Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Prepared by:
Muhammad Tauseef Mukhtar
Asst. Manager, SMEDA
Lahore-Pakistan
Reviewed by:
February 2009
Table of Contents
1. Introduction....................................................................................................................... 2
1.1 Food .......................................................................................................................... 2
1.2 Food Safety ............................................................................................................... 2
1.3 Food Borne Illnesses................................................................................................. 2
1.4 Food Safety Hazards ................................................................................................. 3
1.5 Food Chain................................................................................................................ 3
1.6 Role of Industry in Ensuring Food Safety ................................................................ 3
1.7 Food Safety Management System (FSMS)............................................................... 3
1.8 International Organization for Standardization (ISO) 22000:2005 FSMS ............... 4
1.9 Hazard Analysis Critical Control Points (HACCP) and ISO 22000:2005 FSM Standard
4
1.10 Key Elements of ISO 22000:2005 .......................................................................... 5
1.10.1 Interactive communication................................................................................ 5
1.10.2 System management ......................................................................................... 5
1.10.3 Pre-requisite programs ...................................................................................... 5
1.10.4 HACCP principles ............................................................................................ 5
1.11 Structure of ISO 22000:2005 .................................................................................. 6
1.11.1 Food Chain Approach ....................................................................................... 6
1.11.2 Process Approach.............................................................................................. 6
1.11.3 Continual Improvement (PDCA- Plan-Do-Check-Action) .............................. 7
1.12 Small & Medium Enterprise (SME) ....................................................................... 9
2. Situation Analysis ........................................................................................................... 10
2.1 Food Control System / Legislation ......................................................................... 10
2.2 Food Control System – Management and Inspection Services .............................. 11
2.3 Food Standards........................................................................................................ 11
3. ISO 22000-2005 FSMS - Application in SME ............................................................... 14
4. Preparation for Certification ........................................................................................... 39
4.1 Summary of ISO 22000:2005 Requirements.......................................................... 39
5. Application of ISO 22000:2005 standard in fruit processing SME................................ 41
Time lines / Gantt chart for Implementing ISO 22000: 2005....................................... 47
Conclusion .................................................................................................................... 48
Bibliography ................................................................................................................. 49
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1. Introduction
1.1 Food
Any substance eaten to provide nutritional support for the body is food and has always been
one of the basic necessities of life. We live in a world with rapidly changing elements- our
environments, food supply, population and scientific knowledge. People demand for wider
variety of foods than in the past and therefore, importance of food safety has increased many
folds.
In developing countries food safety is becoming more important issue due to most persuasive
reasons. Increase in population, rapid urbanization, poor sanitation and hygiene, inadequate
potable water supplies, and general health and nutrition status particularly of the vulnerable
groups of population, complexes with problems of food safety and pose greater challenges.
Assurance in safety and integrity of the food supply is a vital need for consumers and an
important requirement for international food trade. Food safety is a component of food
quality and is a global concern, which impacts both consumer and business of the food
industry.
Food safety is linked to the presence of food borne hazards at any point of the food
consumption, thus adequate control through out the food chain should be in place to ensure
safety.
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1.4 Food Safety Hazards
These are biological, chemical or physical agents in food or condition of food, with the
potential to cause an adverse health effect. Food borne disease is clearly the most frequent of
food hazards. The degree of food processing in the food supply influences the type and
severity of individual food borne diseases; for canned food, C. botulism is critical; for fresh
poultry and eggs Salmonella; for milk, Listeria. Naturally occurring food contaminants e.g.
mycotoxins are undoubtedly more prevalent within the less sophisticated food handling
systems. The control of mycotoxicoses requires that mould contamination in food and
feedstuffs should be prevented or reduced to harmless levels. This involves basically the
establishment of good harvesting, drying, handling, storage, transportation and distribution
procedures.
Food additives and pesticide residues are also food hazards, but the associated problems are
risk related and the severity does not compare with food borne illness. There is need to focus
on food safety risk management, risk is an estimate of probability that a hazard can occur. It
is therefore, imperative that all directions be addressed to move toward accomplishment of
food safety.
3
Several approaches have been established and implemented in various parts of the world for
incorporating the best food safety practices in food processing operations. These have
brought variable results in the development of existing food safety situations depending upon
the level of understanding, degree of commitment, effective internal control and strength of
law enforcement bodies. Most of these approaches require the support of complimentary
systems for achievement of effective results.
The most effective food safety systems are established, operated and updated within the
framework of a structured management system. A large proportion of food industry
comprises of small businesses, ranging from production to retailer and catering services,
wherein food safety is of paramount importance. Small enterprise makes more businesses by
complying food safety regulations. In small and medium enterprises application of ISO
22000:2005 FSMS seems difficult but this standard could be implemented in any food
enterprise having serious level of commitment.
ISO 22000:2005 has been defined as a set of interrelated elements to establish policy and
objectives used to direct and control an organization with regard to food safety. It represents
the latest steps in the evolution of food safety system beyond Hazard Analysis Critical
Control Points (HACCP). The standard is auditable and harmonizes national food safety
standards.
1.9 Hazard Analysis Critical Control Points (HACCP) and ISO 22000:2005 FSM
Standard
HACCP is a series of international actions that provides a high degree of food safety
assurance and is not a new concept. It was developed in late 1950s and consisted of three
principles. In 1997, the Codex Alimentarius Commission (CAC) published an international
standard that defined HACCP as five preliminary steps, and seven principles that are
supported by pre-requisite programs. Hazard analysis is the key for an effective food safety
management system, conducting a hazard analysis assist in organizing the knowledge
required to establish an effective combination of control measures.
ISO developed an auditable standard in 2001, which further defines the role of HACCP in
FSMS. This standard does not mean to define minimal regulatory requirements; but intends
to describe prerequisite for companies that desire to exceed the regulatory conditions for food
safety. The ISO 22000:2005 standard integrates the principles of HACCP system and
application steps developed by CAC, for auditable requirements.
4
ISO 22000:2005 and ISO 9001:2000 standards have similar structures and are compatible.
