Human error is a natural part of operations, but its presence should not be taken as an excuse for avoiding a more rigorous root cause analysis. This article will discuss the importance of avoiding human error as a convenient shield when it comes to determining the root cause of an issue, and the potential consequences of doing so.
When human mistake is suggested more regularly than it is expected to occur, it gives inference to reviewers that problems aren’t being reviewed for Root Cause Analysis, organization isn’t allotting required time and resources (this is just an example or case study).
Do your organization using Human Error as a convenient shield to avoid in-depth investigation and find out Root Cause Analysis?
In this present situation, it is useful to equip our-self with a Human Error model for analyzing what might appear to be human errors in order to determine whether those actions were intentional or incidental. Thus error can classified as 1) Intentional 2) Incidental.
Thus Human Error Model, errors that are shown to be “Intentional” can be considered genuinely “human,” which then classified into one of three categories: 1) Skill-based, 2) Rule-based, and 3) Knowledge-based mistakes.
Skill-based: Those that are skill-based can be either a slip or a lapse. Both of these points to the same root cause: a lack of attention, it’s important to note that these types of errors should not be happening frequently.
Knowledge-based Errors
These types of errors occur when someone was multitasking beyond his/her individual Capacity, most important reasons for Knowledge base errors might be due to
- Multi-Tasking of the Analyst/chemist, this is performing more than one task simultaneously?
- Improper distribution of work by supervisor, which leads to multi-tasking by individuals beyond their limit
- Frequent occurring of these errors indicate that the department under-resourced by Human capital.
Rule-based Errors
These errors are more technical in nature, such as someone applying an incorrect rounding rule which ultimately generates an out-of-specification (OOS) result. In this situation, question why the person wasn’t adequately prepared to perform the task correctly.
- Did the analyst/chemist receive sufficient training before performing the activity?
- Did practice actually reflect the operations they were performing on the floor
- Does the procedure specify the details to the degree they need to be explained in order to be performed correctly?
If in rule based error is found to be prime reason for CAPA: then we have take a deeper look at your written documents such as SOP’s, STP and truly investigate them by asking the following questions:
Are change processes long and difficult to understand and execute?
Are lab personnel using out-of-date or obsolete SOPs and STPs?
Are your updated SOPs, STPs are easily accessible? Can lab staff easily reach to them and understand the written procedure and execute them?