Transcript AS9101 Documentation and Execution
AS 9101E Documentation and Execution
Brian Geer (Lockheed Martin) Paul Dionne (ABS QE) 9101 Revision Team AAQG Auditor Workshop Long Beach CA July 16,17 2014 Company Confidential 1
Agenda
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9101E Key Revision Summary
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Process Effectiveness Assessment Report (PEAR) – more structure
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Process Evaluation Matrix - new
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Quality Management System (QMS) Process Matrix – places for Objective evidence
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Definitions- Added to support ISO 9000 definition of effectiveness
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Case study with PEAR and Process Matrix examples
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Q&A 2
PEARs and the QMS Process Matrix
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Objective Evidence is recorded on PEAR’s for all Clause 7 related processes.
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The Pear has 3 areas for collection of Objective evidence:
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Section 1 - Process Details: Inputs, Activities, Outputs and Interactions
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Section 2 – Process Results includes the identification of performance measures and KPIs.
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Section 3 - Process Realization summarizes audit trails and sources of evidence 3
PEARs and the QMS Process Matrix
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Objective Evidence is recorded on the QMS Matrix for non clause 7 related processes.
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Additional fields have been added at the end of clauses 4,5,6 and 8 for this purpose
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Clause 7 evidence will still be captured on the PEAR Why the change ? The Objective Evidence Report is no longer required 4
PEARs and the QMS Matrix
9101E: The PEAR is used to collect objective evidence for Product realization clauses. Added fields in the Process Matrix report are used for other clauses 9101D: The PEAR and OER are used for collection of Objective Evidence and Process effectiveness information
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9101 FORM 3: PROCESS EFFECTIVENESS ASSESSMENT REPORT
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CB Name
PROCESS EFFECTIVENESS ASSESSMENT REPORT
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CB Logo
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CB Name
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Organisation:
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Site(s):
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PEAR Number: Audit Report Number: SECTION 1
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– PROCESS DETAILS ASSESSMENT REPORT
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Organisation:
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Site(s):
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AQMS Standard(s):
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PEAR Number: 7 SECTION 1 – PROCESS DETAILS 9100
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Audit Report Number:
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Inputs: 9110
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9120 Issue Date:
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Process Name:
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AQMS Standard(s): 9100
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9110
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9120
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Inputs:
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Applicable 9100/9110/9120 clause(s): Activities: Outputs: Applicable 9100/9110/9120 clause(s):
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Activities:
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Outputs: 14 Interactions/Interfaces: 14 Interactions/Interfaces: SECTION 2 – PROCESS RESULTS SECTION 2 – PROCESS RESULTS
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Organisation’s method for determining process results:
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KPI 1: KPI 1: KPI 2: KPI 2: KPI 3: KPI 3:
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Auditor observations and comments supporting process result determination: Reference KPI 1: Target for Audited Period Audited Period Comments Target for Audited Period Value Measured for Audited Period Comments KPI 2: KPI 3: KPI 1: KPI 2: KPI 3:
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OIN(s):
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Issue Date: 6
AAQG Auditor Workshop Long Beach CA July 16,17 2014 7
PEARs and the QMS Matrix
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A PEAR is required for all product realization processes audited
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Objective evidence is recorded on the PEAR for product realization processes; can include objective evidence from other clauses related to the audited process
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For non product realization processes, objective evidence is recorded on the QMS Matrix report 8
Key Changes -NCRs PEAR’s and the PEM
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NCRs will be required for processes with an effectiveness level of “1” but no longer required for a level of “2”
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It is expected Nonconformities would be discovered within the process if rated a 2
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MOTL (more on that later)
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It is possible to have an NCR within the process and still have an effectiveness level of 3.
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Key Changes: Definitions
Effectiveness?
Extent to which planned activities are realised and planned results achieved
Source: ISO9000-2005
Key Changes: Definitions
Planned Activities?
The means, methods, and internal requirements by which an organisation intends to achieve planned results of a given process to meet customer requirements. Planned activities include conformity to process requirements and procedures
This is how the organization intends to achieve planned results Source AS/EN/SJAC 9101 Rev E
Key Changes: Definitions
Planned Results?
The intended performance of a process, as defined and measured by the organisation. Planned results include product conformity and OTD to meet customer requirements, and may include other elements as defined by the organisation
This is what the organization plans to achieve Source AS/EN/SJAC 9101 Rev E
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Designed to aid the auditor in determining process effectiveness level.
