Human Error Prevention Training Kit

This training kit is an indispensable resource in preventing human error by identifying gaps, refining processes and improving performance. The methods and tools discussed here will help you logically and systematically identify human errors that undermine the health of your organization and allow you to prevent human errors and deliver the greatest return on your investment. By using the methods in this training kit, you take clear and actionable actions for high performance.

Explore the contents of the training programs and order the today:

All Modules:

Module 1: Human Error Reduction in GMP Manufacturing
Module 2: How to write SOP's that Avoid Human Error
Module 3: Human Error Reduction Techniques for Floor Supervisors
Module 4: How To Implement An Effective Human Error Reduction Program
Module 5: Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
Module 6: Human Factors Engineering in New Product Development
Module 7: User / Human Factors Engineering Under IEC 62366-1, -2

Part 1 : Human Error Reduction in GMP Manufacturing
Instructor: Ginette M Collazo

Areas Covered in the Webinar:

• Background on Human Error Phenomena
• Human Error and GMP around the world
• Importance of Human Error Prevention/reduction
• Training and human error
• Facts about human error
• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Part 2 : How to write SOP's that Avoid Human Error
Instructor: Ginette M Collazo

Areas Covered in the Webinar:

• SOP writing outline
• Content development
• The rationale for procedure use
• Regulatory compliance background
• Universal purpose of procedures
• The Human Perspective
• Human Error as a root cause
• The thinking and reading process
• Common mistakes and causes
• How to create and maintain a procedure
• Goals of a procedure
• Good Procedure Writing practices (Terminology, Formats, layouts, mixed cases, steps content, familiar words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions,”
• Procedure styles
• Use of electronic information networks for procedure access.

Part 3 : Human Error Reduction Techniques for Floor Supervisors
Instructor: Ginette M Collazo

Areas Covered in the Webinar:

• What is Human Error
• Importance of Human Error Prevention/reduction
• Supervision and human error
• Facts about human error caused by supervisors and how to avoid it
• When is operator error the Root Cause?
• How is Human Error controlled by supervision?
• Common mistakes: Memory failures, Overconfidence, Visual Detection, and Vigilance Effectiveness and how supervision can help improve these
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Part 4 : How To Implement An Effective Human Error Reduction Program
Instructor: Ginette M Collazo

Areas Covered in the Webinar:

• 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

Part 5 : Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
Instructor: Ginette M Collazo

Areas Covered in the Webinar:

• Types of human error
• Taxonomy of human error
• 80/20 and human error reduction initiatives
• Individual performance
• Cognitive load and human error
• Cognitive load categories
• Importance and recommendations

Part 6 : Human Factors Engineering in New Product Development
Instructor: Tom Kramer

Areas Covered in the Webinar:

• What is human factors engineering?
• What role does human factors engineering play in the product development cycle?
• How do you implement it in your product development plan?

Part 7 : User / Human Factors Engineering Under IEC 62366-1, -2
Instructor: John E Lincoln

Areas Covered in the Webinar:

• Key parts of IEC 62366-1:2015 and -2:2016 – Use Engineering /
• FDA’s Human Factors Engineering
• IEC 62366m Part 1 focuses on “what”, Part 2 on “how”
• More harmonization – US FDA, ISO 14971 and IEC 62366
• Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3)
• Planning requirements
• The defined engineering process
• “Interface” defined
• User interface considerations
• Formative and Summative Evaluations and their Verification and Validation Equivalents
• Software considerations
• Suggested documentation – a Use Engineering File.

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