CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field. Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management training course teaches you to develop an effective RCA investigation, and develop a corrective and preventive action plan suitable for the identified problems.
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
CAPA data sources, Methods of data analysis
CAPA data flow charts, CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals, ECI
Non-conformances or deviations
RCA tools and methods, Brainstorming methods
More...
TONEX RCA and CAPA Management Training Format:
The course is fun and dynamic
The training is a combination of theory and practice
The theoretical section is delivered in the form of interactive presentation
The practical section includes exercising with real-world examples, individual/group activities, and hands-on workshops
Audience:
CAPA Management is a 4-day course designed for:
CRAs
Project Managers/CRA Managers
Principal Investigators
Site Research Directors/Managers
Clinical Research Coordinators
QA/QC staff
GMP personnel
All individuals who are involved in investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment.
Training Objectives:
CAPA Management training course, the attendees are able to:
Describe what RCA and CAPA are
Identify the non-compliance, Define the investigator
Discuss performance management concepts
Know the purpose of Corrective and Preventive Action
Improve their RCA and CAPA executive skills for effective site risk management
Understand the requirements in 21 CFR 820 Quality
System Regulation
Foster prevention actions
More...
Course Outline:
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
TONEX RCA and CAPA Hands-On Workshop Sample
Learn more. Request more information. Visit Tonex training website link below. Ask for anything related to CAPA (Corrective and Preventive Action) Management Training.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
The document discusses root cause analysis techniques for problem solving. It addresses key questions about when action should be taken to address problems and the importance of treating each problem seriously to find the underlying cause. Various tools for root cause analysis are defined, including brainstorming, cause-and-effect diagrams, the 5 whys technique, checklists and flowcharts. Guidance is provided on effective use of cause-and-effect diagrams and 5 whys to delve beyond symptoms and uncover root causes.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
The document provides an overview of root cause analysis. It defines root cause analysis as a method used to address problems by identifying their underlying root causes in order to correct or eliminate the cause and prevent recurrence. It describes traditional applications, objectives of training, definitions of root cause and approaches. Key steps in root cause analysis are identified as understanding the meaning of root cause, identifying the steps to find the root cause of problems, and using tools like fishbone diagrams, 5 whys, and asking questions.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
Original article from the Flevy business blog can be found here:
http://flevy.com/blog/the-global-8d-problem-solving-process/
“If I had an hour to save the world I would spend 59 minutes defining the problem and one minute finding solutions .” – Albert Einstein
The 8D (Eight Disciplines) Problem Solving Process is a team oriented and structured problem solving methodology that is mainly used to identify, correct and eliminate recurring problems.
The 8D Problem Solving Process focuses on the origin of the problem by determining root causes and establishes corrective and preventive actions.
The U.S. government first standardized the 8D Problem Solving Process during the Second World War, referring to it as Military Standard 1520. It was later popularized by the Ford Motor Company in the ‘60s and ‘70s.
Today, the 8D Problem Solving Process has become a standard in many industries as problem solving or improvement process, as internal Corrective Action Request (CAR) Process or as Supplier Corrective Action Request (SCAR) Process. The 8D Problem Solving Process can be an integral part of an Operational and Process Excellence initiative.
The benefits of a systematic Problem Solving Process are obvious.
• Create a shared understanding about how to systematically solve problems.
• Strengthen cross-functional teamwork, problem solving and collaboration capabilities.
• Reduce defects, lead times and costs through effective problem solving.
• Identify the underlying root cause(s) by applying effective problem solving tools.
• Develop effective process controls to prevent recurrence of known problems.
• Establish a systematic documentation of the Problem Solving Process.
The 8D Problem Solving Process follows a systematic methodology using eight step or disciplines.
This document provides an overview of Root Cause Analysis (RCA) training. RCA is an objective methodology used to determine the underlying causes of problems within an organization. The goals of RCA are to analyze problems to identify what happened, how it happened, and why it happened, in order to develop actions to prevent reoccurrence. RCA training teaches techniques to identify causes of problems, solve issues, and prevent future issues, saving organizations time, money, and resources. RCA is applied to analyze a variety of events like accidents, errors, and failures to develop preventative actions.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
The document discusses root cause analysis techniques for problem solving. It addresses key questions about when action should be taken to address problems and the importance of treating each problem seriously to find the underlying cause. Various tools for root cause analysis are defined, including brainstorming, cause-and-effect diagrams, the 5 whys technique, checklists and flowcharts. Guidance is provided on effective use of cause-and-effect diagrams and 5 whys to delve beyond symptoms and uncover root causes.
The document discusses corrective and preventive actions (CAPA) for recurring problems. It explains that CAPA is a structured process required by ISO 9001 to investigate nonconformities, determine appropriate corrections and actions, and measure effectiveness. The CAPA process involves defining the problem, investigating the root cause, developing solutions, verifying the solutions address the root cause, and checking effectiveness. Root cause analysis tools discussed include 5 whys, cause-and-effect diagrams, IS/IS NOT analysis, and the 8D (eight disciplines) approach. The document emphasizes finding facts over fault to properly solve problems.
The document provides an overview of root cause analysis. It defines root cause analysis as a method used to address problems by identifying their underlying root causes in order to correct or eliminate the cause and prevent recurrence. It describes traditional applications, objectives of training, definitions of root cause and approaches. Key steps in root cause analysis are identified as understanding the meaning of root cause, identifying the steps to find the root cause of problems, and using tools like fishbone diagrams, 5 whys, and asking questions.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
Original article from the Flevy business blog can be found here:
http://flevy.com/blog/the-global-8d-problem-solving-process/
“If I had an hour to save the world I would spend 59 minutes defining the problem and one minute finding solutions .” – Albert Einstein
The 8D (Eight Disciplines) Problem Solving Process is a team oriented and structured problem solving methodology that is mainly used to identify, correct and eliminate recurring problems.
The 8D Problem Solving Process focuses on the origin of the problem by determining root causes and establishes corrective and preventive actions.
The U.S. government first standardized the 8D Problem Solving Process during the Second World War, referring to it as Military Standard 1520. It was later popularized by the Ford Motor Company in the ‘60s and ‘70s.
