Root Cause Analysis
  [Exemptee/Designated Rep] [Site Map] [Free Previews] [Free Tips] [Feedback[Search] [Information]

[Contact Us]

Home
Up

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

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.

 

Contact us for a prompt reply!

Inquiry

Telephone

Email

Information via Email

(415) 487-3500

Click Here

Corporate and Consulting Services

(415) 487-3500

skillsplus@aol.com

Sales: Product and Services

(415) 487-3500

skillsplus@aol.com

Designated Representative

(415) 487-3500

skillsplus@aol.com

Exemptee Certification

(415) 487-3500

skillsplus@aol.com

Fax orders to

(415) 487-1926

 

Webmaster

(415) 487-3500

skillsplus@aol.com

Product and Service Support

On-line tech support for CBT classes   Click Here
On-line tech support for on-line purchases   Click Here

Live computer based training tech support

(415) 487-3500

Allan

Live GMP Content questions

(415) 487-3500

Allan, Jackie, or Jesse

©2008 SkillsPlus International Inc. 


Hit Counter