This two-day hands-on workshop utilizes a teach-do-teach-do approach that keeps participants engaged throughout the course. Many real CAPA examples are presented. CAPA owners are often challenged with understanding how to utilize data analysis tools during the investigation phase. This workshop explains when and how to apply many of the common analysis tools necessary to conduct effective CAPA investigations. Additionally, the course demonstrates methods to scope CAPAs and to develop robust CAPA verification of effectiveness plans utilizing risk-based sampling to ensure CAPA effectiveness is confirmed with a high degree of confidence.
The CAPA Workshop focuses on the three phases of CAPA: Investigation Phase, Action Phase and Verification of Effectiveness Phase. A manufacturing case study is utilized where participants work in teams, following a problem-solving methodology, to identify root cause, brainstorm possible actions, and develop a verification of effectiveness plan. The workshop provides examples of how to document the various CAPA phases. Good and poor examples are presented along the way. Participants find this particularly useful as a reference when documenting their own CAPAs.
Learning Objectives:
This workshop will teach:
- How to conduct CAPA investigations
- How to understand the goals of the investigation
- How to define, measure, and scope the problem
- How to determine the potential causes
- How to eliminate potential causes to identify the Root Cause(s)
- How to apply Capability Optimization:
- Mistake Proofing
- Target Performance/Reduce Variation
- The goals of Verification Of Implementation (VOI)
- The goals of Verification of Effectiveness (VOE) and its relationship to Verification & Validation (V&V)
- Applications of Risk-Based Sampling Plans
- Confidence & Conformance
- Population vs. Sample
- Tolerance Intervals
- How to plan and execute a VOE
Areas Covered:
The areas that will be discussed in this course include:
- CAPA Definitions and Terms
- CAPA from the FDAs perspective
- Two investigation methodologies: Problem Solving vs. Improvement
- Application of analysis tools during the investigation, action, and verification of effectiveness phases
- Capability Optimization to identify corrective actions
- Introduction of Risk-Based Sampling concepts
Who will Benefit:
- CAPA Owners
- CAPA Engineers
- CAPA Investigators
- CAPA Coaches
- CAPA Sponsors
- Others who want to understand how to solve problems
While the focus of this workshop is toward the medical device and pharmaceutical industries, the problem solving methodologies outlined in this course are not limited to CAPA projects. While general CAPA language will be utilized in the course, the methodologies described in this workshop are universal to solving problems across most industries.
- 8:30 AM - 8:59 AM Registration. Meet & Greet.
- 9:00 AM - 10:00 AM
- Seminar objectives review, expectations and scope.
- CAPA Overview: Terms & Definitions, FDA Perspective, Investigation Approaches and the Problem Solving Storyboard
- CAPA Investigation Phase - Define and Measure the Problem
- 10:00 AM - 11:00 AM
- CAPA Investigation Tools: IS/IS NOT Diagram, Concentration Diagram, Control Chart and Timeline of Events
- Workshop 1 - Team Exercise: IS/IS NOT Diagram
- Discuss Additional Tools: Check Sheet, Pareto Chart, Multi-Vari Chart, Baseline Performance, and Process Map
- 11:00 AM - 12:00 Noon
- Workshop 2 – Team Exercise: Understanding the Process
- Workshop 3 – Team Exercise: Analyzing the Data
- 12:00 Noon - 1:00 PM Lunch.
- 1:00 PM - 2:00 PM
- Workshop 3 (Continued) – Small Team Exercise: Analyzing the Data
- Documenting the CAPA Problem Statement
- Introduction to Root Cause Investigation
- Root Cause Investigation Tools: Brainstorming, Fishbone Diagram, Timeline of Changes, and Timeline Analysis
- 2:00 PM - 3:00 PM
- Workshop 4 – Team Exercise: Brainstorm Potential Causes
- Root Cause Investigation Tool: Contradiction Matrix
- Workshop 5 – Team Exercise: Developing a Contradiction Matrix
- 3:00 PM - 4:00 PM
- Workshop 5 (Continued) – Team Exercise: Developing a Contradiction Matrix
- Root Cause Investigation Tool: 5-Why’s Analysis
- Terminology Discussion: Problem, Symptom, and Cause
- 4:00 PM - 4:30 PM
- Discussion of Human Error
- Teams to reveal Root Cause Ideas
- Documenting the Root Cause Investigation
- 8:30 AM - 8:59 AM Registration, Meet & Greet.
- 9:00 AM - 10:00 AM
- Workshop Summary & Questions
- Capability Optimization: Mistake Proofing Definitions and Terminology
- Team Exercise: Mistake-Proofing
- 10:00 AM - 11:00 AM
- Capability Optimization: Target Performance/Reduce Variation
- Capability Optimization Discussion: Histogram, Specification Limits and Use of DOE for improvement
- Verification, Validation and Solution Piloting
- IMDRF Guidance on Verification and Validation
- Verification and Validation (V&V) Vs. Verification of Effectiveness (VOE)
- 11:00 AM - 12:00 Noon
- Workshop 6 – Team Exercise: Identifying the Corrective Actions
- Introduction to Verification of Effectiveness
- Methods for Demonstrating Effectiveness: Comparison Study, Acceptance Sampling for Validation Applications
- 12:00 Noon - 1:00 PM Lunch.
