Michael Taylor: In the spirit of collaboration

02/16/2012 01:20:00 PM
Tom Karst

But, as we move toward globally harmonized safety standards and well-recognized procedures for verifying that those standards are being met, we should be able to reduce the number of food safety audits that are needed.

We at FDA are eager to see how our foreign supplier verification and accredited third-party certification programs can contribute over the long haul toward a global food safety assurance system that is both more effective and more efficient. We think a system like that – a real partnership for prevention – is in the best interest of both consumers and the food industry.

I want to emphasize, of course, that in our vision of the future, we do not see third-party audits – even those conducted under FDA’s program – totally replacing direct regulatory oversight. We are on a pathway to strengthened partnerships and we want to rely on the efforts of others, but appropriate government oversight of importers and foreign facilities will continue to be critical for a number of reasons, including to establish and maintain the credibility of the new certification program.

GFSI Role

As we build our new import system, we want to work closely with GFSI and build on the foundation you have established for effective and credible certification programs. I know that GFSI and its members have a strong commitment to continuous improvement, as clearly reflected in the sixth edition of the GFSI Guidance Document, released in January 2011. The technical working groups you have assembled are tackling many of the most important topics that FDA faces in developing its third-party program.

And some challenging issues lie ahead, especially regarding auditor competence and capacity:

What is the right level of training and experience for an accredited auditor?

How much specialized knowledge do they need to demonstrate competence?

What are the most predictive measures of auditor competence?

How many qualified auditors will eventually be needed, in what disciplines, and in what geographic areas?

What can be done to attract qualified auditors by establishing solid career paths? And who is best situated to drive this discussion?

What is the role of the accredited certification body in assuring the competence of auditors?


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