PET Food Processing - March 2021 - 23

When Pet Food Processing spoke to
Marshall on this subject in 2019, he
identified, among preauditing's key
challenges, the failure to implement
good manufacturing practices, along
with a handful of predictable bugs
(poor machinery, inadequate facility
sanitation, poor line-worker hygiene).
What are his red flags in 2021? Here's
what he says rates an F - for " failure "
- more recently.

* Failure to keep accurate monitoring
records
* Failure to identify all food safety
hazards that are reasonably
foreseeable in the product and
process
* Failure to conduct a well-thoughtout root-cause analysis
* Failure to implement an effective
corrective action
* Failure to consider opportunities to
implement preventive actions

" Plugging major deficiency holes before an audit helps
team confidence and allows for additional time to button up minor oversights. "
Regardless of approach, such rehearsals also provide
opportunities to make FSMA second nature.
" The best way to ensure a successful FDA inspection
is to become exceptionally familiar with the FDA's rules
and regulations governing the food products you manufacture, " Barham said. " Like human food, pet food is
required by the FDA to be safe to eat, produced under
sanitary conditions, and properly labeled. Inspections
therefore focus on the preventive controls requirement
found in 21 CFR 507 - Subpart C. "
If that's alphabet soup to some team members, the internal process is your chance to bring them up to speed.
" It is important that pet food manufacturers ensure
they have knowledge of regulatory compliance in the
countries they manufacture in and are exporting to, " Yap
said. " A lack of controls may mean that the products will
be noncompliant, which is a common weakness in the
industry. It's important to understand the clause or section requirement where this noncompliance was cited.
Then you can assess the gap between your currently implemented procedure compared to the requirement, and
the root cause that prompted the issue.
" Issues can also arise whenever there is a version
change in any of the regulatory standards, " Yap added.
" The manufacturer being audited will depend on the
training provided by approved service providers or auditors' findings to re-direct themselves. "

That was then, this is now

Now that FSMA compliance rules are well established,
audit pros said a picture has emerged of what's been improved, as well as what challenges have stiffened.
Yap said she sees the leveled playing field for manufacturing standards governing US-marketed products as
a net gain. FSMA, she said, has built trust between industry suppliers and customers against the backdrop of
improved compliance.
" It's also made it more difficult for economically motivated fraud to occur, " she added.

* Failure to document out of
compliant situations
* Failure to understand why repeat
occurrences are happening
* Failure to use preventive controls
for hazards reasonably foreseeable
to occur in the product or process
(or using inadequately designed
preventive controls)
* Failure to properly validate process
preventive controls
* Failure to properly conduct
verification monitoring

" Even if you are following
good manufacturing practices,
you are still likely to be cited
if you have not properly
documented those practices. "
Rick Barham, Registrar Corp.

Following 2020s' pandemic disruptions and economic
struggles, Yap said she anticipates something else for auditors to look for: spikes in feed fraud.
" The industry needs to have a plan to ensure there are
no fraudulent ingredients entering their supply chain
prior to processing so the final product is in compliance
with current regulations, " she cautioned.
For his part, Marshall said manufacturers now face
" more emphasis on proving that your preventive controls
are working and verifying that outcomes are achieved
every time. " Compounding this shift is that the industry
suffers from a " major shortage of well-qualified individuals responsible for food safety. " On the other hand, he
added, " many processes that were previously assumed to
work now have scientific evidence of efficacy. "
And for smart firms, a welcome byproduct of the paperwork increase will be better organized documents.
If the pressure is elevated, so are the tools designed
to streamline certain processes: The preaudit market
doesn't lack off-the-rack systems and automation marketed to those daunted by the process. But Yap did not
necessarily counsel a " set it and forget it " approach.
" So far, the turnkey systems are mainly focused on
improving the tracking and tracing of the ingredients
as well as compliance to HACCP and FSMA, efficiency,
and cost-effectiveness in production, " she said. " A challenge with each of these turnkey systems is validation
against their system, which is part of the requirements. "
By and large, best practices start from within,
Marshall said.
PFP

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PET Food Processing - March 2021

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