How to Implement an Effective Human Error Investigation Program

If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must do it because the regulation requires it.

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" That being said, Human Error is NOT a root cause.

Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior CAN be controlled, reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error and implement a process exclusively dedicated to investigating and "fixing" these problems. This course offers practical approaches and models to address human performance issues in GMP-related environments by using a particular methodology to correct, prevent, and avoid the reoccurrence of these matters.

Why You Should Attend:
We need to be able to explain human behavior. Did humans fail because process weaknesses set them up for failure? Do procedures provide for all information and indicate critical steps and warnings or cautions associated with steps? Do systems work for manufacturing, or is it the other way around? These are all tough questions to ask, but most importantly, answer. This training would provide tools to implement and use after this event. These include practical tools. We will discuss human error categories, near root causes, and root causes for these events. We will discuss the latest trends in human error issues in the industry.

Areas Covered in the Session:

• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Root Cause Determination
• Types of error
• Human error and training: when and where
• How to gather data
• Interview
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness
• Chat GPT use

• 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