Executive Director Research Compliance and Quality Assurance RCQA Corrective and Preventive Actions vs CAPA Plan Author Johanna Stamates Objectives Differentiate between corrective vs prev ID: 837122
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1 Johanna Stamates, RN, MA, CCRC, CHRC Exe
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 betwe
2 en corrective and preventive actions vs
en 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
3 the corrective actions? Answers: Risk I
the corrective actions? Answers: Risk Identification - Develop preventative action to mitigate or eliminate risks. Definitions Preventive Action (PA): Action(s) taken to prevent occurrence a
4 nd recurrence of an existing problems. N
nd 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 o
5 ccurrence and recurrence of an existing
ccurrence 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
6 needed for non - compliance issues that
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 d
7 eveloped and implemented to identify, re
eveloped 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
8 is the impact and severity of the issue?
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 al
9 location, execution of the plan, documen
location, 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 t
10 ime. It requires one person to “drive
ime. 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
11 zone, etc. Benefit of CAPA Plans Multif
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 discove
12 red Fosters “compliance thinking” (
red 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. • Sys
13 temic issues: Examples: Informed Consen
temic 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 spari
14 ngly 13 At the U, we transform lives th
ngly 13 At the U, we transform lives through teaching, research, and service. 14 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