Training Course Syllabus:

How to Perform a Cognitive Load Assessment for Human Error Reduction

Course Description:

Attention, memory and decision making errors are directly associated with cognition overload and mistakes. This course explores the human mind, human factors and cognitive overload in GMP related environments.

Through a combination of discussion and interactive exercises attendees will learn:

How to Perform a Cognitive Load Assessment. Participants will begin the course by learning how to perform a cognitive load assessment to reduce errors. Attendees will also be provided examples of poor human factor, engineering and workplace conditions that contribute to errors.

Human Error Reduction Techniques. Participants will be taught how and when to apply engineering controls to correct and prevent errors. Participants will work with fellow attendees to create and analyze results through the use of a box plot chart.

Human Error Investigation. Participants will be taught the proper steps to take for an effective human error investigation from beginning to end. They will be taught how to gather data when analyzing cognitive load. They will also be taught how to perform an effective interview and how to properly report issues to management in a way that they will listen

Through the use of a case study participants will conduct a full cognitive load assessment including a root cause analysis and CAPA development plan.

COMPLEMENTARY COURSE BINDER MATERIALS (Value US$ 549.00)

Root cause determination tool
Interviewing guide – you can take back and use immediately
Example of well-documented HE report
Complete copy of slide deck materials
Copies of applicable FDA regulations referenced in the course
Copies of pertinent FDA guidance documents
Articles focused on human error reductions

Course Outline:

Day One (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

9:00 a.m. – 10:00 a.m.
How to perform a cognitive load assessment for human error reduction

Definitions and Theory
The regulation and human error:
Examples of applicable FDA requirements and what the FDA expects companies to be complying with
Definitions and Theory on Human Error and Cognitive Load
Understanding the latest on cognitive load and attention, memory, and decision making errors — how they commonly occur on the manufacturing floor
Cognitive Load Assessment: scenarios and applications
Human Errors Types and Cognitive Load
Human Error Cause Categories for Cognitive Load
How we got here — why human error reduction is such an important topic
Interactive Exercise: Attendees will be broken into groups and asked to describe the most common human errors related to cognition, within their facilities. The workshop will then reconvene and break-out group leaders will describe what categories were identified as root causes.
10:00 a.m. – 10:15 a.m.
BREAK

10:15 a.m. – 12:00 p.m.
Cognition and Human Error

Human limitations on memory, attention and decision making
How cognitive load affects productivity
The various types of cognition related human errors commonly found on manufacturing floor
Common examples of poor human factors, engineering and workplace conditions that contribute to human error
When training is appropriate and when we should stop
When is individual performance and cognitive load responsible for human error and when does it become a root cause
How to address cognition, attention, and memory failures at your site
12:00 p.m. – 1:00 p.m.
LUNCH

1:00 p.m. – 4:30 p.m.
Cognitive Load Tool Content

Definition of Human Factors Categories (HFC)
How our senses control how we react — it’s more important that you think.
Importance of each HFC and latest investigation on cognition and productivity
Learn the Human Error Risk Multipliers and risk level
How to develop recommendations for each HFC
How to prepare for the Cognitive Load Floor Assessment
Workshop #1 – Floor Assessment Simulation
How to use the excel tool
Workshop # 2 – Data Entry using excel tool

Day Two (8:30 AM – 4:30 PM)

8:30 a.m. – 10:00 a.m.

Human Error Reduction Techniques (Cognitive Load)
Discussion of insights from Day 1
Understanding the Human Error level of Risk
What is the level of risk and how to determine it?
Reporting the level of risk: tools and criticality assessment
Creating the Box Plot
Report Content
How and when to apply engineering
controls to correct and prevent human error deviations
What to do when individual performance is the major contributor
Additional contributors for human errors will be discussed
Interactive Exercise: Creating and analyzing results. Create and export the Box Plot Chart

10:00 a.m. – 10:15 a.m.
BREAK

10:15 a.m. – 12:00 p.m.

Human Error Investigation (Cognitive Load Issues)
Human error investigation process defined from beginning to end
Individual performance: slip, mistakes and violations
How to gather data in the human error investigation process when analyzing cognitive load?
How to perform an effective interview: there’s more than meets the eye?
Important steps for effective human error investigations
How to report issues to make sure management listens?
When to involve Human Resources in CAPA
12:00 p.m. – 1:00 p.m.
LUNCH

1:00 p.m. – 2:30 p.m.
Cognitive Load Assessment- Interactive
Exercise: Full experience on Cognitive Load Assessment. A case study will be analyzed for root cause analysis, determination and CAPA development.

2:30 p.m. – 2:45 p.m.
BREAK

3:00 p.m. – 4:00 p.m.

Writing recommendations
How to determine the kind of recommendation based on the type of error?
High and low end recommendations: benefits and challenges
Type of recommendations based on the type of error (random, systemic and sporadic errors)
How to present to management and make sure you are taken seriously
4:00 p.m. – 4:30 p.m.
Metrics and Human Error

KPI’s
Human error rate
1st time pass rate
Overall equipment effectiveness (OEE)
Trending
Tracking
Closing
4:30 p.m.
ADJOURN WORKSHOP

Seminar Summary:

Attention, memory and decision making errors are directly associated with cognition overload and mistakes. This course explores the human mind, human factors and cognitive overload in GMP related environments. (see full course description)

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