Food Safety

It is the assurance that food will not cause harm to the consumer when it is prepared and /or eaten according to its intended use (ISO 22000:2005 and Codex Alimentarius). It is also defined as all conditions necessary during the production, processing, storage, distribution and preparation of food to ensure that it is safe, sound, and wholesome and fit for human consumption (Joint FAO/ WHO Expert Committee on Food Safety).

AIM OF ISO 22000:2005

It requires an organization to include any applicable food safety related statutory & regulatory requirements into its food safety management system.To harmonize on a global scale the requirements for food safety management for businesses within the food chain.

All size organizations involved inany aspect of food chain that can consistently demonstrate its ability to control food safety hazards and provide safe products. Food chain are needed to organize in direct and indirect organization : Direct organization:Feed producers, harvesters, farmers, producers of ingredients, food producers, retailers, food services, catering services, cleaning & sanitation services, transportation, storage & distribution services. Indirect organization:Supplier of equipment, cleaning &sanitation agents, packaging material, another food contact material.

Food Borne Illnesses

Much of the world’s food supply is not safe; several high profile cases underline the potential danger of food borne illnesses to consumers. In the industrialized countries, an estimated one in three persons is struck by food borne illnesses each year, largely from mass catered food.Some 70000 people die every year in Asia due to food and water borne diseases and many more suffer the long-term effects. Even in the United States, where food safety is widely known and practiced about 76 million cases of food borne illnesses occurred each year.About four million cases of food borne infectious disease occur annually in Australia. The worst E. coli outbreak in 1996 was recorded where 20 people died in Scotland after attending a lunch. A few recent examples include Bovine Spongi form Encephalopathies (BSE) infected beef, the salmonella contamination of poultry and eggs and high levels of Lister in dairy products. For these reasons and others, global retailers, distributors, food manufacturers and food service companies are now concerned more about the safety of their food supply chain than ever before.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.

Food Safety Hazards

These are biological, chemical or physical agents in food or condition of food, with thepotential 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 andseverity of individual food borne diseases; for canned food, C. botulism is critical; for freshpoultry and eggs Salmonella; for milk, Listeria. Naturally occurring food contaminants e.g.mycotoxins are undoubtedly more prevalent within the less sophisticated food handlingsystems. The control of mycotoxicoses requires that mould contamination in food andfeedstuffs should be prevented or reduced to harmless levels. This involves basically theestablishment of good harvesting, drying, handling, storage, transportation and distributionprocedures.Food additives and pesticide residues are also food hazards, but the associated problems arerisk related and the severity does not compare with food borne illness. There is need to focuson food safety risk management, risk is an estimate of probability that a hazard can occur. Itis therefore, imperative that all directions be addressed to move toward accomplishment of food safety.

Food Chain

It is the sequence of stages and operations involved in the production, processing,distribution, storage and handling of foods and its ingredients from primary production toconsumption of food. The global food chain includes product suppliers and service providersalso. Recognition of the organization's role and position within the food chain is essential toensure effective interactive communication throughout the chain in order to deliver safe foodproducts to the final consumer.

1.6 Role of Industry in Ensuring Food Safety

The objectives of food safety programs are universal, shared by industry, government and theconsumers to provide safer food for all. The contribution that could be made by the industryfor safe food supply is to identify food safety problems, policies to address and actionprograms for eliminating the problems. The challenges faced by the industry fall within allthe safety categories. Several challenges are under the total control of industry; safe practicesby producers and safe processing procedures, where as distribution and handling are onlypartially under the control of food industry. The handling of food by consumers must be apart of an educational process, which provides a clear example of the shared responsibilityamong industry and the consumers.

1.7 Food Safety Management System (FSMS)

Food Safety is a systematic approach for protection of foods against contamination,adulteration and spoilage. It assures maximum consumer protection, encourages development of food industry on sound scientific lines and improves potential of export and enables better control of imported foods. The management system is a framework of processes and procedures used to ensure that an organization can fulfill all tasks required to achieve its objectives. Thus a FSMS can bring a considerable improvement in the food industry.

