Root Cause Investigation for CAPA

 

Presented by:

 

Weaver Consulting

Solving Local Problems Globally

 

Root Cause Investigation for CAPA is a two-day training teaching a proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc. It is appropriate for professionals from all industries, particularly those that are highly regulated or organizations maintaining one of the various ISO certifications. Alumni of this program typically (though not exclusively) have a background in: quality, risk management, regulatory affairs, compliance, manufacturing, product development, CAPA, supply chain & purchasing, production, engineering, project management, R&D, etc.

Based upon 40+ years’ experience, this science based methodology integrates problem solving techniques from Total Quality Management, Six Sigma, Kaizen, DMAIC, as well as other techniques to identify:

Technical root cause(s): the change(s) that occurred.
Systemic root cause(s): system failures that allowed the change(s) to occur.
Corrective and/or preventive actions: restore performance to previous levels. 
Control plan: prevent recurrence.

On day one, the participants are introduced to the seven-step root cause investigation methodology. An Investigation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation). 

On day two, several hours are devoted to strengthening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team. 

Participants will be emailed a set of electronic templates. These templates, plus the Investigation Roadmap, guide the investigator through the methodology and provide the basis for documentation.

Upon completion of the training, participants will be able to immediately, effectively, and efficiently apply the methodology to identify root causes and restore performance, saving valuable time, resources, and reputation.

Does this methodology really work? A few years ago a medical device plant had a change in the performance of their sterilization process. The potential cost was in excess of $2 million. The plant began the investigation using the traditional approach. Six weeks passed and no progress had been made while costs and management pressure continued to escalate. Finally, an engineer who had been through the Root Cause Investigation for CAPA training suggested this methodology. Management consented and within three days, 53 possible causes were identified and all but 15 had been eliminated. At that point focused experiments were conducted that identified three technical root causes. Corrective action plans were implemented. Result: Performance was restored, no recurrence, and the loss was averted.
 
Outline

Day 1
8:00 a.m. – 5:00 p.m.

Introduction
Define technical CAPA problem
Common investigation mistakes
Investigation Roadmap template
Introduce first participant real life case study

Step 1: Describe the Performance Problem
Introduce instructor case study
Problem statement
Problem description (Is/Is Not Diagram)
Workshop
Flow chart process(es) being invested and identify their key inputs
Workshop
Timeline of events
Team charter including performance and cost savings goals

Step 2: Collect Data
Determine data needed
Data collection tools and techniques
Data measurement plan
Workshop

Step 3: Identify Possible Causes
Timeline of changes
Differences between Is and Is Not facts
Workshop
Changes associated with any differences between Is and Is Not facts
Risk analysis
Brainstorming techniques (flow diagram, fishbone, group, individual, etc)
Workshop

Step 4: Test Possible Causes
Test possible causes against facts
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)

Day 2
8:00 a.m. – 3:00 p.m.

Step 6: Determine Corrective/Preventive Actions
Mistake proofing techniques
Variation reduction and optimization techniques
Corrective/preventive action(s)
Acceptance criteria
Risk mitigation
Control plan
Workshop

Step 7: Verify Corrective/Preventive Actions
Implement and measure effectiveness of corrective/preventive actions
Evaluate control plan
Determine additional preventive actions

Second Participant Real Life Case Study
Introduction
Workshop to develop problem statement, problem description, and identify possible causes
Workshop to collect data
Workshop to test possible causes
Workshop to determine corrective/preventive actions including risk mitigation, control plan, and acceptance criteria

Finale
Compare/contrast this investigation methodology with the traditional approach
Shortcuts
Simple investigations
Difficult investigations
Investigation report
Return on investment
References

What Others Have Said
“I have had the opportunity to work with Rob three times in the past few months as he delivered Root Cause Investigation training at all of Ikaria's sites. The training was a tremendous success due in no small part to Rob's detailed knowledge of the subject, creative and practical application of the associated tools, and marvelously engaging delivery style. I wholeheartedly recommend him and look forward to future opportunities to engage his services for Ikaria." Jim Handzo, Senior Manager, Quality Systems Service, Ikaria, Inc. 

"Rob is by far one of the best presenters I have had the pleasure of listening to. His seminar on Root Cause Analysis is informative, interesting, presents some very interesting concepts on the subject, and most importantly, the information and techniques are highly applicable to real world investigations. Highly recommended." Richard Williams, Training Manager, Global Jet Services, Inc. 

"I recently attended a 2-day seminar where Rob taught us how to investigate root causes by the use of various techniques and tools. His delivery of the material was seamless and the program was excellent. I see instant applicability of his workshop content in my organization." John Ferrin, Director of Compliance/Fraud Management, CitiBank

"I attended Rob's Root Cause Investigation for CAPA course last week and wish I had the opportunity to take it sooner. This is one of - if not the best training courses I have taken. Rob is a very engaging and captivating instructor, and he explains things in a clear and concise manner. He truly makes the course as interesting and entertaining as possible because let's face it - root cause analysis is not exactly the most exciting topic. I highly recommend Weaver Consulting to anyone new to CAPA or looking to improve their existing CAPA process - you won't regret it. Thanks Rob!" Jasmin Zunzunia, Operations Manager, Qualcomm

"I recently attended Rob's 2 day workshop on 'Root Cause Analysis for CAPA'. Rob is an energetic speaker who keeps attendees on track. He has put together clear real world examples used in the workshop. I had some questions before signing up for the workshop and Rob was prompt and professional in answering my questions. In my 20+ year career where the basics of Root Cause Analysis are frequently performed informally, this workshop validated and built upon my experience. Based on my 'street' knowledge of the process, I couldn't find a single change that I would make to the material, Rob covered it completely." Winston Snider, Store Systems Engineering Manager, GameStop

"I recently attended Rob's Root Cause course. Rob is an organized, informative and effective trainer and consultant. The Weaver approach is logical and approachable. I thoroughly enjoyed the session and plan to put the new knowledge to use in my business immediately." Brian Stewart, Director of Quality & Continuous Improvement, Oberg Industries

 

About Weaver Consulting

Founded in 2003, Weaver Consulting is a two-person enterprise comprised of Tom Weaver and Rob Weaver. They are quality and operations improvement consultants who focus exclusively on root cause analysis. With a worldwide client base, they have helped organizations across a multitude of industries, including pharmaceutical, medical device, aerospace, defense, financial services, food & beverage, consumer products, automotive, telecommunications, semiconductors, and many more, successfully implement their Root Cause Investigation for CAPA methodology. Both Tom and Rob held titles of Vice President in their respective careers before joining the firm, Tom with Baxter Healthcare and Rob with Wells Fargo & Company. To learn more about this training or Weaver Consulting, please visit https://www.weaverconsulting.biz.