CAPA – The Untold Story

Jack Garvey |

Try as I might in my consulting work, I can never seem to get away from CAPA.    As much as I would like to help companies prospectively improve their process control;   embrace better quality system integration and document design;   assess and implement computer-based quality systems; and use process risk analysis to rationalize quality system decisions and improve inspection outcomes (among other things I love to do), it always seems like companies need help – and lots of it – with CAPA.

Now don’t get me wrong – I certainly understand the importance of CAPA, and why it is such a necessary system.     And all you have to do is read a few FDA Warning Letters or look at industry training offerings to see how significant CAPA is to the FDA, and as a result, to FDA-regulated industry.    And CAPA in its current form has been around a long time – at least since the 1996 formal effective date of the medical device Quality System regulation.     Unfortunately though, CAPA has gone far beyond being just an important sub-system that helps to resolve any one of those many, many things that can “just go wrong” for a manufacturer of FDA-regulated products.   CAPA has in recent years become the de facto cornerstone of FDA-regulated quality systems (with the expectation expanding far beyond just devices!)      Given this development, you have to ask yourself:    What does it say about the state of control within FDA-regulated industry that a system that is designed to remediate failures is now the cornerstone of most companies’ quality systems?     As troubling as the implications of this statement are, it is a topic I will leave to discuss another day.

That’s because today I want to talk about CAPA – The Untold Story.

REAL WORLD CAPA PROBLEMS

As I alluded to above, I see lots of CAPA systems.     Or better said, I see a lot of CAPA procedures.     Or more precisely, I see a lot of CAPA procedures masquerading as CAPA systems.        What I mean by that is – I see a lot of companies in their desire to have “an SOP” in place for CAPA, confusing the process of CAPA completion with the need to have a CAPA system of incident identification, analysis, categorization, evaluation, investigation, reporting, follow-up, etc.    In large part, because CAPA has become such a fundamental part of FDA’s regulatory expectations, the scope and extent of what we now call CAPA has grown along with it.    This growth in scope – by well intentioned Investigators looking to CAPA as the primary solution to a company’s problems, and by companies that are only trying to do the right thing by having a comprehensive CAPA program in place – is itself causing some of the poor outcomes with CAPA.   As scope increases, complexity often increases.    So despite the focus on CAPA – what’s wrong?   Why do many companies – solid, name companies in addition to small and mid-size companies – have such continuing trouble with CAPA? From what I see, despite this focus and good intent, there are many causes for poor CAPA system designs and compliance outcomes.  A few of these include:

  1. Failure to differentiate between the CAPA system and the CAPA execution process;
  2. Failure to describe in an easy to understanddocument or documents:
    • how the different elements  of CAPA work together;
    • how to define and differentiate trigger events; and
    • how the different elements  collectively contribute to the overall concept of control.
  3. Insufficient knowledge and lack of training for SMEs on how to document, investigate, analyze, and most importantly, write-up good, understandable CAPA documents;
  4. Overcomplicating the simple; and
  5. Trying to make CAPA something it is not (like Six Sigma/DMAIC) or failing to understand CAPA is a regulatory requirement – not something that you can adapt to your liking in the guise of something like “continuous improvement.”

As figure 1 below shows conceptually, there are a lot of inter-related elements to a good CAPA program, and using text based documents – SOPs – to describe how these inter-related systems work, and where process begins and system ends, can be a challenge.

 

Integration of CAPA and other Quality Systems
Figure 1: CAPA Systems’ Integration

This is where the concept of “The Untold Story” comes into play…

THE UNTOLD STORY

So what do I mean by “The Untold Story?”    I mean – or better said I see (and this may be the biggest “duh” thing I’ve ever written)  – that many firms fail to communicate effectively in their quality and compliance documents.    And, nowhere is this more apparent than in the documents that define and constitute CAPA.

Initially, many of the CAPAs that I read are almost unintelligible!  They are filled with jargon , disconnected statements, proprietary acronyms, unsupported conclusions, data and statistics with no explanation, and often, internal inconsistencies.    Further, many companies have almost no idea of how the sub-process elements (or some would call “inputs”) of CAPA work together, much less are able to describe this effectively.      From this and a review of many other types of compliance documents (submissions, procedures, etc.)  I have come to believe that one of the most important failures in FDA compliance activities is the failure to communicate simply and effectively.

