Seven rules have been issued under
the Food Safety Modernization Act (FSMA), and the compliance dates for the
Preventive Controls for Human Food guideline has passed. FSMA requires that a written record be kept
of the entire Hazard Analysis and Risk-based Preventive Controls (HARPC)
plan. These records must be maintained
for no less than two years, and evaluated whenever there is a significant
change at the facility that might increase a known hazard or introduce a new
one, or every three years if no significant changes occur.
Most companies have identified what
needs to be done in order to comply, but for many the challenge of documenting
those efforts remains. Typically there
is no consistent format or approach for records maintenance, and too often key
information on the same topic or issue is different at different
locations. Information should be easily
accessible and usable across the organization to identify trends and to remind
to follow up on corrective actions and/or audits.
Three key points are the focus for
FSMA documentation: the supplier, the
facility, and the shipper.
Know who you’re buying from
For most food manufacturers, in-depth
knowledge of suppliers is crucial to ensure the quality of the product; now it
is also a critical step of your HARPC plan.
You must document not only the hazard your supplier is responsible for
controlling, but also the action they have taken to prevent or control that
issue. For example, an ice cream company
would want to ensure that the peanut butter entering their facility is not
contaminated with salmonella. Working
with certified suppliers would provide assurance that the ingredients meet
quality and safety standards. Certificates
of analysis from the supplier offer one form of documentation that the product
is within limits; in-house testing prior to use would verify those findings. Annual audits would also be necessary to
evaluate the supplier’s effectiveness in controlling the hazard.
“Trust, but verify” is the mantra
for this stage of documentation. A
thorough, written program that details your verification process is necessary
to meet FSMA requirements. There is
still time to ensure compliance; the supplier verification requirements take
effect March 2017. A fully integrated
Enterprise Resource Planning (ERP) system would track supplier audits and link
the documentation to supplier records.
Proactive controls within an alert management system would prevent
ingredients from advancing to the manufacturing floor until acceptable test
results had been received. When you are
fully aware of your suppliers and their capabilities, you can better execute
when there is a quality or safety issue.
Many businesses already have
preventive controls programs in place; however the challenge now becomes validating
and documenting those processes and procedures.
Some businesses may have been following Hazard Analysis and Critical
Control Points (HACCP) guidelines, but may not have adequate documentation to
prove it. Companies with GFSI
certifications tend to have more complete documentation, but the format can
vary from sophisticated technology to manual logs. Continuing with our example of the ice cream
company, sanitation records would be necessary to prove the processing
environment would not allow listeria to contaminate the finished product. Listeria is found is soil and water, and
can be introduced into a manufacturing facility a number of ways. Floor drains are common sites of
contamination as they can be neglected by cleaning staff. Once introduced into a cold environment, it
can be difficult to contain, partly because the bacteria grows well at
refrigerator temperatures, as low as 40°F.
A thorough cleaning and sanitation program is required to keep listeria
out of the processing environment. Tests
should be run on the finished product to ensure there has been no microbial
contamination. A shipping hold would
prevent the product from being distributed prior to receipt of clean test results. Shipping documentation must be maintained
that would reflect such a hold.
“If it’s not documented, it didn’t
happen” is the call to action at this phase.
A written analysis of both the identifications of the hazards and the
controls to prevent or minimize the issue is required. Verification steps must also be designed and
implemented to ensure the HARPC plans are operating correctly. A manufacturing execution system (MES) can
record quality assurance tests, as well as cleaning and maintenance protocols,
while the alert management system can warn when control checks have not
occurred or when conditions are out of tolerance so that immediate action can
be taken. A detailed record of the full
scope of the plan, including the process, the proof, and the problem, must be
Know who you’re shipping with
The third area of documentation is
for shipment of the finished product. The
Sanitary Transportation of Human and Animal Food rule requires that entities
engaged in the shipping of food and food ingredients ensure that contamination
and adulteration are avoided en route. In
order to ensure the quality of the product, the ice cream company in our
example would want to verify that temperatures are maintained throughout
shipment. In addition, a properly
maintained transport is necessary to prevent cross-contamination.
“Ignorance is not bliss” resonates for this
point. Many food manufacturers already
follow most of the requirements of the Sanitary Transportation rule; the focus going
forward will be on documentation, training, and validation systems. As with supplier verification, it is your
responsibility to document that you provided the shipper with detailed specifications
for transport, such as temperature and cross-contamination controls. All written procedures, agreements, and
training programs must be maintained for a year after use. While the compliance date for this rule is
April 2017, these preventive controls should be put in place as soon as
FSMA states that documentation must
be accurate, detailed, and legible; it must be created at the same time as the
activity being recorded; and it must be provided within 24 hours of the request
for review. An integrated ERP system
serving as a single source of truth for the company satisfies all of these
provisions, gathering documentation from an MES and an alert management solution. A robust ERP will give a food manufacturer
visibility and management of materials, quality, scheduling, and inventory
management in order to track specific orders.
At each step in the process, if a food safety risk is uncovered,
immediate action must be taken to recall the affected product. The traceability feature of ERP allows the
company to track a single ingredient or lot of finished product back to the
supplier, through the inbound carrier, and forward to the outbound carrier and
ultimately the distributor.
The FDA has stated their philosophy
is to “educate before and while they regulate.”
In keeping with this mindset, expect continuous improvement as these
regulations continue to evolve. Implementing
FSMA documentation provides an opportunity to encourage greater collaboration,
instill a broader business perspective, and build stronger relationships that
improve productivity and ensure food safety.