International Organization for Standardization (ISO) 22000:2005 FSMS

The ISO 22000 series is another step forward for ensuring food safety in the food products for consumers with its new ISO 22000:2005 standard on food safety management system to facilitate traceability in the feed and food supply chain. This standard could be implemented by any small or medium-sized enterprise in the food sector. The SME after adopting the FSMS based on ISO 22000:2005 standard would be able to assure safe food production,supply, gain customers confidence and maximize profits.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.

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 inFSMS. 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.

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 ISO9001:2000 for 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.

Key Elements of ISO 22000:2005

This international standard specifies the requirements of a FSMS, which involves the keyelements as given below:

•

Interactive communication

•

System management

•

Pre-requisite programs

•

HACCP principles

Interactive communication

ISO 22000:2005 standard call for interactive communication planned and maintained toensure that all food safety hazards are identified and controlled adequately at each step withinthe food chain through communication to all involved parties. It also assists to confirm therequirements of customer and supplier regarding feasibility, needs and impact on the endproduct.

System management

The effective food safety system is designed, operated and updated within the framework of a structured management system, incorporated into the overall management activities of theorganization, thus providing maximum benefit for the organization. This standard has takeninto consideration the provisions of ISO 9001:2000 in order to enhance compatibility of thetwo standards. The format of the standard is same as ISO 9001 and ISO 14001 and makessuitable to develop an integrated risk based management system.

Pre-requisite programs

Separates infrastructure and maintenance programs, and operational PRP’s, basicallyaddressing the requirements of food hygiene and accepted good practices of a morepermanent nature, and control or reduce the impact of identified food safety hazards in theproduct or in the processing environment.

HACCP principles

The seven principles of HACCP integrates with the twelve application steps developed by the CAC and vigorously combine it with PRPs necessary to control and reduce any food safety hazards identified for the end products delivered to the next step in the food chain to acceptable levels.5

Structure of ISO 22000:2005

The standard adopts the following structure:



Food chain approach



Process approach



Continual improvement (PDCA)

Food Chain Approach

ISO 22000:2005 promotes adoption of a food chain approach while developing,implementing and improving the effectiveness and efficiency of a FSMS. An organization to function effectively and efficiently has to identify and manage numerous linked activities.Recognition of the organization’s role and position within the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver safe food products to the final consumer.

Process Approach

An activity using resources and manage transformation of inputs into outputs is considered asa process. Often output from one process directly forms the input to the next. The process 6

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:



Understanding and fulfilling the requirements



The need to consider processes in terms of food safety and traceability



Obtaining results of process performance and effectiveness



Continual improvement of processes based on objective measurement.The ISO 22000:2005 is a continuous improvement process-based FSMS with systematic approach for developing, planning, validating, establishing, implementing, monitoring,verifying and improving the FSMS.

PDCA Cycle

Plan Act Check Do

a.

Plan

: Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies

b.

Do:

Implement the processes

c.

Check:

Monitor and measure processes and product against policies, objectives and requirements for the product and report the results

d.

Act:

Take actions to continually improve process performance

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 safetyhazards. 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. Asa 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.8

ISO 22000 require that all control measures are validated in order to ensure that they arecapable to control hazards. Validation ensures that performance of the control measure meetsor exceeds the specified expected outcomes.

Situation Analysis

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:

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Government intervention through legislation



Customer’s demand for wholesome and safe food



Voluntary initiative of food processor for manufacturing and sale of safe food,obtaining market share and customers trust.

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.

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 laboratory10

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.

Food Control System – Management and Inspection Services

Effective food control system requires policy and operational coordination at national level.The nature and extent of this policy and operational coordination depends on the organizational structure of the food control system. Therefore, it is important that the structure provides for a leadership or coordinating function performed by a central management entity. The responsibility for effective implementation of mandatory regulatory measures rests normally with the management. Administration and implementation of the food Law and its regulation requires that a qualified food inspection service carries out inspections of food premises, collects food samples for analysis and undertakes other activities necessary to determine compliance with the regulations.

