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Surdick, Matthew, J
Improving the HACCP system through the application of ISO 22000
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MS Risk Control
Spring, 2012
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Surdick, Matthew, J. Improving the HACCP system through the application of ISO 22000
Abstract
The purpose of this study was to develop the framework and systems to advance the
current HACCP food safety program to reflect the standard of ISO 22000. The goals of the
study were to conduct an analysis of identified food safety systems to understand the best food
safety practices, conduct a GAP analysis of the food safety system at XYZ, and finally to
conduct a need assessment focusing on organizational analysis, task analysis, and individual
analysis. The methods used in the study include a review of literature of established food safety
systems to determine necessary improvements and utilize an ISO 22000 audit checklist to
determine the gap between the current food safety system at company XYZ and the ISO
standard. The last method used in the study was a semi-structured interview guide to conduct an
interview with different levels of management at company XYZ. Information collected from the
audit checklist and semi structured interview suggest that the current system established at
company XYZ would benefit from the implementation of ISO 22000 principles. The current
system at Company XYZ fails to properly train employees and managers on HACCP principles
and pre-requisite programs indicated by the results in the audit checklist and semi-structured
interview. Implementing a training program that teaches employees and managers the basics of
the program and the reason for the program, in addition to improving management involvement
will positively affect Company XYZs food safety system.
Acknowledgments
I am sincerely grateful for the experience and knowledge that I have received through
the Risk Control Program at UW-Stout. I would also like to sincerely thank Dr. Elbert Sorrell for
his support and motivation in the completion of my field problem. Lastly, I would like to
sincerely thank my fianc and family for their wonderful encouragement and unwavering support
through the completion of my degree.
Table of Contents
...................................... Page
Abstract ............................................................................................................................................1
List of Tables ...................................................................................................................................5
Chapter I: Introduction ....................................................................................................................6
Statement of the Problem .....................................................................................................7
Purpose of the Study ............................................................................................................7
Goals of the Study................................................................................................................8
Background and Significance ..............................................................................................8
Limitations of the Study.......................................................................................................8
Assumptions of the Study ....................................................................................................9
Definition of Terms..............................................................................................................9
Methodology ......................................................................................................................11
Chapter II: Literature Review ........................................................................................................12
Chapter III: Methodology ..............................................................................................................27
Subject Selection and Description .....................................................................................27
Instrumentation ..................................................................................................................28
Data Collection Procedures................................................................................................29
Data Analysis .....................................................................................................................30
Limitations .........................................................................................................................31
Chapter IV: Results ........................................................................................................................32
Results of Literature Review ............................................................................................32
Results from ISO 22000 Audit Checklist ........................................................................34
Results from Semi-Structured Interview ..........................................................................34
Summary ...........................................................................................................................35
Chapter V: Discussion ...................................................................................................................37

Limitations ........................................................................................................................38
Conclusions ........................................................................................................................38
Recommendations ..............................................................................................................40
References ......................................................................................................................................44
Appendix A: ISO 22000 Audit Checklist Results ........................................................................47
Appendix B: Semi-Structured Interview Guide Results ................................................................53
List of Tables
Table 1: Five Preliminary Steps and Seven Principles to HACCP 16
Table 2: ISO 22000 Basic Outline ......21
Chapter I: Introduction
The concept of food safety has been in existence for centuries and has always upheld one
main objective: to eliminate potential contamination, whether physical, chemical, and/or
biological. According to the Center for Disease Control (CDC), 1 in 6 Americans, or 48 million
people, become ill from foodborne diseases each year. More astoundingly, approximately 3,000
Americans die annually from foodborne illnesses. A contributing factor to this alarming rate of
illness is due to new challenges that manufacturers and consumers face, such as new
microorganisms and toxins, changes in food production, changes in our environments, and the
rising number of multi-state outbreaks (CDC, 2011).
Due to new threats to the health and well being of individuals in the United States,
President Barack Obama passed the Food Safety Modernization Act (FSMA) in January of 2011.
This new bill directs the implementation of food safety systems in the food industry in the United
States. This bill also recognizes animal feed processors as food processors, which requires a
detailed food safety plan indicating potential hazards (Food and Drug Administration, 2011).
With a new focus on food safety, agricultural organizations are feeling more pressure to
implement programs that analyze potential contamination in their processes; the program that is
used and regulated throughout the industry is the Hazard Analysis Critical Control Points, also
known as HACCP. Until President Obama signed the Food Safety Modernization Act requiring
a food safety system, organizations that manufactured finished products enforced their own food
safety requirements. The HACCP food safety program covers all FDA requirements for food
manufacturers and ensures that proper documentation is in place in the event of an inspection or
recall. These new requirements present new challenges for all food processors from the small
farm to the large manufacturer. These challenges include identifying potential physical,
chemical, and biological hazards, determining how to sample critical limits, identifying
monitoring procedures, establishing corrective actions, implementing a verification schedule, and
introducing effective record keeping procedures. The World Health Organization (WHO) has
identified barriers that affect the implementation of a HACCP program, which include financial
constraints, lack of expertise and/or technical support, and inadequate infrastructure and facilities
(World Health Organization, 1999a).
A potential constraint when developing a HACCP plan is identifying likely
contaminations that may enter the process through raw materials or enter the product from the
machinery used in the organizations facility. The issues discussed above will require company
XYZ to conform to the newly regulated food safety regulations. Company XYZ is a small
organization that processes dry edible beans in the upper Midwest of the United States.
Company XYZ receives, processes, and repackages beans grown in Wisconsin, Minnesota, and
North Dakota. This organization has an established HACCP program and a few select prerequisite programs that assist the food safety system, but lack the management involvement and
training needed for an effective food safety system. With the ever-growing focus being placed
on agriculture, there is significant pressure to implement an effective food safety program that
ensures safe products. The FSMA states that food processors are to identify potential physical,
chemical, and biological hazards in their raw material and in the manufacturing facility.
Furthermore, processing controls and programs are required to prevent, monitor, and eliminate
potential foodborne hazards throughout the manufacturing facility.
Statement of the Problem
Even though company XYZ has a HACCP (quality and safety) system in place to address
potential food safety issues, improvements in the current system could ensure better food safety.
Purpose of the Study
current HACCP food safety program to reflect the standard of ISO 22000.
Goals of the Study
The goals of the study are to:

1. Conduct an analysis of identified food safety systems to understand the best food safety
practices.
2. Conduct a GAP analysis of the food safety system at XYZ.
3. Conduct a need assessment focusing on organizational analysis, task analysis, and
individual analysis.
Background and Significance
According Ropkins (2003), as the significant source of raw ingredients in the food
production industry, the agricultural sector is an essential factor of most food products and
supply chains. Subsequently, to have a successful HACCP program, it is imperative that
effective HACCP procedures have been developed. With the implementation of a HACCP
program, procedures are important to establish to determine the proper controls. According to
Galosich (1999) a HACCP plan should contain a list of the food-safety hazards to be controlled,
a list of critical control points (CCPs) and critical limits, monitoring procedures and frequencies,
and finally corrective actions developed. According to the International Journal of
Environmental Health Research conducted a survey on HACCP in food processing and found the
following results: 59% of food processors have not heard of HACCP system; only 27% claimed
to have received information on the approach, while 67% suggested that they would need
assistance in completing the HACCP requirements (Ehiri, 1997). This data appears to clearly
indicate the need for implementing the HACCP program in feed manufacturing so one can
determine where there to target controls.
Limitations of the Study
A primary limitation in the study was the lack of employees with experience in the
HACCP food safety system. Company XYZ is a small organization that requires many of its
personnel to perform other related tasks such as the plant manager also oversees the HACCP
program and quality program. In larger organizations, employees primary responsibilities are in
only one of these areas.
Assumptions of the Study
An assumption of Company XYZ is that a HACCP food safety program has been
properly integrated into the organization. These programs are used as a basis for implementation
of the food safety system. An additional assumption is that the study will be limited to a three
month time period for completion.
Definition of Terms
CCP Decision Tree: A sequence of questions to assist in determining whether a control
point is a CCP (FDA, para 8, 2009).
Control: (a) To manage the conditions of an operation to maintain compliance with
established criteria. (b) The state where correct procedures are being followed and criteria are
being met (FDA, para 9, 2009).
Control Measure: Any action or activity that can be used to prevent, eliminate or
reduce a significant hazard (FDA, para 10, 2009).
Control Point: Any step at which biological, chemical, or physical factors can be
controlled (FDA, para 11, 2009).
Corrective Action: Actions taken when a process deviates from the standard.
Criterion: A requirement on which a judgment or decision can be based (FDA, para
13, 2009).
Critical Control Point: A step at which control can be applied and is essential to
prevent or eliminate a food safety hazard or reduce it to an acceptable level (FDA, para 14,
2009).
Critical Limit: A maximum and/or minimum value to which a biological, chemical or

physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable
level the occurrence of a food safety hazard (FDA, para 15, 2009).
Deviation: Failure to meet the standard.
HACCP: A systematic approach to the identification, evaluation, and control of food
safety hazards (FDA, para 17, 2009).
HACCP Plan: The written document which is based upon the principles of HACCP
and which delineates the procedures to be followed (FDA, para 18, 2009).
HACCP System: The result of the implementation of the HACCP Plan (FDA, para 19,
2009).
HACCP Team: Team of individuals from the organization that have direct influence on
the manufacturing process.
Hazard: A biological, chemical, or physical agent that is reasonably likely to cause
illness or injury in the absence of its control (FDA, para 21, 2009).
Hazard Analysis: The process of collecting and evaluating information on hazards
associated with the food under consideration to decide which are significant and must be
addressed in the HACCP plan (FDA, para 22, 2009).
Monitor: To conduct a planned sequence of observations or measurements to assess
whether a CCP is under control and to produce an accurate record for future use in verification
(FDA, para 23, 2009).
Prerequisite Programs: Procedures, including Good Manufacturing Practices, that
address operational conditions providing the foundation for the HACCP system (FDA, para 24,
2009).
Severity: The seriousness of the effect(s) of a hazard (FDA, para 25, 2009).
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Step: A point, procedure, operation or stage in the food system from primary production
to final consumption (FDA, para 26, 2009).
Validation: That element of verification focused on collecting and evaluating scientific
and technical information to determine if the HACCP plan, when properly implemented, will
effectively control the hazards (FDA, para 27, 2009).
Verification: Those activities, other than monitoring, that determine the validity of the
HACCP plan and that the system is operating according to the plan (FDA, para 28, 2009).
Methodology
The investigator analyzed various food safety guidelines and developed a standard, which
measured the level food safety implementation. Company XYZs food safety system was
reviewed and documented using the tools developed based off the literature review. Then the
author used the information collected to determine applicable recommendation for the
improvement of the current food safety system.
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Chapter II: Literature Review

The purpose of this study was to develop the framework and systems in order to advance
the current HACCP food safety program at company XYZ to reflect the standard components of
an ISO 22000 food safety management system. This chapter discusses the issues and concerns
of foodborne illnesses in the world and the history of HACCP and ISO 22000. This chapter will
also discuss the procedures utilized when conducting a GAP analysis and needs assessment on a
foods safety system.
Issues and Concerns of Food Safety
According to the World Health Organization (2007), over 1.8 million people died in 2005
due to contamination of food and drinking water. Food safety is becoming a focal point
throughout the world as it has the ability to affect the whole population. It is estimated that
foodborne illnesses have increased an alarming 30% in industrial nations. In 1997, the United
States spent over $35 billion in medical costs and lost productivity due to foodborne illnesses
(WHO, 2007). These expenses are a priority area for most countries and organizations, which is
now placing more emphasis on the HACCP food safety program and the ISO 22000 food safety
management system.
The WHO has also stated that additional issues also require addressing to ensure better
food safety. These challenges include the evolution of food trading around the world,
globalization, changes in the standard of living, intentional contamination, and natural or
manmade disasters (2007). The flow of food processing has become more complicated, which in
turn is providing additional opportunities for adulteration and evolution of pathogens. Outbreaks
of foodborne illnesses that at one time were contained in a small region are now becoming a
global issue. (WHO, 2007).
History of HACCP
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The food safety program, HACCP, was first introduced as a joint venture between NASA
and the Pillsbury Corporation in the early 1960s (Mayes & Mortimore, 2001). It was initially
created to eliminate the microbiological hazards from outer space but also increase the
confidence that the space program could effectively maintain personnel safety. The primary
basis for eliminating the microbiological hazards was to ensure that astronauts would be safe
from sickness since they would be without medical care for several weeks (United National
Industrial Development Organization, 2000). Over the past 50 years, the HACCP approach has
gained popularity in both the private and public food sectors. A major turning point with the
implementation of food safety programs was the major outbreak of Clostridium Botulinum in the
early 1970s. Clostridium Botulinum is a spore shaped bacteria that can be found in any region
of the world. The initial symptoms include nausea, vomiting, and diarrhea, which can lead to
paralysis (WHO, 1999b). In response to the outbreak, the United States FDA issued low acid
canned food regulations, which are said to be the first government regulated HACCP programs
(Keener, 1999).
Another major development for the HACCP program was the establishment of the
Codex Alimentarius second edition in 1997. The Codex Alimentarius, which in latin means food
law or code, was established by the joint Food Agriculture Organization (FAO)/WHO
Committee. This standard on food hygiene was established to protect the health of consumers
and to ensure fair practices in the food trade (FAO/WHO, 1999). The basis of the second edition
was to establish the principles and guidelines to conducting microbiological risk assessments.
The code recommends that organizations use a HACCP based approach wherever possible to
enhance food safety (FAO/WHO, 1999). HACCP has evolved over the years due to the
advances in the quality management field, which in turn has allowed food processors to develop
a food safety management system (Surak, 2006).
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Today, with the assistance of the Food Safety Modernization Act, the FDA, and the US
Department of Agriculture requires mandatory food safety programs in all food and feed
manufacturing facilities (Keener, 1999). According to the FDA the new FSMA Act will have a
legislative mandate to require comprehensive, science based preventative controls across the
food supply (FDA, 1999).
History of ISO and ISO 22000
In 1946, representatives from 25 countries joined together to create a common and
unified industrial standard; the organization created was the International Organization of
Standardization (ISO). ISO has published more than 18,500 international standards in a 60-year
time period beginning in 1947. These standards range from agriculture and construction
standards, to mechanical engineering, to state-of-the-art information technology advances (ISO,
2011). Lawrence D. Eicher, the former ISO Secretary-General, stated in the book Friendship
Among Equals The essence of ISO's history is made up of the visions, aspirations, doubts,
successes, and failures of the people who, over the past fifty years, have created this rather
remarkable organization (Latimer, 1997).
According to Morrison and Morikawa, 2004, there were three major turning points for
ISO, the first being the development of the ISO 9000 Quality Management System in the 1980s.
Until this time, ISO was primarily known for creating technical specifications for specific
industries such as clothing size and laser technology. The second major turning point for ISO
was the development and implementation of the ISO 14000 Environmental Management
Standard in 1993 (Morikawa & Morrison, 2004). This was a major step as it started to work with
public policy and general public interest. The third major turning point for ISO was the
development of standards that support sustainability (Morikawa & Morrison, 2004). This
standard was named ISO Horizon 2010: Standards for a Sustainable World. Six decades since its
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inception, ISO has grown into the worlds largest standards development organization with well
over 14,000 standards and 148 countries in the federation (Morikawa & Morrison, 2004).
In 2005, there was an international effort to attempt to standardize the food safety system
worldwide. This effort resulted in ISO creating the ISO 22000 Food Safety Management System
(FSMS)- requirements for any organization in the food chain (Surak, 2007). The ISO 22000
FSMS was created similarly to other ISO management systems, more specifically to the ISO
9001 Quality Management System. The ISO management system forces the continuous process
improvement approach through analysis and considerations. The ISO 22000 system also takes
an integrated food safety approach in which companies are required to analyze potential food
safety hazards in final products and create preventative measures to control the hazards. State of
the art food safety systems are relatively new in the industry and are currently being driven by
customers rather than government regulation.
HACCP Fundamentals
HACCP and the ISO 22000 system were both developed with the intention of preventing
contamination in the food industry. The ISO 22000 standard was the first food safety
management system to go outside the Codex Alimentarius food hygiene recommendations set
forth in 1993 (Blanc, 2006). HACCP has evolved over the years and now has 12 established
steps, which include five preliminary steps and seven primary principles (Surak, 2007). Table 1
identifies the basic requirements to the developing a basic HACCP system.
Table 1
Five Preliminary Steps and Seven Principles of HACCP
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Step
Description
Preliminary Step One
Assemble the HACCP team
Preliminary Step Two
Describe the product
Preliminary Step Three
Identify intended use of the product
Preliminary Step Four
Construct a flow diagram
Preliminary Step Five
Conduct an on-site verification of the flow

