Determining appropriate corrective actions

In any root cause investigation of a product or quality system nonconformance, the ability to determine the appropriate corrective actions can mean the difference between an effective CAPA that successfully addresses the issue and an ineffective CAPA that is doomed to be repeated. Too often, investigators, either in a rush to complete the investigation by its due date, or as a result of a lack of experience, may determine actions that are not appropriate in addressing the root cause of the nonconformance.

It is a given reality that root cause investigations must be completed in a timely manner and corrective and preventive actions must be implemented and verified in order to prevent recurrence of this event. However, compliance to the timeliness of an investigation and determining appropriate corrective actions do not have to be an “either / or” situation. It is possible to complete the investigation within the allotted time and identify appropriate corrective actions to prevent recurrence. Here’s how:

1- Develop an investigation plan at the onset of the investigation and ensure that each person with responsibilities are held accountable for meeting due dates. Why is this step important? Too often, investigations fail to meet its due date not due the complexity of the event, but rather, due to a lack of planning. Remember the old adage: “if you fail to plan, then you plan to fail.” This axiom holds true in the investigation world as well. The significance of an investigation plan is that it is a tool which aids in the tracking and planning of activities and it monitors actions toward completion. This visual aid, if you will, helps keep everyone on the same page and moving towards a unified goal.

2- Ensure that the action address the root cause of the nonconformance and not a symptom. This means that you must drill down to the core of the issue by brainstorming all probable causes and not simply stop at the first cause which “seems” most likely. Drilling down also means gathering input from other applicable SMEs or affected group members to ensure that brainstorming sessions are productive and that all possible scenarios have been evaluated.

3- Verify that the actions are effective in producing the anticipated outcome. On many occasions I have seen investigators come up with proposed actions that either do not address the root cause or are not executable for a variety of reasons. The act of verification may entail communicating with other impacted departments to determine whether the proposed solution may be implemented by the other group. I like to call this “a dry run”. The time to figure out whether an action will work is not during the roll out or implementation phase. A bit of pre-planning can spare you months of aggravation and possibly, another instance of a reportable nonconformance.

Four Simple Steps

In my last blog I discussed the importance of drilling down to the root cause in any nonconformance investigation and how to distinguish between a root cause and a contributing cause. In today’s blog, I will discuss four simple phases in the investigation process to follow once you have identified your root cause that will ensure a thorough investigation and effective corrective and preventive actions.

1. Plan
Once the root cause of the nonconformance has been identified via a thorough investigation, a plan must be identified that will effectively eliminate the root cause for this event. This plan must take into account all of the outcomes from the investigation; i.e., “what broke down?” or “what failed to occur?” The plan must evaluate each of the areas of noncompliance and with input from appropriate subject matter experts, identify a strategy by which each of the identified deficiencies will be remediated.

2. Verify / Validate
Once the plan has been developed, it must be verified / validated to ensure that the action(s) as identified will in fact correct the issue. This step is essential because it provides you with critical information early in the process that will alert you of potential gaps/flaws in your proposed plan. This may include gaps related to lack of resources, ambiguous interpretation / wording, or unrealistic expectations, to name a few. This early notification step allows you to make necessary modifications to a proposed plan that may not be executable as initially projected.

3. Implement
Once the plan has been finalized and approved, the actions have been verified / validated, it is now time to implement the changes. With implementation comes proper documentation to ensure that all affected parties have been appropriately notified, the necessary trainings have occurred, and there is evidence to show that the training is effective.

4. Monitor
This final phase of the process is not only a critical one but also one that is often overlooked by many well meaning quality investigators. The monitoring phase is important because it allows you to see (in real time) how effective your actions have been. Many people falsely conclude that because an activity/ action have been “validated” then it must be effective. This is clearly not the case. Validation is simply “confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled.” Unfortunately, once that validated activity enters the production environment, deviations may occur resulting in the reporting of a nonconformance.

Investigating Cause – Drilling down to the root cause

In any nonconformance investigation, identifying the root cause is an integral part of the process. Identifying the root cause enables one to:

*Implement effective corrective actions
*Accurately trend data for process monitoring
*Implement effective preventive actions
* Develop effective strategies for continuous improvement

With so many different benefits of identifying the root cause of a nonconformance, it is imperative that the investigator does his/her due diligence to ensure that appropriate measures are taken.

One of the biggest challenges that various pharmaceutical / medical device companies face is that oftentimes, investigations stop at the first, immediate cause and fails to drill down further to address the systemic underlying cause(s). Or, their investigation may identify several contributing causes but fails to identify the root cause of a nonconformance. How can you tell the difference between a contributing cause and a root cause? Experience, Experience, Experience!

Experience is a critical factor in any comprehensive root cause investigation of an identified nonconformance. The key to differentiating between a contributing cause and a root cause lies with:

1. Experienced Investigators—they are an integral part of the process in that they are able to bring rational, sound judgment to the table. They have intimate knowledge of what works, what does not work and what requires improvement. They are not prone to “shoot at the hip” and stop the investigation after they have answered the first “why” an event occurred.

2. Experienced Mentors—coupled with an experienced investigator, experienced mentors are crucial in bringing unbiased, thorough, and systematic approach to a nonconformance investigation. They help the experienced investigator drill down even further into their process and to identify potential gaps and areas for process improvement.

3. Experienced Quality Oversight—The Quality dept. must give final approval of any nonconformance investigation and this individual must possess the necessary education, knowledge and experience in order to effectively carry out this quality function. Quality is the final reviewer of the investigation and as such, an experienced Quality reviewer will bring to the table a fresh viewpoint that ensures the comprehensiveness of the investigation.

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.