AS 9101 E Documentation and Execution Brian Geer

AS 9101 E 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 • 9101 E 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 9101 E: The PEAR is used to collect objective evidence for Product realization clauses. Added fields in the Process Matrix report are used for other clauses 9101 D: The PEAR and OER are used for collection of Objective Evidence and Process effectiveness information 5

PEARs and the QMS Matrix 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. 9

Key Changes: Definitions Effectiveness? Extent to which planned activities are realised and planned results achieved Source: ISO 9000 -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. S S E • Understanding if E E F F N E V I CT 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 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 -17 th 2014 16

Questions? 17

CASE STUDY EXAMPLES 18

PEAR 1 19

PEAR 1 20

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PEAR 2 22

PEAR 2 23

Process Evaluation Matrix (PEM) 24

QMS Matrix 25

QMS Matrix 26

Thank you 27