diagram
Principle One
Conduct a hazard analysis
Principle Two
Determine critical control points (CCP)
Principle Three
Establish critical limits for CCPs
Principle Four
Establish a monitoring system for CCPs
Principle Five
Establish corrective actions
Principle Six
Establish verification procedures
Principle Seven
Establish documentation and recordkeeping
Surak, (2007) A recipe for safe food: iso 22000 and haccp
The first preliminary step in applying the HACCP principles is building the HACCP
team. The establishment of a HACCP team is a very important preparatory step prior to the
establishment of a HACCP plan. Prior to creating a cross-functional team, total commitment
from management must exist to ensure that the proper financial support will be in place
throughout the implementation (Hernandez, 1999). A cross-functional team should include
individuals who have specific knowledge to the processes involved and bring different
viewpoints to the group (Keener, 2007b & UNIDO, 2000). Individuals should be selected from
production, quality control, senior management, engineering, and maintenance personnel. Once
the team is established, each member should be trained on the components of the HACCP system
16
to ensure that the team uses common terminology and has the same food safety focus (UNIDO,
2000).
The next step after creating the HACCP team is creating a description of the final product
that is manufactured at the particular facility. According to the United States Department of
Agriculture (1997) components of the description include common name, how it will be used,
type of packaging, shelf life, and how the product will be distributed. Product descriptions
should be tailored to each companys needs based on the amount of product it manufacturers.
The third preliminary step is identifying the products intended use. The products intended
should be based on the end users expected use of the product (FAO/WHO, 1999).
The fourth preliminary step in creating a HACCP program is the construction of a flow
diagram, which covers all steps of the process. The flow diagram should not be complex,
making it easy to understand and can include steps before and after the production of the product
(USDA, 1997). The fifth, and final, preliminary step involves the verification of the flow
diagram, which includes a walkthrough of the manufacturing process to ensure that the flow
diagram matches the actual process.
The first principle of the HACCP program is to conduct a hazard analysis, which includes
a list of steps in in the process where there is a potential for hazards to occur and the preventative
measures currently in place (USDA, 1997). A hazard is defined by the UNIDO as A biological,
chemical, or physical agent in, or condition of, food with the potential to cause an adverse health
effect (p. 7, 2000). The primary objective of creating a hazard analysis is to identify the
primary hazards in a facility that need to be controlled.
The second principle of a HACCP program is to determine the critical control points
based on the hazards indicated in the first principle. A critical limit is defined by the FDA as A
step at which control can be applied and is essential to prevent or eliminate a food safety hazard
or reduce it to an acceptable level (para 14, 2009). Critical control points (CCPs) can be
17
determined through the use of CCP decision trees, which ask a series of questions related to the
effectiveness of an organizations ability to control a hazard. CCP decision trees are not
applicable to all situations, and other approaches might be recommended based on processing
specifications.
The third principle is establishing the critical limits for each designated CCP. Critical
limits are exposed as numbers or specific units of measurement such as temperature, pH level,
time, chlorine level, and/or a specific number of physical hazards found in a period of time. In
certain cases no more than one critical limit needs to be established to control a particular hazard
(USDA, 1997).
The fourth principle is establishing the monitoring procedures for each CCP. Monitoring
procedures are a scheduled measurement or observation of specific process or CCP (FAO/WHO,
1999). The USDA (p.14, 1997) recommends the following monitoring procedures for a HACCP
plan:
Identify the best monitoring technique based on the needs of each CCP.
Determine the frequency of monitoring for each CCP.
Determine if the monitoring activity needs to be done randomly to get a good

representation of the product throughout the days production. If random
sampling is to be conducted it will be described at this step.
Determine what testing procedures need to be done for each monitoring function.
Identify and train the employees responsible for completing the monitoring
process.
Verify that the employee conducting the monitoring is completing all required
documentation associated with that process. All records and documents should be
signed by the individual responsible for monitoring as well as a management
review and verification (FAO/WHO, 1999).
18
19
Enter all the above information into a spreadsheet for proper documentation.
The fifth principle of HACCP is the establishment of corrective actions, which are a
detailed list of procedures in the event that there is a deviation from the established critical limits
at a CCP (FDA, 2009). Corrective actions can be determined prior to any deviation taking place.
A set protocol should be established in the HACCP plan for the proper steps an employee to take
in the event of a deviation. Corrective actions shall be reviewed monthly or annually based on
the needs of the organization and should be reviewed by the HACCP team.
The sixth principle is the establishment of recordkeeping procedures. Records are an
integral part of the HACCP program as they serve as written documentation that policies and
procedures are being followed. Records also allow an organization to trace the history of a
product from the raw material to the finished product in the event of an issue (USDA, 1997). To
follow the requirements of HACCP, records shall be completed for CCPs, establishment of
critical limits, corrective actions taken, and the hazard analysis.
The seventh, and final, principle of the HACCP program is the establishment of
verification procedures. The basis for these procedures is to verify the HACCP system is
working according to the plan. Verification procedures that can be performed are to audit the
monitoring procedures, calibrate testing equipment, sample finished product, and review
completed corrective actions.
ISO 22000 Fundamentals
The ISO 22000 incorporated the HACCP principles described in detail in the Codex
Alimentarius but also developed a management framework to improve effectiveness and
efficiency (Blanc, 2006). The ISO 22000 food safety management standard has the following
characteristics:
Utilizable in all organizations in the food chain industries;
Combines the recognized food safety system elements as defined by Codex;
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Provides an auditable standard that could be used as part of third party

certifications;
Ensures that the process used to control food safety is validated, verified,
implemented, monitored, and managed;
Focuses only on food safety.
(Surak, 2006)
One of the key components to the ISO 22000 FSMS is the integration of documented
management commitment and support (Nowicki & Sikora, 2007). The integration of these
management requirements enhances the ISO 22000 system over the basic HACCP principles.
One of the most significant requirements of the ISO 22000 systems is the commitment and
involvement of management in the food safety management system. The primary components of
a management system include:
Policy- a food safety management policy defines an organizations commitment

to food safety. It describes what management will do to ensure proper food safety
programs and policies are in place as well as describe the direction of the overall
organization.
Planning- the primary goal of planning in a management system is to establish

goals and objectives for the organization to follow. Prior to the development of
the goals, the legal requirements should be analyzed to determine the specific
regulatory needs. Developing goals and objectives provides the guidance for the
food safety management system.
Implementation and Operation- the first step of the implementation and operation
is defining the roles and responsibilities of employees that are associated with the
food safety management system. The second step is to provide training on the
food safety system and then establish internal and external communication.
21
Performance Assessment- a performance assessment is conducted to ensure that

goals are consistently being met in an efficient and effective manner.
Improvement- Improvement or corrective actions are steps that are taken to

eliminate the causes of a non-conformity. Actions necessary to address actual or
potential problems and to improve the food safety system are implemented
through corrective and preventive actions.
Management Review- the primary goal of a management review is to evaluate the

overall performance of an organizations food safety management system. Top
management that is experienced or has a direct impact on the current food safety
system should carry out the review. The management review should be carried
out on a regular basis.
Once the system is implemented, management will then review the documentation to
ensure effectiveness and determine any areas requiring further improvement. Improvement
consists of management reviews, internal audits, corrective actions, verification results, and
validation results. Table 2 represents the basic requirements of the ISO 22000 FSMS. The
requirements of ISO 22000 are generic and are intended to be applicable to all organizations in
the food chain regardless of size (GFSI, 2007).
Table 2
ISO 22000 Basic Framework
ISO 22000 Clause
Number
4
4.1
4.2
5
5.1
5.2
System Requirements
Food Safety System Requirements
Establish a food safety management system
Document your food safety management system
Food Safety Management Requirements
Demonstrate a commitment to food safety
Establish a food safety policy
22
5.3
5.4
5.5
5.6
5.7
5.8
6
6.1
6.2
6.3
6.4
7
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
8
8.1
8.2
8.3
8.4
8.5
Plan a food safety management system

Clarify the FSMS responsibilities
Appoint a food safety team leader
Establish communications
Develop emergency response procedures
Carry out FSMS management reviews
Food Safety Resource Requirements
Provide adequate FSMS resources
Provide adequate human resources
Provide adequate infrastructure
Provide adequate work environment
Food Safety Realization Requirements
Manage the realization for safety products
Establish the prerequisite programs (PRPs)
Prepare for a hazard analysis
Perform organization's hazard analysis
Establish the operational prerequisite programs (OPRPs)
Establish the HACCP plan
Update preliminary documents and programs
Plan and perform verification activities
Establish a product traceability system
Control nonconforming product
Food Safety Confirmation Requirements
Confirm and improve food safety methods
Validate food safety control measures
Control monitoring and measuring methods
Verify the food safety management system (FSMS)
Improve the food safety management system (FSMS)
Blanc, (2006) Iso 22000 from intent to implementation.

