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.
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 that all necessary job tasks are performed in a highly consistent and correct manner.
The FDA is focused more today than ever on the importance of having proper use of the issued SOPs. SOP compliance means that any life sciences company must train its employees on all needed job tasks.
The Code of Federal Regulations Title 21 states:
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, experience, or any combination thereof to enable that person to performed the assigned function.
The FDA code sets a very high bar for compliance. There can be thousands of regularly issued SOP changes that affect thousands of employees. Not only does each employee have to pass through the training of each required SOP, but their acquisition of the required learning has to be checked. The sheer volume of SOP changes that have to be checked and validated for each employee virtually requires an electronic document management system (EDMS) be used to maintain compliance.
Many pharmaceutical companies still manage training control with paper-based training matrix systems or hybrid systems that cost hundreds or even thousands of annual administrative work hours. There are software solutions that can electronically streamline and automate training monitoring in a way that reduces or eliminates error and provides regular training updates to improve compliance.
The fully implemented EDMS becomes the core of a company's quality control management system. It can be configured to automate, distribute and monitor completion of SOP training for each employee. The system has the capability to administer and grade tests and control the sequence of courses.
When one course is satisfactorily completed by an employee, the next course in the sequence will be automatically launched or scheduled. Reports on each employees training are automatically reported to an automated training matrix. Managers will not have to follow employees around to remind them that training is due and assessing their completion level. That process is completely automated (but subject only to personal spot checks).
The EDMS also handles the full range of other quality control data management to ensure compliance. In addition to training management, modules include,
- Document management.
- Process control to reduce manual data entry.
- Corrective and prevention action (CAPA) control.
- Supply Management.
- Regulations library.
The EDMS is nearly infinitely scalable so that it can handle large employee contingents over all the required SOP modules. Cloud-based systems can be monitored on mobile devices which inform each employee and each manager as required. To learn more about the costs of your paper based training matrix, click below.