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ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie...

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ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation
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Page 1: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB AQMS Accreditation

Activity

2009

Lori Scheid-GillespieManager, ANAB Accreditation

Page 2: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Oversight of ANAB (reviewed in Sept 2009)

AAQG Office Assessment August 17-21 2009 Vince May 8 major NCRs and 4 minor NCRs

Many majors were due to the evidence being greater than a “single occurrence”

Minor – RMC chair was not notified of an appeal hearing.

Minor – An AS9120 application review was completed by a non AIEA (against ANAB’s Accreditation Rule)

Minor – Supporting records for an accreditation were not maintained (e.g. a re-audit was decided to not be required, with no evidence documented)

Minor – NCR’s issued outside of an audit were not followed up by ANAB’s team during an office assessment

Page 3: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

AAQG Oversight of ANAB (reviewed in Sept 2009) Major – Document control (referencing outdates documents)

Major – AAQG audit NCR closed without evidence of completing the CA

Major – OASIS was not updated to reflect a withdrawal of a CB’s accreditation

Major – The RMC was not notified immediately when a CB’s accreditation was withdrawn.

Major – Records were not in EQM per our internal process

Major – ANAB’s applications do not take into account all AS9014.

Major - Certification decisions are being made, by an ANAB accredited CB, from an office that is not accredited for Aerospace Quality Management System (AQMS) standards.

Major – NCR’s with multiple occurrences were not categorized as a major.

Page 4: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Oversight of ANAB (reviewed in Sept 2009)

International Accreditation Forum (IAF) Peer evaluation in March 2009

Veronica Garcia of EMA Andrea Melo of CGCRE/INMETRO March 23-27

Office Assessment (at ANAB)Witnessed Audit (witnessing ANAB conduct an

office assessment at a CB) 1 NCR, 4 concerns, and 5 comments Comments do not have to be responded to, but

ANAB is addressing all comments. ANAB is on track for closure to all

Page 5: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

IAF/IAAC Peer Evaluation (reviewed in Sept 2009)

NCR – Did not complete internal audits of the entire

system in 2008. Concerns –

Do not scope for EMS (ISO 14001) which in turn questions the confidence in the ANAB-EMS accreditations.

Preventive action log includes some nonconformances. Nonconforming product log includes some incomplete actions.

our public information on who gives us our authority was not updated.

our web site is not clear when a CB’s accreditation is withdrawn.

Page 6: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

IAF/IAAC Peer Evaluation (reviewed in Sept 2009)

Observations – not recording all actions taken on complaints

(in EQM) There is no evidence of a systematic process

to confirm the continuation of accreditation, based on the results of surveillance.

MCAA refers to an obsolete standard, ISO Guide 61

During the witnessed audit the ANAB team did not complete a full system ISO 9001 audit when the CB was accredited for ISO 17021, option 1.

The ANAB assessors classification for minor nonconformity doesn’t seem to address only single observed lapse in the CB’s systems

Page 7: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

AQMS 2009 OverviewAccredited Certification Bodies (CBs) 35 AS9100 10 AS9110 27 AS9120

Applicant CBs 2 AS9100 (1 in decision) 6 AS9110 0 AS9120

Increased Surveillance Frequency (2009) 2 CB’s (twice per year for office assessments and AS9100

witnessed audits)

Suspensions 4 previous suspensions all lifted

Withdrawals One in January 2009 (DVC-USA, voluntarily)

Page 8: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints against ANAB-accredited CBs

3

2

55

0

5

3

0

3

0

2

3

1 1

2

9

2

11

10

3

13

10

2

12

0

2

4

6

8

10

12

14

Valid Invalid Total

2002 2003 2004 2005 2006 2007 2008 2009

Page 9: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

282 (Jan 2009) – AS client complained the CB’s NCR review was not objective. Closed, unable to substantiate (Feb 2009)

It seemed the CB was following the process to get an appropriate corrective action response & evidence.