Based on the components indicated in Table 2, one of the key differences between the
two systems is that ISO 22000 emphasizes more pre-requisite programs; reference ISO 22000
clause 7.5. Pre-requisite programs are essential to the development and implementation of a
quality HACCP or ISO 22000 program (Keener, 1999). The primary pre-requisite programs
include: Current Good Manufacturing Practices (cGMPs), Sanitation Standard Operating
Procedures (SSOP), and Quality Control programs, which are crucial to the development of a
sustainable food safety system (Keener, 1999). According to Keener K.E., GMP regulations
were first introduced in 1969 by the FDA as Part 128 of the Code of Federal Regulations to
further implement the Food, Drug and Cosmetic Act. In 1997, this was recorded as Part 110 and
was further revised and updated in 1986, to what is now regarded as Current Good
Manufacturing Practices (cGMPs)(para 4, 2007a). Keener continues to say GMP regulations
are designed to control the risk of contaminating foods with filth, chemicals, microbes, and other
means during their manufacture(para 5, 2007a). Common cGMP programs that are found in
different industries include general maintenance of facilities, pest and rodent control, proper
practice and storage of cleaning mixtures, and employee training.
Working hand in hand with cGMPs are SSOPs, which are written procedures that place
specific guidelines on a facility to ensure sanitary conditions. SSOPs are specific to each
organization and/or facility as to when areas of equipment are to be cleaned and maintained. The
two main components of SSOPs are pre-operational and operational (Keener, 2007a). Keener
describes pre-operational SSOPs as established procedures that describe the daily, routine,
sanitary procedures that occur before processing begins. The procedures must include the
cleaning of product contact surfaces of facilities, equipment, and utensils to prevent direct
product contamination or adulteration (p. 3, 2007a). ISO 22000 like many other food safety
certifications focuses on the communication of food safety goals, policies, and procedures to its
employees, customers, and visitors.
Conducting a Needs Assessment
A needs assessment is a systematic approach to studying the state of knowledge, ability,
interest, or attitude of a defined audience or group involving a particular subject (McCawley,
2009). Comprehensive needs assessment research helps document actual problems and
deficiencies (McCawley, 2009). There are four steps are that are used to create a needs
assessment for an organization (Rouda & Kusy, 1995):
1. Conduct a Gap Analysis
2. Distinguish Priorities and Significance
23
3. Identify Sources of Performance Deficiencies and/or Opportunities For Improvement

4. Recognize Potential Resolutions and Development Opportunities
Needs assessments can be used to analyze organization needs, task needs, and training
needs. The first type of analysis is an organizational analysis; this analysis analyzes the efficacy
of the company and determines the level of training that is needed (Miller & Osinski, 2002). An
organizational analysis should identify environmental impacts, state of the current economy,
changing technology, and change of work force demographics (Miller & Osinski, 2002). A
variety of sources can assist in the organizational analysis such as the organizations
goals/objectives; direct labor costs, strategic planning, and/or any changes in equipment.
The task analysis portion provides information about a job or a group of jobs. This
information determines the level of knowledge, skill, and attitudes needed for acceptable
workplace performance (Miller & Osinski, 2002). Sources such as job descriptions, which are a
summary of specific positions responsibilities, can be used to assist in a task analysis. Another
way to conduct a needs assessment of a specific task is conducting interviews and questionnaires
with individuals that are employed at each specific position. The last type of needs assessment is
the individual analysis, which analyzes individual employee job performance and determines the
training needs of employees.
There are multiple sources of information to assist in the completion of an individual
analysis. The first source is conducting a performance evaluation; which assess an individuals
overall performance and indicates any weaknesses. Performance issues can result from lack of
productivity, tardiness, grievances, or a lack of knowledge and training on a specific task.
Another source of information for completing individual analysis is interviewing employees,
supervisors, and management.
According to Rouda and Kusy, 1995, there are four steps to completing a needs
assessment on an organization. The first step of conducting the needs assessment is performing a
24
gap analysis; which analyzes where a process or situation is compared to where it will be in
the future. When conducting a gap analysis, it is crucial that an auditor focuses on what is and
what is not established in the facility. The first significance of the analysis is to assess the
current state of the organization, which can include determining goals, climate, and
internal/external constraints (Rouda & Kusy, 1995). To know where an organization needs to
be, an audit or evaluation should be developed to determine what components are lacking.
According to Rouda and Kusy, 1995, the following are a list of need assessment techniques:
Direct observation
Questionnaires
Consultations with persons in key positions
Review of relevant literature
Interviews
Focus Groups
Tests
Records and report studies
Work samples
An audit, for example, can be created based on a standard to determine where an

organization relates to that standard. Another style of needs assessment is conducting an
interview of specific personnel that have a direct impact to the study area. This interview allows
conducting a gap analysis on an organization; the standards/requirements of ISO 22000 should
be used to create an audit.
The second step of the needs assessment combines the list of deficiencies identified by
the gap analysis. This list will then be examined based on the organizations goals, realities, and
constraints to determine attainable goals for the future.
25
The third step of the needs assessment is identifying causes of performance problems
and/or opportunities. When analyzing performance problems three questions need to be asked:
1. Are employees performing their jobs effectively?
2. Do they know how to do their job properly?
The fourth step to conducting a needs assessment is identifying possible solutions and
growth opportunities. Using steps one through three, deficiencies in a system have been
identified and now a corrective action must be taken. If individuals are not performing a job
effectively and efficiently a corrective action such as training and or organization development
should be used (Rouda & Kusy, 1995). Using organizational development as a tool can benefit
the organization through strategic planning and or proper team building exercises.
26
Chapter III: Methodology

