Elements of a Thorough Investigation- Part 2

In last week’s blog, I discussed the importance of Documentation as one of the elements of a thorough investigation. In this blog, I will discuss 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.

The distinction between “people and process” driven activities is an important one in that it directly impacts your ability to clearly identify the root cause of a nonconformance as well as identifying appropriate corrective actions.

Let me clarify. A process is a sequence of repeatable steps that lead to some desired end or output. When you have a clearly defined and documented process, the outcome is not dependent upon an individual “remembering” to carry it out. Any individual (provided that they have the proper “education, training, and experience, or any combination thereof”) can come into the environment and perform the activity as it is defined and reach the same outcome.

People driven activities on the other hand are:
- Often not documented
- Subject to variation in interpretation and execution
- Often play a crucial role in the identification of the root cause of the nonconformance

An activity that is “people driven” may or may not be reproducible, regardless of the “education, training, and experience, or any combination thereof” of the individual. An activity that solely relies on an individual’s memory to be successfully executed is often wrought with variation in how it is carried out resulting in significantly different outcomes. Such activities will often play a major role in the root cause of a nonconformance. That is, the individuals who are tasked with completing this activity may interpret the steps differently, or place different emphasis on such task and when it is necessary to carry them out.

Therefore, in investigating a nonconformance, you must determine whether the critical parameters are dependent upon the individual, i.e., “people” or a clearly defined “process”. You must still investigate each, regardless of the outcome, but the importance of this step is that it will provide you with an in-depth view of your process and take appropriate actions; i.e., to draft procedure for critical process parameters that are not well defined or documented.