ZenQMS Blog

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

At what point does an Excel spreadsheet management system begin to fail for your training program? 

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.

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

An increasingly critical part of GMP training is to ensure that every company employee has received sufficient education and training regarding key processes in the manufacturing of a product. Companies must also provide detailed documentation regarding the scope of training programs and dates of completion for training modules. Failure to provide detailed evidence of employee training programs may result in warning letters or sanctions by the FDA.  

The FDA's Increased Focus on Training Programs

In recent years, the FDA has devoted increased attention to the review of training records and quality control procedures. With manufacturing problems frequently being linked to improperly trained personnel, the FDA has identified training as an area that requires sustained focus. Training programs have become increasingly important over the past decade as companies lose seasoned employees due to retirement or layoffs. When a company is staffed primarily by contract workers and new hires, effective training becomes critical because a smaller percentage of employees have a long working historywith pharmaceutical products. Companies that have reduced their training budgets or plan to do so in the near future should proceed with caution. 

Measures to Improve Your Company’s Employee Training Program  

In the world of FDA investigations, a verbal acknowledgement of the existence of an employee training program is not sufficient. FDA

Pharmaceutical firms cannot have any errors in the manufacturing process.  One process or supply error can contaminate an entire production cycle. At the same time, the government has strict standards on the manufacturing process that must be followed.  Violating these can result in fines or production halts. To avoid these issues, companies create Good Manufacturing Practices (GMP) and put in place stringent training. GMP training is important to the FDA and helps the company achieve a high level of performance and quality.

In fact, companies must be aware of stepped up actions by the FDA to protect consumers. The FDA questions the training and production of chemical products by employees at every step in the process. For example, the FDA recently warned a cosmetics company because a single chemist in its R&D facility did not have the necessary training on microbial limits to prevent critical errors. The FDA continues to issue more

Trouble with your Training Matrix?

Pharmaceutical companies use large training matrices to track employee's proficiency on SOPs, manufacturing processes, quality controls, and product reviews. When these training matrices are out of order, inefficient for employees, and do not deliver the right information to management, they cause multiple problems.

These seven problems are symptoms that your company's system needs to be updated and upgraded in order to maintain high quality product delivery. How many of these signs is your organization suffering from?

Trouble with a training matrix occurs when people enter information regarding SOP training, or in the entry of other information they should have been trained on. Statistically predictable variations in quality information are almost always a result of management systems.

GMP training remains a necessity in the pharmaceutical industry to keep products in line with FDA compliance. However, many employees who have to hear about Good Manufacturing Practices have little enthusiasm for it, especially because it has to occur at least once a year. The reasoning behind this low opinion comes from recent emerging incidents.

About six years ago, concerns developed about how bad GMP training had become in many pharma industries. The FDA even sent out a warning

The Training Matrix: A Simple Tool

Tracking the training of employees has the highest priority in life sciences organizations that are under regulation of the Food and Drug Administration (FDA). The training matrix is simply a table that lists the skills (documented by training) and completion status for each employee or team member. When the number of standard operating procedures (SOPs) for which employees must be trained gets large, the matrix can get very difficult to maintain by hand. Yet, if procedure violations cause product recalls or other sanctions by the FDA, "inadequate training of personnel" is often the specific cause. Lack of training in particular required SOPs is the secondary cause of many costly failure during inspections. 

Trouble with your Training Matrix?

The complexity of the spreadsheet-based training matrix makes it difficult and costly to maintain it by hand. Keeping the training of each employee up to date in each of the relevant SOPs in life-sciences-based production almost begs for errors. It is one of the most important quality control issues.

Every year, the FDA issues "plenty of 483s and warning letters." Many of them center on the failure to have or to properly utilize their SOPs. The responsibility, as far as the FDA is concerned, is to make sure