A Risk-Based Approach to Deviation Management - Follow a risk-based approach to maintain a state of control. - BioPharm International


A Risk-Based Approach to Deviation Management
Follow a risk-based approach to maintain a state of control.

BioPharm International
Volume 22, Issue 4


The level of investigation should be commensurate with the level of risk. Applying risk-assessment principals helps ensure resources and efforts are used where they are needed most. Instituting a risk-based approach to manage deviation investigations is key to focusing on problems that could result in patient harm. A major biotechnology company recently described how it implemented this type of program.7 Deviations are categorized according to the level of associated risk and investigation techniques are applied proportional to the risk. It is expected that the highest-risk deviations, which are fewer in number, will consume the major part of resources dedicated to DM. The concept of varying the thoroughness of investigation according to the nature of the problem, and the definition of the elements of a thorough failure investigation have been recorded in case law by the United States District Court for the District of New Jersey in United States v. Barr Laboratories, Inc.8

Investigations begin with fact-gathering activities designed to collect as much information as possible to enable proper evaluation of the event. The end product of the investigation is an in-depth analysis of the deviation that will lead to determination of the root cause, not merely a restatement of the problem.

To produce the best results, a team of subject matter experts from the affected department(s) should conduct the investigation according to established procedure(s).

Information sought includes, but is not limited to:

  • the scope of the deviation (i.e., the period over which the deviation occurred, the number of times the deviation occurred, the number (and identity) of products involved)
  • facts and events surrounding the deviation
  • the involvement of other facilities.

Investigation methods include:

  • interviewing people closest to the problem
  • reviewing records and documents
  • inspecting and testing products and materials
  • inspecting equipment and facilities
  • observing operations.
  • reviewing past deviations of the same type
  • experimentation or simulations.

As information is gathered, investigators should resist the temptation to jump to conclusions about what happened and how it happened because this could prevent the discovery of additional information leading to a different or more comprehensive conclusion. There are also pressures to complete the investigation quickly because production and product release may be affected. However, an incomplete investigation affects the ability to analyze risk and the data, which will be used to formulate the preventive action. If done haphazardly, this demonstrates that the process is not in a state of control and the problems will probably recur.


The importance of performing a good root cause analysis (RCA) cannot be overstated because the actions taken to correct or prevent the deviation from recurring are directly related to and depend on finding the right cause. However, investigators often fail to dig deeply enough to find the cause and apply the wrong corrective action, thereby risking recurrence of the problem. By prematurely ending the search, investigators may incorrectly focus on placing blame on an individual involved or providing unneeded retraining rather than seeking an opportunity to design safety into a process. Other notions that impede successful RCA are:

  • believing that when more than one root cause, or potential root cause, is identified, only one may be selected
  • settling on a best guess of the cause as the quickest way to solve the problem and close the deviation.

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