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  1. Human Foods Program

Office of Quality Assessment and Management

Office of Quality Assessment and Management

Ensuring that food is a vehicle for wellness is the vision of the FDA’s Human Foods Program. It is our mission to protect and promote the health and wellness of people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease and ensure chemicals in food are safe. The Office of Quality Assessment and Management (OQAM) supports this mission by assessing and monitoring the efficacy and efficiency of programs within the Human Foods Program.

This office comprises:

  • Quality Management Staff
  • Quality Assessment Staff
Office of Quality Assessment and Management - Org Chart

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 What We Do

  • Lead quality initiatives for the Human Foods Program (HFP) and advises the HFP leadership.
  • Evaluate and make fitness-for-use determinations of food safety systems. Make recommendations to the leadership on maximizing domestic and international regulatory partners’ food safety work to increase public health protection.
  • Assess and monitor efficacy and efficiency of the HFP and recommend improvement options.
  • Lead innovative approaches on leveraging the work of external food safety systems to inform risk prioritization in collaboration with other offices in the HFP.
  • For more information, see the Office’s functional statements.

Quality Management Staff 

  • Establish, implement, and maintain a robust HFP-wide quality management system (QMS) that encompasses the HFP's processes, procedures, and documentation. This includes defining quality standards, guidelines, and templates to ensure consistent practices.
  • Conduct regular internal audits and assessments to evaluate the effectiveness of quality management systems, including planning and executing audits, identifying non-conformities, and making recommendations for corrective actions and improvements.
  • Foster a culture of continuous quality improvement throughout the organization, including collecting and analyzing quality data, identifying improvement opportunities, facilitating process enhancements, and promoting innovation and learning.
  • Monitor and report key quality performance indicators (KPIs) to track the effectiveness of the quality management program, including collecting data, analyzing trends, preparing reports, and communicating the results to HFP leadership.
  • Establish, implement, and maintain a laboratory quality management system (LQMS) to assure data integrity and quality of the operations and human participant protection in the HFP laboratories and applied science areas.
  • Serve as the HFP quality lead to the laboratory International Organization for Standards (ISO) accreditation bodies; lead quality efforts and coordinate laboratory ISO accreditation activities with Office of Chief Scientist.
  • Serve as Application Integrity and Research Integrity Policy coordinators: manage and investigate reported concerns related to the Application Integrity and Research Integrity Policy and reports the findings to the HFP and the FDA leadership.

Quality Assessment Staff

  • Conduct audits of domestic and international regulatory partners to measure their performance against program standards. Audits include reviews of regulatory systems and more specifically the inspection, investigation, sample collection and analysis, enforcement, response, recovery, and/or outreach components of these regulatory systems.
  • Support the development of program standards and associated audit programs that may apply to international and/or State regulatory partners and the HFP.
  • Maintain expertise in the program standards (e.g., Systems Recognition, Equivalence Program, compliance with Food and Drug Administration (FDA) standards, international standards such as Codex, and others).
  • Develop assessment tools, audit reports, and other records for the official administrative file and/or for external stakeholders.
  • Develop processes for analyzing, sorting, leveraging, acceptance for use determinations on external third-party global audits and assessments.
  • Support quality oversight of state food and feed contract inspection activities in coordination with Office of Integrated Food Safety System Partnerships.
  • Perform quality control and auditing as needed, including Internal System Audits.

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