How to implement an effective Root Cause Analysis and CAPA Program; A close loop approach

• Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs and investigation reports
• Describe how accident/incident models can be used when conducting an investigation
• Differentiate between root cause, contributing causes
• Discuss why human error is not a valid root cause
• Discuss a model that can be used to illustrate multiple layers of control and mitigation
• Identify the different sections of an investigation report and what each section should include
• Linkage of Risk Management to investigation levels
• Gain valuable strategies for getting information right away in the “golden hours” after the incident.
• Discover best practices for determining the real cause of human error with tools
• Benchmark current best practices in CAPA and investigations with your peers..
• Obtain sample forms for conducting investigations and case reviews.
• Understand the four components of a well-written report and Identify better ways of finding the real reasons behind the category of “human error” — and ways to better control and mitigate those factors.

FIRST DAY

Module 1. Overview of the Quality System Requirements and cGMPs for Root Cause & CAPA! FDAs Current Inspection practices: FDA’s QSIT + CAPA Inspectional Approach

• FDA Quality Systems Inspection Technique and CAPA (21 CFR 820.100 and 21 CFR 211.180) Introduction to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA)

Exercise/Review: CAPA Requirements Applicability Overview

Module 2. Introduction to Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA)

• 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 List the sources of data involved in a CAPA program Exercise: Review of case scenario

Module 3. Problem definition and Data collection and Risk Ranking to determine levels of investigation

• Identification of the problem
• How to write a complete problem statement Effective Data Collection
• Remedial Actions
• The potential impact of the problem, the actual risks to the user, the company, customers and potentially patients
• How to effectively apply Risk Assessment in order to determine levels of investigation Describe the process of risk ranking and discover how to use trends early
• Identify the extent of product or quality problems
• List the sources of data involved in an investigation process

Exercise: Based on the Identified Nonconformance issues. Write Problem statement (using the Ws and the Hs). Assign Risk level to problem statement

Module 4. The Challenges of Root Cause Analysis Investigations

• Evaluation of the problem vs. Investigation Determining the Whys..
• Human Error analysis Preventing Human error
• Continuous improvement models: 5S Utilize event/RCA flow charting

Exercise: Review of case study using event/RCA flow charting

Second Day

Module 5.  Examine Methods for Understanding and Determining Root Causes

• Review the basic principles of root cause analysis
• Recognize root causes to respond to non-compliances, failures, deviations and complaints Recognize frequent types of non-compliance
• Evaluate common categories of root causes and contributing causes Change Control Barrier Analysis

Exercise: Case Analysis case study

Module 6. How to Conduct Root Cause Analysis (RCA) by effectively using RCA tools

• Introduction of Root Cause Analysis tools
• Examine Ishikawa diagrams/Cause & Effect Diagrams (Fish Bones) Perform trend and other program analyses such as:
• Why Diagrams Control Charts Check Sheets Scatter Plots Pareto Charts
• Process Flow Diagrams Explore Fault Tree Analysis

Exercise: Based on the Identified Nonconformance issues (from problem statement) List data needed for the data analysis phase

Exercise: Perform RCA using a Fish Bone -Apply 5 W Techniques to report determine: Root Cause

Module 7. Validate Effectiveness of Corrective and Preventive Actions

• Developing a CAPA Action Plan
• Determine if the corrective and preventive actions were effective Verify and validate the CAPA program
• Track changes in CAPA

Module 8. Preventive Action, and the linkage to Risk Management Practices

• Review Industry Practices in Quality System Regulation CAPA verifying and validation practices, preventing recurrence of non conforming product, failure investigation.
• Identifying Common Root Causes using an FMEA and Implementing Corrective Actions And Preventive Corrective Actions as a result

Exercise: Participants will generate a process FMEA