Today, the 8D Problem Solving Process has become a standard in many industries as problem solving or improvement process, as internal Corrective Action Request (CAR) Process or as Supplier Corrective Action Request (SCAR) Process. The 8D Problem Solving Process can be an integral part of an Operational and Process Excellence initiative.
The benefits of a systematic Problem Solving Process are obvious.
• Create a shared understanding about how to systematically solve problems.
• Strengthen cross-functional teamwork, problem solving and collaboration capabilities.
• Reduce defects, lead times and costs through effective problem solving.
• Identify the underlying root cause(s) by applying effective problem solving tools.
• Develop effective process controls to prevent recurrence of known problems.
• Establish a systematic documentation of the Problem Solving Process.
The 8D Problem Solving Process follows a systematic methodology using eight step or disciplines.
This document provides an overview of Root Cause Analysis (RCA) training. RCA is an objective methodology used to determine the underlying causes of problems within an organization. The goals of RCA are to analyze problems to identify what happened, how it happened, and why it happened, in order to develop actions to prevent reoccurrence. RCA training teaches techniques to identify causes of problems, solve issues, and prevent future issues, saving organizations time, money, and resources. RCA is applied to analyze a variety of events like accidents, errors, and failures to develop preventative actions.
The document discusses the differences between chronic and sporadic problems and the appropriate approaches to address each type. It defines chronic problems as existing for some time and requiring improvement projects to attain breakthroughs. Sporadic problems are deviations that require troubleshooting to restore normal performance. The document outlines the sequence for breakthrough analysis including diagnosis to find root causes and developing remedies. It also summarizes the key steps in troubleshooting sporadic problems and the link between root cause analysis and the management by fact approach.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
The document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It defines CAPA and explains that it is required to eliminate existing nonconformities and prevent their recurrence. Various regulatory guidance on CAPA is referenced. Tools for root cause analysis discussed include the five whys technique, fishbone diagrams, Pareto charts, and fault tree analysis. Steps for conducting the five whys technique and creating fishbone diagrams are outlined. Advantages and limitations of fishbone diagrams and Pareto charts are also summarized.
This document discusses the 8D problem solving methodology used in the automotive industry. 8D stands for 8 disciplines or 8 steps and was introduced by Ford Motor Company in the late 1980s as a systemic problem solving approach. The 8 steps include establishing a team, defining the problem, implementing containment, identifying the root cause, choosing and verifying permanent corrective actions, implementing the actions, and preventing recurrence. Visualization techniques and a focus on facts are emphasized to support analyzing problems and identifying root causes. The goal of 8D is to stop issues from recurring through a disciplined process.
CAPA - Corrective and Preventive Action Management TrainingTonex
"CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field".
TONEX RCA and CAPA Management Training Format
The course is fun and dynamic
The training is a blend of hypothesis and practice
The hypothetical area is conveyed as intuitive introduction
The reasonable area incorporates practicing with genuine precedents, singular/bunch exercises, and hands-on workshops
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
The definition and differences of the terms corrections, corrective actions, and preventive actions
CAPA data sources
Methods of data analysis
CAPA data flow charts
CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals / ECI
Non-conformances or deviations
RCA tools and methods
Brainstorming methods
Problem solving tools
Process mapping / Regulatory resources
Corrective action plan development steps
Defining the problem statement properly
Isolating and containing the problems
Identifying the root cause
Developing an effective corrective action
Executing and validating the corrective action
Preventing recurrence
Preventive Action process
Communication
Course Outline
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
This document discusses corrective and preventive action (CAPA) basics, including:
- The purpose of CAPA is to identify and address quality problems and prevent recurrence.
- Regulations require manufacturers to establish CAPA procedures, collect and analyze data, investigate issues, identify and validate corrective/preventive actions, and document activities.
- The level of CAPA should be appropriate to the risk level of the problem. Relevant information must be communicated and submitted for management review.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Root Cause Analysis (RCA) is a problem-solving technique that seeks to identify the primary cause of a problem. By focusing on the root cause, organizations can prevent the problem from recurring and develop long-term solutions that improve efficiency, reduce costs, and increase customer satisfaction.
RCA uses tools such as the 5 Whys and Cause & Effect Diagram to identify the underlying causes of a problem. The 5 Whys technique involves asking "why" multiple times to dig deeper into the root cause. The Cause & Effect Diagram categorizes potential causes, such as people, process, and equipment, to identify root causes quickly.
This RCA presentation is designed to provide participants with a comprehensive understanding of Root Cause Analysis (RCA) as a problem-solving technique. The presentation highlights the importance of identifying the root cause of a problem and how RCA can be used to achieve this. Participants will learn how to apply common RCA tools such as the 5 Whys and Cause & Effect Diagram to identify the root cause of a problem. They will also gain knowledge on how to prioritize root causes using a Pareto Chart to focus on the most significant causes first. The presentation will also cover the pitfalls in root cause analysis, highlighting the importance of avoiding making assumptions, involving stakeholders, and making RCA an ongoing process. By the end of the presentation, participants will have a deep understanding of RCA and be equipped with the skills needed to identify and solve problems effectively.
LEARNING OBJECTIVES:
1. Understand the critical role of identifying root causes in effective problem-solving.
2. Apply 5 Whys and Cause & Effect Diagram for practical root cause analysis.
3. Learn to prioritize root causes using Pareto Charts for impactful solutions.
4. Recognize common pitfalls and strategies for overcoming them.
CONTENTS
1. Introduction to Root Cause Analysis
2. Overview of Problem Solving
3. 5 Whys
4. Cause & Effect Diagram
5. Root Cause Prioritization
6. Effective RCA Practices
The document discusses root cause analysis methods and processes. It provides an overview of various analytical techniques like 5 Whys, fault trees, cause-and-effect diagrams. It outlines the basic steps of root cause analysis as understanding the process, identifying sources of errors, collecting and analyzing data, and working backwards. Key aspects are conducting the analysis methodically, getting outside objective advice, and carefully implementing solutions to avoid unintended consequences.
ABOUT THE TRAINING PROGRAM :-
Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to address, correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is more probable that problem recurrence will be prevented.
DESIGNED FOR :-
Managers, Engineers, Supervisor and officers engaged in maintenance operation and engineering activities.
OBJECTIVE :-
At the end of the training program, participants will be able
- To gain a basic understanding of the problem solving and decision-making process and the applicable quality tools that support this process.
