TS16949-AQSR.ppt

1、,2,AGENDA ISO / TS 16949 Update ISO 9001:2000 Update ISO 14001 Update Enhanced Surveillance Audits Highlights of IASG Sanctioned QS-9000:98 Interpretations (Nov. 1, 1999) AQSR Review Registration Process Question more explicit about quality policy objectives,18,ISO/TS 16949,4.1.2.1.3 Quality respons

2、ibility Management with responsibility and authority for corrective action shall be promptly informed of products or processes which becomes non-compliant with specified requirements. Personnel responsible for quality shall have the authority to stop production to correct quality problems. * note ch

3、anged into a requirement,19,ISO/TS 16949,4.1.2.2.2 Shift resources Especially concerning the production process, all the shifts shall be staffed with personnel in charge of, or delegated responsibility for quality. * new requirement,20,ISO/TS 16949,4.1.3.2 Management review - supplemental These revi

4、ews shall include all elements of the quality system and its performance (see 4.2.8) over time as an essential part of the continuous improvement process. Part of the management review shall be the monitoring of strategic quality objectives, and the regular reporting and evaluation of the cost of po

5、or quality. NOTE Management review should be conducted with sufficient frequency to ensure that the established quality system is effective. * more explicit about what to review,21,ISO/TS 16949,4.1.5 Analysis and use of company level data The supplier shall document trends in quality, operational pe

6、rformance (productivity, costs of poor quality, efficiency, effectiveness) and current quality levels for key product and service features. NOTE These should be compared with those of competitors and/or appropriate benchmarks.,22,ISO/TS 16949,4.1.5 Analysis and use of company level data contd Trends

7、 in data and information shall be compared with progress toward overall business objectives and lead to action to support the following: a) development of priorities for prompt solutions to customer-related problems; b) determination of key customer related trends and correlation to support status r

8、eview, decision making and longer term planning;,23,ISO/TS 16949,4.1.5 Analysis and use of company level data contd c) an information system for the timely reporting of product information arising from usage. * item “c” is new,24,ISO/TS 16949,4.1.6 Employee motivation, empowerment and satisfaction T

9、he supplier shall have a process for motivation of employees to achieve quality objectives and to make continuous improvements. The process shall include promotion of quality awareness on all levels. NOTE Quality reviews should be conducted to provide appropriate information, such as “plan/actual” c

10、omparison and improvement suggestions.,25,ISO/TS 16949,4.1.6 Employee motivation, empowerment and satisfaction contd The supplier shall have a process for measurement of employee satisfaction and employee understanding of appropriate quality objectives. * new sub-element,26,ISO/TS 16949,4.1.7.1 Prod

11、uct safety - Due care regarding product safety and means to minimize potential risks to employees, customers, users and the environment shall be addressed in the suppliers quality policy and practices, especially in design control (see 4.4) and process control (see 4.9) procedures and practices. The

12、 supplier shall promote internal awareness of safety considerations relative to the suppliers product. * QS-9000:98; 4.2.3.4 more explicit,27,ISO/TS 16949,4.1.7.2 Regulations - The supplier shall have a process to ensure compliance with all applicable government, safety and environmental regulations

13、, including those concerning storage, handling, recycling, eliminating or disposing of materials. * QS-9000:98; 4.6.1.2 more explicit,28,ISO/TS 16949,Product realization In this Technical Specification, quality planning activities of all pre-launch phases have been integrated under the new heading “

14、Product realization”. For suppliers with product design responsibility, product realization also includes product design (see 4.4). Product realization in the context of quality planning is discussed in 4.2.4. The structure is outlined on the next slide:,29,ISO/TS 16949,Product Realization contd 4.2

15、.3Quality planning 4.2.3.1 Quality planning - ISO 9001 : 1994 4.2.3.2 Quality plan requirements 4.2.4Product realization 4.2.4.1 General 4.2.4.2 Measurements 4.2.4.3Review cycle 4.2.4.4Multidisciplinary approach 4.2.4.5Tools and techniques 4.2.4.6 Computer-aided design,30,ISO/TS 16949,Product realiz

16、ation contd 4.2.4.7Special characteristics 4.2.4.8 Feasibility review 4.2.4Product realization continued 4.2.4.9 Management of process design 4.2.4.9.1 General 4.2.4.9.2 Process design input 4.2.4.9.3 Process design output 4.2.4.9.4 Process verification 4.2.4.10 Control plan 4.2.4.11 Product approva

17、l process *Renumbered and some new requirements,31,ISO/TS 16949,4.2.8 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) obje

18、ctives specified in the quality policy (see 4.1.1.2), b) objectives specified in the business plan (see 4.1.4), c) customer satisfaction with product supplied. The results shall be used for continuous improvement or corrective action as appropriate. * more explicit,32,ISO/TS 16949,4.10.6 Laboratory

