Auditing Methods

1. Auditing Methods What is evidence?

2. Module Overview • Outline basic audit definitions • Needs for sampling while conducting audits • Introduction of methods for collecting evidence • Auditing of Documents and Records

3. Audit Definitions • Audit Criteria • Set of requirements that must be adhered to • Policy • Procedure • Program Requirement • Contract • Regulation

4. Audit Definitions • Audit Evidence • Items used to verify that audit criteria are being met or not • Appropriate audit evidence indicates conformance or non-conformance • Records • Interviews • Observation • Measurement

5. Audit Definitions • Audit finding:conformance/non-conformance • Compare audit evidence to criteria/ requirements and generate an audit finding • Review conclusions with auditees to affirm accuracy of your findings • Resolve diverging opinions and record unresolved points

6. Methods of Finding Evidence • Observing • Interviewing • Listening • Reviewing • Documents & Records

7. Sampling • Used when criteria and evidence pool is large • Statistical significance is not needed • Sample requirements: • Like • Random

8. Validus Sampling Types • Field Samples • Building Samples • Animal Samples • Interview Samples • Document/Record Samples • Other?

9. Observations • Work area • Records/Documents Present • Conditions • Process • Equipment Use, Storage, Handling • Animals

10. Interviews • Questioning Techniques Questions that always work: • How do you know to do that? • Could you show me! • What if…

11. Observation/Interview Audit Tips • Check an employee’s awareness of WI • Ask where they could find WI if needed • Verify the process they are doing matches what is written in the version of the WI you have • View any completed records (if referenced)

12. Auditing Documents/Records • Documents to meet standard • Records to meet documents • Documents and Records that meet processes

13. Doc Review for Std. Conformance Process • Locate each requirement in the standard or checklist • Locate the part of the document that meets each requirement • Check version information as needed

14. Document Review for Company Conformance • Procedures not required • Work Instructions • Relevant Forms

15. Doc Review for Company Conformance Process • Complete a careful review of each sentence for Audit point(s) • Look for action statements • Look for terms: always, everyone, all • Do the entire document • Ask/Write individual questions for each Audit point

16. Are Recs used correctly during the process? • Ask to see docs/recs they are using • Are records complete/dated/initialed • Are records referenced in written procedures • When done - where the records go • Who keeps completed records • Where do employees get a new copy of the record form

17. Note Taking for Evidence • Document Name – Date – Wording Issues • Position Title – Process Observing • Observation Location - # times occurred

18. Following the audit trail… • Audit trails are items that lead you to a requirement but were either: • Not the intention of your original verification plan • Open up a door to more clearly verify and document evidence on the verification plan that you intended • Need to be used to determine you are writing the correct non-conformity

19. Summary ISO 9001: 2000 Certified • Sampling methods are very important to creditability and repeatability • Listening is a technique that is needed that no one can teach • Good note taking is a must if defendable non-conformances are to be written

20. Questions?