1. FOOD SAFETY
A Recipe for Safe
Food: ISO 22000
and HACCP
by John G. Surak
F
ood safety experts insist that the U.S. food hospitalizations and 5,000 deaths.
supply is one of the safest in the world. Recently, there have been several high profile
However, the Centers for Disease Control food recalls. These incidents include three national
and Prevention (CDC) estimate that more than recalls: spinach contaminated with a pathogenic
76 million people get sick from food related ill- strain of E. coli, peanut butter contaminated with
nesses each year.1 This results in more that 300,000 Salmonella, and tainted pet food.
In the spinach incident, 199 people in 28 states
were infected. As a result, 141 individuals were
hospitalized, 31 developed a type of kidney failure,
In 50 Words and three died.2
Or Less
When tainted peanut butter turned up on store
shelves, 425 people were infected with Salmonella,
• Three recent major recalls highlight the and 71 of them were hospitalized. This contamina-
importance of food safety, particularly in tion produced no known deaths.3
The tainted pet food recall began this May and
a global food chain.
involved a long list of both store and major brands
containing melamine in product imported from
• ISO 22000 incorporates and strengthens the China. The exact number of deaths is unknown, but
hazard analysis and critical control point it has been estimated that more than 20 pets died.
It can be estimated that more than 1 billion meals
system to create an effective food safety
are consumed each day in the United States, and
management system. each meal contains multiple opportunities to con-
sume a food safety hazard like pathogenic bacteria.
• It is designed for the entire chain, starting These statistics are further influenced by changes
in the dietary patterns of Americans. They are con-
with producers.
suming fresher and minimally prepared foods. The
QUALITY PROGRESS I OCTOBER 2007 I 21

2. FOOD SAFETY
FIGURE 1 Food Chain
Suppliers
Food producers Pesticides fertilizers
and veterinary drugs
Food manufacturers Ingredients and
typical preparation process for these foods food additives
might not remove or destroy all pathogens
Wholesalers Equipment
that could be present. In addition, the consoli- Regulatory
dation and globalization of the food industry agencies Distributors Cleaning and
has allowed Americans to consume these pro- sanitizing supplies
ducts year-round rather than in season. Thus, Food Packing
if there is a food safety incident, it will affect Retailers
service Other services
more consumers.
As a result, serious questions are raised: Consumers
• How can food supplies remain safe in a
global environment?
Adapted from ISO 22000:2005, Food Safety Management
• How can the food system be improved?
Systems—Requirements for Any Organization in the Food
Ensuring safe food is a responsibility of Chain, International Organization for Standardization, 2005.
everyone in the food chain. Food safety starts
on the farm, continues with the food manufac-
turers and distributors, and ends with the con-
sumer (see Figure 1).
incidents on manned space flights (see “HACCP in
HACCP a Nutshell”).
Hazard analysis and critical control point The original concept of HACCP consisted of
(HACCP) is an effective tool to prevent food three principles:4
from being contaminated. HACCP is not a new 1. Identify and assess hazards associated with
concept. The Pillsbury Co. developed it for food, from growing to marketing.
NASA in the late 1950s to prevent food safety 2. Determine critical control points (CCPs) to
control any hazard.
3. Establish a system to monitor CCPs.
As various food safety practitioners implement-
ed these concepts, HACCP evolved from the
TABLE 1 Five Preliminary Steps original three principles to five preliminary
And Seven Principles of HACCP steps and seven principles listed in Table 1
that are supported by prerequisite programs
Step Description (PRPs) detailed in Table 2.
Preliminary step one Assemble the HACCP team. The first U.S. HACCP standard was pub-
Preliminary step two Describe the product. lished in 1989 by the National Advisory
Committee on the Microbiological Criteria
Preliminary step three Identify intended use of the product.
for Foods and was revised in 1992 and 1997.
Preliminary step four Construct a flow diagram.
In 1993, the Codex Alimentarius Commission
Preliminary step five Conduct an on-site verification of the flow diagram. published the first international HACCP
Principle one Conduct a hazard analysis. standard, which was revised in 1997.