The working group which developed ISO 22000:2005 aimed that it should not be replaced
with ISO 9001:2000 standard. It was proposed that food processors may use both the
standards: ISO 22000:2005 to address the food safety management system (FSMS) and ISO
9001:2000for quality management system (QMS).
ISO 22000:2005 standard require all hazards expected to occur in the food chain are
identified and assessed, also including hazards that may be associated with the type of
processes and facilities used.
• Interactive communication
• System management
• Pre-requisite programs
• HACCP principles
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1.11 Structure of ISO 22000:2005
The standard adopts the following structure:
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approach is referred to the application of system of processes in an organization, together
with identification, interactions and management of these processes. Process approach
whenever used within a FSMS emphasizes the importance of:
The PDCA methodology could be a useful tool to define, implement and control corrective
actions, and improvements. The methodology applies equally to high level strategic
processes and to simple operational activities.
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Fig. 3: PDCA Cycle
Act Plan
Check Do
a. Plan: Establish the objectives and processes necessary to deliver results in accordance
with customer requirements and the organization’s policies
c. Check: Monitor and measure processes and product against policies, objectives and
requirements for the product and report the results
ISO 22000 links prerequisite programs and the HACCP plan into a FSMS. In addition, a
number of prerequisite programs (PRP) ‘should’ become ‘shall’ and in standard terminology
optional requirement become mandatory requirements. ISO 22000 separates the prerequisite
programs into two major groups:
1) Prerequisite programs that address infrastructure and maintenance of the food safety
management system. An example is training on hygiene.
2) Operational prerequisite programs that are used to control potential food safety
hazards. An operational PRP is similar to a control point (CP). An example of an
operational PRP is to check the temperature of raw meat in a poultry processing plant.
The standard recognizes that FSMS may or may not have a HACCP critical control point. As
a result, hazard identification and hazard analysis is conducted on all products. As part of this
process, the food safety team needs to determine if the hazards will be controlled through the
operational prerequisite programs or through the HACCP plan. The selection of the
appropriate control system is dependent on a number of factors including the severity of the
adverse health effect and the likelihood for occurrence of hazard. A number of factors can
contribute to this possibility which includes: frequency of hazard associated with the specific
product, effectiveness of the PRP programs, method used to prepare the product in the plant,
expected conditions during storage and transportation, and additional processing steps that
occur before the consumption of food.
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ISO 22000 require that all control measures are validated in order to ensure that they are
capable to control hazards. Validation ensures that performance of the control measure meets
or exceeds the specified expected outcomes.
• SME Bank: Small enterprises have Rs. 20 million while medium has Rs. 100 million
Assets
• Federal Bureau of Statistics: enterprise having less than 10 employees
• Punjab Small Industries Corporation: Enterprise with fixed investment. up to Rs. 20
million excluding land and building
• Punjab Industries Department: Fixed assets with Rs. 10 million excluding cost of
land
• Sindh Industries Department: Entity engaged in handicrafts or manufacturing of
consumer or producer goods with fixed capital investment up to Rs.10 million
including land and building
• State Bank of Pakistan (SME Prudential Regulations): An entity ideally not being
a public limited company and does not employee more than 250 persons
(manufacturing) and 50 persons (trade / services) and also fulfill one of the following
criteria:
I. A trade / services concern with total assets at cost excluding land and buildings up
to Rs 50 million.
II. A manufacturing concern with total assets at cost excluding land and building up
to Rs 100 million.
III. Any concern (trade, services or manufacturing) with net sales not exceeding Rs
300 million as per latest financial statements.
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2. Situation Analysis
2.1 Food Control System / Legislation
The rationale of food quality control system is to ensure and promote better quality food
articles by the processors and distributors, hence encouraging the food production on sound
scientific lines. Food legislation provides foundation of the food control system. Food safety
is the concern of all i.e. food producer, processor, marketer, retailer and ultimate consumer.
Development and implementation of food safety system through out the food supply chain
depends on the following:
Food legislation provides the foundation of food safety system, being regulatory in nature; a
food control system is based on an appropriate Law giving power to the designated authority
to enforce its provisions. The West Pakistan Pure Food Ordinance, 1960 (VII of 1960) was
the first regulatory frame work relating to preparation and sales of foods in Pakistan and
there under framed “The West Pakistan Pure Food Rules, 1965”, “Cantonment Pure
Food Act, 1966” (applicable in cantonment areas only) and “Pakistan Hotels and
Restaurants Act, 1976” (applicable to all hotels and restaurants).
The Ordinance confers all powers to the Provincial Governments, without defining any role
of the Federal Government. Since food is a provincial subject; hence the enforcement
authority rests with the provincial health departments and the local bodies. As a result of lack
of integration of different laws and regulations at provincial and local levels, and varying
effectiveness of their application, assurance of food quality supplied for domestic
consumption and export is even beyond the awareness of the appropriate government
agencies. This has encouraged supply of adulterated and contaminated food.
The food quality control system in the country is far from satisfactory. The West Pakistan
Pure Food Rules, 1965 cover the quality parameters of 106 food items only and as such
neither meets present day requirements nor expressively covers desired range of food
products due to innumerable developments, which took place in food technology ever since
its adoption. Newer technologies such as genetic engineering to increase yield, food
irradiation and modified atmospheric packaging to enhance shelf life and make foods safer
were introduced much later than the introduction and adoption of said Ordinance. The recent
incidence of milk contamination and other dairy products with chemical melamine exported
from China, has stirred wider public concern over the safety of milk and milk products. Food
legislation has not been revised significantly since 1960 (amendments excluded), therefore,
revision of existing food Law is imperative.
To ensure safe food supply in the market the Law provides a system of licensing of each
manufacturing house. Quality control is guaranteed through inspection of food and laboratory
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services, utilized for analysis of food and food products. Whatsoever is the reason for
development and implementation of food safety system, it results in supply of safe food for
human consumption. Food safety system requires strict monitoring at government level,
based on scientific criteria and conforming to present day internationally accepted principles.
With devolution of powers at district level the Executive District Officer (Health) of the
respective province is responsible for food inspection services. The food control system is
facing problems due to inappropriately qualified trained food inspectors, ineffective and poor
reporting system, lack of coordination, resources, improper enforcement of law, and public
awareness.
