【正文】 sponsibility, product realization also includes product design (see ). ? Product realization in the context of quality planning is discussed in . The structure is outlined on the next slide: 28 ISO/TS 16949 Product Realization cont’d Quality planning Quality planning ISO 9001 : 1994 Quality plan requirements Product realization General Measurements Review cycle Multidisciplinary approach Tools and techniques Computeraided design 29 ISO/TS 16949 Product realization cont’d Special characteristics Feasibility review Product realization continued Management of process design General Process design input Process design output Process verification Control plan Product approval process *Renumbered and some new requirements 30 ISO/TS 16949 Quality system performance ? The supplier shall evaluate the performance of the quality system to verify the effectiveness of its operation. Results shall be recorded to provide, as a minimum, evidence of the achievement of: a) objectives specified in the quality policy (see ), b) objectives specified in the business plan (see ), c) customer satisfaction with product supplied. The results shall be used for continuous improvement or corrective action as appropriate. * more explicit 31 ISO/TS 16949 Laboratory requirements ? Where inspection, testing and calibration services are conducted by a supplier?s laboratory facility shall ply with ISO/IEC 17025, including use of a laboratory scope. NOTE Accreditation of supplier facilities to ISO/IEC 17025 or national equivalent is not required by, nor does it satisfy, all quality system requirements specified in this Technical Specification for a laboratory. Therefore, the laboratory should be included in the onsite audits. 32 ISO/TS 16949 Laboratory requirements cont’d ? Commercial/independent laboratory facilities used for inspection, test or calibration services by the supplier shall be accredited to ISO/IEC 17025 or national equivalent. * new requirement with respect to ISO/IEC 17025 33 ISO/TS 16949 Process audit ? The supplier shall audit the product realization and production processes to determine the effectiveness of process performance (see ) * new requirement 34 ISO/TS 16949 process audit ? onsite verification activity used to: verify conformance to specified requirements, such as control plan, work instructions, ensure that quality objectives are met, verify that specified requirements for process capability/performance are met, assess the effectiveness of activities and related results 35 ISO/TS 16949 Auditor qualification ? The supplier shall ply with customer requirements for internal system and process auditor qualification. * new requirement 36 ISO/TS 16949 Audit Process ? The scope of certification shall include all products supplied to customers subscribing to the certification to ISO/TS 1649. ? Any “site” may elect to pursue third party certification to ISO/TS 16949, however, such “sites” shall have demonstrated capability to conform with all ISO/TS 16949 requirements, including customer specific. ? Remote locations shall be audited as they support a site but cannot obtain independent ISO/TS 16949 certification. 37 ISO/TS 16949 Audit Process cont’d ? Certification body checklists shall include all questions contained in the “Checklist to ISO/TS 16949.” Quality systems shall not be registered to ISO/TS 16949 if open minor or major nonconformities to ISO/TS 16949 exist. After certification, when a nonconformity is identified by the certification body, then the decertification process shall be initiated. NOTE: Such identification can occur as a result of a customer plaint. 38 ISO/TS 16949 Audit process cont’d ? The audit plan shall include evaluation of all supplier quality system elements for effective implementation of ISO/TS 16949 requirements as well as for effectiveness in practice. Assessment shall evaluate the effectiveness of the system, its linkages, its performance and its requirements. Part of the evidence required is the result of at least one plete internal audit and management review cycle. NOTE: Effectiveness of the system should consider how well the system is deployed. 39 ISO/TS 16949 Audit process cont’d ? Each onsite audit, including initial and surveillance audits, shall include a review of: – customer plaints and supplier response, – supplier internal audit and management review results and actions, – progress made toward continuous improvement targets, – effectiveness of the corrective actions and verification since the last surveillance audit. Elements , , and for design responsible supplier shall be reviewed at least once during an onsite audit within each consecutive 12month period. 40 ISO/TS 16949 Audit Activities ? Contract between certification body and supplier ? Analyse readiness for onsite audit ? Readiness for onsite audit (In case of doubts, the certification body and the supplier may decide to execute a preaudit). In this phase, the certification body can perform a “preaudit” at the supplier?s sites. ? Document review 41 ISO/TS 16949 ? Audit Activities cont’d ? Preaudit ? The preaudit shall not be considered as part of the initial certification audit. ? Time dedicated to the preaudit will not reduce audit days requirement (see Annex 3) ? If there is insufficient readiness to conduct the initial audit, the Supplier can stop the process, in consultation with the certification body. 42 ISO/TS 16949 ? Audit Activities cont