So what does this mean to CAPA?   Well, in my strong belief, good CAPA is nothing more than a good story – or better said, a series of related stories.    But why stories?     Why not a report?  Why not a quality record?   Why not an investigation protocol?    Why not a journal?

Well simply, because humans are hard-wired for stories!

It’s in our DNA – it’s in our genes.    From the water-cooler to the television;  from the dinner-table to the cinema;    from political speeches to the evening news, humans process communication best if it the communication takes the form of a story.   And with CAPA (like other FDA-required documents) why do we create these documents anyway?    Because we have to?   Well yes, but more importantly, we create them so that we can communicate – effectively – in this case to an FDA Investigator – what we do, and how we do it.

So if we want to communicate effectively to FDA, we need to communicate more stories.   We need both our CAPA system and our individual CAPAs to tell a story!

My experience has been extremely positive working with clients on this one simple concept.    Stories are actually pretty simple to write – and CAPA’s actually are perfectly adapted to follow the same basic structure:

STORY STRUCTURE1 CAPA STRUCTURE
Exposition:    Character /
Scene Development
Background and Details of Event/Incident
Conflict / Rising Action Investigation
Crisis / Climax Root Cause Analysis
Falling Action / Resolution Corrective / Preventive Action

The application of a basic, simple story structure can help you immensely improve your technical writing for FDA compliance.   Clearly though, we are not writing childrens’ novels, or even adult fiction.   There will be references to SOPs, technical details, organizational structures, complex activities, etc.  However, when you place all of these complicated elements in the structure of a simple story, it becomes so much easier to understand than if you are forced to simply read, e.g.,  fishbone diagram outlining the factors in a root cause analysis without any context.   This type of writing will help FDA Investigators understand your operation, help you to know that your SMEs and responsible CAPA authors understand the issues associated with the failure, and overall, improve your compliance outcomes.

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For information on how to build sustainable FDA compliance with world-class CAPA programs for pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® at info@compliancearchitects.com or at 888-734-9778.

1 Literary Elements (http://www.orangeusd.k12.ca.us/yorba/literary_elements.htm)

7 thoughts on “CAPA – The Untold Story

  1. Great perspective on CAPA, Jack. I liked your observations and the diagram. They serve to reinforce that many companies have a hard time getting a handle on their CAPA processes – it’s like they are at the mercy of their CAPAs rather than having consistent control and performance. I also liked your analogy of a “story” but I would emphasize that it has to be a structured story, as you have laid out. I have seen many CAPAs written like a “story” – but more like the confusing, rambling stories that some people tell which don’t reflect any analytical thinking or logical structure. I would advocate using a standard story template, using the CAPA structure elements you presented, but at a more granular level. For example, “Background” might include “when did the incident happen”, “who observed it”, “who reported it”, “what were the environmental conditions”, etc

    Thanks,
    Jason

  2. Jack:

    Thanks for great article, and for identifying a neglected and yet unrecognized CAPA trait in th FDA regulated envionment. Have you done further work on this? Have you successfully resolved this for any of your customers? Can we look foward to further insights from you on this subject?

    1. Shabana, What I can say is that this is an uphill battle. In many of the companies I see, the need for having good data as a basis for an acceptable investigation creates an overwhelming focus on data and investigation tools, but a significant lack in then explaining what the data and all the fancy charts actually mean — either individually or in the aggregate. For the last year I have been offering a course — Writing for Compliance — which I spend a bit of time on CAPA and structuring CAPA writeups. I also work with individual clients on CAPA programs and writing good CAPAs.

      Unfortunately, there is no magic bullet for this topic. Companies have to be willing to recognize that 1) they should be telling a story with their CAPA writeups, and 2) focusing on how the stories come together in the writeup. They also need to be training their people in the importance of writing with this style.

      Thanks for the comment!

      1. Jack,

        I’d like to learn more about “Writing for Compliance”. Topics covered, length of course and when and where is it scheduled for next and the cost?

        Thx,

  3. I like the story approach similar to that below

    Problem Statement/Summary/Background

    Intended actions

    Intended results

    Analysis of what may or may not happen and how the results of that analysis will or won’t affect SQIPP…with a breakdown of each if possible quality part and effect.

    Measures in place that will mitigate the “bad” from the above

    Plan if those measures fail

    Conclusion wrapping the above up in a bow

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