Registration Management Committee 9101 Forms July 20 21

Registration Management Committee 9101 Forms July 20 -21, 2016 9101 Revision Team Paul Dionne Jeanette Preston Brian Geer Company Confidential 1

Registration Management Committee 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. RMC Workshop Fort Worth Texas 21– 22 July 2016 2

Registration Management Committee Workshop Session Agenda Ø 9101 F changes affecting forms ØSpecial Audits ØRecording objective evidence : What are the expectations? Ø QMS matrix Ø PEAR including PEM Ø Audit report ØQ&A RMC Workshop Fort Worth Texas 21– 22 July 2016 3

Registration Management Committee 9101 F what is new? ØUpdated to allow the recording of process information into a combined QMS Process Matrix Report ØNew explicit requirement to verify the effectiveness of corrective actions taken for nonconformities during the previous audit ØClarified the requirement for the audit team leader to provide the organization with applicable NCR(s) and PEAR(s) associated with those NCRs ØClarified the reasons for conducting a Special Audit RMC Workshop Fort Worth Texas 21– 22 July 2016 4

Registration Management Committee 9101 F Forms what is new? Ø General • Removed most signature boxes • Updated terms to meet ISO 9001 and 17021 Ø Form 1 (Stage 1 Audit Report): § ”Key Requirements” replaced with “Confirmation of Requirements” and now includes a listing of 9100 series clause numbers & titles Ø 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 RMC Workshop Fort Worth Texas 21– 22 July 2016 5

Registration Management Committee 9101 F Forms: what is new? Ø Forms 5 and 6 (Audit Report and supplemental audit report) Ø Box added to signify Integrated Audit (Yes/No) Ø Inclusion of a statement to verify the effectiveness of corrective actions taken for nonconformities identified during the previous audit Ø Clarified statement for the audit team leader’s certification recommendation Ø Audit type expanded to include reason for “Special Audit” RMC Workshop Fort Worth Texas 21– 22 July 2016 6

Registration Management Committee Special Audit RMC Workshop Fort Worth Texas 21– 22 July 2016 7

Registration Management Committee 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! RMC Workshop Fort Worth Texas 21– 22 July 2016 8

Registration Management Committee When can a special audit be conducted? The requirements of ISO/IEC 17021 -1 clause 9. 6. 4 apply Per AS 9101 F 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. RMC Workshop Fort Worth Texas 21– 22 July 2016 9

Registration Management Committee How many audit days are required? • Table 2 – Audit Duration Requirements of AS 9104/1 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 RMC Workshop Fort Worth Texas 21– 22 July 2016 10

Registration Management Committee What activities required of special audit? RMC Workshop Fort Worth Texas 21– 22 July 2016 11

Registration Management Committee What forms do you use and when? RMC Workshop Fort Worth Texas 21– 22 July 2016 12

Registration Management Committee What can be the results of Special Audit? • Nonconformity(ies) may be issued (follow the nonconformity management process) • Recommendation recorded (Form 5) RMC Workshop Fort Worth Texas 21– 22 July 2016 13

Registration Management Committee Do Special Audits get entered into OASIS? RMC Workshop Fort Worth Texas 21– 22 July 2016 14

Registration Management Committee Recording Objective Evidence QMS matrix RMC Workshop Fort Worth Texas 21– 22 July 2016 15

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Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 17

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Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 19

Registration Management Committee Recording Objective Evidence Audit Reports RMC Workshop Fort Worth Texas 21– 22 July 2016 20

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 21

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 22

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 23

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 24

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 25

Registration Management Committee Recording Objective Evidence PEAR RMC Workshop Fort Worth Texas 21– 22 July 2016 26

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 27

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 28

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Registration Management Committee Audit of Operational processes (9100 series clause 8) Record process performance results on the PEAR (Section 2) Issue an NCR when the process is not delivering the planned results and appropriate action is not being taken Record process realization results on the PEAR (Section 3) Issue an NCR when planned activities of a process are not realized or not fully realized Evaluate the audit evidence from the PEAR and select the corresponding effectiveness value from the PEM 9101 clause 4. 2. 2. 5. 2 9101 clause 4. 2. 2. 5. 1 Process evaluation 9101 clause 4. 2. 2. 5. 3 RMC Workshop Fort Worth Texas 21– 22 July 2016 30

Registration Management Committee 9101 Forms Effectiveness levels 3 4 2 3 RMC Workshop Fort Worth Texas 21– 22 July 2016 31

Registration Management Committee 9101 Forms Audit findings and resultant effectiveness level Process Results Process Realization and Process Results 3 NCR(s) have not been issued 4 NCR(s) have not been issued 2 3 Process Realization NCR(s) have been issued related to Process Results NCR(s) have been issued related to Process Realization and Process Results RMC Workshop Fort Worth Texas 21– 22 July 2016 32

Registration Management Committee RMC Workshop Fort Worth Texas 21– 22 July 2016 33

Registration Management Committee Wrap Up • Group input / Q&A – Open Discussion • Forms location http: //www. sae. org/iaqg/ RMC Workshop Fort Worth Texas 21– 22 July 2016 34

Registration Management Committee Backup slides RMC Workshop Fort Worth Texas 21– 22 July 2016 35

Registration Management Committee 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 RMC Workshop Fort Worth Texas 21– 22 July 2016

Registration Management Committee 9101 Key Revision Detail Updated PEM Assessment Levels 3 & 4 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. 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. Level 4 here means that the process is determined but planned activities are not fully realized. The process however is delivering the planned results. 37 RMC Workshop Fort Worth Texas 21– 22 July 2016

Registration Management Committee 9101 Key Revision Detail Updated PEM Assessment Level 5 means that the process is determined and planned activities are fully realized. Furthermore the process is delivering the planned results. 38 RMC Workshop Fort Worth Texas 21– 22 July 2016