- To develop specific competencies to use the structured approach to problem solving and decision making and the supporting quality tools.
TRAINING PROGRAM COVERAGE :-
- Basic knowledge about RCA program.
- What are the RCA tools ?
- More about Why- Why analysis ?
- Videos and case studies on RCA
Root Cause Analysis - Tools, Tips and Tricks to Get to the Bottom of Root CauseCraig Thornton
This webinar discusses and investigates how to conduct root cause analysis. Root cause analysis is something that companies really struggle with. There will be plenty of practical advice in the webinar to help with you understand the concepts and the tools.
If you would like to watch the recording of this webinar then copy and paste the below link into your web browser:
http://www.mangolive.com/blog-mango/root-cause-analysis-tools-webinar
The document provides an overview of root cause analysis (RCA) tools and processes. It defines RCA as a systematic process for identifying the root causes of problems in order to prevent recurrence. The document outlines the key concepts, types of causes, common tools like fishbone diagrams and 5 whys, and a 5-step DMAIC process for conducting RCA including defining the problem, measuring its scope, analyzing root causes, implementing solutions, and controlling effectiveness. The goal of RCA is to develop sustainable solutions by understanding underlying causes rather than just addressing symptoms.
Root Cause Analysis (RCA) is a structured technique used to identify the underlying cause of problems. It involves defining the problem, finding the cause, and charting a solution. The process typically includes determining what happened, why it happened, and what can be done to prevent reoccurrence. RCA aims to address the real cause of problems rather than just the symptoms. One common technique in RCA is the "5 Whys" method, which involves repeatedly asking "Why?" until the root cause is identified. RCA benefits organizations by helping improve processes, create lasting solutions, and develop a roadmap for thorough understanding. However, its limitations include assuming a single source of problems when in reality issues can have multiple interconnected causes.
CAPA, Root Cause Analysis and Risk ManagementJoseph Tarsio
This document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It describes CAPA and its regulatory requirements. Various tools for root cause analysis are explained, including the five whys technique, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. FMEA involves calculating a risk priority number to identify high-risk failures for corrective action. The document emphasizes the importance of identifying root causes of problems in order to implement effective preventative actions and reduce risks.
The document discusses elements of an effective Corrective and Preventive Action (CAPA) process. It outlines key aspects such as having a documented procedure, risk assessment, investigation techniques, defined action plans, effectiveness checks, and management review. The goals of a CAPA process are to determine the root cause of problems, implement corrective actions to address the cause, and verify that the actions were effective in preventing recurrence. An effective CAPA system relies on analyzing various quality data sources, taking actions to continuously improve products and processes, and demonstrating the ability to meet business and compliance needs over time.
The document provides an overview of the 5 Whys root cause analysis tool. The 5 Whys involves asking "Why?" five times to determine the root cause of a problem. It should address both why a defective part was made and why the defect was not detected earlier. While typically involving five questions, the number may vary depending on the complexity of the problem. The tool helps analyze problems by tracing them back from obvious to less obvious causes through a series of why questions. The goal is to identify systemic root causes that allow problems rather than just resolving the specific problem.
For years, we've performed root cause analysis with whiteboards, Post-Its & spreadsheets using The 5 Whys, Ishikawa diagrams, FMEA, and DMAIC methodologies. Now, newer technologies have made the RCA discovery process faster and more precise, and support a direct link to CAPAs.
1. Human error is a leading cause of deviations in pharmaceutical companies, accounting for 25-60% of incidents.
2. Regulators expect thorough investigations of deviations to determine the most likely root cause, ensuring process, procedural or system errors are not overlooked before attributing a cause to human error.
3. Common ways of currently handling human errors, such as blaming employees or limited retraining, are ineffective; more robust corrective actions addressing underlying systems and processes are needed.
The document discusses root-cause analysis (RCA) and provides definitions, goals, cognitive biases to avoid, and tools to use when performing RCA. It defines root causes as specific underlying causes that can be reasonably identified and resolved. The goals of RCA are to identify what happened, how it occurred, why, and how to prevent reoccurrence. Tools mentioned for RCA include Five Whys, Current Reality Tree, Interrelationship Diagram, and Cause-and-Effect Diagram. The document emphasizes avoiding cognitive biases and adhering to a seven-step problem-solving process for objective, effective RCA.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
This document provides an overview of root cause analysis (RCA) and corrective and preventive action (CAPA) processes. It defines failure, outlines objectives of investigations such as corrective actions and preventive actions. It discusses quality of investigations and common but incorrect initial responses. The document then covers starting an RCA with a positive mindset, avoiding bias, not blaming individuals, and effective teamwork. Steps in an investigation and CAPA process are defined including identification, risk assessment, immediate action, root cause analysis, action planning, implementation and follow-up. Tools for root cause analysis like brainstorming, field trips, 5 whys, and Ishikawa diagrams are described.
Root Cause Analysis Training for Healthcare Professionals : Tonex TrainingBryan Len
Tonex offers a 4-day root cause analysis training course for healthcare professionals. The training teaches the concepts, tools, and strategies for conducting effective root cause analyses of safety incidents in healthcare organizations. It aims to educate participants on the root cause analysis methodology and improve their skills so they can independently apply the process. The course outline covers topics like understanding root cause analysis in healthcare, the root cause analysis process, methods for analyzing incidents, and developing action plans. It is designed for healthcare managers, physicians, nurses and other professionals involved in root cause analyses.
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
The document discusses the differences between chronic and sporadic problems and the appropriate approaches to address each type. It defines chronic problems as existing for some time and requiring improvement projects to attain breakthroughs. Sporadic problems are deviations that require troubleshooting to restore normal performance. The document outlines the sequence for breakthrough analysis including diagnosis to find root causes and developing remedies. It also summarizes the key steps in troubleshooting sporadic problems and the link between root cause analysis and the management by fact approach.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
The document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It defines CAPA and explains that it is required to eliminate existing nonconformities and prevent their recurrence. Various regulatory guidance on CAPA is referenced. Tools for root cause analysis discussed include the five whys technique, fishbone diagrams, Pareto charts, and fault tree analysis. Steps for conducting the five whys technique and creating fishbone diagrams are outlined. Advantages and limitations of fishbone diagrams and Pareto charts are also summarized.
