Microbiological Quality and Safety in Dairy Industry

Module 2. Food safety and quality management systems

Lesson 9
INTRODUCTION TO FOOD SAFETY MANAGEMENT SYSTEM (FSMS) –ISO: 22000

9.1 Introduction

Food safety is a global concern, not only because of the importance for public health but also because of its impact on international trade. Globalisation of food production and procurement makes food chains longer and more complex and increases the risk of food safety incidents. Effective and harmonized food safety systems shall manage and ensure the safety and suitability of food in each link of the supply chain. For this reason ISO developed the standard for food safety management systems ISO 22000 which applies to all organizations in the food chain and thus ensures integrity of the chain. ISO 22000 is a generic food safety management system standard. It defines a set of general food safety requirements that apply to all organizations in the food chain. If an organization is part of the food chain, ISO 22000 wants it to establish a food safety management system (FSMS). It then wants it to use this system to ensure that food products do not cause adverse human health effects. Since ISO 22000 is a generic food safety management standard, it can be used by any organization directly or indirectly involved in the food chain. It applies to all organizations in the food chain. It doesn’t matter how complex the organization is or what size it is, ISO 22000 can help ensure the safety of its food products.

9.2 Definition and Terminology

9.2.1 Control (noun)

To state wherein correct procedures are being followed and criteria are being met.

9.2.2 Control (verb)

To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.

9.2.3 Control measure

Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

9.2.4 Corrective action

Any action to be taken when the results of monitoring at the CCP indicate a loss of control.

9.2.5 Critical control point (CCP)

A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

9.2.6 Critical limit

A criterion which separates acceptability from unacceptability.

9.2.7 Deviation

Failure to meet a critical limit.

9.2.8 End products

Product that will undergo no further processing or transformation by the organization.

9.2.9 Flow diagram

A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.

9.2.10 Food safety hazard

Biological, chemical or physical agents in food, or condition of food, with potential to cause an adverse health effect.

9.2.11 Food safety policy

Overall intentions and direction of an organization related to food safety as formally expressed by top management.

9.2.12 HACCP plan

A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.

9.2.13 HACCP

A system which identifies, evaluates and controls hazards which are significant for food safety.

9.2.14 Hazard analysis

The process of collecting and evaluating information on hazards and conditions loading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.

9.2.15 Hazard

A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect. It is the potential to cause harm; risk on the other hand is the likelihood of harm (in defined circumstances, and usually qualified by some statement of the severity of the harm).

9.2.16 Monitor

The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.

9.2.17 Operating limits

Criteria more stringent than critical limits that are used by an operator to reduce that risk of contamination, eg., if a certain chemical concentration is required to control a hazard, the operating limit is generally set above the minimum concentration needed to ensure effective treatment.

9.2.18 Operational prerequisite programme (OPRP)

Identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazards (and/ or the contamination or proliferation or food safety hazards in the product (s) or in the processing environment.

9.2.19 Prerequisite programme (PRP)

Basic condition and activities that is necessary to maintain a hygienic environment throughout the food chain suitable for production, handling and provision of safe end products and safe food for human consumption.

9.2.20 Risk

An estimate of the likely occurrence of a hazard.

9.2.21 Severity

The seriousness of a hazard (if not properly controlled)

9.2.22 Step

A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.

9.2.23 Validation

Verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.

9.2.24 Verification

The use of methods, procedures or test, in addition to those used in monitoring, those determine if the HACCP system complies with the HACCP plan and/ or whether the plan needs modification.

9.3 ISO 22000, Food Safety Management Systems – Requirements

ISO 22000, Food safety management systems – Requirements for any organization in the food chain, was first published in 2005. The standard provides international harmonization in the field of food safety standards, offering a tool to implement HACCP (Hazard Analysis and Critical Control Point) throughout the food supply chain. The process module of ISO 22000:2005 has been shown in Fig. 9.1.

Fig. 9.1 Process module of the standard ISO 22000:2005

9.4 Goal of ISO 22000

The goal of ISO 22000 is to control and reduce to an acceptable level, any safety hazards identified for the end products delivered to the next step of the food chain. An end product is defined as a product that will not undergo any further processing or transformation by the organization. The standard combines the following generally-recognized key elements to ensure food safety at all points of the food chain:

• Requirements for good manufacturing practices or prerequisite programs
• Requirements for HACCP according to the principles of the Codex Alimentarius (an international commission established to develop food safety standards and guidelines)
• Requirements for a management system
• Interactive communication between suppliers, customers and regulatory authorities.

ISO 22000:2005 specifies requirements for a food safety management system 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. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/ or external resources. ISO 22000: 2005 specifies requirements to enable an organization

• To plan, implement, operate, maintain and update a food safety management system aimed at providing products those, according to their intended use, are safe for the consumer,
• To demonstrate compliance with applicable statutory and regulatory food safety requirements,
• To evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety in order to enhance customer satisfaction,
• To effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,
• To ensure that the organization conforms to its stated food safety policy,
• To demonstrate such conformity to relevant interested parties and
• To seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.

