【文章內(nèi)容簡(jiǎn)介】 ructure Control ? Element Document and Data Control ? Requirements: ? Ensure that: ? Documents and data are reviewed and approved for use ? Changes to the documents are reviewed, approved, and controlled ? Control external documents (., customer drawings) ? Additional: ? Have current releases of referenced documents available ? Identify special characteristics on documents ? Timely review, distribution, and implementation of customer specifications and standards ? Keep records of the implementation date Quality System Structure Control ? Element Corrective and Preventive Action ? Requirements: ? Investigate nonconformances and take corrective actions ? Initiate preventive measures ? Take measures to prevent nonconformances from occurring ? Ensure corrective and preventive actions are effective ? Additional: ? Use disciplined problemsolving methods ? Respond in customer prescribed manner for external nonconformances ? Analyze parts returned by the customer and take action to prevent recurrence Quality System Structure Control ? Element Control of Quality Records ? Requirements: ? Control records through: ? Identification ? Collection, indexing, and access ? Filing and storage ? Maintenance and disposition ? Store and retain records in a way which makes them: ? Readily retrievable ? Prevents deterioration, damage, or loss Quality System Structure Control ? Element Control of Quality Records (cont.) ? Additional: ? Follow customer or government retention periods ? If none are specified, use the following as minimums: ? while active plus one calendar year: – PPAP approvals, tooling records, , and amendments ? one calendar year after year in which created: – quality performance records, ., control charts, test results ? three years: – internal quality system audits and management reviews ? Retain documents from superseded parts required for new part qualification in new part file Quality System Structure Control ? Element Internal Quality Audits ? Requirements: ? Plan and implement internal quality audits: ? Verify that activities ply with the quality plan ? Determine the effectiveness of the quality system ? Base the schedule on status/importance of the activity ? Done by independent personnel ? Record and report results to the audited department ? Take timely corrective action ? Verify the effectiveness of the corrective action with followup audits ? Additional: ? Include suitable work environment as part of the internal audit process Product Process Management ? Describes the controls necessary for the management of processes, activities, and materials necessary to provide assurance in the product: ? Requires: ? a review of contracts before acceptance ? product identification and traceability ? test status identification ? measures to control handling and delivery of product ? identification of statistical techniques needed Product Process Management ? Provides controls for: ? Design activities ? Purchased and customer supplied product ? Production processes ? Inspection and testing processes and related equipment ? Nonconforming product ? Servicing activities (if in contract) Product Process Management ? Element Contract Review ? Requirements: ? Review contracts to ensure that: ? Customer requirements are adequately defined and documented ? Verbal orders are agreed upon before acceptance ? Differences are resolved ? Supplier has the capability to meet the requirements ? Identify contract amendments process ? Maintain contract review records ? Additional: ? Meet all customer requirements (including customer specific) Product Process Management ? Element Design Control (applies to design responsible suppliers only) ? Requirements: ? Identify activities, resources, responsibilities, and technical interfaces (use qualified personnel with adequate resources) ? Identify design input requirements ? Include statutory/regulatory requirements ? Resolve unclear requirements ? Consider results of contract reviews Product Process Management ? Element Design Control (cont.) ? Requirements (cont.): ? Document design output (verifiable and reviewed before release) ? Plan and conduct design reviews with appropriate functions/specialists ? Perform design verification (ensure design output meets input requirements) ? Perform design validation (ensure product conforms to user needs) ? Review, approve, and control design changes Product Process Management ? Element Design Control (cont.) ? Additional: ? Have ability to use CAD/CAE (unless waived) ? Design output results from a process that includes: ? Efforts to simplify, optimize, innovate, and reduce waste ? Use of geometric dimensioning and tolerancing as applicable ? Analysis of cost/performance/risk tradeoffs ? Use of feedback from testing, production, and the field ? Use of design FMEAs Product Process Management ? Element Design Control (cont.) ? Additional (cont.): ? Have a prehensive prototype program, using the same production subcontractors, tools, and processes, wherever possible ? Include product life, reliability, and durability in performance testing。 track to monitor timely pletion and conformance to requirements ? Have written customer approval or waiver on design changes ? Have customer review proprietary design changes Product Process Management ? Element Purchasing ? Requirements: ? Evaluate, select, and control subcontractors ? Maintain records of acceptable subcontractors ? Ensure purchasing documents clearly describe the product ordered ? Review and approve purchasing documents ? Verify product at subcontractor or by c