This document discusses the 8D problem solving methodology used in the automotive industry. 8D stands for 8 disciplines or 8 steps and was introduced by Ford Motor Company in the late 1980s as a systemic problem solving approach. The 8 steps include establishing a team, defining the problem, implementing containment, identifying the root cause, choosing and verifying permanent corrective actions, implementing the actions, and preventing recurrence. Visualization techniques and a focus on facts are emphasized to support analyzing problems and identifying root causes. The goal of 8D is to stop issues from recurring through a disciplined process.
CAPA - Corrective and Preventive Action Management TrainingTonex
"CAPA Management training covers the rationale, concepts, tools, techniques, and practices of RCA and Corrective and Preventive Action (CAPA) management in FDA field".
TONEX RCA and CAPA Management Training Format
The course is fun and dynamic
The training is a blend of hypothesis and practice
The hypothetical area is conveyed as intuitive introduction
The reasonable area incorporates practicing with genuine precedents, singular/bunch exercises, and hands-on workshops
Learn About:
CAPA application and implementation
CAPA management
FDA’s requirements for CAPA systems
Importance of CAPA systems
CAPA system main components
The definition and differences of the terms corrections, corrective actions, and preventive actions
CAPA data sources
Methods of data analysis
CAPA data flow charts
CAPA tracking tools
Medical device reporting and tracking
FDA guidance for failure investigations and root cause analyses
FDA’s trending principals / ECI
Non-conformances or deviations
RCA tools and methods
Brainstorming methods
Problem solving tools
Process mapping / Regulatory resources
Corrective action plan development steps
Defining the problem statement properly
Isolating and containing the problems
Identifying the root cause
Developing an effective corrective action
Executing and validating the corrective action
Preventing recurrence
Preventive Action process
Communication
Course Outline
Overview of CAPA
RCA Definition
Non-Conformances or Deviations
Nonconformance Classification
Problem Solving Process
Creative Thinking Approaches
FMEA Application in Clinical Devices
Analysis and Prioritization Techniques
Digging Down for the Root Causes
Gathering Valuable Data for RCA and CAPA
Analyzing Data
Accidents Analysis and Role of Human Error
Role of Management Behaviors in the Success of RCA/CAPA
Implementing Corrective and Preventive Action Plans (CAPA)
Elements of Effective CAPA
Trending Requirements and CAPA
CAPA Regulatory Requirements
Call us today at +1-972-665-9786. Learn more about this course audience, objectives, outlines, seminars, pricing , any other information. Visit our website link below.
CAPA (Corrective and Preventive Action) Management Training
https://www.tonex.com/training-courses/capa-management-training/
This document discusses corrective and preventive action (CAPA) basics, including:
- The purpose of CAPA is to identify and address quality problems and prevent recurrence.
- Regulations require manufacturers to establish CAPA procedures, collect and analyze data, investigate issues, identify and validate corrective/preventive actions, and document activities.
- The level of CAPA should be appropriate to the risk level of the problem. Relevant information must be communicated and submitted for management review.
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Root Cause Analysis (RCA) is a problem-solving technique that seeks to identify the primary cause of a problem. By focusing on the root cause, organizations can prevent the problem from recurring and develop long-term solutions that improve efficiency, reduce costs, and increase customer satisfaction.
RCA uses tools such as the 5 Whys and Cause & Effect Diagram to identify the underlying causes of a problem. The 5 Whys technique involves asking "why" multiple times to dig deeper into the root cause. The Cause & Effect Diagram categorizes potential causes, such as people, process, and equipment, to identify root causes quickly.
This RCA presentation is designed to provide participants with a comprehensive understanding of Root Cause Analysis (RCA) as a problem-solving technique. The presentation highlights the importance of identifying the root cause of a problem and how RCA can be used to achieve this. Participants will learn how to apply common RCA tools such as the 5 Whys and Cause & Effect Diagram to identify the root cause of a problem. They will also gain knowledge on how to prioritize root causes using a Pareto Chart to focus on the most significant causes first. The presentation will also cover the pitfalls in root cause analysis, highlighting the importance of avoiding making assumptions, involving stakeholders, and making RCA an ongoing process. By the end of the presentation, participants will have a deep understanding of RCA and be equipped with the skills needed to identify and solve problems effectively.
LEARNING OBJECTIVES:
1. Understand the critical role of identifying root causes in effective problem-solving.
2. Apply 5 Whys and Cause & Effect Diagram for practical root cause analysis.
3. Learn to prioritize root causes using Pareto Charts for impactful solutions.
4. Recognize common pitfalls and strategies for overcoming them.
CONTENTS
1. Introduction to Root Cause Analysis
2. Overview of Problem Solving
3. 5 Whys
4. Cause & Effect Diagram
5. Root Cause Prioritization
6. Effective RCA Practices
The document discusses root cause analysis methods and processes. It provides an overview of various analytical techniques like 5 Whys, fault trees, cause-and-effect diagrams. It outlines the basic steps of root cause analysis as understanding the process, identifying sources of errors, collecting and analyzing data, and working backwards. Key aspects are conducting the analysis methodically, getting outside objective advice, and carefully implementing solutions to avoid unintended consequences.
ABOUT THE TRAINING PROGRAM :-
Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to address, correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is more probable that problem recurrence will be prevented.
DESIGNED FOR :-
Managers, Engineers, Supervisor and officers engaged in maintenance operation and engineering activities.
OBJECTIVE :-
At the end of the training program, participants will be able
- To gain a basic understanding of the problem solving and decision-making process and the applicable quality tools that support this process.
- To develop specific competencies to use the structured approach to problem solving and decision making and the supporting quality tools.
TRAINING PROGRAM COVERAGE :-
- Basic knowledge about RCA program.
- What are the RCA tools ?
- More about Why- Why analysis ?
- Videos and case studies on RCA
Root Cause Analysis - Tools, Tips and Tricks to Get to the Bottom of Root CauseCraig Thornton
This webinar discusses and investigates how to conduct root cause analysis. Root cause analysis is something that companies really struggle with. There will be plenty of practical advice in the webinar to help with you understand the concepts and the tools.
