Understanding the Fundamentals of a Structurally Sound CAPA System

Last week, we introduced the concept of a structurally sound CAPA system. The post discussed what the true intent of a CAPA system was as well as the concept of exceeding quality standards and requirements. Understanding these concepts is the key to developing a CAPA system with a strong structure for future quality management endeavors. To end the post, I briefly mentioned the main principles of the CAPA Process as an introduction.  In this entry, we will go further into the details of the 5 Fundamentals of the CAPA Process.

1.  Dispositions or Corrections

These mean the same thing but how they are used often depends on which industry you are in. Personally, I like dispositions because correction is often confused and too similar with the word Corrective Action. Let me say this emphatically…It ain’t! It amazes me how many quality professionals in large world class companies try to pass off their disposition type actions as a corrective action. A disposition or correction is nothing more than cleaning up the mess you made. It’s a containment action. One of my theories on why managers will try to use the disposition activity as a corrective action is that the alternative is hard work and it replaces firefighting or crisis management. And whether one wants to admit it or not, firefighting actions are much more exciting and intoxicating because it makes us feel important.

Don’t get me wrong. On the fly, quick decision making and crisis management is a valuable and necessary skill but it should not be a constant activity and should not be a replacement for Corrective Actions. Dispositions/corrections might mean quarantining, sorting, reworking, recalling and/or all of the above.  All of these are necessary but they do not address root cause and do not provide long term CAPA solutions.  To use an analogy, if you have water dripping from the ceiling of your house, the disposition (or correction) might be mopping up the mess on the floor of the house and putting a bucket there to catch the dripping water. Did you fix the problem? Certainly not. Did you need to do something quick before there was more damage? Yes.

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. This often requires tenacity, discipline, critical thinking skills and persistence. It’s hard work.  In the analogy of the house, the investigation /root cause analysis might be crawling around in the attic, going up on the roof, etc. to find out when the water leaks and where the water is coming from. There are many tools that add rigor and structure to this process (i.e. fishbone, control charts, is / is not, etc.), but they are all designed to do the same thing… identify why something occurred.  The biggest problem I see with this is the lack of objectivity. Remember that one fact is often worth a thousand opinions. I often see personal opinions and biases of managers taint their objectivity.

In the example above, just because a water line was installed recently by a plumber we didn’t like very much, it doesn’t necessarily mean the cause of the problem is that the water line is leaking.  The aforementioned tools above attempt to remove subjectivity and bias.  In my previous life I always had to chuckle to myself when our production manager knew why something happened, without ever taking any time to investigate and analyze it.  One of the great grandfathers of quality, Joseph Juran once said, “It is not what you don’t know that hurts you; it’s what you know for sure that isn’t so”.

Personally, I am partial to the 5 Why’s approach of Root Cause Analysis because it is a simple exercise and can often eliminate prejudices and increase objectivity to root cause analysis.

It might look something like this:

Q: Why is there water on the floor? A: Because the drywall on the ceiling is saturated and it’s leaking through that.

Q: Why is the ceiling saturated? A: Because when I crawled up in the attic above the ceiling, I found that water is dripping from the underside of the roof in the attic when it rained.

Q: Why is water dripping from the underside of the roof? A: Because flashing and shingles are starting to break down and the water is getting underneath them.

Q: Why are the flashing and shingles breaking down? A: Because the roof is designed and manufactured to last 20 years and it’s been over 25 years since it’s been replaced.

Q: Why is it that we have not replaced the roof if it is designed to last 20 years? A: Because we didn’t realize it had been that long.

3. Corrective Actions

These are actions taken to eliminate the cause(s) of a problem, thus preventing recurrence. Please read that slowly again. Note that this is about eliminating the cause in order to PREVENT the problem(s) from occurring again. Corrective actions are about prevention! I  have found many folks either don’t understand this or don’t really want to understand it. I am not sure why but it may be that the amount of work to develop CAPA solutions that  prevents a problem from occurring again is often not trivial so by default its easier to blur the lines of a disposition into a Corrective Action. In continuing with our example, too I’ve seen the Corrective Action as putting a tarp on the roof. While it ‘may’ prevent the roof from leaking temporarily, it really doesn’t address the root cause and thus doesn’t prevent it from happening again in the mid to long term.  On the other hand, the Corrective Action might be to immediately replace the roof (shingles, flashing and tar paper) with a 25 year roof and then set a reminder in the electronic e-calendar to have the roof checked at 10 years, 15 years and replaced at 20 years.  In this example we have eliminated the cause (old roof) of the nonconformance (water in the house).   This is the difference between a mediocre corrective action that might pass an audit and good one that will improve the company and lower cost long term.  Also, note that the corrective action should address the cause or causes that are appropriate with the risk of the issue. That basically means that we do not always need to address the absolute true root cause because it simply might not be economically feasible or justified in all cases.   In the case above, it might be suggested that we replace the roof with a lifetime roof like slate so it would never wear out. However, the cost to do this might be so expensive that this is not feasible or even realistic just to prevent some water in the house.

