White Paper

Automating Quality
Compliance and Business
Process within the Food
and Beverage Industry
 White Paper

In recent years, there has been no dearth of headlines highlighting foodborne

nightmares, including E. coli from spinach (2006), melamine in pet food (2007),
listeriosis from cantaloupes (2011) and salmonella in salmon (2012). In turn, food
contamination has grown in concern among consumers and manufacturers alike.
These outbreaks, mishaps or accidents are more than scares, though – they are
real adverse events and too serious to ignore.

Each year, one in six Americans gets sick by consuming contaminated foods or
beverages. The Centers for Disease Control and Prevention (CDC) estimates that
about 48 million people get sick, 128,000 are hospitalized and 3,000 die from
foodborne diseases each year. In addition to being an important public health
burden in the United States, foodborne diseases also cause billions of dollars in
healthcare-related and industry costs annually. One recent study estimates the
economic loss of food recalls and foodborne illness in the U.S. to be more than
$77 billion annually.

There are plenty of entry points throughout food production, processing and
handling for food to become contaminated.

“We live in a microbial world, and there are many opportunities for food to become
contaminated as it is produced and prepared,” the CDC explains. “Later in food
processing, other foodborne microbes can be introduced from infected humans
who handle the food, or by cross contamination from some other raw agricultural
product. The way that food is handled after it is contaminated can also make a
difference in whether or not an outbreak occurs.”

The frequency of recalls related to contaminated food in recent years has led
to reduced consumer confidence in the safety of the food supply, resulting in
consumers becoming hyper-vigilant about the quality and safety of what they eat.
What can food and beverage companies do to regain and maintain the trust of
foodstuff consumers?

Food and Beverage: Manufacturing Responsibly

Food and beverage companies already have the responsibility to seek compliance
with standards, regulations and principles that already exist, including ISO
22000, HACCP, FDA 21 CFR Part 110 and others. Companies must always keep
in mind that even if their food or beverage product isn’t directly regulated now,
the companies will still suffer if food becomes adulterated (whether knowingly or
unknowingly) and results in injury or death.

That is why successful food and beverage companies continue to work hard to
create faster and more efficient business processes, increase productivity and
maintain their company’s respective quality standards. However, as we’ve seen in
recent years, there is still plenty of room for improvement.

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Today, there is a legitimate urgency among food and beverage companies to take
more ownership of food safety to protect their brands. As awareness of food-safety
issues and the globalization of the food chain increases, regulators and consumers
are demanding more ways to ensure safer food. For food and beverage companies,
the focus is shifting away from response and onto prevention, making the need to
optimize product quality and minimize foodborne hazards all the greater.

To make maintaining quality even more complex and urgent, the Food Safety
Modernization Act (FSMA), signed into law by President Barack Obama in January
2011, creates a blueprint for the most sweeping changes to the nation’s food
protection system since Theodore Roosevelt held office.

What FSMA Means for the Food and Beverage Industry

The goal of FSMA is to ensure the U.S. food supply is safe by shifting the focus of
federal regulators from responding to contamination to preventing contamination.
To that end, the law provides the U.S. Food and Drug Administration (FDA) with
new enforcement authorities designed to achieve higher rates of compliance with
prevention- and risk-based food safety standards and to better respond to and
contain problems when they do occur. In particular, FSMA gives the FDA new
authority to regulate food facilities, establish standards for safe produce, recall
contaminated foods, oversee imported foods and more.

The elements of the FDA’s new key authorities and mandates are generally divided
into five key areas:

Preventive controls – For the first time, the FDA will have a legislative
mandate to require comprehensive, science-based preventive controls
across the food supply. This mandate includes: 1) mandatory preventive
controls for food facilities; 2) mandatory product-safety standards; and
3) authority to prevent intentional contamination.

Inspection and compliance – For the first time, the FDA has been given
an inspection mandate. FMSA requires inspections to be based on risk
and the frequency of inspections to increase. The law provides the FDA
with new tools for inspection and compliance, including: 1) mandated
inspection frequency; 2) records access; and 3) testing by accredited
laboratories.

Response – For the first time, the FDA will have mandatory recall
authority for all food products. FSMA gives the FDA other new tools to
respond effectively when problems emerge despite preventive controls,
including: 1) expanded administrative detention; 2) suspension of
registration; 3) enhanced product-tracing capabilities; and 4) additional
recordkeeping for high-risk foods.

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Imported food safety – FSMA gives the FDA unprecedented authority to

better ensure that imported products meet U.S. standards and are safe
for U.S. consumers. New authorities include: 1) importer accountability;
2) third-party certification; 3) certification for high-risk foods; 4) a
voluntary qualified importer program; and 5) authority to deny entry.

Enhanced partnerships – To build a system of collaboration with other

domestic and foreign agencies, FSMA explicitly recognizes that all food
safety agencies need to work together to achieve public health goals.
Examples of enhanced collaboration include: 1) state and local capacity
building; 2) foreign capacity building; and 3) reliance on inspections by
other agencies.

Some of the changes envisioned under FSMA are already in place, including the
FDA’s mandatory food-recall authority and the authority to detain food products
that the agency has reason to believe are adulterated or misbranded. Yet FSMA
is a massive undertaking, and the FDA still has a long way to go in implementing
it. One major, open-ended aspect of the law is the rulemaking process and the
publication of regulations and guidance.

