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8 Biggest Mistakes in Conducting Deviation Investigations-Part I

8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I

This post, the 8 Biggest Mistakes in Conducting Deviation Nonconformance Investigations-Part I discusses the first two mistakes industry professionals need to avoid.

Deviation investigations are one of the most important quality activities of any GMP organization. It is also an area that FDA and other regulatory authorities frequently cite in observations, Warning Letters and consent decrees: ”There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.” For a summary of 2015 FDA areas of observations click here. 

Deviation investigations are perennially near the top of this list. Based on my experience, two of the areas that many organizations could improve upon upon most are writing and managing deviation investigations.

  1. Not leveraging historical data for continuous improvement

Embodied in all the information gathered over time in investigations is a wealth of information that can be used for continuous improvement, productivity increases and reducing the recurrence of investigations. Unfortunately, many organizations only review this data once a year and in a somewhat perfunctory manner.

A good trending program is an important element in monitoring and proactively responding to developing issues. Investigation data (root cause, functional group, process area) can easily be entered into a data trending program. Doing so aids in continuous monitoring of the types of events and root causes occurring in a facility by product, area of process and functional group, etc.

In order to trend deviation and investigation data (event and root cause0, developing a list of standard, event categories and actionable root causes that can be selected can provide powerful new insights. This list can be upwards of 200 or more. While this may seem like an overwhelming amount, using this list is not daunting. By categorizing the list and using a standard tool, trained and practiced end-users can readily find the root cause that applies to their investigation, usually less than 15 seconds.

2. Relying on and stating “Human Error” as a root cause

This is a common finding that the authorities will cite companies for not locating the true root causes and correcting the underlying issues.

Human error is usually a root cause category, but rarely is the true and actionable root cause. The true root cause is usually something else in areas such as: procedures, e.g., “step x.x unclear”; training, e.g., “wasn’t assigned training on procedure since SOP was not on training curriculum”; environment, e.g. “distraction due to false fire alarm”; machine, e.g., “improper equipment design and layout”. 

It is important to find a true underlying root cause described in actionable terms to prevent recurrence and reduce the number of future human error events. Human error events cost the industry a staggering amount of money in terms of lost productivity, compliance and labor costs dealing with their impact, and the human resources needed for investigating non-conformances. The average cost of an investigation run’s into tens of thousands of dollars. Preventing their recurrence not only saves organizations money, but reduces the likelihood of compliance issues, including a regulatory finding that a recurring issue was not addressed.

Some quality systems do not allow “human error” as a root cause in order to prevent organizations from not addressing the true root cause behind most of these types of errors. In most (but definitely not all) human error events, the human involved had the ability to detect the error prior to it becoming a deviation. Therefore, an “inadequate ability to detect the problem” may be the actionable root cause in such situations. The CAPA would be counseling or additional training that focuses on increasing the person’s ability to eliminate or catch an error before it becomes a deviation in the future or other job aids or improvements in HMI (human machine interface) that allow operators to better detect problems in time to prevent a deviation. Counseling just on “paying attention to detail” or on “the importance of GMPs” is inadequate as a stand alone CAPA. If someone doesn’t understand the importance of GMPs, they shouldn’t be working in a GMP environment and need more training.

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This Post Has 12 Comments

  1. Declaration of cause without using any investigation tools is the biggest problem. Sometimes due to overconfidence peoples are not using the required tool for the findings of investigation…..Sometimes peoples are in pressure of management to overlook some small issues, but after sometime this overlooking become their practice and later they unknowingly overlook the big issue which leads to failure of quality management system.

    1. I agree this is very common. Even simple Minor investigations need a justification of rationale for conclusions, even if a formal root cause tool is not used. A root cause tool should be used for Major and Critical investigations. Small issues can sometimes cause big problems and should be addressed with CAPAs for the root cause. This becomes even more important for recurring issues.

  3. One leads to the other..Lack of continuous monitoring leads to inefficient root cause analysis and finding the easy to blame ” human error”!!..Worse, not paying attention to this if it is pointed out stating management pressure and meekly obeying the same point during an audit!!

    1. Agree, Continued Process Verification including products like ProcessPad, save time and money. Many problems can be anticipated and prevented or the impact reduced from monitoring changes in trends. You can’t do this without current, easily accessible data.

    1. Thanks for sharing Anshu. Most systems do an initial impact assessment based on severity of impact and some consideration of frequency. E.g., a recurring Minor could get elevated to Major. A recurring Major could become a Critical if it could indicate a loss of control.

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