9101 2009 Status Prepared by Tony Marino The
9101: 2009 Status Prepared by: Tony Marino – The Boeing Company September 16, 2009 BOEING is a trademark of Boeing Management Company. Copyright © 2005 Boeing. All rights reserved. 1
Situation Target Proposal Target Situation § Current mandatory use and completion of the 9101 Checklist drives undesirable results: – Inhibits process approach. – Focus of auditor becomes completing the checklist. § Provide requirements on process auditing and development of a 9100 series audit approaches and tools that has a focus on conformity and effectiveness of a Quality Management System (QMS). – Time intensive. – Takes time away from actual auditing. § Not in alignment with ISO 17021 (Stage 1 & 2) Proposal § Develop an enhanced audit process for evaluating process based management systems, including alignment with ISO 17021: – Process-based information gathering (Stage 1, Surveillance and/or Re-Certification). – Stage 1 Assessment/Analysis and Audit Planning (Stage 2, Surveillance and Re. Certification). – Development of a performance-based, process-oriented audit methods and techniques. – Capture objective evidence of process conformity and effectiveness. 2
9101 Major Changes Ø One document covering 9100/9110/9120 standards. Ø Elimination of “Scoring” and “Key Requirements” designation. Ø Use of Customer feedback concerning QMS Organization performance as an input for process oriented audits (e. g. , OASIS, customer satisfaction/performance scores). Ø In addition to conformity, also determination of Effectiveness included. Ø More emphasis on performance measuring. Ø Introduction of the Objective Evidence Record. 3
What has not Changed ØDetermining conformity to the standard's. ØNonconformity’s discovered during the audit are to be documented. ØBased on information collected during the audit, the auditor will have to draw conclusions on conformity and effectiveness of the organizations quality management system. 4
Comments Received Ø 393 comments received from IAQG members Ø 160 editorial comments received from SAE editor (except spelling and notation issues) ØMAJOR ISSUES: • Problems with use of draft ISO 17021 -2 text in 9101, dispositioned as follows: instead of using draft 17021 -2 use of ISO 19011 reference, not as guideline but as requirements + relevant text of 17021 -2 not in 19011, paraphrased in new 9101 • 4. 1. 2 "Audit Approaches", it will be changed from "shall" (requirements ) to "should" (guidance) • Use of OER form (Appendix H) 5 5
SWG/COUNCIL Presentation Ø After 2 nd ballot/review of 9101 draft issue April 2009, the following conclusion can be made: The use of the Objective Evidence Report (OER) is very controversial: • Some IAQG members considers the OER as absolutely necessary, even want to go back to the format as in the previous version of 9101, using it as detailed questionnaire; • Some members and the certification bodies consider this OER as not necessary, too detailed, too time consuming, going back to clause based auditing, duplication with other forms (PEAR, NCR, etc) Note 1: these positions are not related to a specific sector: pro’s and con’s are in each sector. Note 2: the main reason for the 9101 team not to continue with the questionnaire was that it invites too much to a ‘clause based’ audit approach instead of a ‘process based’ audit approach. Ø Due to the extreme reactions, the 9101 team is not able to ‘bridge the gap’ and to develop a compromise that satisfies everybody 6 6
9101 team proposal § The 9101 team proposes the following ‘solution’: § To mandate the use of the slightly modified appendix E (of 9101 draft of SWG July 2009) as the high level document to summarize nonconformance results and observations (part of the audit reporting): see embedded file § To add the following text to the 9101: CBs shall record detailed objective evidence, e. g. reviewed procedures, shop orders, training records, products, verification records. This can be on a standardized form (OER) as made available by IAQG, or on the CBs own standardized document(s). In this case the certification body document shall meet the intent of the OER and shall be included in the audit file maintained by the CB. § The OER document shall be included as an appendix to the 9101 standard for reference purposes. SWG endorses as modified on July 8, 2009 above 7 7
9101: 2009 Certification Deployment Planning 9101: 2009 J A 2009 S O 2010 N D J F SWG & Council approval Update after Seattle meeting + editing AAQG Ballot + APAQG reaffirmation Final update (Ballot AAQG) Publication of 9101 IAQG standard Note: ballot draft to be used as training development input 8
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