The Food Safety Modernization Act (FSMA), which was signed into law in January 2011, places the responsibility for food
safety squarely on food producers, with requirements that will come into force as all portions of
the Act are finalized and implemented.
FSMA also gives the FDA expanded authority in requiring recalls, which the agency has
already used on numerous occasions.
In short, FSMA represents a major shift in the
regulatory landscape and a major influence on
how food manufacturers and processors manage their operations.
One of the critical assets that most food companies use to comply with FSMA requirements
is a systematic, machine-based inspection of
products and packages to detect and reject contaminated or otherwise non-compliant products
or packaging, while at the same time maintaining
accurate, complete records of those actions —
an essential feature, since those records will
have to be produced if the FDA comes inspecting.
For years, food manufacturing and packaging
companies have thought of the Hazard Analysis
and Critical Control Points (HACCP) approach to
food safety developed in the 1960s as the gold
standard of food safety assurance. But the FDA’s
2013 Proposed Rule for Preventive Controls
for Human Food as required by FSMA takes
a broader approach to food safety. It requires
preventive controls be based on careful hazard
analysis, but describes those controls as being
“similar” to the HACCP system, and including
controls that may be required at points other
than the traditional Critical Control Points.
This broader approach to food safety assurance reflects the FDA’s revised position. It states
that, while the proposed preventive controls are
science- and risk-based, and require controls
where necessary to prevent hazards to public
health, they also need to be flexible to allow firms
to develop preventive controls that fit their specific products and operations. This works as long
as they are adequate to significantly minimize or
prevent all food safety hazards that may occur.
Preventive controls are intended to ensure
that hazards which are “reasonably likely to
occur” will be significantly minimized or pre-
vented. As a result, affected companies are
advised to look beyond HACCP solutions when
establishing food safety assurance programs and
to establish in-house teams dedicated to estab-
lishing a complete program of hazard prevention
controls. This written plan will contain a detailed
documentation of identified potential hazards,
The written docu-
mentation will detail
what potential hazards
have been identified,
what preventive con-
trols have been imple-
mented to prevent
or otherwise affecting
the safety of the food
being processed and
packaged, and how
those controls will be
verified, validated and
The Role of Automated
Once a safety regimen is established, it is
automated inspection systems that most effectively provide the means to control both contamination and other safety issues, ensure overall
product and package quality and document the
process and results. Documentation is critical,
because it is an essential requirement of FSMA
and one of the first things the FDA is going to
ask for during an inspection.
The following are basic food safety inspection
systems and how they help food processors and
manufacturers avoid recalls and the potential liability involved should a defective or contaminated
product reach the marketplace:
• Checkweighing systems weigh packaged
products to ensure stated package weights
are accurate, and to ensure packages are
correctly filled. Underweight packages expose
the company to regulatory penalties; overweight packages give away product. Weighing
is done on-the-fly at production line speeds
and does not slow production. Continuing
technical advances have made checkweighers
faster, more precise and more compact. Nonstandard weight packages are automatically
rejected from the production line.
• Metal detection systems inspect products
to ensure they are free from metal contamination that may have been included in raw
materials or may have been dislodged from
processing equipment during production.
Developments in inspection technology mean
today’s systems can detect very small contamination reliably and without false rejects.
Products with contamination are automatically rejected from the line, and can then be
reworked or discarded.
• In some cases, depending on processing
steps that may introduce metal contamination, metal detectors may be placed at several locations on the line.
• X-Ray inspection systems inspect products
for both metal and other types of contamination — glass, bone, stone, certain plastics
Automated Inspection Systems Ensure
Quality and Safety while Maintaining
By Robert Rogers, Senior Advisor for Food Safety and Regulation, METTLER TOLEDO Product Inspection Group