Corrective action and preventive action are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.[1] CAPA is a concept within good manufacturing practice (GMP). It focuses on the systematic investigation of the root causes of non-conformities in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
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This course teaches the following tools: 5W2H, Brainstorming, Ishikawa/Fishbone, Cause & Effect Tree, Five Why’s and Pareto Charts.
Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.
A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities.
Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain a basic knowledge the the most common tools for Root Cause Analysis and Corrective & Preventive Action
- Root Cause & Corrective/Preventive Action Definitions
- Depth of Root Cause Analysis
- Eight Step Process
- Root Cause, Corrective/Preventive Action Tools
- 5W2H
- Brainstorming
- Ishikawa or Fishbone Diagram
- Cause & Effect Tree Analysis
- Five Whys Method
- Pareto Chart
- Conclusion
In this course, you’ll learn how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in your organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.
Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.
This corrective action training is a great course for anyone learning to deal with corrective actions for the first time or anyone who needs a refresher to calibrate your knowledge and build confidence in your abilities.
Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-step approach for CAPA’s.
Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools
Days: 2
Time: 7:30 AM- 4:30 PM MST
Audience: Beginner to Advanced
Human Factors is a term that appears in the latest versions of several ISO standards, including:
This Human Factors online training helps you to understand human factors in the context of each standard. You will learn how to apply the concept of human factors to your management system and address the standard requirements. You will also receive practical tools, proven methodologies, and helpful tips to make the job easier for you.
As with all of Axeon’s courses, this is a practical, how-to that is not bogged down in academic discussions. We use case studies, practice exercises, and learning activities to keep the training activities and build competence.
· Quality managers | Also: |
· Management representatives | · Quality consultants |
· Quality engineers | · Those involved in performing corrective actions |
· Safety managers | · Those involved in medical device risk management |
· Top management | · Preparation Of Checklists From Process Analysis |
· Regulatory affairs specialists | |
Prerequisites
None. Our students range from seasoned quality professionals to novices. Our goal is to meet everyone at their current level of competence and increase it.
Intro to Human Factors
Review ISO Standard Requirements: 9001, AS9100D, 14971, 45001
Definitions of Human Factors by Standard
Human Factors and Root Cause Analysis
Corrective Action and Human Factors
The 13 Most Common Human Factors
Activity: Applying Human Factors in Corrective Action
Human Factors and Poka-Yoke
Definition & History of Poka-Yoke
Methodology for Poka-Yoke
Activity: Applying Poka-Yoke to Human Factors
Human Factors and Health & Safety
Definition of Human Factors in Health & Safety
Human Factors and Ergonomics
How Human Factors influence Safety at Work
Activity: Applying Human Factors to Safety
Human Factors and Medical Devices
Methodology for Considering Human Factors in Risk Assessment
Device Design According to Human Factors Consideration
Human Factors in Post-Market Surveillance
Final Test
Come learn the FDA 21 CFR and ISO 13485 requirements for a regulatory-compliant CAPA system and records. You will leave this training knowing how to perform effective root cause investigations that address, resolve, and prevent the issue(s) from recurring. This same CAPA methodology can be used to address Regulatory audit findings throughout the world.
This course teaches:
✔ The regulatory requirements for pharmaceutical and medical device CAPA:
✔ How to perform effective fast-paced root cause analysis and complaint investigations– no more “best-guesses”
✔ How to document complaint investigations and maintain records to demonstrate compliance
✔ Root cause investigation methods, such as:
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✔ Other helpful pharma & medical device CAPA Tools including:
Day 1
Day 2
Days: 2
Time: 7:30 a.m.- 4:30 p.m. MST
As Root Cause CAPA for Aerospace, an AS13000 training is a must-have. If you are a Boeing, Airbus, or other top OEM supplier, you need this class! All suppliers for the top OEM’s are required to have an 8D Practitioner. This course fulfills the training and testing requirements to become an 8D Practitioner.
AS13000 defines the Problem-Solving standard for suppliers within the aero-engine sector, with the Eight Disciplines (8D) problem-solving method being the basis for this standard.
This 2-day course provides students with a comprehensive and standardized set of tools to become an 8D practitioner and meets all the requirements of “training syllabus” (see AS1300 APPENDIX C). Successful application of 8D achieves robust corrective and preventive actions to reduce the risk of repeat occurrences and minimize the cost of poor quality. This is essential to enable long-term customer-supplier relationships and positively contributes towards zero defects and customer satisfaction.
This course includes the practical application of each of the 8D disciplines. |
Learning Objectives:
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An AS13000 training is a requirement for Aerospace Suppliers of any top OEM. Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-D process.
Days: 1
Time: 7:30 AM-4:30 PM MST
Audience: Top management
A QMS (Quality Management System) is NOT a cost of doing business. It’s an investment. And top management should expect to get a financial return on that investment. However, the Return On Investment (ROI) they receive will be greatly impacted by the level of leadership and commitment they provide concerning the management system.
The newest versions of most ISO management standards have amplified the requirements for top management, in accordance with ISO 9001:2015. In this highly interactive course, senior managers will learn how to fulfill their new responsibilities, take accountability, and maximize the ROI they get from their management systems.
This class will help to show the true value of your quality management system and how much it really adds to your bottom line. It will also help your company to increase the ROI of your QMS.
If you want to improve your company’s bottom line or show your boss how much your QMS is already contributing to profits then this class is for you.
Benefits of a Quality Management System
Overview of Quality Principles
How to Maximize the ROI from your QMS
The Five Biggest Mistakes Executives Make with Quality Management
Final Test