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Audience

 

Appropriate for professionals from all industries, particularly those highly regulated. Participants often have backgrounds in quality, engineering, production, risk management, regulatory affairs, R&D, purchasing, project management, etc.

 

Description

Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify:

 

Technical root cause: the change that occurred resulting in performance decline.

Systemic root cause: failures that allowed the change to occur.

Corrective and preventive actions: restore performance to previous levels or requirements.

Control plan: monitor and prevent recurrence.

 

Day one the participants are introduced to the methodology. After each step is presented leveraging an instructor case study, the participants immediately apply the methodology on a real-life case study. Day two the participants continue to develop their skills through practice on another more complex real-life case study.

 

Participants are provided a training manual, an Investigation Roadmap, and a set of electronic templates that guide them through the methodology, recommend tools, and establish the basis for documentation.

Syllabus

 

Day One

8:00 a.m. – 5 p.m.

 

Introduction

  • Overview of methodology and when to use

  • Discuss common investigation mistakes

  • Define critical terms

  • Introduce first participant real life case study

 

Step 1: Define the Performance Problem

  • Introduce instructor case study

  • Problem statement (investigation focus)

  • Problem description (investigation scope)

  • Workshop

  • Flow chart with key inputs of process(es) within scope of investigation (what will be reviewed)

  • Workshop

 

Step 2: Collect Data

  • Determine data needed (verify and narrow investigation scope)

  • Identify methods for collecting data

  • Consider tools and techniques for analyzing data

  • Workshop

 

Step 3: Identify Possible Causes

  • Timeline of changes

  • Differences and Changes

  • Workshop

  • Risk analysis review

  • Brainstorming techniques (gemba, fishbone, group, individual, etc)

 

Step 4: Test Possible Causes

  • Challenge possible causes against data

  • Define “reasonable” assumptions

  • Document testing process results

  • Summarize testing leveraging contradiction matrix

  • Workshop

 

Step 5: Identify Technical and Systemic Root Cause(s)

  • Verify assumptions

  • Studies/experiments

  • Identify technical root cause(s)

  • Identify systemic root cause(s)

 

Step 6:  Determine Corrective/Preventive Actions

  • Mistake proofing (poke-yoke) vs. variation reduction and optimization techniques

  • Corrective/preventive action(s)

  • Risk mitigation

  • Control plan

  • Acceptance criteria

  • Workshop

 

Step 7:  Verify Corrective/Preventive Actions

  • Implement corrective/preventive actions

  • Evaluate effectiveness (control plan)

  • Determine additional preventive actions

  • Disseminate knowledge gained

 

Day 2

8:00 a.m. – 2:00 p.m.

 

Second Participant Real Life Case Study

  • Introduction

  • Workshop developing problem statement, problem description

  • Workshop developing data collection plan

  • Workshop to select and test a possible cause

  • Workshop to develop corrective/preventive action plans for technical and systemic root causes

 

Finale

  • Compare/contrast this investigation methodology with other approaches

  • Shortcuts

  • Simple investigations

  • Investigation report

  • Return on investment