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Corrective And Preventive Action (CAPA) Report Checklist

Learn how the seven steps to successfully writing and completing a CAPA report with the help of an example. Use CAPA methodology using Lumiform’s free digital checklists to identify and eliminate regulatory and organizational deviations early on.

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What Is a CAPA Report?


As you might have already guessed from its name — CAPA (Corrective and Preventative Action) — is a method that is used in a variety of settings such as businesses, healthcare, Economics, etc. to correct existing problems and prevent future errors from occurring. It includes an identification of the problem as well as the precise evaluation and implementation of solutions and corrective actions. It is the job of the compliance officers to use a CAPA report form to comprehensively document a summary of the problem solution.


A CAPA record contains information pertaining to a defect or deficiency found within the frame of operation, how the deficiency was dealt with, and who dealt with the problem. From there the compliance officer will write up a corrective and preventative action plan.


It’s important to businesses because of its solution-oriented approach to standardizing operation procedures (SOP) so that tasks are made more efficient, employees are more productive, and failures are made more infrequent. The whole concept revolves around the idea of continuous improvement with the clear aim to reduce business expenditure and overhead.



The following topics are covered in this article:


1. The 7 steps of the CAPA report


2. Example of how to write a CAPA form


3. Lumiform: Your digital tool for CAPA reports


A team working on a CAPA report

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The 7 Steps of the CAPA Report


An effective CAPA report helps companies work efficiently and reduce the risk of errors and non-compliance with laws. The following 7 steps are based on the defined FDA regulations regarding the CAPA report:


  1. Analyze - The Capa process begins with a comprehensive analysis and documentation of all existing data. These should be evaluated to identify the root cause of a problem.
  2. Examine - A plan for identifying the problem must be worked out, preferably with a responsible person to identify the basic problem.
  3. Identify - Finally, the problem should be precisely identified and defined. The evaluated data should support the identification.
  4. Verify - Possible corrective actions should be evaluated and thoroughly checked for their suitability. It is important that they do not have any negative effects on the end product.
  5. Implement - The measures and any other changes must be implemented and documented in order to monitor the progress of the implementation of solutions.
  6. Guarantee - Those responsible for combating the problem should have all possible information on quality gaps in order to guarantee the quality and safety of the product in its entirety.
  7. Submit - All data collected in the report, including quality issues and solutions, should be presented to the management team to enable them to evaluate the changes.


How to Write a CAPA Report Form With an Example?


Since CAPA investigations are written on a wide array of topics, including anything from medical device reporting to nonconforming products, it will be helpful to have an example of a completed CAPA form to act as a template and guide for your purposes.To get started writing your own CAPA report template click here.


As already noted above, there are seven steps to writing an effective CAPA investigation: analyze, examine, identify, verify, implement, guarantee, and submit. For the intents and purposes of outlining each step of the process, the following example will cover an audit of the healthcare sector.



The CAPA Report Form Example



Who is the principal investigator?
John Smith


A defect was found. Explain the deficiency briefly
A pharmacist mistook Adderall, a stimulant medication used to treat Attention Deficit Hyperactivity Disorder (ADHD), with medication Inderal, a beta-blocker used to treat high blood pressure, and gave it to a patient.


Attatch photo evidence of the deficiency
ADD PHOTO


How did you deal with the deficiency?
The patient called the pharmacy later the same day to inform the pharmacist of his mistake and to get the correct medications. The pharmacy took the wrong medication and disposed of it properly, and then issued the correct prescription medication to the patient.


Write down a corrective action plan (action that was taken to correct particular deficiency identified)
See section below


Write down preventative action plan (action plan that was taken to prevent recurrence of this problem in the future)
In order to prevent this mistake from happening again, sound-alike medications will be color-coded to act as a failsafe against misidentification.



What Is a Corrective Action Plan With an Example?



It wouldn’t be a CAPA report with a corrective action plan. To start, writing a CAPA investigation involves the five Ws: who, what, when, where, why, and how. If you need more help writing, try out our sample corrective action plan template for free.


Below, you’ll find a sample of a corrective action plan:


Description of the problem
A pharmacist accidentally issued the incorrect medication with a similar sounding name to the wrong patient.


What actions will be taken to correct the problem?
All pharmacist employees will receive additional supplemental training on how to prevent pharmaceutical errors that put patients at risk. This training will cover how to eradicate sound-alike errors in addition to providing strategies to combat other common pharmaceutical mistakes such as mislabeling, the dispensation of expired drugs, errors in compounding, etc.


Location where corrective action will take place
The training will take place in the staff lounge.


When will the correction take place?
The training will take place on the third of October, 2019 at 3:30 pm.


Who will carry out the corrective action
Dr. David Jones.


How will the corrective action be implemented?
Dr. David Jones will present a PowerPoint covering the prescribed training material. This remedial course will aim to requalify the pharmacist in their daily duties and tasks.


It’s important to note that some situations require more than one corrective action to be put in place to resolve the problem. Remember to start by answering the five Ws to frame your corrective actions. In the end, you should have successfully completed a CAPA record form.



Team discusses results of a CAPA report

Your Mobile App for the CAPA Method


With Lumiform's mobile app, you can easily conduct any kind of quality and safety inspection via tablet or smartphone - online or offline. With the desktop software, you can create checklists and evaluate the data collected in the field. This significantly reduces the risk of quality loss, accidents at work, documentation errors and damage to reputation.


Digitize checklists and internal processes with Lumiform:


  • The flexible checklist builder from Lumiform helps you to convert any individual paper list into a digital checklist without much effort.
  • In addition, we offer more than 12,000 ready-made templates to help companies get started digitally in no time.
  • Using the super intuitive mobile app, you and your teammates conduct check in the field with ease and in no time.
  • All results, images and comments are automatically bundled in a digital report.
  • Comprehensive analyses help you to identify inefficient areas in your company more quickly and thus to continuously improve your auditing and inspection processes.

Worker works on a CAPA report

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