Weaver Consulting
Solving Local Problems Globally
Syllabus
Introduction
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Overview of methodology and when to use
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Discuss common investigation mistakes
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Define critical terms
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Introduce the first participant real-life case study
Step 1: Define the Performance Problem
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Introduce the instructor case study
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Problem statement (investigation focus)
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Problem description (investigation scope)
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Workshop
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Flow chart with key inputs of process(es) within the scope of investigation (what will be reviewed)
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Workshop
Step 2: Collect Data
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Determine data needed (verify and narrow investigation scope)
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Identify methods for collecting data
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Consider tools and techniques for analyzing data
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Workshop
Step 3: Identify Possible Causes
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Timeline of changes
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Differences and Changes
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Workshop
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Risk analysis review
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Brainstorming techniques (gemba, fishbone, group, individual, etc)
Step 4: Test Possible Causes
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Challenge possible causes against the data
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Define “reasonable” assumptions
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Document testing process results
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Summarize testing leveraging the contradiction matrix
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Workshop
Step 5: Identify Technical and Systemic Root Cause(s)
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Verify assumptions
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Studies/experiments
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Identify technical root cause(s)
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Identify systemic root cause(s)
Step 6: Determine Corrective/Preventive Actions
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Mistake proofing (poke-yoke) vs. variation reduction and optimization techniques
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Corrective/preventive action(s)
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Risk mitigation
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Control plan
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Acceptance criteria
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Workshop
Step 7: Verify Corrective/Preventive Actions
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Implement corrective/preventive actions
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Evaluate effectiveness (control plan)
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Determine additional preventive actions
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Disseminate knowledge gained
Finale
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Compare/contrast this investigation methodology with other approaches
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Shortcuts
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Simple investigations
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Investigation report
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Return on investment
Second Participant Real Life Case Study (Optional)
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Introduction
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Workshop developing problem statement, problem description
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Workshop developing data collection plan
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Workshop to select and test a possible cause
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Workshop to develop corrective/preventive action plans for technical and systemic root causes
Every challenge has a solution. At Weaver Consulting, our approach is defined by a powerful and proven methodology. In this overview, Rob Weaver explains how our unique process sets us apart and ensures success.
Audience
Appropriate for professionals from all industries, particularly those in highly regulated industries. Participants often have backgrounds in quality, engineering, production, risk management, regulatory affairs, R&D, purchasing, and project management, among other fields.
Description
Root Cause Investigation for CAPA is a globally renowned methodology for investigating technical performance challenges. Problem-solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM, and others are leveraged to identify:
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Technical root cause: the change that occurred, resulting in performance decline.
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Systemic root cause: failures that allowed the change to occur.
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Corrective and preventive actions: restore performance to previous levels or requirements.
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Control plan: monitor and prevent recurrence.
On 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 to a real-life case study.
On 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.