2.3.1 The West Pakistan Pure Food Ordinance 1960: The current food standards are
based on the West Pakistan Pure Food Ordinance 1960, and subsequently Pure Food
Rules 1965, for raw, processed or cooked foods. It includes provisions in respect of
food hygiene, food additives, pesticides residues, contaminants, labeling and
presentation, methods of analysis and sampling.
2.3.2 Pakistan Standards and Quality Control Authority Act 1996: Pakistan Standards
and Quality Control Authority (PSQCA) under Ministry of Science and Technology, is
also developing food standards. Previously it was working as Pakistan Standardization
Institute (PSI). The adoption of these standards is on voluntary basis and only few are
mandatory in nature. PSQCA provides a one-window service for food and other
products, it is also responsible for enforcement of standards in the country and has
mandate to inspect and test products and service for quality, specification and
characteristics during use and for export purposes.
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2.3.3 International Food Standards: Several food standards and laws are prevailing in
different regions of the world. Many organizations have their own set of standards that
becomes obligatory for the suppliers to follows. Similarly different countries have
enforced their set of laws/ standards and every food product entering their border needs
to fulfill those laws. The internationally recognized food standards pertaining to food
safety system in the industry are:
i. Codex Alimentarius Commission (CAC): The CAC, a subsidiary body of FAO and
WHO was created in 1962. The Codex Alimentarius is a series of food standards, codes
and other regulations. The codex standards are used as models in different countries of
the world in their domestic food legislation and regulations. These international
standards protect the health of consumers; ensure fair food trade practices in
international food trade.
The Sanitary (human and animal health) and Phyto-sanitary (plant health) Measures
(SPS) ensure that food is safe for consumers, prevent the spread of pests and diseases
among animals and plants and Technical Barriers to Trade (TBT) Agreement calls on
countries to harmonize their national standards with international standards and
guidelines or recommendations. The TBT Agreement calls on countries to use relevant
international standards when they exist.
Difference between Codex and ISO Standards: codex standards are used to develop
national regulations, are slow to change and describe minimal acceptable practices. The
ISO standards are voluntary, describe current standard industrial practices and are
revised every five years.
iii. ISO 22000: New Family of Standards - ISO has developed additional standards
that are related to ISO 22000. The following four standards make up the ISO 22000
family of standards initiated in 2001:
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b) ISO 22000:2007 – requirements for bodies providing audit and certification of food
safety management systems
c) ISO TS 22004:2005 – Food safety management systems- guidance on the
application of ISO 22000:2005
d) ISO 22005:2007 – traceability in the feed and food chain -general principles and
basic requirements for system design and implementation.
The above mentioned standards and audit programs though similar but are slightly
different. As a result, there was an international effort to harmonize the standards into
a single ISO standard. Therefore, ISO 22000 was published in 2005 which defines a
state-of-the-art food safety management system. The standard has the following
characteristics:
ISO 22000 fitness checker is a practical, easy to use checklist designed to help SME
to assess their readiness for ISO 22000 certification. This book has been published by
the International Trade Centre, Geneva, Switzerland.
iv. International Food Standards (IFS) Ver. 4:2004. In 2002 German food retailers
developed this common audit standard. In 2003 French food retailers joined and
contributed in development of this standard to create a consistent evaluation system for
all companies supplying retailer branded food products with uniform formulations,
uniform audit procedures and mutual acceptance of audits, which creates a high level of
transparency through out the supply chain. It defines requirements in content, procedure
and evaluation of audits requirement profile for the certification bodies and auditors.
v. British Retail Consortium Global Standard Food (BRCGSF Issue 4:2005) - The
BRC standard was originally designed for manufacturers supplying their own labeled
products. It sets the minimum standard of hygiene in food manufacturing plants
designed for any supplier, regardless of product or country of origin. Compliance is not
a legal requirement, but UK retailers highly recommend for its observance.
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3. ISO 22000-2005 FSMS - Application in SME
The ISO 22000:2005 standard is available in both English and French languages from ISO
Central Secretariat (www.iso.org.), the standard is also available from ISO member bodies.
Many countries have adopted this as a national standard and have published in their national
languages.
The primary elements of ISO 22000:2005 standard for implementation in a food organization
include:
1. Scope
2. Normative Reference
3. Terms and definitions
4. Food Safety Management Systems
5. Management responsibilities
6. Resource management
7. Planning and realization of safe products
8. Validation, verification and improvement of FSMS
1. Scope
ISO 22000:2005 standard specifies requirement for FSMS where an organization in the food
chain needs to demonstrate its ability to control food safety hazards in order to ensure that
food is safe at the time of human consumption.
This international standard can be accomplished through use of internal and\or external
resources and allows an organization, such as small and\or less developed organization e.g.
small farm, small packer distribution or food service outlet to implement an externally
development combination of control measures. This includes organization directly or
indirectly involved in one or more steps of the food chain.
a) Plan, implement, operate, maintain and update system aimed to provide safe products
for consumer
b) Demonstrate compliance with safety statutory and regulatory food safety
requirements
c) Evaluate and assess customer requirements and demonstrate conformity to enhance
customer satisfaction
d) Effectively communicate food safety issues to suppliers, customers and relevant
interested parties in the food chain
e) Conforms with stated food safety policy
f) Demonstrate conformity to relevant interested parties
g) Seek certification or registration by an external organization; make self assessment or
self declaration of conformity to this international standard.
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2 Normative References
ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary
3.1 Food Safety: Concept that food will not cause harm to the consumer when it is prepared
and /or eaten according to its intended use.
