New ORA QMS MOU

NTEU and the Department of Health and Human Services (HHS) have executed an agreement over the FDA Office of Regulatory Affairs (ORA) Quality Management System (QMS). This Memorandum of Understanding (MOU) concludes a long litigation and bargaining history dating back to 2010, when NTEU filed a grievance against the agency for violating the terms of a prior QMS MOU. Ultimately, the parties agreed to reopen and negotiate a new QMS MOU.

The QMS is a system the agency uses to address work processes and systemic issues that could compromise quality of service. QMS essentially sets forth quality policies and objectives to improve agency programs, work products, and services. This MOU reflects ORA’s intent to create a work environment for employees that actively encourages them to identify opportunities to improve QMS without fear of retaliation.

Per the MOU, the QMS system will not be used to evaluate employee performance and employees will not be evaluated based on the results of QMS audits. Where the agency plans to make changes to QMS procedures, it will provide informational notice to employees prior to implementing the change, as well as appropriate training. When the agency conducts management reviews, it will provide the impacted NTEU chapters with a courtesy notice in advance. The MOU also requires the agency to encourage and empower employees to identify opportunities to improve agency work processes and ensures that employees who provide such feedback will not be subject to retaliation by the agency.

I thank the members of the bargaining team – fellow Chapter Presidents Sam Collins (Chapter 210), Mike Roberts (Chapter 212), Cheryl Monroe (Chapter 230), and Joe Teixeira (Chapter 288) – for their hard work and persistence in negotiating this matter. We could not have negotiated such a strong agreement without their valuable insight and perspective on QMS.

I welcome and encourage your questions or comments regarding this MOU.