19、requirements Where inspection, testing and calibration services are conducted by a suppliers laboratory facility shall comply 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 sat

20、isfy, all quality system requirements specified in this Technical Specification for a laboratory. Therefore, the laboratory should be included in the on-site audits.,33,ISO/TS 16949,4.10.6 Laboratory requirements contd Commercial/independent laboratory facilities used for inspection, test or calibra

21、tion services by the supplier shall be accredited to ISO/IEC 17025 or national equivalent. * new requirement with respect to ISO/IEC 17025,34,ISO/TS 16949,4.17.2.3 Process audit The supplier shall audit the product realization and production processes to determine the effectiveness of process perfor

22、mance (see A.43) * new requirement,35,ISO/TS 16949,A.43 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/perf

23、ormance are met, -assess the effectiveness of activities and related results,36,ISO/TS 16949,4.17.3 Auditor qualification The supplier shall comply with customer requirements for internal system and process auditor qualification. * new requirement,37,ISO/TS 16949,Audit Process The scope of certifica

24、tion 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

25、specific. Remote locations shall be audited as they support a site but cannot obtain independent ISO/TS 16949 certification.,38,ISO/TS 16949,Audit Process contd Certification body checklists shall include all questions contained in the “Checklist to ISO/TS 16949.” Quality systems shall not be regist

26、ered 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 complaint.,39,ISO/T

27、S 16949,Audit process contd 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

28、 its requirements. Part of the evidence required is the result of at least one complete internal audit and management review cycle. NOTE: Effectiveness of the system should consider how well the system is deployed.,40,ISO/TS 16949,Audit process contd Each on-site audit, including initial and surveil

29、lance audits, shall include a review of: customer complaints 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. Elem

30、ents 4.1, 4.2, and 4.4 for design responsible supplier shall be reviewed at least once during an on-site audit within each consecutive 12-month period.,41,ISO/TS 16949,Audit Activities Contract between certification body and supplier Analyse readiness for on-site audit Readiness for on-site audit (I

31、n case of doubts, the certification body and the supplier may decide to execute a pre-audit). In this phase, the certification body can perform a “pre-audit” at the suppliers sites. Document review,42,ISO/TS 16949,Audit Activities contd Pre-audit The pre-audit shall not be considered as part of the

32、initial certification audit. Time dedicated to the pre-audit 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.,43,ISO/TS 16949,Audit Activities contd Th

33、e certification body shall record this fact in its data base. The initial audit shall be completed within a 3 month period from the document review. Multiple visits for initial audit are not permitted. Team of 2 auditors minimum if auditor-days requirements exceed 4.,44,ISO/TS 16949,Audit Mandays fo

34、r certification to ISO/TS 16949,45,ISO/TS 16949,Audit ActivitiesRequirements on audit mandays Initial Audit (On-site Mandays) cannot include pre-audit and/or document review. On-site review of corrective actions arising from the initial audit will be additional to the specified audit mandays. The on

35、ly deviations permitted from this chart is an upgrade from the current third party certifications to AVSQ, EAQF, QS-9000 or VDA6.1.,46,ISO/TS 16949,Audit Activities contd Each audit shall include auditing on all shifts. If weekend crews are dedicated and non-rotating, then auditing of the weekend sh

36、ifts is also required. Non design capable suppliers may reduce on-site audit mandays by 15%. The certification body shall prepare monthly audit schedule (to forward to A/B and IATF common database). Site audit + reports,47,ISO/TS 16949,Audit Activities contd Initial certification audit activities sh

37、all be conducted according to the following rules: Use of the “Checklist to ISO/TS 16949” Check list to be covered in each site included in certification scope (no site sampling allowed) Review effectiveness of the implementation of the ISO/TS 16949 requirements and for effectiveness in practice, re

38、lated to planned and achieved quality performance.,48,ISO/TS 16949,Audit Activities contd Major nonconformities may provide a basis for termination of the audit by the supplier in consultation with the audit team leader. In this case audit team leader will stop the certification process immediately:

39、 a report will be prepared for the certification body (copy for the Supplier) The certification body will record the reasons for termination in their database and report to IATF. When this occurs, any re-audit shall commence from the beginning of the process.,49,ISO/TS 16949,Audit Activities contd A

40、t the end of the site visit, the Lead auditor conducts the final presentation and releases a draft report including: description of all nonconformities opportunities for improvement audit team recommendations to certification committee Under no circumstances can a nonconformity be identified as an o

41、pportunity for improvement.,50,ISO/TS 16949,Audit Activities contd Audit team leader within 15 working days after the end of the site visit will send to the supplier and the certification body the final report: Scope - products - customer specific requirements with issue level Summary of audited ele