3.2 Food Chain: Sequence of the stages and operations involved in the production,
processing, distribution, storage and handling of a food and its ingredients, from
primary production to consumption
3.3 Food Safety Hazard: Biological, chemical or physical agent in, or condition of, food
with the potential to cause an adverse health
3.4 Food Safety Policy: Overall intentions and direction of an organization related to food
safety as formally expressed by top management
3.5 End Product: Product that will undergo no further processing or transformation by the
organization
3.6 Flow Diagram: Schematic and systematic presentation of the sequence and interactions
of steps
3.7 Control measure: Action or activity that can be used to prevent or eliminate a food
safety hazard or reduce it to an acceptable level
3.8 PRP prerequisite Programme: Basic conditions and activities that are necessary to
maintain a hygienic environment throughout the food chain suitable for production,
handling and provision of safe food for human consumption
3.9 Operational PRP: PRP (3.8) identified by the hazard analysis as essential in order to
control the likelihood of introducing food safety hazard and/or the contamination or
proliferation of food safety hazards in the product(s) or in the processing environment
3.10 Critical Control Point: 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
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3.14 Corrective action: Action to eliminate the cause of detected nonconformity or other
undesirable situation
3.15 Validation: Obtaining evidence that the control measures managed by the HACCP plan
and by operational PRP’s are capable of being effective
3.16 Verification: Confirmation, through the provision of objective evidence that specified
requirements have been fulfilled
3.17 Updating: Immediate and\or planned activity to ensure application of the most recent
information
The organization \SME shall establish document, implement and maintain an effective FSMS
and update it when necessary in accordance with ISO standard. The SME shall define the
scope which shall specify Products/ Product categories, Processes and Production sites that
are addressed by the FSMS
a) Ensure that food safety hazards are identified, evaluated and control hazards in such a
manner that the products directly or indirectly do not harm the consumer
d) Evaluate periodically and update the system to reflect the organization's activities and
recent information on hazards subject to control.
An SME chooses to outsource any processes that may effect the end product conformity
should be controlled, identified and documented in FSMS
4.2.1. General
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b) Procedure (seven minimum) and records (30 types) required by this standard
The FSMS documents shall control and ensure that all proposed changes are reviewed prior
to implementation and to determine effects on food safety impact on the system.
Documented procedure shall be established by organization\ SME
f) to ensure that external document are identified and their distribution controlled
g) to prevent the unintended use of obsolete documents, and to ensure that they are
suitably identified as such if they are retained for any purpose.
Note: Mandatory document procedures specified in standard for organization\ SME are
• Control of documents
• Control of records
• Corrections
• Corrective actions
• Handling potentially unsafe products
• Withdrawals (Recalls)
• Internal audits
The Organization\ SME shall establish and maintain records to provide evidence of
conformity to requirements and evidence of the effective operation of the food safety
management system. It shall be legible, readily identifiable and retrievable. Documented
procedure shall be established to define the controls needed for the identification, storage,
protection, retrieval, retention time and disposition of record.
Note: Records are special type of documents may be on paper, electronic or picture or any
other formats for organization\ SME. Records retention based on intended use of products
and expected shelf life in food chain.
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5. Management Responsibility
The Organization / SME top management shall provide evidence of its commitment to the
development and implementation of FSMS and to continually improving its effectiveness by:
Note: Top management is a person or group of people who direct and control an organization
/ SME at the highest level.
The Organization/ SME top management shall define, document and communicate its policy,
and ensure that policy is:
b) Conforms with statutory and regulatory and with mutually agreed food safety
requirements of customers
Note: An Organization/ SME need to develop food safety policy, which should be short,
focused, time framed and achievable. Measurable objectives may include identification of
activities to improve any aspect of the system e.g. reduce number of recalls; decrease the
occurrence of foreign bodies.
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The Organization/ SME top management shall ensure that:
a) Planning of the FSMS is carried out to meet requirements given in clause 4.1 as well as
objectives of organization that support food safety.
b) Maintain integrity of FSMS when changes to the system are planned and implemented.
The Organization / SME top management ensures that responsibilities and authorities are
defined and communicated within the organization to ensure effective operation and
maintenance of food safety management system. All personals shall have responsibility to
report problems with the FSMS to identified person(s) and appoint personnel to handle safety
problems and record actions.
Top Management shall appoint the Organization/SME’s food safety team leader with
responsibility and authority to:
Note: Structure of SME and job description must be precise. Team leader should be a person
having knowledge of food quality and safety and possess working experience in Quality
Assurance\control\Production areas. Food safety team leader may include liaison with
external parties on matters relating to FSMS.
5.6. Communication
The Organization/ SME shall establish, implement and maintain effective arrangements for
communicating with:
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c) Statutory and regulatory authorities
d) Other organizations that have an impact on, or will be affected by, the effectiveness or
updating of the FSMS
These communications shall provide information on food safety aspects of the organization’s
products that may be relevant to other organizations in the food chain. Records of
communications shall be maintained.
Food safety requirements from statutory and regulatory authorities and customers shall be
available.
Designated personnel shall have defined responsibility and authority to communicate any
information concerning food safety. Information obtained shall be included as Input for
updating system and management review
Note: In SME the communication will improve interaction, exchange information to control
relevant hazards in food chain. Personnel communication training may be an important
aspect. Food safety requirements from statutory authorities should be available.
The Organization / SME shall establish, implement and maintain effective arrangements for
communicating with personals on issues having an impact on food safety.
The effectiveness of the FSMS is maintained by informing changes in timely manner
including but not limited to:
a) Products/ new products
b) Raw material, ingredients and services
c) Production systems and equipment
d) Production premises, location of equipments, surrounding environment
e) Cleaning and sanitation programmes
f) Packaging, storage and distribution systems
g) Personnel qualification levels and\or allocation of responsibilities and authorizations
h) Statutory and regulatory requirements
i) Food safety hazards and control measure
j) Customer, sector and other requirements that the organization observes
k) Enquiries from external interested parties
l) Complaint indicating food safety hazards associated with the product
m) Other conditions that have impact to food safety.
The FS team shall ensure that this information is included in the updating of FSMS and top
management shall ensure that relevant information is included as input to the management
review.
Note: SME shall ensure that food safety team is informed about the changes e.g. new
products, cleaning and sanitation programs, customer complaints etc. Any member of the
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organization seeing something which may have impact on food safety should know how to
report this event.
The Organization/ SME Top management shall establish, implement and maintain procedure
to manage potential emergency situations and accidents that can impact to food safety and
which are relevant to the role of the organization in the food chain.
Note: In SME the Top management must be prepared to respond the potential emergency
situations and accidents that can impose impact on food safety e. g. Fire, Flood, Bio-
terrorism and sabotage, energy failure and customer complaints etc.
