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This document describes the processes for creating, implementing, and documenting corrective and preventative actions (CAPAs). Action should be taken to eliminate the cause of nonconformities in order to prevent recurrence and to eliminate the cause of potential nonconformities in order to prevent their occurrence. Corrective and preventative actions should be proportionate to the effects of the nonconformities and/or issues encountered or the effects of the potential problems, respectively.
This procedure applies to all actual or potential nonconformities (or other undesirable situations) that may affect the quality of Company operations, products or services.
Not all events lead to the implementation of a CAPA. Examples of what can initiate a CAPA include:
The quality team shall determine if a CAPA is required for the resolution of any events that have been identified internally or externally to the company. If the quality team determines that a CAPA is necessary then it can initiate a CAPA for the issue.
The following risk based approach should be used to determine if an input requires a CAPA.
As mentioned, the quality team should perform CAPA qualification. Using the metric below, a member of the quality team can score the event to determine if a CAPA should be initiated. Go through each row sequentially. For each row that presents a numerical score, summarize the appropriate score from each row. For each row with an agree/disagree question, answer each question to be best of your knowledge. Follow the CAPA Initiation Criteria instructions below the table to determine if a CAPA should be initiated.
CAPA Initiation Criteria
Once each row has been visited and answers have been collected, sum all numerical values if they designate a number value for the answer. Use the criteria below to determine if a CAPA should be initiated or not.
Initiate CAPA if:
MAY NOT initiate CAPA if:
Note: CAPA can be initiated if these criteria are not met but if there is a need for a CAPA.
If it has been determined through the CAPA qualification process above that a CAPA is required, the CAPA Report shall be created by the quality team. The quality team is required to participate in CAPA Report creation and resolution process.
If immediate action is necessary in the case of field safety corrective action or a notification to authorities, the quality team shall initiate that process without undue delay according to SOP Vigilance.
As mentioned, the quality team shall create the CAPA Report. As part of the CAPA Report, a root cause analysis shall be performed alongside the member of the company closest to the issue that initiated the event. For example, events related to software issues shall involve the software team and events related to marketing materials shall involve the business team.
As part of the CAPA Report, a root cause analysis should be performed on the initiating event according to the Five Whys method or a similar root cause analysis method.
For the Five Whys method, fill in the problem statement below and ask the "Why" question to the problem statement for "Why #1". Provide the answer to the question "Why did this problem occur" in the box next to "Why #1". Each consecutive "Why" asks the same question, "why did this happen?" to the previous "Why" answer above it, until it is determined that the root cause has been identified for the original problem statement. This can take less than 5 "Whys" or more than 5 "Whys".
For the Five Whys method, the following table can be used to perform the Five Whys analysis but is not required. The final root cause shall be added to the CAPA Report.
Continue with more "Whys" if the root cause isn't identified at 5th Why.
For more complex issues, the CAPA teams may use other methods including but not limited to the Fishbone Diagram / Ishikawa (Man, Machine, Environment, Measurement, Material and Method) etc.
The quality team coordinates defining and implementing corrective and preventive actions to correct each root cause and ensure the problem is resolved. This can also include containment actions.
Additionally, the quality team shall take into account adverse negative implications and verifies that the actions do not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device. Subject matter experts related to the problem and actions to be taken should be consulted, as needed, in order to ensure that the actions are reasonable and address the root cause.
After defining the planned actions to be implemented, the team will sign the CAPA Report and execute the planned actions.
Once the actions have been undertaken, the CAPA Report can be updated with the actions performed. Once all actions have been performed to resolve the problem, the second set of signatures can be signed by the team. This is considered verification of the CAPA action plan.
Once all actions have been verified, the quality team conducts an effectiveness review of the implemented actions. After the effectiveness review is complete, the CAPA can be closed. If the CAPA is not deemed to be effective, a new CAPA can be opened to address the open problems.
