9.1 Introduction

This section provides the basic instructions for performing a failure mode and effects analysis (FMEA) and a failure mode, effects, and criticality analysis (FMECA) for the purpose of analyzing procedures for risk. Also provided are examples of commonly used symbols and tables used in the analysis process. An example of how these techniques are used for analyzing procedures is also provided.

9.1.1 Description

An FMEA is a detailed document that identifies ways in which a process or product can fail to meet critical requirements. It is a living document that lists all the possible causes of failure from which a list of items can be generated to determine types of controls or where changes in the procedures should be made to reduce or mitigate risk. The FMEA also allows procedure developers to prioritize and track procedure changes (2).

9.1.2 Why is a Failure Mode and Effects Analysis Effective?

The process is effective because it provides a very systematic approach for evaluating a system or a procedure. It provides a means for identifying and documenting the following:

1. Potential areas of failure in process, system, component, or procedure.
2. Potential effects of the process, system, component, or procedure failing.
3. Potential failure causes.
4. Methods of reducing the probability of failure.
5. Methods of improving the means of detecting the causes of failure.
6. Risk ranking of failures, allowing risk informed decisions by those responsible.
7. A ...

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