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ISO 9000 Database
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by Carey Wilson

A Registrar’s Eye-View

Quality Digest talks with Peter Marriott, director of systems and services certification North America for SGS.

Quality Digest: As director of a certification organization, what do you see as the biggest advantages of registering to ISO 22000?

Peter Marriott: The standard gives an organization a way to demonstrate, in an internationally understood format, that they have a comprehensive management system targeted to the control of food safety that meets the food safety requirements of both customers and regulatory agencies.

It can be considered a business management tool that links food safety to business processes and encourages organizations to analyze customer requirements, define processes, keep them in control, and continue to improve their food safety management. It enables integration of quality management and food safety management. It is intended for organizations directly or indirectly associated with the food supply chain irrespective of size or complexity, and is regarded as being able to bring transparency since it has been designed to cover every link in the food supply chain.

QD: How does it compare to previous food safety management systems?

PM: ISO 22000 is a management system standard that specifies the requirements for a food safety management system by incorporating all the elements of good manufacturing practices (GMP) and Hazard Analysis and Critical Control Points (HACCP).

It thus incorporates the technical requirements of most previous food safety standards but integrates them into the systematic “plan-do-check-act” approach which assures ongoing effectiveness through tools such as audits and corrective actions.

A significant change to previous food safety management systems is the requirement for communication both upstream and downstream, which helps to better control risk and improve food safety.

QD: In organizations that you’ve audited, what are some of the challenges faced by your clients to achieve registration?

PM: The majority of our clients are well-versed in and have well-established food safety practices, but although they have experience in applying the management system approach to quality or environmental issues, they have often not incorporated their food safety practices to the same degree. They have good food safety practices but may not be operating these as efficiently as possible.

They often are challenged to meet the varying specific requirements of different customers, which though fundamentally similar, may have different emphases. As a result, they may have compartmentalized food safety practices involving duplication of efforts and resources. SGS encourages them to use the management system approach to provide the framework in which they can implement their good practices, and through our single audit pack solution we can enable them to demonstrate the satisfaction of various requirements through a single audit event.

QD: Is it easier for a company to maintain ISO 22000 registration if its supply chain members are also registered to the standard?

PM: Registration of suppliers is not a specific requirement, but having a clear vision that they have good food safety practices is, and registration is one systematic way of achieving this. Using the international standard as the basis for approval can also help to introduce better and more consistent communication between the different members of the supply chain, thus giving a greater confidence and easier resolution of queries.

QD: Currently in the news is a recall of 143 million pounds of ground beef products. Could registration and compliance to ISO 22000 have prevented this recall?

PM: A key requirement of the standard is the planning and realization of safe products, incorporating the elements of GMP and HACCP, including any regulatory requirements applicable to the organization and processes. Adequate prerequisite programs (e.g., training, sanitation, maintenance, traceability, supplier review, control of nonconforming product, and recall procedures) are required that address general requirements to provide a foundation for the production of safe food.

Although it is not realistic to say that any management system or certification would entirely prevent future problems and recalls, it is reasonable to assume that having more systematic and effective hazard analysis in place, including supplier monitoring systems, will make inadequate and inappropriate practices more visible and enable the identification and implementation of effective corrective action at an earlier stage.

As food processing and food-ingredient supply chains multiply and develop increasingly intertwined relationships, it seems only natural that safeguard systems to protect companies and their customers would develop to ensure the quality of all aspects of food production. Such is the aim of ISO 22000 and its goal of continuous improvement of food-safety management system (FSMS) processes.

In plain terms, ISO 22000 is a generic FSMS standard that defines a set of general safety requirements for any organization that is part of the food supply chain. The standard is designed to be used for registration purposes, so that once a company has met the established requirements it can apply to a certification body to be audited and issued an official certification stating that all FSMS requirements established by the standard have been examined and met. A company may also self-declare; that is, declare itself to be ISO 22000-compliant without becoming formally registered, but many customers and stakeholders may prefer that a third-party auditor or certification body verify that declaration.

Since ISO 22000 is a generic FSMS standard, it can be useful to any business involved in any area of food processing, from direct producers such as farms, ranches, dairies, and fisheries to manufacturers of packaged foods, and service providers such as grocery stores or restaurants, storage facilities, or transportation providers. It can even apply to producers of tools, processing equipment, additives, packaging materials, or cleaning agents.

Finding out that ISO 22000 wasn’t established until 2005, one might reasonably ask, “Weren’t there plenty of recognized food safety management systems in existence before this standard came along?” There were, but not as many and not for as long as the average consumer might think. The Food and Agricultural Organization of the United Nations (FAO), along with the World Health Organization (WHO), established the Codex Alimentarius Commission (CAC) in 1962 to, according to its web site ( www .codexalimentarius.net ), “develop food standards, guidelines, and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program.” The main purposes of the CAC program are “protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and nongovernmental organizations.”

The CAC established its 12-step Hazard Analysis and Critical Control Point (HACCP) management system in 1997 as a methodology to identify, prevent, and control food safety hazards on an international basis. The 12 steps include:

1. Assemble HACCP team. Develop a team that has the appropriate product- specific knowledge and expertise to develop an effective food safety plan.

