A Systematic Approach to Human Error Reduction: Investigations, Root Cause Determination and CAPA Effectiveness

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. 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 for human error reduction. To work with these challenges, it is essential to understand human behavior, the psychology of error and root causes for human error deviations as well as implementing a process exclusively dedicated to investigating and “fixing” these problems.
This human error prevention training offers practical approaches and models for addressing and controlling human error in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
We need to be able to explain human behavior. Did the human fail because process weaknesses set them for failure? Do procedures provide for all information and clearly indicate critical steps and warning or cautions associated with steps? Do systems work for manufacturing or it’s the other way around? These are all tough questions to ask, but most importantly answer.
This training would provide tools that can be implemented and used after this event for human error reduction. These include practical tools. We will discuss human error categories, near root causes and root causes for human error deviations. We will discuss latest trends in human error issues in the industry.

Human error as the root cause
What is human error
Controlling human error
Root cause determination
Types of human error
Human error and training: when and where
Human error rates and measurement
Trending and tracking
CAPA effectiveness


Understand the psychology of error
Regulatory requirements in GMP environments for managing human performance deviations
Root cause determination and investigations
Root cause determination tool
Establishing the human error rate at your site
Implementing the human error reduction program
Metrics and KPI’s


Training managers and coordinators
Plant engineering
QA/QC staff
Process excellence/improvement professionals
Industrial/process engineers
Compliance officers
Regulatory/legislative affairs professionals
General/corporate counsel

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