ISO 22000:2005 is fully compatible with ISO 9001:2000, so it is suitable for the development of a fully integrated, risk-based management system. This also means that organizations with an existing management system should find it fairly easy to expand its scope to include ISO 22000. ISO 22000 was the first in a new family of standards related to food safety namely:

• ISO/ TS 22004:2005 provides guidance on the application of ISO 22000:2005.
• ISO 22005:2007 provides requirements for the design and implementation of a feed and food traceability system.
• ISO/ TS 22003:2007 set requirements for bodies providing audit and certification of ISO 22000.

9.5 Use of FSMS (ISO 22000)

• Primary producers: Dairy Farms, Ranches, Fisheries, Dairies
• Processors: Dairy, Fish, Meat, Poultry, Feed
• Manufacturers of Soups, Snacks, Breads, Cereals, Dressings, Beverages, Seasonings, Packaging, Frozen food, Canned food, Confectionery, Dietary supplements
• Food service providers: Grocery stores, Restaurants, Cafeterias, Hospitals, Hotels, Resorts, Airlines, Cruise ships, Seniors lodges, Nursing homes
• Other service providers for Storage service providers, Catering service providers, Logistics service providers, Transportation, Distribution, Sanitation, Cleaning
• Product suppliers: Suppliers of tools, utensils, equipment, additives, ingredients, raw materials, cleaning agents, sanitizing agents, packaging materials, other food contact materials

9.6 Methodology for Developing an ISO 22000 and HACCP

ISO 22000 uses HACCP. It was developed by the CAC. HACCP is a methodology and a management system. It is used to identify, prevent and control food safety hazards. HACCP management systems apply the following methodology:

1. Conducting a food safety hazard analysis.
2. Identifying your critical control points (CCP’s).
3. Establishing critical limits for each critical control point.
4. Developing procedures to monitor critical control points.
5. Designing corrective actions to handle critical limit violations.
6. Creating a food safety record keeping system.
7. Validating and verifying the system.

An HACCP plan is a document that describes how an organization plans to manage and control its food safety hazards. An HACCP plan contains at least the following information:

1. Critical control points (CCP’s)
2. Hazards that will be controlled at each CCP
3. Control measures that will be used at each CCP
4. Critical limits that will be applied at each CCP
5. Procedures that will be used to monitor CCPs
6. Actions that will be taken when limits are violated

ISO 22000 shows organizations how to combine the HACCP plan with pre-requisite programs (or programmes) and operational pre-requisite programs into a single integrated food safety management strategy.

9.6.1 Prerequisite programs (PRPs)

There are the conditions that must be established throughout the food chain and the activities and practices that must be performed in order to establish and maintain a hygienic environment. PRPs must be suitable and be capable of providing food that is safe for human consumption. PRPs are also referred to as good hygienic practices, good agricultural practices, good production practices, good manufacturing practices, good distribution practices and good trading practices.

9.6.2 Operational pre-requisite programs (OPRPs)

These are pre-requisite programs (PRPs) that are essential. They are essential because a hazard analysis has shown that they are necessary in order to control specific food safety hazards. OPRPs are used to reduce the likelihood that products will be exposed to hazards, that they will be contaminated and that hazards will proliferate. PRPs are also used to reduce the likelihood that the processing environment will be exposed to hazards.

9.7 Comparison of ISO 22000 with HACCP and ISO 9000:2000

Developed with the participation of food sector experts, ISO 22000 incorporates the principles of HACCP and covers the requirements of key standards developed by various global food retailer syndicates, in a single document. The prerequisite programmes (PRPs) are the main difference between ISO 22000 and HACCP. The incorporation of PRPs in the ISO 22000 made the system more flexible as a smaller number of CCPs was introduced. ISO 22000 strengthens the HACCP system in several ways. It is a management standard, therefore, it shares the following common elements with other management system standards

• Policy
• Planning
• Implementation and operation
• Performance assessment
• Improvement
• Management review

The main changes of ISO 22000 compared with HACCP are the following:

1. Extension of the scope to include all the food businesses from feed and primary production as well as the organizations indirectly involved in the food chain.
2. The hazards that require control are those managed not only by CCPs but also through prerequisite programmes (PRPs).
3. There is provision of crisis management procedures in the case that external dangers turn up.
4. Exist additional requirements for external communication between the food organizations and the relevant authorities involved in food safety beyond the internal communication requirements.
5. ISO 22000 uses a systems approach to prevent new hazards from occurring in the food products and recognize the new technologies to control food safety hazards. On the other side, HACCP is inherently a system to prevent food safety hazards.
6. ISO 22000 strengthens HACCP by linking the plan to PRPs and defining management’s responsibilities.
7. ISO 22000 is implemented through the whole supply chain and not only in this final stage. The ISO 22000 standard is fully compatible with other ISO management system standards such as ISO 9001. However, there are differences between the two standards.
8. The focus of ISO 9001 is quality while the focus of ISO 22000 is food safety.
9. ISO 22000 extends the successful management system approach of the ISO 9001:2000 quality management system standard which is widely implemented in all sectors but does not itself specifically address food safety.
10. The standard ISO 22000 can be applied on its own, or in combination with other management system standards such as ISO 9001:2000 with or without independent (third party) certification of conformity. Companies already certified to ISO 9001 will find it easy to extend this to certification to ISO 22000.