A CAPA form is a tool used to initiate the CAPA process from different non-conformance events.
Corrective Actions and Preventive Actions (CAPA’s) can also be used to eliminate causes of other events such as complaints, audit findings, and others.
Let’s imagine that you are a medical devices manufacturer and produce life-saving equipment that is used by people across the globe. This is made possible by the rigorous attention that your company gives to ensuring the safety and efficacy of each device that is manufactured.
Unexpectedly, one of these devices, let’s say an implantable pacemaker (Class III medical device) malfunctions, and the lives of users are put at risk. This malfunctioning (namely, non-conformance) needs to be identified, investigated, solved, corrective action needs to be taken, and you will have to ensure that this problem does not occur again.
For such instances, your medical devices company is regulated by the FDA and other international regulatory agencies to maintain Corrective and Preventive Actions (CAPA) procedures and policies. You will initiate the non-conformance issue into the CAPA process by using a CAPA form, which will ensure that it is turned into your organization’s process improvement.
This article educates about the CAPA form and also provides a free downloadable template for a CAPA form.
Let us look at CAPA and the CAPA form in more detail:
- What Are Corrective Action and Preventive Action (CAPA)?
- What Is a Corrective and Preventive Action (CAPA) Form?
- What Does a Corrective and Preventive Action (CAPA) Form Include?
- Best Practices for Creating Effective CAPA Form
- Example of a Filled Corrective and Preventive Actions (CAPA) Form
- Corrective and Preventive Actions (CAPA) Form Template
- Streamline Your CAPA Process With CAPA Management Software
What Are Corrective Action and Preventive Action (CAPA)?
CAPA is a set of actions that your organization (medical devices, biotechnology, pharmaceuticals, food, beverages, etc.) maintains to eradicate all causes of recurring non-conformances and other unexpected situations.
Thus, Corrective and Preventive Actions (CAPA) will provide your organization with a structure to discover the root cause of a problem(s) and to resolve the same.
Let us look at the example mentioned in the introduction section – the malfunctioning implantable pacemaker. With a proper system in place, your company will be able to immediately execute a CAPA process because of the resultant non-conformance.
Recommended Reading: What Is Non-Conformance And How to Minimize It
This CAPA process has various steps, each of which needs to be successfully executed and submitted to the CAPA program.
- Create a CAPA request and submit the same for review
- The quality manager/quality management review board of your organization will review the request
- The CAPA request is either accepted or rejected
- If accepted, the request will be formally initiated as a CAPA
- Departments, processes, procedures will be finalized as the CAPA resources
- Identify whether immediate action/corrections are needs
- All findings are investigated and documented
As you can see, inherently, a thorough CAPA process is necessary to maintain a high level of product quality and safety. That’s why more organizations nowadays implement digital and integrated CAPA software solutions to execute the CAPA process following regulatory requirements. It integrates with the core quality management system and automates processes like routing, notifications, reminders, escalation of activities, and approvals, which results in a more streamlined CAPA management process.
What Is a Corrective and Preventive Action (CAPA) Form?
Once your organization has identified a non-conformance and initiated a CAPA, you will escalate the issue by using a CAPA form. This CAPA form is the mechanism by which your organization will initiate non-conformance issues into the CAPA process.
The CAPA form is a tracking form of all corrective and preventive actions taken for a given non-conformance. It will be initiated as soon as the CAPA request is accepted and converted into a formal CAPA.
Your organization is mandated by international regulatory agencies to maintain a thorough record of all CAPAs. This is proof of your commitment to the continuous improvement of all quality processes, products, and operations.
The CAPA form is crucial to this entire process.
When relevant personnel complete the CAPA form with accurate data and receive authorization, the form’s status changes to the CAPA report.
Let us look at the implantable pacemaker that your medical device company manufactures and markets across the globe. The malfunctioning is a major non-conformance and a CAPA needs to be initiated without fail. Once the CAPA request has been formalized, your quality manager/quality review board will maintain the CAPA form.
What Does a Corrective and Preventive Action (CAPA) Form Include?
Corrective and Preventive Action (CAPA) form template includes four main components of a CAPA form.
Those components are:
- Description of the problem
- Root cause analysis and action plan
- Effectiveness checks
- Signature and closure date
Let’s look at each one in more detail.
1. Description of the Problem
The CAPA form will have sufficient space for providing a detailed description of the non-conformance. This will also include the name of the person initiating the CAPA, date, and other essential details.
2. Root Cause Analysis and Action Plan
This component of the CAPA form is detailed by the person conducting the analysis. Using an eQMS like SimplerQMS you can assign each action to specific employees who can work asynchronously on these tasks.
Here, the immediate action is taken, methodology, and the root cause analysis that will determine the source of the non-conformance will be mentioned.
Also, think about whether any other factors are contributing to the non-conformance?
Lastly, outline the CAPA plan that after implementation will prevent the particular non-conformance from occurring again.
For instance, you have corrected the non-conformance in one product, but to prevent the problem from occurring somewhere else, you will need to go through preventive action steps. You will take the lessons learned from a particular issue and apply them across the entire organization concerning related situations, processes, or equipment.
3. Effectiveness Checks
How do you determine whether the corrective or preventive actions that you have taken do correct or prevent the problem?
This is possible by using effectiveness checks which will help you determine whether the action taken was correct. Verification and validation are examples of such effectiveness checks.
The actions that you take before the implementation of the remedial process are referred to as verification. On the other hand, validation means the steps you take after the remedial process has been implemented.
Over time, you will have to monitor all quality reports to authenticate the effectiveness of the corrective or preventive actions. This also means that you will have to document the solution to the issue, the person(s) who did the verification or validation, and the date.
