Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
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
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News


FDA Compliance

ACLASS’s Greenaway Speaks on Food Safety Modernization Act

FDA should embrace a model of international consensus, he says

Published: Tuesday, June 14, 2011 - 06:00

Keith Greenaway, vice president of ACLASS, a brand of ANSI-ASQ National Accreditation Board that provides accreditation, gave a brief talk titled “Focus on Inspections and Compliance” at the FDA Food Safety Modernization Act public meeting held on June 6, 2011. His prepared remarks follow:

The ANSI-ASQ National Accreditation Board is a nonprofit, nongovernmental organization that provides accreditation services to public- and private-sector organizations in the areas of management systems, laboratories, inspection, reference material producers, proficiency test providers, product certification, and personnel certification. It is jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ).

The ANSI-ASQ National Accreditation Board operates predominately in the realm of international standards from the International Organization for Standardization (ISO), which are developed based on consensus, and then adopted globally and subsequently adopted as American National Standards. Two organizations provide oversight and a recognition infrastructure for accreditation bodies operating inside this global infrastructure. The International Laboratory Accreditation Cooperation (ILAC) was established to oversee laboratory and inspection body accreditation, and the International Accreditation Forum (IAF) was established to oversee management systems and product and personnel certification. Recognized accreditation bodies then accredit conformity assessment bodies (that is, inspection agencies, laboratories, certification bodies, and product certifiers) to specific international standards, which then audit and/or test for competence.

Figure 1: Oversight and a recognition infrastructure for accreditation bodies

This generic third-party conformity assessment model (see figure 2) illustrates the conformity assessment activities that are offered competently and credibly by ILAC and IAF member bodies. The ANSI-ASQ National Accreditation Board developed the model in conjunction with the National Institute of Justice and the National Institute of Standards and Technology (NIST) to support a new private-public sector partnership for accredited third-party conformity assessment activities with oversight.

Figure 2: Generic third-party assessment model


U.S. regulators that embrace accredited third-party conformity assessment:

• Consumer Product Safety Commission
• Department of Defense
• Department of Energy
• Department of Justice
• Department of Homeland Security
• Environmental Protection Agency
• Federal Aviation Administration
• Federal Communications Commission
• National Institute of Standards and Technology (NIST)
• Nuclear Regulatory Commission


The FDA must embrace a model based on international consensus standards that has already proven to work across international borders and within multiple industries through the existing recognition infrastructure of ILAC and IAF. In today’s political environment, uncertainty remains whether funding will even be available for the mandated inspectors under the Food Safety Modernization Act. Given this uncertainty, it is imperative that the FDA work together with the private sector under the existing international infrastructure and rely on accredited private-sector conformity assessment bodies to work in coordination with appropriate government inspectors to help fulfill the mission of the FDA under the Food Safety Modernization Act. The food industry is already operating under a realm of uncertainty as they prepare for both private-sector food safety certification programs and government inspections. This is unnecessary duplication, which increases costs to the consumer and wastes taxpayer money.

The infrastructure that’s used globally and by many U.S. regulators will support the FDA’s role in protecting our nation’s food supply under the Food Safety Modernization Act, and it will do so without adding unnecessary duplication for private industry and without wasting taxpayer dollars.

To have a truly effective food safety system in the United States, we must have a level of oversight that works in partnership and supports the role of the FDA to provide confidence in the entire life cycle of the product. The best way to achieve this type of system is through accredited third-party conformity assessment services with oversight, through which an independent party verifies and provides written assurance of conformance to internationally recognized standards.


About The Author

ACLASS’s picture


ACLASS is one of two brands (ANAB is the other brand) of the ANSI-ASQ National Accreditation Board, a nonprofit, nongovernmental organization that provides accreditation services to public- and private-sector organizations and is jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ). ACLASS provides accreditation to ISO/IEC 17025 for testing and calibration laboratories, ISO/IEC 17020 for inspection bodies, ISO Guide 34 for reference material producers, and ISO/IEC 17043 for proficiency testing providers. ACLASS also provides ISO 17025 training and training on other topics. ACLASS is internationally recognized by ILAC, APLAC, and IAAC as a signatory of multilateral recognition arrangements that facilitate acceptance of test and calibration data internationally.