2. Describe product. Draw up a full description of the product, including composition, physical/chemical structure, microcidal/static treatments, packaging, storage conditions, and distribution methods.

3. Identify the intended use. Usage should be based on expected intended use of the product by the end-user.

4. Construct flow diagram. Create a diagram that covers all steps of the operation, including steps preceding and following the specified operation.

5. On-site confirmation of flow diagram. Determine that the flow diagram is aligned with actual operations.

6. Conduct a hazard analysis. Identify any biological, chemical, or physical hazards.

7. Determine critical control points (CCPs) . CCPs are areas where previously identified hazards may be eliminated.

8. Establish critical limits. Develop processes that limit risk at CCPs.

9. Monitor CCPs . Develop processes for ensuring that critical limits are followed.

10. Establish preplanned corrective actions.

11. Establish procedures for verification.

12. Maintain HACCP process documentation.

 

ISO 22000 endorses the above Codex Alimentarius recommendations but also strives to fill some gaps and inconsistencies that have been brought to light by 13 years of experience with using the HACCP guidelines. For instance, ISO 22000 makes explicit the responsibilities of the food safety team leader (FSTL), whose designated duty is to report on the effectiveness of the food safety management team to top management. The FSTL is also the designated contact with the company’s registrar, coordinates the audits, and monitors corrective action responses.

ISO 22000 also emphasizes internal and external communication, both upstream and downstream throughout the supply chain, to determine and ensure that all team members are fully informed in real time of changes in raw materials, facilities and installations, recipes, or requirements that are likely to affect system operations.

Key to the effectiveness of communication is the documentation of processes, which provides control and consistency of how processes are performed. Documentation of procedures that are required by the standard as well as of those required to control other processes of the FSMS will ensure that all procedures are being carried out. Documented procedures and work instructions are an integral part of an ISO 22000-compliant FSMS.

One of the differences between HACCP and ISO 22000 is the ISO standard’s emphasis of the use of prerequisite programs (PRPs) and operational prerequisite programs (OPRPs). PRPs are generic controls used by any food business operation to maintain hygienic conditions in the food-processing environment. Such practices are referred to as good hygienic practices, good manufacturing practices, good distribution practices, and good agricultural practices.

OPRPs are specific to particular industries and food operations. These are regarded as essential procedures because a hazard analysis of a specific aspect of a particular operation has demonstrated that the OPRPs are necessary to control specific food safety hazards for that operation. Properly applied, OPRPs reduce the likelihood of food products or the processing environment being exposed to contamination or other hazards.

PRP and OPRP implementation may call for an investment in the infrastructure of a company’s operations. Just as likely, the formation of the FSMS team will require research and investment in manpower, specifically in the hiring or training of a team leader and supporting staff that can oversee the control of the FSMS.

The financial challenges of recruiting, training, and funding a team capable of implementing and maintaining compliance to ISO 22000 can be significant, but some expenses can be alleviated or moderated by:

Having team members from several companies in the supply chain share such functions as internal auditing and data analysis

Integrating experts in hazard control from different levels of the supply chain into the team

Taking advantage of e-learning to access vocational training without being bound by the limitations of class time frames, class locations, or the availability of quality teaching personnel

 

Another requirement of ISO 22000 certification is the creation and validation of documented control measures that are designed to address hazards that have been assessed as needing controls, and which must be validated before being implemented. Although such scientific validations might appear beyond the human resources and financial scope of smaller companies, careful assessment of potential control measures can help moderate such concerns.

If a company already has an HACCP-compliant FSMS or is registered to another quality management system, such as ISO 9001, trying to start ISO 22000 implementation from scratch is neither necessary nor desired. In such cases, a gap analysis that pinpoints the areas within the company’s operations that fall short of meeting the standard is the most practical approach. By concentrating efforts on filling in the gaps between the existing FSMS and the requirements of the standard, a company can move quickly toward ISO 22000 compliance.

And as more and more food-producing organizations interlock their supply chains across international markets, demonstrating ISO 22000 compliance and registration may provide a portal for improving business bottom lines while simultaneously improving the safety and confidence of consumers worldwide.

References:
Thanks to Ron Krebs at Praxiom Research Group for his invaluable assistance. For more information, visit "ISO 22000 Food Safety Standard in Plain English" at www.praxiom.com/iso-22000.htm.

Other resources on food safety:
FAO/WHO. Food Standards Codex Alimentarius--www.codexalimentarius.net
SGS. ISO 22000 registrar--www.foodsafety.na.sgs.com
ISO. ISO 22005--www.iso.org/iso/pressrelease.htm?refid=Ref1063
International Food Safety and Quality Network--www.ifsqn.com
World Health Organization. Food standards (Codex Alimentarius)--www.who.int/foodsafety/codex/trustfund/en/index1.html
ISO. "ISO 22000: From intent to implementation"--www.iso.org/iso/22000_implementation_ims_06_03.pdf

About the author
Carey Wilson is Quality Digest’s news editor.