18.2 Failure Mode and Effect Analysis

As discussed in prior chapters, 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 (1). The process is effective because it provides a very systematic process for evaluating a system or a procedure, in this instance. It provides a means for identifying and documenting

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 starting point from which the control plan can be created.

FMEA can be used to analyze the following:

1. Process. Documents and addresses failure modes associated with the manufacturing and assembly process.
2. Procedure. Documents and addresses failure points and modes in procedures.
3. Software. Documents and addresses failure modes associated with software functions.
4. Design. Documents and addresses failure ...

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