Sunday 31 July 2022

Managing workplace human error


 

Managing Workplace Error Part 1: Unpicking Patterns Of Human Error

 

It is well established that regulators do not like the root causes of deviations to conclude ‘human error’ and for the resultant corrective or preventative action (CAPA) to recommend additional training. Instead, regulators expect organizations to go deeper and to unpick the underlying reasons as to why a person made an error and, from this, error risk reduction actions can be initiated. Probing the cause of human error can be achieved through an interactive process, such as by asking ‘why’ multiple times until the answer emerges (this parallels the 5-whys technique or the repetitive questioning of a recalcitrant child).

 

The paper demonstrated why simply resorting to ‘human error’ as the root cause of an incident is often inaccurate and generally prejudicial; it also hides too much about how a system functions or malfunctions and hence prevents an appropriate preventative actions from being formulated. As an adjunct to this, this article looks more closely at why human error may occur.

 

Sandle, T. (2022) Managing Workplace Error Part 1: Unpicking Patterns Of Human Error, IVT Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-part-1-unpicking-patterns-human-error

 

Managing Workplace Error #2: Getting to the Heart of the Matter Through Human Error Checklists

 

In terms of how human error can be defined, then one potentially useful definition of human errors is as “any member of a set of human actions that exceed some limit of acceptability, i.e., an out-of-tolerance action, where the limits of tolerable performance are defined by the system”. In other words, an outcome that was not intended or desired. At first glance the cause of a human error may seem straightforward, all too often followed by the hasty conclusion that training or retraining can fix the issue. However, ‘human error’ is very rarely the root cause and instead a more detailed and iterative human error root cause analysis investigation will more often reveals a deeper issue at the heart of the matter and allows for an appropriate preventative action to be set.

 

This article looks at a process of defining human error and provides some guidance on constructing a checklist for getting to the root of the error. In following this method, there are very few cases of actual human error; instead, there is typically a fault with a system, procedure, knowledge, or with the environment within which the error occurred.

 

Sandle, T. (2022) Managing Workplace Error #2: Getting to the Heart of the Matter Through Human Error Checklists, IVT Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-2-getting-heart-matter-through-human-error-checklists


 

Managing Workplace Error #3: Dissecting Reasons and Causes of Laboratory Error

 

This article looks at some of the reasons for, and patterns behind, laboratory errors. The article represents a brief look into the subject area, drawing on some of the issues that the author is aware of. Generally, laboratory errors should not be categorized as "human error" since these are not the problem but generally a symptom of a system or facility or operation. By delving deeper into the nature of the event (using techniques to get to the real cause of the problem) more meaningful CAPAs can be developed, CAPAs with a stronger chance of remedying the problems first time. Hence an important focus is to seek a significant reduction of repeat observations. This should lead to improved laboratory efficiency supported by right first-time testing and control.

 

Sandle, T. (2022) Managing Workplace Error #3: Dissecting Reasons and Causes of Laboratory Error, IVT Network, at: https://www.ivtnetwork.com/article/managing-workplace-error-3-dissecting-reasons-and-causes-laboratory-error


 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday 26 July 2022

Penicillin: A primer


 

Antibacterial agents include penicillins, chloramphenicol, aminoglycosides such as gentamicin, macrolides such as erythromycin, tetracyclines and antimetabolites such as sulphamethoxazole-trimethoprim. These agents are used to treat and manage infections caused by pathogenic bacteria. 

 

 

This article provides a primer for penicillin, looking at the sources, mode/mechanisms of action, spectrum of activity, clinical application/usage, and the side effects and/or toxicity.

 

Sandle, T. (2022) Penicillin: A primer, Pharmig News, Issue 88, pp13-16

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday 25 July 2022

USP revises microbiology best practices chapter


 

The USP microbiology committee has undertaken a review and revision of the ‘Microbiology Laboratory Best Practices’ chapter USP <1117>. The new chapter came into effect on 1st August 2022. There are a number of changes within the chapter, for which the biggest update relates to the manufacture and use of culture media. Other sections of importance include the necessity to assess samples for low endotoxin recovery where endotoxin testing is required. This article reviews and discusses the changes, to highlight the changes for the laboratory manager and auditors of microbiology laboratories to evaluate.

 

Sandle, T. (2022) USP revises microbiology best practices chapter, Pharmig News, Issue 88, pp10-13

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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