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What is CAPA and Why You Need it

To understand how to achieve greater quality in manufacturing, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management, continuous improvement and process discipline. Indeed, you cannot achieve compliance to ISO 9001 and myriad other quality standards – particularly if you are a quality professional and operate in a federally regulated industry, such as life science – without strong, consistent CAPA processes. To give an introduction into the basics of CAPA from a general manufacturing point of view, this article defines CAPA from a high level and also delves into why you need it to lift quality to new heights. What is CAPA and why do you need it

What is CAPA?

Since CAPA is such a commonly used tool in quality management, you should remember that this process for identifying and mitigating nonconformances and deviations, both internal and external, consists of two key elements: corrective actions and preventative actions. When used together effectively, these two aspects of CAPA complement and reinforce one another to improve quality.

CAPA is so integral to quality management and compliance that it is a fundamental aspect of compliance standards and Good Manufacturing Practices. As such, CAPA is applicable across several fields aside from industries that are heavily regulated domestically and abroad. Here is a closer look at each element of CAPA, because there are key distinctions you should understand to gain a firm grasp on the overall concept.

Defining corrective actions

Corrective actions are the processes you initiate to respond to an identified nonconformance through root cause analysis, which can take any form, whether it be a supplier defect, an uncalibrated gauge, or fabricating a part based on an obsolete specification. Corrective actions begin by acknowledging that a nonconformance exists, assigning the right personnel to mitigate it, finding the root cause and creating an executable plan for correcting the nonconformance. Analyzing the impact of an identified nonconformance to assign follow-up actions and validating the implementation of the corrective action are two additional key facets to remember.

Defining preventative actions

There is a common misconception that preventative actions merely represent the follow-up steps to corrective actions. Remember that preventative actions are a separate, albeit very closely related, activity to corrective actions. Essentially, preventative actions seek to avoid a potential nonconformance from occurring in the first place, which could adversely affect quality at a future date.

As such, there is a predictive element to preventative actions. Preventative actions follow a process that includes identifying the potential nonconformance, assigning the right personnel to further investigate the preventative action, developing an actionable plan, and validating that the action has worked by averting the potential nonconformance.

Why you need it

The manufacturing industry needs CAPA for a few reasons. First, CAPA processes afford the benefit of identifying current and potential quality issues as early as possible during production. It is a well known mantra in quality management that cost of quality rises as defects surface closer to the customer. CAPA gives you a tool to prevent costly mishaps from reaching the consumer.

Today, CAPA is so essential to quality that many enterprise quality management software (EQMS) have automated traditionally manual, spreadsheet-based CAPA processes into a holistic quality system.  In fact, CAPA is one of the most frequently automated processes by EQMS, which shows how important it is to quality management from an enterprise perspective. You need CAPA simply because it has been proven time and again to be an effective tool to mitigate nonconformances, or prevent them from occurring altogether.

Remember that CAPA consists of two separate activities: corrective actions and preventative actions. Without CAPA, you will not be able to manage cost of quality and will not reap the benefits of such a proven quality process.

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