FMEA

Agenda

Failure Mode Effect Analysis is the primary tool used in medical device, in vitro medical device and pharmaceutical industries to assess risk both at product design and development stage, and during manufacturing. The overall objective of the FMEA analysis is to ensure that the product release to the patient is safe.     

   Module 1. Background to Risk

  Module 2. Risk within a Business

  Module 3. Quality System Risk 

  Module 4. Product Risk 

  Module 5. Cognitive Bias

  Module 6. Process Risk

  Module 7. What Level of Risk do we accept 

 Module 8. Workshop

Learning Objectives

A process FMEA identifies process deficiencies to enable process experts to focus on controls for inputs and outputs of the process reducing the probability of producing unacceptable outputs (products and services).

A design FMEA aids in the objective evaluation of design requirements and design alternatives and increases the probability that potential failure modes and their effects on product and service delivery have been considered at the design/development stage.

A Product FMEA aids in the objective evaluation of product functionality and increases the probability that potential failure modes and their effects on product and service delivery have been considered.

A Quality system  FMEA aids in the objective evaluation of sub quality system functionality and requirements and increases the probability that potential failure modes and their effects on product and service delivery have been considered.