MHPM H P C O N S U L T A N T S, L L C

Title: Handling of Out-of-Specification Test Results/Unplanned Deviations 

Description: The scope of this workshop covers performing an investigation from the point of event observed/discovered through CA/PA closure and verification.  The focus of this workshop will be to provide an overview of techniques, including strategy meetings, root cause analysis, compilation and evaluation of supporting data and writing a comprehensive, compliant Investigation Report.

An interactive workshop using industry related examples resulting in investigation quality improvement and deviation reduction.

Length:  2 days

Audience:  Personnel conducting investigations, Quality Assurance, Quality Control, Laboratory Management.

Learning Objectives:

·        “How to”….the systematic approach to understanding and documenting the process used to determine what happened, why did it happen (root cause analysis) and how to prevent recurrence

·        Root Cause analysis and its linkage to appropriate CAPA identified

·        Writing a comprehensive and compliant investigation report

·        CAPA management/CAPA Pitfalls

·        Techniques in facilitating strategy meetings and operating in a “team” environment 

Workshop participants are taught to: challenge, ask questions, and evaluate each event in an appropriate scope while maintaining an open mind approach.

Content Outline:

Day 1 of 2

I.                     Introduction and Workshop Objectives

II.                   Why are you required to perform an Investigation?

A.      Corporate Policy

B.      Regulatory Requirement

1. Know your audience

C.      Key Elements of the Investigation Process

III.                  What is an event?

IV.                What do you do first?

A.  STOP

B.      Assess/Evaluate

C.      Next Steps

V.                  What is a Deviation?

A.      Documentation requirements of the deviation

B.      What is an “Immediate Action”

C.      What is an “Impact Assessment”

1. Timing

a.                   Immediate

b.                   Ongoing throughout the investigation

D.      Classification of the deviation

VI.                How to perform an investigation

A.      Strategy Meeting

B.      Collecting Information

C.      Assessment

VII.               Root Cause Analysis

A.      Qualitative Tools

1.      Use of knowledge & experience (Brainstorming)

2.      Cause and Effect

3.      5 Whys

Day 2 of 2

            Root Cause Analysis (cont’d)

B.      Quantitative Tools

1.      Process Mapping

2.      Trending Charts

3.      Pareto Charts

C.      How to evaluate all potential root cause(s)

1. Decision Making Process

a.       Determine Most Probable Cause

b.       Documentation of justification for exclusion

VIII.             CA/PA

A.      Definition

B.      Pitfalls

IX.                 The Investigation Report

A.      Step 1 – Compile Thoughts

B.      Step 2 – Draft

1.  Putting It All Together

X.                   The Investigation Package

A.      What does it look like

B.      Expectations

C.      The Final Report

1.  Supporting documentation

Exercises/Breakout Sessions

Exercises are included throughout the 2-day session. The objective is to apply all techniques learned in performing an investigation.