The cornerstone of any regulated industry is a quality management system (QMS). While creating procedures and policies is excellent, they cannot be implemented and thus effective without adequate training. Stakeholders must be trained with the knowledge necessary to execute the procedures, and there must be suitable training records to verify this.
Competence training is essential to help ensure employees produce a high standard of work and thus help produce a safe and effective product. While regulations and industry standards do not specify training requirements for particular roles, they state that personnel competence should be established through necessary means. Competence on specific procedures and policies does not occur without knowledge retention –which good training helps ensure. Having personnel effectively trained will help ensure that fewer human-error mistakes arise and can help mitigate issues before they even happen.
Training personnel on processes they are required to utilize is common practice in the industry. In large companies where employees only need to be trained on their area of expertise and the best practices accompanying it, this can save a tremendous amount of time. For instance, someone working on process validation does not necessarily need to be trained in supplier management. By tailoring the processes personnel are trained on to their function, the overall comprehension of the specific processes will increase.
Insufficient training practices can result in a less safe and effective product being released on the market. Failure to train on a procedure may also result in a regulatory body determination of inadequate training procedures and/or records and possible enforcement action. While there should be protections to mitigate this happening, any unnecessary risk, such as insufficient training, increases the likelihood of it occurring.
Since procedures and policies evolve and are revised, training and change management must be connected. While the majority of changes will affect the training, there may be instances where a procedural update is minor enough, it does not affect the training. The effect a procedural change has on the training of the procedure should be evaluated on a case-by-case basis.
As important as the physical training is, so is the training documentation. In the eyes of notified bodies, if the training is not documented within the QMS, it did not happen.
Training is a vital step to help ensure a safe and effective product is produced. By standardizing the work, reducing the amount of rework required, and creating repeatable processes, training can help build a quality foundation. This foundation can help produce reliable products and implement a culture of quality in the company. For help with training management or implementation of a QMS, the experts at EMMA International are here to assist. For more information, contact EMMA International by phone at 248-987-4497 or by email at info@emmainternational.com.
