AS9104/1 Impacts

Report
Registration Management Committee
AS9104/1
Impacts to CB’s &
Organizations
Bob Cruse, ANAB
Vince May, ANAB
Tim Lee, The Boeing Company
Company Confidential
RMC Workshop
Minneapolis, MN 19 – 20 July 2012
1
Registration Management Committee
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
RMC Workshop Minneapolis, MN 19 – 20 July 2012
2
Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
• Purpose:
Supplemental Rule (SR) 002
Rules for Transition to AS9104/1:2012
24 May 2012
– 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
RMC Workshop Minneapolis, MN 19 – 20 July 2012
4
Registration Management Committee
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
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
6
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
1)
The auditor must educate themselves on certification
structures and audit duration requirements, as defined
in Appendix B and Table 2
2)
The CB shall initiate the client certification suspension
process, when an organization fails to demonstrate that
conformance to the applicable standard has been reestablished within 60 days from the issuance of a
Nonconformity Report (NCR) (8.4.d)
3)
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)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
7
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
1)
The auditor must educate themselves on certification
structures and audit duration requirements, as defined
in Appendix B and Table 2
2)
The CB shall initiate the client certification suspension
process, when an organization fails to demonstrate that
conformance to the applicable standard has been reestablished within 60 days from the issuance of a
Nonconformity Report (NCR) (8.4.d)
3)
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)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
8
Registration Management Committee
Appendix B, Page 1
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
Appendix B, Page 2
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
Appendix B, Page 3
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
Chapter 8, Table 2
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
Chapter 8, Table 2
No reductions in frequency or audit
duration allowed, unless specifically
defined in the 9104/1 standard.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
1)
The auditor must educate themselves on certification
structures and audit duration requirements, as defined
in Appendix B and Table 2
2)
The CB shall initiate the client certification suspension
process, when an organization fails to demonstrate that
conformance to the applicable standard has been reestablished within 60 days from the issuance of a
Nonconformity Report (NCR) (8.4.d)
3)
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)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
14
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
1)
The auditor must educate themselves on certification
structures and audit duration requirements, as defined
in Appendix B and Table 2
2)
The CB shall initiate the client certification suspension
process, when an organization fails to demonstrate that
conformance to the applicable standard has been reestablished within 60 days from the issuance of a
Nonconformity Report (NCR) (8.4.d)
3)
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)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
15
Registration Management Committee
OASIS Feedback Process (Chapter 14, Figure 1)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
4)
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)
5)
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)
6)
SMS has the right to withdraw or suspend authentication
based on, but not limited to poor performance, nonconformity to requirements, or falsification of data.
(4.13)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
IAQG/ICOP/OASIS
Resolutions Log #96
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
4)
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)
5)
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)
6)
SMS has the right to withdraw or suspend authentication
based on, but not limited to poor performance, nonconformity to requirements, or falsification of data.
(4.13)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
4)
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)
5)
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)
6)
SMS has the right to withdraw or suspend authentication
based on, but not limited to poor performance, nonconformity to requirements, or falsification of data.
(4.13)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
20
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
7) 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)
8) 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)
9) CBs shall not allow requests by clients for auditor
changes/substitutions without substantiated evidence of
improper activity or contract violations. (6.12)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
7) 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)
8) 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)
9) CBs shall not allow requests by clients for auditor
changes/substitutions without substantiated evidence of
improper activity or contract violations. (6.12)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
22
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ Things Auditors Should Know about 9104/1
7) 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)
8) 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)
9) CBs shall not allow requests by clients for auditor
changes/substitutions without substantiated evidence of
improper activity or contract violations. (6.12)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
23
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ (or Eleven or Twelve) Things Auditors Should
Know about 9104/1
10) Classified material or export control requirements,
related to CB auditor access must be determined prior
to audit activity (6.11)
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)
12) The new 9104/1 standard is firmly based upon the new
ISO 17xxx –series standards and the IAF Mandatory
Documents [MD-series] (2.0)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
24
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ (or Eleven or Twelve) Things Auditors Should
Know about 9104/1
10) Classified material or export control requirements,
related to CB auditor access must be determined prior
to audit activity (6.11)
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)
12) The new 9104/1 standard is firmly based upon the new
ISO 17xxx –series standards and the IAF Mandatory
Documents [MD-series] (2.0)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
25
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ (or Eleven or Twelve) Things Auditors Should
Know about 9104/1
10) Classified material or export control requirements,
related to CB auditor access must be determined prior
to audit activity (6.11)
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)
12) The new 9104/1 standard is firmly based upon the new
ISO 17xxx –series standards and the IAF Mandatory
Documents [MD-series] (2.0)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
26
Registration Management Committee
9104/1 ‘Top Ten’
• ‘Top Ten’ (or Eleven or Twelve) Things Auditors Should
Know about 9104/1
10) Classified material or export control requirements,
related to CB auditor access must be determined prior
to audit activity (6.11)
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)
12) The new 9104/1 standard is firmly based upon the new
ISO 17xxx –series standards and the IAF Mandatory
Documents [MD-series] (2.0)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
27
9104-001 Transition
Registration Management Committee
Transition Ends
Jan 2012
• Sector Management Structures (SMS) will establish risk mitigation plans to
accelerate and manage transition activities. (Due 17 Feb 2012)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Registration Management Committee
Questions ?
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
Value Stream
Stream 1
Site A
Customer
Orders
Product X
Customer
Related
Process
Design
Purchasing
Product
Realization
Product X
delivered to
Customers
Central
Function
Site A
Stream 2
Site B
Customer
Orders
Product Y
Customer
Related
Process
Design
Purchasing
Product
Realization
Stream 3
Site C
Customer
Orders
Product Z
Customer
Related
Process
Purchasing
Product Y
delivered to
Customers
Product
Realization
RMC Workshop Minneapolis, MN 19 – 20 July 2012
Product Z
delivered to
Customers
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
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.
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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Registration Management Committee
AS9104/1
Jeopardy
Hosted 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)
RMC Workshop Minneapolis, MN 19 – 20 July 2012
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