corrective and preventive actions vs. capa...

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

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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

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At the U, we transform lives through

teaching, research, and service.

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Contact Information

Johanna Stamates, Executive Director, RCQA

E-mail: jstamates@med.miami.edu

http://uresearch.miami.edu/RCQA

Telephone: (305) 243-4538 / (305) 243-4215

Fax: (305) 243-6160