Process Audit Techniques Flashcards
7 cards from real ISO AUDITOR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Process Audit Techniques flashcards as text
An auditor is preparing a process audit checklist for a welding process. Which item most directly relates to verifying 'special process' controls under ISO 9001?
Answer: Verification that welders are qualified and that welding parameters are recorded
Clause 8.5.1 (f) requires special attention to special processes where output cannot be fully verified by inspection; welder qualification and parameter records are core controls for welding.
When auditing a customer-related process, which piece of evidence best demonstrates that the organization reviews requirements before accepting an order?
Answer: Completed order review records showing issues identified and resolved prior to commitment
Clause 8.2.3 requires review of requirements related to products and services before commitment; completed review records with documented resolutions are the most direct evidence.
An auditor notices that the organization uses 'mistake-proofing' (poka-yoke) devices on an assembly line. These devices most directly support which ISO 9001 requirement?
Answer: Clause 8.5.1 — Control of production and service provision
Poka-yoke devices are operational controls used during production to prevent errors, directly supporting the controlled conditions required under clause 8.5.1.
During a process audit wrap-up meeting, the auditor presents a finding the auditee strongly disputes. The auditor should:
Answer: Acknowledge the disagreement, note it in the audit report, and allow the auditee to provide additional objective evidence
ISO 19011 guidance calls for auditors to note disagreements and allow auditees to provide additional evidence; unresolved disputes are documented in the audit report.
A process audit of a procurement process reveals that supplier evaluations are performed but the criteria used vary each time with no documented selection criteria. This finding indicates a gap in:
Answer: Clause 8.4.1 — Control of externally provided processes, products and services
Clause 8.4.1 requires the organization to apply defined criteria for the evaluation, selection, and re-evaluation of external providers; undocumented, varying criteria fails this requirement.
Which audit technique is most suitable for understanding how tacit knowledge (undocumented know-how) is transferred in a process?
Answer: Direct observation combined with open-ended interviewing of experienced operators
Tacit knowledge exists in practice rather than in documents, so observing work and asking experienced operators open-ended questions is the most effective way to surface it.
An auditor observes that process metrics are collected but never analyzed or used to drive decisions. Which ISO 9001:2015 clause is most directly not being fulfilled?
Answer: Clause 9.1.3 — Analysis and evaluation
Clause 9.1.3 requires the organization to analyze and evaluate data from monitoring and measurement to assess QMS performance and identify improvement opportunities.