- 1:00 PM - 2:00 PM
- Review of 21 CFR 820.250 – Statistical Techniques
- Discussion of Acceptance Sampling for Validation: Definition of Confidence Level and Conformance Rate
- Validation Sampling vs. Audit Sampling
- Validation Sampling for Attribute Data: Procedure for Sampling Plan Selection
- 2:00 PM - 3:00 PM
- Explanation of Confidence Level vs. Conformance Rate
- In-Class Simulation: Bean Exercise
- Sampling Concepts: Definition of Population, Sample and representative sampling
- Sampling Strategies: Random Sampling, Stratified Random Sampling, and Periodic Sampling
- 3:00 PM - 4:00 PM
- Team Exercise: Sampling Plan Selection and Execution
- Sample Size Considerations: Strategies for addressing small sample size applications
- Verification of Effective Plan: Design and Execution Examples
- 4:00 PM - 4:30 PM
- Workshop 7 – Team Exercise: Developing a Verification of Effectiveness Plan
- Improvement Investigations vs. Problem Solving Investigations
- CAPA Recommendations
- Wrap-up and Q&A
David J Ingram
Owner and Principal at CAPA Coach LLC
David J. Ingram is founder and Owner of CAPA Coach LLC. Prior to his current role, Dave worked 26 years with Baxter Healthcare Corporation where he held positions of increasing responsibility including Senior Quality Engineer, Critical Systems Manager, Principal Statistician, Senior Principal Engineer, Manager II Quality and most recently as Director, Global Business Excellence with a staff of 12 individuals. During his tenure as Global Business Excellence Director, Dave also served as Baxter’s Corporate Master Black Belt for 13 years.
Dave has trained and coached hundreds of engineers in statistical techniques, including Lean and Six Sigma Concepts, CAPA Problem Solving, Designed Experiments (DOE), SPC, Sampling Plans and other related topics. He has coached, facilitated, lead, and/or analyzed hundreds of continuous improvement projects and investigations including CAPAs, DOEs, Green Belt and Black Belt Projects.
Dave holds a B.S. in Industrial Engineering from Bradley University and a M.S. in Statistics from DePaul University. Dave has written and presented numerous papers for ASQ and the Journal of Validation Technologies in the areas of SPC, Sampling Plans and Process Validation. Dave has over 30 years of continuous improvement experience in the medical device industry.
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Local Attractions of Chicago, IL
Windy
One of the more breathtaking scenes on the lake is this tall ship approaching the docks at Navy Pier. The 148-foot four-masted schooner (and its new sister ship, the Windy II ) sets sail for 90-minute cruises two to five times a day, both day and evening. (Because the boats are sometimes booked by groups, the schedule changes each week; call first to confirm sailing times). The boats are at the whims of the wind, so every cruise charts a different course. Passengers are welcome to help raise and trim the sails and occasionally take turns at the ship's helm (with the captain standing close by). The boats are not accessible for people with disabilities.
Adler Planetarium and Astronomy Museum
The building may be historic (it was the first planetarium in the Western Hemisphere), but some of the attractions here will captivate the most jaded video-game addict.
Your first stop should be the modern Sky Pavilion, where the don't-miss experience is the StarRider Theater. Settle down under the massive dome, and you'll take a half-hour interactive virtual-reality trip through the Milky Way and into deep space, featuring a computer-generated 3-D-graphics projection system and controls in the armrest of each seat. Six high-resolution video projectors form a seamless image above your head -- you'll feel as if you're literally floating in space. If you're looking for more entertainment, the Sky Theater shows movies with an astronomical bent; recent shows have included Secrets of Saturn and Mars Now!
Arlington International Racecourse
With its gleaming-white, palatial, six-story grandstand and lush gardens, this racecourse is one of the most beautiful showcases for thoroughbred horse racing in the world. Its storied history stretches back to 1927, and such equine stars as Citation, Secretariat, and Cigar have graced the track. The annual Arlington Million (the sport's first million-dollar race, held in mid-Aug) attracts top jockeys, trainers, and horses and is part of the World Series Racing Championship, which includes the Breeders Cup races. Arlington's race days are thrilling to behold, with all of racing's time-honored pageantry on display -- from the bugler in traditional dress to the parade of jockeys.
Art Institute of Chicago
You can't -- and shouldn't -- miss the Art Institute. (You really have no excuse, since it's conveniently located right on Michigan Ave. in the heart of downtown.) No matter what medium or century interests you, the Art Institute has something in its collection to fit the bill. Japanese ukiyo-e prints, ancient Egyptian bronzes, Greek vases, 19th-century British photography, masterpieces by most of the greatest names in 20th-century sculpture, and modern American textiles are just some of the works on display, but for a general overview of the museum's collection, take the free "Highlights of the Art Institute" tour Saturday and Sunday.
Auditorium Building and Theatre
A truly grand theater with historic-landmark status, the Auditorium gives visitors a taste of late-19th-century Chicago opulence. Because it's still a working theater -- not a museum -- it's not always open to the public during the day; to make sure you'll get in, schedule a guided tour, which are offered on Mondays at 10am and noon.
Designed and built in 1889 by Louis Sullivan and Dankmar Adler, the 4,000-seat Auditorium was a wonder of the world: the heaviest (110,000 tons) and most massive modern edifice on earth, the most fireproof building ever constructed, and the tallest building in Chicago. It was also the first large-scale building to be lit by electricity, and its theater was the first in the country to install air-conditioning. Originally the home of the Chicago Opera Company, Sullivan and Adler's masterpiece is defined by powerful arches lit by thousands of bulbs and features Sullivan's trademark ornamentation -- in this case, elaborate golden stenciling and gold plaster medallions. It's equally renowned for otherworldly acoustics and unobstructed sightlines.
