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Root
Cause Analysis for Better Investigations
Purpose
To
conduct or facilitate an individual or team-based investigation that solves
problems and gets results, and complies with FDA expectations in the
pharmaceutical and biotech industries. Objectives
1.
Use
tools and techniques to effectively identify the deviation statement. 2.
Identify
the root cause of the deviation. 3.
Generate
and objectively select the best corrective and preventive actions. 4.
Assess
the risk of implementing the corrective action and preventive action. 5.
Develop
a contingency plan to preventive action implementation. 6.
Create
corrective actions and preventive action metrics. About
the Class
1.
This
class uses current deviations to practice the techniques taught. 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. Course TopicsCGMPs
and Investigations 1.
The
CGMPs and investigations 2.
Investigation
citation issues Deviation
Statement 1.
Defining
the problem 2. Tool: 5-Why’s 3.
Class Project: Work on a real plant example with instructor coaching Deviation
Investigation 1.
Deviation
investigation defined 2.
Tool:
Distinctions 3.
Tool:
Walk-Through-Analysis 4.
Tool:
Change
Analysis 5.
Tool:
Control
Barrier Gap Analysis 6. Research assignments 7.
Class Project: Work on a real plant example with instructor coaching Root
Cause Analysis 1.
Root
Cause defined 2. Root Cause types 3. Path forward 4.
Tool:
Root
Cause Analysis Diagram 5.
Prioritizing
root causes 6. Identifying the most likely root cause 7.
Class Project: Work on a real plant example with instructor coaching Corrective
Actions
1. Corrective Action defined 2.
Tool:
Brainstorming 3.
Solution
identification 4. Corrective action generation tools and techniques 5.
Class Project: Work on a real plant example with instructor coaching Preventive
Actions
1.
Preventive
Action defined 2. Tool: Control Barrier Needs Analysis 3.
Class Project: Work on a real plant example with instructor coaching Risk
Analysis
1.
What
is acceptable risk? 2.
Tool:
Simple
Risk Assessment 3. Go/no-go decisions 4. Tool: Failure Mode and Effects Analysis 5.
Prioritizing FMEA results 6. Managing the risks of a corrective and preventive action 7.
Class Project: Work on a real plant example with instructor coaching Metrics 1.
Measuring
corrective action and preventive action success 2.
Assuring
follow-up success 3. Setting follow limits
Summary 1. Review of tools used in class 2.
Optional on line exam To speak with the lead instructor for this class please call Allan Dewes at 415.487.3500 or submit the information request form below.
©2008 SkillsPlus International Inc.
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