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From: Food Quality & Safety magazine, October/November 2006

Food Safety Management Systems for the International Supply Chain

by Jeff Cawley

Standardized food safety and quality management have been well established in the United States and the European Union. Since much of the food industry is highly internationalized, both in general supply chain and in contract manufacturing, there are substantial business needs for internationally standardized safety and quality systems.

ISO 22000, released in September 2005, is the international auditable standard designed to ensure safe food in worldwide supply chains. It makes it feasible for all parts of the worldwide food chain from producers, processors, transport and retail outlets to implement HACCP for food safety in a standardized way.

In addition, food safety management systems that conform to ISO 22000 can be certified, which speaks to the growing demand in the food industry for vendor certification programs. ISO 22000 extends the successful management system approach of the ISO 9001 quality management standard, which does not itself specifically address food safety.

ISO 22000 is based on the assumption that the dependable and effective food safety systems are designed, operated and continually improved within the framework of a structured production management system, and incorporated into the overall management activities of the organization. It is the best and most effective strategy to incorporate food safety into the overall organizational and management system. The current models and standards provide the road map to achieve this.

Serving the International Supply Chain

The worldwide food and ingredients market includes ever increasing outsourcing and contract production. This commercial reality has driven the need for an auditable, standard food safety system. The question is how to develop and maintain a system across both the enterprise and extended supply chain that will produce supply chain safety and quality success.

Food production is heavily regulated in all important aspects including food safety, portion size, quality and grading. Since a failure upstream in the supply chain can have serious commercial and regulatory impact, it is good business practice to develop and maintain the systems’ infrastructure that will help maximize food safety and quality compliance at all points in the supply chain.

Each food processor should periodically examine its supply chain quality management system to determine if it meets the demands of ISO 22000 compliance. What are the model and the system infrastructure that enable this level of performance?

Standards Among us – What to Do and How to Do it International professional, industry and standards organizations have put great effort and expertise to solve supply chain quality and safety management. Using these standards allows us to benefit from this composite group expertise.

What to do? One group of standards enables us to define food safety and quality performance goals and the organizational infrastructure and operating procedures that support these efforts. How to do it? A second set of standards describes how to define, build and maintain effective manufacturing management information systems.

The reality in the food industry is that management generally has some familiarity with the standards that explain what to do, but often is not well versed in the standards that can lead them to establishing a successful information management infrastructure.

Management can use these standards to provide them with the distillation of industry best practices and to guide them on the path to greatest likelihood of success.

What to Do?

Two ISO standards set goals for food processing firms that are involved in international trade. ISO 9001 describes a quality system model that is universally recognized. The recently accepted ISO 22000 supplies an international recognized food safety model that suppliers and processors can develop widely accepted HACCP systems.

While the ISO standards are providing well-defined operational targets, they are not specific as to the organizational and system infrastructures that will enable the food industry to dependably reach the goals. What problems need to be recognized to get the desired result?

With more complex enterprises and supply chains that are described, we need to recognize that more complex data management systems are needed. The systems we invested in when the extended enterprise counted a few facilities are now inadequate to handle the tasks we have defined.

The greater number of participants in the supply chain substantially increases the complexity of coordination tasks. All the different components of supply chain need to be aligned and synchronized or the system will fail. How do we transfer data and control from supply chain segment to segment? How do we speak the same language throughout a diverse, multi-company system?

How to Do it?

Just as the scope and goals of the systems are defined by the ISO standards, we can use manufacturing data systems to provide us the roadmap and enabling techniques to get us there.

The ISA-95 (ISO/IEC-62264) standard developed by the ISA (Instruments, Systems and Automation Society), provides that roadmap for the integration of manufacturing systems with business systems. ISA maps all workflow, data interactions and the processes for data handling functions ranging from process data collection through to integrating the production data with financial and customer data for management processes and decision making.

The ISA-95 functional hierarchy model describes best practices integration of manufacturing and business sides of enterprise management. ISA-95 and B2MML (Business to Manufacturing Markup Language) provide the vehicle to enable universal systems across all languages and cultures involved in supply chain.

