Auditing Methods ISO 9001 2000 Certified What is

Auditing Methods ISO 9001: 2000 Certified What is evidence?

2 Module Overview ISO 9001: 2000 Certified • Outline basic audit definitions • Needs for sampling while conducting audits • Introduction of methods for collecting evidence • Auditing of Documents and Records Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

3 Audit Definitions ISO 9001: 2000 Certified • Audit Criteria – Set of requirements that must be adhered to • • • Policy Procedure Program Requirement Contract Regulation Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

4 Audit Definitions ISO 9001: 2000 Certified • 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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

5 Audit Definitions ISO 9001: 2000 Certified • 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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

6 Methods of Finding Evidence ISO 9001: 2000 Certified • • Observing Interviewing Listening Reviewing – Documents & Records Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

7 Sampling ISO 9001: 2000 Certified • Used when criteria and evidence pool is large – Statistical significance is not needed – Sample requirements: • Like • Random Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

8 Validus Sampling Types ISO 9001: 2000 Certified • • • Field Samples Building Samples Animal Samples Interview Samples Document/Record Samples Other? Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

9 Observations ISO 9001: 2000 Certified • • • Work area Records/Documents Present Conditions Process Equipment Use, Storage, Handling Animals Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

10 Interviews ISO 9001: 2000 Certified • Questioning Techniques Questions that always work: • How do you know to do that? • Could you show me! • What if… Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

11 Observation/Interview Audit Tips ISO 9001: 2000 Certified • 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) Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

12 Auditing Documents/Records ISO 9001: 2000 Certified • Documents to meet standard • Records to meet documents • Documents and Records that meet processes Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

13 Doc Review for Std. Conformance Process ISO 9001: 2000 Certified • Locate each requirement in the standard or checklist • Locate the part of the document that meets each requirement • Check version information as needed Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

Document Review for Company Conformance 14 ISO 9001: 2000 Certified • Procedures not required • Work Instructions • Relevant Forms Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

15 Doc Review for Company Conformance Process ISO 9001: 2000 Certified • 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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

16 Are Recs used correctly during the process? ISO 9001: 2000 Certified • 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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

17 Note Taking for Evidence ISO 9001: 2000 Certified • Document Name – Date – Wording Issues • Position Title – Process Observing • Observation Location - # times occurred Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

18 Following the audit trail… ISO 9001: 2000 Certified • 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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

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 Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07

20 ISO 9001: 2000 Certified Questions? Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07