Root Cause Analysis in Pharmaceutical Industry

“In many organization, politics are allowed to influence the CAPAs simply because there are too many people involved in the approval process—approval to actually open a CAPA, or approval to finish one.

 

Very often there are too many people, or the wrong people, in the approval process. I’ve seen real problems get swept under the rug because somebody won’t approve the effort to go forward with it.

 

I’ve also seen good solutions get shot down on real problems, because somebody didn’t want to spend the money or the time.

 

I would be cautious about adding too many levels and too many people to the process.”

 

While much attention is given to the tools, techniques, and methodologies for “extinguishing the problem at the source,” much less attention is given to the fact that none of them will be effective if they aren’t implemented properly!!

 

The factors for proper use boil down to two fundamentals:

1. Having the right team(s) in place to collect data and conduct the investigation in order to determine what factors should and shouldn’t be included in analysis.

 

2. Crystal clear communication with the proper measures in place to minimize bias and the role of interorganizational politics in obstructing the free and open exchange of facts and ideas.

 

Without these two fundamentals, even the best root cause analysis process will likely fail to properly identify and address the true root causes of the problems affecting your products and quality system.

 

Once a foundation is established on these two important pillars, turn your attention to the major challenges companies face in conducting root cause effectively.

• Challenge 1: Devoting too little time to investigating and determining the root cause of an issue.
• Challenge 2: Simply restating the problem statement as the root cause of the problem.
• Challenge 3: Not having a reliable set of tools and methods for carrying out an effective  investigation.
• Challenge 4: Failing to reference the tools you do use in your CAPA procedure, thereby opening the door to regulatory scrutiny.

 

Since each company faces their own set of challenges, prescribing a universal set of solutions is impossible. A solution for one organization can end up introducing more problems when applied the same way in another.

 

To truly resolve problems at their root, a cross- functional group must be established to solve the problem from every angle.

 

To do this effectively, knowledgeable representatives and owners from all functional areas including engineering, sales, quality, regulatory, etc., must work together. Cross functionality is especially important given that the point a problem is detected is rarely where the root cause truly lies.

 

Read also:

• Basic Tools for Root Cause Analysis (RCA) in Pharmaceutical Industry
• Corrective and Preventive Action (CAPA) in Pharmaceutical Industry