17 Questions
When should the drafting of the CAPA plan be initiated?
30 to 45 days after the close-out meeting
What does Day 0 represent in the timeframe for developing the CAPA plan?
The day of the closeout meeting
Why is it recommended not to wait for the inspection report to discuss CAPA preparations?
To ensure all CAPAs are addressed in a timely manner
How are all CAPAs from inspection/audit findings documented according to the text?
In a separate eQMS document
When are CAPA discussions initiated according to the text?
After inspection close-out
What is the recommended timeframe for implementing interim corrective action if it poses an imminent threat to safety or health?
Within 14 days
When should immediate verification of implementation be done after the initial detection of an issue?
Within 30 days
What is the timeframe suggested for scheduling major design projects with lead time for testing in production facilities?
Within months
If verification cannot wait for regular review, what actions should be implemented according to the text?
Corrective or preventive actions
What should be done within a month of initial detection according to ISO standards?
Immediate verification of implementation
Why are there no strict timelines for CAPA implementation in ISO standards?
To allow each organization to set their own deadlines
What are the three main phases involved in a Corrective and Preventive Action (CAPA) plan?
Identification, investigation, and prevention
Why are CAPA plans considered essential according to the text?
To decrease the risk of product recalls
What is the purpose of the 'Investigation' step in a CAPA plan?
To gather data to understand the root cause(s) of nonconformities
How many steps do CAPA plans typically follow according to the text?
Seven steps
What does a structured CAPA procedure provide evidence of?
Evidence of carrying out thorough investigations
In a CAPA plan, what comes after identifying the problem and correcting it?
Recurrence prevention
Study Notes
Corrective and Preventive Action (CAPA) Plan
- The drafting of the CAPA plan should be initiated immediately after an issue is identified.
Timeframe for Developing the CAPA Plan
- Day 0 represents the initial detection of an issue in the timeframe for developing the CAPA plan.
Initiating CAPA Discussions
- It is recommended not to wait for the inspection report to discuss CAPA preparations.
- CAPA discussions should be initiated immediately after the initial detection of an issue.
Documenting CAPAs
- All CAPAs from inspection/audit findings should be documented.
Implementing Interim Corrective Action
- If an interim corrective action poses an imminent threat to safety or health, it should be implemented immediately.
- Immediate verification of implementation should be done after the initial detection of an issue.
Scheduling Major Design Projects
- Major design projects with lead time for testing in production facilities should be scheduled within 6-12 months.
Verification
- If verification cannot wait for regular review, interim verification should be implemented.
- Verification should be done within a month of initial detection according to ISO standards.
ISO Standards
- There are no strict timelines for CAPA implementation in ISO standards.
- Within a month of initial detection, the root cause of the issue should be identified, and a corrective action plan should be developed.
Phases of a CAPA Plan
- The three main phases involved in a CAPA plan are Investigation, Corrective Action, and Preventive Action.
Importance of CAPA Plans
- CAPA plans are considered essential to ensure the effectiveness of corrective actions and prevent recurrence of issues.
Investigation Step
- The purpose of the 'Investigation' step in a CAPA plan is to identify the root cause of the issue.
CAPA Plan Steps
- CAPA plans typically follow 7-10 steps: Identify, Investigate, Correct, Verify, Validate, Close, and Review.
Structured CAPA Procedure
- A structured CAPA procedure provides evidence of a company's commitment to quality and compliance.
Corrective Action
- After identifying the problem and correcting it, the root cause of the issue should be identified, and a corrective action plan should be developed.
Learn about the specified frequency and timeframe for drafting, reviewing, and approving a Corrective and Preventive Action (CAPA) plan as outlined in the given process steps. Understand when CAPA discussions are initiated and the timeline for drafting preliminary CAPA.
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