AS9104/1 Impacts to CB’s & Organizations

AS9104/1 Impacts to CB’s & Organizations Bob Cruse, ANAB Vince May, ANAB Tim Lee, The Boeing Company RMC Workshop Minneapolis, MN 19 – 20 July 2012

Agenda • Rationale for AS9104/1 • Application for Accreditation to AS9104/1 • SR-002 • Impacts to Stakeholders • Authenticated Auditors • Top 10 things we need to know • Exercise on Audit duration • Jeopardy • Questions & Open Discussion

Rationale for AS9104/1 • After the initial publication of International Aerospace Quality Group (IAQG) 9104 standard in 2004, it became evident that a single standard containing all aspects of the Industry Controlled Other Party (ICOP) Aerospace Quality Management System (AQMS) was too complex. It was decided that the standard be broken into three sections: • 9104/1 – Requirements for Aviation, Space, and Defense Quality Management System Certification Programs; • 9104/2 – Requirements for Oversight of Aerospace Quality Management System Registration/Certification Programs; • 9104/3 – Requirements for Aerospace Auditor Competency and Training Courses. • The requirements for oversight and AQMS auditor qualification information (9104/2 and 9104/3 respectively) were removed from the original 9104 text. This effort necessitated the total rewrite of the initial standard, now re-designated as 9104/1, which is the keystone document of the 9104-series trilogy. 3

Supplemental Rule (SR) 002 Rules for Transition to AS9104/1:201224 May 2012 • Purpose: • To provide supplemental rules for all stakeholders to facilitate the transition from the existing 9104 standard to the new 9104-1 standard, ‘Requirements for Aviation, Space, and Defense Quality Management System Certification Programs’. • AB’s shall make a decision to withdraw all 9104 accreditations of CBs on July 1st, 2013. • Transition risk mitigation plans required for all stakeholders (e.g.; SMS, AB, CB’s) • Analysis of all existing certification structures by the CB’s • Re-approval of AB’s and re-accreditation of all CB’s • ANAB approved on May 22, 2012 • Incentives for CB transitioning in 2012 versus 2013 • Selected AS9104/1 certification structure must not conflict with customer, regulatory or other requirements 4

Notable Impacts • OPMT • Establish certification structure committee • SMS • Will need to review and re-approve all ABs, AABs, TPABs to 9104-001 • AB’s • Undertaking accreditation transition to 9104-001 for CBs. assessment of ASRP (Ref IAF MD3) and CAAT (Ref IAF MD4). • Changes to CB suspension process. • Training

Notable Impacts - CBs - • AS&D experience for persons involved in certification decisions. • Assurance that clients have OASIS admin. • Changes to the client transfer process. • Auditor team leader rotation. • The new cert structures with clients and process to document structure decisions, including submission for IAQG OPMT for complex organisations. • All client contracts will need to be updated (Cert structure, conformance to 9104-001). • Auditor resources due to new cert structures. Will need to update client suspension process • Constraints related to 9101 completion of forms, NCs etc. • Training. • The use of ASRP and CAAT.

9104/1 ‘Top Ten’ • ‘Top Ten’ Things Auditors Should Know about 9104/1 • The auditor must educate themselves on certification structures and audit duration requirements, as defined in Appendix B and Table 2 • The CB shall initiate the client certification suspension process, when an organization fails to demonstrate that conformance to the applicable standard has been re-established within 60 days from the issuance of a Nonconformity Report (NCR) (8.4.d) • OASIS Feedback Loop - CB auditors are expected to address this feedback during their management review activity, as well as investigations of product, process, and system issues (14.2)

Appendix B, Page 1

Chapter 8, Table 2

Chapter 8, Table 2 No reductions in frequency or audit duration allowed, unless specifically defined in the 9104/1 standard.

9104/1 ‘Top Ten’ • ‘Top Ten’ Things Auditors Should Know about 9104/1 • The auditor must educate themselves on certification structures and audit duration requirements, as defined in Appendix B and Table 2 • The CB shall initiate the client certification suspension process, when an organization fails to demonstrate that conformance to the applicable standard has been re-established within 60 days from the issuance of a Nonconformity Report (NCR) (8.4.d) • OASIS Feedback Loop - CB auditors are expected to address this feedback during their management review activity, as well as investigations of product, process, and system issues (14.2)

OASIS Feedback Process (Chapter 14, Figure 1)