5.8.1. General
The Organization/ SME top management shall review the FSMS at planned intervals to
ensure its suitability, adequacy and effectiveness. This review shall include assessing
opportunity for improvement and the need to change to the FSMS including review the food
safety policy.
Record of management reviews shall be maintained.
Note: SME must consider that Management review is a process not just meeting.
The Organization/ SME shall include but not limited to, information on:
a) Follow up actions from previous management review.
b) Analysis of results of verification activities.
c) Changes circumstances that can affect food safety.
d) Emergency situations, accident and withdrawals\recalls.
e) Reviewing results of system updating activities.
f) Review of Communication activities including customer feed back
g) External audit/inspections
The out put shall include decisions and actions related to:
a) Assurance of food safety
b) Improvement of the effectiveness of the FSMS
c) Resource needs
d) Revision of the food safety policy and related objectives.
Note: SME must consider that management review must have these seven inputs and four
out put in it.
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6. Resource Management
The Organization/ SME shall provide adequate resource (money) for establishment,
implementation, maintenance and updating of FSMS
6.2.1. General
The organization/ SME shall have competent personals [appropriate education, training,
skills and experience] to carry out activities related with food safety.
The organization/ SME can hire external expert for the development, implementation,
operation or assessment of the FSMS, records of agreement defining the responsibility and
authority of external expert shall be available.
c) Ensure that trained personnel handle monitoring, corrections and corrective action of
FSMS.
Note: Trainings in the organization/ SME shall be maintained at a level that ensures all
employees know their responsibilities to maintain FSMS.
6.3. Infrastructure
The Organization/ SME shall provide the resources for establishment and maintenance of the
necessary infrastructure needed to implement the requirements of the international standard.
Note: Infrastructure includes buildings, process equipment, utilities, surrounding areas and
supporting devices
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6.4. Work environment
The Organization\SME’s shall provide the resources for establishment, management and
maintenance of the necessary work environment needed to implement the requirements of
International Standard.
Note: SME shall create work environment to prevent cross contamination, work space
requirement, protective work requirements, availability and location of employee’s facilities
7.1. General
The Organization / SME shall plan and develop the processes needed for the realization of
safe products. The Organization / SME shall implement, operate and ensure the effectiveness
of the planned activities and any changes to those activities. This includes PRP(s) as well as
oPRP(s) and/or the HACCP plan.
Note: ISO 22000 reorganizes the traditional concept of dividing control measures into two
groups [prerequisites and measures applied at critical control points (CCPs)] in a logical
order for the development, implementation and control of the food safety management
system. Control measures are grouped into three groups.
a) Prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPs
are not selected for the purpose of controlling specific identified hazards but for the purpose
of maintaining a hygienic production, processing and/or handling environment
b) Operational prerequisite programmes (operational PRPs) that manage those control
measures that the hazard analysis identifies as necessary to control identified hazards to
acceptable levels, and which are not otherwise managed by the HACCP plan;
c) A HACCP plan to manage those control measures that the hazard analysis identifies as
necessary to control identified hazards to acceptable levels, and which are applied at critical
control points (CCPs).
7.2.1. The Organization\SME’s shall establish, implement and maintain PRP(s) to assist the
control of
c) Food Safety hazard(s) levels in the product and product processing environment.
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a) Appropriate to the organizational needs with regard to food safety.
b) Appropriate to the size and type of the operation and nature of products being
manufactured and handled.
The Organization/ SME shall identify statutory and regulatory requirements related to the
above.
7.2.3. Selecting and establishing PRP(s) shall consider and utilize appropriate information
e.g. statutory and regulatory requirements, customer requirements, recognized guidelines,
codex Alimentatrius commission (codex) principles and codes of practices, national,
international or sector standards
i) Pest control
j) Personnel hygiene
PRP(s) shall be verified as planned and modified as necessary. Records shall be maintained
for verifications and modifications.
Documents should specify how activities are included in the PRP(s) are managed.
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Note: Purchase material management e.g. raw materials, ingredients, chemicals and packing.
Supplier management e.g. water, air, steam, ice etc.
7.3.1. General
All relevant information to conduct hazard analysis shall be collected, maintained, updated
and documented. Record shall be maintained
All relevant information means product characteristics, intended use, flow diagrams, process
steps, control measures etc
The Organization/ SME shall describe all raw materials, ingredients and product conduct
materials in documents to the extent needed to conduct hazard analysis including the
following
a) Biological, chemical and physical characteristic
c) Origin
d) Method of production
25
Statutory and regulatory food safety requirements shall be identified. All descriptions shall
be kept updated.
b) Composition
e) Packaging
f) Specify labeling relating to food safety and or instruction for handling, preparation and
usage
Statutory and regulatory food safety requirements shall be identified for above. All
descriptions shall be kept updated
The Organization / SME shall prepare flow diagrams for the products or process categories
covered by the FSMS. It provide basis for hazards analysis and are to be clear, accurate and
sufficiently detailed. Flow diagrams shall include as appropriate
26
e) Output of end products, intermediate products, by- products and waste are released or
removed.
Safety team shall verify the accuracy by site checking. Verified flow diagrams shall be
maintained as records.
The Organization/ SME shall specify existing control measures, process parameters, and/
stringency applied or procedure that influence food safety be described to conduct hazard
analysis.
External requirements (e.g. from regulatory authorities or customers) shall also be described.
All descriptions shall be kept up-to-date.
7.4.1. General
The food safety team of Organization\SME’s shall conduct hazard analysis to determine
which hazards need to be controlled, decide degree of control measures and combinations of
control measures required.
7.4.2.1 All hazards that are reasonably expected to occur [product, process, and facilities]
shall be identified and recorded. Identification shall be based on
b) Experience
d) Information from the food chain on the food safety hazard that may be relevance for the
safety of the end products, intermediate products and food at consumption.
The step(s) (from raw materials, processing and distribution) at which each food safety
hazard may be introduced shall be indicated.
27
a) The steps preceding and following the specified operation
Note: Hazards identification may be good by applying brainstorming and cause and effect
analysis because aim of both is to generate ideas and they can be used separately and
together.
