Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Matthew M. Lowe
Don’t wait until something bad happens to make a change
Kari Miller
A lack of integration hampers quality compliance across a product’s life cycle
Etienne Nichols
A well-defined CAPA program is a framework for quality and effectiveness
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Etienne Nichols
What’s the difference?

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News


FDA Compliance

FDA Inspectional Observations Increase Focus on Qualifications, Personnel Training

Appropriate training will bring considerable business value to your organization.

Published: Friday, May 7, 2010 - 16:18

In recent years, there have been published reports of an increase in Food and Drug Administration (FDA) inspectional observations associated with training deficiencies. Specifically, these inspectional observations have focused on training related to the quality system requirement that manufacturers "shall" have personnel with the necessary background, education, experience, and training to assure that all required activities are correctly performed in accordance with the governing requirements.

This is actually not a new issue, but rather one to which the FDA is paying closer attention. The FDA has long maintained that a key aspect of a compliant quality system is management’s responsibility to provide adequate resources—including the assignment of trained personnel—for management, performance of work, and assessment activities, including quality audits to meet the requirements of the quality system regulation.

However, in many organizations today, management often considers training as merely a task that needs to be performed and checked off as completed instead of a process that has strategic value and should be regarded as a critical success factor for achieving business, quality, and compliance objectives. In other words, management often considers training as something they have to conduct in order to satisfy the FDA instead of recognizing that training will also bring considerable business value to their organization.

Another 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?


About The Author

Oriel STAT A MATRIX’s picture


Since 1968, Oriel STAT A MATRIX has delivered billions of dollars of increased profitability by helping organizations drive revenue and reduce costs. Oriel STAT A MATRIX is a global leader in consulting and training related to performance improvement and regulatory compliance. It has helped hundreds of companies throughout the world effectively develop the potential from within their organizations to successfully integrate and deploy performance improvement principles and practices, and to meet organizational, regulatory, and strategic goals.