February 17, 2016 | Brianna Schaeffer

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Successfully Implementing a CAPA Process


The framework of corrective and preventive action (CAPA) can be intimidating to tackle; especially if you are in a new organization or one that does not already have an institutional understanding and belief in it.  At its core, the CAPA framework provides common terminology to an organization and helps organize people and thoughts in order to facilitate problem solving and critical thinking. Problem solving can be fun and rewarding, but in the wrong environment, it can also be discouraging and counterproductive.

A CAPA system is a critical component of ISO business standards and many of us are familiar with it.  However, ISO and ISO certifying bodies, only provide a framework for CAPA, they don't design and implement a functioning system for you. Creating and maintaining an effective CAPA system is up to each individual business and requires a few key components to be successful. Below is a simplified outline of CAPA to help you understand the framework and begin to institutionalize it constructively within your organization.


Defining the CAPA Process

An effective CAPA process is ultimately driven by critical thinking, strong problem solving, and organizational control. The first step is to create a defined process to manage corrective actions within your organization and to make sure that it is implemented each time a corrective action is initiated.  With a defined process in place, an organization can begin to work on completing the process efficiently and putting preventive actions in place more readily.  Assessing the long term sustainability of those corrective actions is a key part of the feedback loop. 

In a strong Quality Management System most critical control points continuously pass through the CAPA system making it an easy way to identify existing problems in a company. Typically, quality auditors and regulatory organizations focus on the CAPA system to find deficiencies within a Company's Quality Management System. This is especially true in medical device manufacturing and biotech manufacturing. When this happens inspections are based on the documents that are controlled within the CAPA system; including but not limited to, customer complaints, quality audit reports, and nonconforming material reports. Monitoring the internal operations of your company and preparing risk assessments are a good way to ensure compliance with the quality and regulatory bodies.


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Identifying the Event and the Root Cause

One of the key success factors to design and customize your own CAPA system is a management team's ability to determine the non-conformance event and root cause quickly and effectively. This has to be done without spreading risk to other areas of the business by misidentifying the root cause. It is also important to cultivate an atmosphere where teamwork and collaborative problem solving thrives, and blaming and disenfranchising individuals does not. 

Quickly and comprehensively gathering as many details as possible about the event is critical. With the information gathered putting next steps into action to determine the root cause and following through on them can be executed efficiently. Digging deep to determine the root cause is important and strategies like the "5 Whys" can be a helpful tool in accomplishing this. Above all, strong teamwork and project management skills are essential.


Containing the Non-conformance Risk

When there is an occurrence and a corrective action response is in activation mode, aspects of the business become vulnerable. Awareness of the occurrence and efforts towards corrective actions are a key strategy to control the non-conformance risk from reoccurring or spreading into other areas of the business. identifying areas of the business where there are potential voids and putting robust corrective actions in place is critical. Highlighting these areas and maintaining awareness about them will help support their long-term sustainability.

The main focus is always to eliminate and control the risk of a non-conformance reoccurring - and this is accomplished with robust corrective actions. With that said, strong organizations build Quality Management Systems that put ample focus on preventative actions that shore up the risk surrounding a corrective action and help to mitigate both the direct and indirect risks associated to a non-conformance event. This is critical in advanced flexible materials markets.


Plan Do Check Act (PDCA)

Problem prevention and containment must always be documented to help prevent reoccurrence. This is the golden rule of a strong Quality Management System in any organization in the advanced flexible materials market. Sometimes it is tricky to keep steps in line with one another, but if you follow the simple Plan, Do, Check, Act cycle (PDCA), then your process will flow in a predictable pattern that eventually becomes an institutionalized way of working.

Plan, Do, Check, Act itself is a great tool to strengthen your organization's project management skills and continuous improvement goals. Learning from the output is an efficient way to reduce repeating quality problems that are costly and could greatly harm the business. Using this tool will help institutionalize pragmatic thinking and risk analysis into daily practices which is critical for medical device manufacturing and biotech manufacturing.


Reaping the Benefits of CAPA

Using CAPA to resolve non-conformance events and determine the root cause is an important problem solving tool for a business.  It forces a team to review the correction, determine if corrective actions are considered effective, and then validate the successful impact of the corrective action. Implementing preventive actions and identifying risk in areas that affect product quality can prevent future nonconforming products. Analyzing your CAPA data and determining trends can then become an integral part of continually improving your business processes. This is where an organization can make a Quality Management System go beyond compliance to becoming an integral part of the strategic growth and improvement of a business over the long term. 

Being prepared for any non-conformance should be the goal of your CAPA system, since the severity of a corrective action is usually at the utmost degree and requires immediate attention. It is important for the team to remain engaged throughout the process in order to drive the corrective action all the way to completion. A robust CAPA system for medical device manufacturing is critical because regulations require complete traceability within the organization. Investing in the process and your team's ability to efficiently and effectively execute it will benefit your company in the long run because after all CAPA is truly about strengthening and improving the core operations of your business.



Defining and institutionalizing CAPA is a critical part of a strong Quality Management System and it will benefit your organization in the long run. This is especially true in advanced flexible materials markets. To get started, define a CAPA process, learn how to identify an event, determine the root cause, and contain the risks associated to non-conformities. Utilizing tools like the "5 whys?" and "PDCA" can be helpful. Creating an environment that cultivates teamwork and problem solving is a key success factor to a strong CAPA system. Taking it all one step further by analyzing your CAPA data and identifying trends is a great strategic input for the long term growth and improvement of your organization.


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