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From: Food Quality & Safety magazine, October/November 2007

What's Your Line?

The role of plant management in food safety systems has constantly evolved, transferring greater responsibility from government agencies and inspectors to management

by Steven Wilson

The U.S. Department of Commerce’s (USDC) National Oceanic and Atmospheric Administration (NOAA) provides a key service to the seafood industry in the form of the voluntary Seafood Inspection Program, which offers a variety of professional inspection services that assure compliance with all applicable food regulations. In addition, product quality evaluation, grading, and certification services on a product-lot basis are also provided. Benefits include the ability to apply the U.S. Grade A, Processed Under Federal Inspection (PUFI), and lot inspection marks.

One service offered is the National Marine Fisheries Service’s Hazard Analysis and Critical Control Point Quality Management Program (HACCP-QMP). This full-focus program emphasizes product safety, plant and food hygiene, economic integrity, and product quality. Firms participating in this program operate its approved quality system and are audited at a defined frequency by Seafood Inspection Program personnel. Audits are based on the firm’s adherence to the approved plan. Firms that do not follow the plan well but take responsibility for corrections and improvement are typically audited more frequently.

If a firm can maintain its system, it can be audited as seldom as once every three months. In return, compliant firms may place inspection marks on any products that meet the program’s requirements. Because the only other alternative is having an inspector present during all processing of identified products, this means notable savings on inspection costs.

Relationship of Plant Management With Government

The traditional model of food safety and quality control has typically relied upon companies presenting their products to regulators to evaluate their conformance. The standards ranged from simple to complex, but the pressure was as much on the regulators as it was on the companies producing the products.

Inevitably, this model placed the government into the role of inspector, in many ways taking ownership of product safety and quality away from the producer. If a government inspector passed the product, it was considered fine. One downside of this model is that it led companies to focus on satisfying inspectors rather than on accepting responsibility for the safety and acceptability of their products.

From the beginning of the use of systems to evaluate food safety and quality, management clearly had a pronounced role. The first quality systems used a general plan of quality assurance that became management’s eyes and ears. But, in such systems, production remained the lead driver, and quality reports were often ignored as long as production and profits were high.

As quality management standards matured, however, management was specifically brought into the system. As the ISO 9001 Quality Management System Standard states, “top management shall provide evidence of its commitment to the development and implementation of the quality management system.” This commitment required a change from mere intention to actual demonstration. In addition, management review needed documentation and records.

This was a bold statement in the early days of quality management standards and systems. Until this change, many quality assurance managers had felt pressure from top management for a quality product only if it did not hinder production.

Management’s Role in HACCP

In the early 1970s, the food safety system of HACCP was introduced. This system outlined a strong method of identifying food safety hazards and subsequently monitoring and documenting their control. It was used sporadically until 1997, when it became required in the U.S. seafood industry. Until this time, it was industry driven and, with the exception of low-acid canned foods, was not fully in place in many food systems, let alone used as a regulatory tool.

Once HACCP principles took root, they were eventually outlined in Codex Alimentarius and generally standardized throughout the world, with some minor modifications from location to location. These principles outline, in general terms, a procedure of verification performed to evaluate the overall effectiveness of the system. In many cases, however, verification was not defined, and when it was, it tended to be narrow in scope.

Some adopters of HACCP saw verification as a management role but failed to describe how the role was to be performed. Others saw it as a method to evaluate a particular point in the process. Both groups put the burden on the shoulders of management and, consequently, on the quality assurance manager. Regardless, it was clear that there must be a review and evaluation of the overall system.

Later, as a part of the natural evolution of the system, HACCP practitioners began to define verification, which arose from benchmarking other system methods. Validation was simply the name given to the process that determined whether or not a system could deliver what it was designed to deliver. Once the system was designed, a validation was performed to determine whether or not it worked correctly. If not, modifications were made. If the system functioned as planned, it was put into standard procedure. This process augmented verification activities, enabling them to determine not only that a system could deliver but also that it would continue to deliver.

Again, because validation was generally thought of as a scientific practice, management was at least one step removed from ownership of the system. Eventually, government inspection agencies found it necessary to improve the system evaluation process.

Auditing became the tool used by inspection programs, allowing the entire system to be evaluated. This meant that, in spite of regulations stating that the firm and its management were responsible for the safety of the food produced, the government was still, to some extent, taking ownership of the system.

Management’s Role in ISO 22000

In late 2005, official publication of the food safety management standard ISO 22000 provided an opportunity to take a hard look at the role of management in food safety and quality systems. ISO 22000 gives a number of advantages to the food processor wishing to improve its food safety management system. The system approach of the standard, for example, with its compatibility to ISO 9001, is a great advantage. The ISO 22000 standard is meant to simplify the myriad of different audit program requirements that buyers currently face.

ISO 22000 is designed to address Codex requirements specific to the food industry. Companies adopting the standard will now be on an even playing field with many other firms across international lines. Further, buyers can be assured that products from these firms will, with proper outside auditing, meet their food safety needs. Because the standard is written in similar terms to those of ISO 9001, the roles of verification, validation, and management review are clearly outlined. The role of management review is stated outright—even though top management may or may not have a role in verification and validation, they are still responsible, ultimately, for the function and effectiveness of the system.

When discussing the USDC Seafood Inspection Program’s use of ISO 22000, many field inspectors were concerned that those in the industry would be distressed by the requirement of management review. After all, the program was voluntary, and wasn’t this the function of audits?

An announcement regarding changes to the HACCP Quality Management Program went out to all program participants. Program leaders waited, anticipating negative reactions regarding the changes to management roles.

But the result was astounding. Not only were few comments received; none were directed at the management requirements. Discussions showed that the seafood industry strongly supported changes involving management review and commitment.

Ultimate Role of Management

Recent media announcements make it clear that all eyes are on the nation’s food supply. This is not surprising. What is unexpected is that industries are taking a leading role in accepting more responsibility for the function of their systems. Now, not only are there food safety and quality concerns to consider, but also liability issues. No one in upper management desires to be the focus of a recall, investigation, or import detention; they are showing that they desire to take a more informed role in the products produced.

It has taken some time to define the role of management in food systems. But many firms have taken pride in their work, and this can be seen in the safety and quality of their products. Now, through system evaluation, the roles of managers, quality assurance personnel, scientists, and government are well defined. Safe, wholesome, properly labeled, quality food is the result.

Wilson is chief quality officer of the Seafood Inspection Program under the United States Department of Commerce. He was a member of the delegation and technical expert to the meetings of Working Group 8 of ISO TC 34, which wrote ISO 22000 and ISO TS 22004. Reach him at (301) 713-2355 or



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