Validating Your Foreign Material

Inspection System
Validation, verification and monitoring – each term identifies a distinct process
that has a clear purpose and role to play at different points throughout the
equipment lifecycle.

The Food Safety Modernization Act (FSMA) requires that food manufacturing and processing
companies identify potential hazards within their production systems and then:

 Put in place preventive controls to address those hazards,

 Monitor those preventive controls to ensure their effectiveness &
 Provide documentation proving compliance with these requirements.

There are also requirements for each company to develop and establish its own plan identifying
potential food safety hazards and preventive controls to counter them, and to establish the
monitoring procedures that will verify the efficacy and reliability of the preventive controls.

Validating, verifying and monitoring the performance of the systems that ensure that only safe
food enters the market enables food manufacturers and processors to meet the specific regulatory
standards mandated by the countries where they operate and sell. This enables them to avoid
product recalls that are costly and that severely damage brand identity. But these processes, in
addition to satisfying regulators, also play a valuable part in protecting the companies from
potential liability lawsuits, which can often be even more damaging.

The preventive controls most often used to effectively deal with such identified hazards are
inspection systems (checkweighers and metal detection, X-ray and machine vision inspection
systems) that quickly and efficiently detect non-standard and contaminated products and
defective packaging and reject them from production lines before they can enter the marketplace.
The performance of these systems must be validated, verified and monitored on an ongoing basis
to ensure that they are performing as intended.

These terms–validation, verification and monitoring–are often used interchangeably, creating

confusion within organizations and across industries because people interpret and use these terms
in different ways. In fact, each term identifies a distinct process that has a clear purpose and role
to play at different points throughout the equipment lifecycle. It is important to understand the
purpose of each process to make sure that validation, verification and routine performance
monitoring tests are performed to comply with regulatory requirements, particularly where the
equipment is designated as a Critical Control Point (CCP).

Validation

The fundamental act of “validation,” when applied to inspection systems that are part of a food
manufacturing or processing production line, is conducting an objective, data-based confirmation
that the system does what it was designed, manufactured and installed to do. The International
Featured Standards (IFS) organization defines validation as “confirmation through the provision
of objective evidences, that the requirements for the specific intended use or application have
been fulfilled.” In 2008, the Codex Alimentarius Commission defined validation as, “Obtaining
evidence that a control measure or combination of control measures, if properly implemented, is
capable of controlling the hazard to a specified outcome.” An important part of the validation
procedure is the production of detailed data that demonstrates to line managers and to regulators
that the system is operating as designed.

The manufacturer of each inspection system will validate its performance before delivery, testing
it with generic products and packaging similar to what the customer will be producing. But that
is only the beginning of the validation process. Onsite, that same system needs to be validated
when inspecting the specific products that the production line where it will operate will be
processing 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 re-validated for each change.

Verification

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 and
verification services are often included as part of equipment purchase contracts.

Monitoring

Routine performance monitoring, as 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 re-inspected.

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 from
regulators.

Routine performance monitoring can also have a direct impact on the production line’s OEE.
Installing a system with built-in condition monitoring capability that automatically detects when
the system may need correction and communicates that information directly to line operators
reduces the frequency needed for verification testing, maximizing the line’s production uptime.

Reliance on the experts

Finally, food manufacturers and processors should remember that, while they are knowledgeable
experts regarding their products, it is their equipment suppliers that are the experts on the
capabilities and qualification procedures of their equipment. That expertise makes them the best
source of reliable recommendations on questions from 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 time and that needed for verification and ongoing monitoring
procedures, increasing productivity.

Companies can also rely on these experts to be knowledgeable on 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.