As technology advances, human error in manufacturing is becoming more apparent every day. In the pharmaceutical industry, more than 80% of deviations are caused by human error, but unlike process or equipment failures, human error is usually not investigated in depth, and despite the underlying cause, companies will eventually only provide retraining for the relevant employees, and this simple method is usually evaluated as "imperfect quality system". To this end, Amy and everyone together to see how to identify the root causes of human error and really reduce human error.

Why do people make human errors?

There are three main factors that are potential triggers for human error, namely task complexity, behavioral characteristics, and error-prone situations. In addition, there are a variety of precursors to human error that can cause errors to occur:

(1) Mission requirements

Time pressure (rush)

High workload (to have enough memory)

Perform multiple tasks simultaneously

Repetitive and monotonous work

Incorrect understanding

personal ability

Not familiar with the task.

lack of knowledge/proficiency/experience

Lack of effective communication

Insufficient problem-solving skills

Insufficient focus on key tasks

Illness and/or fatigue

Working environment:

Distraction and Interference

Change or deviation from regular

Noisy work environment

Cannot accept work culture

Humanity

Stress (limiting attention)

Habit mode

Assumptions (inaccurate mental picture)

complacency and overconfidence

Mentality

Inaccurate risk perception

Memory is limited

Human error investigation

After an error occurs, the risk impact of the error varies. It is best to decide whether to conduct a comprehensive human error investigation while considering the risk impact. The most commonly used method of investigation is fishbone diagram:

If the preliminary investigation indicates that the cause of the error was human error, the following investigation path will help further the investigation:

(1) Quality incident report;

(2) survey according to their respective sops

(3) Preliminary investigation indicates that human error is the root cause or contributing factor

(4) Initiate an investigation of human error (see the following flowchart for the investigation) and focus on the following points:

Do people have the ability and knowledge to do this?

Is the person aware of the importance of the task and the end result of the task?

Do people remember & apply knowledge (habits) when needed?

On the basis of the preliminary investigation, the real cause of human error should be further understood through the following methods:

(1) Investigators observe the operations of the analyst/operator

(2) Investigators interact with analysts/operators to understand the quality and gaps in processes and procedures.

(3) Get feedback from other operators on the task/possible cause

(4) Structured brainstorming

(5) If it is found that the cause of the error is related to the ability of personnel, it should be classified accordingly

(6) For system-related defects, the following assessment needs to be followed to understand whether the error is caused by one or more of the following factors:

Missing or inadequate processes (are the instructions in the procedure completely clear?)

Is the training adequate (Is the training adequate?)

Lack of experience (Is the person involved experienced?)

Communication Gaps (Is Oversight Adequate?)

Deliberate mistakes (are there any signs of unwisdom?)

Timely provision of required resources (is the infrastructure available to support the mission adequate?)

Stress conditions (physical and/or psychological) (Will fatigue play a role in this failure?)