ISO AUDITOR Process Audit Techniques 3 — Questions and Answers
Question 1: An auditor reviewing a production process notes that control plans reference inspection criteria not found in any current work instruction. This most likely constitutes a nonconformity against:
- Clause 7.1.5 — Monitoring and measuring resources
- Clause 8.5.1 — Control of production and service provision (Correct answer)
- Clause 6.3 — Planning of changes
- Clause 9.3 — Management review
Correct answer: Clause 8.5.1 — Control of production and service provision
Clause 8.5.1 requires documented information defining the results to be achieved; misalignment between control plans and work instructions violates this requirement.
Question 2: Which question type is most effective for probing whether a process actually achieves its intended outputs?
- 'Do you have a procedure for this?'
- 'What happens when this process does not produce the expected result?' (Correct answer)
- 'Is this process ISO-certified?'
- 'Who approved this document?'
Correct answer: 'What happens when this process does not produce the expected result?'
Asking about failure scenarios encourages the auditee to demonstrate real understanding of process controls and response mechanisms, revealing actual effectiveness.
Question 3: The SIPOC model used in process auditing stands for:
- System, Inspection, Process, Output, Control
- Supplier, Input, Process, Output, Customer (Correct answer)
- Standard, Instruction, Procedure, Objective, Criteria
- Scope, Interaction, Plan, Operate, Check
Correct answer: Supplier, Input, Process, Output, Customer
SIPOC maps Suppliers, Inputs, Process steps, Outputs, and Customers to give auditors a holistic view of a process's boundaries and interactions.
Question 4: During a process audit, you find that a critical measurement device is out of calibration. What is the auditor's immediate obligation?
- Repair the device on the spot
- Record the finding and assess its impact on product conformity since the last calibration (Correct answer)
- Halt all production immediately and call the client
- Ignore it if the device is rarely used
Correct answer: Record the finding and assess its impact on product conformity since the last calibration
ISO 19011 requires auditors to record findings and assess their significance; for an out-of-calibration device, this includes evaluating the validity of previous measurements.
Question 5: Process performance indicators (PPIs) differ from process effectiveness measures in that PPIs primarily measure:
- Whether the process meets customer requirements
- The efficiency with which the process converts inputs to outputs (Correct answer)
- Compliance with regulatory requirements
- The number of nonconformities raised in audits
Correct answer: The efficiency with which the process converts inputs to outputs
PPIs focus on efficiency metrics such as cycle time, yield, and resource consumption, while effectiveness measures assess whether intended results are achieved.
Question 6: An auditor wants to verify that the 'Plan-Do-Check-Act' cycle is applied to a logistics process. Which evidence would best confirm the 'Act' phase is functioning?
- A documented logistics procedure
- Corrective action records showing improvements implemented based on performance data (Correct answer)
- Delivery performance KPI dashboards
- Customer satisfaction survey forms
Correct answer: Corrective action records showing improvements implemented based on performance data
The 'Act' phase of PDCA involves taking action on significant differences between planned and actual results; corrective action records demonstrate this closing of the loop.
Question 7: When an auditor identifies a cluster of minor nonconformities in the same process area, the best practice is to:
- Report each minor separately and move on
- Consider whether the cluster indicates a systemic issue warranting a major nonconformity (Correct answer)
- Dismiss them because they are individually minor
- Combine them into a single opportunity for improvement
Correct answer: Consider whether the cluster indicates a systemic issue warranting a major nonconformity
A cluster of related minor nonconformities may indicate a systemic breakdown; auditors must assess whether the pattern elevates the finding to a major nonconformity.
ISO AUDITOR Process Audit Techniques 3
An auditor reviewing a production process notes that control plans reference inspection criteria not found in any current work instruction.
This most likely constitutes a nonconformity against: