Company Confidential 1

IAQG 9101:2009 Revision Workshop

Prepared by IAQG 9101 TeamPrepared by IAQG 9101 TeamRev: 0 Dated: 16 April 2010Rev: 0 Dated: 16 April 2010

““It’s All About Performing”It’s All About Performing”

Quality Management Systems Audit Requirements for Aviation, Space, and Defense Organizations

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9101 Team Charter9101 Team Charter

“Revise 9101 to align with the next revision of 9100 and upcoming ISO 17021, review scope and identify any additional stakeholder needs and restructure the standard for a more process-based assessment approach to auditing an organization’s quality management system.”

13 Members on the 9101 Team representing:

• Americas, Europe, and Asia-Pacific IAQG Sectors

• 6 Different Countries

• 8 IAQG member companies

• 4 Certification Bodies

IAQG Initiative Study dated 30 Sept 2006 and presented at the IAQG meeting in Seville, Spain on 5 Oct 06.

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9101 Major Changes

• One document covering 9100/9110/9120 standards.

• Elimination of “Scoring” and “Key Requirements” designation.

• Use of Customer feedback concerning QMS Organization performance as an input for process oriented audits (e.g., OASIS, customer satisfaction/performance scores).

• In addition to conformity, also determination of Effectiveness included.

• More emphasis on performance measuring.

• Introduction of the Objective Evidence Record (OER).

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WHAT’S NEW?WHAT’S NEW?

• Expanded the Scope (QMS Audit Req’mts for Aviation, Space, Defense Orgs)

• Eliminated scoring

• Eliminated use of the clause based questionnaire (replaced by Objective Evidence Record)

• Greater emphasis on audit planning (more pre-work, on-site Stage 1 by Team Leader)

• Introduces audit methodologies

• Strengthened NCR requirements (standard form, containment, single entry, recurring finding upgrade, 30-day C/A response window)

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WHAT’S NEW?WHAT’S NEW?

• Greater Focus on evaluation of process effectiveness (use of the Process Effectiveness Assessment Record form for each audited product realization process)

• Use of a QMS Process Matrix form

• Use of Standard Audit Report forms

• Provides Special Audits criteria (in response to a customer/interested party request, scope change, certification transfer)

• Replaces existing versions of 9101, 9111 and 9121

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What has not Changed

• Determining conformity to the standard's.

• Nonconformity’s discovered during the audit are to be documented.

• Based on information collected during the audit, the lead auditor will have to draw conclusions on conformity and effectiveness of the organizations quality management system.

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Development Model for Process Based Auditing - 9101

AuditRecords

Methods/Tools

Process Approach

Process-Based Auditing

Inputs Outputs

Performance Focused

1 Auditing Company Name Nonconformity Report (NCR)

2 Auditing Company

Logo 3 Organization: 5 Site/OIN:

4 Audit Report ID/type:

4 NCR Number:

6 Issue Date:

7 SECTION 1 - DETAILS OF NONCONFORMITY: 8 Process/Area/Department:

9 Requirement/Clause No.(s): 10 Classification (ma/mi):

11 Statement of Nonconformity:

12 Objective Evidence:

13 Due Date:

14 Auditor 15 Auditee Representative Acknowledgement

NAME: Signature: Name: Signature:

7SECTION 2- AUDITEE PLANNED ACTIONS (Attach separate sheet, as needed.) 16 Containment Action(s), including correction, with supporting completion date(s):

17 Planned Completion Date:

18 Actual Completion Date:

19 Root Cause:

20 Cause Code:

21 Corrective Action(s), including supporting completion date(s): 22 Planned

Completion Date:

23 Actual Completion Date:

15 Auditee Representative Name and Signature:

Date:

24 Auditor Signature for Acceptance of C/A(s):

Date:

7/25 SECTION 3 - DETAILS OF AUDITOR VERIFICATION OF ACTION:

7/26 SECTION 4 - NCR CLOSURE (Auditor Name /Signature/Date):

27 Approved by Audit Team Leader (Name/Signature/Date):

NCRs PEARs

OER

Evidence of conformity Evidence of effectiveness

Controls

Resources

3Site: 4Issued Date:

7Support Process(es) Assessed:

69100/9110/9120 Section Reference:

5□ Core Process Assessed:

□ Support Process Assessed:

□ Foundation Process Assessed:

Effectiveness Assessment Record1Organization: 2Report Number:

8Statement of Effectiveness:

□The assessed core/support/foundation process has been determined to be effective.

□The assessed core/support/foundation process has been determined to be ineffective.

9How was process effectiveness determined (methodology)?

10Objective Evidence, Observed Conditions, Data, and Comments to Support Effectiveness Determination

11Assessment Team Leader 12Signature and Date

Signature indicates that all relevant requirements (including requirements for support processes identified in Block #7) have been assessed to determine effectiveness of the core or support process identified in Block #5.

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What is the Effectiveness of YourOrganization?

• Process not implemented; planned results are not achieved?

• Process implemented; planned results are not achieved and appropriate actions not taken?

• Process implemented; planned results are not achieved, but appropriate actions being taken?

• Process implemented; planned results are achieved?

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What is Effectiveness?

Extent to which planned activities are realized and planned results achieved

(Reference ISO 9000 Quality management systems – Fundamentals and Vocabulary)

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What will this Mean to the Auditor?

Will use client and client customer performance data to plan audit

activities.

Review and examine an organization’s “Effectiveness” from:

• The customer viewpoint; Satisfaction and performance.

• Organizational leadership goals and objectives.

• Operational processes of the organization.

Construct and follow “audit trails”.

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What will this Mean to You as an Organization?

Your QMS Organization should be able to…

• Demonstrate conformity of the QMS Organization to the standard.

• Show process mapping (identified, sequence and interaction).

• Explain process measures identified:

– Who reviews the data?

– Targets defined?

– Targets are met?

– Are the measures actionable?

– How is the data used?

• Show actions taken when product quality and on-time delivery performance targets are not met.

The ultimate measure of QMS Organizational effectiveness –

Customer satisfaction

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The Gains

• Emphasizes process approach within organizations.

• Shifts energies from completing the clause based questionnaires to determining and documenting conformity and effectiveness of processes.

• Provides useful information to stakeholders concerning process performance and effectiveness.

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9101 SUMMARY9101 SUMMARY

• 9101D represents a significant advancement to aerospace auditing. Although auditing for effectiveness has always been an expectation of the standard and to customers, the reality is that most auditors focus on process conformity to procedural requirements overlooking process results.

• Customers have long complained about “certified” suppliers that continually have poor performance issues (on-time and/or quality). This standard addresses performance in a way that has not been approached before.

• This change sets a stage for a new journey and as with any journey, there will be challenges. We must stay on course.

Company Confidential 14

QUESTIONS

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