Root Cause Analysis and Deviations

Q. What is a deviation & do all deviations need a root cause analysis?


A. A deviation is when there is a failure to follow the instructions guiding the performance of an activity. The purpose behind understanding a standard deviation is critical to execute for optimal results. Simply put, deviations result from people not following their standard operating procedures (SOP) and is often the root cause analysis of many quality problems.


For example, deviation meaning can often be based on work instructions or batch record instructions. A root analysis often starts with documents that explain how a team performs certain functions or tasks. Deviation investigations related to non-compliance look to determine the root cause of the problem. While not all SOP deviation issues are equal in their impact on root cause, any quality deviation should be investigated. The basics of this investigation is historically considered the “five whys”  (or 5whys). 


Q. What is a planned deviation?


A. In our opinion, there is no such thing as a planned deviation. Planned deviations were often a SOP deviation supposed to justify changes from SOPs that would be utilized to carry out the operation over a certain period of time.


The current thinking by regulatory authorities is there is no such thing as a planned deviation. During a breakfast session at a recent PDA  Joint Regulatory Conference, a representative from the FDA stated, “it’s a very strange term, and it kind of makes your skin crawl a little bit”.


If you need to make a CAPA deviation change to a procedure, we suggest using the change control system to document. This may seem like a picky point in average deviation process flow. However, until the change is evaluated in process validation requirements, a short term deviation is still non compliance. The deviation process in manufacturing must product reliable and durable solutions. This standard deviation step by step process can only help to reduce quality issues in the long term, especially for large deviation issues. 


Q. What’s the best process for investigating deviations?


A. There is no single best process for investigating deviations. The ultimate goal of deviation investigations is to determine why something went wrong in the final pharmaceutical deviation report. Above all, understand what caused the deviation to go wrong and how to address the issue from reoccurring. To achieve successful resolution of deviations, keep the following in mind when searching for types of root causes:


  • A one-size investigation doesn’t fit all situations. Simple errors require simple documentation while more serious deviations require broader investigations.
  • The best tool to have is inquisitiveness during the 5why analysis. Ask yourself how far this process deviation could extend.
  • Widen your perspective. Look for ways to relate, not separate, similar issues across CAPA deviation investigations.
  • Human error in the 5whys is rarely a sufficient root cause.
  • Always verify information or your instincts and never assume you are correct without proper data to support your instincts.


Q. Why is human error not an acceptable finding for deviations?


A. The overuse of human error as a root cause to a deviation represents lost opportunities to reduce future issues. A root cause analysis must identity of the true root cause of the problem and not mask it. Sometimes in a rush to get to the root of the problem, the problem lies within the human error inside human error


There is a bigger root cause corrective action question that needs to be considered. The initial investigation should determine what the root causes are that led the employee to make the human error. Asking this question early in the root analysis leads to better identification for continuous improvement. It can also solidify agreement in the team regarding the cause analysis associated with improvement priorities. 


Root Cause Analysis Example


Let’s look at types of root causes that might help clarify examples of why human error can mask the real root cause of a deviation. Suppose, for example, you have a second shift manufacturing operator who continually forgets to sign the batch record for a specific product. This operator is the only one who seems to have this issue. Your initial investigation into the first occurrence of the issue determines a root cause of human error.


Because the operator works the second shift, it is inconvenient to interview him and find the root problem. This relies on the word of his supervisor as an important source that influences the root cause corrective action, which may not be the whole story. This small factor can impact the root causes of the bigger issue while the team may not recognize the significance. 


Root Cause Failure Analysis


You decide to retrain the operator on the proper use of filling out the form and skip the operator interview. This helps to increase the speed of the root cause failure analysis in order to complete the investigation in the allotted 30-day time frame. This scenario repeats itself 10 times over the course of four months. You finally decide to interview the operator directly after the root cause investigation is completed.


When you talk to the operator, he informs you of the process to sign the batch record when it needs to be signed. He must exit the aseptic core, degown and sign the batch record. Now, you finally begin to determine the root cause meaning based on the common repetition of employee actions. 


Root Analysis and Process Flow


The root cause analysis deviation unveils the operator leaves the product unattended when signing the batch record. After signing the batch record, he must then regown and return to work.  The operator tells you he chose to stay with the product and sign the batch record later. Consequently, he sometimes forgets to sign after the manufacturing run. In this simple exchange with the operator, you find the root cause of the repeat deviation is not a result of human error but a result of poor process flow.


Q. How much time should I allow for a deviation to be investigated?


A. Interpreting standard deviation often depends on the length of time it takes to complete an investigation. This can change depending on the complexity of the circumstances involved. Simple deviations can be completed in a short time frame, but more involved deviations will take longer. We recommend you set a root cause investigation time frame that is reasonable for the size of your organization. For example, you might indicate that investigations will be completed between 30–60 days after the documented deviation. This gives you some flexibility to conduct a proper search during root cause problem solving.


Q. Are out-of-specification (OOS) results considered deviations?


A. No. OOS results need to be investigated separately due to the potential impact to the product. If the root cause of the OOS cannot be attributed to laboratory error, you should initiate a deviation/investigation.  Additionally, a separate root cause tree can help determine what happened during product manufacturing that led to the erroneous laboratory result.



root cause analysis





Pharmaceutical Technology

Volume 45, Issue 4

Pages: 66, 65


About RCA’s Pharmaceutical Consulting Services 


Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.


Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 


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As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.


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pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:



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Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.


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