Principle two Determine critical control points (CCPs). Both of these are guidance standards,
Principle three Establish critical limits for CCPs. rather than auditable standards. They are
Principle four Establish a monitoring system for CCPs. designed to help organizations implement
Principle five Establish corrective actions. HACCP.
HACCP has been slowly incorporated into
Principle six Establish verification procedures.
the food safety system. In the early 1970s, the
Principle seven Establish documentation and recordkeeping.
Food and Drug Administration (FDA) incor-
22 I OCTOBER 2007 I www.asq.org

3. porated HACCP principles into the regulations TABLE 2 Prerequisite Programs
that govern the production of low acid canned
foods. These regulations have successfully pre-
vented outbreaks of foodborne disease caused by Prerequisite programs (PRPs) provide the foundation for hazard
Clostridium botulinum toxin in commercially analysis and critical control point (HACCP) to function. Food safety
canned foods. experts have found that well-functioning PRPs simplify and
In 1985, the Food Protection Committee of the strengthen the HACCP plan. The PRPs are based on good manufac-
National Academy of Sciences issued a report turing practices or good hygienic practices.1
stating that HACCP was the most effective sys- PRPs include:
tem for ensuring the safety of the food supply.5 • Facilities, including construction and layout of buildings, asso-
As a result, U.S. regulatory agencies incorpo- ciated utilities, premises, workspace and employee facilities.
rated HACCP requirements into the regulations • Supporting utilities including air, water and energy.
that govern the processing of red meats (pri- • Supporting services including waste and sewage disposal.
marily beef and pork), poultry (primarily chicken • Suitability of equipment and accessibility of equipment for
and turkey), fruit and vegetable juices, and sea- cleaning and maintenance.
food. • Management and control of purchased materials.
As of Jan. 1, 2006, the European Union man- • Prevention of cross contamination.
dated all food manufacturing facilities that • Cleaning and sanitizing.
produce food for the European market to incor- • Pest control.
porate HACCP into their food safety systems. • Personal health and hygiene.
Starting in the 1990s, various customers in the • Environmental monitoring.
food chain required their suppliers to have certi- • Chemical control.
fied HACCP systems. Therefore, a number of • Glass and hard plastic control.
countries, including Australia, Denmark, • Product trace and recall.
Germany, Ireland, the Netherlands and the • Complaint investigation.
United States, developed auditable national food • Labeling.
safety management standards (FSMSs). • Employee training and competencies.
In addition, some private organizations devel-
REFERENCE
oped standards. The national and private stan-
dards provided auditable standards that could be 1. V.N. Scott and K. E. Stevenson, HACCP—A Systematic Approach to Food Safety,
Food Products Assn., 2006.
used for third-party certifications. All of these
HACCP in a Nutshell
Hazard analysis and critical control point (HACCP) is a food safety system designed to prevent
biological, chemical and physical hazards in food.
The process starts with identifying the food safety hazards most likely to occur in a specific food
product manufactured by a specific process. Next, the food safety team determines the likelihood of
occurrence of the hazard and its severity.
Hazard analysis has the same roots as failure mode effects analysis. A strategy is developed to
prevent the occurrence of the food hazards by controlling the environment and processes that keep
food safe. The strategy is summarized in the HACCP plan.
The success of a food safety management system depends on ensuring a safe environment to
produce food, implementing a proper HACCP program and having management commitment to
food safety and the HACCP approach. —J.S.
