Human Error

                            HUMAN ERROR

In Pharmaceutical Industries human error and its reduction is very bib challenge.

During regulatory audit most of the investigator asking data of human error trend for OOS/OOT/Deviatrion/Incident and way forward to reduce the human error.

“Human Error is commonly defined as a failure of a planned action to achieve a desired outcome”.

Human error Categories :

Failures of action, or unintentional actions, are classified as   
  1-Skill-based errors: This error type is categorised into--

             A-Slips of action 

             B-Lapses of memory.

         2-Mistakes: Failures in planning are referred  to as mistakes, which are categorised as 

         A:Rule based

         B: knowledge-based

  

Skill-based errors:

Slip of Action tend to occur during highly routine activities, when attention is diverted from a task, either by thoughts or external factors. Generally when these errors occur, the individual has the right knowledge, skills, and experience to do the task properly. The task has probably been performed correctly many times before. Even the most skilled and experienced people are susceptible to this type of error. As tasks become more routine and less novel, they can be performed with less conscious attention – the more familiar a task, the easier it is for the mind to wander. This means that highly experienced people may be more likely to encounter this type of error than those with less experience. This also means that re-training and disciplinary action are not appropriate responses to this type of error.

A memory lapse occurs after the formation of the plan and before execution, while the plan is stored in the brain. This type of error refers to instances of forgetting to do something, losing place in a sequence, or even forgetting the overall plan. 

A slip of action is an unintentional action. This type of error occurs at the point of task execution, and includes skipping or reordering a step in a procedure, performing the right action on the wrong object, or performing the wrong action on the right object.

Slips and lapses can be minimised and mitigated through workplace design, use of checklists, independent checking of completed work, discouraging interruptions, reducing external distractions, and active supervision.

Mistakes:

Mistakes are failures of planning, where a plan is expected to achieve the desired outcome, however due to inexperience or poor information the plan is not appropriate. People with less knowledge and experience may be more likely to experience mistakes. Mistakes are not committed ‘on purpose’; as such, disciplinary action is an inappropriate response to these types of error.  

 Mistakes can be minimised and mitigated through robust competency assurance processes, good quality training, proactive supervision, and a team climate in which co-workers are comfortable observing and challenging each other. 

 Mistakes can be rule-based or knowledge-based.

Rule-based mistakes refer to situations where the use or disregard of a particular rule or set of rules results in an undesired outcome. Some rules that are appropriate for use in one situation will be inappropriate in another.  

Knowledge-based mistakes result from ‘trial and error’. In these cases, insufficient knowledge about how to perform a activity to get a accurate result.

Violation:

Failure to apply a good rule is also known as a violation. Violations are classified as human error when the intentional action does not achieve the desired outcome, or results in unanticipated adverse consequences. Violations tend to be well-intentioned, targeting desired outcomes such as task completion and simplification. 

Note: Violations are classified as human error only when they fail to achieve the desired outcome. Where a violation does achieve the desired outcome, and does not cause any other undesired outcomes, this is not human error. These types of violations may include violation of a bad rule, such as a procedure that, if followed correctly, would give unexpected data. In such cases, a review of the rules and procedures is advisable.