Food Standards

Food standards aim to protect consumer’s health and ensuring fair practices in food trade and are intended for processed, semi- processed or raw foods. It includes provisions in respect of food hygiene, food additives, pesticide residues, contaminants, labeling, methods of analysis and sampling. The current food standards in the country are based on the statutory regulations and ordinances.

International Food Standards:

Several food standards and laws are prevailing indifferent regions of the world. Many organizations have their own set of standards thatbecomes obligatory for the suppliers to follows. Similarly different countries haveenforced their set of laws/ standards and every food product entering their border needsto fulfill those laws. The internationally recognized food standards pertaining to foodsafety system in the industry are:i.

Codex Alimentarius Commission (CAC)ii.

International Organization for Standardization (ISO)iii.

International Food Standard (IFS) Version 4, 2004iv.

British Retail Consortium Global Standard –Food (Issue 4, 2005)

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.

ii. International Organization for Standardization (ISO):

It is a non governmental organization –a federation of national standards bodies from all regions of the world,one per country, including developed, developing and transitional economies. Each ISO member is the principal standards organization in its country. The members propose new standards, participate in their development and provide support in collaboration with ISO Central Secretariat for the 3000 technical groups that actually develop the standards.

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:

a) ISO 22000:2005

– food safety management systems – requirements for any organization in the food chain.12

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:

•

Utilizable by all organizations in the food chain

•

Combines the recognized food safety system elements as defined by Codex

•

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

•

Ensures that the process used to control food safety is validated, verified,implemented, monitored and managed

•

Focus only on food safety.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.

ISO 22000-2005 FSMS - Application in SME

The ISO 22000:2005 standard is available in both English and French languages from ISOCentral 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.

Scope2.

Normative Reference3.

Terms and definitions4.

Food Safety Management Systems5.

Management responsibilities6.

Resource management7.

Planning and realization of safe products8.

Validation, verification and improvement of FSMS

1. Scope

ISO 22000:2005 standard specifies requirement for FSMS where an organization in the foodchain needs to demonstrate its ability to control food safety hazards in order to ensure thatfood 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 externallydevelopment combination of control measures. This includes organization directly or indirectly involved in one or more steps of the food chain.The requirements enable organization / SME to:a)

Plan, implement, operate, maintain and update system aimed to provide safe productsfor consumerb)

Demonstrate compliance with safety statutory and regulatory food safety requirementsc)

Evaluate and assess customer requirements and demonstrate conformity to enhance customer satisfaction#)

Effectively communicate food safety issues to suppliers, customers and relevant interested parties in the food chain)

Conforms with stated food safety policy)

Demonstrate conformity to relevant interested parties)

Seek certification or registration by an external organization; make self assessment or self declaration of conformity to this international standard.14

2 Normative References

ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary

3 Terms and Definition3.1 Food Safety:

Concept that food will not cause harm to the consumer when it is preparedand /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

3.11 Critical Limit:

Criterion that separates acceptability from unacceptability

3.12 Monitoring:

Conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended

3.13 Correction:

Action to eliminate a detected nonconformity.

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

4 Food Safety Management Systems4.1 General Requirements

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 FSMSThe organization\ SME shall: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) Communicate food safety issue of products throughout the food chain) Communicate information concerning development, implementation and updating FSMS through the organization to ensure food safety required by the standard.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 Documentation Requirements 4.2.1. General

The Organization\ SME shall document:a) Statements of food safety Policy and related Objectives.

b) Procedure (seven minimum) and records (30 types) required by this standard) Needed by the organization to ensure for effective development, implementation and updating of the FSMS.