QUALITY PROGRESS I OCTOBER 2007 I 23

4. FOOD SAFETY
TABLE 3 General Structure of ISO 22000:2005
Element Description
4 Food safety management system
4.1 General requirements
Documentation requirements:
4.2 • Control of documents
• Control of records
standards and audit programs are similar 5 Management responsibility
but vary slightly . 5.1 Management commitment
5.2 Food safety policy
Addition of ISO 22000 5.3 Food safety management system planning
5.4 Responsibility and authority
An international effort developed to har-
5.5 Food safety team leader
monize the food safety standards into a Communications
single International Organization for Stan- 5.6 • External
dardization (ISO) standard. ISO 22000— • Internal
5.7 Emergency preparedness and response
Food Safety Management Systems—Require-
Management review
ments for Any Organization in the Food Chain6 5.8 • Review input
was published in 2005 (see Table 3). • Review output
6 Resource management
The standard defines a state-of-the-art
6.1 Provision of resources
FSMS as having the following characteris- Human resources
tics: 6.2 • Competence, awareness and training
• Can be used by all organizations in the 6.3 Infrastructure
food chain. 6.4 Work environment
• Incorporates the five preliminary steps 7 Planning and realization of safe products
7.1 General
and seven principles of HACCP.
7.2 Prerequisite programs
• Provides an auditable standard that Preliminary steps to enable hazard analysis
can be used as part of third-party certi- • Food safety team
7.3 • Product characteristics
fication. • Intended use
• Ensures that the process to control food • Flow diagrams, process steps and control measures
safety is validated, verified, imple- • Hazard analysis
7.4 • Hazard identification and determination of acceptable levels
mented, monitored and managed. • Hazard assessment
• Focuses only on food safety. • Selection and assessment of control measures
ISO 22000 strengthens the HACCP sys- 7.5 Establishing the operational prerequisite programs
Establishing the hazard analysis and critical control point (HACCP) plan
tem in several ways. It is a management • Identification of critical control points
standard; therefore, it shares the following 7.6 • Determination of critical limits for critical control points
• System for the monitoring of critical control points
common elements with other management • Actions when monitoring results exceed critical limits
system standards: Updating of the preliminary information and documents specifying the
7.7 prerequisite programs and the HACCP plan
• Policy.
• Planning. 7.8 Verification planning
7.9 Traceability system
• Implementation and operation.
Control of nonconformity
• Performance assessment. • Corrections
• Improvement. 7.10 • Corrective actions
• Handling of potentially unsafe products
• Management review. • Withdrawals
The standard is fully compatible with 8 Validation, verification and improvement of the food safety management
other ISO management system standards system
8.1 General
such as ISO 9001. However, there are differ-
8.2 Validation of control measure combinations
ences between the two standards. 8.3 Control of monitoring and measuring
The focus of ISO 9001 is quality, while the Food safety management system (FSMS) verification
focus of ISO 22000 is food safety. ISO 22000 8.4 • Internal audit
• Evaluation of individual verification results
assumes a food product exists alongside a • Analysis of results of verification activities
process to manufacture that product. This Improvement
includes having an effective purchasing sys- 8.5 • Continual improvement
• Updating the FSMS
24 I OCTOBER 2007 I www.asq.org

5. tem and a product quality assurance system. In addi-
Food Safety
tion, there are small differences in the organizational
structure between the two standards.
In the Home
Other additions to ISO 22000 beyond ISO 9001
include: Most consumers believe the primary cause of
• No exclusions in the requirements are permitted. foodborne illness is unsafe food handling practices
• The FSMS must conform to appropriate statuto- in food processing plants or restaurants.
ry and regulatory requirements.
In contrast, most food safety experts believe the
• The organization must demonstrate that food
safety is supported by the business objectives. biggest source of foodborne illness is unsafe food
• The organization must develop an emergency handling practices in the home. Therefore, food
preparedness procedure. safety is also the responsibility of individuals who
• The infrastructure or prerequisite programs
prepare food in the home.
(PRPs) needed for a FSMS are defined in detail.
These programs provide the environment for the The Partnership for Food Safety Education is an
production of safe food. association of industry, government and academia
• PRPs are recognized as being managed in differ- with a mission to educate the public on safe food
ent ways. For example, different protocols are
handling practices. This partnership developed the
needed to implement and maintain training and
competencies, facilities, cleaning and sanitation, Fight BAC (Fight Bacteria) program.1
and personal hygiene. Fight BAC consists of the following four princi-
• Analysis for food safety hazards must be con- ples:
ducted as a part of the process for planning the
1. Clean: Wash hands and food preparation sur-
safe realization of food production.