current HACCP food safety program for Company XYZ to reflect the ISO 22000 criteria. The
following are the goals of the study:
1. Conduct an analysis of identified food safety systems to understand the best food safety
practices.
2. Conduct a gap analysis of the food safety system at Company XYZ.
3. Conduct a needs assessment focusing on organizational analysis, task analysis, and
This chapter will discuss the methodology for the selection of the interviewees as well as
the strategy that was used in the determining the needs of company XYZ.
Subject Selection and Description
Due to the small size of the organization, many positions take on a variety of
responsibilities that have a direct impact on food safety. Participants were selected for the semi structured interview and audit by identifying the key roles in the organization that rely on food
safety principles. These key roles include:
President- The president of the organization has complete control of the office personnel
and has the final authority to establish new policies and procedures.
Plant Manager- The plant manager is responsible for production controls, implementation
of programs and procedures, and overall system performance. Decisions on monitoring
and corrective actions on quality and food safety fall on the responsibility of the plant
manager.
VP of Receiving and Procurement- Receiving and procurement are the first steps to
limiting the potential for hazards to enter the facility. This important role is to monitor all
incoming raw product prior to storage, identifying type, quality, and potential hazards.
27
This individuals role is to work directly with the president, assisting in decision-making.
It is also the responsibility of this individual to assist the plant manager with process
changing decisions.
Shipping Manager- The shipping manager has control over the final step of the process
before the product leaves the facility. The shipping manager reports to the plant manager
on a daily basis for updates on shipping schedules and changes in production. This role
has the responsibility of working with other warehouse personnel on the preparation of
finished product for shipping.
The semi-structured interview and audit were conducted on a voluntary basis. There were
no consequences for any individual who declined to participate. All participants were
encouraged to ask any questions pertaining to the structure of the audit and interview prior to
starting.
Instrumentation
The first instrument used in analyzing the organizations established food safety
programs and procedures was an audit checklist. The audit consisted of yes or no questions
related to each of the fundamental components of ISO 22000. The checklist focused on current
management responsibilities, communication procedures, hazard analysis, and the establishment
of prerequisite programs. The first portion of the checklist indicates Managements responsibility
and their commitment to food safety through a mission statement, a vision statement, and
established programs.
The second portion of the checklist was the established communication procedures. This
determined how deficiencies, new programs or procedures, and any updates are communicated
throughout the organization. The third section of the checklist identified key components to the
HACCP system, which included identifying hazards, establishing CCPs, identifying critical
28
limits, and the procedures to monitor and verify each established CCP. The fourth, and last,
section of the audit checklist was based on established pre-requisite programs.
The second instrument used in the study to determine the organizations needs was a
semi-structured interview guide. This guide was facilitated by an interview conducted by the
researcher utilizing key personnel in the organization. The semi-structured interview guide
focused on six major components: management support, prerequisite programs, establishment of
HACCP principles, documentation, and verification and principles. The procedures for the semistructured interview included asking open-ended questions, which were designed to promote
conversation between the researcher and the interviewee. The major components were used to
start the interview and lead into more specific questions with the process, structure, and
programs. The structure of the interview was developed based on the literature reviewed
pertaining to ISO 22000 components.
Data Collection Procedures
Due to the extensive food safety background with food safety systems and the
understanding of the plant processes, the plant manager was selected to assist in the audit process
and conduct the gap analysis with the researcher. The audit was conducted by asking a series of
questions related to each component of the ISO 22000 standard. The questions were asked in a
format in which resulted in a yes or no answer. Any components that were answered as nonapplicable (N/A) or as unknown were documented in the comments box next to the question.
Any additional comments added to any of the components of the ISO 22000 system were added
to the comments section in audit form.
The semi-structured interview was designed to identify established or lacking
components of the food safety system and was conducted between the investigator and HACCP
experienced management personnel. The President, Plant Manager, Vice President of Receiving
and Procurement, and the Shipping Manager completed the interview in a two-day period. As
29
interviewees answered questions related to the ISO 22000 system, the interviewer recorded the
responses utilizing a voice recorder and detailed notes. This procedure was conducted to ensure
that answers were recorded accurately.
Data Analysis
The main objective of this study was to determine deficiencies in the current system and
to identify potential improvements following the ISO 22000 food safety management principles.
Based on the importance of understanding food safety principles in the organization, the
positions of interviewees were included in the results to determine if there are deficiencies in the
overall structure. The first instrument used in the study was the audit checklist conducted with
the Plant Manager. The audit checklist results were analyzed to determine the deficiencies,
which were presented with response; No. The basis of this analysis was to identify key programs
and procedures that are established or lacking at the facility.
The interview instrumentation will be analyzed to determine if there are any differences
in answers between the different subjects. The basis for this interview is to compare the
identified established programs in the audit checklist to the how each program is implemented in
organization. Proper implementation includes training to all employees on the components of the
program or step-by-step procedures. Differences in answers will display lack of overall
management buy-in throughout the organizations structure. The audit and interview responses
were analyzed based on the three major points.
These points are:
1. Current implementation of HACCP policies and procedures- these were measured by
analyzing the results of the interview compared to the components of the ISO 22000
standard. An important part of implementation is employee training on the specific topic;
employees should have a knowledge base for HACCP policies and procedures.
30
2. GAP between current HACCP system and ISO 22000 principles- these are measured by
using the audit checklist to determine what ISO 22000 principles are implemented in the
facility.
3. Food safety training needs- food safety training needs is determined through the semistructured interview. The interview will establish the amount of training on specific
components of a food safety system.
Limitations
The primary limitation in the study was the lack of employees with experience in the
personnel to perform other related tasks. For example, the plant manager also oversees the
HACCP program and quality program. In larger organizations, employees primary
responsibilities are in only one of these areas.
31
Chapter IV: Results

current HACCP food safety program for Company XYZ to reflect the ISO 22000 criteria. The
following were the objectives of the study:
1. Conduct an analysis of identified food safety systems in order to understand the best food
safety practices.
2. Conduct a gap analysis of the food safety system at Company XYZ.
To achieve the objectives of the study, the methodology utilized a review of literature, an
ISO 22000-audit checklist, and a semi-structured interview. To accomplish the first objective, a
literature review was conducted to identify significant components to the ISO 22000 Food Safety
Management System to assist in creating the ISO 22000 audit checklist. To complete the second
objective, the ISO 22000 audit checklist was created to determine the current gap between
established HACCP principles and ISO 22000 components. Results of the created checklist are
shown in Appendix A. To complete the third objective, a semi-structured interview was
conducted using a guide to identify critical organization needs. The interview was conducted
with four key members of the organization to determine current HACCP components,
management commitment to food safety, and current training practices; which are all key
components to the ISO 22000 FSMS.
Results from Literature Review
To accomplish the first objective, a review of literature was used to identify current food
safety systems in the food industry. The two systems that were analyzed were HACCP and the
ISO 22000 Food Safety Management System. The HACCP system focuses on the
implementation of preventative measures to effectively reduce the probability of hazards
32
entering into a process. The HACCP system utilizes a seven-step process to identify the
likelihood of risk and associate controls to reduce or eliminate potential hazard (Varzakas &
Arvanitoyannis, 2008). It has been suggested that the implementation of HACCP doesnt
provide enough system control to prevent some food borne illness outbreaks (Keener, 1999).
These systems controls include good manufacturing practices and other supporting pre-requisite
programs. The ISO 22000 Food Safety Management System applies the same principles of
HACCP but places a greater deal of emphasis on pre-requisite programs and overall management
commitment. The emphasis on management commitment resembles other management standards
as it has the following elements (Surak, 2007):
Policy Statements
Food Safety Planning
Implementation and operation of pre-requisite programs
System Improvement
Management Review
The ISO 22000 system utilizes an approach that food safety is more than just a quality
control program but requires a cross functioning organization. Through the implementation of
ISO 22000 principles, organizations are improving system performance with the involvement of
research and development, engineering, purchasing, sales, and human resources (Surak, 2006).
By involving other departments into the food safety system, the organization creates a complete
understanding of proper food safety practices that can be emphasized at all levels. Not only does
this system require a cross functioning team, but it also requires more involvement in manpower,
improvement, and involvement of the HACCP team, and places higher emphasis on the food
safety system (Blanc, 2006). ISO 22000 incorporates and enhances the HACCP system to create
an effective food safety management system (Surak, 2007). The literature review also provided a
33
basis for the creation of the audit checklist that was used to determine the current gap between
Company XYZs HACCP system and the ISO 22000 FSMS.
Results from ISO 22000 Audit Checklist
The audit checklist conducted with the plant manager established the level at which
Company XYZs current food safety system was operating. Company XYZ has established
some of the critical components to the ISO 22000 system but fails to have proper training to
assist in the implementation of the programs. Programs in clause 7.2 that need improvement are:
Allergen Control Program, Security Program, and Preventative Maintenance Program. Training
programs for pre-requisite and HACCP components are essential to the implementation of a
successful food safety management system (Surak, 2006). Corrective actions for pre-requisite
programs are not currently being documented by managers, which were indicated in response of
clause 7.2. The corrective actions serve as a basis for improvement and are required to show
improvement in process deficiencies.
In addition to the lack of training programs, a lack of management support in the HACCP
and in the pre-requisite programs could suggest a deficiency in the management system. Clause
5.3 indicates management was not involved in the development, implementation, or evaluation
of the food safety management system.
Results from Semi-Structured Interview
The semi-structured interview established a clear divide between management and
employees on food safety principles at Company XYZ. The first topic was based on
understanding of HACCP components. Based on the results provided, respondents understand
food safety and the importance of establishing controls in the facility. The interview shows that
while employees have an understanding of hazards, they lack the technical training to identify
the sources of contamination in the processing line. Additionally, while the new Plant Manager
at Company XYZ has an extensive background and overall knowledge of HACCP and food
34
safety, this individual lacks the resources to apply the basic concepts. All respondents answered
that they understand the major concerns in food safety with recalls, glass awareness, lack of
industry knowledge, and food hazards being the primary concerns. These elements are all part of
a food safety system, however, suggest that a reactionary approach is used to identify food safety
concerns. A successful HACCP program should proactively identify and reduce the likelihood of
food safety concerns opposed to waiting for the negative event to happen first (Keener, 2007b).
The second topic was managements commitment to food safety, which is a key
component to ISO 22000 system. Respondents indicated that while commitment to food safety is
present through physical controls, there is a clear need for improvement. The president
suggested that providing the managers with more resources, such as time and the tools necessary
to conduct food safety training, would improve managements commitment to food safety.
Additionally, another area of concern is the financial support that would be necessary to
implement an effective food safety management system.
Training was the third and last topic of the interview. Respondents suggest that there is a
serious deficiency in current food safety training programs at Company XYZ. The president and
vice president of receiving and procurement suggest there is a training program in place for some
pre-requisite programs, however, the shipping manager indicated there is no training currently in
place. This individual also indicates that employees are trained only by other employees. This
method of training does present successful real life examples but fails to present a consistent
message put forth by management. Suggestions for improvement include setting aside more
time for training, improving managements commitment to training, implementing a consistent
training program for employees and managers.
Summary
The purpose of this study was to identify areas of improvement for Company XYZs
food safety system using components of the ISO 22000 Food Safety Management System. This
35
chapter provided a synopsis of the results collected by the study. The first objective of the study
was to identify the current food safety systems. This was accomplished by reviewing literature
on HACCP and ISO 22000 Food Safety Management Systems.
The second objective of the study was to conduct a gap analysis between current food
safety systems and the components of ISO 22000. By utilizing the information gathered in the
literature review, an audit checklist was created to determine the current level of the food safety
system at Company XYZ.
The third and last objective of the study was to conduct a needs assessment focusing on
organizational, task, and individual needs. The needs assessment was facilitated using a semistructured interview guide that focused on current food safety system, management commitment,
and training. The information gathered from the audit checklist and semi-structured interviewed
were used to determine the recommendations presented in Chapter V.
36
Chapter V: Discussion
Restatement of the Problem
Even though company XYZ has a HACCP (quality and safety) system in place to address
potential food safety issues, improvements in the current system could ensure better food safety.
Purpose of the Study
current HACCP food safety program to reflect the standard of ISO 22000.
Goals of the Study
1. Conduct an analysis of identified food safety systems in order to understand the best food
safety practices.
2. Conduct a GAP analysis of the food safety system at XYZ.
Methods and Procedures
To accomplish the goals of the study, the methods consisted of a literature review, audit
checklist, and a semi-structured interview. These methods assisted in the collection of
information related to company XYZ and the areas that could be improved related to food safety
programs and training.
A literature review was used to analyze two food safety systems, HACCP and ISO 22000
FSMS, and identify the specific components to each. The literature also served as the basis in
creating the audit checklist, in which each component of the ISO 22000 system was broken down
and questions were created based on each clause.
An audit checklist was conducted with Company XYZ to determine the current gap
between the current implemented food safety system and the requirements of the ISO 22000
37
FSMS. The results were used to determine deficiencies in the system and assisted in the
application of the semi-structured interview with employees.
A semi-structured interview was conducted with four members of Company XYZ, which
included the president, vice president of receiving and procurement, plant manager, and shipping
manager. The information attained from the interview assisted in the completion of the third
goal; conduct a need assessment focusing on organizational analysis, task analysis, and
Major Findings
The audit checklist and semi structured interview used in the study indicated there was a
strong deficiency in the training of employees and managers as well as a lack management
involvement in the food safety system. There are a few major critical programs established that
will create a foundation for implementing further controls. Company XYZs current food safety
system utilizes a reactionary approach to identifying food safety hazards in product and the
facility.
Limitations
A primary limitation in the study was the lack of employees with experience in the
personnel to perform other related tasks such as the plant manager also oversees the HACCP
program and quality program. In larger organizations, employees primary responsibilities are in
only one of these areas.
Conclusions
Objective 1 was to conduct an analysis of identified food safety systems in order to understand
the best food safety practices. The following conclusions were developed based on the results:
38
39
Company XYZ will be better served by implementing the ISO 22000 components to
improve their current food safety system. The current HACCP system fails to implement
a structured management commitment that would better serve the employees as well as
improve system effectiveness.
It was established that management commitment is an important component to

