“8 Steps to Writing an Effective CAPA Procedure” is the first in the “The Best Of” Medical Device Academy’s previously published blogs. We’re republishing these blogs due to tremendous popularity and response from our readership. In this blog, Rob Packard provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.
The author provides a list of 8 steps to writing a more effective CAPA procedure, proper implementation, creating a CAPA process flow chart, training, etc.
During a recent internal audit I was performing for a new client, I noticed that they were not meeting one of the requirements of their CAPA procedure. Specifically, the procedure indicated that all CAPA plans must be written within seven calendar days of initiating the CAPA. Despite this requirement in their procedure, the client was indicating that CAPA plans were due within 30 calendar days on their CAPA form (http://bit.ly/CAPAForm).
This example is a minor nonconformity, but the reason why this client was not following their procedure is more interesting. The procedure was 100% compliant with FDA regulations (http://bit.ly/21CFR820100), but the procedure did not match how the company performed the process. The procedure and the process MUST match.
This client purchased their CAPA procedure from a consultant, changed the title, and had everyone in the company “read and understand” the procedure for training. If this sounds like your company, I’m not surprised, because this is not uncommon.
To avoid the mistakes this client made, follow the steps below for writing your own CAPA procedure:
8 Steps for Writing an Effective CAPA Procedure
- Create a CAPA process flow chart first
- Organize the layout of your CAPA form to match the process flow chart
- Write a procedure that follows the process flow chart
- Add references to the process flow chart for each section of the procedure
- Conduct group CAPA training using the draft version of your flow chart, form and procedure
- Make revisions to the procedure to clarify steps the trainees had difficulty with
- Ask the trainees to review the revised procedure and comment/edit
- Make final revisions and route the procedure for approval
The specific order of steps is important to creating a CAPA procedure—or any procedure. Process flow charts help people understand the input, outputs and tasks within a process. Flow charts are also used by auditors to plan process audits (http://bit.ly/AdjacentLinkAuditing).
Most important of all, it’s very easy to create a form that is missing a step, but it is less likely to be missing a step if you create the flow chart first. [The flow chart example provided was created by Brigid Glass (http://bit.ly/BrigidGlass). Please connect with Brigid, or send her an email (email@example.com) and tell her thank you.]
Procedures are often unclear, because the author is more familiar with the process than the intended audience for the procedure. An author may abbreviate a step, or skip it altogether. Authors should use outline formats that match the process flow and the form used exactly. There should be nothing extra in the procedure and nothing left out.
99% of companies hold off on their training until a procedure is officially released as a controlled document. In my experience, however, these procedures seem to have a lot of revisions made immediately after the initial release. New users ask simple questions that identify sections of procedures that are unclear, or were written out of sequence. Therefore, you should always conduct at least one training session with users prior to final review and approval of a procedure. This will ensure that the final procedure is correct the first time, and it will give those users some ownership in the new procedure.
After you train your initial group, and after you make the edits they recommended, ask those trainees to review and edit your changes to the procedure. Sometimes, we don’t completely understand what someone is describing, and sometimes may be only half listening. Going back to those people to verify that you accurately interpreted their feedback is the most important step for ensuring that users accept your new procedure.
After you approve the procedure, make sure everyone in your company is trained on the final version of the CAPA procedure. CAPA is a critical process in your quality system. Everyone should understand it. You should also provide extra CAPA training for department managers, such as root cause analysis training (http://bit.ly/RootCauseTraining), because they will be responsible for implementing CAPAs assigned to their department.
You can use this 8-step process for any procedure, but ensure you use it for the most important process of all—CAPA.
If you are interested in more information on conducting effective CAPAs, please see our How to Improve Your CAPA Process Toolkit.