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Failure Mode and Effects Analysis (FMEA)

FMEA is a proactive safety technique that helps to identify process and product problems before they occur. It is one of several types of proactive risk assessment that can be used in healthcare settings. It is also widely used as an integral aspect of improving quality and safety in other industries, e.g., automotive, aviation, and nuclear power.

Canadian Failure Mode and Effects Analysis Framework©

ISMP Canada has developed the Canadian Failure Mode and Effects Analysis Framework — Proactively Assessing Risk in Healthcare©, with assistance from healthcare and human factors engineering consultants. It can be applied to all healthcare processes, such as, medication use, patient identification, specimen labelling, emergency room triage, identification of risk of patients falls, to list a few examples. It can be used in acute care, long-term care and community settings.

The 8 steps for conducting an FMEA described in the Framework constitute a straightforward and understandable technique that users can readily apply to their own practice settings.

Steps for conducting an FMEA:

Step 1

Select process and assemble the team

Step 5

Prioritize failure modes

Step 2

Diagram the process

Step 6

Redesign the process

Step 3

Brainstorm potential failure modes and determine their effects

Step 7

Analyze and test the changes

Step 4

Identify the causes of failure modes

Step 8

Implement and monitor the redesigned process

ISMP Canada provides FMEA training and workshops. Consults for conducting FMEA within an organization are also offered.

For more information, send an e-mail to: or call 1-866-54-ISMPC (1-866-544-7672).

The Canadian Failure Mode and Effects Analysis Framework© booklets are available in English or French from ISMP Canada

To order, please download and print the Order Form

Additional ISMP Canada Resources:

Failure Mode and Effects Analysis: Proactively Identifying Risk in Healthcare. ISMP Canada Bulletin 2006; 6(8)

Greenall J, Hyland S, Colquhoun M, and Jelincic V. Applying Engineering Principles to Medication Safety. Medication Safety Alerts. Can J Hosp Pharm 2004; 57(2): 110-113

How to Use 'Failure Mode and Effects Analysis' to Prevent Error-Induced Injury with Potassium Chloride. ISMP Canada Safety Bulletin 2002; 2(5).

Designing Effective Recommendations Ontario Critical Incident Learning Bulletin 2013; (4).

Usability Testing in Proactive Risk Assessments ISMP Canada Safety Bulletin 2012; 12(11).

Include Cognitive Walkthrough in Proactive Risk Assessments ISMP Canada Safety Bulletin 2012; 12(1)