FOOD Safety Global Issues :-

According to the World Health organisation, the key food safety issues in 2017
included:

• Hazardous food containing harmful bacteria, viruses, parasites or chemical

substances, resulted in more than two hundred diseases (starting from diarrhea
to cancers).
• Around six hundred million i.e. about one in ten persons in the world fell ill
after consuming hazardous and contaminated food. Four hundred twenty
thousand persons died every year due to it. 
•  Children aged under five carried forty percent burden of the food-borne
disease. One lac twenty-five thousand children died every year due to it. 
• Diarrheal illnesses were the most reported disease resulting from eating
hazardous food. Five hundred fifty million people fell ill due to Diarrhea.
Diarrhea resulted in two lac thirty thousand deaths every year.
• Diseases, due to unsafe food, obstructed socioeconomic development by
pushing health care systems to its extreme. It hurt national economies, tourism,
and trade.

ISO 22000 :-

Food supply chains are now operating beyond national borders. Good
cooperation, between governments, producers, and consumers, assists in food
safety. Different groups and government bodies are now concerned about food
safety. 
ISO 22000:2018 is the management system for food chain businesses. ISO
22000 assists them to manage and to improve their food safety performance.
ISO revises the standard considering the challenges food businesses face today
in terms of legal requirements, business context, and the changing realm.

Transition Guidelines :-

Companies now need to upgrade from ISO 22000:2005 to ISO 22000:2018. For
the transition, numerous steps must be followed in order to upgrade the existing
management system to the new standard. Based on the guidelines of ISO
22000:2018, the following sequence of steps is recommended:

1. Perform analysis on Organization's Context: Analyze interested parties (i.e.

those individuals or food organizations that can influence or get influenced by
your organization’s activities). Analyze internal and external issues that might
influence organization’s food safety management system. Then check how these
risks and opportunities can be managed with the help of the management
system.

2. Recognize the scope of the FSMS, while reflecting what management

system is bound to deliver.

3. Utilize context study data and information to institute food organization’s

processes, risk evaluation & assessment and, most significantly, to develop the
key performance indicators (KPIs) for the organization’s activities related to
food safety.

Transition Plans to ISO 22000:2005 compliant and certified food

organizations

If you are presently implementing ISO 22000:2005, then prior implementation

will be helpful for transition to ISO 22000:2018. Multiple requirements of ISO
22000:2018 are the equivalent or analogous. But the clauses are stated in a
different order and has slightly different terminologies.

Existing users of ISO 22000:2005 should take note of the following

suggestions:

·  Get a copy of the standard from ISO Store

(https://www.iso.org/standard/65464.html) or your national ISO representative
store.
· Examine the changes in the standard or use the comparative matrix with this
course as a free resource.
· Conduct a gap analysis against ISO 22000:2018 versus your current FSMS
system.
·  Plan and apply actions to fulfill highlighted gaps in your study.

 Benefits of ISO 22000

 Food organizations should employ ISO 22000:2018 to build an effective

food safety management systems. Implementation will help food
companies to gain the benefits of ISO 22000. 
 Implementing ISO 22000:2018 has numerous advantages for food
organizations. Organizations and companies can attain benefits in
following ways:

o Offer assurance that food hazard is being controlled and safety is

ensured.

o Increase resource efficiency.

o Gain competitive advantage in food supply chain.

o Grow with new business opportunities.

o Comply legal obligations related to food safety.

o Gain stakeholder and customer trust.

o Manage food safety obligations with consistency.

o Strengthen internal teams to ensure food safety with effective

implementation.

Certifications :-

Most of the food organizations will make use of ISO 22000:2018. Organizations
also want recognition for their food safety management system that comes with
the certification of ISO 22000:2018. 

Certification, from third-party auditors, is simply a recommendation that

exhibits external parties that the subject organization proves its conformance
with ISO 22000:2018 standard during the sample-based audits.

Continual Impprovement :-

ISO 22000 can offer companies a range of benefits provided that the company
can implement the standard in an effective and efficient manner. The standard
directs organizations to manage and mitigate food safety hazards. For the risk
management approach to be effective, the system should be continually
improved. Objectives should be updated with new targets considering the
business context.

