SPECIAL AUDITS WHAT, WHY AND HOW?

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1 SPECIAL AUDITS WHAT, WHY AND HOW? Mike McRandall and Don McFarland (NSF-ISR)

2 Introductions: Mike McRandall NSF-ISR Business Unit Manager, Aerospace Don McFarland NSF-ISR Technical Scheme Manager, Aerospace

3 Activity Two volunteers needed One to describe an image we will show on the screen One to draw the image on the pad, from verbal description (won't see the picture) 2 minutes to draw the image on the board with only provided directions Draw as close as possible! Ready??

4 Time has started 2 minutes!

5 Time is up Markers down! How d we do? Does picture show what we saw? Was communication effective?

6 For comparison We will circle back to this later

7 Discussion Points: What is a Special Audit? When is a Special Audit indicated? How are Special Audits reported? Questions?

8 What is a special audit? An audit activity, based on a report from an interested party, that requires further analysis of a business practice

9 When is a Special Audit indicated? (#1) ISO Section Expanding Scope The certification body shall, in response to an application for expanding the scope of a certification already granted, undertake a review of the application and determine any audit activities necessary to decide whether or not the extension may be granted. This may be conducted in conjunction with a surveillance audit. AS9101F Section Special audits In addition, special audits shall be conducted, during the certification cycle, in response to one of the following situations: An organization s request to revise their existing certification scope, certification structure, number of site(s) and/or location(s)

10 Expanding (or Reducing) Scope Describes the extent and boundaries of the audit, such as sites, organizational units, activities and processes to be audited Changes to this would be handled through a Special Audit May be combined into another audit type, with time added to table 2 time

11 Evidence of Expanding (or Reducing) Scope Review (and capture) evidence of the modified requirements Paint the picture of conformance (or nonconformance)

12 When is a special audit indicated? (#2) ISO Section Short-notice audits It may be necessary for the certification body to conduct audits of certified clients at short notice or unannounced to investigate complaints, or in response to changes, or as follow up on suspended clients. AS9101F Section Special audits In addition, special audits shall be conducted, during the certification cycle, in response to one of the following situations: Note: A special audit can also be conducted in response to a customer or other relevant interested party request, when a serious issue (supported by objective evidence) has been identified.

13 9101F FAQ 13 -

14 Short Notice Audits Review OASIS feedback complaints Escapes Corrective actions Inaction to customers We don t get involved in every OASIS feedback

15 Short Notice Audits Reporting Review (and record) evidence of the system failure(s), as needed We are NOT product inspectors We are (typically) NOT responsible for closing the Corrective Actions Review information (and record evidence) for associated process/system failures, associated with reported escape / product failures

16 When is a special audit indicated? (#3) AS9101F Section Special audits In addition, special audits shall be conducted, during the certification cycle, in response to one of the following situations: Transferring certification from one CB to another (see 9104/1 clause 8.8).

17 Transfer Audits 9104 FAQ 53

18 Special Audit Reporting 9101F Table

19 Special Audit Reporting 9101F FAQ 10

20 FAQ 10 Reporting Requirements Reason for Special Audit QMS Matrix Report PEAR(s) Transferring certification from one CB to another No, unless the existing certificate expires within the next 12 months, in which case a stage 1 and stage 2 audit required (See 9104/1 clause 8.8) Change to an organization s certification structure Investigate complaints for serious issue Follow-up from organization suspension Expanding an organization s certification scope, number of sites and / or locations Reducing an organization s certification scope, number sites and / or locations. Yes No Yes, Special audit activity conducted against 9100-series clause

21 Special Audit Durations 9104 FAQ 51

22 Reporting Considerations AS9101F Section For surveillance, recertification audits, the audit team leader shall advise, within the Audit Report (see Form 5), whether the recorded nonconformities should be reason for suspension of withdrawal of the certificate. Failure by the organization to demonstrate effective corrective action to deal with repeat nonconformities shall warrant suspension of the certification.

23 Exercise #1 Old Scope: Manufacturing of machined parts New Scope: Manufacturing, thermal processing and coatings of machined parts. No PEARs or Matrix was provided, but form 5 summary says, Thermal processes and coatings were sampled and found to be acceptable. Acceptable? What report forms would be expected? What evidence should be provided?

24 Exercise #2 CB is notified of Customer Major Corrective Action Auditor notified by CB and investigates with client Determine a special audit is needed and performed on-site. Form 2, 3, and 5 are submitted to reflect that customer CAR was reviewed and investigated. No concerns were noted with the CAR. Is this sufficient? What evidence should be expected? What report forms would be expected?

25 Exercise #3 Transfer from CB X to CB Y No Open NCRs 9100C Cert is in good standing and expires in 2019 What forms are required? What evidence should we see in the report?

26 In Summary We have discussed: Why Special Audits are needed When a Special Audit would be used Expectations of the audit reporting for a Special Audit

27 Describe It So Others Can Understand It This Is not that

28 Audit Reports Paint The Picture

29 Thank You!