Hints for Managing an Audit Program Kristin L. Case

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

2. Schedule quarterly gaps

1Q05 2Q05 3Q05 4Q05 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 • Plan for the unexpected

3. Leave scheduling details up to auditor(s)

• Give auditor a date range • Allow auditor to contact auditee / department • Auditor sets date / time

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!

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

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.

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

8. Implemented and Effective??

• Was corrective action implemented?

• Was it effective?

9. Change schedule basis annually

• Clause or element of the standard • Department or work area • Function or process • Product type or cell

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

11. Borrow and loan auditors

Internal auditors in small companies have “conflict of interest” and “independence” problems.

12. Simplify numbering

• On audit reports • On corrective action requests • Etc.

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...

14. Ineffective C/A responses

Top Guy Mgr 1 Mgr 2 Mgr 3

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

16. Who does what?

• Flow chart the internal audit process with a deployment matrix.

Auditor Program Mgr Auditee

Establish schedule Set date/time Prepare Assign auditor(s) {in coordination} Agree on date/time

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

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

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

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

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.

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

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

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

.”

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

The End

Questions?