CVM CVM Change Control & Deviation Management 2 — Questions and Answers
Question 1: What is the recommended first step when a validated process experiences an out-of-specification (OOS) result?
- Immediately revalidate the entire process
- Initiate a laboratory investigation to determine if it is a true OOS or a laboratory error (Correct answer)
- Release the batch and document the event
- Shut down production permanently
Correct answer: Initiate a laboratory investigation to determine if it is a true OOS or a laboratory error
Per FDA guidance, the first step is to assess whether the OOS result stems from a laboratory error before concluding it is a true process failure.
Question 2: Which element is essential in a change control procedure to protect validated status?
- Cost-benefit analysis approval by finance
- Impact assessment on validation and regulatory filings (Correct answer)
- Vendor performance scorecard review
- Customer satisfaction survey
Correct answer: Impact assessment on validation and regulatory filings
An impact assessment evaluates whether the proposed change affects the validated state, regulatory submissions, or product quality before approval.
Question 3: What does 'revalidation' mean in the context of change control?
- Repeating employee training programs
- Re-executing validation protocols after a significant change to confirm validated state is maintained (Correct answer)
- Renewing vendor qualification certificates
- Reviewing batch records from the previous year
Correct answer: Re-executing validation protocols after a significant change to confirm validated state is maintained
Revalidation involves re-executing relevant validation protocols after a major change to demonstrate that the process still performs within specified parameters.
Question 4: A 'planned deviation' (also called a temporary deviation or exception) is best described as:
- An unauthorized departure from a procedure discovered during audit
- A pre-approved, time-limited departure from a standard procedure for a specific batch or event (Correct answer)
- A permanent change to an SOP
- A laboratory instrument failure report
Correct answer: A pre-approved, time-limited departure from a standard procedure for a specific batch or event
A planned deviation is approved in advance for a specific situation where following the standard procedure is not possible, with defined scope and timeframe.
Question 5: Which tool is most commonly used to perform root cause analysis for deviations?
- Gantt chart
- Fishbone (Ishikawa) diagram (Correct answer)
- Validation master plan
- Risk management register
Correct answer: Fishbone (Ishikawa) diagram
The Fishbone (Ishikawa) diagram is a structured root cause analysis tool that categorizes potential causes (man, machine, method, material, environment, measurement) contributing to a deviation.
Question 6: After implementing a CAPA, what is the critical final step to close the CAPA record?
- Archiving the original deviation report
- Verifying the effectiveness of the corrective/preventive action to confirm recurrence was prevented (Correct answer)
- Updating the annual training curriculum
- Notifying the FDA of the resolution
Correct answer: Verifying the effectiveness of the corrective/preventive action to confirm recurrence was prevented
Effectiveness verification confirms that the implemented CAPA actually resolved the root cause and prevented recurrence, which is required before the CAPA can be formally closed.
CVM CVM Change Control & Deviation Management 2
What is the recommended first step when a validated process experiences an out-of-specification (OOS) result?