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
In a process audit, 'process inputs' that must be evaluated include all of the following EXCEPT:
Answer: Corrective actions from unrelated processes
Corrective actions from unrelated processes are not direct inputs to the process being audited; inputs are the materials, information, and requirements that the process transforms.
An ISO 9001 auditor asks: 'How does this process monitor and measure its performance?' The auditee replies, 'We just know when something goes wrong.' This response most suggests a gap in:
Answer: Clause 9.1.1 — Monitoring, measurement, analysis and evaluation
Clause 9.1.1 requires the organization to determine what needs to be monitored and measured and to evaluate performance; an informal 'we just know' approach does not satisfy this.
Which of the following best describes 'vertical' (or 'depth') sampling in a process audit?
Answer: Tracing a single transaction or product from start to finish through the entire process
Vertical sampling (depth sampling) follows one item or transaction through every stage of the process, testing end-to-end conformity and process integration.
A process auditor finds that the operator performs a step differently from the work instruction but the outputs always meet specification. The auditor should:
Answer: Raise a nonconformity because the process is not followed as documented
ISO 9001 requires controlled conditions including the use of documented information (work instructions); undocumented deviations are nonconformities regardless of output quality.
The concept of 'process approach' in ISO 9001:2015 requires organizations to manage processes as a system. What does this mean for auditors?
Answer: Assess process interactions and how outputs of one process become inputs to another
The process approach requires understanding how processes interrelate; auditors must therefore evaluate the handoffs, interfaces, and dependencies between processes.
During an audit, an auditor discovers that a process change was implemented without following the organization's change management procedure. This finding is best classified as:
Answer: A minor nonconformity against Clause 6.3 — Planning of changes
Clause 6.3 requires that planned changes be carried out in a controlled manner; bypassing the change management procedure is a nonconformity against this clause.
What is the main advantage of process-based auditing over purely element-based auditing?
Answer: It reveals how multiple clauses interact within real operations rather than checking them in isolation
Process-based auditing evaluates how several ISO 9001 requirements work together in practice, providing a more realistic picture of QMS effectiveness than checking clauses one by one.