If you would like to watch the recording of this webinar then copy and paste the below link into your web browser:
http://www.mangolive.com/blog-mango/root-cause-analysis-tools-webinar
The document provides an overview of root cause analysis (RCA) tools and processes. It defines RCA as a systematic process for identifying the root causes of problems in order to prevent recurrence. The document outlines the key concepts, types of causes, common tools like fishbone diagrams and 5 whys, and a 5-step DMAIC process for conducting RCA including defining the problem, measuring its scope, analyzing root causes, implementing solutions, and controlling effectiveness. The goal of RCA is to develop sustainable solutions by understanding underlying causes rather than just addressing symptoms.
Root Cause Analysis (RCA) is a structured technique used to identify the underlying cause of problems. It involves defining the problem, finding the cause, and charting a solution. The process typically includes determining what happened, why it happened, and what can be done to prevent reoccurrence. RCA aims to address the real cause of problems rather than just the symptoms. One common technique in RCA is the "5 Whys" method, which involves repeatedly asking "Why?" until the root cause is identified. RCA benefits organizations by helping improve processes, create lasting solutions, and develop a roadmap for thorough understanding. However, its limitations include assuming a single source of problems when in reality issues can have multiple interconnected causes.
CAPA, Root Cause Analysis and Risk ManagementJoseph Tarsio
This document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It describes CAPA and its regulatory requirements. Various tools for root cause analysis are explained, including the five whys technique, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. FMEA involves calculating a risk priority number to identify high-risk failures for corrective action. The document emphasizes the importance of identifying root causes of problems in order to implement effective preventative actions and reduce risks.
The document discusses elements of an effective Corrective and Preventive Action (CAPA) process. It outlines key aspects such as having a documented procedure, risk assessment, investigation techniques, defined action plans, effectiveness checks, and management review. The goals of a CAPA process are to determine the root cause of problems, implement corrective actions to address the cause, and verify that the actions were effective in preventing recurrence. An effective CAPA system relies on analyzing various quality data sources, taking actions to continuously improve products and processes, and demonstrating the ability to meet business and compliance needs over time.
The document provides an overview of the 5 Whys root cause analysis tool. The 5 Whys involves asking "Why?" five times to determine the root cause of a problem. It should address both why a defective part was made and why the defect was not detected earlier. While typically involving five questions, the number may vary depending on the complexity of the problem. The tool helps analyze problems by tracing them back from obvious to less obvious causes through a series of why questions. The goal is to identify systemic root causes that allow problems rather than just resolving the specific problem.
For years, we've performed root cause analysis with whiteboards, Post-Its & spreadsheets using The 5 Whys, Ishikawa diagrams, FMEA, and DMAIC methodologies. Now, newer technologies have made the RCA discovery process faster and more precise, and support a direct link to CAPAs.
1. Human error is a leading cause of deviations in pharmaceutical companies, accounting for 25-60% of incidents.
2. Regulators expect thorough investigations of deviations to determine the most likely root cause, ensuring process, procedural or system errors are not overlooked before attributing a cause to human error.
3. Common ways of currently handling human errors, such as blaming employees or limited retraining, are ineffective; more robust corrective actions addressing underlying systems and processes are needed.
The document discusses root-cause analysis (RCA) and provides definitions, goals, cognitive biases to avoid, and tools to use when performing RCA. It defines root causes as specific underlying causes that can be reasonably identified and resolved. The goals of RCA are to identify what happened, how it occurred, why, and how to prevent reoccurrence. Tools mentioned for RCA include Five Whys, Current Reality Tree, Interrelationship Diagram, and Cause-and-Effect Diagram. The document emphasizes avoiding cognitive biases and adhering to a seven-step problem-solving process for objective, effective RCA.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
This document provides an overview of root cause analysis (RCA) and corrective and preventive action (CAPA) processes. It defines failure, outlines objectives of investigations such as corrective actions and preventive actions. It discusses quality of investigations and common but incorrect initial responses. The document then covers starting an RCA with a positive mindset, avoiding bias, not blaming individuals, and effective teamwork. Steps in an investigation and CAPA process are defined including identification, risk assessment, immediate action, root cause analysis, action planning, implementation and follow-up. Tools for root cause analysis like brainstorming, field trips, 5 whys, and Ishikawa diagrams are described.
Root Cause Analysis Training for Healthcare Professionals : Tonex TrainingBryan Len
Tonex offers a 4-day root cause analysis training course for healthcare professionals. The training teaches the concepts, tools, and strategies for conducting effective root cause analyses of safety incidents in healthcare organizations. It aims to educate participants on the root cause analysis methodology and improve their skills so they can independently apply the process. The course outline covers topics like understanding root cause analysis in healthcare, the root cause analysis process, methods for analyzing incidents, and developing action plans. It is designed for healthcare managers, physicians, nurses and other professionals involved in root cause analyses.
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
How to solve problems (or at least try) with 8DStefan Kovacs
This document provides an overview of the 8D problem solving method. It begins with the goals of learning how to use 8D for problem solving. It then discusses the history and development of the 8D method at Ford Motor Company in the 1980s. The document also includes definitions of key terms used in 8D. It describes the typical steps and process flow for 8D problem solving. Finally, it provides details of an 8D procedure used at an X factory, outlining the initiation and requirements for conducting 8D analyses.
This document discusses developing a workforce using the Certified Maintenance and Reliability Technician (CMRT) exam. It describes how the CMRT exam can be used to assess skills across four areas - maintenance practices, preventive and predictive techniques, troubleshooting and analysis, and corrective maintenance. Taking the exam allows organizations to identify strengths and weaknesses in individuals and target training accordingly to improve skills. The goal is to continuously develop workforce skills through training in order to gain a competitive advantage.
Mary Lewis presented "Medical Device Development Lifecycle: Demonstrating Clinical Utility" at the Regulatory & Quality Solutions’ Medical Device Breakfast Briefing held at JumpStart, September 11, 2014.
This document discusses corrective and preventive action (CAPA) systems. It defines key terms like nonconformance and defines CAPA's goals of eliminating causes of non-conformities. CAPA has two functions - corrective actions to address root causes of problems, and preventive actions to prevent reoccurrence. The document outlines objectives of an effective CAPA system and provides steps to implement corrective and preventive actions, including defining problems, identifying causes, designing measures, and ensuring documentation is updated. It stresses the importance of planning, communication, and documentation for successful CAPA execution.
