Rejection is Good
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corrective action must take place in order to close it and what preventative action is needed to make sure it stays closed.
Next, food manufacturers must implement the new system,
and identify and correct any errors in it. Errors in a system may
be readily apparent or may require an internal audit. Once errors
have been resolved, it is best to employ an impartial third party to
review the system. This can be achieved through a consultant or
an audit company performing a third party certified audit, or gap
assessment. Food safety systems must be reviewed and re-evalu-ated again when changes are made in the system, to a product or at
least once a year.
If you are a food manufacturer outside the U.S. and its territories,
or you import food and ingredients for food into the U.S., then you
must make sure your importer and manufacturer and your operations comply with U.S. domestic requirements and all additional
Q: What challenges do food companies face when adjust-
ing their processes and food safety controls in order to comply
with new FSMA requirements?
A: The challenges faced by food companies will depend on
the level of their existing food safety controls and their processes.
For a large corporation with GFSI certified facilities, there will be
some adjustments such as adding radiological hazards analysis to
their food safety plans, or it might be finished product testing (this
is still part of the proposed regulation). Other impacts on large
corporations include ensuring supplier compliance with the law
and regulations. Under their GFSI supplier verification program,
they must make sure suppliers comply with the laws and regulations. The FSMA constitutes another level of regulation to verify.
Previously a facility only had to be a USFDA-registered facility,
but under FSMA it must re-register every other year.
For small- and medium-sized firms, the FSMA will require a
certain expenditure of time, effort and money in order to establish
some of the programs that the FDA requires. As mentioned above,
the most difficult task will be to understand what is required. The
second biggest challenge is finding the time and the money to get
this done. It can take between six months and one year — or more
— to do this, so companies need to start soon. If the enterprise
already has a GFSI program, or a third party audit has evaluated
their programs, then they have a basis for identifying the gaps
which need filling. If this is not already in place, the food safety
program and facility need to be evaluated by an independent party.
If they do not already have a food safety system, or if the system
has many gaps, then they will need to develop a food safety system
or dramatically improve their existing system. This can be done by
reviewing a certification audit program’s requirements and implementing a system to meet those specific requirements.
Q: What food safety solutions does SGS offer food
A: SGS is a certification, inspection, auditing and testing
Q: What outside resources are available for food com-
company which provides certified audits such as GSFI certi-
fied audits of facilities and a supplier’s operation and systems.
We have developed the SGS U.S. Food Safety Management
Assessment Program ( www.sgs.com/usfsma), an audit program
specifically designed to assess a facility and its systems against
the FSMA and other laws and regulations of the FDA and USDA.
panies to help ensure they are meeting the latest food safety
A: The FDA offers a host of guidance materials. It has held
meetings to answer questions, made speeches and developed videos, fact sheets and webinars. All materials can be found at the
FDA website http://www.fda.gov/food/guidanceregulation/fsma/
default.htm. Additionally, the FDA has developed alliances with
the Illinois Institute of Technology for Food Safety and Health to
develop training courses and other materials for small- and medium-sized companies ( http://www.iit.edu/ifsh/alliance).
SGS publishes free industry updates, called Safeguards (http://
advise businesses of new legislation and issues, briefly explaining
the legislation or the issue. ◆
Interview by Lindsey Jahn, Associate Editor