9101 Forms July 20-21, 2016 9101 Revision Team Paul Dionne Jeanette Preston Brian Geer

Subtle Disclaimer This material is not for training and was created for workshop discussion purposes. It is not intended to be perfect, however any mistakes or omissions are a figment of your imagination.

Workshop Session Agenda 9101F changes affecting forms Special Audits Recording objective evidence : What are the expectations? QMS matrix PEAR including PEM Audit report Q&A Introductions, agenda, session rules i.e. turn off cell phones, lap tops down, one conversation at a time. Status that Rev F is complete through balloting and will be published in all sectors in the fall Scope To introduce some changes in 9101F while explaining documentation expectations for both standards and special audits. Even though 9101F hasn’t published yet, there are principles from this session and can be used today. Also cover time is a premium and this session has set timing. Any issues or questions that can’t be resolved will be captured on a parking lot list. Responses will be provided later after the workshop via email.

9101F what is new? Updated to allow the recording of process information into a combined QMS Process Matrix Report New explicit requirement to verify the effectiveness of corrective actions taken for nonconformities during the previous audit Clarified the requirement for the audit team leader to provide the organization with applicable NCR(s) and PEAR(s) associated with those NCRs Clarified the reasons for conducting a Special Audit Bullet 2 More flexibility when common processes exist also provides more unified audit reporting Bullet 4 To strengthen the verification of correction action during subsequent audits (if applicable) and to align with a new requirement in ISO17021-1 clause 9.4.8.2 r

9101F Forms what is new? General Removed most signature boxes Updated terms to meet ISO 9001 and 17021 Form 1 (Stage 1 Audit Report): ”Key Requirements” replaced with “Confirmation of Requirements” and now includes a listing of 9100- series clause numbers & titles Form 2 (QMS Process Matrix Report): Clarified when “N/A” and ‘empty boxes’ can be utilized in populating the matrix 1 QMS matrix use on common processes for multiple sites, campus ETC Form 1 To provide more consistency when confirming requirements agains the 9100 series standards Form 2 – Streamlining and use of OASIS NextGen, To allow combined reporting for multiple sites, campus, several sites or complex organizations

9101F Forms: what is new? Forms 5 and 6 (Audit Report and supplemental audit report) Box added to signify Integrated Audit (Yes/No) Inclusion of a statement to verify the effectiveness of corrective actions taken for nonconformities identified during the previous audit Clarified statement for the audit team leader’s certification recommendation Audit type expanded to include reason for “Special Audit” Forms 5 and 6 To provides more consistency when recommending the certification decision To support OASIS NextGen

Special Audit

What is a special audit? It is not part of the audit program, it can be applicable after initial certification, when directed by special request. It is not part of nonconformity management!

When can a special audit be conducted? The requirements of ISO/IEC 17021-1 clause 9.6.4 apply Per AS9101F section 4.3.6: a. an organization's request to revise their existing certification scope, certification structure, number of site(s) and/or location(s); and b. transferring certification from one CB to another (see 9104/1 clause 8.8). NOTE: A special audit can also be conducted in response to a customer or other relevant interest party request, when a serious issue (supported by objective evidence) has been identified.

How many audit days are required? Table 2 – Audit Duration Requirements of AS9104/1 is not utilized Audit duration is dependent on the situation and is determined by the CB Audit duration shall be justified and documented utilizing the audit planning process

What activities required of special audit?

What forms do you use and when?

What can be the results of Special Audit? Nonconformity(ies) may be issued (follow the nonconformity management process) Recommendation recorded (Form 5)

Do Special Audits get entered into OASIS?

Recording Objective Evidence QMS matrix

Recording Objective Evidence Audit Reports

Recording Objective Evidence PEAR

Process evaluation 9101 clause 4.2.2.5.1 9101 clause 4.2.2.5.2 Audit of Operational processes (9100-series clause 8) 9101 clause 4.2.2.5.1 Record process performance results on the PEAR (Section 2) Record process realization results on the PEAR (Section 3) 9101 clause 4.2.2.5.2 Issue an NCR when the process is not delivering the planned results and appropriate action is not being taken Issue an NCR when planned activities of a process are not realized or not fully realized 9101 clause 4.2.2.5.3 Evaluate the audit evidence from the PEAR and select the corresponding effectiveness value from the PEM 30

9101 Forms Effectiveness levels 3 4 2 31

3 4 2 9101 Forms Audit findings and resultant effectiveness level Process Results NCR(s) have not been issued NCR(s) have not been issued 3 4 2 NCR(s) have been issued related to Process Realization Process Realization and Process Results Process Realization NCR(s) have been issued related to Process Results NCR(s) have been issued related to Process Realization and Process Results 32

Wrap Up http://www.sae.org/iaqg/ Group input / Q&A – Open Discussion Forms location http://www.sae.org/iaqg/

Backup slides

Updated PEM Assessment Levels 1 & 2 9101 Key Revision Detail Level 2 here means that the process is determined and planned activities are partly or fully realized. The process however is not delivering the planned results and appropriate action is not being taken. Updated PEM Assessment Levels 1 & 2 Level 1 means that the process is not determined and planned activities are not realized. Furthermore the process is not delivering the planned results and appropriate action is not being taken. Level 2 here means that the process is not determined and planned activities are not realized. The process however is delivering the planned results or if not, appropriate action is being taken. 36

Updated PEM Assessment Levels 3 & 4 9101 Key Revision Detail Level 4 here means that the process is determined and planned activities are fully realized. The process however is not delivering the planned results but appropriate action is being taken. Updated PEM Assessment Levels 3 & 4 Level 4 here means that the process is determined but planned activities are not fully realized. The process however is delivering the planned results. Level 3 means that the process is determined but planned activities are not fully realized. The process however is not delivering the planned results but appropriate action is being taken. 37

Updated PEM Assessment Level 5 9101 Key Revision Detail Updated PEM Assessment Level 5 Level 5 means that the process is determined and planned activities are fully realized. Furthermore the process is delivering the planned results. 38