4.2.2. Control of Documents

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\ SMEa) to approve documents for adequately prior to use) to review and update documents as necessary, and to re-approve documents) to ensure that identified changes and revision status of documents ) to ensure that relevant versions are available at point of use) to ensure that documents remains legible and readily identifiy label) to ensure that external document are identified and their distribution controlled) to prevent the unintended use of obsolete documents, and to ensure that they are suitable 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

Control of records

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.

Management Responsibility5.1. Management Commitment

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:a) Business objectives to support food safety) Communicate the importance to meet requirements of this standard, statutory and regulatory as well as customer requirements relating to food safety.c) Establishing food safety policy) Conducting management reviews) Ensure the availability of resources

Note

: Top management is a person or group of people who direct and control an organization / SME at the highest level.

Food Safety Policy

The Organization/ SME top management shall define, document and communicate its policy,and ensure that policy is:a) Appropriate with organization's role in the food chain) Conforms with statutory and regulatory and with mutually agreed food safety requirements of customers) Communicate, implement and maintain at all levels) Continued suitability is reviewed) Adequately addresses communication) Supported by measurable objectives

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.

Responsibility and Authority

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.

Note

: SME top management responsibility is to ensure planned management reviews.

5.5. Food Safety Team Leader

Top Management shall appoint the Organization/SME’s food safety team leader with responsibility and authority to:a) Manage the food safety team and organize its work b) Relevant training and education of the team members) FSMS is established, implemented, maintained and updatedd) Report to top management on the effectiveness and suitability of the FSMS.

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.

Communication5.6.1. External Communication

The Organization/ SME shall establish, implement and maintain effective arrangements for communicating with:a) Suppliers and contractorsb) Customers or consumers in relation to product information (including instructions regarding intended use, specific storage requirements, shelf life) enquiries, contracts or order handling amendments, and customer feed back including customer complaints,

c) Statutory and regulatory authoritiesd) Other organizations that have an impact on, or will be affected by, the effectiveness orupdating of the FSMSThese communications shall provide information on food safety aspects of the organization’sproducts 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 beavailable.Designated personnel shall have defined responsibility and authority to communicate anyinformation 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.

Internal Communication

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) Raw material, ingredients and services) Production systems and equipment) Production premises, location of equipments, surrounding environment) Cleaning and sanitation programmes) Packaging, storage and distribution systems) Personnel qualification levels and\or allocation of responsibilities and authorizations) Statutory and regulatory requirements) Food safety hazards and control measure j) Customer, sector and other requirements that the organization observes) Enquiries from external interested parties) Complaint indicating food safety hazards associated with the product) 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 organization seeing something which may have impact on food safety should know how toreport this event.

Emergency Preparedness and Response

The Organization/ SME Top management shall establish, implement and maintain procedureto manage potential emergency situations and accidents that can impact to food safety andwhich 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 emergencysituations 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. Management Review5.8.1. General

The Organization/ SME top management shall review the FSMS at planned intervals toensure its suitability, adequacy and effectiveness. This review shall include assessingopportunity for improvement and the need to change to the FSMS including review the foodsafety policy.

Record of management reviews shall be maintained.

Note:

SME must consider that Management review is a process not just meeting.

Review Input

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

Review Output

The out put shall include decisions and actions related to:a) Assurance of food safetyb) Improvement of the effectiveness of the FSMSc) Resource needsd) 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.

Competence, Awareness and Training

The Organization/ SME shall) Identify competencies of personals whose activities have an impact on food safety.b) Provide personals training or take other action for necessary competencies) Ensure that trained personnel handle monitoring, corrections and corrective action of FSMS.) Evaluate the implementation and effectiveness.

Ensure awareness of personnel in contributing to food safety) Ensure effective communication is understood) Maintain appropriate record of training and actions described in b and c.

Note:

Trainings in the organization/ SME shall be maintained at a level that ensures allemployees know their responsibilities to maintain FSMS.

6.3. Infrastructure

The Organization/ SME shall provide the resources for establishment and maintenance of thenecessary infrastructure needed to implement the requirements of the international standard.

