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Auditing Methods. What is evidence?. Module Overview. Outline basic audit definitions Needs for sampling while conducting audits Introduction of methods for collecting evidence Auditing of Documents and Records. Audit Definitions. Audit Criteria Set of requirements that must be adhered to
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Auditing Methods What is evidence?
Module Overview • Outline basic audit definitions • Needs for sampling while conducting audits • Introduction of methods for collecting evidence • Auditing of Documents and Records
Audit Definitions • Audit Criteria • Set of requirements that must be adhered to • Policy • Procedure • Program Requirement • Contract • Regulation
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
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
Methods of Finding Evidence • Observing • Interviewing • Listening • Reviewing • Documents & Records
Sampling • Used when criteria and evidence pool is large • Statistical significance is not needed • Sample requirements: • Like • Random
Validus Sampling Types • Field Samples • Building Samples • Animal Samples • Interview Samples • Document/Record Samples • Other?
Observations • Work area • Records/Documents Present • Conditions • Process • Equipment Use, Storage, Handling • Animals
Interviews • Questioning Techniques Questions that always work: • How do you know to do that? • Could you show me! • What if…
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)
Auditing Documents/Records • Documents to meet standard • Records to meet documents • Documents and Records that meet processes
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
Document Review for Company Conformance • Procedures not required • Work Instructions • Relevant Forms
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
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
Note Taking for Evidence • Document Name – Date – Wording Issues • Position Title – Process Observing • Observation Location - # times occurred
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
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