【文章內(nèi)容簡(jiǎn)介】 lysis (Process FMEA)Process FMEA’s are used to improve the process with a focus on defect prevention.The Control PlanControl Plans will be developed at the system, subsystem, ponent and/or material level as appropriate and required. These may cover Prototype, Prelaunch and Product phase as appropriate.Use of crossfunctional teams, reviews and updates are performed per APQP and Control Plan Manual guidelines. Contract Review GeneralThe purpose of this section of the Quality Manual is to outline the system in place for contract review. ReviewGOLDENRAM 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, municated, and documented.c) Verification of the Company39。s capability to meet contractual requirements.d) All customer requirements, including those in Section III of QS9000, if applicable, can be met. Amendment to ContractWhen contract amendments are required, the amendments are made per established procedures and municated to all concerned. RecordsRecords of contract reviews and their amendments will be maintained. Design Control GeneralGOLDENRAM shall define and maintain procedures to control and verify the product design to ensure that the design is meeting the customers39。 and manufacturers39。 requirements. Design and Development PlanningThe 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. Organizational and Technical InterfacesGOLDENRAM uses organizational and technical interface during the design development process, particularly for design input and design review/revision. Design InputGOLDENRAM 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, manufacturers39。 like designs, marketing data and manufacturers39。 technical data of subponents. Contract review activities shall also be evaluated for its relevance to design input. GOLDENRAM is equipped with appropriate resources for CAD/CAE and twoway interface with customers. Design OutputGOLDENRAM shall verify that the design output meets all the designinput 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 tradeoffs, design FMEA’s, feedbacks from testing, production and the field.  Design ReviewAt 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. Design VerificationGOLDENRAM 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, parison 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 prehensive prototype program that includes performance testing is in place and used when required.GoldenRAM will use the same subcontractors, tooling and processes, as will be used in production wherever possible. Design ValidationGOLDENRAM will validate design configuration and systems patibility 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. Design ChangesAll design changes and modifications are identified, documented, reviewed and approved by the program39。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. Document and Data Control GeneralThe 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 QS9000/ISO 9001 standards, including form, approval, issuance, and updates.Reference DocumentsAs appropriate, GOLDENRAM shall acquire amp。 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 Identif