Legislation :-

The enforcement of the standard ensures compliance with present applicable

legislation. Whenever a legal requirement changes it may be highlighted in the
compliance review meeting or in the management review.

 High Level Structure (HLS)

 ISO 9001:2015 (i.e. Quality Management System), ISO 14001:2015 (i.e.
Environment Management System), ISO 45001:2018 (i.e. Occupational
Health and Safety Management Systems) are all based on HLS Structure.
Food safety management system standard i.e. ISO 22000:2018 is also
based on HLS Structure. It means ISO 22000:2018 can be easily
integrated with other business systems based on HLS structures.


o Clause – 1 SCOPE

o Clause – 2 NORMATIVE REFERENCES

o Clause – 3 TERMS AND DEFINITIONS

o Clause – 4 CONTEXT OF THE ORGANIZATION 

o Clause – 5 LEADERSHIP

o Clause – 6 PLANNING 

o Clause – 7 SUPPORT 

o Clause – 8 OPERATION  

o Clause – 9 PERFORMANCE EVALUATION 

o Clause – 10 IMPROVEMENT 

 Background of ISO 22000 Revision

 Need of revised Edition on ISO 22000

 The need of revision came with many considerations. The changing
business dynamics contributed towards the change. Business risk
management inclusion in food safety management system was another
important consideration. The change was led by incorporating the Plan-
do-check-act model both at the organizational as well as the operational
level.

Behind ISO 22000 Revision

ISO 22000 revision proposal was initially presented in the year

2014. ISO/TC 34/SC 17 is the committee, who had worked on bringing
out this change. ISO 22000:2018 was published on June 2018.

Experts claim that the development of the new FSMS standard was well timed
in June 2018. 

ISO 22000:2018 matches the structure of the publication of newly revised ISO
9001:2015 (quality management system), ISO 14001:2015 (environment
management system) and ISO 45001:2018 (occupational health and safety
management system). 

ISO 22000:2018 versus ISO 22000:2005

ISO 22000:2005 was the international standard for Food safety management
systems and was adopted by many different companies operating in various
countries around the world. It is important to check the differences between the
two editions so as to help food organizations to update their management
systems from ISO 22000:2005 to ISO 22000:2018.

What are the major differences between ISO 22000:2005 and ISO
22000:2015

There are many secondary differences, but the primary difference is that ISO
22000:2018 focuses on the interface of a food organization with its business
 environment.  Whereas, ISO 22000:2005 was concentrated on managing food
safety hazards and other internal issues at the operational level.

ISO 22000:2018 ISO 22000:2005

ISO 22000:2018 is built on process-based approach

incorporating incorporating PDCA at two levels i.e. ISO 22000:2005 is built on the
operational and organizational levels. procedure-based approach.

ISO 22000:2005 considers risk

ISO 22000:2018 incorporates both risk and opportunities.
exclusively.

ISO 22000:2005 does not

ISO 22000:2018 incorporates the views of interested parties. include the views of interested
parties.

 Note: Study the free resource "Comparison Matrix" to analyze Clause by

Clause variation analysis of ISO 22000:2018 standard versus ISO
22000:2005 standard. 

 The PDCA Cycle (Plan-Do-Check-Act) 


 

 PDCA (Plan-do-check-act) Model

 ISO 22000:2018 is comprised of the simple approach i.e. Plan-Do-Check-
Act (PDCA) model, which offers a mechanism for food organizations to
plan what they need to enforce. Planning is necessary for effective
implementation as it helps to mitigate the occurrence or severity of food
safety hazards. The PDCA approach is integrated at two levels in the
standard; one at the organization level and the other at operational level. 

Important areas of publication

Organization’s context :-
External and Internal Issues: External and internal issues of food organization
need to be addressed as per Clause 4.1. It is actually a business context analysis
but having a food safety perspective. It mandates organizations to
systematically recognize the internal and external issue. The company must study
the numerous issues related to food safety which affects their business operations
as well as the                                                                     management system.
 Interested parties: Clause 4.2 presents a prerequisite on analyzing the needs
and expectations of interested parties in the domain of food safety. The company
is required to recognize and comprehend the issues related to these parties. The
relevant issues should be analyzed and controlled through the Food safety
management system.

