Telephone:
Country code outside the U.S. : 001
Phone Number: 847-846-2072

E-mail:
info@weaverconsulting.biz

Blast Wire Design

Carolyn Jacobs – Director of Microbiology, Laboratories at Bonfils

On the first day of this 2-day program, the participants are introduced to the 7-step root cause analysis (RCA) methodology. A roadmap is used to guide the participants through the 7 steps and suggest questions to ask and appropriate tools to use. After each step is presented, the participants immediately apply the learning on a case study of a real problem. Most of the second day is devoted to strengthening that knowledge and practicing the skills on a second, more complex, real issue. With this additional experience the participants are prepared to immediately apply the training back on the job. As the participants work on the second case study they will compare their work with that of the investigation done by the real team.

Why attend?
Most organizations, when faced with a technical problem, resort to the traditional problem solving approach. The characteristics of the traditional approach include:

• finger pointing
• focus on the usual suspects of possible causes
• management by gut feel
• little discipline
• many experiments & studies conducted

The traditional approach typically results in significant time and money wasted. All too often people give up in frustration and the problem is not solved!

With the Root Cause Investigation for CAPA methodology you:

• identify both the technical root cause (the change that caused the problem) and any systemic root causes (system failures that allowed the change to occur),
• identify effective corrective and preventive actions, and
• save tremendous amounts of time and cost.

This is not the classical root cause analysis course where participants sit back, listen, and take a few notes.  Root Cause Investigation for CAPA is extremely workshop intensive and interactive, using real case studies. The experience will fully engage the participants as they apply the concepts enroute to the root causes and corrective actions. The participant will return to the organization highly motivated to apply the methodology to solve your most frustrating technical problems.

After completing the course, the participants will be able to:

• Apply a seven step investigational methodology to determine the root cause of a technical problem.
• Identify the technical root cause(s) and any systemic root cause(s).
• Implement effective corrective actions to restore the original product or process performance.
• Identify and implement a control plan to assure you do not have this same issue again.

The entire training program is 2 days in length.

Professionals in:

• Manufacturing
• Quality
• Product Development
• Process Development
• Engineering
• R&D
• Distribution
• Operations
• Regulatory Affairs

who conduct investigations / root cause analysis (RCA) to identify and eliminate the root cause of a change in the performance of a product, machine or work process.

First Day:

Introduction

• Define a change in performance
• Discuss common investigation mistakes
• Introduce the CAPA investigation road map
• Introduce the first case study

Step 1: Describe the Problem

• Develop a problem statement
• Describe the problem in 8 dimensions
• Conduct Workshop 1
• Describe the processes under investigation and identify their inputs
• Conduct Workshop 2
• Develop a time-line of events
• Develop the investigation charter including the performance and cost savings goals

Step 2: Collect Data

• Determine what data is needed
• Examine data collection tools and techniques
• Develop a measurement plan
• Conduct Workshop 3

Step 3: Identify Possible Causes

• Develop a timeline of changes
• Search for differences
• Conduct Workshop 4
• Identify changes associated with any differences
• Review the risk analysis
• Apply brainstorming techniques
• Conduct Workshop 5

Step 4: Test Possible Causes

• Test the possible causes against the facts
• Summarize results on the contradiction matrix
• The greatest detective who never lived - an historical perspective
• Conduct Workshop 6

Step 5: Identify the Technical and Systemic Root Causes

• Verify assumptions
• Conduct focused studies / experiments
• Identify technical root cause(s)
• Identify systemic root cause(s)
• Conduct Workshop 7

Second Day:

Step 6: Determine Corrective & Preventive Actions

• Examine mistake proofing techniques
• Apply variation reduction and optimization techniques
• Determine corrective / preventive action(s)
• Evaluate the risk of adverse consequences
• Develop a control plan

Step 7: Verify Corrective / Preventive Actions

• Implement and measure effectiveness of corrective / preventive actions
• Evaluate the control plan
• Determine additional preventive actions

Introduction to Second Case Study

• Workshop to define the performance problem & identify possible causes
• Workshop to collect data
• Workshop to test possible causes
• Workshop to identify root cause
• Workshop to identify corrective actions

The Finale

• Shortcuts
• Additional shortcuts for the simple investigation
• Handling extremely difficult investigations
• References for the journey

Contact Weaver Consulting

Telephone:
Country Code outside the U.S.: 001
Phone Number:  847-846-2072