1 1 9104/1 - PowerPoint Presentation

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9104/1“Completing the Trilogy”

Atlanta, GAJuly 23, 2010Michael C Roberts9104/1 Team LeadThe Boeing Company

Auditor Workshop

Atlanta, GA

July 22-23, 2010Slide2

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Agenda / ContentsTask & History

Team ActivitiesAudit Day Table Multiple Site TableSite DefinitionOther Significant ChangesWhat Does This Mean To Auditors

Latest ScheduleQ & ASlide3

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Caveat EmptorThe information contained herein is the latest recommendations. But, the final draft has not been released and this material has not been balloted.

Any deviations between this presentation and the draft or balloted works of the 9104/1 rewrite team or the special requirements team – the teams’ proposals shall prevail. This presentation is a best effort to summarize the recommended requirements.Slide4

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9104/1 Rewrite TeamSlide5

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Original Task RequirementsComplete the Trilogy of 9104-series documents, by revising 9104A

Remove sections made redundant by the release of 9104/2 (Oversight) and 9104/3 (Auditor Training and Qualification)Address the areas of ICOP concern, by enhancing/revising topics identified in the OPMT FMEA (eg. audit days, multi-site, etc.)Upgrade to the new ISO and IAF audit docs.Slide6

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HistoryProject initiated in Melbourne AUS in Apr. ’07

Team activity at each Spring and Fall IAQG OPMT meetingFull week face-to-face in Long Beach, Jun. ’08Several focus meetings due to controversial topics (eg. audit day table, multi-site, ASRP)Formal Preliminary Review 8/09 to 11/09Formal Ballot initiated 1/10 Slide7

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History CONTINUED

Ballot failed in the Americas (3/10) due to controversy over definition of ‘site’Ballot failed in Asia (3/10) due to audit days and a variety of individual concerns.Ballot stopped in Europe (4/10) due to majority voting ‘disapprove’ due to mandatory requirements of audit day tableDiscovered that Europe and Asia have not

been following IAF audit day requirements and fear consequences and costs of requiring suppliers to meet the new requirements.Slide8

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History CONTINUED

At the Wash DC IAQG meeting, the OPMT reached an impasse, as it was unable to achieve consensus as to what direction to be given to the 9104/1 team to solve the ballot failure issues.The OPMT Sector Leads brought the issue to the SWG for guidance and direction.The SWG ordered that a special, non-advocate team be commissioned to review the issues, identify and resolve conflicts, and define new requirements that, as a minimum, meet the ISO 17xxx and IAF-MD standards.Slide9

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History CONTINUED

The Special Non-Advocate Review TeamFacilitators:

Ian Folland & Tim LeeTeam Members:Roger Bennett - International Independent Organization for Certification (IIOC) – IAF MD 1 Convener and IAF MD 5 Co-convenerReg Blake - Certification Body (CB) representing the Independent Association of Accredited Registrars (IAAR)Norbert Borzek - German AB - DAkkS – Chair of the IAF Technical Committee .

Patrick Boucheron – Turbomeca, France, OPMT Voting Member

Buddy Cressionnie - IAQG 9100 International Document Representative (IDR)

Randy Dougherty – USA AB - ANAB Director – Chair of the IAF

Michel Jacquaniello – Zodiac Aerospace, France

Kunihiro Tanabe - Japanese AB - JAB

Norikazu Tsuchiya – KHI, Japan, OPMT Voting MemberSlide10

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Team RecommendationsThe team developed a detailed document containing the following concepts:Definitions and eligibility criteria for single site, multiple site, campus, several site, and complex organizations

Audit day calculations methodology for all organizational types (above)Information in the form of a matrix and diagrams to help understand and train the different types of organizationsUtilized as much of IAF Mandatory Documents language, as possible Slide11

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Audit Day Table 2 [same as balloted 9104/1]Slide12

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Multiple Site Table 6 [same as balloted 9104/1]Slide13

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Sites – New Organizational StructuresSingle Site

Multiple SiteCampusSeveral Sites Complex Sites

The above takes into consideration the unique organizational structures that exist in the Aviation, Space, and Defense industry today.Slide14

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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.Slide15

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Single Site Structure

EligibilityStand alone self-supporting organization with no dependencies operating under single QMSAudit Day Req’mtTable 2, using number of employees at site.

Reductions – none, except for ASRP or CAATAdditions – allowed/expected per MD-5 Initial – one site using Table 2 audit durationSurveillance – annual using 1/3 Table 2 audit durationRecertification

– using 2/3 Table 2 audit duration

Certificate/OASIS

Single address listing

Scope declared

Single OINSlide16

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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.Slide17

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Multiple Site Structure

EligibilityAll sites have a legal, contractual link with central office. One QMS, central control, mgt review, and internal audit. Meets MD-1 criteria. One address per site.Audit Day Req’mt

Table 2, separately using number of employees at each site.Reductions – none, except for ASRP or CAATAdditions – allowed/expected per MD-5 Initial – all sites audited using Table 2 audit durationSurveillance – using 9104/1 Table 6 (Cat. 1 & Cat. 2)

Recertification

– using 9104/1 Table 6 (Cat. 1 & Cat. 2)

Certificate/OASIS

Central function and all sites listed.