Scope: Clause 4.3 is related to the scope. Unlike FSMS ISO 22000:2005, the scope should only
be defined when an organization performs analysis on external and internal issues, needs and
expectations of interested parties. 

Leadership and commitment :-

Similar to ISO 9001 and ISO 14001, there is higher stress on the responsibility of
top management in the area of improvement of food safety performance and
ensuring the effectiveness of the FSMS.

FSMS Policy 
Top management i.e. Leadership will be accountable for developing organizational
food safety policy. As per Clause 5.2, there is an increased requirement for
effective communication and participation so as to ensure compliant food safety
conditions. The policy should be in accordance with the company’s processes and
its context.

Organizational Roles, Responsibilities & Authorities

As per Clause 5.3, all roles, responsibilities, and authorities must be properly
defined, communicated and understood. However, accountability of top
management for the overall system can never be delegated. Unlike ISO 9001 and
ISO 14001, ISO 22000:2018 mandates the role of food safety team leader, who is
assigned specific responsibilities by the standard. 

Risk and opportunities :-

As per Clauses; 6.1.1, 6.1.2 and 6.1.3; food organizations have to identify, ponder and take
action to optimize opportunities and risk. The analysis on risk and opportunities should come
up with the factors of organization’s context referenced in clauses 4.1 and 4.2. 

These issues, needs, and expectations may favor the organization or go against it. Therefore
risk should not only be managed for negative food safety impact but also for internal and
external issues, and the needs and expectations of interested parties related to FSMS. All
these factors together influence the capability of the management system to yield its
envisioned results i.e. improved food safety performance.

When planning for the food safety management system, the food organization must consider:
a)  The issues referred to internal and external issues
b)  The requirements referred in needs and expectations of interested parties
c) The scope of its food safety management system
Objectives and performance :-
Clause 6.2 emphasizes objectives as incentive for improvements (Example Clauses 6.2.1 and
6.2.2) and performance evaluation (Example Clause 9.1.1). 

The objectives should support the food safety policy and reflect the strategic direction. Moreover,
the context of the organization will also help in identifying relevant objectives.

Support :-
From Clause 7.1 to 7.5, there are various support functions which include the availability of
sufficient resources, competency among the workers to ensure food safety, necessary
awareness of workers and suppliers, sufficient communication for food safety, and
requirements for documented information. 

Some important points in these support requirements are:

• Actions related to communication must be appraised for their effectiveness.
• Awareness must cover the policy, critical food safety hazards, employees’ role and
contractors’ role for food safety performance. Awareness also includes knowledge of related
personals on critical control points. 
• The words ‘documented information’ has been presented similar to ISO 9001. It
encompasses how an organization should opt to create, maintain and retain information
which is compulsory for the food safety management system. 
• The organization is required to decide what documented information (both internal and
external) should be controlled. It also includes the need for documented procedures.


o Operations and Emergency Preparedness

o Performance Evaluation

o Improvement

From Clause 8.1 to 8.9; it is the operational planning and control, prerequisite
programs PRPs, traceability systems, emergency preparedness
response, hazard control, verification related to hazard control plan and PRPs,
control of product and process nonconformities, control of measurement and
monitoring. Each section has detail requirements to maintain effective food
safety management systems.

Planning has been incorporated, explicating plans to control the identified risk
and hazards. Hazards needs to be addressed with critical controls that are to be
implemented.

Procurement and outsourcing, in the new standard, is required to scrutinize

 purchased goods and services. These procured materials and services
should meet the requirements of the food safety management system. 

One more improvement in the standard is to clarify users, the differences of Pre-
requisite Programs (PRPs), Operational Prerequisite Programs (OPRPs) and
Critical Control Points (CCPs)

 Fundamental Terminologies
 Contamination in end product is the primary reason for a food safety hazard. Therefore
organization has to decide an acceptable level for each food safety hazard where
contamination (resulting the food safety hazard) is considered acceptable to the
organization. Action criterion are monitoring processes to keep a check on controls and
measures for example Operational Prerequisite Programs (OPRPs) to control a food
safety hazard. Acceptable level, action criterion, and contamination are defined and
explained by the ISO 22000:2018 standard.  