The Organization/ SME shall conduct hazard assessment to determine each hazards
identified whether its elimination/reduction to acceptable levels is essential to produce safe
food, and whether its control is needed to meet the acceptable level to met.
Hazard evaluation is according to possible Severity of adverse health effects and the
Likelihood of their occurrence. Food safety hazard assessment methodology and results to be
recorded.
Risk assessment word is used in HACCP; it is likelihood or probability that a hazard will
occur.
The Organization/ SME shall select an appropriate control measures which are capable to
shall prevent, eliminate or reduce the hazard to defined acceptable level.
Control measures selected categories whether they need to be managed through
Operational PRP(s) or by HACCP plan
The Organization / SME shall review each control measures with respect to effective against
identified food safety hazards.
The selection and categorization shall be carried out using a logical approach that includes
assessments with regard to the following
a) Its effect of identified food safety hazards relative to strictness applied (Hazard versus
intensity applied)
b) Its feasibility for monitoring (Ability to monitor and make correction in timely manner)
28
d) Likelihood of failure in functioning (significant processing variability)
g) Synergistic effects
The Organization\SME’s shall document oPRP(s) and include the following information for
each program
b) Control measure(s)
f) Record(s) of monitoring
The organization\SME’S shall have a documented HACCP plan which includes following
information for each identified critical control point (CCP):
b) Control measure(s)
c) Critical limit(s)
d) Monitoring procedure(s)
29
f) Responsibility for monitoring
g) Record(s) of monitoring
Note: HACCP plan manages those control measures that the hazard analysis identifies as
necessary to control identified hazards to acceptable levels, and which are applied at critical
control points (CCP’s).
The Organization/ SME shall control each hazard by the HACCP plan while CCP(s) shall be
identified for the control measures identified.
Note: The Hazard Analysis will determine the Critical Control Points (CCPs) of raw
materials in different locations of the SME process at which safety control is critical. There is
no limit to the number of CCP’s and it will vary considering on complexity of the SME
process and the type of procedure. It is hence advisable to keep the number of CCP to a
minimum and attention is given to oPRP’s (preventive measures) that are essential for food
safety.
The Organization\SME’s shall determine the critical limits for the monitoring established at
each CCP. Critical limits shall be established to ensure that the identified acceptable level of
the food safety hazard in the end product is not exceeded. Critical limits shall be measurable
and the rationale for the chosen critical limits shall be documented.
Critical limits shall be Based on subjective data (such as visual inspection of product,
process, handling etc) and supported by instructions and/or education and training.
Note: The critical limit established in SME’s CCP should not exceed otherwise the safety of
the product cannot be assured. The selection of parameters for which critical limits have to be
established requires an in depth understanding of the technologies used for controlling the
hazards and the processing. It is difficult for setting target levels and critical limits, it is
essential that technical decisions about targets and critical limits are made by appropriate
staff based upon evidence and not derived by guess work.
The Organization\SME’S shall establish monitoring system for each CCP that is in control
and system shall include scheduled measurements or observations relative to critical limits.
The monitoring system shall consist of relevant procedures, instructions and records that
cover,
a) Measurements/observations provide results with in an adequate time frame
30
c) Applicable calibration methods
d) Monitoring frequency
The monitoring methods and frequency shall be capable of determining when the critical
limits have been exceeded in time for the product to be isolated before it is used or
consumed.
The Organization/ SME shall establish planned corrections and corrective actions whenever
critical limits exceeded in the HACCP plan and ensure that
Establish and maintain documented procedure to handle potential unsafe products to ensure
that they are not released until they have been evaluated
Note: SME shall take action when the results of monitoring at the CCP indicate a loss of
control or trend towards loss of control. Management of the deviation and the following up of
actions on product batches, to be subject to corrective action, are made possible by the
effective operation of a system of upstream and downstream traceability.
Following the establishment of operational PRP(s) and\or the HACCP plan, the organization/
SME shall update the following information, if necessary
a) Product characteristic
b) Intended use
c) Flow diagram
d) Process steps
31
e) Control measures
If necessary, the HACCP plan and the procedures and instructions specifying the PRP(s)
shall be amended.
The Organization\SME’s shall define purpose, methods, frequencies and responsibilities for
verification the activities
Verification activities shall confirm:
a) Implementation of PRP
c) Effective implementation of operational PRP(s) and HACCP plan and company other
procedures
The output of this planning shall be in a form suitable for the organization’s method of
operations.
Verification results shall are recorded and communicated to food safety team. Verification
results shall be provided to enable the analysis of the results of the verification activities.
If verification based on end product testing samples, any NC lot to be handled as potentially
unsafe
The Organization/ SME shall establish and apply system for product lots, link to Raw
materials, processing and delivery records
Traceability system shall be able to identify raw material from immediate suppliers and
finished products distribution route to immediate distributors
Traceability records shall be maintained for a defined period for system assessment to enable
the handling of potentially unsafe products and in the event of product withdrawal. Records
shall be accordance to statutory and regulatory and customer requirements and may for
example, be based on the end product lot identification.
Note: The SME needs to check simulations of upstream and downstream traceability either
on raw materials, or in production, or finished products.
7.10.1. Corrections
32
The Organization/ SME shall ensure that when critical limits for CCP’(s) are exceeded or
there is a loss of control of operational PRP(s), the products affected are identified and
controlled with regard to their use and release.
Documented procedure shall be established and maintained defining
a) Identification and assessment of affected end products to determine their proper handling
The Organization\SME’S derived data from the monitoring of operational PRPs and CCPs
shall be evaluated by designated person(s) with sufficient knowledge and authority to initiate
corrective actions. Corrective actions shall be initiated when critical limits are exceeded or
when there is a lack of conformity with operational PRP(s).
The Organization\SME’s shall establish and maintain documented procedures that specify
appropriate actions to identify and eliminate the cause of detected nonconformities, to
prevent recurrence, and to bring the process for system back into control after nonconformity
is encountered. These actions include
b) Reviewing trends during monitoring that may indicate development towards loss of
control
Note: The SME’s confirm that monitoring sheets of corrective actions are correctly and
progressively filled, until the effective reworking, removal or destruction of any affected
batches
33
7.10.3. Handling of potentially unsafe products
7.10.3.1. General
The organization shall prevent the nonconforming products entering the food chain unless it
is possible to ensure that
b) The food safety hazard(s) of concern will be reduced to identified acceptable levels prior
to entering in to the food chain, or
c) The product still meets the defined acceptable level(s) of the food safety hazard(s) of
concern despite of nonconformity
Nonconformance products shall be held under control of Organization\SME’s until they have
been evaluated and released unsafe product to be recalled after notifying relevant parties.
