Regardless of the problem, whether we face a deviation, an aberrant unexpected analytical result (OOS), or a perceived weakness or risk in a process, we must solve the most important question first:

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What is the problem?

 

Anyone who has faced this question knows that it is often not as easy to answer as it may seem. We want to know the root cause and find the right action to remediate or improve. Often, we fall short of a long-term solution, having jumped over requisite discussion of the actual or underlying problem(s). In many cases, we also get feedback at a later stage, when an effectiveness check demonstrates that the problem was not solved or worse, exacerbated by our implemented actions.

 

As such we have to do it right the first time. Starting at the beginning there must be a clear definition of the problem - and it is a problem: we are only distracted by using the euphemistic term “issue”.

 

To begin, there are a few things to avoid, most involving some level of erroneous assumption:

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1. The “I’ve seen this before” mindset and its associated, early stage “I know what the root cause is”.

2. Jumping to conclusions, not considering all relevant factors (see above).

3. Blaming human error.

4. Stopping the root cause analysis prematurely, there be another underlying root cause(s).

5. Repeating what was done when same or similar things happened before, expecting different outcome – Einstein’s (mis)attributed definition of insanity.

 

It may be necessary to assemble a cross-functional team to review the problem from multiple angles. Often, it is at that point the original “What is the problem” question can first be answered, when the perception of the problem is different, and the team can align their thinking. Such an approach generally allows a better definition of the problem and can serve to uncover other associated, process-related issues.

 

With a well-defined problem the team may commence the root cause analysis. This, ideally, will pave the way for the organization to identify the underlying true root cause(s) leading to subsequent corrective and preventive actions (CAPA) which are so vital to organizational efficiency.

 

There are problem-solving tools. Using them successfully lies in creating a problem-solving process that is fit for purpose and suitable to the organization.

 

Our organization can help in problem solving - identification, and implementation of next level processes. May it be a particular problem you face in a process, any deviation, or OOS- investigation. Minimizing risk and getting rid of a problem are key factors in establishing