Karin Ashkenazi has more than 15 years of experience in the life sciences industry, including experience as a quality leader for clinical laboratories. Prior to joining ZenQMS last year to lead the Quality team, Karin worked in a laboratory with a paper-based quality management system (QMS). They were a small organization with a limited budget and so they initially felt that a paper-based system was their only option.
GMP Training - Are You Watching it as Closely as the FDA Requires?
Reasons for a Heightened Focus on Training and Quality Control
Training programs are under the FDA’s microscope because insufficient employee training has been identified as a root cause of defects. Additionally, the changing composition of the manufacturing workforce has resulted in an overall lower level of experience among production employees. As layoffs continue to occur and seasoned employees approach retirement age, the following changes have resulted:
- A loss of experienced employees
- A growing percentage of contract workers
- An influx of new hires with little work experience
It is not easy for companies to compensate for this loss of manufacturing expertise, especially as companies feel pressured to reduce spending across the board. Bolstering training and educationprograms therefore becomes a necessity for companies seeking to maintain quality production.
How to Strengthen Your Company’s Training and Educational Initiatives
With the FDA’s increased focus on employee training, it is imperative that companies devote attention to improving their employee
Variety in Data
The more data you include in a training program, the more information your management team has to track in Excel. Once a program gets more than two parameters, additional data becomes increasingly difficult for a manual spreadsheet to manage.
Even if the number of variables is only of two types, as the numbers of those increase, the information becomes unwieldy and difficult to manage. A small organization training 5 staff on a limited number of SOPs (200) will still have over 1000 entries to manage. Manual data management becomes difficult to do, and even with limited functionality in Excel, a robust training and data management system will overwhelm any spreadsheet used.
Topics: Manual QMS
Pharmaceutical firms are burdened with more and more regulations to remain in compliance. Today, management teams and compliance departments have an amazing amount of SOPs that they must keep track of and monitor. In fact, for the average firm the training matrix significantly exceeds 100,000 combinations. With such an enormous volume of data, no single individual can keep track of all of it. For that reason, more companies are implementing cloud-based Quality Management Systems with an eye for improving the training matrix.
Over the last few decades, companies have been using excel sheets or crude list applications to monitor their SOP compliance. However, a few problems began to emerge with this method. Firstly, unrelenting regulations by the FDA and guidelines by industry associations have exploded the number of SOPs. At the same time, industry consolidation has led to companies getting bigger. The average pharmaceutical firm is actually 150 people now and the average number of SOPs is 1,250. Multiply those together and you get 187,500 cells in your training matrix.
Excel simply is not made for this many matrix combinations.It becomes slow and unwieldy. Data sometimes does not
Trouble with your Training Matrix?
Most companies face trouble with their training matrix because employees are unable to track the individual SOPs they need to follow, management is unable to interactively train employees, and the entire system tends to get lost in the mix. This is often caused because Excel or limited database-managed systems have over 100,000 entries. These entries are difficult to search and track and cost users time and energy just to guarantee that they have fulfilled training
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According to the Journal of Pharmacy, the average pharmaceutical company has 1250 Standard Operating Procedures (SOPs) and over 150 employees. This makes a typical Excel training matrix responsible for at least 187,500 combinations of training (1250 x 150). These combinations do not account for tracking revisions of SOPs, managing relationships between different offices, or integrating research and development with SOP updates.
Maintaining a non-validated Training matrix at even a fraction of that size is a prime area to fail an audit or fall out of compliance. Good Quality Management Systems (QMS) reduce the time
The true costs of paper based Quality Management Systems are shocking. Investing 6 figures and 12 months to fix that problem can be shocking too. ZenQMS can solve your run-away costs faster than you realize and with an Instant Return on Investment. Take a look at this infographic which outlines many of the costs of a paper based Quality Management System