Frequently Asked Questions - CAPA

An action taken to address and correct identified non-compliance.

An action taken to prevent non-compliance from occurring or recurring by eliminating the root cause of a problem.

A plan that is developed and implemented to identify, remediate, and prevent recurrence or occurrence of existing or potential causes of non-compliance or other quality issues. A CAPA Plan is typically created in response to internal or external audits/Quality Reviews.

A full CAPA Plan should be implemented when a problem or non-compliance issue is identified at the Department or Unit level. In other words, this CAPA Plan is designed to address systemic issues which affect more than one clinical trial, more than one PI within a specific Department or Unit, or for an isolated issue which represents a high risk to research subjects, the PI, the University, etc. Please see 7 Steps to Creating an Effective CAPA Plan

Root Cause Analysis (RCA) is a structured process for identifying “root causes” of problems or non-compliance. There are many approaches, tools, and techniques available to conduct a RCA. Two very common approaches are the “5 Whys” and “Fish-bone” diagrams. Please see below for more details.

Without knowing the root cause of a problem, you run the risk of only addressing or correcting the symptoms of a problem. Determining the root cause of an issue allows you to address the source of the problem and prevent its recurrence. When significant non-compliance is discovered by internal or external sources, the Principal Investigator/study team should perform a RCA and implement appropriate corrective and preventive actions. If there is more than one root cause identified (true in many cases) after conducting the RCA, all the causes should be addressed in the CAPA Plan for it to be successful. The RCA and CAPA Plan are considered successful when the problem or non-compliance does not recur.

5 Whys or Cause-and-Effect Diagrams: The “5 Whys" is an interrogative technique used to explore the cause-and-effect relationship underlying a non-compliance situation. The primary goal of this technique is to determine the root cause of a problem by repeating the question Why? (Why did this problem occur?) at least 5 times to identify the true cause of the problem. Each answer forms the basis of the next question. This technique forces you to think of several causes for a problem, instead of settling for the first cause that comes to mind. Please see link to 5 Whys or Cause-and-Effect Diagrams.

Fish-bone/Ishikawa Diagrams: This technique visually displays the many potential causes of a specific problem onto a Fish-bone/Ishikawa Diagram. It helps facilitate the brainstorming of causes by grouping the causes into major categories to identify the source of variation or non-compliance. Please see link to Fish-bone/Ishikawa Diagrams.

Pareto Analysis: This is a statistical technique used to select a limited number of tasks that produce the most significant overall effect. It uses the Pareto Principle (also known as the 80/20 rule) which states that approximately 80% of the effects or problems come from 20% of the causes. Another way to view this is that by doing 20% of the work you can generate 80% of the benefit of doing the entire job. Pareto analysis is a technique that allows management to focus on the risks that have the greatest impact on a project. This method is useful when there are multiple potential causes to a problem and you want to concentrate your efforts to solve the most significant ones.

Yes, the CAPA Manager is available to help research teams with the development, implementation, execution, and evaluation of CAPA Plans. Please contact RQA for CAPA assistance.

It depends... Human subject research conducted at the University is routinely audited and monitored by internal and external entities. As part of these visits, non-compliance with federal, state, and local regulations or institutional policies may be identified. Depending on the severity of these issues, it may be required that a CAPA plan be created and implemented. The RQA CAPA Manager assists University researchers and their team with the creation and implementation of CAPA plans in response to internal or external audits/Quality Reviews. Please refer to Policy No. HSR-004 Corrective and Preventive Action (CAPA) Plan Investigators and study teams are encouraged to contact the CAPA Manager for CAPA Plans developed to correct non-compliance issues detected internally by the PI or study team. The CAPA Manager is available to support Investigators and study teams in the creation, implementation, and follow up of these CAPA Plans, if requested.

Every CAPA Plan is different in content and actions. The duration of a CAPA Plan depends on many factors, such as the severity of the non-compliance issues that need to be corrected and prevented, the risk level associated with them, the resources that each study team has, and the complexity of the clinical trial.

 A CAPA Owner is the main person responsible for the creation, implementation, and evaluation of a CAPA Plan. Typically, the PI is the CAPA Owner of a CAPA Plan created in response to an internal or external audit/Quality Review. For full CAPA Plans that are created to address systemic issues affecting several clinical trials, etc., the CAPA Owner may be Department leadership or anyone designated as the CAPA Owner.

CAPA Owners are responsible and accountable for the content and implementation of their CAPA Plan.

After a CAPA Plan is written, all the corrective and preventive actions outlined in the CAPA Plan should be implemented in the timeframe documented in the CAPA Plan.

RQA follows up on CAPA Plans created in response to internal or external audits/Quality Reviews.

Effectiveness checks are conducted to verify that the implemented actions of the CAPA Plan have addressed the non-compliance issues and that the issues have not recurred. If the non-compliance issues have recurred after the implementation of the corrective and preventive actions, the CAPA Plan should be revised and new actions should be implemented

CAPA Plans created in response to internal or external audits/Quality Reviews should be submitted to the CAPA Manager, who in turn will submit them to the IRB.

It depends. CAPA Plans created in response to an internal Quality Review should not be shared with a Sponsor. CAPA Plans requested by the Sponsor or in response to Federal or other Governmental inspections, can be shared with the Sponsor, but only after the CAPA Plan has been reviewed by the CAPA Manager and University leadership.