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

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 - 9101 Working Team 1/17/2019 Sheet 1 of 2

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

Core, Support & Foundation Process 101 Inputs Output Definition and Measures Linkage To Next Planned Core, Support & Foundation Processes Actions Draft - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

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 - 9101 Working Team 1/17/2019

Questions