QS0010-01: Corrective Action and Preventive Action (CAPA) Flashcards
QS0010-01: Corrective Action and Preventive Action (CAPA)
What is the purpose of this policy?
The CAPA process aims to identify, investigate, and correct critical issues and take appropriate action to correct the problems and prevent a recurrence.
QS0010-01: Corrective Action and Preventive Action (CAPA)
Where are the CAPA Event and Continuous Improvement investigations documented?
They are documented within tickets, following the typical workflow described in the current version of WI0003, “Redmine Configuration and Usage.”
QS0010-01: Corrective Action and Preventive Action (CAPA)
How is Corrective Action defined?
Immediate action to a problem that has already occurred or has been identified.
QS0010-01: Corrective Action and Preventive Action (CAPA)
How is Preventive Action defined?
Action taken to eliminate the root cause of the potential problem, including the detection/identification of problems.
QS0010-01: Corrective Action and Preventive Action (CAPA)
What is a CAPA Event?
A ticket that requires investigation due to a quality deviation.
QS0010-01: Corrective Action and Preventive Action (CAPA)
What is the CAPA Action item?
A ticket created as a result of a periodic CAPA review is required to address a risk or problem identified by the review.
QS0010-01: Corrective Action and Preventive Action (CAPA)
How is Continuous Improvement Event described?
A ticket marked with “Quality Review” to help identify areas for improvement that are reviewed during the periodic CAPA review.
QS0010-01: Corrective Action and Preventive Action (CAPA)
What is the “5 Whys” tool of Root Cause Analysis (RCA)?
Keep asking why until the root cause is determined. Five is standard; you’ll have identified the root cause when you can no longer ask “why” and get an answer.
Note: Since CAPA investigations take place after something has been delivered to a live system, the root cause will nearly always have come from work done (or not) in a prior ticket.
