Frequently Asked Questions - CAPA

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 Below is a list of Frequently Asked Questions about Corrective and Preventive Actions at the University of Miami.  Please Contact Us if you still have unanswered questions.

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  • What is a CAPA Plan?

    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.

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  • What is a Full CAPA Plan?

    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

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  • What is Root Cause Analysis?

    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.

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  • Why Should we Conduct a Root Cause Analysis?

    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.

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  • What are Some Common Methods of Conducting Root Cause Analysis?

    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.

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  • Do We Have to Involve RCQA When Developing a CAPA Plan?

    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 RCQA 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.

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  • What is a CAPA Owner?

     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.

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  • What are Effectiveness Checks?

    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

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  • Can I Send a Copy of my CAPA Plan to my Study Sponsor?

    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.