Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
There are various moving parts when developing a medical device, some parts that you can physically see but others that aren’t quite as visible. The ones that are more subtle can raise your company’s margin of error, especially when dealing with unavoidable regulations. You will learn that CAPAs are a vital solution to lower or even prevent errors.
As your team decides what regulatory path to choose, it can become overwhelming trying to decipher all these acronyms and what they mean for your product’s journey to market. Using our compliance expertise, we have broken down what Corrective and Preventive Actions (CAPAs) actually are and how they impact your medical device as they are on the top of the priority list for FDA inspections and ISO audits.
Purpose of CAPAs
Like anybody who has sought medical attention, we have complete trust on the doctors or caregivers who tend to us. It isn't any different for medical devices.
Because of the specific and unique way regulations are administered in healthcare, the expectations are high for not only caregivers but also any medical devices legally approved. These same expectations are set by regulatory bodies like the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) demand a rigorous process of investigation when a failure does occur.
Corrective Action Preventive Action (CAPA) is a process that investigates and solves these problems by identifying the causes to enforce proper corrections. The underlying purpose of any CAPA is to prevent the problem from ever reoccurring for your organization.
Want to learn how to utilize CAPAs in 10 Easy Steps to achieve FDA compliance? Click Here.
What is CAPA?
Corrective Action & Preventive Action (CAPA) ensures continuous improvement measures on your company's processes, allowing it to stay in operation. CAPA impacts every aspect of your day to day business and is a critical component of the FDA's analysis.
- Corrective Action: To identify and eliminate the causes of existing nonconforming products and other quality problems. This action targets the root cause in an attempt to correct it.
- Preventive Action: To identify and eliminate the causes of potential nonconforming product and other quality problems. Think of this action as risk management where steps must be taken to anticipate the risks or undesirable situations that may occur and then think of actions that shall eliminate the cause of nonconformity.
Regulations and Implications of CAPA
Here are the excerpts clearly defining CAPA in FDA 21 CFR Part 820.100:
(a) The manufacturer should create and maintain a documented procedure that includes the following:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. The appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to the product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
We have summarized the excerpts clearly defining CAPA in ISO 13485:2016 Clause 8.5.2 and 8.5.3:
8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent a recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.
The organization shall document a procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken.
8.5.3 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.
The organization shall document a procedure to describe requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate.
Worry-free CAPA Integration
For newer medical device companies, developing and managing CAPAs should be a priority from the beginning of your product's development. Your organization can avoid costly and exhaustive issues with the implementation of well-written CAPAs at early stages, but it isn't the simplest task to do.
Sierra Labs has experience working with early-stage medical device companies who do not have a clear criteria outlined for their own CAPA processes. We can simplify this process for your team by implementing successful CAPAs with well-documented procedures for FDA audits and ISO standards. Sierra Services ensures your CAPAs are progressing in the right direction, while simultaneously providing beginning-to-end traceability.
Here at Sierra Labs, we help companies solidify their regulatory foundation by creating a unique and tailored quality program to meet organizational objectives with complete transparency and visibility across their entire operation.
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