AS 9101E
Documentation and Execution
Brian Geer (Lockheed Martin)
Paul Dionne (ABS QE)
9101 Revision Team
Company Confidential
AAQG Auditor Workshop
Long Beach CA July 16,17 2014
1
Agenda
• 9101E Key Revision Summary
• Process Effectiveness Assessment Report
(PEAR) – more structure
• Process Evaluation Matrix - new
• Quality Management System (QMS) Process
Matrix – places for Objective evidence
• Definitions- Added to support ISO 9000
definition of effectiveness
• Case study with PEAR and Process Matrix examples
• Q&A
2
PEARs and the QMS Process Matrix
•
Objective Evidence is recorded on PEAR’s for all
Clause 7 related processes.
•
The Pear has 3 areas for collection of Objective
evidence:
•
Section 1 - Process Details: Inputs, Activities, Outputs and
Interactions
•
Section 2 – Process Results includes the identification of
performance measures and KPIs.
•
Section 3 - Process Realization summarizes audit trails
and sources of evidence
3
PEARs and the QMS Process Matrix
•
Objective Evidence is recorded on the QMS Matrix
for non clause 7 related processes.
•
Additional fields have been added at the end of
clauses 4,5,6 and 8 for this purpose
•
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
5
9101 FORM 3: PROCESS EFFECTIVENESS ASSESSMENT REPORT
1
3
2
CB Name
PROCESS EFFECTIVENESS
ASSESSMENT REPORT
4
CB Logo
5
OIN(s):
8
Issue Date:
PEARs and the QMS Matrix
Organisation:
6
7
Number:REPORT
9101 FORM 3: PROCESS EFFECTIVENESSPEAR
ASSESSMENT
1
2
CB Name
3
Organisation:
6
PEAR Number:
10
12
4
7
10
Site(s):
AQMS
5
Standard(s):OIN(s):
9100 ☐
Audit Report Number:
AQMS Standard(s):
9110 ☐
Applicable 9100/9110/9120 clause(s):
9110 ☐8 Issue9120
☐
Date:
11
Inputs:
12
Activities:
13
Outputs:
14
Interactions/Interfaces:
9120 ☐
Applicable 9100/9110/9120 clause(s):
Inputs:
Activities:
13
Outputs:
14
Interactions/Interfaces:
SECTION 2 – PROCESS RESULTS
SECTION 2 – PROCESS RESULTS
15
CB Logo
Process Name:
9100 ☐
11
Audit Report Number:
SECTION 1 – PROCESS DETAILS
PROCESS EFFECTIVENESS
9
ASSESSMENT
REPORT
Process
Name:
SECTION 1 – PROCESS DETAILS
9
Site(s):
15
Organisation’s method for determining process results:
Organisation’s method for determining process results:
16
16
Performance Measures
KPI 1:
KPI 2:
KPI 3:
17
Performance Measures
KPI 1:
KPI 2:
KPI 3:
17 process result determination:
Auditor observations and comments supporting
Reference
KPI 1:
KPI 2:
KPI 3:
Auditor observations and comments supporting process result determination:
Target for
Audited Period
Value Measured for
Audited Period
Reference
Comments
Target for
Audited Period
Value Measured for
Audited Period
Comments
KPI 1:
KPI 2:
KPI 3:
6
AAQG Auditor Workshop
Long Beach CA July 16,17 2014
7
PEARs and the QMS Matrix
• A PEAR is required for all product realization
processes audited
• Objective evidence is recorded on the PEAR for
product realization processes; can include
objective evidence from other clauses related
to the audited process
• For non product realization processes,
objective evidence is recorded on the QMS
Matrix report
8
Key Changes-NCRs PEAR’s and the PEM
• NCRs will be required for processes with an
effectiveness level of “1” but no longer required
for a level of “2”
– It is expected Nonconformities would be discovered
within the process if rated a 2
– MOTL (more on that later)
• 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
CONFORMANCE
• Designed to aid the
auditor in determining
process effectiveness
level.
• Understanding if
appropriate action is
being taken is key.
PERFORMANCE
13
Process Evaluation Matrix (PEM)
14
Summary
• The OER is no longer required
• Objective Evidence will be recorded on the PEAR
and the QMS process Matrix
• Definitions of planned activities and planned
results have been added.
• No Required NCR at effectiveness level of “2”
• 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.
• The QMS Process Matrix will show how
additional evidence is collected in lieu of the
Objective Evidence Report.
• 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 16-17th 2014
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Questions?
17
CASE STUDY
EXAMPLES
18
PEAR 1
19
PEAR 1
20
21
PEAR 2
22
PEAR 2
23
Process Evaluation Matrix (PEM)
24
QMS Matrix
9101 FORM 2: QMS PROCESS MATRIX REPORT
12 Conformity
Clauses
(* = not applicable for 9120)
1
2
3
C
N/A
N/A
4.
Quality Management System
4.1
General Requirements
4.2
Documentation Requirements
4.2.1
General
C
N/A
N/A
4.2.2
Quality Manual
C
N/A
NA
4.2.3
Control of Documents
C
C
N/A
4.2.4
Control of Records
C
C
N
4
5
6
7
13
8
9
10
11
NCR Number
12
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 – 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,
Corrective Action Reports. NCR#2 issued to Purchasing process – ASL records not maintained – approved supplier (the Casting Company) not added to latest
ASL report.
5.
Management Responsibility
5.1
Management Commitment
C
N/A
N/A
5.2
Customer Focus
C
N/A
N/A
5.3
Quality Policy
C
N/A
C
5.4
Planning
5.4.1
Quality objectives
C
N/A
C
5.4.2
Quality Management System Planning
C
N/A
N/A
5.4.3
Safety Objectives (9110 only)
N/A
N/A
N/A
5.5
Responsibility, Authority, and
Communication
5.5.1
Responsibility and Authority
C
N/A
N/A
5.5.1.1
Accountable Manager (9110 only)
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
Management Review
5.6.1
General
C
N/A
N/A
5.6.2
Review Input
N
N/A
N/A
NCR# 1 mi
5.6.3
Review Output
N
N/A
N/A
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 – 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
nonconformance.
6.
Resource Management
6.1
Provision of Resources
6.2
Human Resources
6.2.1
N/A
C
C
General
N/A
N/A
C
6.2.2
Competence, Training and Awareness
N/A
N/A
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
Planning of Product Realisation
N/A
N/A
NA
7.1.1
Project Management *
N/A
N/A
N/A
7.1.2
Risk Management *
N/A
N/A
N/A
7.1.3
Configuration Management
(7.1.1 for 9120) N/A
N/A
N/A
NA
Clauses
12 Conformity
13
NCR Number
26
Thank you
27