• There is an assumption that it is possible for an faces often.
unsafe product to enter the food chain; therefore, 2. Separate: Do not
organizations must have recall or product with- create an environ-
drawal procedures.
ment in which
• The traceability system requires organizations to
trace all ingredients and components for food potentially patho-
products from the immediate suppliers through genic bacteria can
the manufacturing processes. In addition, it spread through
requires the traceability of end products to the
cross contamination.
immediate customers.
• If the organization produces an unsafe product, 3. Cook: Cook all foods
the hazard must either be eliminated or reduced to the proper tem-
to an acceptable level before the product enters perature.
the food chain.
4. Chill: Chill food
• Concessions cannot be made if the product is
unsafe or contains a food safety hazard. quickly because cold
ISO 22000 does not have a requirement for a pre- temperatures slow
ventive action procedure. HACCP is inherently a sys- the growth of all
tem to prevent food safety hazards. However, ISO
bacteria, including pathogenic bacteria. —J.S.
22000 recognizes that new food hazards emerge and
new technologies are developed to control food safety
REFERENCE
hazards. Therefore, ISO 22000 uses a systems 1. Partnership for Food Safety Education, Fight BAC program,
approach (continual updating of the FSMS) to prevent www.fightbac.org.
new hazards from occurring in the food products.
When compared with other food safety standards,
ISO 22000 strengthens a number of the management
related elements with the following:
• The organization must first effectively plan for
QUALITY PROGRESS I OCTOBER 2007 I 25

6. FOOD SAFETY
ASQ’s Food, Drug and
Cosmetic Division
ASQ’s 5,600-member Food, Drug and Cosmetic (FDC) Division published the new Certified HACCP
[hazard analysis and critical control point] Auditor Handbook through ASQ Quality Press this spring.
The division is also currently in the process of developing a new pharmaceutical certification called
certified pharmaceutical good manufacturing compliance professional, or CPgmpCP. It also is working
with other divisions on a risk management book.
June M. Morita of Prospect Heights, IL, is chair of the division, and Diane G. Kulisek of Simi Valley,
CA, is chair elect. The Midwest Conference on Feb. 20, 2008, is the FDC Division’s next major event.
Additional information on the division, its activities and accomplishments can be found at
www.asq.org/fdc/index.html. —Susan E. Daniels, editor at large
the realization of safe food and then imple- zation in the food chain, including producers, sup-
ment the plans to ensure the production of pliers, manufacturers, distributors, retailers and
safe food. food service organizations.
• The standard requires that food safety be
supported by the organization’s business Using Other ISO Standards
objectives. ISO technical committee 34, which deals with food
• The standard defines the inputs and outputs products, recognized the need to ensure a creditable
to the senior management review process. certification process for FSMSs. Thus, technical com-
• The standard strengthens the internal and mittee 34 and the ISO Committee on Conformity
external food safety communication require- Assessment developed a standard that defines the
ments. requirements of accreditation bodies, certification
• The standard requires the development of an bodies and auditors that will be involved in the ISO
emergency response procedure. 22000 certification process.
• The standard requires that responsibilities of On Feb. 15, 2007, ISO published TS 22003:2007,
the food safety team leader (traditionally the Food Safety Management Systems—Requirements for
HACCP coordinator) be expanded to include Bodies Providing Audit and Certification of FSMSs.7
continual management of the FSMS, manag- The working group intends to use ISO 22003, ISO
ing the food safety team and reporting to top 170218 and ISO 190119 to define the fundamental
management on the status of the FSMS. principles for the accreditation, certification and
• The standard requires the training element be auditing processes for ISO 22000 certification.
strengthened to include competencies. ISO TS 22003 defines the specific competency
• The standard requires PRPs to be verified. requirements FSMS auditors must demonstrate in
• The standard formally accepts that an FSMS the following areas:
might not have a CCP. • Management system audits.
