Evaluating Responsibilities

In last week’s blog, I discussed an oftentimes overlooked but nonetheless, significant element of a thorough QS or GMP investigation, namely, accurately defining the problem description, which is the nature of the nonconformance. In today’s blog, I will discuss the importance of evaluating responsibilities in an investigation and the associated documentation required as supporting evidence.

Once a determination has been made that a nonconformance has occurred, whether it be a product or process nonconformance, the responsibilities associated with the activities involved play a key role in the investigation process. The task of evaluating responsibilities is important for several reasons, but of significance are the following:

1. it helps to quickly define the tasks at hand and identify key roles and responsibilities
2. it sheds light on areas in the process that may be vulnerable to potential nonconformance
3. helps to establish a process for continuous improvement of the quality management system

In attempting to evaluate the responsibilities of the individuals involved in a process, one must evaluate the procedures associated with the tasks, in addition to conducting interviews with the respective individuals. I will briefly describe the relevance of each activity.

Evaluating responsibilities as it is defined in a given procedure is relevant in that it allows you to clearly identify the requirements as they are documented for a process. This sets the foundation for providing the evidence to substantiate the activities taken. Recall my motto in previous blogs: “if it’s not documented, it’s a rumor”. So, the fact that the responsibilities are defined in a given procedure is great, but do not stop there.

Next, you must interview the appropriate individuals to determine the “unwritten” responsibilities that are often a part of many activities in a given function. Those are what I like to call the “fluid” responsibilities that are often performed by individuals in order to: (a) clarify a task, (b) increase output, (c) facilitate better time management, and/or (d) “other”, which can include a host of other reasons. While any person working in an FDA regulated environment will quickly admit that following the procedure is foremost in their responsibilities, upon further investigation, you may find that points “a – d” above also is a factor in the way in which activities are performed in this environment.

In order for an investigation to be effective in determining the root cause of a nonconformance, the responsibility factor must play a key role. It must be made clear however, that in the process of evaluating responsibilities the individual(s) involved must feel secure enough to be open and honest about the activities that they have performed, both documented and undocumented. If individuals are fearful of losing their jobs, feel intimidated by the investigator, or are concerned that the outcome of the nonconformance may have a negative impact on future advancement opportunities within the company, then the effectiveness of this activity will be significantly diminished. Individuals must be made to feel that this is an activity that seeks to identify gaps/weaknesses in the process, not in the individual themselves.