Investigating Cause - Are nonconformance Investigation Procedures Followed?

In my last blog I discussed the importance of evaluating responsibilities in an investigation and the associated documentation required as supporting evidence. Today’s blog will discuss investigating root causes as it relates to following established protocol and procedures.

In any failure or nonconformance investigation, the procedure(s) that govern the process under investigation play a key role in the determination of root causes. Once a nonconformance has been obtained, the investigation procedures must be detailed enough to answer or address the following:

-What are the necessary steps to control product disposition?
-What are the required approvals?
-Timeframes for acquiring approvals and product disposition?
-Timeframes for actual investigation?
-Development of a plan of action

Nonconformance investigation procedures must clearly define product disposition and the necessary approvals for the actions taken. Depending on the nature of the nonconformance, the risk that the organization is willing to assume, as well as the governing procedures, product disposition may dictate: use-as-is, quarantine, scrap, or rework. Whatever option is selected, the rationale for this decision must be clearly evident and governed by departmental procedures. A decision to use-as-is, for example, should not be left to the discretion of individuals who are not authorized to make such decisions, nor provide the justification for such use.

Nonconformance investigation procedures must also dictate the timeframes for acquiring approvals as well as the disposition of the product. In any nonconformance investigation, time plays a critical role and any unnecessary or timely delays may result in loss of vital information critical to the investigation. Therefore, it is essential that the investigator or other applicable personnel adhere to the established timeframe requirements in order that the flow of critical information may be evaluated in a timely fashion.

Nonconformance investigations procedures must also establish some clear foundation for a plan of action. This plan of action is not required to be so prescriptive as to prohibit or hinder the normal investigative flow. However, it should lay the preliminary foundation for the way in which the investigation is to flow. Action plans may incorporate as appropriate, to retest or resample; responsibilities for evaluating the data; as well as the required approvals of the data.

Depending on the nonconforming product as well as the procedures governing such products, each company must evaluate its own process and procedures for nonconformance investigation and revise as necessary to ensure that they continue to operate in a consistent state of control.

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.

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.

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.