Risk Assessment (FMEA)
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We also recommend: [Root Cause Analysis for Better Investigations] [Human Errors - Overcoming The Challenges] [Deviation Investigation Reports]


Risk Assessment: CGMP/QSR for the 21st Century




To be able to conduct an FMEA on any issue within the facility.



  1. To design an FMEA

  2. To conduct an FMEA

  3. Respond to the data from an FMEA

About the Class

  1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 8 hours as a minimum. Depending on the project selected, this class may take several days.




1. Definitions

2. FMEA Overview


FMEA Components

1. Failure modes

2. Root cause categories

3. Control barriers

4. Severity

5. Frequency

6. Detection

7. Calculating risk

8. Prioritization

9. Risk mitigation strategies



1. Activity: Class works in small teams to develop a simple FMEA

2. Presentations


Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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