• The standard requires continual improvement • Applicable laws and regulations.
and updating of the FSMS. • HACCP and food safety, including the
ISO 22000 is designed to be used by any organi- identification and evaluation of food safety
26 I OCTOBER 2007 I www.asq.org

7. hazards linked to the supply chain. REFERENCES
• Methods to determine, implement and man- 1. Centers for Disease Control and Prevention (CDC),
age control measures for HACCP plans and www.cdc.gov/foodsafety.
PRPs. 2. CDC, www.cdc.gov/ecoli/2006/september/updates/
• Knowledge of products, processes and prac- 100606.htm.
3. CDC, www.cdc.gov/ncidod/dbmd/diseaseinfo/
tices in the food sectors they will audit.
salmonellosis_2007/outbreak_notice.htm.
The food chain is quite diverse. Thus, different
4. V.N. Scott and K. E. Stevenson, HACCP—A Systematic
technical competencies are needed to conduct food Approach to Food Safety, Food Products Assn., 2006.
safety audits. It will be unlikely any one auditor 5. Ibid.
will be able to effectively demonstrate competency 6. ISO 22000:2005—Food Safety Management Systems—
in all areas of the food chain. Requirements for Any Organization in the Food Chain, ISO, 2005.
7. ISO TS 22003: 2007—Food Safety Management Systems—
Strengthening Food Safety Requirements for Bodies Providing Audit and Certification of Food
The Institute of Medicine of the National Acade- Safety Management Systems, ISO, 2007.
my of Sciences10 convened a special committee to 8. ISO/IEC 17021:2006—Conformity Assessment—
develop recommendations to Congress and the Requirements for Bodies Providing Audit and Certification of
Management Systems, ISO, 2006.
two national agencies that regulate the production
9. ISO 19011:2002, Guidelines for Quality and/or
of food: the FDA and the FDA’s Food Safety and
Environmental Management Systems Auditing, ISO, 2002.
Inspection Service. The recommendations include: 10. National Academy of Sciences, Scientific Criteria to
• Food safety regulatory agencies must contin- Ensure Safe Food, National Academies Press, 2003,
ue to emphasize prevention, reduction or www.nap.edu/catalog/10690.html?se_side.
elimination of foodborne disease hazards.
• HACCP plans that are specific to a product BIBLIOGRAPHY AND NOTE
and a processing line should be developed. ASQ Certified HACCP Auditor, www.asq.org/certification/
• Statistical process control linked to continu- haccp-auditor/index.html.
ous improvement must be a part of food safe- Food Safety Gateway, www.foodsafety.gov. This site pro-
ty regulations. The concept of continuous vides links to food safety organizations.
improvement is central to food safety.
• Imported produce should follow the same
JOHN G. SURAK is the principal of
good agricultural practices required for
domestic produce. Surak and Associates, which provides
• Microbiological samples provide organiza- consulting for food safety and quality
tions and the regulatory agencies with a score- management systems, designing and
card of performance. Future significant gains implementing process control systems,
in the safety of the U.S. meat and poultry sup- and implementing Six Sigma and busi-
ply can be realized only by implementing ness analytics systems. Surak is a
more effective process control measures. fellow of ASQ and an ASQ certified quality engineer, man-
• The U.S. food processing industry must move ager of quality/organization excellence, quality auditor and
from an inspection based system to a process HACCP auditor. He is the ASQ standards committee liai-
control based one to ensure the production of
son from the Food, Drug and Cosmetics Division.
safe food.
The report makes additional recommendations
to improve the regulations governing the safety of
seafood, dairy products, fruits and vegetables. In
addition, it makes specific recommendations for
Please
improving the process used for disease surveillance comment
and monitoring microbial contamination of food.
U.S. consumers expect their food supply to be If you would like to comment on this article,
safe. ISO 22000 strengthens HACCP by linking the please post your remarks on the Quality Progress
plan to PRPs and defining management’s respon- Discussion Board at www.asq.org, or e-mail
sibilities. them to editor@asq.org.
QUALITY PROGRESS I OCTOBER 2007 I 27