Accurate and appropriate personnel training in our highly regulated Life Sciences industry is the bedrock component to successfully producing quality pharmaceutical/ medical products. Whether they are drugs, vaccines, supplements, regenerative tissues or medical devices, there is a requirement that needs to be met for their manufacture to be in compliance with federal regulations. This also extends out to their marketing and distribution.
For medical products, if personnel are not educated and trained in current Good Manufacturing Practice (cGMP), then the products are not licensable and indeed these products would be considered adulterated, so appropriate training ,to provide a reliable skill level is paramount in the whole process of commercializing medical products.
From benchmarking studies and the analysis of FDA 483s & Warning Letters, it is apparent that a major weakness in our industry’s ability to consistently produce products without issues is associated with human errors. This is unacceptable and sabotages or ability to produce products efficiently using a competitive Lean process.
Ultimately “we” as an industry, must develop a sustainable approach to guarantee that this does not derail attempts to meet the consumers desires of competitively priced products, as well as federal needs for appropriate standards of manufacturing quality. If we review some benchmarking data to look at answers for this apparent deficiency, we see some interesting trends which might help to explain things.
It’s a fact that much of our training is still either paper based, or general digitally, represented as SOP training. There is very little video content being used across our industry and here in is one of the potential issues.
On average companies train their operators for 18days, but 70% train for less than a week!
In terms of continuous training, companies tend to spend 3.5 hrs. /month and mechanisms to measure effectiveness vary from productivity improvements to improvements in compliance. A more complete listing is as follows:
1.Productivity
2.Quality Improvement
3.Safety
4.Time to competency
5. Compliance
6.Exam results
7. Time spent Shadowing
8. Other
Many companies struggle to deal with the inevitable issue that it takes someone out of their job function to train others.
For example; areas of difficulty include:
1. 54% of companies struggle with scheduling
2. 44% have an issue determining effectiveness
3. 42% feel retention of information is a problem.
4. 41% believe that negativity disrupts operations.
5. 32% feel keeping training content current is an issue
6. 31% believe developing an effective curriculum is frequently rate limiting
7. 24% explain availability and consistency of training is an issue.
Monitoring and tracking training is also a problem, which affects reliability of technical operations. Contributing to this, mechanisms to track also vary and are as diverse as electronic systems (including excel spreadsheets and Track wise), to paper records and even white boards.
Benchmarking data shows that in general 10% of the workforce will learn effectively in classroom situations, with another 20% learning by copying the habits of fully trained colleagues. This leaves 70% that struggle to learn effectively, and this is why we see so many deviations occurring due to human error situations.
Much of this is due to the fact that procedures are very difficult to produce, are poorly written leading to misinterpretation , are difficult to maintain and often are not accessible on the shop floor of laboratory.
So, the challenge is there to find a way.
When it comes to shadowing, we discover there are similar issues with scheduling people, there’s inconsistency between trainers and due to variability amongst the aptitude of personnel, that means knowledge retention will vary considerably and lead to inconsistencies in performance.
To overcome this, we at SMART favor visual approaches to learning which can include pictures and /or videos. We all know that a picture is worth a thousand words, well a video is better than a thousand pages of instructions and retention is 100% better.
Using these techniques, it’s a good idea to create a continuous log of improvements as a video log so anyone can replay the process to see progression
of instructions and why they were changed.
This kind of approach is micro learning and can be group or individual on a repeat basis. Using the same materials means standardization is much higher and access is always available for those requiring reinforcement training to make it stick.
Creating operator profiles in tablets allows a time stamped training history to be developed that a supervisor can check periodically to assure staff are
appropriately current.
Using this type of approach, untrained people can be coded out preventing problems and deviations through staff not being appropriately versioned. This reduces deviations compliance issues and increases the operational compliance of the group.
This is a better way to mange skills and provides opportunities to standardize the level a type of problems. Using a digital log book for training provides a better mechanism to troubleshoot issues and these results can be uploaded into a master training matrix.
In terms of effectiveness, mechanisms like this benefit the supervisor to be able to have an instant snapshot in time of where an individual training is.
In summary then, any move to use electronic training aids that have an upload capability to a master management system will benefit employee skills retention and this will result in a reduction in human error deviations, leading to an enhanced level of quality compliance.
