Determine the Error Type
Last month we started a discussion on the reasons we need a Human Error Investigation Program. Now that we all know we pretty much don’t have a choice, either because of productivity shortcomings or because the regulation requires it (see the last blog) let’s get to work!
Human error investigation starts when we know or suspect that it was a human action or lack of action that caused the quality defect or deviation from the process to occur (non-conformance, failure). Remember Human Error is not a root cause as stated by the GMP’s and these events must be fully investigated (211.22). Let’s start with the first step; understanding the type of error.
Why #1 Causal Factor: Human Error
Step 1: Identify the Type of Error
There are two types of errors (1) errors of omission and (2) errors of commission. Also, there are two different psychological factors associated with them (1) intentional and (2) unintentional actions for a total of 4 types.
- Intentional error of omission
- Unintentional error of omission
- Intentional error of commission
- Unintentional error of commission
ERRORS OF OMISSION: Refers to a lack of action or failure to execute a task. It can be either skipping or forgetting to perform a required step, e.g., did not document a critical parameter or failed to pick up the “end of batch” sample. The action was not performed.
Solution: Add a trigger for the action (alarm) and/or a detection mechanism for critical to quality steps.
ERRORS OF COMMISION: It is when the action deviates from what is expected from the worker. An example would be to rinse a filter for 10 minutes when the instructions require to do it for 15 minutes. The action is performed but not as expected.
Solution: Look for instructions, procedures, tribal knowledge and myths, training design and content or any other factor that can be affecting the correct execution.
UNINTENTIONAL ERRORS: Something that unconsciously happens to us; without realizing it. Memory failures and attention failures are some examples. A worker chose the incorrect grease without realizing it.
Solution: Re-training does not improve memory or attention capacity, so consider engineering controls like the layout, placement, color coding, or labeling.
INTENTIONAL ERRORS: Intentional actions, but there is NO harm intended. It’s related to decision making and the thinking process in which we decide to deviate from the rules because we perceive some benefit from doing it. What we do, we do consciously because we do not know the consequences. People break the rules when the rules don’t make sense to them.
Solution: Make sense of the rules. Train on the why’s, the science, dangers, and risks when rules are not followed. We must address by providing information that will guide the behavior towards the right actions. When the rules make sense, we humans self-regulate.
It’s important to clarify that Intentional Errors need to be differentiated from sabotage. If there is an intention to do harm then it is not an error; it would be an error if the planned event goes wrong, but if it works, there is no error there which is the reason we want to fix the problem and not the blame.
Well, now that you know how to identify the type of error, you have an idea of what to look for when establishing the root cause; this way your CAPA’s will make sense!
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