Elements of a Thorough Investigation- Part 3

In Elements of a Thorough Investigation- Part 2, I discussed the second aspect of a through Quality System or GMP investigation, and that is, determining the difference between people and process driven activities as they relate to a comprehensive investigation. In today’s blog, I will discuss an oftentimes overlooked but nonetheless, significant element of a through QS or GMP investigation, namely, accurately defining the problem description, which is the nature of the nonconformance.

Throughout my years in the industry evaluating investigation reports, I have found that many investigations do not clearly describe the nature of the nonconformance, i.e., the problem statement. Why is having a clearly defined and succinct problem statement so critical? Well, it can mean the difference between an effective investigation that identifies and eliminates the root cause of the nonconformance; and an ineffective investigation that identifies symptoms of a much larger problem and fails to identify the root cause.

In the former case, a clearly identified problem statement that describes the nature of the nonconformance is likened to an arrow hitting its targeted bulls’ eye every time. When you have clearly identified your problem, it helps to establish a laser-like focus in the investigation that is less likely to stray from the true intent of what is being investigated. A well-defined problem statement also helps guard against scope creep and facilitates the identification of the true root cause of the problem as opposed to addressing the symptom of the problem.

In the latter case, an ill-defined problem statement often leads the team astray as they focus their attention on various aspects of the problem that may not be relevant to the root cause. In such instances, the nonconformance is likely to reoccur requiring additional resources, time, effort, and energy in trying to resolve a matter that has not been clearly defined in the first place.

So, how do you ensure that you have drafted a clearly defined and concise problem statement? Well, you can begin by asking the following questions:
• What is the nonconformance that has been identified? E.g, product “X”
failed to meet its specification of “Y – Z”.
• When did the nonconformance occur?
• How was the nonconformance identified?
• At what point in the process was the nonconformance identified?

As you evaluate and begin to answer each question, it is important that you keep the focus on answering the specific question at hand and not attempt to offer any conclusions or potential causes at this point. In other words, your problem description should not say: “Product “X” failed to meet its specification of “Y – Z” due to operator error”. That is a conclusion that will be brought out during the course of the investigation and its validity either confirmed or eliminated with objective evidence.