Using FMEA (Failure Mode Effects Analysis) as a proactive approach to Contamination Control


Product or process failures can be costly. To that end, minimizing contamination is crucial.

While a contamination plan can be an excellent tool to identify routes of contamination after the fact, Failure Mode and Effects Analysis is a proactive approach to minimize or eliminate failures before a product reaches the consumer.
At the 2016 Quality Performance Leadership Team Summit hosted by Johnson and Johnson, attendees engaged in a simulation exercise to demonstrate the value of Failure Mode and Effects analysis (FMEA), we encourage the widespread adoption of this pro-active process to mitigate risk and reduce the potential for losses.

The contamination control plan is central to good manufacturing practice, and is critical to the success of aseptic, terminal sterilization, and non-sterile manufacturing facilities, as evidenced by the word “contamination” that appears no fewer than 24 times in 21 CFR Parts 210 & 211.

While this is most obvious in aseptic manufacturing, what is less obvious is the even greater need for a plan to address contamination control in non-sterile manufacturing environments. Within this context, the requirement is to control the types and numbers of microorganisms in the finished products. Regulatory compliance has now been extended into personal care products (e.g., cosmetics, toiletries, and soaps). Historically, this requirement only became obvious after a problem arose and frequently resulted in costly product recalls.

Contamination control can be approached from the perspective of root cause analysis and can be an excellent tool in the determination of likely routes of contamination after the fact, and during an investigation. A more traditional proactive approach to risk management might be through the use of FMEA, which can be extremely useful in determining the most important aspects of control for your process. This is a bottoms-up, iterative approach for analyzing a design of a product or process in order to determine what could go wrong, how badly it might go wrong, and what needs to be done to prevent it.

This is a formal process for eliminating or mitigating the risks of a failure and it’s an on-going process that documents and tracks problems and changes through the product development phase. The basic concept is to begin at the lowest level of the system, proactively identify the potential failure modes, assess the effects and causes, prioritize based upon the effect through redesign or additional controls, and eliminate the failure or mitigate its effect prior to the product being released to the public.

There is an FMEA process available to F4SS members located on the F4SS website – Quality Performance Leadership Tools.

Has your organization already adopted FMEA as part of its strategy? If so, share your experience with us.


Lauren Wilson


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