Suleman S. khoja 1 , Sohil S. khoja 1,
Farhad S. Khoja 2,Shamim Khoja2,Narmin Pirani2

1)Resource person in pharmaceutical quality assurance and Audit Compliance,VAPI 2) Registered Pharmacist , Gujarat
Suleman salim khoja

Human Error is commonly defined as “a failure of a planned action to achieve a desired outcome”. GMPs clearly state in CFR 211.22 that “[the quality control unit has]…the authority to review Production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.” Let’s analyze this statement. If the FDA expects that errors be fully investigated, it is safe to assume that the term error is NOT a root cause. That’s why it needs to be fully investigated, hence determine the root cause of the human error.  In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations. review article accurately how to accurately identify human errors, determine when a deviation or nonconformance requires CAPA, and get started using human performance improvement tools and processes in your organization.


PharmaTutor (ISSN: 2347 - 7881)

Volume 5, Issue 2

Received On: 21/09/2016; Accepted On: 17/10/2016; Published On: 01/02/2017

How to cite this article: Khoja SS, Khoja S, Khoja FS, Khoja S, Pirani N; Impact and management tool for identification and reduction of human Errors in pharmaceuticals Industry; PharmaTutor; 2017; 5(2); 7-13

Human Error is commonly defined as “a failure of a planned action to achieve a desired outcome”. According to Irish Medicines boards “Human errors is frequently cited as primary cause of quality defect issues that have led to batch recalls.” Its report suggest that nearly 25% of all quality defects-such as deviations, laboratory errors, complaints and inspection issues – are attributed to human error

Which includes 
-Failing to follow procedures correctly
-Using technical dossiers to support batch releases that do not correctly reflect the contents of    the marketing authorisation
-Poor line clearance, resulting in rogues being left on a processing line
-Failing to implement variations following their approval by the competent authority 
90% of recalls relating to packaging and labelling are attributed to human error and that quality defects are often attributed to human error without scientific evidence. Human behaviour is complex and just like equipment, product, and process it needs to be Analyzed in depth

Types of  Human Error 
A) Stressor Error- Stressor RIFs (pressure causing a feeling of stress)
B) Structural Error - Structural RIFs (inherent weakness in activity) RIFs can be grouped into ‘families’ of issues that might affect the risk of human error, e.g. process, information, resource, competence, organisation and stressors (PIRCOS). 

Stressor Error - RIFs increase the probability of human error. They are often temporary but may re-occur, i.e. if they are caused by fatigue or very tight work deadlines. Therefore, they are subjective as they depend on the person within the team making an error. They also; however, expose structural vulnerability, which will need further investigation. 

Structural Error - RIFs are relatively persistent in nature but are often not immediately obvious, unless triggered by stressors. Structural RIFs occur across a company and can be caused in any one of a number of areas: for example, processes where several concurrent activities are competing for attention; information giving (poor layout of batch manufacturing record); resource characteristics such as environmental conditions causing distraction; and organisational planning, including when shift arrangements undermine vigilance.

Reducing Human Error by LEADERSHIP & TEAMWORK
To ensure a true understanding of human error and its contributor factors, a strategic approach should be taken. It is extremely important to create awareness and understanding of risks in an organisation by analysing its processes and understanding human error risks. To do this, Study Approach QRM (quality risk management) approach is recommended, which includes risk assessment, risk control, risk review and risk communication. It must also include routine tracking, evaluation and analysis of human error metrics.(Details and Tracking with Effective Evaluation )

Proactive Approach 
Proactively assess potential risks, situations occur where retrospective analysis is necessary. There are a number of key activities that should be undertaken in each situation. For retrospective risk identification, you will need to identify how and where in the process human error is likely to occur through the use of a scientific approach:  -Review process flow and information flow
-Identify the RIFs;
-Identify the issues with which RIFs are commonly associated (PIRCOS);
-Plan your processes to minimise and control these risks.
- For retrospective analysis, you will need to capture the event in real time, taking note of environmental and other factors that may be relevant to a thorough evaluation of the issue.

You will also need to consider the level of the RIF effect: 
Individual – affects a single individual;
Local – within a limited physical area, relevant to specific activity, affects a finite number of people;
Generic – this could be common, where the risks are shared across numerous instances of a common problem (e.g. misreading a table in a document used widely in the company); or independent, where there are several risks in different parts of an organisation (e.g. misreading a typeface used in numerous documents only used locally). Then you should analyse whether your con-compliances associated with human error can provide further insight (e.g. from QMS, deviations and CAPA complaints management system software). There are number of root-cause analysis (RCA) tools and techniques that can be used, such as Brainstorming sessions, fishbone diagrams, ‘five whys’ and fault-tree analysis

Blame Approach –Not Useful and Must Avoided 
Despite the industry’s awareness of human errors, companies still frequently fail to substantively and correctly address errors. The typical response to a human error is retraining but this often fails to produce the desired result. Training (or lack thereof) is responsible for only about ten percent of the human errors that occur, since it basically takes care of issues related to lack of knowledge, skill, or ability. If the error was not due to one of these then training is practically useless. Also, many companies are still taking the “blame” approach to human error, which appeals to the individual’s sense of fear. The blame perspective only leads to less trust from people to bring up issues that can lead to failures, which in turn results in management being less aware of system weaknesses that eventually result in more mistakes. A systemic view (for human error), instead, assumes that some degree of error is inevitable and puts systems in place to detect, prevent, and correct it.

How Can we Improve – Area to evaluate Human Errors 
-Management System: documentation control, investigation management, risk management and project management are important to set the bases for the rest of the operation.
-Procedures: these need to be accurate, human-engineered, available and enforceable. 
-Human factors : Work areas need to be designed with human factors and human capabilities in mind. Excessive monitoring, mental calculations, housekeeping, and work layout, among others, become the main reasons for error in this category. 
-Training: training needs to include the whys as well as the whats and hows. Also, on the job training and qualification (OJT) is necessary, especially for critical tasks and activities.  -Immediate supervision: pre-job briefs, walkthroughs, presence and instructions to workers are necessary. We need to have supervisors on the floor, not in the office. 
-Communication: between groups, shifts, radio communication rules and training. Employees should know what needs to be achieved daily and the proper way to do it. 
-Individual Performance: need to evaluate conditions that could potentially create cognitive overload that creates attention and memory failures. Some of these conditions include available time for the job,fittness for duty or fatigue management, and complexity and task



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