corrective and preventive actions vs. capa...

14
Johanna Stamates, RN, MA, CCRC, CHRC Executive Director Research Compliance and Quality Assurance (RCQA) Corrective and Preventive Actions vs. CAPA Plan Author: Johanna Stamates

Upload: trinhnhu

Post on 04-Feb-2018

245 views

Category:

Documents


3 download

TRANSCRIPT

Page 1: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

Johanna Stamates, RN, MA, CCRC, CHRC

Executive Director

Research Compliance and Quality Assurance

(RCQA)

Corrective and Preventive Actions vs.

CAPA Plan

Author: Johanna Stamates

Page 2: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

Objectives

• Differentiate between corrective vs. preventive

actions

• Differentiate between corrective and preventive

actions vs. CAPA plans

3

Page 3: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 4: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 5: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 6: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 7: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 8: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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

Page 9: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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.

Page 10: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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)

Page 11: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

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

Page 12: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

Final Thoughts

Corrective and Preventive Actions: use often

CAPA Plan: use sparingly

Page 13: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

13

At the U, we transform lives through

teaching, research, and service.

Page 14: Corrective and Preventive Actions vs. CAPA Planmiamictsi.org/documents/CAPA_vs_CAPA_Plan_04_07_2016.pdf · Corrective and Preventive Actions vs. CAPA Plan ... • Differentiate between

14

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