What is CAPA?
To achieve greater quality in manufacturing you need to understand the essential elements of quality management, continuous improvement, and process discipline .ie. CAPA (Corrective action and preventive action)is the result of a US FDA requirement, FDA 21 CFR 820.100. The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS).
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- QMS certification service including QMS certification training, layout designs, manufacturing and post market support as we have regulatory expertise in auditing, executing and maintaining all features.
CAPA Management Consultant For Medical Devices
Operon Strategist audits the existing (Corrective And Preventive Action) CAPA management system of clients determines how effective it is in identifying & correcting quality problems.
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CAPA Splits Between Two Distinct but Related Functions:
Corrective Action (CA) is a step that is taken to remove the causes of an existing nonconformity or undesirable situation. As Corrective action will target the root cause so that the non-conformity or undesirable situation does not re-occur. Corrective Action can be considered as a ‘Problem Solving’. It is an extension of Root Cause Analysis (RCA). The first goal of CA is to find the root cause, base event or error that preceded the problem. The second goal is to take action directed at the root cause or error.
Preventive Action (PA) is a step that is taken to remove the causes of potential nonconformities or potential situations that are undesirable. Preventive action is like risk management, where the non-conformity or undesirable situation has not actually occurred. We need to anticipate the risks or undesirable situations that may occur and then think of actions that shall eliminate the cause of nonconformity.
Preventive Action has to be identified protectively, against the potential non-conformities, risks, defects, or non-compliances. It is similar to the Lessons Learned / Read Across. The primary goal of PA is to inform an organization and prevent the problem from returning to other facilities lines or products.
A small example will clear the term CAPA, say that a person left for a long drive and after riding the motorbike for a couple of miles breaks down in the middle of his journey. He comes across that the spark plug is fully covered with carbon. And he also realized that his bike was not serviced for the last 6 months and the last service his bike ran for almost 10000km. And at that point, the situation goes very bad, when he knows that he does not have an extra spark plug at the moment. Take this problem in CAPA review and you mention the problem and the preventive action of this situation.
Correction: Cleaned the spark plug and he placed it back. And the bike starts.
Corrective Action: From next onward, you have to be aware of keeping an extra spark plug.
Preventive Action: Before going for a long drive, you shall anticipate what all can go wrong or undesirable situations. And shall identify the preventive action for all the undesirable situations or problems.
Purpose of CAPA
One of the most important quality system elements is the corrective and preventive action subsystem. And its purpose of this corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures.
As a leading medical device regulatory consultant, Operon Strategist offers comprehensive solutions tailored to your specific needs. From FDA submissions to CE marking and beyond, our experienced team will guide you every step of the way.
We are providing services like CDSCO Medical Device Registration Consultants and Medical Device QMS Services, such as ISO 13485 certification and US FDA 21 CFR Part 820.
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