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.

 

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Description

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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.

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Syllabus

 

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

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Finale

• Compare/contrast this investigation methodology with other approaches

• Shortcuts

• Simple investigations

• Investigation report

• Return on investment

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Second Participant Real Life Case Study (Optional)

• 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