FDA narrows down on Qualifications and Personnel Training

The key aspect of management responsibility is that, through organizational leadership, management should strive to establish a unity of purpose and direction that will increase the level of knowledge, skills, and abilities throughout the organization and its personnel. This involvement of competent, qualified, and trained personnel at all levels of an organization enables those people’s abilities to effectively translate requirements, including a company’s own policies, into practice.

According to the FDA, “Establishing a quality system should be an integrated and universal effort. A total quality system approach should be designed to satisfy the particular quality, safety, and performance needs of a specific manufacturer, process, and user-market."

Organizational personnel obviously play an important role in achieving business, quality, and compliance success. Bearing this in mind, consider the following questions as they apply to your organization:


• Has a training strategy that aligns with your specific business needs been developed and executed?

• Are training objectives aligned with key performance indicators and business metrics?

• Have the scope, approach, and process for qualifying and training personnel been established?

• Have the roles, responsibilities, authorities, and accountability of those involved with training and assessing personnel been clearly defined?

• When, where, and how is the effectiveness of the training process verified? Who verifies the effectiveness and what criteria do they use? [/b]