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Johanna Stamates, RN, MA, CCRC, CHRC
Executive Director
Research Compliance and Quality Assurance
(RCQA)
Corrective and Preventive Actions vs.
CAPA Plan
Author: Johanna Stamates
Objectives
• Differentiate between corrective vs. preventive
actions
• Differentiate between corrective and preventive
actions vs. CAPA plans
3
Definitions
Corrective Action (CA): Action(s) taken to eliminate identified non-
compliance and/or action(s) taken to address and correct a problem
Non-compliance issue: protocol required safety labs not done
What are the corrective actions?
Answers:
Risk Identification
-Develop preventative action to mitigate or
eliminate risks.
Definitions
Preventive Action (PA): Action(s) taken to prevent occurrence
and recurrence of an existing problems.
Non-compliance issue: protocol required safety labs not done
What are the preventive actions?
Answer:
Training / Retraining
SOPs or SOP revisions
Protocol revisions etc.
Definitions
Preventive Action (PA): Action(s) taken to prevent occurrence
and recurrence of an existing problem
How do you prevent occurrence?
Answer:
Deviation reports to IRB
If possible, obtain safety labs
Many times, a problem cannot be
“corrected” but just documented.
When do you need CAPA?
Corrective and preventive actions are needed for non-compliance issues that are not
systemic and do not carry a high risk:
• Protocol procedures not done
• Informed consent issues
• Missed visit
• Missed safety lab
• Errors in study drug accountability, etc.
What is a CAPA Plan?
A plan that is developed and implemented to identify, remediate,
and/or prevent recurrence or occurrence of existing and/or potential
causes on non-compliance or other quality problems.
The 7 Steps of a CAPA Plan
• Identification – what is the issue/problem?
• Evaluation – what is the impact and severity of the issue? Risk assessment!
• Investigation – objectives, procedures and responsibilities are defined
• Analysis – documented root-cause-analysis
• Action Plan – remediation and prevention
• Implementation – resource allocation, execution of the plan, documentation of all steps
• Follow-up – verification for adherence to CAPA plan effectiveness; if CAPA plan is not effective,
return to Investigation
CAPA Plan – What is Needed
Creating and implementing a CAPA Plan takes a lot of time.
It requires one person to “drive it” = CAPA Owner
Requires an entire team of motivated people
Anybody involved in the non-compliance issue must be involved in CAPA
team
Requires learning, being open, non-judgmental, critical thinking, stepping
outside your safe zone, etc.
Benefit of CAPA Plans
Multifunctional areas work with each other
The real causes are evaluated, there is no guessing
If the CAPA Plan works, the non-compliance issue is eliminated
Great exercise for team building
At many times “incidental” issues are discovered
Fosters “compliance thinking” (it’s easier to do it the right way)
When is a CAPA Plan Needed?
• Major issue(s) – those are usually high risk issues
Examples: subjects no consented
overdose or incorrect study medication
altering data
backdating, etc.
• Systemic issues:
Examples: Informed Consent issues
lack of protocol adherence
AE reporting
Chain of Custody issues, etc.
• High risk areas:
Examples: issues in investigator-held IND/IDE studies
Final Thoughts
Corrective and Preventive Actions: use often
CAPA Plan: use sparingly
13
At the U, we transform lives through
teaching, research, and service.
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Contact Information
Johanna Stamates, Executive Director, RCQA
E-mail: [email protected]
http://uresearch.miami.edu/RCQA
Telephone: (305) 243-4538 / (305) 243-4215
Fax: (305) 243-6160