Registration Management Committee (RMC) Body Of Knowledge for OP Assessors Will Tate Triumph Aerostructures Company Confidential OP Assessor Workshop San Diego, CA January 19, 2012 Registration Management Committee (RMC) Body of Knowledge • Purpose of the training module: – Training on the criteria and processes that OP assessors will be implementing when performing oversight on behalf of the AAQG/RMC • Objective: – Provide OP assessors with knowledge and tools to perform effective oversight of ABs, CBs, AABs and TPABs. San Diego, CA January 19, 2012 Registration Management Committee (RMC) Documents comprising BOK • • • • • • • • • AS9104-1 & AS9014 AQMS Standards AS9100/9110/9120 AS9104-2 AS9104-3 ISO 19011 ISO 17011 ISO 17021 ISO 17024 IAF Mandatory Documents San Diego, CA January 19, 2012 Registration Management Committee (RMC) Additional relevant documents • “Official ISO 9001 Interpretations” • ISO 9001 Auditing Practices Group papers • Accreditation Auditing Practices Group papers • AB specific documents • IAQG Supplemental Rules Doc – SR001 • IAQG Resolutions log San Diego, CA January 19, 2012 Registration Management Committee (RMC) Where to obtain the documents • All AS documents and ISO standards are copyrighted • AS documents can be purchased from www.sae.org • ISO Standards can be purchased from several places, such as the ASQ website, ANSI webstore or www.iso.ch • The IAF Mandatory documents can be downloaded for free from www.iaf.nu • OP Assessors MUST bring the relevant documents to the assessments San Diego, CA January 19, 2012 Registration Management Committee (RMC) Links to the available documents. • • • • • • IAF Mandatory documents IAQG Resolutions log ANAB Accreditation Manual, MA 6000 ISO Auditing Practices Group Accreditation Auditing Practices Group Supplemental Rules Document SR001 San Diego, CA January 19, 2012 Registration Management Committee (RMC) Remember • It is the OEM’s responsibility to gain access to these standards; standards are not provided by the AB or CB. • OP Assessors must read and familiarize themselves with the applicable parts of the Standards prior to the oversight assessments. San Diego, CA January 19, 2012 Registration Management Committee (RMC) Applicability AQMS Stds ISO 17021 ISO 17011 ISO 17024 AS9104 AS9014 AS9104-2 AS9104-3 AB X X X X CB X X X X AAB X X X X X TPAB X X X X X X X San Diego, CA January 19, 2012 ISO 19011 IAF Docs X X X X Registration Management Committee (RMC) CB Office Assessment Body of Knowledge San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Office Assessment • Gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation. ISO 17011 (7.7.2) • OP Assessor to Focus on AS specific elements as they relate to: – Impartiality - ISO 17021 (5.2) – Management - ISO 17021 (5, 6, 7) – Inclusion of AS in internal audits & management reviewISO 17021, AS9104 – Review AS complaints - ISO 17021, AS9104 – Effective closure of previously issued aerospace related findings – File Review San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Office Assessment • Main activity by OP Assessor – File Review – Registration, surveillance, re-certification process - ISO 17021 (9) – Competency (qualifications) of audit team - AS9104 (7, 8.1), AS9104-3, ISO 17021 (7) – Citation of findings (by CB) – AS9104 (8.3), ISO 17021 (9) – Appropriate resolution of findings – AS9104 (8.3), ISO 17021 (9) – Reporting – AS9104 (8.4), ISO 17021 (9) – Certification decisions (including competency of reviewers) – AS9104 (8.6), ISO 17021 (7, 9) – OASIS – AS9104 – Proper site structure determination (New AS9104-1) San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Office Assessment • A critical aspect is the audit time – Correct audit duration – Supplemental Rule (SR 001: 7e, k) or AS9104-1: table 2/3 when published – Multi-site – AS9104 (8.2.3), IAF Guidance to Guide 62 (Annex 3) • AS9104-1 Table 3 – when published – Competency of staff – AS9104, ISO 17021 (7) – ASRP / CAAT Process(es) approved by AB if applicable (IAF MD 3/MD 4) • Max reduction of 30% from AS9104-1 table 2 values • OPMT assessors must understand IAF Mandatory Document 5 and the auditor-days estimation process. – Supplemental Rules SR 001, Section 7e, k – New AS9104-1 Tables 2 and 3, San Diego, CA January 19, 2012 Registration Management Committee (RMC) Audit Time Determination process: AS91XX:2009 • Surveillance Transition – 50% of initial audit day from IAF MD-5 – Add 100% of initial audit day from AS9104 table 2 • Recertification Transition – 80% of initial audit day from IAF MD-5 – Add 100% of initial audit days from AS9104 table 2. – CB is required to have documented justification for any time (plus or minus) the table. San Diego, CA January 19, 2012 Registration Management Committee (RMC) Additional time per AS9104 San Diego, CA January 19, 2012 Registration Management Committee (RMC) Audit Time Determination process: AS91XX:2009 (con’t) • CB to determine any additional audit days required to assess to AS91XX:2009 • CB must have documented justification for audit days – Justification for increasing/decreasing audit days • Complexity of product • Maturity of QMS • Complexity of business, etc. – AS9104-1 Tables 2/3 (when published) San Diego, CA January 19, 2012 Registration Management Committee (RMC) “Upgrade audits” San Diego, CA January 19, 2012 Registration Management Committee (RMC) Another critical issue – Multi-site • AS9104, paragraph 8.2.3 • IAQG Resolution # 76 • Changing with the rewrite of AS9104 – Refer to table 3 in new AS9104-1 for audit frequency San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Witness Assessment Body of Knowledge San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Witness Assessment • Silently gather objective evidence that the CB is competent and conforms to the relevant standard(s) and other requirements for accreditation. ISO 17011 (7.7.2) San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Witness Assessment Focus on: • Opening and closing meeting (and team caucuses) ISO 17021 (9) • Audit days and audit efficiency, effectiveness AS9104 (8.2), ISO 19011 (6.5), IAF Guidance to Guide 62, Annex 2 • CB’s audit team’s competency to perform audit • Including knowledge of standards, industry, regulatory requirements and interpretations • Including CB’s process for assigning audit team AS9104 (7, 8), AS9104- 3, ISO 17021 (7) • Certificate accuracy ISO 17021 (8) San Diego, CA January 19, 2012 Registration Management Committee (RMC) CB Witness Assessment KEY Focus: • Audit depth and trails to the AQMS Standard (e.g. AS9100) AQMS (e.g. AS9100) AS9104 (8), ISO 19011 (6.5), IAF Guidance to Guide 62 • OP Assessor must complete all applicable AS9104-2 appendices (J, K, etc) San Diego, CA January 19, 2012 Registration Management Committee (RMC) For AB, AAB & TPAB Oversight see Presentation Attached San Diego, CA January 19, 2012 Registration Management Committee (RMC) Burning questions San Diego, CA January 19, 2012