【導(dǎo)讀】©DaimlerChrysler,FordMotorCompany,GeneralMotorsCorp.,©lifeofISO/TS16949,SecondEdition.ISO/TS16949:2020(E)?conversionmatrix.16949:2020(E)?actions.theseprocesses?conversionmatrix.managementsystem?

　　

【正文】 of floor space and shall facilitate synchronous material flow? () uuuuu) Process flow analysis vvvvv) Plant layout (current and planned) Has the anization developed and implemented methods to evaluate and monitor the effectiveness of existing operations? () ww) Metrics for ergonomics, automation, line balance, inventory levels Contingency plans Has the anization prepare contingency plans to satisfy the customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure, and field returns? () xxxxx) Contingency plans yyyyy) Identification of Key Equipment ?? Work environment Does the anization determine and manage the work environment needed to achieve conformity to product requirements? () Quality manual according to TS 16949. Personnel safety Does the anization’s quality policy and practices address product safety and means to minimize potential risks to employees, especially in design and development process and in the manufacturing process activities? () zzzzz) Preventive activities in design and process control aaaaaa) Knowledge and application of legislation bbbbbb) Risk analysis such as FMEA cccccc) Results of internal/external audits including: a) System certifications b) Corrective actions dddddd) Records of accidents eeeeee) Safety related customers plains Cleanliness of premises Does the anization maintain its premises in a state of order cleanliness and repair consistent with the product? () ffffff)Tour of plant Product realization Planning of product realization Has the anization planned and developed the processes needed for product realization? () gggggg) Quality Planning process hhhhhh) Project Planning process iiiiii)Quality plans for new products Is the anization’s planning of product realization consistent with the requirements of the other processes of the quality management system? () jjjjjj)Development of Quality plan(s). In planning product realization, does the anization determine the following, as appropriate: quality objectives and requirements for the product? the need to establish processes, documents, and provide resources specific to the product? required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? records needed to provide evidence that the realization processes and resulting product meet requirements? () kkkkkk) Quality plan and Design Record, Control Plan, Operator Instructions, Product Approval records, resources/facilities and any plans to enhance them llllll)Design validation at the various stages of the design mmmmmm)Link between process changes and updates in the quality plan(s) Is the anization’s planning of product realization output in a form suitable for the anization39。s method of operations? () nnnnnn) Product realization output format amp。 content. Planning of product realization supplemental Is the customer requirements and references to its technical specifications included in the planning of product realization as a quality plan? () oooooo) Quality plans pppppp) Customer specifications qqqqqq) Technical specifications Acceptance criteria Did the anization define acceptance criteria for the product being developed and where required, approved by the customer? () rrrrrr)Test specification. ssssss) Product validation test plan with defined acceptance criteria. Is the anization’s acceptance criteria For attribute data sampling zero defects? () tttttt)Acceptance criteria in test plan and test specifications. Confidentiality Does the anization ensure the confidentiality of customer contracted products and projects under development, and related product information? () uuuuuu) Information access security vvvvvv) Security for product development. Change control Does the anization have a process to control and react to changes that impact product realization including those initiated by the supplier? () ) Engineering change request process xxxxxx) Change records. Does anization assess the effects of changes? () Impact study including proprietary design. Change management process Has the anization defined the verification and validation activities for changes, to ensure pliance with customer requirements? () yyyyyy) Test specification. zzzzzz) Product validation test plan with defined acceptance criteria. Does the anization validate changes before implementation? () aaaaaaa) Evidence of design and production validation tests conducted for product changes. Does the anization review proprietary designs, impact on form, fit, function, (including performance, and/or durability) with the customer so that all effects can be properly evaluated () Impact study including proprietary design. Change management process Does the anization meet additional verification/identification requirements such as those required for new product introduction when required by the customer? () bbbbbbb) Design and production validation test report. Customerrelated processes Determination of requirements related to the product Does the anization determine: requirements specified by the customer, including the requirements for delivery and postdelivery activities? requirements not stated by the customer but necessary for specified or intended use, where known? statutory and regulatory requ