The Training Matrix: A Simple Tool
In Life Sciences organizations regulated by the Food and Drug Administration (FDA), tracking employee training takes priority. To ensure that all employees remain compliant, companies will use a training matrix to help keep things organized. A 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) on which employees must be trained gets large, the matrix can be difficult to maintain using spreadsheets or paper-based quality management systems (QMS). If procedure violations or incomplete training compliance causes product recalls or other sanctions by the FDA, "inadequate training of personnel" is often the specific cause. Lack of training on required SOPs is the secondary cause of many costly failures during inspections.
The complexity of a manual, spreadsheet-based training matrix can make it difficult and costly to maintain by hand. Keeping employee training records up to date on all relevant SOPs in Life-Sciences-based production almost begs for errors. It is one of the most important quality control issues.
The responsibility of organizations in regulated industries, 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. Failure to have or properly utilize SOPs will result in a warning letter or Form 483.
More than ever, the FDA is focused on the proper usage of all 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 train on each required SOP, but proof of that completed training has to be verified. The sheer volume of SOP changes that have to be checked and validated for each employee practically requires an electronic document management system (EDMS) be used to maintain compliance.
Many pharmaceutical companies still manage their training with paper-based matrix systems or hybrid systems that cost hundreds or even thousands in annual administrative work hours.
Alternatively, there are software solutions that can electronically streamline and automate training in a way that reduces or eliminates errors and provides regular updates to improve compliance.
A 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.
An EDMS also has the capability to administer and grade tests and control the sequence of courses. When one course is satisfactorily completed, the next course in the sequence is automatically launched or scheduled, and progress is automatically reported to an automated training matrix. Managers no longer have to follow employees around to remind them that training is due, assess their completion level, or beg for signatures. The process is completely automated (but subject only to personal spot checks).
An 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.
An EDMS is nearly infinitely scalable so that it can handle large employee contingents across all required SOP modules. Cloud-based systems can be monitored on mobile devices that inform employees and managers as required.