In accordance with FSMA, the FDA is promulgating seven new rules to support and
strengthen the nation’s food safety system. These rules focus on the following:

1. Preventive controls for human food

2. Preventive controls for animal food
3. Produce safety
4. Foreign-supplier verification
5. Third-party accreditation
6. Food transportation
7. Intentional adulteration

Together, the proposed rules will establish requirements for farmers, food
companies and importers to prevent foodborne illness. As of early 2014, all seven
major rules have been proposed. After comment periods on the proposed rules end,
the FDA will make adjustments to the rules’ language and require departmental and
Office of Management and Budget (OMB) review. The FDA must publish the final
rules in the Federal Register by meeting staggered deadlines throughout 2015 and
2016, to be followed by years of implementing the regulations.

FMSA not only increases the power of the FDA to regulate the food and beverage
industry, but also increases the already-weighty burden of food manufacturers,
importers and the entire food supply chain to ensure that risk of foodborne illness
and manufacturing deviations is greatly reduced and that risk-reduction processes
are far more effective within food and beverage environments.

FMSA essentially compels food and beverage companies to create more efficient
quality systems and processes. Are food and beverage companies prepared for
new regulations?

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What’s the Next Step?

While FSMA ushers in a stricter regulatory environment, it also represents an

opportunity for food and beverage companies to improve their own processes and
operations and to implement preventive controls.

Currently, many food and beverage companies still find that their quality
documentation and processes are managed manually. This significantly reduces
the efficiency and accuracy of quality process management and contributes to
inefficient business processes, a lack of valuable real-time data and the inability to
get better products to market faster.

By establishing a holistic, integrated approach with the right set of software

capabilities, food and beverage companies are better positioned to gain – and
leverage – the insights necessary to identify and address potential food-safety
issues. Automation is a critical enabler for streamlining food safety systems,
thereby improving efficiencies, reducing compliance costs and ensuring
product safety.

Complying with FSMA requirements will require some investment, but

noncompliance that could lead to food recalls would be even costlier. The damage
to a company’s reputation can be devastating. Recall costs include notifying
consumers, removing food from shelves and paying damages that result from
lawsuits. Short-term revenue is lost because of the recalled/destroyed product; in
the long term, the damage done to branded products may take years to repair in
some cases.

Simply put, food and beverage companies can’t afford not to automate their
document management/control, quality processes, business processes and entire
product lifecycles into one automated system. In today’s age of globalization, ever-
increasing consumer awareness and continually evolving government regulations,
failure to automate manual processes means failure to keep pace with the
industry and competition.

Although there is no silver bullet, foodborne illnesses are largely preventable

through efforts made by food and beverage companies to arm themselves with
the right technological tools and capabilities.

How MasterControl Can Help

When it comes to food safety, quality management must take into account the
broad array of activities and varying degrees of risk involved in the production of
food. MasterControl software is designed to automatically streamline quality,
business and product lifecycle management processes from start to finish.

With MasterControl’s QMS, food and beverage companies can readily respond
to new quality requirements without sacrificing productivity or business profits.

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MasterControl helps companies in the food and beverage industry comply with
FSMA by:

Automating document control processes to ensure efficiency and compliance

Establishing automated corrective action procedures (CAPA) to mitigate risks
Connecting all document control and quality processes to increase inspection
readiness

In 2009, the FDA selected MasterControl’s QMS as the agency’s quality

management system of choice. Learn more about MasterControl’s solutions and
how they can effectively streamline and automate document, quality and business
process management within food and beverage environments of all sizes.

Quality Requirement MasterControl Solution

Documentation Quality plans, testing documentation, SOPs, pre-audit checklists,

quality manuals, food safety/defense plans and more can be edited and
controlled by approved users within a secure, centralized collaboration
environment. Documentation can be automatically routed and approved
by specified personnel, and MasterControl provides a complete
electronic trail, automated analytics and reporting features.

Training Management MasterControl’s automated quality system streamlines the delivery of

training assignments, courses and full-scale units. One training unit,
when complete, can trigger a subsequent training unit, and follow-ups
and escalations are automatic. Training reports also provide real-time
data to help keep quality in check.

Deviations/ Nonconformance MasterControl streamlines the delivery of deviations and

Events nonconformance reports, and automates risk assessment, to ensure the
problem can be corrected and analyzed for possible preventive action.
Both deviations and nonconformance events with high levels of risk
automatically trigger a CAPA.

Customer Complaints MasterControl automates the delivery of customer complaints and can
Management automate the trigger of a CAPA when high-risk customer complaints
information is received. Lower risk information is automatically
forwarded to a resolution and archival stage.

CAPA MasterControl’s incredibly strong events management funnel automates

the delivery of adverse events to the appropriate quality “roadways.”
These roadways guide employees with essential CAPA-related questions
that allow employees to quickly resolve, investigate and prevent future
adverse events.

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Change Control MasterControl’s integrated change control management connects

separate departments with data and processes under a secure,
centralized system. This connectivity dramatically improves efficiency
through automatic task assignment, routing, scheduling, notification and
escalation of incomplete tasks.

Audit Management MasterControl streamlines management of internal and third-party

audits by: centralizing audit information across departments; enabling
users to raise quality issues across departments; providing advanced
CAPA functionality; automating reporting and report responses;
enabling standardization of documents and processes; and automating
prioritization of audit findings.

About MasterControl

MasterControl Inc. creates software solutions that enable life science and other
regulated companies to deliver life-improving products to more people sooner.
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by
automating and securely managing critical business processes throughout the
entire product lifecycle. More than 1,000 companies worldwide, ranging in size
from five employees to tens of thousands, rely on MasterControl cloud solutions
to automate processes for new product development, clinical, regulatory, quality
management, supplier management, manufacturing and postmarket surveillance.
MasterControl solutions are well-known for being scalable, easy to implement, easy
to validate and easy to use. For more information, visit www.mastercontrol.com.

© 2019 MasterControl Inc. All rights reserved.

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