When a customer complains, an audit results in a finding of non-compliance, or a deviation occurs, a CAPA plan should be developed to correct the issue and prevent recurrence of the non-conformance. When non-conformance involves human subjects’ rights or welfare, or regulatory non-compliance, a CAPA should be completed. Please review the Non-compliance Reporting Guide for assistance.
In This Section
There are five core steps needed to complete a CAPA:
- Review the issue.
- Correct the Non-Conformance.
- Identify the Root Cause.
- Develop Preventive Actions.
- Assess the Effect of the Preventive Actions.
Issue review is the evaluation phase, a scoping process where a determination is first made whether or not an investigation is warranted. Issue-review specifics are defined by asking these five questions:
- What is the non-conformance?
- Where in the process did the non-conformance occur?
- When did the non-conformance occur?
- How significant is the non-conformance?
- Who is responsible for the non-conformance?
An organization’s ability to begin and close an effective CAPA is directly related to a thorough understanding of the non-conformance. Once CAPA specifics have been defined, and the effect and magnitude of the non-conformance has been determined, it’s time to take corrective and preventive actions.
Correcting the non-conformance is an action that should be taken as soon as possible. The specific action to take will be based on the non-conformance. For example, if the non-conformance involves use of an incorrect or inaccurate consent document, the corrective action would be to obtain consent from participants using a document that meets all applicable requirements. In some instances, investigators will not be able to correct the non-conformance. For example, participants may no longer be available to sign a revised consent document. In these instances, the CAPA should document reason the non-conformance could not be corrected.
The next step is to determine why the non-conformance occurred. Many CAPAs fail because the investigator automatically assume the reason for the non-conformance and do not thoroughly investigate the cause. Causes of non-conformance could include:
- Lack of procedures used to identify risks of non-compliance before study start-up
- Insufficient infrastructure/tools to prevent non-compliance (e.g. electronic systems, checklists, forms, reminder calendars, etc.)
- Lack of qualified research staff;
- Lack of understanding of the protocol requirements due to ambiguous language
Investigators should ask “Why” the non-conformance occurred several times to get to the root cause. For example:
- Why was the procedure not completed during the study visit?
Because the coordinator was not aware of the need for the procedure.
- Why wasn’t the coordinator aware of the need for the procedure?
Because the protocol involves multiple procedures at each visit and it is difficult to remember which procedures need to take place during a visit.
- Why can’t the coordinator remember which procedures need to take place?
Because no tools are available to help the coordinator remember.
- Why are there no tools?
Because there is no established process for reviewing a protocol, identifying compliance risks and developing needs prior to study start-up.
As you can see a thoughtful investigation into the root cause of a non-conformance can lead to identification of important processes that can lead to reductions in non-compliance across multiple studies.
Once the root cause is established, the preventive action plan can be written. Investigators should identify methods to eliminate the root cause. For example, in the illustration above, the preventive action plan could include:
- Develop a new procedure describing a process for reviewing new protocols, identifying compliance risks and establishing tools to reduce each identified risk.
- Develop a tool to help the research staff identify every required protocol procedure for each visit. Examples of effective tools for this non-conformance include a calendar, a checklist that requires the responsible party’s signature, template orders, etc. Checklists are often very useful tools because a checklist can simultaneously ensure compliance and provide documentation of research activities.
The preventive action plan should include target achievement dates. Once the plan is implemented, investigators should keep records describing when and how each element of the plan was achieved.
Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system is working. Data tracking is a mandatory component of CAPA so that the organization can ensure that all CAPA-related information can be confirmed, monitored, measured, and, if necessary, corrected.
Documenting CAPAs is another vital CAPA factor to take into account. If the CAPA is not thoroughly documented, auditors and regulators will assume it was not done and that investigators did not consider the non-conformity a serious matter.