Acceptable Level

Acceptable Level is defined as per Clause 3.1 of ISO 22000:2018 as “level  of  a  food 
safety  hazard  not  to  be  exceeded  in  the  end  product   provided  by the food
organization.”

Action Criterion

Action Criterion is defined as per Clause 3.2 of ISO 22000:2018 as “measurable or

observable specification for the monitoring of an OPRP”.

An action criterion is established to determine whether an OPRP remains in control, and

distinguishes between what is acceptable (criterion met or achieved means the OPRP is
operating as intended) and unacceptable (criterion not met nor achieved means the
OPRP is not operating as intended). 

Contamination
 Contamination is defined as per Clause 3.6 of ISO 22000:2018 as “introduction or
occurrence of a contaminant including a food safety hazard in a product or processing
environment”.

Control Measure is defined as per Clause 3.8 of ISO 22000:2018 as “action or activity that is
essential to prevent a significant food safety hazard or reduce it to an acceptable level”.
Critical Control Point (CCP) is defined as per Clause 3.1.1 of ISO 22000:2018 as “step in the
process at which control measures are applied to prevent or reduce a significant food safety
hazard to an acceptable level and defined critical limits and measurement enable the application
of corrections”.
Critical Limit is defined as per Clause 3.1.2 of ISO 22000:2018 as “measurable value which
separates acceptability from unacceptability”.

Critical limits are established to determine whether a CCP remains in control. If a critical limit is
exceeded or not met, the products affected are to be handled as potentially unsafe products.
“End Product is defined as per Clause 3.1.5 of ISO 22000:2018 as “product that will undergo
no further processing or transformation by the food organization”.

A product that undergoes further processing or transformation by another organization is an

end product in the context of the first organization and a raw material or an ingredient in the
context of the second organization.
Flow Diagram is defined as per Clause 3.17 of ISO 22000:2018 as” schematic and systematic
presentation of the sequence and interactions of steps in the process”.
Food Chain is defined as per Clause 3.2 of ISO 22000:2018 as “sequence of the stages in the
production, processing, distribution, storage and, handling of food”.

The food chain also includes the production of materials intended to come into contact with
food or raw materials. The food chain also includes service providers.

Applicability of Standard
Many organizations in food chain are small or medium enterprises. ISO 22000
is applicable to them, just as it is applicable to big enterprises. The easy risk
oriented approach in ISO 22000 is implementable for SMEs as well, and is well
matched with the approach used in FSSC 22000.

A Food safety management system (FSMS) is a collaborative and systematic approach to

effectively manage food safety risks. 

Food safety system certification (FSSC 22000) is one of the known requirements on food safety
management systems other than ISO 22000. It is also recognized by Global Food Safety
Initiative (GFSI)

ISO 22000:2005 is the only previous edition of ISO 22000:2018.

FSSC is an acronym for Food Safety System Certification. 

Codex Alimentarius are transitively known as “Food Code". It is a globally recognized series of
standards and recommendations sourced in many national laws. 

ISO 22000:2018 also focuses on the interface of a food organization with its business
environment.  Whereas ISO 22000:2005 was concentrated on managing food safety hazards
and other internal issues at operational level. 

The committee responsible for the revision of ISO 22000 is known ISO/TC 34/SC 17. 

The Plan part at management system level is the analysis of organization’s context. It also
includes the role of leadership in the form of FSMS policy, owning accountability of the
system and providing necessary resources needed for the smooth progression of the
management system.

All operational activities are part of “Do” phase of the management system. 

Verification activities for OPRPs and HACCP are then planned in the Planning phase of
Operations.

The do part of the operations include implementation of all plans i.e. OPRPs, HACCP, etc. 

Verification activities for all implemented plans and the analysis on results of verification
activities are included in check part of operations. 

Some of the outputs of check part can mandate changes in OPRPs and HACCP so as to have
the correct verification results.