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Human Errors: Overcoming the Challenges

Purpose

Learn to overcome human errors as a root cause to deviations.

Objectives: At the completion of the class, students will be able to:

1. State what the CGMPs imply regarding human errors.

2. State the FDA’s current thinking about human errors and deviations.

3. Describe the basics of root cause determination.

4. List the possible root causes to human errors.

 Prerequisite: Students must have a solid understanding of CGMPs.

 Who should attend this class?: This class is intended for anyone from line personnel to senior executives who wants to change their approach to human errors.

 About the class

1. Students use in-house deviations and industry case examples to explore overused category of human errors in deviation investigations.

2. Each student receives a student guide containing a representation of the program’s slides.

3. This class can accommodate up to 25 people.

4. Duration: 8 hours.

Topics Covered

 Introduction

1. Activity: Heard on the street

2. What the FDA says about human errors and deviations

3. Percent of human errors in industry

4. Overview of 483 Observations and connection to human error

Psychology of Human Failures

1. Memory slips and lapses

2. Mistakes

3. Attention, memory and human errors

4. Activity: Memory

5. Sources of human failures

Investigating Human Errors

1. Building adequate controls

2. 5-Why’s

3. Interviewing

4. Sequence of events

5. Distinctions

6. Walk through analysis

7. Change analysis

8. Control barrier analysis

9. Fishbone diagrams

10. Root cause analysis

Preventing Human Errors

1. Retraining

2. Learning domains

3. System design issues

 Outlines subject to modification with notification based on changes to content or the regulatory environment. Please request an updated outline if there are specific questions that need to be addressed.

Call to learn about how we can customize this outline for any of your site's training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500.

For a prompt reply to requests and questions:  415.487.3500   |  allan.dewes@skillsplusinc.com   |   Fax: 415.487.1926

©2012 SkillsPlus International Inc.