Keep records related with unsafe products
Nonconformance product can be released as safe product when any of the following
condition applies
a) Evidence other than the monitoring system demonstrates that the control measures have
been effective.
b) Evidence shows that the combined effect of the control measures for that particular
product complies with the performance intended.
Organization/ SME lot of product which is not acceptable for release shall be handled by one
of the following activities
b) Destruction/disposal as waste
7.10.4. Withdrawals
The Organization/ SME to enable and facilitate the complete and timely withdrawals of lots
of end products which have been identified as unsafe
34
a) Appointed authorized personnel to initiate and execute the withdrawals by the top
management
The Organization/ SME shall secure or held the withdrawn products under supervision until
they are destroyed, used for purposes other than intended, or reprocessed in a manner to
ensure they become safe.
The cause, extent and result of withdrawal as an input to management review while the
programmed shall be verified and recorded through appropriate technique [challenge testing,
mock withdrawal, practice withdrawal]
8.1 General
The food safety team shall plan and implement the process needed to validate control
measured and / or control measure combinations, and to verify and improve the FSMS.
a) Capability of selected control measure for intended control of food safety hazard and
ensuring control of identified food safety hazard for end product.
b) Effectiveness of control measure and are capable of, in combination, ensuring control of
the identified food safety hazard(s) to obtain end products that meet the defined acceptable
levels.
If results of validation not comply above elements then control measures shall be modified
and re-assessed
Modifications may include changes in control measures and\or in raw materials,
manufacturing technologies, end product characteristics, methods of distribution and\or
intended use of end product.
35
The Organization/ SME shall provide evidence that the specified monitoring and measuring
methods and equipment are adequate to ensure the performance of the monitoring and
measuring procedures.
The Organization/ SME shall use measuring equipment and methods to ensure valid results
that
If the result of validation is nonconforming then take actions on the equipment and any
product affected
Records of such assessment and resulting actions shall be maintained.
Usage of computer software shall be confirmed prior initial used and reconfirm as necessary.
Note: The Organization\SME’s shall provide evidence specified monitoring and measuring
method and equipments are adequate to ensure performance of monitoring and measuring
procedures
The Organization/ SME shall conduct internal audits at planned intervals to determine
whether FSMS
The Organization/ SME shall plan internal audit by considering importance of process and
areas to be audited as well as any updating actions from previous audits. The audit criteria,
scope, frequency and methods shall be defined. Auditors shall be independent and trained.
36
The responsibilities and requirements for planning and conducting audits, and for reporting
results and maintaining results shall be defined in documented procedure.
Follow up to eliminate nonconformity and their causes without delay is mandatory,
Verification of corrective action taken and reporting of verification results.
Note: Internal Audit in an Organization/ SME helps ascertain whether the company’s food
safety objectives are achieved and promotes continuous improvement of FSMS. It helps to
identify and correct discrepancies between documented procedures and actual practices.
The Organization/ SME food safety team shall systematically evaluate the individual results
of planned verifications. The evaluation result is not conforming the require conformity,
actions shall be taken but not limited to, review of
c) PRP(s)
The Organization\SME’s food safety team shall analyze the results of verification activities,
internal audits and external audits, purpose may be to
d) Input for Internal audit programme concerning the status and importance of areas to be
audited.
The results of the analysis and the resulting activities shall be recorded and reported, in an
appropriate manner, to top management as input to management review. It shall also be used
as an input for updating the FSMS.
8.5. Improvement
37
8.5.1. Continual Improvement
• Communication
• Management Review
• Internal audit
• Evaluation of individual verification results
• Analysis of results of verification activities
• Validation of Control measure
• Corrective actions
• FSMS updating
The Organization\SME’s food safety team shall evaluate FSMS at planned intervals and
consider whether it is necessary to review the hazard analysis, the established operational
PRP(s) and the HACCP plan. The evaluation and updating activities shall be based on
b) Input from other information concerning suitability, adequacy and effectiveness of the
FSMS
System updating activities shall be recorded and reported, in an appropriate manner, as input
to the management review.
38
4. Preparation for Certification
Organization\SME’s select certification body (CB) for final audit is selected on its reputation
and accreditation, cost, audit approach and most importantly competence and experience in
the certification scope in this phase. CB will do stage 1 assessment\audit on site to determine
readiness of the organization to proceed to stage 2, no nonconformance reports are issued but
observation are highlighted of the FSMS. CB will undertake stage 2\final audit within six
months after stage1 to determine that organization is adhering the system, audit top
management and nonconformance reports are issued. Corrective actions to eliminate the
cause of a detected nonconformity are necessary for certificate. Audit is successfully
completed, an independent report and certificate of registration identifying scope of the
FSMS. ISO 22000 certificate is valid for three years subject to surveillances agreed on six
month or yearly basis to check the compliance of system.
