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Root Cause Analysis of Human Error in GMP Environments
- Introduction (10 min)
- Welcome & Objectives of the Webinar
- Brief overview of the agenda
- Importance of addressing human error in GMP settings
- Understanding Human Error in GMP
- Definition and types of human errors
- Common misconceptions about human error
- Regulatory expectations (FDA, EMA, MHRA, WHO)
- Welcome & Objectives of the Webinar
- The Role of Root Cause Analysis (15 min)
- Why Root Cause Analysis (RCA) Matters
- Preventing recurrence of human error
- Compliance and risk mitigation
- Key RCA Principles in GMP Environments
- Reactive vs. proactive approaches
- Correlation between human error and system weaknesses
- Common RCA Tools and Techniques
- Fishbone Diagram (Ishikawa)
- 5 Whys
- Failure Mode and Effects Analysis (FMEA)
- Human Factors Analysis
- Why Root Cause Analysis (RCA) Matters
- Human Error Taxonomy & Contributing Factors (20 min)
- Types of Human Errors
- Slips & Lapses (Unintentional)
- Mistakes (Rule-based vs. Knowledge-based)
- Violations (Routine vs. Reckless)
- Contributing Factors to Human Error in GMP Settings
- Procedural complexity
- Training gaps and competency issues
- Environmental factors (lighting, noise, distractions)
- Workload and fatigue
- Organizational culture and management influence
- Types of Human Errors
- Case Study & Interactive Exercise (20 min)
- Case Study on Human Error in GMP
- Real-world GMP compliance violation due to human error
- Walkthrough of RCA application
- Interactive Exercise: Conducting a Root Cause Analysis
- Participants analyze a provided scenario
- Apply RCA tools (5 Whys, Fishbone Diagram)
- Group discussion on findings and solutions
- Case Study on Human Error in GMP
- Preventive & Corrective Actions (15 min)
- Designing Effective CAPAs (Corrective and Preventive Actions)
- Moving beyond “retraining” as a fix
- System-based corrections vs. individual blame
- Developing a Human Error Prevention Strategy
- Error-proofing procedures (Poka-Yoke)
- Improved SOP design and simplification
- Enhancing training effectiveness (simulation-based, scenario-driven)
- Building a culture of quality and accountability
- Designing Effective CAPAs (Corrective and Preventive Actions)
Identify and classify human errors in GMP environments by understanding the different types of errors (slips, lapses, mistakes, and violations) and their contributing factors, including procedural, environmental, and organizational influences.
Apply Root Cause Analysis (RCA) techniques such as the 5 Whys, Fishbone Diagram, and Human Factors Analysis to systematically investigate human errors and determine their true root causes.
Develop effective corrective and preventive actions (CAPAs) that go beyond retraining and disciplinary measures by focusing on system-based improvements, procedural enhancements, and error-proofing strategies.
Foster a culture of quality and continuous improvement by implementing proactive human error prevention strategies, refining Standard Operating Procedures (SOPs), and leveraging training methodologies to reduce the recurrence of GMP-related human errors.
Overview of the webinar
In Good Manufacturing Practice (GMP) environments, human error is a persistent challenge that can lead to deviations, batch failures, regulatory non-compliance, and even product recalls. Studies show that over 70% of GMP deviations are attributed to human error, yet many organizations rely on retraining as a default corrective action—often without addressing the systemic root causes. Factors such as complex procedures, inadequate training, fatigue, workplace distractions, and ineffective SOP design can all contribute to recurring errors. Regulatory agencies, including the FDA, EMA, and MHRA, expect organizations to move beyond blame-based approaches and implement structured Root Cause Analysis (RCA) methodologies to drive sustainable error reduction. This training is designed to help GMP professionals identify the underlying causes of human error, apply effective RCA tools, and implement corrective and preventive actions (CAPAs) that improve compliance, operational efficiency, and product quality.
Human error remains one of the leading causes of deviations, non-conformances, and compliance issues in GMP-regulated industries. While retraining is often the default response, true error reduction requires a deeper understanding of the root causes and contributing factors. This 90-minute webinar will provide a structured approach to Root Cause Analysis (RCA), equipping participants with essential tools such as the 5 Whys, Fishbone Diagram, and Human Factors Analysis to systematically investigate and prevent recurring human errors. Participants will explore the different types of human errors—slips, lapses, mistakes, and violations—and understand how procedural complexity, environmental conditions, workload, and organizational culture contribute to errors in GMP settings.
Through real-world case studies and an interactive RCA exercise, attendees will gain hands-on experience in identifying the true root causes of human error and developing effective Corrective and Preventive Actions (CAPAs) that go beyond superficial fixes. The session will also cover proactive error prevention strategies, such as error-proofing procedures (Poka-Yoke), SOP simplification, and competency-based training enhancements. By the end of this webinar, participants will be equipped with practical techniques to foster a culture of quality, accountability, and continuous improvement, ultimately reducing compliance risks and operational inefficiencies in their organizations.
Who should attend?
- Quality & Compliance Functions
- Quality Assurance (QA) – Ensures compliance with GMP regulations, manages deviations, and implements corrective actions.
- Quality Control (QC) – Identifies and investigates errors in laboratory and production processes.
- Regulatory Affairs – Supports compliance with global regulatory expectations (FDA, EMA, MHRA, etc.).
- Compliance & Auditing – Conducts internal audits and regulatory inspections, ensuring robust CAPA processes.
- Manufacturing & Operations
- Production & Manufacturing – Ensures GMP-compliant execution of processes and investigates human errors in production.
- Process Development – Optimizes manufacturing processes to minimize human errors.
- Engineering & Maintenance – Improves facility and equipment design to reduce human error-related risks.
- Training & Human Resources
- Learning & Development (L&D) – Enhances training programs to address the root causes of competency-related errors.
- Human Resources (HR) – Supports cultural shifts from blame-based approaches to continuous improvement.
- Supply Chain & Logistics
- Warehouse & Distribution – Ensures GMP compliance in material handling, labeling, and shipping to prevent errors.
- Procurement & Supplier Quality – Works with suppliers to minimize human error risks in raw materials and components.
- Research & Development (R&D)
- Clinical & Preclinical Operations – Identifies human error trends affecting study integrity and regulatory compliance.
- Product & Process Development – Designs robust systems that minimize human error in early-stage development.
Why should you attend?
Attending this training will provide GMP professionals with essential skills and tools to effectively analyze and prevent human errors, reducing compliance risks and improving operational efficiency. Rather than relying on ineffective quick fixes like retraining, participants will learn structured Root Cause Analysis (RCA) techniques to uncover the true sources of errors and implement meaningful, system-based Corrective and Preventive Actions (CAPAs). Through real-world case studies and interactive exercises, attendees will gain hands-on experience in applying RCA tools such as the 5 Whys and Fishbone Diagram, enabling them to develop practical, long-term solutions that enhance quality, compliance, and productivity. This training is ideal for quality assurance, manufacturing, regulatory, and operations professionals who want to move beyond a blame culture and build a proactive, error-prevention mindset in their organizations.
Faculty - Mr.Charles H. Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.