The Key to Creating a Structurally Sound CAPA System

April 7, 2014

By Vince Smith


“Success is neither magical nor mysterious. Success is the natural consequence of consistently applying the basic fundamentals” – Jim Rohn Early in my career, I worked in various capacities at a contract manufacturing company.  I remember the struggles the company had walking that fine line of getting product shipped and ensuring quality. Many executives look at quality and cost as directly proportional (if quality increases and then cost increases). However, I have seen numerous companies have a properly designed Enterprise Quality Management System which saved their company money as the result of the system.  A good proficient Corrective Actions and Preventive Actions (CAPA) system is the foundation of a strong quality system. To have a solid CAPA system, it is critical to have a good comprehension of the basic components of the CAPA process. In other words, before your CAPA system can become mature, you must consistently apply the fundamentals.  The below examples are based on my observations over the years, so this is more anecdotal evidence than scientific and is not to say that most companies operate this way or this is a representative sample.

The True Intent of a CAPA System

First and foremost, when I refer to a solid CAPA system, let me be clear that I am NOT speaking from a standpoint of software and/or what will pass an audit because, quite frankly, even though you have some slick best of breed software or pass a “rigorous” audit from a 3rd party like the FDA, your CAPA system may still be mediocre at best. Through my experience, I have seen numerous companies with a software system in place, sail through audits of their quality system, yet they constantly have the same nagging quality problems over and over again. How can this be? Remember, the intent of a CAPA system is to correct problems AND continuously drive improvement to make the company more efficient and /or more effective. The reality of a company’s CAPA system being ineffective and doesn’t improve over time is often not the result of a quality system itself, but rather the intent of how the requirements of the quality system are approached.

Exceeding Quality Standards & Requirements

No matter a company’s quality policy on their website or what their marketing materials convey, the CAPA process itself is often a litmus test for the quality culture of the organization. Sadly, I have seen cultures in many so-called world-class organizations resemble something more like “does this issue really need to be in our CAPA system?” or “what can we do to quickly to close out this CAPA and move on?”.  It’s my theory the reasons that quality standards and requirements (like ISO, GXP, etc.) are constantly updated or corrected is due to the industry’s ability to just maintain the compliance to standards and requirements, yet never really improve.  Some quality professionals will often argue that a company could make concrete life preservers and still be in compliance with strict quality standards like ISO or GMP. That may be technically true but that certainly is/was not the intent of the standards. Any quality system worth its weight, with trained, competent people working with the system, would recognize a problem with a product like that and would initiate and implement a CAPA so the product they are making is not ridiculous.

5 Basic Fundamentals of the CAPA Process

In order to address CAPA effectively, it’s important to properly define and agree on the basic fundamentals of a Corrective and Preventive Action process, including dispositions or corrections (as some call them), root cause analysis, corrective actions, preventive actions and effectiveness.  In other words, what are the fundamentals, the basics?  These seem fairly obvious, but you might be surprised how often I hear the wide variance of the meaning around these terms.

  1. Dispositions or Corrections - A disposition or correction is nothing more than cleaning up the mess you made. It’s a containment action.

  2. Root Cause Analysis - This is the activity of identifying basic cause(s) that management has control to fix and, when fixed, will prevent (or significantly reduce the likelihood of) the problem’s recurrence.

  3. Corrective Actions - These are actions taken to eliminate the cause(s) of a problem, thus preventing recurrence.

  4. Preventive Actions - These are actions taken to prevent or eliminate the causes of potential nonconformities or potential situations.

  5. Effectiveness - This is simply confirming that the action addresses the cause appropriately and has or will with confidence, prevent it from happening again.

Next week, we will walk through the five fundamental pillars of a structurally sound CAPA system in more detail. In the meantime, download our eBook that breaks down building blocks of a CAPA management software solution.

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