establishing an effective food safety management system. The ISO 22000 standard
focuses on the improvement of food safety management efficacy through the
implementation of a more compressed food safety management system (Nowicki &
Sikora, 2007).
Pre-requisite programs provide the basic foundation to support a food safety management
system. Pre-requisite programs are designed for supporting an infrastructure and
establishing a clear hygiene program in a food manufacturing facility (Nowicki & Sikora,
2007). These programs also assist in the prevention of introducing food safety hazards
from the work environment.
Objective 2 was to conduct a GAP analysis of the food safety system at Company XYZ. Based
on the results, the following conclusions were developed:
Based on the results in appendix A, there is a clear gap between the food safety system at
Company XYZ and the component of the ISO 22000 food safety management system.
Company XYZ answered 58% of the questions with a yes indicating that that the
programs or procedures have been implemented. In comparison, 42% of the programs or
procedures are currently not being completed.
40
The results show that there are many critical components that Company XYZ has
established to reduce likelihood of food safety hazards. Major programs that are
established to assist the food safety system are: HACCP program, preventative
maintenance program, good manufacturing practices, allergen program, glass program,
pest control program, and document control program. These programs build a strong
foundation for future improvement of the food safety system.
Finally, the results show there are critical components missing that effectively verify and
validate the current food safety system. Verification and validation steps that are missing
are the proper training on pre-requisite program and the HACCP principles. In addition
there is a lack of management involvement with the creation, implementation, and
validation of the current food safety system.
Objective 3 was to conduct a needs assessment focusing on organizational analysis, task

analysis, and individual analysis. The following conclusions were developed based on the
results:
First, the current system implemented at Company XYZ is based on reactive measures
instead of proactive measures. Actions are based on what customers are indicating as
issues instead of creating a system that identifies hazards before they enter the processing
facility.
Finally, there is a strong need to implement a training program that emphasizes the need
for workplace practices that focus on food safety. There were clear differences in opinion
of current training levels indicated in the semi-structured interview. The difference in
opinion of training levels indicates the lack of an established training program.
Recommendations
Based on the results from the study, the following recommendations were made
regarding the food safety program at Company XYZ:
41
Management commitment is a fundamental concept that must be further implemented at

Company XYZ. Commitment should include training, providing financial resources to
assist in the implementation of food safety programs, and assisting in implementing the
food safety program as a management team. The ISO 22000 standard requires that food
safety should be supported by the overall organizational objectives (Surak, 2007).
Expand the responsibilities of the food safety team leader (HACCP Coordinator) to
include more interaction with top management on current issues in training and
implementation and updates of the foods safety system. The food safety leader is a
critical link in the implementation of the food safety system (Surak, 2007).
Develop a food safety-training program that emphasizes the pre-requisite programs and
the food safety system components. Prior to the implementation of the training program,
it is vital that there is management commitment and employee buy-in to the food safety
programs. The lack of buy-in from employees and managers will result in a deficient
training program and could lead to an ineffective food safety program. Employees and
managers should be trained on the fundamentals of the program, the importance of the
program, and how the program relates to the employees tasks. Suggested training topics
are:
o Background of Food Safety- Teach employees the history of food safety and
current updates in regulation. Understanding the evolution of food safety will
contribute to the foundation of your food safety system.
o HACCP principles- Train employees on the five preliminary steps and seven
principles of HACCP. It is vital that employees and managers understand how
HACCP is created and the basic steps to identify and control potential
contaminates.
o Critical Control Point Training- Train employees and managers what steps in the
process are identified as critical control points and the critical limits associated
with those steps. Operators in the processing line need to understand why a
specific process is a critical control point and the consequences associated with
the critical limit.
o Hazard Awareness Training- Teach employees how to recognize physical,
chemical, and biological hazards that could be potentially originate in raw product
or result from equipment breakdown. This training will also cover hazard
investigations, which will allow employees to assist in the identification of hazard
type and point of origin.
o Pre-requisite Program Training- Train employees on each program and how they
create a foundation to support the food safety system.
Implement a program that will identify effectiveness of training to managers and

employees. This program should include a quiz or a question and answer session, which
can be used as a resource to identify if employees understand the information that was
covered and will assist to identify areas of improvement in training. In addition to the
quiz and question and answer session, observations shall be conducted daily, weekly, and
monthly to verify and validate managers are holding employees accountable for food
safety principles. This also identifies that employees are following established prerequisite programs. Training should be conducted on a monthly basis to promote
continuous learning and promote a constant message of food safety.
Areas of Further Research