This document provides a summary of Darral Addison's qualifications and experience. It includes over 20 years of experience in clinical, pharmaceutical, biotech, medical device, food and IT industries, with strong communication and regulatory skills. Addison has held roles at various companies focused on quality assurance, validation, clinical trials, and project management. He has a background in chemistry and quality systems with various industry certifications and a master's degree.
Xybion presents the 7 Habits of Highly Effective CAPA programs. This detailed webinar provides best practices and deep-dive informaiton on how to implement a CAPA program in a regulated industry.
Tips and Tricks on how to go about certifying yourself quickly for the Quality Payment Program in 2018. How does it impact workflow, security and means to accelerate certification.
The document discusses business process management (BPM) and business process reengineering (BPR). It defines BPM as combining quality tools and lean management principles to quickly analyze and improve business process effectiveness and efficiency. BPR is defined as fundamentally rethinking and radically redesigning processes to achieve dramatic improvements in areas like cost, quality and speed. The document also lists the core phases of BPR as beginning organizational change, building a reengineering organization, identifying opportunities, understanding the current process, reengineering the process, blueprinting the new system, and performing the transformation. It notes potential benefits of BPR include increased productivity, reduced costs, improved quality and reduced risks, while potential challenges include major layoffs and lack of management support
Case Study “Analytics Strategies to Improve Quality & Outcomes”
Trevor Strome, MSc, PMP
Analytics Lead
WRHA Emergency Program
Assistant Professor, Department of Emergency Medicine
University of Manitoba
iHT2 case studies and presentations illustrate challenges, successes and various factors in the outcomes of numerous types of health IT implementations. They are interactive and dynamic sessions providing opportunity for dialogue, debate and exchanging ideas and best practices. This session will be presented by a thought leader in the provider, payer or government space.
The study of Perpetual Evolution_Group 5_ Final Project_PPT.pdfRuhiRangwala1
The continuous improvement process is a framework used to plan for local improvement across different areas to impact student achievement.
It involves following quality-by-design principles, utilizing data and platforms, and managing performance to encourage growth.
The process typically includes four stages: defining the problem or opportunity, measuring current performance, analyzing data to identify root causes of problems, and implementing solutions while tracking their effectiveness.
Know what are the 5 most common reasons behind CAPA Management problems and how to deal with them with the help of Qualityze CAPA Management software. Request for demo today
Corrective actions and preventive actionsANKUSH JADHAV
This document discusses corrective and preventive actions (CAPA) in quality management. CAPA aims to eliminate causes of non-conformities or undesirable situations. It has two functions - corrective action finds root causes of problems and takes direct action, while preventive action informs an organization to prevent problems from recurring. Successful CAPA implementation requires effective planning, preparation, writing, evaluation, procedure updates, execution proof, change management and meetings. CAPA plays an important role in continuously improving products and processes in a quality management system.
The document provides an overview of Lean Six Sigma as a process improvement methodology. It discusses key Lean concepts like eliminating waste, standardizing processes, and continuous improvement. It also explains Six Sigma's statistical focus on reducing defects and variation. The DMAIC process of Define, Measure, Analyze, Improve, Control is introduced as the framework for process optimization projects using this methodology.
White paper: "Human performance improvement"APARNA SANAKA
The document discusses using root cause analysis and Ben Marguglio's Human Error Causal Factor Taxonomy to reduce human errors in a software maintenance project. It describes a case study where a financial services company outsourced website maintenance work. Root cause analysis identified that 44% of low quality ratings were due to human performance issues. Applying the taxonomy helped analyze causal factors and improve processes, training, and communication. As a result, customer satisfaction increased by 8% while the number of low quality ratings decreased.
This document outlines a seven step process for Corrective and Preventive Action (CAPA) programs: 1) Identification, 2) Evaluation, 3) Investigation, 4) Analysis, 5) Action Plan, 6) Implementation, and 7) Follow-Up. It defines corrective and preventive actions and provides examples. A comprehensive CAPA process identifies problems, determines the root cause, develops a plan to fix the problem and prevent recurrence, implements the plan, and ensures effectiveness. The seven steps provide a framework to systematically address issues in a way that satisfies regulatory requirements and drives continuous improvement.
Six Sigma, Lean and organizational change management strategies and techniques were discussed. The presentation provided background on the presenter's experience with Six Sigma and Lean. An overview of the history and evolution of Six Sigma, Lean and related methodologies was given. Key aspects of the Six Sigma DMAIC process and commonly used tools were summarized. Change management strategies like the Change Acceleration Process and McKinsey 7S model were also reviewed briefly.
The document provides an overview of Lean Six Sigma as a process improvement methodology. It discusses key Lean concepts like eliminating waste, standardizing processes, and continuous improvement. It also explains Six Sigma's statistical focus on reducing defects and variation. The DMAIC process of Define, Measure, Analyze, Improve, Control is introduced as the framework for process optimization projects using Lean Six Sigma.
The document provides an overview of Lean Six Sigma as a process improvement methodology. It discusses key Lean concepts like eliminating waste, standardizing processes, and continuous improvement. It also explains Six Sigma's statistical focus on reducing defects and variation. The DMAIC process of Define, Measure, Analyze, Improve, Control is introduced as the framework for process optimization projects using Lean Six Sigma.
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During an organizational transformation, the shift is from the previous state to an improved one. In the realm of agility, I emphasize the significance of identifying polarities. This approach helps establish a clear understanding of your objectives. I have outlined 12 incremental actions to delineate your organizational strategy.
Originally presented at XP2024 Bolzano
While agile has entered the post-mainstream age, possibly losing its mojo along the way, the rise of remote working is dealing a more severe blow than its industrialization.
In this talk we'll have a look to the cumulative effect of the constraints of a remote working environment and of the common countermeasures.
A presentation on mastering key management concepts across projects, products, programs, and portfolios. Whether you're an aspiring manager or looking to enhance your skills, this session will provide you with the knowledge and tools to succeed in various management roles. Learn about the distinct lifecycles, methodologies, and essential skillsets needed to thrive in today's dynamic business environment.
A team is a group of individuals, all working together for a common purpose. This Ppt derives a detail information on team building process and ats type with effective example by Tuckmans Model. it also describes about team issues and effective team work. Unclear Roles and Responsibilities of teams as well as individuals.
