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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. Situation. Target.

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En as sjac 9101 re write l.jpg

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


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Situation Target Proposal

Situation

Target

  • 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


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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


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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


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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


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Inputs

Output

Output

Definition

and

Measures

Linkage

To Next

Planned

Inputs

Core, Support & Foundation

Processes

Actions

Process 101

Draft - 9101 Working Team


Our development model for a process based 9101 l.jpg

Process-Based Auditing

Our Development Model for a Process-Based 9101

Process Approach

Audit

Records

Tools

Evidence of Conformance

Evidence of Effectiveness

Inputs

Output

Core, Support & Management

Processes

Effectiveness Focused

Draft - 9101 Working Team


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What is Effectiveness?

Extent to which planned activities are realized and planned results achieved

Reference ISO 9000Quality 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


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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


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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


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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


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Schedule

  • Coordination Draft comments July 6, 2008

  • Comment Review and Disposition July 8-11, 2008

  • Beta Testing (CB)August, 2008

  • Beta Testing Process CheckAugust, 2008

  • Comment Review and DispositionSeptember, 2008

  • Training Requirements DevelopmentOctober, 2008

  • Competency Requirements Development October, 2008

  • IAQG BallotingNovember, 2008

  • ReleaseMid November, 2008

Goal is to release in conjunction with AS9100

Draft - 9101 Working Team


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Questions


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