Audit Execution
What the candidate must know
Execution is gathering objective evidence through interviews, observation, document and record review, and sampling, then evaluating it against criteria. Understand the opening meeting (confirm plan, scope, criteria, logistics) and closing meeting (present findings, agree on facts, timelines). Know how to conduct effective interviews: open questions, active listening, avoiding leading questions, and verifying statements with evidence.
Understand nonconformity classification (major vs. minor) based on significance and system impact, and the difference between a nonconformity, an observation/opportunity for improvement, and a conformity. Findings must be supported by evidence and stated clearly (requirement, evidence, gap). Auditors should avoid consulting (telling the auditee how to fix) during the audit, which compromises independence.
Traps
Questions often blur observation and nonconformity - an observation is not a failure to meet a requirement. Another trap: accepting verbal assurances without evidence. Watch for items where the auditor proposes the solution, crossing into consulting. Also, findings must be verified with the auditee before reporting to avoid factual disputes.
Worked example / rule of thumb
Rule of thumb: Requirement → Evidence → Gap → Classification. Example: procedure requires operator training records; three of ten sampled operators have none. Requirement = training records; evidence = missing records; gap = 30% nonconformance; classification depends on risk and system impact. State facts, not opinions.