Root Cause
Home Up Essentials for Pharmaceuticals Root Cause Procedure Writing Executive Session GMP/QSR Trainer Certification Evaluations

 

We also recommend: [Human Errors - Overcoming The Challenges] [Deviation Investigation Reports] [Risk Assessment: CGMP/QSR for the 21st Century]

 

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 Topics

CGMPs and Investigations

The CGMPs and investigations

Investigation citation issues

 

Deviation Statement

Defining the problem

Tool: 5-Why's

Class Project: Work on a real plant example with instructor coaching

 

Deviation Investigation      

Deviation investigation defined

Tool: Distinctions

Tool: Walk-Through-Analysis

Tool: Change Analysis

Tool: Control Barrier Gap Analysis

Research assignments

Class Project: Work on a real plant example with instructor coaching

 

Root Cause Analysis

Root Cause defined

Root Cause types

Path forward

Tool: Root Cause Analysis Diagram

Prioritizing root causes

Identifying the most likely root cause

Class Project: Work on a real plant example with instructor coaching

 

Corrective Actions              

Corrective Action defined

Tool:  Brainstorming

Solution identification

Corrective action generation tools and techniques

Class Project: Work on a real plant example with instructor coaching  

Preventive Actions              

Preventive Action defined

Tool: Control Barrier Needs Analysis

Class Project: Work on a real plant example with instructor coaching

 

Risk Analysis       

What is acceptable risk?

Tool: Simple Risk Assessment

Go/no-go decisions

Tool: Failure Mode and Effects Analysis

Prioritizing FMEA results

Managing the risks of a corrective and preventive action

Class Project: Work on a real plant example with instructor coaching

 

Metrics

Measuring corrective action and preventive action success

Assuring follow-up success

Setting follow limits

 

Summary

Review of tools used in class

Optional on line exam  

 

Bonus! - A free GMP tip on Root Cause Analysis (by SkillsPlus International Inc.)

 

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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