WHITE PAPER

Understanding
FSSC 22000 Certification

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Table of Contents
1. Introduction
2. The Purpose & Benefits of FSSC 22000
a. Why choose FSSC 22000 as your GFSI-benchmarked audit scheme?
b. Overview: Foreign Material Risk
3. Establishing an FSSC 22000 Program
a. Overview of the PDCA Cycle
b. ISO 22000 Requirements
c. ISO/TS 22002-1:2009 Food Manufacturing
d. Additional Requirements
4. Navigating the Audit

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Introduction
This document serves as introduction to the FSSC 22000 Food Safety System
Certification standard requirement. While not meant to be exhaustive in nature,
it seeks to provide a heightened understanding of FSSC 22000, its purpose, and
benefits to food manufacturers.

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The Anatomy & Benefits
of FSSC 22000
The FSSC 22000 program is a risk-based certification program that helps food
producers reduce the risk of providing an unsafe product to consumers and
maintain an effective, tailored food safety program in a dynamic regulatory
environment. As a GFSI-benchmarked certification program since 2010, FSSC
22000 is internationally accepted by accreditation bodies and recognized by
important industry stakeholders like Food Drink Europe, Consumer Brands
Association and global retailers. The standard incorporates elements of
Good Manufacturing Practices, Hazard Analysis Critical Control Points and
comprehensive management systems, bringing the entire food chain together
under a single food safety management system umbrella.

The FSSC 22000 Certification Program consists of three components:

• ISO 22000
• Sector-specific PRPs
• Additional Requirements

In addition, the Certification Program also includes an FSSC Quality option based on
the additional requirements of ISO 9001.

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Why should I choose FSSC 22000 as my
GFSI-benchmarked audit scheme?
More and more, consumer become concerned about food safety. Incidents of
foodborne illness and recalls are seemingly ubiquitous as supply chains globalize
and controls struggle to keep up. Manufacturers must make efforts to address
these vulnerabilities in their processes. One way to do so is to adopt a widely
recognized food safety and quality standard.

More than 20,000 progressive food producers worldwide have chosen FSSC 22000
to such ends. Of the GFSI-certified schemes, FSSC 22000 is one of the most
recognized standards in the food industry, and it can be customized to your facility
in a way other GFSI schemes cannot.

There are a number of benefits that come from FSSC 22000. These include:

1. Improves the quality of food and food packaging products

2. Improves food safety processes by reducing hazard and incident risk

3. Optimizes resources resulting in reduced costs

4. Helps prove your products and services are safe, high quality, and reliable

5. Builds trust in the supply chain

6. Ensures production of food products with prerequisite programs

7. Helps facilities enter new markets and establish new customer relationships

8. Simplifies food safety plans and programs

Given these benefits, it should come as no surprise that such a certification

enhances reputation, which can bring in new customers and increase bottom lines.

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The Purpose of FSSC 2200:
Mitigating Foreign Material Risk

Foreign material risks are top of mind for food producers in recent years, and
FSSC 22000 provides a variety of tools to help reduce those risks. It can help
build a foreign material detection program, proactively reduce the risk of foreign
material entry in the product stream and encourage the use of methodologies to
reduce foreign material risk. Some example methodologies include supplier control,
incoming inspection, prevention and detection methods, internal audits, Root-
Cause Analysis, and complaint trending.

A strong foreign material contamination program helps reduce the possibility of a

physical contamination-related recall. The FDA’s dashboard indicates that the most
common causes for food recalls in the USA are undeclared allergens, pathogen
contamination – such as Listeria and Salmonella -- and physical contamination. In
fact, a study of 176 Walmart sites conducted by the University of Arkansas and
published in the Journal of Food Protection found that over a four-year period --
two years before and after implementation of a GFSI standard -- there was a 34%
reduction in recalls.

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Establishing an FSSC 22000 Program
Overview of the PDCA Cycle

PDCA stands for Plan Do Check Act. The PDCA cycle is a four-step, iterative quality
management method used in business for the control and continuous improvement
of processes and products. It’s also known as the Deming cycle, the Shewhart
cycle, the control cycle, or PDSA, which is Plan Do Study Act. This cycle is helpful for
beginning a new project such as introducing a new product, new equipment, new
production line, and so one. It is also helpful for defining a repetitive work process,
such as on an assembly line. Additionally, you can use the PDCA cycle when making
any kind of change in your process – whether as a result of a corrective action or as
part of your facility’s continuous improvement process.

Plan
This stage refers to the analysis of needs, which come from a process-specific data
review of product specifications or customer complaints. Take care to consider
cause-and-effect analysis, like Root Cause Analysis, as well as internal and external
data sources.

