If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
This training will provide you with the steps required to help you implement a Human Error Reduction Program at your site. It includes practical tools, and how to measure effectiveness to continuously improve human reliability at your site.
The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…”
Also, the European Commission reads “Where human error is suspected or identified as the cause; this should be justified having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked if present. Appropriate corrective actions and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.”
We in Human Error Solutions have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations around the world. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving desired to results.
Learning Objectives:
- Introduction to the Human Error Reduction Program
- Understanding Human Error and Human Behavior
- Learn the 6 Step Implementation Process (step by step)
- Introduction to Human Error Solution Tools
- Implementing the program by phases
- Human Error Rate, Metrics, and KPI’s
Areas Covered :
- What is Human Error
- How is Human Error controlled?
- 6 step method for error prevention
- Human error rates and measurement
- Trending and tracking
- Prediction
- Effectiveness
Who will benefit:
GMP regulated manufacturing facilities including Pharma, medical devices, biologics, food and nutrition and any other organization that has employees executing activities in which they can make mistakes (ALL).
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
- Lecture 1: Understanding the Basics of Human Error in Manufacturing
- How human errors intersect with manufacturing regulations
- Examples of applicable FDA requirements and what the FDA expects companies to be complying with
- A review of other industry standards that apply to drug and device manufacturing
- What FDA investigators look for during inspections and the most common violations found in Form 483s and Warning Letters
- Which violations tied to human errors and manufacturing are trending up
- The various types of human errors commonly found on manufacturing floors
- Break
- Lecture 2: Human Error and Human Factors
- The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes
- Why administrative and management systems factor so prominently into deviations and nonconformance.
- The role of innovative operational controls and their role in reducing human errors
- When training is appropriate and when we should stop
- Learn how common day-to-day communication gaps contribute to human error
- How supervision can be one of the best human error reduction strategies at your site
- When is individual performance responsible for human error and when does it become a root cause
- How to address cognition, attention, and memory failures at your site
- Lunch
- Lecture 3: Psychology and Human Error
- How our biology affects our thinking process and individual performance
- Understanding the latest on cognitive load and attention, memory, and decision-making errors — how they commonly occur on the manufacturing floor
- How our senses control how we react — it’s more important that you think
- Best practices for controlling human factors for optimum people performance
- How to create an organizational environment that supports human error reduction initiatives — from senior management to floor level staff
- Why our culture with regards to human error has to change; it’s not an easy process but vitally necessary for drug and device companies
- Break
- Lecture 4: Corrective and Preventive Action (CAPA) — FDA’s #1 Manufacturing Compliance Problem
- How to develop corrective actions that make sense —what’s working and not working
- Creating preventive actions that truly prevent; how to stop errors that have not yet happened
- Understanding the human error prediction process and tools
- Prevention and human error control: proven ways to measure improvement and on-going trend analysis
- When to use detection mechanisms instead of preventive mechanisms — the pros and cons of each
- Human error detection and recovery rate — are you really uncovering all the errors within your facilities?
- Assuring the FDA your CAPA program is effective and you’ve adequately focused on human error
- Lecture 5: Human Error Reduction Techniques
- Discussion of insights from Day 1
- When is human error a human resources issue?
- How and when to apply engineering controls to correct and prevent human error deviations
- What to do when individual performance is the major contributor
- Human error and documentation: from design, construction, change management and implementation.
- Additional contributors for human errors will be discussed.
- Break
- Lecture 6: Human Error Investigation
- Human error investigation process defined from beginning to end
- How to gather data in the human error investigation process
- How to perform an effective interview
- Important steps for effective human error investigations
- How to report issues to make sure management listens
- Lunch
- Lecture 7: Root Cause Analysis Tools
- A brief review of common tools used in determining root cause
- Hierarchy and use of the root cause determination tool for human error investigations
- How to perform a cognitive load assessment
- The interview process and interview techniques for human error root cause analysis.
- When and how to use the human error prediction tool
- When to perform a process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error
- Break
- Lecture 8: Metrics and Human Error
- KPI’s
- Human error rate
- 1st time pass rate
- Overall equipment effectiveness (OEE)
- Trending
- Tracking
- Lecture 9: Review and Key Insights Materials
- Copies of the presentations
- Pertinent guidance documents
- Articles on human error
- Manual tools
- Interviewing guide
- Report example
- Root Cause Determination Tool
Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity.
She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.
Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.
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