Government requirements from the Food and Drug Administration to regulators such as the International Organization of Standards (i.e., ISO 9001) mandate that companies execute and thoroughly document employee training. These requirements ensure that employees know how to do their jobs in a way which will meet industry guidelines. The documentation provides a paper trail that can be audited to find gaps in the training. The system will minimize the risk of noncompliance with quality and safety standards.
Here's where the gap between automated computer-based documentation and paper based systems documentation becomes glaringly apparent. Post hoc explanations are of little value when an important gap in training leads to a mishap. The system auditor will look at the record. Auditors will need documented proof of compliance with training standards. Paper documents are hard to trace and collect and for the auditor "if it isn't documented, it didn't happen."
Companies need documented proof of a planned and systematic training process to obtain standards certifications whether they are GMP or ISO based. Tracking and documenting each step of training is a legal requirement for regulated companies. When the company makes something that is ingested or injected the FDA legally mandates documented proof that each employee in the process completed required and mandated training.
What the training supervisor has to do, in addition to supervising the work of trainers, is to
- understand what training is required by guidelines in the mandate;
- have a way of documenting what training elements have been completed by each employee;
- be able to compare requirements with what is actually completed to identify gaps;
- make sure every employee has completed all required training and eliminate any gaps.
You can imagine the nightmare in a large company where records are kept only on paper. The training supervisor spends many unproductive hours accumulating the records for each employee, dealing with handwriting problems and lost records and trying to evaluate where each employee stands within each training unit. Once a paper record is misplaced or poorly sorted, the entire practice can be at risk.
The volume of tasks is mind-boggling based on corporate requirements for orienting employees, training them in safety practices, environmental quality management, best manufacturing practices, job-specific, and machine specific requirements. Moreover, most of the time the entire training regimen has to be repeated every year to maintain certification. It would take an army of training supervisors to handle that.
It's hard to imagine the life of a training supervisor in a paper based system. Each employee has to be informed about the course of training required of them. The process of informing employees must itself be documented for each employee in the facility. In each case two-way communication is required as he training supervisor has to pass communication to the employees and then has to receive notice that each task has been completed. The form of each communication also has to be documented.
The training supervisor's problems are further complicated by issues of problem ownership and accountability when tracking training. Problems arise when the responsibility for tracking training is assigned to a training coordinator. The organization implies that it is the coordinator's problem, not the company's problem and certainly not the employee's problem. Coordination decrement and communication failure can cause much disruption in this complex social system. For an unsympathetic auditor, this usually means big gaps in the record.
To make the matter more complicated, the records themselves, once collected, being highly sensitive, get stored away in a secure location not directly accessible to anyone. For employees to check their own training status they may have to visit a different location and secure "viewing rights" from the company. These requirements may prevent employees from seeking the training they need, and create training gaps that needn't exist.
ZenQMS can alleviate this problem for most organizations in less than 30 days and for a price that offers an immediate return on your investment (ROI). To learn more contact us for a demonstration or dowload our latest eye opening pdf below.