The following is a guest article by Pharmatech Associates‘ Stephanie Gaulding.
One of the central processes in a modern drug product quality management system (QMS) involves getting to the bottom of why things did not go as planned so these events can be prevented from happening in the future. Inadequate deviation investigations, however, continue to be one of the most common observations in inspections conducted by health authorities.
Avoiding subpar investigations is easy if you understand how to prevent three of the most common pitfalls which lead to this type of inspectional observation.
These three pitfalls are:
- Not getting to root case
- Inadequate scoping
- Treating investigations the same
Pitfall #1 – Not Getting to Root Cause
Temptation abounds when conducting a deviation investigation to take the easy way out and attribute the root cause to the first thing that pops into one’s head, or easier yet, “human error.” The reality is that the root cause of a deviation is rarely a result of human error; often, the first thing that comes to mind is part of the symptoms of the issue and not the actual cause. Searching for root cause involves digging through evidence collected during the investigation, reviewing historical data, and analyzing them for root causes.
One of the most important best practices in conducting thorough deviation investigations is collecting information at the time a deviation occurs as evidence can be transient, especially when dealing with people. The ability of an individual to recall specifics about an event diminishes greatly over time.
Human memory is not designed to be a repository of every moment, but is more of an amalgamation of information gathered by our senses that is then sorted and filtered by our minds. Time alters the clarity of memory, meaning that if personnel need to be interviewed to understand what led up to an event or how they responded to it, that information must be collected as soon as possible after the event occurs.
[Editor’s Note: Learn what happened when an FDA investigator identified inadequate deviation investigations during an inspection in the article, “GMP Inspection Case Study Focuses on Inadequate Deviation Investigations.”]
It is also imperative to avoid jumping to conclusions while gathering information during the initial stages of a deviation investigation. Often what initially appears to be the cause of the issue is actually a symptom. Root cause should be determined using the data and information gathered during the initial stages in conjunction with an appropriate root cause analysis tool (e.g., 5 Whys, fishbone diagram, fault trees, etc.). Additionally, historical data may need to be mined for similar occurrences or additional clues as to what might have happened and why.
…the root cause of a deviation is rarely a result of human error…
In analyzing the data and information, efforts should be made to avoid the “human error” trap. When investigators suspect human error, they should dig deeper to understand whether the error was a deliberate violation or an inadvertent error. Rarely do personnel consciously make a choice to do something wrong (e.g., not follow a procedure) with malicious intent.
It is more often that there is an issue driving them to make a conscious choice such as an out-of-date procedure or process that is behind routine deliberate violations. On the other hand, unintentional errors such as a slip-up or mistake could stem from several possible causes and only a robust investigation will uncover the real reason why the event happened.
Pitfall #2 – Inadequate Scoping
One of the most challenging aspects of conducting a root cause investigation is getting the scope of the investigation right. Often, investigators focus on the immediate batch, piece of equipment, or process involved in the event and do not extend the investigation to other batches, similar pieces of equipment, or related processes. It is important to not only understand if similar events have previously happened, but if they could happen on another batch, with another product, on a similar piece of equipment, or as part of a similar process.
Retrospective examination looking for similar occurrences can provide clues into the root cause of the event. The historical review, however, should not only look at previous batches of the product involved. Consideration should be given by reviewing historical data and events from products made using the same equipment or process technology as well as similar pieces of equipment or processes. A larger dataset can provide clues that can be difficult to see in a small sample size.
Often what initially appears to be the cause of the issue is actually a symptom
Once the root cause is determined, scoping becomes an extremely important factor when considering the impact of a deviation as well as in determining corrective and preventive actions. Looking through a broader lens ensures that consideration is given to whether the root cause could have impacted previously manufactured batches or could occur on another product or manufacturing process.
Often investigation teams are narrower in their view of the impact of the event, readily excluding other batches, products, or processes without much analysis. Careful thought and due diligence should be exercised when determining scope boundaries and investigation teams should document the rationale for setting the scope as part of the investigation.
Pitfall #3 – Treating Investigations the Same
Many organizations treat deviation investigations as a check-the-box exercise. Even worse, some still treat every deviation with the same toolkit or worse, go to a previous similar investigation and “copy and paste,” followed by a “find and replace” to update the investigation information.
The reality is that not all deviations are the same nor do they require the same amount of effort to get to root cause. While it is tempting to use a previous investigation as a starting point, caution should be used as this can put blinders on the investigation team and they can miss important data or information leading them to uncover the actual root cause of the new occurrence.
Careful thought and due diligence should be exercised when determining scope boundaries
Not all events leading to deviations are created equally; therefore, not all deviation investigations should be treated in the same manner or performed with the same intensity and urgency. Some events and processes are more complicated requiring more time to conduct a thorough investigation. Sometimes, a root cause cannot be determined in investigating the first occurrence of an event, but a second occurrence sheds light on the likely root cause that the previous investigation could not uncover.
Deviation systems should also be built to triage events into risk-based categories with sufficient time allocated to each category to drive risk-based investigations and focus the most time and effort on the highest risk and most complex events. Investigation timelines and processes should prevent deviations from sitting around and not being investigated. After all, if root cause is not determined and addressed, the issue can, and often does, keep happening, which leads to more work for the organization.
These three common deviation investigation pitfalls are avoidable by developing a thorough deviation investigation process. In addition, personnel who conduct investigations should be trained not only in the tools and methodologies for investigating events and getting to root cause, but also on common traps that can occur during the investigation process. Without a well-designed investigation approach that accounts for these pitfalls, the likelihood of receiving inspectional observations relating to inadequate deviation investigations remains high.
About the Author
Stephanie Gaulding is the Executive Director, Regulatory Compliance at Pharmatech Associates, Inc., a consultancy serving the regulated life science industry. She draws on over 25 years of experience in quality management systems and leadership roles in the regulated life science industry to develop and deliver efficient and sustainable quality management systems, assuring compliance with global regulatory requirements and industry best practices.
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