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
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CAPA (Corrective and Preventive Action) Management : Tonex Training
1. CAPA
MANAGEMENT TRAINING
4 days training from Tonex
https://www.tonex.com/training-courses/capa-management-training/
CORRECTIVE AND
PREVENTIVE ACTION
2. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
CAPA Management Training Course Description :
CAPA Management training covers the rationale, concepts, tools,
techniques, and practices of RCA and Corrective and Preventive Action
(CAPA) management in FDA field.
As you may know, it is crucial in clinical trials to identify the
noncompliance, correct them, and inhibit them from happening again
in future. Root cause analysis methods allow you to dig down to the
bottom of the problem, identify the underlying causes, and
change/eliminate them.
Root Cause Analysis (RCA) and Corrective and Preventive Action
(CAPA) Management training course teaches you to develop an
effective RCA investigation, and develop a corrective and preventive
action plan suitable for the identified problems. Such efficient CAPA
process can significantly help you enhance preventing the human-
errors and confidence in the truthfulness of the data.
CAPA / RCA
3. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Otherwise, absence of an effective corrective action management in
place can result in frequent non-compliance, unreliable subject safety,
poor data quality, and/ or improper investigation outcomes followed
by drastically harmful effects on the final submission.
Root Cause Analysis (RCA) and Corrective and Preventive Action
(CAPA) Management training course emphasizes on how to effectively
manage the noncompliance problems happening at research spots. All
stakeholders in clinical research including the sponsor, CRO,
investigator/site, and IRB/IEC can benefit from this hands-on training
course.
4. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Learn About:
• CAPA application and implementation
• CAPA management
• FDA’s requirements for CAPA systems
• Importance of CAPA systems
• CAPA system main components
• The definition and differences of the terms corrections, corrective
actions, and preventive actions
• CAPA data sources, Methods of data analysis
• CAPA data flow charts, CAPA tracking tools
• Medical device reporting and tracking
• FDA guidance for failure investigations and root cause analyses
• FDA’s trending principals, ECI
• Non-conformances or deviations
• RCA tools and methods, Brainstorming methods
• Problem solving tools, Process mapping, Regulatory resources
• Corrective action plan development steps
• Defining the problem statement properly
• Isolating and containing the problems, Identifying the root cause
• Developing an effective corrective action
• Executing and validating the corrective action
• Preventing recurrence, Preventive Action process
• Communication
5. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
How Can You Benefit from this Training?
• Learn how to collect & analyze information to identify actual, potential product & quality problems
• Investigate product and quality problems and take appropriate and effective corrective or preventive
action
• Verify or validate the effectiveness of corrective and preventive actions
• Learn root cause analysis to see underneath the complication of pharmaceutical and bio-
pharmaceutical manufacturing, securely answer warning letters, please auditors, and inhibit future
issues
• Set up an organized technique to categorize and prioritize studies, explore the real cause, select the
most effective and efficient corrective and preventive actions to secure compliance and enhance
output
• Shorten the cycle time for study approval and the frequency of open investigations.
• Integrate risk analysis into decision making to inhibit the same problems from happening again in
future and empower the chances of improvement
• Utilize rational and data to analytically explore and approve real root causes
• Decrease the investigations costs by improving the CAPAs (in efficiency and timing)
• Apply insightful questioning approaches
• Improve your thinking method and communication skills.
• Avoid FDAhttp://www.fda.gov 483s warning letters
• Improve your internal audits
• Speed up the reviews/approvals
6. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
TONEX RCA and CAPA Management Training Format:
• The course is fun and dynamic
• The training is a combination of theory and practice
• The theoretical section is delivered in the form of interactive
presentation
• The practical section includes exercising with real-world examples,
individual/group activities, and hands-on workshops
7. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Audience:
CAPA Management is a 4-day course designed for:
• CRAs
• Project Managers/CRA Managers
• Principal Investigators
• Site Research Directors/Managers
• Clinical Research Coordinators
• QA/QC staff
• GMP personnel
• All individuals who are involved in investigations in a
pharmaceutical, clinical manufacturing, biologics and medical
device environment.
8. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Training Objectives:
• CAPA Management training course, the attendees are able to:
• Describe what RCA and CAPA are
• Identify the non-compliance, Define the investigator
• Discuss performance management concepts
• Know the purpose of Corrective and Preventive Action
• Improve their RCA and CAPA executive skills for effective site risk
management
• Understand the requirements in 21 CFR 820 Quality
• System Regulation
• Foster prevention actions
• Guarantee satisfactory site issues management
• Apply the suitable models based on the nature of the root cause
analysis process
• Implement performance management notions
• Understand deeply the elements of effective Corrective Action
planning and documentation
• Discuss successful Preventive Action planning and implementation
• Improve their current CAPA system
• Increasing their confidence with FDA audits
• Recognize effective corrections, corrective actions and preventive
actions, resulting in saving time and resources.
9. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Course Outline (Can be Customized with Optional Module):
• Overview of CAPA
• RCA Definition
• Non-Conformances or Deviations
• Nonconformance Classification
• Problem Solving Process
• Creative Thinking Approaches
• FMEA Application in Clinical Devices
• Analysis and Prioritization Techniques
• Digging Down for the Root Causes
• Gathering Valuable Data for RCA and CAPA
• Analyzing Data
• Accidents Analysis and Role of Human Error
• Role of Management Behaviors in the Success of RCA/CAPA
• Implementing Corrective and Preventive Action Plans (CAPA)
• Elements of Effective CAPA
• Trending Requirements and CAPA
• CAPA Regulatory Requirements
• TONEX RCA and CAPA Hands-On Workshop Sample
CAPA / RCA
10. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Overview of CAPA:
• What is CAPA?
• Principles behind Corrective and Preventive Action (CAPA)
• CAPA definition
• Corrective action and preventive action
• The purpose of the corrective and preventive action
• Analytical vs creative thinking
• Content vs process thinking
• Investigator Noncompliance definition
• Regulatory definitions and categories
• FDA’s requirements for CAPA systems
• FDA guidance for failure investigations and root cause analyses
• FDA’s trending principals
• Performance Management Concepts
11. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
RCA Definition:
• RCA importance
• CA Definition of RCA
• Origin and evolution of RCA
• Applications of RCA
• Benefits and limitations of RCA
• RCA and CAPA application in pharmaceutical, clinical
manufacturing, biologics and medical device industries
• Data gathering methods
Non-Conformances or Deviations:
• What is nonconformance or deviation?