Charlie Gifford, director of lean production management, GE Fanuc Automation Inc. (Charlottesville, Va.), explains the problem. “Everyone likes to invent their own terms to describe work activities and the variables that are monitored,” he says. “We have to agree on terms to communicate. With ISA-95, we have broken the units of work into segments and all levels from plant to enterprise, define the work. Every segment is described in terms of people, equipment or materials.”

This process provides context and infrastructure and every data-related task from data capture, management, analysis and reporting is defined and mapped to the manufacturing data system. This advance work minimizes overhead, maximizes function and accuracy, enables SOP compliance and timeliness of action.

Production Activities

The ISA’s SP95 committee has defined activities and processes in great detail. This enables systems designers and implementers to drill down in their planning process. The diagram above drills down on level to reveal production activities. The segments in red indicate the sections that describe the analytical and reporting functions, enabling us to monitor and control safety and quality activities.

We will not go into the host of flow diagrams and definitions that are in the ISA-95 activity models. All of these operations, its components and interface to other activities have been thoroughly mapped and are available to use to optimize our chances for a successful systems implementation.

Since only about 30 percent of IT projects are judged complete successes, we want to use the ISA-95 standard to increase the likelihood of success. The goal from our perspective is to unify supply chain information systems to enable supply chain success.

Additional professional organizations have joined with ISA to converge their standards through the Manufacturing Interoperability Guideline Working Group. The group develops an industry guideline that defines generic business process models between the operations management and business layers of the manufacturing support systems.

ISA-95 is gaining acceptance as the basis for planning large scale manufacturing enterprise management systems. For example, Dave Emerson, Yokogawa (Tokyo), at the 2005 World Batch Forum cited an ISA-95 enterprise system being developed for Nestle to integrate disparate systems for different divisions.

This system uses SAP for the large scale enterprise management software. It is critical to note that all major systems vendors including SAP are now underwriting ISA-95. ERP and business process management systems are not set up to aggregate and analyze manufacturing data. For these functions, they depend on manufacturing execution systems. By observing ISA-95 standards, they will be secure in their ability to request and receive the appropriate data and reporting.

The ISA-95 acceptance and support covers firms of all sizes and different disciplines. This includes the large industrial automation companies such as GE Fanuc, Rockwell Automation Corp. (Milwaukee, Wis.) and Yokogawa and smaller specialty firms such as Northwest Analytical Inc. (Portland, Ore.), where our CTO participates in the subcommittee dealing with SPC and analytics. All industry vendors have a stake in ISA-95 working with minimum overhead and maximum effectiveness.

Because all major vendors have a stake in ISA-95 success, not only is it official, but it becomes a real, functioning standard. ISA-95 is gaining traction and now being used in the planning and design of new systems by forward looking companies. For example, Gifford at GE Fanuc reports that two major breweries are now designing their next generation control and manufacturing systems based on the ISA-95 model.

Analytics for Successful Food Supply Chain Safety and Quality Management

ISA-95-based systems provide critical support for supply chain safety and quality. It structures all the important data-related tasks of data capture, management, analysis and reporting. All between-application communications use B2MML for a consistent structure that can be used by ISA-95 systems at all points in the supply chain.

This set of standards enables us to dependably pull the appropriate data we need when we need it from enterprise databases, analyze it, and deliver the appropriate role specific reports to each individual working in the supply chain. This significantly reduces the overhead and problems to effectively manage food safety and quality throughout the supply chain.

Three core analytical reports are commonly used to completely describe and support supply chain safety and quality. These are:

  • Certificate of analysis which provides a quantitative instant view of product quality;
  • Control chart which provides an analysis of process stability;
  • Process capability reports which describe the vendor’s ability to meet specifications.

These analytics are necessary to effectively monitor vendor certification and continuing process performance. They provide the effective means to guarantee food safety performance in the supply chain. An excellent example of applying this method is the USDA AMS food safety and quality management program covering ground beef purchase for the National School Lunch program.


Jeff Cawley is vice president, market development for Northwest Analytical, Inc. in Portland, Ore. Reach him at 503-224-7727 ext. 5112 or at



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