Body of Knowledge - SAE International

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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
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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.
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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
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