4. Signatures and Closure Date
An important component of the CAPA form is the signature of the person(s) who initiated the CAPA process and the person(s) who analyzed the CAPA and executed the solution to the non-conformance.
This is necessary for both responsibility and traceability all through the CAPA process.
Again, these are mandatory guidelines set forth by international regulatory agencies such as the U.S. FDA. At times, regulatory agencies may only review the completed records.
To make this process easier, an eQMS with FDA 21 CFR Part 11 compliant electronic signatures can be used to sign off CAPA’s.
Best Practices for Creating Effective CAPA Form
As an organization dealing with life-saving medical devices, pharmaceuticals, etc., you will be taking utmost care to ensure that non-conformances do not occur. However, non-conformances may happen, in which case a CAPA is required along with a detailed CAPA form.
An effectively filled CAPA form will ensure that all actions are complied with.
Let us look at the 5 best practices for creating effective CAPA forms.
1. Correct Filling of Dates
Ensure that all dates in the CAPA form are correctly filled and actions strictly adhered to. These dates will include the date on which the CAPA was initiated, the target due date, and the date on which the CAPA was closed.
For example, the clear mentioning of the date on which the CAPA was commenced will help calculate the due date and ensure that there is no unwarranted delay in completion.
QMS software like SimplerQMScan help by automatically reminding you about the due date of each CAPA.
We know that all CAPAs have a sequentially assigned log number that has to be prominently highlighted on each page. Cross-referencing becomes particularly important if you still have a paper-based system in place. What if one or more sheets of a particular CAPA form go missing?
Using efficient QMS software with robust CAPA management functionality this problem would be avoided.
With SimplerQMSyou can make cross-references to any other document such as non-conformance, customer complaint, and audit finding. Furthermore, you can make references to products, equipment, suppliers, and more.
3. Authorized Signatories
Each of the sections in the CAPA form will need to be filled and validated by a designated responsible person.
These will include the person initiating the CAPA and the person who will review and sign the completed CAPA form.
4. Root Cause / Investigation
Several root cause analysis tools are available, including fishbone analysis. Your organization will need to choose the best depending on the current non-conformance.
Also, you may use more than one tool for this part of the investigation.
5. Capture All Details
The CAPA form will have to capture all details from the beginning till the CAPA is closed. These details will include the sources for the CAPA, the actions taken, and the verification for the actions taken. The CAPA form is not a succinct description, but rather a comprehensive explanation of why a particular CAPA was created.
One or more designated persons may become unavailable due to unavoidable reasons. So, ensure that each designated person completes all details, such that even in their absence, the CAPA form will speak for itself.
Example of a Filled Corrective and Preventive Actions (CAPA) Form
Let us look at the example of the malfunctioning implantable pacemaker and briefly look at the details to be filled in the appropriate CAPA form fields.
- Description of issue: Malfunctioning implantable pacemaker.
- Scope of the problem: Failure in the electronic circuit.
- Root cause: Break in wire insulation.
- Risk assessment: This can result in reducing or increasing the heart rate and increased morbidity or mortality.
- Immediate correction: Recall all lots of malfunctioning products.
- Corrective action and preventive actions: Check wire insulation for integrity and, if necessary, change it. Replace insulation in all products to ensure the problem does not arise again.
- Verification of corrective and preventive actions: Implemented.
Ok, we are now at the last step of the CAPA for the malfunctioning implantable pacemaker (verification of corrective/preventive actions).
For example, you have found out that a break in the wire insulation has led to the EC failure. Your organization has recalled all the malfunctioning devices and replaced the insulation.
In the last step, namely, verification of the corrective and preventive actions, you will take a relook at the design, specs, and requirements. This will give you the confidence that the replacement of the insulation will work. You will also establish that there aren’t any hidden/unanticipated quality problems. If otherwise, you will have to make supplementary alterations to the process to prevent the problem from reoccurring again.
Keep in mind that these effectiveness checks are required to determine whether the corrective or preventive actions you have taken do correct or prevent the problem from occurring again. Verification and/or validation are examples of an effectiveness check. Verification implies the steps you take before implementing the remedial process, whereas validation indicates the steps you take after the implementation of the remedial process.
Corrective and Preventive Actions (CAPA) Form Template
Our free CAPA form template has all the required fields and is a quick, readymade solution for busy life science professionals who are looking to save time.
All you need is to fill the fields with essential details, signatures, and dates.
Download the CAPA form template and use it to initiate non-conformance issues into the CAPA process.
Streamline Your CAPA Process With CAPA Management Software
Manual, paper-based systems that are used for performing documentation processes have a lot of drawbacks, including validations, signatures, loss of documents, etc.
These problems can be easily resolved with the use of an eQMS solution with powerful CAPA capabilities that digitizes and automates the CAPA process.
With the SimplerQMS CAPA management software solution, you can automate the collection of data, routing, follow-ups, notifications escalation, and approvals. It integrates with other quality system processes throughout the entire product life cycle. This results in a more compliant and streamlined CAPA management process.
Your organization will need to maintain Corrective and Preventive Actions (CAPA) protocols and policies in order to ensure compliance with international regulatory agencies’ guidelines.
A very crucial tool during the CAPA process is initiating and maintaining the CAPA form.
Since paper-based manual CAPA forms have lots of drawbacks, eliminate these problems with the use of the SimplerQMS CAPA software solution that digitizes and automates the entire CAPA workflow.
To learn more about CAPA Management Software and see for yourself how SimplerQMS can help your organization streamline your CAPA processes book a free, personalized demo today!