The scope of this research was relatively narrow; consequently the following should be
considered for further research:
42
1. Analyze the Safe Quality Food (SQF) standard and determine the relation between ISO
22000 and SQF.
2. Conduct further semi-structured interviews with employees located in the processing line
to more accurately determine levels of training.
43
44
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46
Appendix A: An Introduction to APA Style and Research Paper FAQs.
.
ISO
22000
Clause
Numbe
r
System Requirements
4
Food Safety System Requirements
Established Food Safety Management System
4.1
(FSMS)
Does the organization have an established Food
Safety Management System?
Has the system been certified by an external party?
Documentation to support the Food Safety
4.2
Management System
Does the organization have documentation to support
the FSMS?
Are food safety management documents controlled?
Are procedures established to control FSMS records?
5
Food Safety Management Requirements
5.1
Food Safety Management Commitment Policy
Is there an established Food Safety Management
Commitment Statement?
Is Management Commitment Statement visible for all
employees?
Have top management signed the Food Safety
Management Commitment Statement?
Is there a food safety vision statement?
Is there a food safety mission statement?
5.2
Food Safety Policy
Is there a food safety policy?
Is the food safety policy posted for all employees?
Have managers implemented food safety policy
throughout the organization?
5.3
Plan your food safety management system
Are top managers involved in the development of the
FSMS?
Are top managers involved in the implementation of
the FSMS?
Are top managers involved in the evaluation of the
FSMS?
5.4
Clarify the FSMS responsibilities
Yes
No
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Comments
47
48
5.5
5.6
5.7
5.8
6
6.1
6.2
Are responsibilities of the FSMS defined?

Are designated personnel given the authority to solve
FSMS problems?
Are all affected personnel trained on FSMS
responsibilities and authorities?
Appoint a food safety team leader
Is a food safety team leader established?
Does the food safety team leader have the authority to
make changes to the FSMS?
Is there an established HACCP Team?
Are HACCP team roles and responsibilities defined?
Is a member of management a HACCP team member?
Does the HACCP team meet monthly at a minimum?
Are HACCP meeting notes documented?
Establish communications
Are external communication procedures established to
handle food safety issues or concerns?
Are these procedures verified and validated?
Are internal communication procedures established to
handle food safety issues or concerns?
Are these procedures verified and validated?
Develop emergency response procedures
Is there an established recall program?
Have responsibilities and authority been defined in the
recall program?
Has the recall program been verified?
Is there an established emergency response program?
Has the emergency response program been verified?
Carry out FSMS management reviews
Does management review the food safety
management system?
Does all management review FSMS objectives?
Are records kept on all FSMS management reviews?
Food Safety Resource Requirements
Provide adequate FSMS resources
Are the proper resources provided to establish the
FSMS?
Are the proper resources provided to implement the
FSMS?
Are the proper resources provided to monitor the
FSMS?
Are the proper resources provided to validate the
FSMS?
Provide adequate human resources
Is annual HACCP training conducted?
Is annual training conducted on CCP's?
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
49
6.3
6.4
7
7.1
7.2
Is training evaluated based on effectiveness?

Are proper records of training kept?
Are training needs reviewed on a regular basis?
Is there a documented plan to provide consistent
training?
Provide adequate infrastructure
Is there an infrastructure to establish a FSMS?
Is there an infrastructure to maintain a FSMS?
Provide adequate work environment
Does the work environment comply with ISO 22000
standards?
Food Safety Realization Requirements
Manage the realization of safety products
Is the process designed to produce safe products?
Establish your prerequisite programs (PRPs)
Are PRP's suitable for the operation?
Are PRP's effective?
Preventative Maintenance Program
Are employees trained on the Preventative
Maintenance Program?
Is there a verification procedure for effective
preventative maintenance?
Are corrective actions documented?
Waste Disposal Program
Are employees trained on waste disposal?
Is there a verification procedure for effective waste
disposal?
Good Manufacturing Practices (GMP's)
Are employees trained on GMP's?
Is there a verification procedure for effective GMP's?
Personal Hygiene
Are employees trained on proper personal hygiene?
Is there a verification procedure for effective personal
hygiene?
Pest Control
Are employees trained on pest control practices?
Is there a verification procedure for effective pest
control?
Cleaning and Sanitization
Are employees trained on cleaning and sanitation
procedures?
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
50
7.3
7.4
Is there a verification procedure for effective cleaning

and sanitation?
Allergen Control Program
Are employees trained on the allergen control
program and procedures?
Is there a verification procedure for effective allergen
program?
Calibration Program
Are employees trained on calibration program?
Is there a verification procedure for effective
calibration program?
Security Program
Are employees trained on the security program?
Is there a verification procedure for effective security
program?
Supplier Approval Program
Are employees trained on the importance of supplier
approval?
Is there a verification procedure for effective supplier
approval program?
Prepare for a hazard analysis
A member of the HACCP team has been trained in
HACCP?
Overall assessment of hazards associated with product
was conducted?
Has a product description indicating the end product's
use been developed?
Has a flow chart been created?
Have controls been identified on the flow chart?
Perform your organization's hazard analysis
Have all potential chemical, biological, and physical
hazards been identified?
Was hazard analysis performed with the HACCP
team?
Was the hazard assessment methodology described?
Was a hazard analysis performed on raw material?
Were all the process steps included in the hazard
analysis?
Were preventative measures established for identified
hazards?
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
51
7.5
7.6
7.7
7.8
7.9
7.10
8
8.1
Do the preventative measures reduce the hazard to an

acceptable level?
Are these preventative measures verified and
validated?
Establish the operational prerequisite programs
(OPRPs)
ORP's are suitable for the operation?
ORP's are verified for effectiveness?
Establish the HACCP plan
Critical Control Points are established based on
potential hazards?
Are critical limits determined?
Are monitoring procedures are established?
Corrective actions are predetermined for critical
deviations?
Record keeping documentation is established?
Are records are verified?
Update preliminary documents and programs
Is there a document control program?
Have documents been approved by a manager or
management prior to implementation?
Is a history of record changes documented?
Are records kept to limit damage or deterioration?
Are records retained for a period longer than two
years?
Plan and perform verification activities
Verification procedures are established for the
HACCP plan?
Establish a product traceability system
Can you properly trace a product based on a lot
number?
Can you properly trace a supplied product?
Can you trace product distribution?
Control nonconforming product
Is there an established hold and release program?
Is there an established nonconforming product
program?
Are personnel trained on the procedures for
nonconforming product?
Is the nonconforming product program verified and
validated?
Food Safety Confirmation Requirements
Confirm and improve food safety methods
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Records are
retained for a five
year period
X
X
X
X
X
X
X
X
X
52
8.2
8.3
8.4
8.5
Are there procedures to confirm food safety methods

are effective and efficient?
Validate food safety control measures
Did you validate your control measures before they
were implemented in the process?
Are these control measures validated in your HACCP
plan?
Can you validate your food safety control measures
are effective?
Can your validations confirm that your control
measures are capable of eliminating the food safety
hazard?
Control monitoring and measuring methods
Can monitoring and measuring methods be verified?
Verify the food safety management system (FSMS)
Are internal audits being conducted?
Is there an established internal audit program?
Is the HACCP team annually reviewing all FSMS
components?
Are all verification steps documented?
Improve the food safety management system
(FSMS)
FSMS is analyzed for improvement annually?
Internal audits are used to improve the FSMS?
Corrective actions are used to improve the FSMS?
Management reviews are used to improve the FSMS?
X
X
X
X
X
X
X
X
X
X
X
X
Appendix B: Semi-Structured Interview Guide Results
Question 1:
President
VP of Receiving and
Procurement
Plant Manager
Shipping Manager
Question 2:
President
What is your understanding of the HACCP food safety

system?
Its a model that allows us to put a process in place to
monitor the processing line and establish critical control
points.
First word that comes to mind is safety; I dont really have a
good understanding of HACCP. HACCP system has been
established for three years and created by an ex employee.
A food safety control system built on a number of
manufacturing programs, the complete understanding of the
process at hand and managements commitment to Food
Safety.
Safety measures that are in introduced in the work area.
What are your concerns to food safety?
Having a problem that would result in a recall is a big
concern to food safety. We want to manufacture a product
that would result in a high quality and healthy product for the
end user but is also safe for the end user. Wants to reduce a
hazard that might affect an end user.
VP of Receiving and
Procurement
Glass awareness is a big concern at our facility. Being

responsible to removing glass and not having the proper
equipment to remove the glass from the processing line are a
big challenge. Intentional hazards are a big worry as there
isnt much control over the incoming product from the
growers.
Plant Manager
The number of general public and Food Producing

Companies who lack an understanding of Food Safety. Food
kills people.
Shipping Manager
Question 3:
Any type of contamination, molds, germs, foreign objects.

