1. EN/AS/SJAC 9101 Re-Write
EN/AS/SJAC 9101 Audit Process Coordination Draft
IAQG Working Group
Prepared by:
Tony Marino
The Boeing Company
Supplier Quality

2. Situation Target Proposal
Current mandatory use and completion of the 9101 Checklist drives undesirable results:
Inhibits process approach.
Focus of auditor becomes completing the checklist.
Time intensive.
Takes time away from actual auditing.
Provide guidance on process auditing and development of a 9100, 9110, and 9120 audit tool or tools that promotes/supports process approach readiness reviews, audit planning, and QMS assessment.
Proposal
In lieu of the current 9101 Checklist, or in the absence of Certification Body (CB) developed tools, develop an example of a multi-purpose process based audit tool that facilitates:
Process-based intelligence gathering (Stage 1, Surveillance and/or Re-Certification).
Stage 1 Assessment/Analysis and Audit Planning (Stage 2, Surveillance and Re-Certification).
Development of a performance-based, process-oriented process or generic questionnaire.
Capture of objective evidence of process effectiveness and conformance.
Draft Working Team
1/17/2019
Sheet 1 of 2

3. The Triple Challenge
Balancing the implementation of a process-based audit with the need for
Adequate audit records which meet stakeholder needs, while
Driving out complexity and moving toward simplicity.
Draft Working Team
1/17/2019

4. Proposed Major Changes to 9101
Elimination of Scoring and “Key Requirements” designation.
Recognition that the “checklist” is a tool.
A reference or “memory jogger” for the assessor.
A repository for auditor notes – not a mandatory objective evidence repository.
A record of conformance status and audit plan completion.
CB Tools that accomplish the same objectives are acceptable – but, shall become part of the audit report/record.
Introduction of the Process Matrix.
Move “Guidance Notes” on “checklist” to an appendix.
Introduction of the “Effectiveness Assessment Record” form.
Conformance and Effectiveness will be considered when considering initial, sustaining and recertification recommendation.
Draft Working Team
1/17/2019

5. What has not Changed Determining conformance to the standard.
Nonconformance discovered during the audit are to documented.
Based on information collected during the assessment, the auditor will have to draw conclusions on conformance (and effectiveness) of the organizations quality management system.
Draft Working Team
1/17/2019

6. Core, Support & Foundation
Process 101
Inputs
Output
Definition
and
Measures
Linkage
To Next
Planned
Core, Support & Foundation
Processes
Actions
Draft Working Team
1/17/2019

7. Our Development Model for a Process-Based 9101
Process Approach
Audit
Records
Tools
Process-Based Auditing
Evidence of Conformance
Evidence of Effectiveness
Inputs
Output
Core, Support & Management
Processes
Effectiveness Focused
Draft Working Team
1/17/2019

8. What is Effectiveness? What does this mean to you? 1/17/2019
Extent to which planned activities are realized and planned results achieved
Reference ISO 9000 Quality management systems - Fundamentals and vocabulary
A measurement related to how well the processes yield meets the needs of the customer requirements or
specification (i.e. on-time delivery, observance of specifications or procedures, accurateness, and total
customer satisfaction, six sigma, or TCS), levels as well as how cost efficient any given product or process
is to run and maintain. Linked mainly to a customer satisfaction statement, but can also be related to a process
and the like.
Can be measured by using value adding activities vs non-value adding activities.
Reference Six Sigma SPC's Quality Control Dictionary and Glossary
What does this mean to you?
Draft Working Team
1/17/2019

9. Questions on Effectiveness
Planned activities are not realized and desired results not achieved – Effective?
Planned activities are not realized but desired results achieved – Effective?
Planned activities are realized but desired results not achieved – Effective?
Planned activities are realized and desired results achieved – Effective?
Draft Working Team
1/17/2019

10. Leading Indicators of Ineffective Quality Management Systems
Customer of the organization has onsite resident teams.
Increased customer 2nd party assessment activities.
High nonconformance rates.
High escape rates to the customer.
Late deliveries.
Draft Working Team
1/17/2019

11. The Gains
Emphasizes process approach with organizations, as well as assessors/
Shifts energies from completing the checklist to determining and documenting conformance and effectiveness of processes.
Provides useful information to stakeholders concerning process performance and history.
Draft Working Team
1/17/2019

12. Schedule Goal is to release in conjunction with AS9100
Coordination Draft comments July 6, 2008
Comment Review and Disposition July 8-11, 2008
Beta Testing (CB) August, 2008
Beta Testing Process Check August, 2008
Comment Review and Disposition September, 2008
Training Requirements Development October, 2008
Competency Requirements Development October, 2008
IAQG Balloting November, 2008
Release Mid November, 2008
Goal is to release in conjunction with AS9100
Draft Working Team
1/17/2019

13. Questions