The NCR’s were eventually closed and the complainant would not respond to ANAB’s request for additional information.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 10: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

294 (Mar 2009) – AS client complained their CB suspended their certificate due to an issue at the CB (not client) Closed, with correction (Jul 2009)

ANAB required the CB to suspend the client’s certificate due to the 2008 annual audit not being completed.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 11: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

299 (Mar 2009) – A CB has missed annual audits, including AQMS audits. Closed, with correction (Jul 2009)

ANAB discovered this issue previously.ANAB completed a complaint investigative

office assessment in April 2009 to determine extent.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 12: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

301 (Apr 2009) – A CB has taken a transfer while suspended. Closed, invalid (May 2009)

The transfer was completed prior to suspension.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 13: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

307 (Apr 2009) – An organization is claiming AS9100 certification but they are not in OASIS. Closed, with correction (May 2009)

The organization had not entered an administrator in OASIS so their certification was not showing up.

Administrator was set up within a few days of complaint.

CB knows to not certify without an administrator in OASIS.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 14: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

309 (May 2009) – A CB completed an AS9100 transfer and the organization was complaining about the previous CBs’ auditor’s actions. Unprofessional, untimely and incomplete paperwork, etc. Closed with correction (Oct 2009)

An onsite investigation took place during an office assessment.

Issues found were addressed.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 15: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

311 (June 2009) – An OEM issued a complaint against a CB for not closing their nonconformity(s) in a timely and appropriate fashion. Closed, with correction (Aug 2009)

The CB provided appropriate responses and the NCR was closed.

The CB was notified to have a process in place to respond to OEM issues appropriately and in a timely fashion.

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 16: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

318 (June 2009) – A CB was notified that their client was switching CB’s to avoid the rigor on audits and to go back to their “usual” auditor. Open, under investigation

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 17: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

326 (Sept 2009) – An OEM issued a complaint against a CB for not closing their nonconformity(s) in a timely and appropriate fashion. Open, correction required

Issued an NCR, being addressed

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 18: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

334 (Dec 2009) – Complaint against an AS9100 certified organizationOpen, under investigation

Issued an NCR, being addressed

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 19: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

335 (Dec 2009) – a non-AS CB issuing AS certificates Open, under investigation

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 20: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

Aerospace Complaints

336 (Dec 2009) – A CB did not update OASIS within 30 days of re-certification. Open, under investigation

Complaints in italics were provided previously and has no changes.

Complaints in bold are new or were updated since the last meeting.

Page 21: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A43 – Received February 2009 - WITHDRAWN CB appealed an NCR issued during a AS9100 witnessed audit

in regards to documented justification for audit time.CB addressed the NCR and withdrew the appeal

A46 – Received April 2009 – APPEAL UPHELD CB appealed an NCR issued during an AS9110 initial

witnessed audit in regards to the scope of the organization; exclusions were taken against 7.3 that ANAB did not agree with.

Based on information from the organization and a position statement from a Boeing representative.

Note; this is from an AS9110 initial witnessed audit

Appeals in italics were provided previously.

Appeals in bold are new.

Page 22: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A50 – Received May 2009 - WITHDRAWN CB appealed an NCR issued during an AS9120 witnessed

audit in regards to the CB not notifying ANAB of ITAR issues (ANAB sent an assessor who was not a US citizen and subsequently we left the audit)

The CB & ANAB found evidence that the CB had notified ANAB (via e-mail) and ANAB did not follow our process for scheduling.

ANAB downgraded the NCR to an OFI since the CB did not notify ANAB on the appropriate document (notified us in an e-mail)

Appeals in italics were provided previously.

Appeals in bold are new.

Page 23: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A53 – Received May 2009 – WITHDRAWN CB appealed an NCR issued during an AS9110 initial

witnessed audit in regards to ITAR issues. ANAB’s team lead spoke to the CB’s office and

provided clarification and the CB withdrew their appeal.