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Understanding if appropriate action is being taken is key.
PERFORMANCE
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Process Evaluation Matrix (PEM)
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Summary
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The OER is no longer required
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Objective Evidence will be recorded on the PEAR and the QMS process Matrix
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Definitions of planned activities and planned results have been added.
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No Required NCR at effectiveness level of “2”
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Forms will no longer be part of the standard and will appear online. 15
Case study and examples
What follows is a case study with an example of the QMS process matrix and a PEAR.
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The QMS Process Matrix will show how additional evidence is collected in lieu of the Objective Evidence Report.
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The PEAR will be presented with two Possible outcomes for the rating. This should allow for a good discussion of the elements of effectiveness. RMC Workshop Long Beach CA July 16-17 th 2014 16
Questions?
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CASE STUDY EXAMPLES
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PEAR 1
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PEAR 1
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PEAR 2
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PEAR 2
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Process Evaluation Matrix (PEM)
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QMS Matrix
9101 FORM 2: QMS PROCESS MATRIX REPORT Clauses (* = not applicable for 9120) 1 2 3 4 5 12 Conformity 6 7 8 9 10 11 12
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NCR Number 4. Quality Management System
4.1 4.2 4.2.1 General Requirements Documentation Requirements General
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C N/A N/A N/A N/A 4.2.2 4.2.3 Quality Manual Control of Documents C C N/A C NA N/A 4.2.4 Control of Records
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NCR# 2 mi 14 Summary of Objective Evidence: Evaluated Quality Manual #QM0001 dated November 2, 2013 Rev. 3, Evaluated Internal Audit procedure IA-101, documentation reviewed and approved by senior management. Evaluated the following records: (4) Purchase Orders and (5) Receiving Documents/ Certificates of Conformity Corrective Action Reports. NCR#2 issued to Purchasing process – R12456, R32290, R65574, R23349, and R22957. Purchase Orders [refer to PEAR reports for detail document numbers]. TEI Database includes all records including the Supplier ASL, – ASL records not maintained – approved supplier (the Casting Company) not added to latest ASL report. 5. Management Responsibility
5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.4.3 5.5 5.5.1 5.5.1.1 Management Commitment Customer Focus Quality Policy Planning Quality objectives Quality Management System Planning Safety Objectives
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Responsibility, Authority, and Communication Responsibility and Authority Accountable Manager
(9110 only)
C C C C C N/A C N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A C C N/A N/A N/A N/A
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QMS Matrix
9101 FORM 2: QMS PROCESS MATRIX REPORT 1 2 3 4 5 6 7 8 9 10 11 12
5.6 5.6.1 Management Review General C N/A N/A 5.6.2 5.6.3 Review Input Review Output N N N/A N/A N/A N/A
NCR# 1 mi NCR# 1 mi
5.7 Safety Policy
(9110 only)
N/A N/A N/A
14 Summary of Objective Evidence: Evaluated the TEI 2013 and 2014 Management Review reporting. Reporting is set up on templates that include the mandatory AS9100C inputs (5.6.1) and the output reporting is also in template format that includes results for each of the mandatory inputs and output (5.6.3). NCR# 3 minor issued nonconformance. – Customer Feedback information is not included in the Management Review Input data or the reporting reviewed (2013 or 2014). Refer to NCR form for specifics on this 6. Resource Management
6.1 6.2 6.2.1 6.2.2 Provision of Resources Human Resources General Competence, Training and Awareness N/A N/A N/A C N/A N/A C C C 6.3 Infrastructure N/A N/A C 6.4 Work Environment N/A N/A C
14 Summary of Objective Evidence: Evaluated the training records for internal auditors. Adequate records – in accordance with TEI requirements for internal auditors. Facility is well maintained, clean and organized. Evaluated room for Supplier Improvement Meetings – adequate resources for these activities. 7. Product Realisation
7.1 7.1.1 7.1.2 7.1.3 Planning of Product Realisation Project Management
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Risk Management * Configuration Management
(7.1.1 for 9120)
N/A N/A N/A N/A N/A N/A N/A N/A N/A NA N/A N/A NA
Clauses 12 Conformity
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NCR Number 26
Thank you
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