What are some opportunities for improvement in the
HACCP system?
Installation of better controls and checks/balances. Learn
about more third party audits and start to move away from
farm and become more of a processing facility.
President
VP of Receiving and
Procurement
Plant Manager
Better pest control. More screens and seal the buildings up

better.
Implement more training and improve training. Keep
programs and requirements simple so that common
53
54
Shipping Manager
Question 4:
President
production workers (those who ultimately carry out the

procedures/documentation) can understand each aspect of
the programs. Figure out how to minimize the repetitive
paperwork.
Moisture issues related to food safety in storage bins
How can these concerns be overcome?
Having the system in place to consistently monitor helps the
company do a better job monitor product coming in.
Following the protocol gives us a better idea of what to
expect and if they find something they can better strategize
to remove that hazard from the facility.
VP of Receiving and
Procurement
There isnt a real good control for removing glass and is

having issue with canning plants looking at the company
XYZ for correction.
Plant Manager
The industry to put forth more stringent controls and

requirements for companies to follow but still allow you to
conduct your daily operations.
Magnets are very important in the processing line. Climate
controlled warehouses and keep product off the ground.
Shipping Manager
Question 5:
President
VP of Receiving and
Procurement
Plant Manager
Shipping Manager
Question 6:
President
VP of Receiving and
Procurement
What is Company XYZs Management Commitment to food

safety?
Management is very committed to food safety. Management
is committed to a long term future of food safety and is
committed to showing employees.
Extending all resources to properly remove all potential
hazards from the processing line.
Company is very committed to food safety. They have
evolved dramatically over the past year. Committed to
developing and furthering the HACCP program. Committed
to the GFSI standard. Food safety commitment is posted near
the time clock for all employees to see. Employees can see
managements commitment to food safety. Management has
done an unbelievable job showing their commitment to food
safety.
Dont know more checks as far as quality. No training.
How is managements commitment shown to employees?
Commitment is shown from owners and is pushed down to
managers. Show that they want to put in controls over food
safety and wants employees to be involved in the food safety
program.
Consistent meetings to discuss food safety concerns and the
constant improvement of processes to remove food safety
hazards shows commitment.
55
Plant Manager
Shipping Manager
Question 7:
President
VP of Receiving and
Procurement
Plant Manager
Shipping Manager
Question 8:
President
VP of Receiving and
Procurement
Plant Manager
Shipping Manager
Question 9:
President
VP of Receiving and
Procurement
Plant Manager
Shipping Manager
Question 10:
President
Management has shown its commitment through posting of

policy and support documents near the time clock. It is also
shown through the improvement of the processing line to
remove potential hazards.
Yes, the installation of magnets and food safety concerns.
More checks in the processing line.
What is issue in regards to managements commitment to
food safety?
Training is a big concern as well as financial issues are a big
concern as it is too great. The list of improvements put forth
by customers is very expensive.
Finding the financial support to fix every food safety issue in
the processing facility.
Providing the time and the resources necessary to conduct
food safety training.
Not enough support for training activities.
What are the opportunities for improvement?
It has to have a long term commitment. Bring in someone as
a plant manager that has a background and drive in the food
safety. Getting managers the time and resources to improve
the food safety issues. Showing the importance of the food
safety and how it will affect the bottom line.
None were given.
Providing a consistent message that food safety is a major
priority in the company.
Provide more controls in the warehouse. Not told much
What are some suggestions for improving managements
commitment to food safety?
Participation in more training sessions with employees. Set
aside more resources for improving the overall food safety
system.
New magnets and steel boxes in the processing plant.
Improve food safety training and education for employees to
show that management is committed.
Need to have more management meetings on business
strategy. Allocate more financial resources to food safety.
More involvement with employees on training and food
safety related topics.
What training programs are currently conducted at
Company XYZ?
Training on the documentation, training on preventative
maintenance, training on safety related topics. Train on
awareness, monitoring, and documentation.
56
VP of Receiving and
Procurement
There isnt much for training programs being conducted at

the company. Employees are trained on the proper receiving
procedures. Employees are also trained in looking for
hazards in raw product.
Plant Manager
Employees trained on record keeping: employees are training

on warehouse move sheets, trailer load sheets.
Shipping Manager
None, its a learn as you go mentality. Employee teaches

employee mentality.
What are some issues in the food safety training?
Attitudes and barriers to understanding the issues with food
safety. Eliminating the old habits from the processing plant.
Conduct all the training and still create profit.
Dont contaminate the product. Doors are properly shut.
Question 11:
President
VP of Receiving and
Procurement
Plant Manager
The lack of experience and understanding of food safety with

management and managers. Time is another barrier to
conducting food safety training.
Shipping Manager
Lack of training, practically no training for warehouse
employees. Learn of issues through complaints.
Question 12:
What are some opportunities for improvement?
President
Improving maintenance training, improve the training for
identifying hazards and food safety concerns. Improve safety training.
Continually work in improving the training of controlling inventory.
Improve safety training and identifying safety issues
VP of Receiving and
None were given
Procurement
Plant Manager
Need more training, need more help with conducting
training. Need more experience with specific areas.
Management needs more experience with food safety.
Shipping Manager
None were given.
Question 13:
How can food safety training be improved?
President
Management commitment, staff understanding the
importance of food safety, and time
VP of Receiving and
More training. Improve more bagging training to look for
Procurement
more hazards.
Plant Manager
Shipping Manager
Set aside more time for training sessions with employees.

Allow more employees to get a background in food safety.
More knowledge in food safety training will assist in
showing the importance of food safety training.
Training program, need one. No training for food safety.

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Author:

Graduate Degree/ Major:

Elbert Sorrell, CSP

Style Manual Used: American Psychological Association, 6th edition

2. CMTE MEMBERS NAME:

3. CMTE MEMBERS NAME:

--------------------------------------------------------------------------------------------------------------------------------This section to be completed by the Graduate School

Chapter V: Discussion ...................................................................................................................37

The goals of the study are to:

Critical Limit: A maximum and/or minimum value to which a biological, chemical or

Chapter II: Literature Review

Preliminary Step One

Assemble the HACCP team

Preliminary Step Two

Describe the product

Preliminary Step Three

Identify intended use of the product

Preliminary Step Four

Construct a flow diagram

Preliminary Step Five

Conduct an on-site verification of the flow

Conduct a hazard analysis

Determine critical control points (CCP)

Establish critical limits for CCPs

Establish a monitoring system for CCPs

Establish corrective actions

Establish verification procedures

Establish documentation and recordkeeping

Determine the frequency of monitoring for each CCP.

Determine if the monitoring activity needs to be done randomly to get a good

Utilizable in all organizations in the food chain industries;

Combines the recognized food safety system elements as defined by Codex;

Provides an auditable standard that could be used as part of third party

Focuses only on food safety.

Policy- a food safety management policy defines an organizations commitment

Planning- the primary goal of planning in a management system is to establish

Performance Assessment- a performance assessment is conducted to ensure that

Improvement- Improvement or corrective actions are steps that are taken to

Management Review- the primary goal of a management review is to evaluate the

Plan a food safety management system

Blanc, (2006) Iso 22000 from intent to implementation.

3. Identify Sources of Performance Deficiencies and/or Opportunities For Improvement

Consultations with persons in key positions

Review of relevant literature

Records and report studies

An audit, for example, can be created based on a standard to determine where an

Chapter III: Methodology

Chapter IV: Results

Food Safety Planning

Implementation and operation of pre-requisite programs

It was established that management commitment is an important component to

Objective 3 was to conduct a needs assessment focusing on organizational analysis, task

Management commitment is a fundamental concept that must be further implemented at

Implement a program that will identify effectiveness of training to managers and

Areas of Further Research

Appendix A: An Introduction to APA Style and Research Paper FAQs.

Are responsibilities of the FSMS defined?

Is training evaluated based on effectiveness?

Is there a verification procedure for effective cleaning

Do the preventative measures reduce the hazard to an

Are there procedures to confirm food safety methods

Appendix B: Semi-Structured Interview Guide Results

What is your understanding of the HACCP food safety