Note; this is from an AS9110 initial witnessed audit

Appeals in italics were provided previously.

Appeals in bold are new.

Page 24: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals A54 – Received May 2009 - WITHDRAWN

CB appealed an NCR issued during an office assessment in regards to not updating OASIS in a timely fashion.

OASIS was not updated because the auditor’s information in OASIS was not correct. The CB worked the issue out with RABQSA.

The CB addressed the NCR with ANAB

A57 – Received July 2009 – WITHDRAWN CB appealed an NCR issued during an AS9100 witnessed

audit in regards to the audit day and was the audit time used appropriately (the team stayed together for ½ day).

ANAB had a teleconference with the CB and downgraded the NCR to an OFI since the team work was minimal in relationship to the full audit time and the CB’s process was explained and better understood by ANAB’s audit team.

Appeals in italics were provided previously.

Appeals in bold are new.

Page 25: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals A58 – Received July 2009 – APPEAL UPHELD

CB appealed an NCR issued during an AS9110 initial witnessed audit in regards to the scope of the organization; exclusions were taken against 7.3 that ANAB did not agree with.

The Panel concluded that AS9110 only applies to organizations responsible for the design of modifications and this organization was not.

Note; this is from an AS9110 initial witnessed audit

A59 – Received July 2009 – WITHDRAWN CB appealed an NCR issued during an AS9100 witnessed

audit in regards to the CB not having legally enforceable arrangements with the organization.

The CB provided the appropriate paperwork and ANAB withdrew the NCR.

Appeals in italics were provided previously.

Appeals in bold are new.

Page 26: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A60 – Received July 2009 – WITHDRAWN CB appealed an NCR issued during an AS9110 initial

witnessed audit in regards to the use of the checklist. The CB explained their process to ANAB’s team lead and

based on the information and clarification ANAB withdrew the NCR.

Note; this is from an AS9110 initial witnessed audit

Appeals in italics were provided previously.

Appeals in bold are new.

Page 27: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A63 – Received Nov 2009 – Pending CB appealed an NCR issued during an office

assessment in regards to how they are managing 9104 requirements within one office.

ANAB is discussing the issue with the CB.

Appeals in italics were provided previously.

Appeals in bold are new.

Page 28: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A64 – Received Nov 2009 – WITHDRAWN ANAB issued an NCR during an AS9100 witnessed

audit in regards to the organization’s procedure not identifying an “interval” for internal audits and the CB not documenting it as an NCR. The CB provided evidence to show the organization’s procedure said annually.

Based on the evidence ANAB withdrew the NCR.

Appeals in italics were provided previously.

Appeals in bold are new.

Page 29: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Aerospace Appeals

A65 – Received Dec 2009 – Scheduling Hearing ANAB issued an NCR during an AS9100 witnessed

audit in regards to the CB’s certificate to the organization not including all addresses.

Pending Hearing

Appeals in italics were provided previously.

Appeals in bold are new.

Page 30: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB Office Assessments & Witnessed Audits

Office Assessments43 required and completed

35 Annual 8 Follow-up

Witnessed Audits39 required and completed

35 Annual 4 increased surveillance

Page 31: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

ANAB 2009 NCR’s

Office Assessments 46 NCR’s to aerospace requirements during 37 office

assessments7 major & 39 minor

– 3 minor escalated to major due to timing

177 NCR’s to ISO 17021 or general requirements during 37 office assessments23 majors & 154 minors

– 13 additional minors escalated to majors due to CA timing

Witnessed Audits 91 NCR’s issued during 37 witnessed audits

19 majors & 72 minors– 6 minor escalated to majors due to CA timing– 6 minors decreased to OFI’s based on evidence provided by CB

Page 32: ANSI-ASQ National Accreditation Board ANAB AQMS Accreditation Activity 2009 Lori Scheid-Gillespie Manager, ANAB Accreditation.

ANSI-ASQ National Accreditation Board

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