The CAPA process is the most important part of medical device quality management systems (QMS). This process allows medical device companies to effectively respond to feedback about their products, investigate internal sources of error that lead to non-conforming product and implement corrective and preventive actions to improve processes.
When a company becomes aware of a possible CAPA issue, the first step is to create a CAPA request and submit it for review to either a quality manager or quality review board (QRB). From here, the request can either be rejected or formally initiated as a CAPA.
Once a cross-functional team has been established to investigate the CAPA, the team conducts a root cause analysis to determine the cause of the non-conformance event. The next step is the formation and execution of a corrective action plan that will rectify the issue at its source and prevent the non-conformance from recurring.
The goal of creating a corrective action plan in CAPA is to ensure that systemic quality issue never happens again. To achieve this, it is crucial that CAPA investigators use the appropriate tools to conduct a root cause analysis and determine the cause of the issues. Root cause analysis can be done a number of different way including with a Fishbone/Ishikawa diagram, or with a 5 WHYs analysis.
Fishbone/Ishikawa Diagram - CAPA investigators use a Fishbone Diagram to assess impacts from various sources on a non-conformance. Fishbone diagrams encourage investigators to expand their thinking and investigate additional possible sources of error - human error, methodological deficiencies, environmental factors, material defects, and mechanical problems are all covered in Fishbone diagrams.
5 WHYs Analysis - This technique encourages investigators to drill down and find the root cause of a problem by continuing to ask "Why" things are the way they are. Following up each answer with a new question helps investigators get to the root cause and ultimately develop a corrective action plan that addresses the cause directly and resolves the issue.
A corrective action plan can include one step or several steps with the ultimate goal of ensuring that the systemic issues do not happen again. The exact nature of a corrective action plan depends on the results of the root cause analysis that was conducted to determine the cause - a corrective action plan is only effective at resolving a CAPA event if it successfully addresses the root cause.
Corrective action plans can include corrective steps such as:
An effective corrective action plan depends on your ability to successfully determine the root cause of the systemic issues using root cause analysis and the CAPA process.
The CAPA process is the heart of the QMS for medical device companies and the focal point of crucial FDA audits that will determine whether your company can sell medical devices in the United States. CAPA activities, including root cause analysis and corrective action plans, must be documented in the QMS so they can be reviewed during an audit.
Greenlight Guru offers the only electronic QMS built specifically for the medical device industry. Our paperless QMS platform enables medical device companies to better organize and document their efforts around CAPA while ensuring traceability, transparency, compliance and genuine quality throughout the CAPA process. As a result, our customers breeze through FDA and Notified Body audits and substantially reduce time-to-market.