The summary of ISO 22000:2005 standard for application in an organization / SME is given
below:
39
6.2.2 (g) Records of training 7.10.1 Conformance evaluation
7.2.3 Records of verifications and modifications 7.10.1 Correction results
7.3.1 Information needed to conduct hazard 7.10.2 Corrective action results
analysis
7.3.2 Food safety team knowledge and 7.10.2 Corrective action
experience
7.3.5.1 Verified flow diagram 7.10.4 Withdrawal
7.4.2.1 Food safety hazard identification 7.10.4 Withdrawal effectiveness
7.4.2.3 Acceptable level of food safety hazard 8.3 (a) Basis for calibration or
verification
7.4.3 Hazard assessment 8.3 Results of calibration
7.4.4 Control measures 8.4.1 Assessment of NC
equipment measuring
result
7.5 (f) Assessment of PRP monitoring 8.4.1 Internal audit
7.6.1 (g) HACCP plan monitoring 8.4.3 Analysis of results of
verification of activities
7.6.4 Monitoring of CCP 8.5.2 Updating of FSMS
40
5. Application of ISO 22000:2005 standard in fruit processing SME- An
Example
For better understanding of certain processes of ISO 22000:2005 standard like product
description, hazard analysis, Critical control points determination, CCP plan, flow diagram
and gantt chart in a fruit processing SME is discussed below. The standard can be
implemented in the following five phases
Product Description
Product description may be described as
41
Fruit Processing
Flow Diagram (Typical Operations)
Reception
Sorting
(Roller Sorter)
Washing
Chopping
Crude Pulp
(Pulp + Fiber + Pieces of Peel)
Heating No Heating
(Continuous Cooker)
Refining
(Refiner)
pH
Adjustment
CCP # 1 Pasteurization
Chemical
CCP # 2
Preservation
& Filling
Storage
42
HAZARD ANALYSIS
SME’s should conduct hazards analysis based on hazards probability (likelihood of
occurrence), severity and significance to consumers in order to determine which of the
potential hazard presents a significant risk in the raw materials or process. Fruit pulp raw
materials and processing steps are included as an example
Probability (Evaluating the likelihood of occurrence of the hazard is the most difficult
aspect of Hazard Analysis.)Chance of occurrence of any biological, chemical or physical
hazard
Probability Scale:
Numeric number range from 1- 5
1 - Very rare probability of occurrence
5 - Very often to occur
Severity
How much hazards is dangerous/sever for human health.
Severity Scale:
Numeric number range from 1- 5
1- Less sever to human health
5-Very sever to human health
Significance of Hazard
Threshold value is 12
Hazard is significant > 12
Significant factor = Probability x Severity
HAZARD ANALYSIS
Ingredient Potential Food Safety Control Measures Risk Assessment Signi
receiving and Hazard type Sev Prob Res fican
storage B= Biological erit abilit ult ce of
C= Chemical y y (Sx Haza
P= Physical P) rd
(+/-)
Fruit/Vegetab C- Pesticide residues, GMP + Certificate of 4 2 8 -
le Ash, Color, Sulfur analysis from supplier
Dioxide
B- Pathogenic Microbes Heat treatment during 5 1 5 -
processing
Water P- slit, Dirt etc Water filtration, cleaning 2 2 4 -
of storage tank
C- Could contain heavy Prerequisite program 4 1 4 -
metals, chemical (Premises- Water Quality)
residues
B- Water not meeting Prerequisite program 5 1 5 -
the drinking water (Water testing and
criteria treatment)
43
Citric Acid P- could contaminated if Prerequisite programs for 2 2 4 -
packing is open or storage
broken
Processing
Sorting No hazard found
CCP Determination
CCP’s can be identified by using decision tree based on hazard analysis and is tabulated as
for Fruit pulp
CCP Determination
INGRED Q1. Is there any hazard Q2. Is it likely that contamination Q3. Is consumer or process CCP
IENT associated with raw with the identified hazard could step eliminate/reduce the number
RECEIV materials? occur in excess of the acceptable likely occurrence of the
ING level or could increase to an identified hazard to an *Proceed
AND If no then process to next unacceptable level? acceptable level? to next
STORA material *if no = not CCP + proceed to the *if no = CCP identifie
GE next identified hazard *if yes = explain and d hazard
*if yes process to next question proceed to next material
If Yes = Explain Hazard
and process to next
question
Water YES= SLIT DUST ETC YES YES=WATER
COULLD CONTAIN FILTERATION AND
HEAVEY METALS NOT WATER TESTING
MEETING DRINKING
WATER CRITERIA
44
Citric YES= COULD YES YES=VISUAL
Acid CONTAIMINATED INSPECTION BEFORE
FROM THE USE
SURROUNDINGS IF
PACKING IS OPEN OR
BROKEN
Pasteuriz MICROBIAL GROWTH YES=TEMPERATURE GUAGES NO CCP
ation MONITORING
45
CCP PLAN
Process C Hazard Critical Monitoring Procedures Deviatio HACC
Steps C Description Limits What How Frequency Wh n P
P o Procedur Recor
e d
#
Pasteuriz 1 Microbes NO Temperatur Lab EVERY Sup Re WI
ation GROWTH e test BATCH ervi wor
Monitoring sor k
Chemica Biological No growth Checking Lab Every batch Qcc Product Labor
l 2 Hazard as of microbes test hold atory
Preservat wrong Report
ion quantity can
cause
microbes
growth
46
Time lines / Gantt chart for Implementing ISO 22000: 2005
Management Commitment
Food Safety Policy
Planning of FSMS
FSMS responsibility and authority
Appointment FS team and Leader
System Procedures
Communication System
Training and awareness
Establishment of PRPs
Food Safety Hazard Analysis
Determine/establish CCPs
Monitoring of CCPs
Establish oPRPs
Finalize HACCP plan
Verification Planning
Product Traceability System
Non conformance Product Protocol
Validation of FS Control Measures
FSMS Internal Audit
FSMS Review Procedure
Update and Improve system
Select Certification Body
Final Audit
Corrective Actions
47
Conclusion
The study was conducted to review existing Food Safety Management System (FSMS) in the
country and to draft a document on strategy for implementation of ISO 22000:2005 standard
for SMEs dealing in Food Supply Chain. Several professional from food processing industry
and public sector organizations were contacted and information was sought regarding the
existing food safety situation in the country.
Existing food laws and international prevailing food standards were studied in detail that has
revealed that in order to improve the poor food safety condition of country there is a need to
harmonize the local food laws with international food standards such as ISO 22000:2005 as
existing food laws are becoming obsolete with the technological advancement and
emergence of new food products.
For the understanding and adoption of SMEs, ISO 22000:2005 has been elaborated along
with necessary explanations and a practical example has been quoted with reference to a
typical food processing of industry indicating and explaining in detail about description of
products, conducting hazard analysis and Gantt chart for implementation of Standard.
However, it can be implemented by any food processing and packaging firm dealing in any
component of food supply chain.
48
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49
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50
Annexure-I
Contributors
51
Mr. Shahid Baig Production Manager
Abdullah Foods
52