Scope declared for each site. Central function identified.

Central Function OIN and all other sites OIN listed.Slide18

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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.Slide19

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Campus Structure CONTINUED

Explanation: Although there are different products that go through different processes in the organisation the controlling factors are that more than 80% of the processes in the realisation of the product are the same and all products flow through the same overall value chain before being delivered to the customer. Even if site B was split into four separate sites making different types of detail parts such as machined, formed, carbon-fibre or similar and where appropriate using the treatments site this organisation would still be a campus as all sites contribute to a value steam of processes running through the organisation with a commonality that 80% of the processes that make up each product are the same. Slide20

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Campus Structure

EligibilityAll sites have a legal, contractual link with central office. One QMS, central control, mgt review, and internal audit. Output (can be dissimilar) of one site feeds input of other sites. One address per campus.Audit Day Req’mt

Table 2, using number of employees from campus.Reductions – none, except for ASRP or CAATAdditions – 10% required, plus additions per MD-5 Initial – all sites, Table 2 for campus population + 10% Surveillance – 1/3 initial per Table 2 plus 10%

Recertification

– 2/3 initial per Table 2 plus 10%

Certificate/OASIS

Single controlling address listing on certificate

Scope declared for entire campus. Central function ID’d.

Single OIN for controlling address. Central function ID’d.Slide21

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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.Slide22

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Several Site Structure CONTINUED

Explanation: This organization has three essentially different sites with three different sets of processes. The organization does not qualify for multiple site because of the different processes and does not qualify for campus as products in the value stream do not flow from one site to another. The organization is a several site organization.Slide23

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Several Site Structure

EligibilityAll sites have legal contractual link with central office, but processes and products not substantially similar.Audit Day Req’mtTable 2, using number of employees separately at each site.

Reductions – up to 30% for reduced scope complexity, or reductions for ASRP or CAATAdditions – allowed/expected per MD-5 Initial – all sites using Table 2 audit durationsSurveillance – 1/3 Table 2 audit duration, reduced as above

Recertification

– 2/3 Table 2 audit duration reduced as above

Certificate/OASIS

Central function and all sites listed on certificate

Overall scope declared, and scope for each site

Central function and all sites have unique OIN. CF identified.Slide24

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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.Slide25

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Complex Organization Structure CONTINUED

Explanation: This organization is a complex organization because it has elements of multiple site and several campuses within it. Sites C and D are eligible for a multiple site approach. Sites E and F would also be eligible for multiple site approach. However the combination of C, D, E and F are not eligible for multiple site all together because the processes are different between C or D and E or F. There are however two campuses within the organization. The value stream through A, B and C or D and the second value stream through A, B and E or F. This organization is therefore made up of two campuses with a multiple site combination within each campus, an example of a complex organization.

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Complex Organization Structure

EligibilitySites have legal contractual link with central office. One QMS with combinations of site structures. Requires IAQG OPMT approval. Individual addresses per sites or campus.Audit Day Req’mt

Use Table 2 for each case of single, multiple, campus, several.Reductions – per individual site typeAdditions – per individual site type, & expected per MD-5 Initial – all sites using Table 2 audit durationSurveillance – dependent upon combination

Recertification

– dependent upon combination

Certificate/OASIS

Central Function and all sites and/or campuses.

All sites & campuses scopes declared. CF identified.

All sites & campuses have unique OIN. CF identified.Slide27

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Reductions (and Additions)

“No reductions allowed unless applying ASRP or CAAT.

”“Additions allowed” Some reductions

allowed for “Several Sites”Slide28

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Other Significant ChangesDefines AQMS and ICOP

Updates to the new ISO-17xxx-series and IAF MD-x –series requirements standardsSets surveillance requirements (# files, # assessments)Sets CB requirements (OASIS data responsibility, administrator, resolution process, suspension and withdrawal requirements, ASRP and CAAT rules, export and confidentiality rules)Sets auditing rules (team lead must be AEA and on-site, site-limited to two certification cycles, 8 hour audit day)

Sampling of sites limited to 9120 and in same countrySlide29

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Other Significant Changes CONTINUED

Rules for certificate issuance and transfers, loss of certification, scope changesRules for adding and auditing multiple AQMS standards Introduces Auditor Authentication Bodies (AABs) and Training Provider Approval Bodies (TPABs)Rules for OASIS responsibility and administrationAuthority of OPMT and SMS structures

Requirements for OASIS Feedback ProcessRules for organization access, loss notification, T1 dataRules for confidentiality and conflict of interest Slide30

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What Does This Mean To AuditorsThe requirements for ICOP have become more controlled and complex.

Due to the new ‘site’ structures of the organizations, better audit planning will be required.There is a higher level of expectation of auditor competency.While 9100 focuses on process, 9104/1 adds focus to the ‘central function’ processes.

Auditors will be held to a higher standard in the future.Publication of 9104/1 will complete the “Trilogy”, fully describing the aerospace management of quality systems. Slide31

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Latest ScheduleSlide32

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Questions ?