9104/1 ‘Top Ten’ • ‘Top Ten’ Things Auditors Should Know about 9104/1 • The same audit team leader shall be limited to a maximum of two consecutive certification cycles at the client (organization). Rotation of supporting AEAs and auditors after each certification cycle is recommended. (8.3.8) • The CB and audit team leader shall ensure that an AEA is on-site and actively involved at each site during the entire audit. In addition, the audit team leader shall be on-site at one or more sites during all audit activity (8.3.3) • SMS has the right to withdraw or suspend authentication based on, but not limited to poor performance, non-conformity to requirements, or falsification of data. (4.13)

IAQG/ICOP/OASISResolutions Log #96

9104/1 ‘Top Ten’ • ‘Top Ten’ Things Auditors Should Know about 9104/1 • The same audit team leader shall be limited to a maximum of two consecutive certification cycles at the client (organization). Rotation of supporting AEAs and auditors after each certification cycle is recommended. (8.3.8) • The CB and audit team leader shall ensure that an AEA is on-site and actively involved at each site during the entire audit. In addition, the audit team leader shall be on-site at one or more sites during all audit activity (8.3.3) • SMS has the right to withdraw or suspend authentication based on, but not limited to poor performance, non-conformity to requirements, or falsification of data. (4.13)

9104/1 ‘Top Ten’ • ‘Top Ten’ Things Auditors Should Know about 9104/1 • Auditors who are withdrawn for cause by an AAB shall not reapply for authentication for 12 months in any sector of the ICOP scheme (7.4) • The CB’s audit program shall ensure that a certified organization’s ‘Control of Purchasing’ process is audited at least annually. (8.2.2.n) • CBs shall not allow requests by clients for auditor changes/substitutions without substantiated evidence of improper activity or contract violations. (6.12)

9104/1 ‘Top Ten’ • ‘Top Ten’ (or Eleven or Twelve) Things Auditors Should Know about 9104/1 • Classified material or export control requirements, related to CB auditor access must be determined prior to audit activity (6.11) • The audit team leader shall present the complete audit report to the organization within two weeks of the closing meeting using the audit report and associated forms defined in the 9101 standard. (8.5.a) • The new 9104/1 standard is firmly based upon the new ISO 17xxx –series standards and the IAF Mandatory Documents [MD-series] (2.0)

9104-001 Transition Jan 2012 Transition Ends • Sector Management Structures (SMS) will establish risk mitigation plans to accelerate and manage transition activities. (Due 17 Feb 2012)

Questions ?

Sites – New Organizational Structures • Single Site • Multiple Site • Campus • Several Sites • Complex Sites The above takes into consideration the unique organizational structures that exist in the Aviation, Space, and Defense industry today.

Single Site Structure A1.1 Example of a Single Site Organization The organization has one location. It could be organised under one large building or several buildings in one location. In either case the organisation is located on one site. The organisation has multiple products or product families flowing through multiple processes.

Multiple Site Structure A1.2 Example of a Multiple Site Organization The organization has two sites, A and B. They make two product families X and Y. Product family X is made the same way using the same processes on both sites A and B. Product family Y is only made on site A. This organization makes to customer specification. The central function is located on site A. Explanation: Site B conducts the same but fewer processes than site A making the same product X. In this way the organization is eligible for a multiple site approach.

Campus Structure A1.3 Example of a Campus Organization The organisation has four sites with four buildings on site A, four buildings on site B and one building on each site C and D. The organisation has multiple products and product families that all flow through substantially similar processes i.e. one value stream.

Several Site Structure A1.4 Example of a Several Site Organization The organization has three sites A, B and C that make different product families by mainly dissimilar processes although some of processes such as purchasing are the same. Site C makes to customer specification. Sites A and B design and manufacture their products. Some of the customers for products from each site are the same, others are not.

Complex Organization Structure A1.5 Example of a Complex Organization This organization has 6 sites. It has two different product families. One family is made through product stream 1, the other through product stream 2. The processes carried out within sites C and D are identical realizing the same product through the same processes. The same is true for sites E and F however the processes in E and F are dissimilar from those used in C and D. Sites A and B support both product streams. Sites and A and B use the same facilities for all products even through the types of products manufactured are different and utilize different technologies in their production. Where during the realization processes in sites A and B products in value stream 1 and in value stream 2 use the same processes.

Interactive Activity • Evaluating an organization to determine the appropriate Certification Structure • Determining the appropriate audit duration based on the conclusion of site structure & personnel within the organization.

AS9104/1JeopardyHosted by Alex Trebek(Note: Due to circumstances beyond our control, Alex could not make it to this workshop, so this round of Jeopardy will be hosted by a similarly iconic individual, Mr. Tim Lee from The Boeing Company)

AS9104/1 Impacts to CB’s & Organizations