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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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.
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
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:
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. You can get started writing your own report using our CAPA report template.
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.
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.
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.
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