Pharma Knowhow

The Failure Mode and Effect Analysis method (FMEA)

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By guestauthor Dr. Aline Cossy-Gantner 

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Introduction of the powerful FMEA risk analysis method into the risk management of pharmaceutical companies to identify,and reduce/prevent failures in processes and products.


The pharma world in the ICH region and associated countries is highly regulated. Medicinal products whether small molecules or complex biotechnology products or ATMPs are subject to stringent regulation. To receive marketing authorization the pharmaceutical companies have to show that the product is safe and efficacious including data on the pharmaceutical quality, nonclinical and clinical data. The identification of risks, risks minimization and risk management are major topics and these relate to the pharmaceutical quality as well as to pharmacovigilance. As pointed out in the ICH Quality Risk Management Q9 risk management is a systematic process for the assessment, control, communication and review of risks. Several tools of risk management are suggested by the guideline and one of these tools is called FMEA:


The Failure Mode and Effect Analysis method called FMEA is an established and proven method. It was developed and introduced in the sixties by the NASA and continuously expanded. Nowadays it is used routinely in many industries such as automotive, automation and chemical industry. The FMEA method is also expanding to the pharmaceutical and medical device industry. It is the first risk analysis method mentioned in the list of Methods and Tools in the ICH Quality Risk Management Q9 guideline. Users of the method are appreciating the tool because its results are condensed in a very compact central document easy to review. The FMEA helps to detect failure in a preventive way, to implement corrective action and continuously record the improvements. Moreover, the FMEA process itself triggers a great team building, training and quality awareness and spirit among the team members: a central aspect to provide excellent products and processes.


An experienced coach can assist companies to ensure a smooth and adequate implantation of the methods. Small but also large companies have made very good experience with having an external a coach during the initial implementation phase (1-2 years) to establish a consistent way of using the method and a standard quality in the application.


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