42、ments and related results Nonconformities as evidenced during the audit process Opportunities for improvement,51,ISO/TS 16949,Audit Activities contd Audit team (plus additional technical experts if any) Cross-references to supplier quality system documentation Nonconformities shall be acknowledged b

43、y the supplier. The auditor shall record all nonconformities identified on the audit report even if the corrective action is implemented immediately.,52,ISO/TS 16949,Audit Activities contd For each nonconformity the Supplier shall perform corrective action within three months from the end of the sit

44、e visit. The supplier will inform the audit team of corrective actions and target date for implementation. Upon verification of corrective action, a supplementary report shall be issued by the audit team to accompany the final audit report.,53,ISO/TS 16949,Audit Activities contd The audit team may p

45、ropose to the certification body a follow-up visit in order to verify the implementation of corrective actions. Certificates will be issued only if there is 100% compliance to requirements which means that nonconformities found during the audit are 100% resolved within three months of the start of t

46、he on-site audit.,54,ISO/TS 16949,Audit Team The audit team shall provide a full report on the operations audited to the supplier within 15 working days of each initial and surveillance audit unless otherwise agreed by the supplier. Auditors shall identify opportunities for improvement without recom

47、mending specific solutions. These opportunities shall be included in the report to the supplier. Authorization to provide the final report shall be specified in the certification contract between the certification body and the supplier.,55,ISO/TS 16949,Other Requirements Consultants to the supplier

48、cannot participate in the audit. Certification bodies shall notify the IATF of all scheduled audits including witness audits and shall allow IATF members, or their designates, to attend. Certificates to ISO/TS 16949 shall only be issued by IATF contracted certification body offices for a maximum val

49、idity of three years.,56,ISO/TS 16949,Other Requirements contd Upgrading of a current automotive certificate, AVSQ, EAQF, QS-9000, VDA 6.1, by one of the IATF contracted certification bodies will be taken into account prior to the initial assessment to ISO/TS 16949, as follows: If the scope is uncha

50、nged, at least 50% of the required audit mandays for initial audit shall be applied. The audit must fully include the ISO/TS 16949 elements 4.1, 4.2 and 4.14 and the customer specific requirements, and assess the remaining ISO/TS 16949 requirements on a sampling basis.,57,Other Requirements,Other Re

51、quirements contd If the scope is changed, 100% of the required audit mandays for the initial audit shall be applied. The audit must fully include all ISO/TS 16949 requirements, including customer specific requirements; sampling of ISO/TS 16949 requirements is not permitted. IATF reserves the right t

52、o send a delegate to the executive management committee of the certification body concerning certification decisions regarding ISO/TS 16949.,58,ISO/TS 16949,Other Requirements contd If a certification body places an existing ISO/TS 16949 certified company on suspension because of quality system nonc

53、onformities or a violation of the rules of registration, the certification body shall notify IATF, within 10 working days.,59,ISO/TS 16949,Going forward, IATF plans to: begin work on a revised ISO/TS 16949 to align with the ISO 9001 year 2000 text; 2000 - 2001: ISO 9000: 2000 or - The supplier is no

54、tified by Ford of “Q-1 Revocation”, by Daimler-Chrysler of “Needs Improvement” (“Quality Rating only - not Total Rating”), or by General Motors of “New Business Hold”; or - Minor non-conformance corrective action is not verified by the Registrar as being effectively implemented within 60 days of the

55、 date identified.,102,IASG Sanctioned QS-9000 Interpretations,* Probation is defined as notice given a supplier by their registrar that failure to take corrective action to eliminate the major or minor nonconformities within the specified time period will result in a suppliers certificate being revo

56、ked by their registrar (refer to clause R3.D, R3.E, R3.F). *The QSA states “number of minor nonconformities against one requirement which when combined can represent a total breakdown of the system and thus be considered a major nonconformity.”,103,IASG Sanctioned QS-9000 Interpretations,Additionall

57、y, minor nonconformances, which occur on successive surveillance assessments, should be viewed as a pattern. If a pattern of minor nonconformities occurs over successive assessments, it may represent a total breakdown of the system and a major nonconformance shall be issued. A. If probation results

58、from the issuance of a major nonconformance, the registrar will notify the supplier in writing of the probation within five days of the issuance of the major nonconformance (whether or not an appeal is initiated.,104,IASG Sanctioned QS-9000 Interpretations,B. If probation is warranted for any other

59、reason, written notification will be provided to the supplier immediately. C. If the certification is “corporate” then all sites under the corporate certification must be placed on probation. If a “corporate” probation from QS-9000, “new” locations may be added to the corporate registration, or a location within a corporate certification may be removed if such location is completely closed.,105,IASG Sanctioned QS-9000 Interpretations,D. If a supplier files an appeal with their registrar, the supplier and registrar will have 30 days from notification to complete the appeal pro