Root Cause Analysis for CAPA

This course is intended for all personnel concerned with quality and the analysis & correction of problems. The material will be presented in such a way as to be of value to varying levels of expertise among the participants, and will be pragmatic in emphasis. It will be particularly valuable to those newer to this field or those who wish to refresh their knowledge of these technologies.

Learning Objectives

Upon completion of this course, a participant will have gained an understanding of the basic concepts involved in Root Cause Analysis and the tools used to conduct this activity. Participants will learn through experiential activities such as group discussions, role-plays, games, and case studies tailored to regulated industries.

Course Description

The primary objective of this course is to develop an understanding of the principles and techniques involved in the practice of Root Cause Analysis. Emphasis is placed on the practical aspects of how to perform an analysis. In addition, this course will provide effective methods which can be used with a Corrective Action system to helps you and your team to ensure costly issues are resolved quickly and do not get dropped through the cracks.

The course will provide the attendees with a system to categorize all types of issues, assign responsibility and track team activities to resolve important issues.

Attendees will also learn advanced skills in root cause analysis, problem prevention, and continuous improvement. Included will be the identification of the characteristics and changes that have contributed to simple and complex problems, and how to fix them, as well as, working with the tools and templates to capture all needed data to comply with CAPA reports.

Topics to be covered include:

 Efficient root cause analysis programs
 Developing effective training programs to ensure compliance
 Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions
 Developing and implementing programs to prevent reoccurrence
 Essential SOPs and Other Documentation
 Understanding and interpreting OOS results
 Increasing accuracy through efficient documentation practices
 Areas of FDA concerns
 Identifying and tracking deviations and non-conformances
 Responding to complaints and deviations with corrective and preventative actions
 Learning to analyze and trend data to identify existing and potential causes of non-conformance
 Integrating RCA with other systems: internal auditing, CAPA and complaint handling
 Gathering, organizing and managing the data required to conduct RCA
 Determining whether or not a complaint should go through a CAPA program
 Determining internal and external reporting requirements
 Writing effective SOPs
 Verifying and validating a CAPA program
 Performing trend analysis and using effective RCA tools (Flow Charting, Fault Tree Analysis, Fishbone Diagrams, etc.)
 Optimizing CAPA and RCA documentation procedures
 Analyzing FDA Warning Letters and common citations to avoid non-compliance

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COURSE AGENDA

DAY ONE

Introduction to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA)

• Outline course goals and objectives
• Identify drug, biologic and medical device RCA and CAPA requirements
• Define the different types of actions: corrective, preventive and remedial
• Describe the "closed loop" CAPA approach
Exercise: CAPA Requirements Applicability Overview

Develop and Implement an Effective CAPA Program

• Problem Definition and Data Collection
• List the sources of data involved in a CAPA program
• Analyze and trend the sources of data in a CAPA program
• Identify the extent of product or quality problems
• Determine whether or not a complaint should go through a CAPA program
• Develop the SOPs and training on procedures of a CAPA system
Exercise: Assess issues concerning sources of CAPA Data, Procedures, and appropriate use of such data

The Challenges of Root Cause Analysis Investigations

• Describe the process of risk mitigation and discover how to detect trends early
• Set up a CAPA system, addressing the requirements of the quality system regulation
• Change Control Barrier Analysis
• Reduce report creation time and keep routine reports
• Close out open requests in order to avoid unaddressed CAPA commitments
Exercise: Review Examples of CAPA Requests

Conduct Root Cause Analysis (RCA)

• Recognize root causes to respond to non-compliances, failures, deviations and complaints
• Define all causes primary and secondary
• Recognize frequent types of non-compliance
• Evaluate common categories of root causes and contributing causes
• Describe the basic principles of root cause analysis
• Recognize RCA techniques from other industries
• Perform the logic tree, gap analyses, Failure Modes and Effects Analyses (FMEA) modified approach
Exercise: Apply RCA Techniques to Case Study Scenarios

DAY TWO

Corrective Action & Preventive Action, Trends & Practice

• Review Industry Practices in Quality System Regulation CAPA verifying and validation practices, preventing recurrence of non conforming product, failure investigation.
• Review FDA’s Quality Systems Inspection Technique on CAPA including case studies on root cause analysis, 21 CFR 820.100 and 21 CFR 211.180, ISO 8402
• Analyze CAPA future trends in Management Review & Design Controls, Closed loop continuous improvement systems
• Identifying Common Root Causes and Implementing Corrective Actions
• Development of Corrective Actions

Examine Methods for Understanding and Determining Root Causes

• Introduce Root Cause Analysis tools
• Identify the 5 W's
• Determination of root cause analysis
• Perform trend and other program analyses
• Utilize event / flow charting
• Explore Fault Tree Analysis
• Examine Ishikawa diagrams (Fishbone)
Exercise: Review case study and as a group identify RCA by using a Flow-Chart

Preparing a Report and presenting it to Management

• Describe approaches when dealing with a complaint
• Outline alternative approaches when the usual approach is ineffective
• Communicate major issues effectively to senior management
• Utilize routine reports
• Describe commitment and buy-in from affected departments
Exercise: Brainstorm Important Points for Management review of CAPAs

Validate Effectiveness of Corrective and Preventive Actions

• Determine if the corrective and preventive actions were effective
• Verify and validate the CAPA program
• Handle and report OOS results
• Track changes in CAPA
• Confirm that the corrective actions did not affect the product or system
• Confirm closure of CAPAs
Exercise: Analyze a Warning letter issued as a result of a CAPA Program

DAY THREE

Ensure Accurate Documentation

• Assign responsibilities to ensure RCA and CAPA issues are handled in a timely manner
• Maintain accurate RCA and CAPA documentation using proper procedures
• Outline the databases, logs and computer systems used in a CAPA program
• Revisit how to keep adequate routine reports and establish a good audit trail

Corrective Action & Preventive Action, Trends & Practice

• Industry Practices in Quality System Regulation CAPA verifying and validation practices, preventing recurrence of non conforming product, failure investigation.
• FDA Quality Systems Inspection Technique on CAPA including case studies on root cause analysis, 21 CFR 820.100 and 21 CFR 211.180, ISO 8402
• CAPA future trends in Management Review & Design Controls, Closed loop continuous improvement systems
• Identifying Common Root Causes and Implementing Corrective Actions
• Development of Corrective Actions

Determine what constitutes a Comprehensive CAPA SYSTEM?

• Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.
• Determine if appropriate sources of product and quality problems have been identified.
• Review that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.
• Review that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.
• Challenge the quality data information system. Verify that the data received by the CAPA system are complete, accurate and timely.

Review Current Regulatory Enforcement Trends
• Determine requirements for efficient CAPA
• Determine what triggers an inspection
• Analyze the FDA’s new risk-based approach to inspecting drug manufacturers
• Understand the inspection process and potential enforcement actions

Exercise: Quiz