Académique Documents
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Changes Overview
April 2010
Company Confidential
Presentation Objectives
Part one: Provide an overview of: 9101 Team Membership 9101 Revision Process 9101:2009 Key Changes 9101 Implementation Schedule Part two: Provide details of: 9101 content of audit and certification processes
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9101 Stakeholders
Civil Aviation Industry and Authorities Defense Industry and Authorities Space Industry and Authorities Certification/Accreditation Bodies Auditors Suppliers IAQG Member Companies IAQG Strategy Streams and Teams
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NCRs
Auditing Company Name
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Process-Based Auditing
Controls
PEARs
Effectiveness Assessment Record
1Organization: 3Site: 2Report 4Issued
Number: Date:
Organization: Site/OIN:
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Objective Evidence:
Inputs
Signature:
15 Auditee Representative Acknowledgement Name: Signature: 17
Outputs
7Support
8Statement
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
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Due Date:
14 Auditor NAME: 7
SECTION 2- AUDITEE PLANNED ACTIONS (Attach separate sheet, as needed.) Containment Action(s), including correction, with supporting completion date(s): Planned Completion Date: Actual Completion Date: Cause Code:
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Root Cause:
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Resources
10Objective
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7/25
23 Actual Completion Date: Auditee Representative Date: Name and Signature: Auditor Signature for Date: Acceptance of C/A(s): SECTION 3 - DETAILS OF AUDITOR VERIFICATION OF ACTION:
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7/26
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Signature indicates that all relevant requirements (including requirements f or support processes identif ied in Block #7) have been assessed to determine ef fectiveness of the core or support process identif ied in Block #5.
Performance Focused
Evidence of conformity
Evidence of effectiveness
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CP 1: Customer driven
Customer focus (4.1.2.1: evaluation of customer satisfaction based on performance information and feedback Customer QMS requirements to be audited also Audit focus on processes that directly impact the customer Customer importance must be reflected in the planned audit time Information and review of customer satisfaction and complaint status and processing
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CP 3: Organization Performance
Identifies process, output and improvement
Performance measuring and monitoring, e.g. KPIs, on Quality and On-Time Delivery (OTD) Performance targeting Measuring Improvement Fulfilling customer expectations
Organizational Leadership:
review of top management commitment and role in establishing the QMS, policies, objectives, performance targets/measuring, implementation, and continual improvement
Process Management:
use of audit trails, interactions/sequence (interfaces), process controls
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Continual improvement:
Evaluation of the organizations interrelated processes and activities for continual improvement of the quality management system, its processes, their conformity, and effectiveness
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CP 5: QMS effectiveness*
Evaluation of effectiveness of the quality management system and its associated processes:
Fulfilling customer expectations? Delivering quality products, on time? Improving Continually? As part of the QMS requirements conformity audit!
Use of Process Effectiveness Assessment Report (PEAR)
* ISO 9000: Extent to which planned activities are realized and planned results achieved
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CP 6: Improved reporting
Standardized methods for reporting of audit results:
Reduced variation, and more consistent interpretation of audit results Easier to read/understand for all stakeholders, including customers and assessors(oversight) More effective and efficient supplier surveillance Provides focused improvement for the audited organization
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ge Pa 24 1/
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9101 Publication :
9101:2009 published : March 2010 Deployment support materials :
Press Release, FAQs*, Overview of changes April 2010 Examples of PEAR cases + filled-in Forms Guidance for auditors* : (what to look for, what to ask for) May 2010 June 2010
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Implementation
Transition schedule:
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Summary
From clause/element based auditing to process based auditing Not only conformity auditing but also effectiveness Actual organization output performance, customer satisfaction and product quality are the main drivers and input for the audit Improved, standardized reporting
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Questions?
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9101:2009 Details
Part two
Detailed information
Note 1: The key changes are not inclusive of all the changes in the new 9101 Note 2: the requirements in 9101, as summarized in this presentation, are in addition to ISO19011 and 17021
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References:
9101 is an addition to 17021 and 19011 (overarching) ISO 19011 is added as reference: to be used mandatory, not as guideline!
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Navigation tool
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Relationship:
Audit Phase (4.3) Pre-Audit Activities (4.3.1) X Stage 1 Stage 2 Surveillance (4.3.2) (4.3.3) (4.3.4) X X X X X X X X X X X Re-Certification (4.3.5) X X X X
Common Activities (4.2) Audit Planning (4.2.1) On-site Auditing (4.2.2) Audit Reporting (4.2.3) Non-Conformity Mgmt (4.2.4)
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During the audit, the use of relevant audit methods, as described in clause 4.1.2, shall be considered.
