Corrective and preventive action (CAPA) training is a vital component for any medical device manufacturer or provider to implement in all field technicians, since this is the main line of defense against malfunctions and failures that can harm patients. The following guide can help supervisors ensure that their techs are on the same page when implementing the company CAPA policies.

#1: Set up a chain of reporting

You need to make sure all of your techs are following the same chain of reporting when it comes to reporting. If your techs provides and work on devices across multiple departments, then try and bring all departments in line with each so there are no confusing differences in the chain of reporting. For example, a chain of report may begin with reporting to the immediate supervisor and then with the quality assurance department. There should also be a time limit on the reporting so that all problem and malfunctions issues are lodged with the proper supervisors and departments within 24 hours of being found.

#2: Train employees on problem descriptions

The quality assurance or device affairs department will ultimately be the ones that will have to decipher your tech's CAPA reports. Take some time to train all employees on how to succinctly and accurately describe the problem. This means teaching all terminology that is commonly used to describe the device and its machinations, along with a succinct definition of the problem encountered.

#3: Set up a standard operating procedure

Make sure that all field techs are on the same page when it comes to addressing a malfunction. This is best done by implementing a standard operating procedure. The following is a general example of what this can entail:

  • Define the issue, problem, or malfunction.

  • Assess patient safety.

  • Issue immediate action (such as fine tuning device or referring patient to their medical provider).

  • Create a timeline of the malfunction, including any input from the patient and finishing with the immediate action.

  • Research and brainstorm possible causes – for example, is a defibrillator only misfiring when the patient is involved in a specific activity or in a specific location?

  • Work with associated departments to come up with a solution or corrective action plan and work on implementing it in a timely manner.

Investing in CAPA training for all techs will help them learn how to best follow through on the above advise. For example, an in depth training programming will teach them how to quickly analyze data and ask the correct questions to quickly hone in on the root cause of any device malfunction. This will allow them to quickly implement a fix across all device manufacturing so malfunctions are less likely to occur with other patients. For assistance, talk to a professional like Pathwise.