• Nonconformance types
• Who is responsible for reporting a nonconformance?
• Regulatory agencies
• cGMP compliance
• GDP requirements
• Nonconformance exceptions
• When is Regulatory Affairs Approval Required?
• Standard non-conformance process
• Standard deviations process
CAPA / RCA
12. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Nonconformance Classification:
• Minor NC
• Major NC
• Critical NC
Problem Solving Process:
• Discovering the problem
• Defining problems
• Studying the situation
• Collecting the required data
• Determining solutions requirements
• Generating creative solutions
• Evaluating the alternatives
• Selecting the best solution
• Implementing the solution
• Developing CAPA
• Monitoring the effectiveness of CAPA
• Fixing and changing the issues of the implemented CAPA
CAPA / RCA
13. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Creative Thinking Approaches:
• Definition of creativity
• Definition of creative thinking
• How do these techniques work?
• How can creative thinking generate new ideas?
• How to use creative thinking in brainstorming sessions
• Advanced tools of creative thinking
• Computer-based methods
• Manual methods
• Create creative environment
14. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
FMEA Application in Clinical Devices:
• Failure definition
• Failure modes classification
• Potential failure modes
• Potential causes of failure
• The effects of the causes
• Failure mode ID
• Assembly, sub-assembly, parts
• Failure description
• Alarming signs
• Techniques of failure detection
• All potential effects on assembly and on complete product
• Failure modes exercise
Analysis and Prioritization Techniques:
• Analysis models
• Systematic techniques to problem solving
• Decision analysis
CAPA / RCA
15. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Digging Down for the Root Causes:
• Main objectives and phases of effective failure investigations
• How to execute a proper failure investigation to its root cause
• 00S (Out-of-Spec) investigations
• Five ways to identify potential causes
• Detailed examination of Gilbert’s Behavioral Engineering Model
and its application to root cause analysis
• Behavioral interviewing
• Effective, open-ended questioning
• Three ways to choose or remove causes
• Fault tree analysis
• Cause and effect diagrams
• Tools for Problem Cause Brainstorming
• Principals of brainstorming
• Brainstorming components
• How to conduct a brainstorm session
• Brainstorming tools
• Fishbone diagram
CAPA / RCA
16. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Gathering Valuable Data for RCA and CAPA:
• Problem cause data gathering
• Historical records
• Operations records
• Steps in using samplings
• Population vs sampling
• Use check sheets, graphs, and tables
• Advantages of surveys, interviews, and field observation for
opinions
• Problem cause data collection checklist
Analyzing Data:
• Understanding problem cause data analysis
• Tools for data analysis
• Integrative data analysis tools
Accidents Analysis and Role of Human Error:
• Various incident/accident analysis
• Human error, causes and solutions
CAPA / RCA
17. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Role of Management Behaviors in the Success of RCA/CAPA:
• RCA affected by the cognitive biases
• Organizational culture effects
• Supportive roles
• Application of Performance Management Concepts
• 7 comprehensive compliance management steps
Implementing Corrective and Preventive Action Plans (CAPA):
• CAPA data gathering tools
• Organizing the solutions implementation
• Deriving an action plan
• Use tree diagrams
• Develop change acceptance
• Force-Field analysis
• Problem solving and implementing both short-term corrective and
long-term preventive actions
• Review and criticize simulated monitoring reports documenting
noncompliance and CAPA
CAPA / RCA
18. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
Elements of Effective CAPA:
• Structure of an effective CAPA
• Definitions of a correction, corrective action, and preventive action
• How do you organize your CAPA and if it’s effective?
Trending Requirements and CAPA:
• Drug and device trending requirements
• How to apply proper statistics to discover and fix CAPA problems
• Often dismissed but crucial sources of internal and external
feedback
• Use of Risk (Process, Product) to identify when and if to escalate an
observation to a CAPA
CAPA Regulatory Requirements:
• FDA’s requirements for CAPA
• Specific GLP, Drug GMP, and Medical Device CAPA regulations
• Why CAPA matters to FDA
• Role of CAPA in meeting international rules and standards
CAPA / RCA
19. https://www.tonex.com/training-courses/capa-management-training/
CAPA ( Corrective And Preventive Action ) Management Training
TONEX RCA and CAPA Hands-On Workshop Sample:
• Providing real-world scenarios and case-studies to practice each of
the performance management concepts
• Individual and group activities to perform based on a real example
of FDA warning letters
• Determining all the noncompliance in the case-studies
• Problem solving methods
• Methods for collecting and analyzing information
• Identify and investigate product and quality problems
• Taking appropriate and effective corrective and/or preventive
action to prevent recurrence
• Verifying or validating corrective and preventive actions
• Communicating corrective and preventive action activities to
responsible people, Providing relevant information for
management review, Preparing surveys and questioners to gather
data for the RCA investigation
• Identifying the real causes associated with the targeted problem
• Brainstorming all the possible solutions
• Choosing the best solution
• Developing a corrective actions plan, Developing a preventive
actions plan, Documenting the issue in monitoring reports and
correspondence, Presenting the RCA process and CAPA to the class
• Discussing the problems and strengths of each CAPA
20. CAPA
MANAGEMENT TRAINING
4 days training from Tonex
https://www.tonex.com/training-courses/capa-management-training/
CORRECTIVE AND
PREVENTIVE ACTION
VISIT TONEX.COM
21. • Tonex has been documenting the cybercrime evolution for 25 years
when it first began training organizations on how to better deflect
contemporary cyberattack.
• Our Cybersecurity training courses and seminars are continuously
updated so that they reflect the latest industry trends, and they are
also created by specialists in the industry who are familiar with the
market climate.
• So far we have helped over 20,000 developers in over 50 countries
stay up to date with cutting edge information from our training
categories.
• We’re Different because we take into account your workforce’s
special learning requirements. In other words, we personalize our
training – Tonex has never been and will never be a “one size fits all”
learning program.
• Ratings tabulated from student feedback post-course evaluations
show an amazing 98 percent satisfaction score.
Contact Tonex for more information, questions, comments.
Why Tonex?