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Site tour:
to address any changes in scope or facilities since the last visit, or to familiarize (new) audit team members with the organizations activities.
Audit conduct*:
Use of audit methods(4.1.2) and audit trails
Closing Meeting *
Information on NC-process, complaints, team recommendation
* In addition to ISO 19011 /17021
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c) Verify for outsourced special processes if the organizations supplier control process addresses these items accordingly.
The completed QMS Process Matrix shall be part of the audit record.
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All forms have instructions attached Exclusions to be included in stage 1 and 2 report
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4.3
Any additional requirements/requests from the organization and/or the organizations customer(s) Ensure that audit time is identified in accordance with ISO 17021 [see clause 9.1.4] and 9104 Determine access to proprietary or classified information, and/or areas due to the competitive sensitivity or national security regulations (ITAR,EAR)
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4.3
Performed by audit team leader, plus additional members if needed On-site visit, including site tour, mandatory (except for 9120), for multi-sites sample of similar sites + central function(s) Information collection, needed to determine readiness, audit plan for stage 2 and audit team composition:
quality manual; description of processes showing their sequence and interactions, NOTE : Processes can be depicted in various ways [e.g., process maps, turtle diagrams, SIPOC method (breakdown of supplier, inputs, process steps/tasks, outputs, customer), octopus]. performance measures and trends for the previous 12 months; evidence that the requirements of the applicable 9100-series QMS standards are addressed by the organizations documented procedures (e.g., by referencing them in the quality manual or by using a cross reference);
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4.3
Collection of information(cont.):
interactions with support functions on-site or at remote locations/sites; evidence of internal audits of processes/procedures, including internal and external QMS requirements; the latest management review results; list of all major (e.g., top five) customers requiring 9100series standard compliance, including an indication of the related business volume, and specific customer QMS requirements, if applicable; and evidence of customer satisfaction and complaint summaries, including verification of customer reports, scorecards, and special status or equivalent.
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4.3
4.3
4.3
Stage 1 and Stage 2 audits not performed on the same day or on consecutive days (back to back). the elements and processes of the QMS to be audited for conformity (see Appendix D), and effectiveness. Detailed audit findings, including reference to the audited processes, process documentation, and associated records, to be documented (see clause 4.2.2.5). To reconfirm during the opening meeting the issues identified during the Stage 1 audit (see clause 4.3.2) After the opening meeting to: decide on conducting a facility tour to review substantial changes in scope or facilities, since the last visit; and revise planning, as needed, due to organization changes since the Stage 1 audit. All nonconformities shall be closed and verified by the audit team before a recommendation for certification can be made.
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4.3
All clauses of the QMS standard(s) (except exclusions) and the organizations processes that are part of the QMS to be audited during surveillance within one certification cycle Audit method(s) to be used (e.g., audits on specific problems, areas, products, or sub-processes) to be based on the outcome of the audit teams review of QMS performance data. Audit plan for the surveillance audit shall take consideration of changes in the organization (see clause 4.2.1). Composition of the audit team to be based on the audit plan for the surveillance audit. Audit plans for surveillance to be based on continuing operational control of process and on product performance indicators and trends for the previous 12 months (both for quality and OTD). All findings shall be documented (see clause 4.2.2.5). To advise in the audit report (see Appendix E) whether the recorded nonconformities should be reason for suspension of the certificate. Failure to demonstrate effective corrective action to deal with repeat nonconformities, the lack of actual performance data, or lack of operational control shall warrant suspension of the certification.
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USE OF APPENDICES
9101 FORMS AND TEMPLATES (Appendices) AUDIT PHASES
A
OER
B
NCR
C
PEAR
D
Matrix
E
AR
F
AR
G
SAR
() * * *
() () ()
* or equivalent () Optional use
Objective Evidence Record (OER) Nonconformity Report (NCR) Process Effectiveness Assessment Report (PEAR) QMS Process Matrix Report Stage 2, Surveillance, & Re-certification/Approval and Special Audit Report (AR) Stage 1 Audit Report (AR) Supplemental Audit Report (SAR)
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Questions ??????
FAQs and answers can be found on
http://www.iaqg.sae.org/iaqg/organization/requirements.htm under Deployment Support Material: 9101 FAQs
Company Confidential