Do
Implement outputs defined in the planning stage, such as mixing specifications,
equipment settings or employee training. You may have to develop a series of
steps to repair the gaps identified in the planning phase. You’ll also want to define
your goals and deliver any necessary instructions to individuals in the process.

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Check
In this phase, you check that the actions put in place in the “Do” phase actually
work. Monitoring can be formal, meaning that we define and document the
frequency of monitoring activities, or informal, where documenting is lax or
nonexistent. Monitoring also includes a measurement of the process and its
resulting product, as well as analysis and evaluation of that data to ensure the
expected results. Finally, monitoring requires you to report your findings.

Act
In this phase, manufacturers react to whether goals are met. Take any necessary
action to improve performance, as the central concept of any GFSI standard is
continuous improvement. You may even use the results of this process as inputs
for another PDCA cycle or the Management Review processes required by
the standard.

PDCA serves a critical principle of the FSSC 22000 program.

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Requirements for ISO 22000
To fully understand the certification requirements of FSSC 22000, it is important
to include an overview of ISO 22000, since it helps form the basis of the standard.
ISO 22000 is a risk-based methodology that aims to prevent undesirable results in
production by taking advantage of opportunities within a facility. Unlike it’s GFSI
counterparts BRC and SQF, ISO is less prescriptive, meaning it lacks step-by-step
procedures. This gives processors more flexibility to define the processes that
work best for their operation.

ISO 22000:2018 Overview:

1. Scope

2. Normative References

3. Terms and Definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance Evaluation

10. Improvement

Scope

Scope refers to the controls measures implemented as a means to solidify

processes in place to meet regulatory, food safety, and consumer demands or
requirements. Regardless of the size or complexity of your business, ISO 22000 is
applicable to any organization directly or indirectly involved in the food chain.

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Normative References

Materials used to determine definitions of terms used in the formal ISO

standard document.

Terms & Definitions

Provides clarity of terminology used in the ISO standard document and promotes
the use of common language.

Context of the Organization

Ensures that your organization understands the internal and external issues that
may affect the goals of its Food Safety Management System, or FSMS. Such issues
can be legal, technological, competitive, cultural, social, economic, and more. A
critical step in determining this context is to consider all regulatory requirements,
customer requirements, and product specifications that you may have to include as
part of your Food Safety Management System.

Leadership

Here, ISO 22000 discusses management commitment and having a Food Safety
Policy that clearly describes the organization’s responsibility to produce a safe
and legal product. The policy itself is a quick way to show the site’s commitment
to comply with regulatory and customer requirements. This section also reviews
organizational roles, employee responsibilities, and naming the authorities who
determine things like what to do when members of your food safety team are
on vacation.

Planning

Here, you identify what the significant issues within your facility are that need
mitigation. You define the objectives of your Food Safety Management System and
how you plan to achieve them. This section also looks at how you plan to deal with
changes in your organization or facility – anything from a change in management
to the addition of new equipment.

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Support

First, this means resources – whether it be human, financial, infrastructure or

technical – and what improvements companies may have to make to them, such as
updating equipment or adding people to the workforce. Competence, which defines
the type of training to provide to your employees to ensure they can perform their
assigned duties also falls under this umbrella.

Next is awareness, which refers to the idea that your employees understand the
responsibilities of their position. Another aspect of support is communication.
There’s internal, which includes discussion between the facility’s employees,
departments, subsidiaries, or corporate offices – and there’s external, which
includes dealing with customers, certification bodies, certification program owners,
and regulatory agencies like FDA or USDA.

Finally, the documented information part outlines parameters for you to ensure
that things like records are created, completed, and updated properly. Consider
not only internal SOPs but documentation for external customers such as supplier
specifications or customer expectations as applicable.

Operation

Describe the operational planning and control, which is primarily your Food
Safety Plan, as well as PRPs and your traceability system. This section also takes
into account emergency preparedness and response. Known in some cases as
business continuity, this requires a program to deal with either man-made or
natural disasters. Section 8 also discusses any updates you may make to product
specifications, PRPs, or HACCP; the control of monitoring and measuring activities;
and verification. Finally, there’s control of product and process nonconformities,
also known as nonconformity deviation.

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ISO/TS 22002-1:2009
Food Manufacturing
In addition to ISO 22000, ISO/TS helps form the basis of the FSSC 22000 Program.
Note that there are a variety of sector-specific prerequisite programs within
the ISO/TS standard such as catering, farming, food packaging manufacturing,
transport and storage, and feed and animal food production. This document
displays key sections relevant to ISO TS 22002-1:2009 Food Manufacturing.

