【正文】 content. 企業(yè) ()大量管理資料下載 21 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? () ? Quality plans ? Customer specifications ? Technical specifications Acceptance criteria Did the anization define acceptance criteria for the product being developed and where required, approved by the customer? () ? Test specification. ? Product validation test plan with defined acceptance criteria. Is the anization’s acceptance criteria For attribute data sampling zero defects? () ? 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? () ? Information access security ? 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 ? 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? () ? Test specification. ? Product validation test plan with defined acceptance criteria. 企業(yè) ()大量管理資料下載 22 Does the anization validate changes before implementation? () ? 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? () ? Design and production validation test report. Customerrelated processes Determination of requirements related to the product Does the anization determine: a) requirements specified by the customer,。s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? () ? Review of all the elements of the quality system to insure its continuing suitability and effectiveness ? Review of quality cost indicators ? Management review meeting minutes, attendance and adequate frequency. ? Action plans and followup. Do the anization’s management reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives? () ? Evidence of continuous improvement projects initiated from management reviews. 企業(yè) ()大量管理資料下載 14 Are the anization’s records from management reviews maintained? () ? Retention of management reviews meeting minutes. Quality management system performance Do the management reviews include all elements of the quality management system and its performance trends as an essential part of the continual improvement process? () ? Review of all the elements of the quality system to insure its continuing suitability and effectiveness ? Trends in metrics (business and customer satisfaction). ? Basis for continuos improvement projects. Do the management reviews include monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see elements and of ISO/TS16949:20xx(E)) ? () ? Policy, business plan and customer satisfaction metrics reports ? Product results (quality, cost, time) against quality policy goals and customer specified targets Are the results of the management reviews recorded to provide, as a minimum, evidence of the achievement of: objectives specified in the quality policy? objectives specified in the business plan? customer satisfaction with product supplied? () ? Trends in metrics (business and customer satisfaction) ? Basis for continuos improvement projects ? Management review meeting minutes. ? Action plans and followup. 企業(yè) ()大量管理資料下載 15 Review input Does the anization’s input to its management review include information on: a) results of audits? b) customer feedback? c) process performance and product conformity? d) status of preventive and corrective actions? e) followup actions from previous management reviews? f) planned changes that could affect the quality management system? g) remendations for improvement? () ? Reports prepared for management reviews. ? Management review meeting minutes. ? Action plans and followup. ? Content of management review meeting agenda. Review input Supplemental Do management reviews include an analysis of actual and potential fieldfailures and their impact on quality, safety, or the environment? () ? Content of management review meeting agenda. Review output Does the output from the anization’s management review include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes? b) improvement of product related to customer requirements? c) resource needs () ? Examples of continuous improvement projects initiated from management reviews. ? Examples of product improvem