Dan O’Leary, president at Ombu Enterprises, LLC, started an interesting discussion on LinkedIn’s Corrective and Preventive Action Group. He was wondering where the term “root cause” came from.
O'Leary says he disagrees with the terms root cause, true root cause, and ultimate root cause because they “don’t add value and confuse the distinction between symptom and cause.”
I say that adding modifiers to root cause doesn’t help, either. You either find the cause of the problem or you don’t.
MasterControl’s Ken Peterson, known as our “Death by CAPA” expert, weighed in on the discussion.
“The outcome of every CAPA (if the situation warrants it) is to find a solution to the problem. Some of the solutions are best addressed with a correction, others a corrective, and when appropriate a preventive action.
Correction or containment action is designed to be immediate containment and is directed at bringing the symptoms of the problem into a manageable zone to where we can meet objectives without undue risk. These actions often take place ahead of the formal CAPA process where root cause is investigated. Tracking and trending should be done to insure that the frequency and impact of the situation does not get worse or warrant a more complete investigation.
Corrective action is to eliminate the root cause. Another way to say this is to prevent the reoccurrence of the problem. The term root cause simply means you have investigated to a level of detail where you know where to aim your corrective response. It may have a few variables working together to combine for the noted problem. It is important to note that those causes that are analyzed that are not determined to be root cause are generally referred to as “likely causes.” The elimination of most likely causes using both deductive facts from the investigation and verification help to substantiate the root cause. Of course you may have additional information come forward during your effectiveness checks that require adjustment to your corrective action and more complete understanding or root cause.
Preventive action is future-oriented, examining the potential problems that are likely to occur. In other words, you are looking at the most likely causes of problems not yet occurring. There are several questions that one should ask during the CAPA process:
- What problems may occur downstream in the process as you implement your corrective action?
- How will the information you learned through this investigation be applied in another area?
Knowing the difference between these actions and when to deploy them is paramount to a successful CAPA process. Knowing the risk of the situation/problem before you advance to action tells you what type of action will be needed even before you determine the actual action.
A common language and approach to CAPA and the appropriate actions based upon risk are what enable a CAPA process to handle any type of input (complaint, deviation, OOS, etc.) and become a workable efficient process that doesn’t ultimately cripple the organization through death by CAPA.
Ken Peterson is MasterControl’s director of quality solutions with a strong background in both life sciences and engineering. He has more than 25 years' experience in consulting and organizational change, quality management and product development. He frequently travels across the United States and internationally, educating audiences about best practices in CAPA.
Peterson is the author of a number of CAPA articles, including:
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.