Auditing Fundamentals

Review questions

Summary: Auditing Fundamentals

This module separates audit subject, party relationship, assignment purpose, and evidence channel. Learners classify product, process, and system reviews; identify first, second, and third party relationships; and bound conclusions when access is limited to documents or remote observation. They then draft an auditable objective, scope covering sites, period, processes, and exclusions, and criteria drawn from an effective agreement, approved procedure, or applicable reference without confusing criteria with records. The roles lesson assigns responsibilities to the client, team leader, auditor, and auditee, and tests independence and confidentiality before work begins. Practice produces a classification card, an audit charter, and an assignment decision. Each output states which facts support a conclusion and which important facts remain unknown. Added practice separates hybrid coordination from mandates and tests conflict disclosure and urgent safety communication.

Review questions

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Question 1A package buyer hires an independent consultant to examine its supplier's labeling process. The buyer will use the report for a purchasing decision; no independent certification is requested. What is the party relationship? First party because the consultant works under the buyer's commission. Second party because a customer is evaluating its supplier for a customer decision. Third party because the consultant is on neither firm's payroll. The party cannot be determined until the audit channel is known.
Question 2A customer team reviews label-change records for six supplier batches and watches label application by live video. It seeks a conclusion about process control, not one batch's conformity. Which description is best? A desk-only product audit, because the records concern labels. A complete system audit, because six batches support an enterprise-wide conclusion. A remote process audit whose conclusion is limited to the available sample and evidence. An on-site audit, because live video is equivalent to being physically present.
Question 3In the fictional case, three label complaints concern two of 40 batches. After investigation the supplier closes its CAPA entry, and the buyer schedules follow-up one month later. What is the most complete follow-up decision? Close follow-up because the electronic CAPA entry says closed. Report a 7.5% defective-batch rate because three complaints divided by 40 batches is 7.5%. Repeat the original investigation without checking what was changed afterward. Check evidence that the change was implemented and evidence of its effectiveness over an appropriate period and sample, while stating inference limits.
Question 4An audit follows change approval, training, calibration and management review across two production lines, but does not inspect individual lots. Which audit subject best describes the planned evidence? System audit, because it tests interacting management controls across functions and lines. Product audit, because two lines produce physical goods. Process audit limited to one operation, because calibration is mentioned. Desk audit, because management review leaves written records.
Question 5A remote live observation follows a document review. Which description fits the evidence method? Desk-only review because documents were opened. On-site observation because activity was live. System audit solely because a camera was used. Remote evidence collection with a document component.
Question 6In a fictional case, a January transaction followed procedure V2 requiring one approval. V3 requiring two approvals became effective in July. Which criterion governs the January transaction? V3 because the auditor reads the current document now. V2 effective in January after its effective date is confirmed. No criterion, because every internal procedure is always optional. The most common approval count in the July sample.
Question 7A team cites a complaint as its audit criterion without an effective requirement. What must it establish? The age of the complaint as sufficient criterion. The team's custom after reviewing the records. The applicable agreement, specification or procedure against which evidence is compared. The complainant's preferred outcome as binding rule.
Question 8An internal auditor authored the supplier-acceptance form she is due to audit tomorrow and has not told the lead. What is the strongest action before evidence collection? Audit her own form alone because she knows it best. State that she will be objective without recording the conflict. Disclose her prior design role so the lead can reassign the test or arrange independent review. Pre-label the outcome an improvement opportunity rather than a nonconformity.
Question 9A technical expert joins an audit to explain calibration readings. After seeing a failed result, the expert asks to replace the approved acceptance criterion in the field notes. The client has authorized no scope change. What role boundary applies? Ignore every reading from the expert because technical experts may not issue findings. Use the expert's technical explanation as input, keep the authorized criterion for the finding, and route any proposed change through the client and lead. Let the expert change the criterion because expertise includes approval authority. Ask the auditee to sign the new criterion during the visit so it becomes retroactive.
Question 10Two audit bodies visit one supplier, each applying its own criterion. What label is established by that fact alone? Joint audit Integrated certification audit First-party audit Desk-only audit
Question 11The remote camera never shows the press guard; the rest of the line is visible. What may the report conclude? The guard complies because nearby stations comply. The guard fails because the camera omitted it. The visit becomes a desk audit automatically. Guard status is unverified and needs access or a narrower conclusion.
Question 12One maintenance order is relevant to label release and machine guarding. How should an integrated report use it? Assign both conclusions to the quality auditor. Exclude it because evidence cannot serve two topics. Compare it separately with each effective criterion. Treat it as proof both criteria were met.
Question 13During a remote audit, a rotating cutter appears to run with its guard open. The named safety contact does not answer two calls, and the site plan names an emergency deputy. What should the auditor do next? Use the video controls to stop the cutter personally without site authorization. Record a legal violation as proven from the remote image. Escalate the exact observation and failed contacts to the named deputy promptly, preserve times, and leave machine intervention to site personnel. Keep calling only the absent contact until the closing meeting.
Question 14An auditor sees an apparently open guard while a machine turns, but the operating mode is unknown. What should happen immediately? Declare an illegal operation in the meeting minutes. Alert the designated safety contact with the precise observation. Wait until the final report to avoid uncertainty. Operate the machine to reproduce the condition.
Question 15A complaint alleges deliberate falsification, but the team has only an anonymous note. Which report language fits? Record the allegation and evidence gap, then seek corroboration through the agreed channel. Name a technician as a fraudster. Delete the note and close the matter. Publish the accusation to all staff.