1. Hints for Managing an Audit Program Kristin L. Case

2. 1.Recurrent training Promotes professionalism Keeps training current Provides in-depth knowledge of audit topics –Active listening –Report writing –Interviewing skills Short intervals –E-training –Lunch trade

3. 2. Schedule quarterly gaps Plan for the unexpected 1Q052Q053Q054Q05 Preventive action Manufacturing Area 1 Manufacturing Area 2 Shipping / Final Inspection Receiving Management review Purchasing / Suppliers Document control Records control Customer satisfaction Internal audit program Corrective action Manufacturing Area 3 Resources Training

4. 3. Leave scheduling details up to auditor(s) Give auditor a date range Allow auditor to contact auditee / department Auditor sets date / time

5. 4. Limit corrective actions Set a manageable not-to-exceed number Force improvement prioritization Spend resources carefully Increases chances of success End audit when number is reached Document audit scope carefully!

6. 5. Do not appoint due dates Agree on due dates (auditor and assignee) Not all corrective actions are the same size Not all corrective actions require the same time

7. 6. Record corrective actions taken Example discrepancy: –Welder’s certification had expired Example corrective action: –Training Dept will correct the database to ensure welders and leads are notified in advance of expiration dates Example corrective action taken: –Training Dept has corrected the database (reduced interval from 60 to 36 months) to ensure advance notice. See attached.

8. 7. Have original auditors perform follow-up The person most likely to determine whether corrective action is preventing recurrence is the person who originally found the discrepancy Provides auditors closure Ensure communication on actions taken

9. 8. Implemented and Effective?? Was corrective action implemented? Was it effective?

10. 9. Change schedule basis annually Clause or element of the standard Department or work area Function or process Product type or cell

11. 10. “January” audit Sub-group of auditors Multiple days (6 hour days) Information sharing Audit entire quality management system Distribute corrective action requests at audit close or management review immediately after

12. 11. Borrow and loan auditors Internal auditors in small companies have “conflict of interest” and “independence” problems.

13. 12. Simplify numbering On audit reports On corrective action requests Etc.

14. 13. Review discrepancies To current practice and procedure To standards and requirements To organization’s quality objectives –We have a discrepancy (good or bad) –We are currently at risk...

15. 14. Ineffective C/A responses Top Guy Mgr 1Mgr 2Mgr 3 Re-Issue Up

16. 15. Q: How many do you need? Ans: 4 PER YEAR Rotate auditors IN Continually train new auditors Drop-outs will be better auditees than those not trained

17. 16. Who does what? Flow chart the internal audit process with a deployment matrix. AuditorProgram MgrAuditee Establish schedule Assign auditor(s) Set date/time{in coordination}Agree on date/time Prepare

18. 17. Let auditors prepare plan Pre-established check sheets have potential drawbacks: –Currency with related procedures and specifications –Lack local terminology –Generic Preparing the plan forces researching related requirements

19. 18. Get auditor feedback Auditing is stressful My supervisor never lets me go I don’t always understand ISO 9001 I don’t have time to prepare, audit, and document No one ever fixes anything so why bother I’m not appreciated so auditing can’t be that important

20. 19. Evaluate auditors On-going evaluation of performance –Review records –Interview –Observe –Post audit review –Gather feedback (negative and positive) Share evaluation with auditor’s supervisor

21. 20. Don’t ISSUE corrective actions Request Do not target the person “at fault” Find the individual in the organization who –(a) agrees with the finding, and –(b) agrees he has the power to fix it

22. 21. Require volunteerism If auditors are “volunteer”, insist on a defined amount of time in which they will perform internal auditor functions in exchange for initial training.

23. 22. Reject bogus C/A “I talked to my guys” “He just wasn’t paying attention” “Oh yeah, we had a meeting about that” Close findings based on OBJECTIVE EVIDENCE

24. 23. Communicate Share with auditors –Summary report prepared for management –Status of all findings –External auditor report(s) Use multiple communication techniques –Meetings –Newsletters –E-mail or intranet

25. 24. Procedurally, Do NOT address the corrective action process in the Internal Audit procedure. “In the event of a negative finding, refer to Procedure # xx, Corrective Action.”

26. If your organization is ISO 9001... 4.1 Improve the internal audit process 5.5.3 Communication about QMS 6.2.2 Ensure auditors understand their relevance and importance 8.1 Continually improve QMS effectiveness 8.2.3 Monitor and measure processes 8.5.3 Preventive action

27. The End Questions?