible for tracking and follow-up of sub-contracted tooling. 4.23.4 Tooling Management GOLDENRAM’s tooling management system shall include maintenance, repair, storage, recovery, set-up and tool change programs for perishable tools. Page 37 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E 4.24 Customer Specific Requirements Where applicable for QS-9000 contracts, GOLDENRAM shall fully comply with the relevant customer specific requirements per Section III of QS-9000 except for the ones waived by the customer. Page 38 of 40 OLDENRAM Quality Manual G COR-1001-POL Revision: E (Insert Appendix 1 here - Organization Chart) Page 39 of 40 GOLDENRAM Quality Manual Revision: D QS / ISO ELEMENT/PROCEDURE MATRIX 4.1 Management Responsibility 30003 4.2 Quality System 30002 30012 4.3 Contract Review 40013 40015 *40000 *10015 *40011 4.4 Design Control 90012 90008 90009 90010 90011 4.5 Document and Data Control 30000 30001 30002 25000 4.6 Purchasing 60000 60001 60002 *60003 *60004 30019 4.7 Control of Customer Supplied 70012 4.8 Product Identification and Traceability *70010 70002 70003 70007 80030 *70014 *80026 4.9 Process Control 30004 30011 80026 80001 80004 *80005 *80006 80007 80008 4.9 Process Control (continued) 80009 80011 *80013 *80014 *80015 80016 *80019 *80020 30017 *80021 4.9 Process Control (continued) *80022 *80025 *80028 *80029 80017 30016 80030 30018 80010 4.10 Inspection and Testing 30008 70008 *80002 *80003 *80010 *80015 80016 30018 *80005 80024 4.10 Inspection and Testing (continued) 80026 4.11 Control of Inspection Measuring Test 30004 Equipment 4.12 Inspection and Test Status 30007 *80002 *80003 *80010 *80015 80030 *30008 *30018 *80024 *80026 4.13 Control of Non-Conforming Product 30009 30011 30014 4.14 Corrective and Preventative Action 30006 30010 30015 *95000 *20043 *90003 *30003 4.15 Handling, Storage, Packing, Preservation 70010 70003 *70007 *70008 80001 80007 *80013 *80014 *80022 & Delivery 4.16 Control of Quality Records 30013 4.17 Internal Quality Audits- 30005 30006 *30003 4.18 Training 00001 4.19 Servicing N/A 4.20 Statistical Techniques 30017 *30008 *80016 *80006 4.21 Production Part Approval Process 4.22 Continuous Improvement 4.23 Manufacturing Capabilities 4.24 Customer Specific Requirements *Secondary documentation that supports the QS/ISO Element APPENDIX 2 Page 40 of 40