and/or packaging. This is ideally done at
the time the system is originally installed
in a production line, and then becomes
one element of a complete program of
validation, periodic verification and ongoing
monitoring that will keep the system
operating as intended and ensure that
products are adequately and accurately
inspected, and that accurate records of
those inspections are kept.
It is critical for producers to remember,
however, that the original onsite validation
relates only to the specific products tested
at the time. As new or additional sizes of
products are developed and run on the
production line, or packaging (including
labeling) changes, the system will need to
be revalidated for each change.
Verification is the process of periodically
confirming that the inspection equipment
continues to be as effective as when it was
first validated. The verification process uses
standard, established tests to determine
whether the inspection system is still
under control and continuing to operate as
originally demonstrated. This verification
process is conducted periodically at
regular intervals to provide evidence-based confirmation that the system
continues to be effective as specified.
Formal performance verification is typically
an annual process, to support audit
requirements. It should continue throughout
the productive life of the system.
Both validation of an installed system,
and periodic verification of operating
systems, can be conducted either internally
by the end-user, or by the supplier of the
equipment. Validation ands verification
services are often included as part of
equipment purchase contracts.
Routine performance monitoring, which
is distinct from periodic verification,
consists of a series of frequent regular
performance checks, during production,
completed to determine whether processes
are under control and to confirm that there
has not been a significant change in the
system’s performance level since the last
successful test. The monitoring frequency
may be as often as every two hours,
depending on company standards, industry
standards and/or retailer codes of practice.
If the monitoring process finds that a
particular device is out of specification,
all product that has passed through the
production line since the last successful
routine performance-monitoring event must
be considered suspect and reinspected.
In many cases, it is line operators that
conduct online performance monitoring.
However, many of today’s more
sophisticated product inspection systems
incorporate built-in performance monitoring
software that automates this process and
alerts operators when deviations occur.
This valuable software feature removes
any human error factor from the monitoring
activity to help ensure that inspection
processes are still being performed
properly. It also provides documentation
that will guide the end user company’s QA
groups in their continuous improvement
efforts, and that will also be a valuable
asset in the event of an inspection visit
Routine performance monitoring
can also have a direct impact on the
production line’s OEE (Overall Equipment
Effectiveness). Installing a system with
built-in condition monitoring capability that
when the system may
need correction, and
information directly to
line operators, reduces
the frequency needed
for verification testing,
maximizing the line’s
remember that while
they are knowledgeable
experts regarding their
products, it is their
that are the experts
on the capabilities and
of their equipment.
makes them the best
source of reliable
on questions surrounding the most
effective inspection equipment type for
specific product needs, where to place
that equipment on the production line for
optimum results, and how to validate,
verify and monitor its performance.
Relying on these experts to conduct
onsite validation and to advise on
conducting periodic verification and
ongoing performance monitoring can
reduce both the time needed for the original
onsite validation and the time needed
for verification and ongoing monitoring
procedures, thereby increasing productivity.
Companies can also rely on these
experts to be knowledgeable about the
most current food safety regulations and
the technology that affect equipment
validation. It is critical for their success
that they stay current on those topics, and
sharing that knowledge is a valuable part
of their service.
Robert Rogers is Senior Advisor for Food
Safety and Regulation at METTLER TOLEDO
Product Inspection Group.
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