In this course, Root Cause Analysis Tools & Medical Device 21 CFR 820.100 (CAPA) Online Training Course, one of the most important elements of a Quality Management System (QMS) will be examined. This element is Corrective and Preventive Action (CAPA).

CAPA is one of the cornerstones of a QMS. And yet, many medical device manufacturers struggle to establish and maintain an effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources.

CAPA is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. It is critical that a medical device company establishes a compliant, effective process. In this course you will learn tools that will help you have an effective CAPA system.

Effective root cause analysis is at the heart of a successful CAPA system. The CAPA process hinges on your team’s ability to understand the true cause of each problem you encounter. In this course you will learn some tools that will help you you identify the true root cause of a problem.

Firstly, you will learn about the US regulatory requirements for CAPA that are found in 21 CFR 820 (the Quality System Regulation). You will next will learn how to write a problem statement. This is one of the first steps needed before root cause analysis can take place. You will also learn a technique, affinity analysis, that will help you to capture and group the output of problem-solving meetings in order to provide better understanding of the topic discussed. These 2 techniques, in our experience, are fundamental in setting up an environment where effective root cause analyses activity can take place.

You will then learn 2 root cause analysis tools. These tools are the Five Why Analysis and Fishbone Diagram. You will learn how each one can help conduct effective root cause analysis.

Who should take this course?

It is important that all levels of employees from senior management to floor personnel understand the how to do effective root cause analysis. They must also understand the regulatory requirements for CAPA to do this. 

1. Learn about the content of 21 CFR 820.100 – CAPA.

2. Learn about a Warning Letter documenting issues relating to 21 CFR 820 .100 – CAPA.

3. Gain knowledge about what a problem statement is and the important elements of it. 

4. Understand what an affinity diagram is and how to use it. 

5. Learn what 5 Whys Analysis is and how to do a 5 Why Analysis.

6. Learn what a Fish bone Diagram is and how to create one. 

The following topics will be covered in this course;

• CAPA definitions (CAPA, Correction, Corrective action and preventative action),
• 21 CFR Part 820 Subpart J requirements,
• The CAPA process,
• FDA CAPA related warning letters.
• Problem Statements
• Affinity Analysis
• 5 Whys Analysis
• Fishbone Diagram
• FDA CAPA related warning letters

Supplemental Material:

1. The link to 820.100 (CAPA) of 21 CFR 280 The Quality System Regulation.
2. The FDA’s Quality System Inspection Technique Manual.
3. Downloadable infographic that outlines the key elements of a CAPA process 
4. Downloadable infographic that outlines the key elements of the 5 Why Analysis Technique. 

Assessment:

Quiz, consisting of 10 questions.

Upon completing the course and when you obtain a passing grade on your final quiz (80% or over), you will receive a PDF certificate to show that you have completed all the course content. 

Dr. Fiona Masterson. 

Fiona is the founder of The Learning Reservoir. She has 25+ years of parallel paths in quality management, operations management and education. She has broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. She has worked in start-ups and high‐tech, fast paced manufacturing environments. She lectures part-time in technical universities on subjects related to her industrial expertise.

Fiona has Bachelor and Masters of Science degrees, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is a certified lead auditor. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.

She writes many of The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn.