Every pharmaceutical / bulk drug / chemical substances facility that is involved with production, manufacturing and Quality Control employs many instruments / Equipment as part of different processes.
During the process of Production, manufacturing or analysis, there is a chance of many errors and Deviations. Finding the root cause of error is moderate to difficult based on the type of error.
Generally, Errors happen from many sources like …
- Environment and
many other critical and non-critical factors..
Equipment and instruments are susceptible to break down due to many reasons. Errors happening by them are easily traceable as well as, can be prevented / reduced very well by periodic maintenance and monitoring.
But, of all these the first source of error is Human and very difficult to manage in so many cases. Every Company wrestles with Human Error.
To err is Human, No one is perfect. But the important question is … How many
Of course, errors can happen from Machine, Method and Material also but Upon investigation of many incidents and even independent surveys, it is identified that majority of root causes are Human Errors.
These errors give rise to many incidents, OOS and OOT and very difficult to justify by proper CAPA.
How Do Industry and Regulatory Expectations and Approaches Differ?
Existing regulation supports that industry regulators expect only a small quantity of deviations to result from human error. From Chapter 1 of the European GMPs:
1.4 (xiv): …Where human error is suspected or identified as the cause, this should
be justified, having taken care to ensure that process, procedural or system-based
errors or problems have not been overlooked, if present…
Our regulators see human error as a last resort. Their expectation is that you can - and have - eliminated any possible process issues and confirmed that the individual had everything they needed and simply wasn’t focused.
Industry sees human error as a first-line response. We almost assume our processes, procedures and training are bulletproof, and 'the issuemust have resulted from someone not paying appropriate attention to what they were doing at the time'. When we do look at our training, procedures or process, we often verify that they make sense tous – the reviewer. And then we retrain the operator on the same process or procedure, using the same training process – quickly! – so they can return to performing the task again.
There are a number of Root Cause Analysis (RCA) tools and techniques that can be used such as Brainstorming; Fishbone Diagrams; 5 Whys and Fault Tree Analysis.
Simpruv can help in Error Management and CAPA Addressal by understanding of the type of error and systematic investigation into
- identification of source
- Review process flow and information flow
- Zeroing on Reasons and causes by
- Team-based approach and
- Science-based approach
- Defining the process / next steps to prevent errors
- Identifying Necessary Training requirements
- Executing the Training programmes and empower personnel
- Resource improvements
- Plan your processes to minimize and control these risks
- Proper Documentation
The above is a very comprehensive list and the process may employ dynamic approach based on the respective situation. And the approach can provide further insight into many. (for example, from QMS, Deviations and Complaints Management System, CAPA).