Note:

Infrastructure includes buildings, process equipment, utilities, surrounding areas and supporting device.

Planning and Realization of Safe Products7.1. 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 effectivenessof the planned activities and any changes to those activities. This includes PRP(s) as well asoPRP(s) and/or the HACCP plan.

Note:

ISO 22000 reorganizes the traditional concept of dividing control measures into twogroups [prerequisites and measures applied at critical control points (CCPs)] in a logicalorder for the development, implementation and control of the food safety managementsystem. Control measures are grouped into three groups.a) Prerequisite programmes (PRPs) that manage the basic conditions and activities; the PRPsare not selected for the purpose of controlling specific identified hazards but for the purposeof maintaining a hygienic production, processing and/or handling environmentb) Operational prerequisite programmes (operational PRPs) that manage those controlmeasures that the hazard analysis identifies as necessary to control identified hazards toacceptable 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 asnecessary to control identified hazards to acceptable levels, and which are applied at criticalcontrol points (CCPs).

7.2. Prerequisite Programmes (PRPs)

The Organization\SME’s shall establish, implement and maintain PRP(s) to assist the control of a) Likelihood of introducing hazards to the product from work environment) Biological, chemical and physical contamination of the product(s) including cross contamination between products) Food Safety hazard(s) levels in the product and product processing environment.

The PRP(s) shall be:

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.c) Implemented across the entire production system. Approved by the food safety team.The Organization/ SME shall identify statutory and regulatory requirements related to the above.

Selecting and establishing PRP(s) shall consider and utilize appropriate information.g. statutory and regulatory requirements, customer requirements, recognized guidelines,codex Alimentatrius commission (codex) principles and codes of practices, national,international or sector standards.The Organization/ SME shall consider the following:a) Construction and lay-out of building and associated utilities) Lay-out of premises, including workspace and employee facilities) Supplies of air, water, energy and other utilities.d) Supporting services including waste and sewage disposal) Suitability of equipment [cleaning, maintenance and preventative maintenance]f) Management of purchase materials, supplies, disposals and handling of products) Measures for the prevention of cross contamination) Cleaning and sanitizing) Pest control j) Personnel hygiene) Other aspects as appropriate 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.

Purchase material management e.g. raw materials, ingredients, chemicals and packing.Supplier management e.g. water, air, steam, ice etc.

7.3. Preliminary Steps to Enable Hazard Analysis. 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

7.3.2. Food Safety Team

The Organization/ SME shall appoint food safety team.Team shall have a combination of multi discipline knowledge and experience in development and implementation of FSMS. This includes but not limited to, the organization’s products,processes, equipment and FS hazards within the scope of FSMS. Records shall be maintained that demonstrates the food safety team has the required knowledge and experience.

7.3.3. Product Characteristic

Raw materials, ingredient & product contact materials

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) Biological, chemical and physical characteristic) Composition (including additives and processing aids)c) Origin) Method of production) Delivery methods and packaging) Storage conditions and shelf life) Preparation &/ handling before use or processing) Food safety related to acceptance criteria or purchased materials and ingredients appropriate to their intended use.

Statutory and regulatory food safety requirements shall be identified. All descriptions shallbe kept updated.

7.3.3.2. End product characteristics

The Organization\SME’s shall document the characteristics of end products to conducthazard analysis including the followinga) Product name or similar identificationb) Compositionc) Biological, chemical and physical characteristics relevant to food safetyd) Intended shelf life and storage conditionse) Packagingf) Specify labeling relating to food safety and or instruction for handling, preparation andusageg) Method (s) of distributionStatutory and regulatory food safety requirements shall be identified for above. Alldescriptions shall be kept updated

7.3.4. Intended Use

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Information for users and consumers

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Intended use and handling of the end product

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Product and process category

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Vulnerable group of consumers

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Mishandling and misuse of end product

FINANCIAL STATUS ON BUSINESS