Supplies of air, water, energy, and other utilities

This section requires us to define if potable water is needed and then ensure its
use. The water must be tested by the facility or an external party. Facilities must
define if any of those utilities presents a hazard and what mitigation strategies
need to be in place. This could include water treatment, which some beverage
industries are required to do. However, water treatment activities must revolve
around food safety and not just overall quality.

Supporting services, including waste and

sewage disposal

Section seven discusses supporting services, including waste and sewage disposal,
but also may include providers whose services impact food safety, such as
calibration, uniforms, janitorial, and transportation.

Suitability of equipment and its accessibility for

cleaning, maintenance, and preventive maintenance

Section eight describes the requirements and suitability of the processing

equipment - in other words, the preventive maintenance, design, location, and
maintenance of the equipment or the buildings in which it lives.

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Management of purchased materials

If there are significant known hazards in your supplier approval program, you must
examine who will control those hazards - you or your supplier. You may also need
guarantees from suppliers in terms of ingredients, packaging materials, processing
aids, and so on.

Measures for prevention of cross-contamination

This may include looking at strainers, filtration systems, metal detection, and glass
inventory. The specific controls that you implement will depend on the types of
products that you’re producing.

Cleaning and sanitizing

A well-defined master cleaning program may include SSOPs with cleaning

frequencies, chemicals to be used and required concentrations, equipment
breakdown instructions, and cleaning verification activities.

Pest control

In most cases, facilities will outsource this service. In that case, you want to
make sure that the service provider is properly trained, qualified, and licensed
by the relevant authority according to the state under which you are operating.
Routine service reports should detail service provided, pesticide applications, pest
sightings, recommendations and corrective actions.

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Personnel hygiene

Covers handwashing, hairnets, and other PPE considerations. It also includes how
to address on the job injuries, communicable diseases, and things of this nature.
You must evaluate communicable disease programs so that you can mitigate any
risks presented to the operation due to situations such as a global pandemic.

The ISO/TS 22002-1 standard also includes requirements for the following:
rework, section 14; product recall procedures, section 15; warehousing, section
16, which includes temperature requirements and cross-contamination prevention;
product information and consumer awareness, section 17, which includes things
like labeling, declaration of allergens, and cooking instructions; and finally, food
defense, biovigilance, and bioterrorism, section 18.

A Closer Look at FSSC 22000-Q

FSSC 22000-Q is a type of certification that incorporates the ISO 9001 standard
as part of what is known as an integrated audit. This certification serves facilities
looking to add the quality aspect of their food safety and quality management
system to an FSSC 22000 audit.

Facilities looking for an FSSC 22000-Q certification must be audited against four
documents: the ISO 22000 document; the sector-specific PRP, the Additional
Requirements document under FSSC 22000; and the ISO 9001 document.

The Q certification is a recent optional addition. Many facilities have yet to

take advantage of this opportunity. It indicates that you have documented and
implemented quality standards.

The Q certification has not been very popular in the industry because, in general,
facilities try to address food safety and quality as two separate ideas. It is certainly
wise to consider to help implement a consistent process control and quality
management system.

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Navigating the Audit
The best way to stay compliant is to conduct an internal audit. Below are Zosi’s
tips for conducting an effective internal audit:

Do what you say, say what you do. Then prove it!
Have detailed monitoring activities.
Verify those activities follow documented procedures.
Validate programs are effectively controlling hazards.

Be tough on yourself.
You know your strengths and weaknesses.
Challenge yourself to be better prepared for certification or
regulatory audits

Don’t be complacent.
Challenge your systems with a robust internal auditing process.
Improve your programs by completing corrective actions.

Use multifunctional audit team members.

Have varied but complementary skills on your team.
Include skills that contribute to the specific objectives of the
organization. This ensures you have auditors who…

• Aren’t auditing their own work.

• Have knowledge of the process being audited and can
challenge it.

Use risk-based frequencies.

Base monitoring frequency on risks associated with the
audited programs.
Audits may be weekly, monthly, or even annually.

Trust but verify.

Conduct business by trusting your employees.
Ensure employees understand their duties.
Remind them that everyone is responsible for a safe and
legal product.

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Conclusion
The FSSC 22000 standard is an excellent choice for food manufacturers looking
to be certified under a renowned GFSI scheme. Its benefits are wide ranging, from
improving the quality of food and food packaging products to facilitating new
market entry. Understanding the requirements of the standards basis – ISO 22000
and ISO 22002 TS can aid in your journey to certification. For further clarification
and a complete picture of FSSC 22000 program certification requirements, join the
waitlist for Zosi’s upcoming FSSC 22000 course.

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