4. Preventive Actions

These are actions taken to prevent or eliminate the causes of potential nonconformities or potential situations.  It is important to note that it also deals with eliminating causes BUT it is for issues that have NOT YET occurred. Therefore, if a nonconformance has happened, IT IS NOT and CAN NOT be, by definition, a preventive action. It’s a corrective action. Therefore, in the analogy of the house above, a preventive action would have been to replace the roof prior to it ever leaking, possibly as the result of a home inspection (i.e. audit) or because your neighbor mentioned that the house has the original roof and you know the house was built 25 years ago.

If the roof has already leaked, then it’s too late to classify it as a preventive action. It’s similar to preventive maintenance, which is maintenance you do despite a problem ever occurring. Changing the oil on our car is the prime example of that. The engine never blew up but if we don’t change the oil every 3000-5000 miles, the potential for problems increase. This is the reason the word CAPA is used as one acronym. Corrective actions and preventive actions are both actions that prevent the cause from reoccurring. What delineates the two is at the issue/problem stage.  If the issue actually occurred then it’s a corrective action and if the issue has not occurred but could potentially occur, then that is a preventative action.

Based on what I have seen over the years, companies tend to be weak when it comes to preventive actions, usually for a couple of reasons.  First, they either don’t understand or choose to ignore the definitions as mentioned above. Combine this with a large volume of actual problems and the result is all their efforts are spent in the disposition/corrective stage and addressing inaccurate causes in the corrective action stage.  In other words, they waste their resources mopping up the floor, placing buckets around the house and tacking down tarps on the roof. The “lack of training” root cause and “re-train” corrective action is a classic example of this.  It is often used repeatedly. At some point, when you use the root cause as training more than a few times, you should then be taking a corrective action on your training system because it is clearly deficient.

The other big reason that preventive action systems are fragile is because the process itself is often flawed. Companies usually have very rigorous systems for capturing problems that have occurred (i.e. non-conformances, customer complaints, audit findings, etc.) but lack capturing potential issues.  They get creative by scheduling specified intervals. This might arise through management reviews or reviewing issues that have happened somewhere else and using these as a seed for potential issues elsewhere. It could be argued however, that using issues that happened elsewhere is not really a preventative action. Internal audits are another method for capturing data but usually audits are only done at specified times by specified people.  Companies, therefore, might consider implementing structured processes for consistently collecting this data.

The best companies have a simple process in place similar to their NCMR or complaints process that allows and encourages virtually anyone, at any time, to identify a potential problem or issue. This is called “Internal Complaint Process” or “Potential Problem Process”. This process incents those that have identified the best or highest impact issues. These systems are invaluable for a couple of reasons. First, as opposed to auditors and/or managers, the “people on the floor” closest to the work are usually the ones that know of the potential problems before anyone else. Therefore, it is more effective to allow them to report these findings.  Second, having a structured process in place not only allows for efficiently capturing the potential issues but it often creates a culture of quality and trust that didn’t exist before.

5. Effectiveness

This is simply confirming that the action addresses the cause appropriately and has or will with confidence, prevent it from happening again.  It is NOT just a confirmation that what was done was what the company said they would do.  Some personal observations about this are the person or group responsible for implementing the CAPA should not be the one that checks its effectiveness.  I think this needs no explanation but it is astonishing how often I’ve seen companies do this.   Another point is in the haste of closing out the CAPA so everything is neat and tidy from a documentation standpoint, effectiveness simply becomes a verification exercise. Did we do it? Check.

We all know saying we did something doesn’t mean it is effective. In our house example, what if the roofers forgot to install the flashing around skylights or vent pipes? Sometimes, we have to make a judgment call that the CAPA is effective based on the verification of implementation simply because the time at which it might take to truly deem it effective might be decades.  For example, if after putting up a roof we waited for a year, allowing for various types of weather conditions, in addition to checking to make sure the warranty receipt was with our important papers and that the reminder activity was scheduled as an event in our electronic calendar, I would submit to you that confirming effectiveness in one year would be appropriate.

Of course, waiting for 20 years when our calendar reminder goes off would be the absolute confirmation of effectiveness but not realistic.  Renowned journalist H.L. Mencken once said “Complex problems have simple, easy to understand, wrong answers”.  I like this quote because it speaks such obvious truth. As much as we would like to believe and no matter what senior management might sometimes say, if we are honest with ourselves, you often cannot fix a difficult, nagging problem with simple CAPA solutions.  If that were the case, then it would have and should have been fixed a long time ago! You can fix a complex problem; however, you need to start with solid, basic fundamentals so hopefully the above serves as a simple reminder to the importance of fundamentals.

I have played the extremely challenging game of golf since I was about 7. If you play, you know how frustrating it can be. More so than any other sport, the golf swing is fairly complex and there are nuances and intricacies of the swing that has books, coaches, and the like, dedicated to explaining it and helping any golfer of any ability to improve. In fact, virtually every touring pro has his own full-time swing coach. I consider myself a little better than average golfer and know a fair amount about the golf swing since I have played my entire life. I am constantly tweaking it. However, I will never drive the ball with a nice high draw, if I fail to do the basics of keeping my head still, eye on the ball, and swing with a nice tempo. Therefore, when I find myself playing poorly, I often remind myself of the fundamentals to get me back on track. That same basic philosophy can apply to Quality.

To dig deeper into the CAPA software itself, download our eBook that breaks down building blocks of a CAPA management software solution.

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