A mere 10 years ago, the title "food safety director" didn't exist in the majority of food manufacturing, foodservice and retail companies. Responsibilities for food safety efforts often were spread out among various personnel in different departments, many of whom held a variety of titles indicating the emerging importance of the food safety function in the business. The monikers HACCP Manager, Food Safety Specialist and Zone Food Safety Manager, among others, could be applied to more than one person in more than one department within any given company. As food companies began to observe the enormous costs of food safety failure, the industry began a concerted effort to centralize the food safety function, spurring the creation of a new, dedicated discipline in its own right.

Today, the food safety department enjoys the same level of visibility in the corporate structure as research and development (R&D), quality assurance (QA), marketing, purchasing and finance. The fact that food safety aims and considerations factor into every aspect of today's food business requires the constant assessment and development of strategies to identify and manage food safety risk throughout the entire manufacturing process. This is a tall order for the food safety professional who knows that the implementation of a Hazard Analysis and Critical Control Point (HACCP) program alone does not a food safety system make.

The recipe for success in attaining a comprehensive food protection system involves fully integrating five fundamental food safety programs and five ancillary strategies into the company's operations. With these top 10 ingredients in the mix, the food safety professional will achieve greater protection for the company's brands, reputation, consumers and earnings.

1. Current Good Manufacturing Practices (cGMPs)
The guidance found in 21 CFR 110, "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food," is considered the most fundamental of all food safety programs. The GMP regulations set forth criteria for complying with provisions of the Federal Food, Drug, and Cosmetic Act, which requires that all human foods be free from adulteration. The guidance lays the groundwork for the production and preparation of safe and wholesome food in several general areas, including provisions for personal hygiene and dress codes, sanitary operations, sanitary facilities and controls, buildings and facilities, equipment and utensils, process and production controls, and warehousing and distribution.

"The importance of GMPs relative to a comprehensive food safety system is clear," states Paul Hall, Ph.D., Director of Microbiology and Food Safety, Kraft Foods North America. "We consider GMPs one of the prerequisite programs to HACCP. If you don't have a sound GMP program in place on your plant manufacturing floor, you're not going to have an effective HACCP program."

While the regulation presents good detail on the specific areas that need to be covered, it does not necessarily in all cases provide direction on how to achieve compliance. It is up to each individual company to select and implement the specific approach and technologies to satisfy the basic criteria. Recently, the U.S. Food and Drug Administration indicated that the agency may seek to refine the language of the GMP regulations. The original regulations were developed based on water testing data, and as a result, tend to focus on turn-of-the-century concerns, mainly the control of filth. By refining the language of the guidance, the agency hopes to incorporate provisions for more recent food safety hazards such as the more newly emerged microbiological contaminants of the last decade.

In the meantime, the most important element of effective implementation of GMPs, says Hall, is the ongoing training of plant employees. "I think that the training aspect of GMP implementation is absolutely essential to the success of the program. The food company has got to have very good initial training of plant floor employees. You also must have a good mechanism in place for documenting your training and for checking that these employees have a good understanding of the GMPs, including how these affect their specific job, their specific line, their specific plant manufacturing environment, and their specific responsibilities. The key is to retrain employees on an ongoing basis to ensure that understanding.

"When you have procedures in place to ensure GMP compliance over time--whether that is ensuring that line supervisors are properly trained on an ongoing basis and have a good understanding of GMP compliance for their particular areas in the plant, or whether that is verification through an independent audit function, for example--and you are documenting that you are, in fact, doing what you say you are doing relative to GMPs, other food safety programs in the company will be strengthened."

2. Sanitation
"Sanitation is a cornerstone to a company's food safety program," says Mike Cramer, V.P. of Food Safety and Quality Assurance with Specialty Brands, Inc. "It is difficult, if not impossible, to prepare safe product without a clean facility."

Cleaning and sanitizing are the two essential elements that comprise a food sanitation program, and both must be performed in tandem in order to successfully achieve food safety and quality assurance goals. Cleaning is defined as the use of mechanical agitation and detergents to remove visible soil, biofilms and other residuals from the surfaces of equipment, floors, walls, etc. Sanitizing is the application of chemicals or chemical treatments to remove any remaining bacteria or residuals that cannot be seen with the naked eye.

Critical elements of an effective sanitation program include selection and training of sanitors, personnel safety, sanitary equipment design, sufficient quantity of hot water, knowledge of chemical interactions with food plant soils and proper cleaning techniques. Integral to this process is pre-operational and operational sanitation auditing. Sanitation records will include clear and thorough documentation of organoleptic findings, corrective actions when deviations are found and implementation of preventive measures to avoid repetitive deficiencies.

Notes Cramer, "Sanitation programs that include all of these elements will help companies meet their food safety obligations while providing products that conform to quality requirements in an economic manner."

Further, says John Butts, Ph.D., V.P., Research with Land O'Frost, company management must not allow the passing of pre-operational inspection to be the primary success measure of the sanitation department. Today, companies can attain a higher level of confidence by refocusing their efforts on the critical factors of the sanitation process.

"We use critical factors as a component in defining how thermal process controls, such as canning, aseptic processing and similar processes, actually function," says Butts. "We use critical factors to develop and identify components of critical control points. We can apply the concept of critical factors to the sanitation process, where we are managing various components through good execution of GMPs.

"An example of a critical factor in the sanitation process is the degree of disassembly of the equipment, which is critical to environmental pathogen control. Other critical factors include the thoroughness of sanitizer application and flood sanitization. These are just a few examples of the elements that we need to clearly define and effectively communicate to our employees to improve the effectiveness of our sanitation programs."

3. Regulatory Compliance
All foods are regulated in part or in whole by myriad federal, state and local government agencies. An effective regulatory compliance program ensures that the food company is adhering to national regulations and legislation, state and local rules and any applicable international standards related to the production of foods fit for human consumption. The federal system alone is comprised of 35 different laws and involves 12 different agencies, six of which have major roles in carrying out food safety and quality assurance activities. The recent implementation of several new federal rules and the need to keep current on relevant state and local public health and food safety standards makes it more critical than ever that the regulatory compliance program is streamlined and integrated into the total food protection program.

The critical elements of the regulatory compliance program include training; record keeping and documentation; plant registration and process filing; process authority, inspection readiness and recall procedures; inspection and testing protocols; and auditing. Taken together, these elements provide an enhanced framework for managing each of the applicable regulations that apply to a particular manufacturing operation.

Tony LoBue, owner of Scotts Food Products, a Paramount, CA-based manufacturer of specialty sauces, marinades and seasonings, states that the key to a workable regulatory compliance program is employee education. "We take the county health department, state and applicable federal rules and give them to the plant manager, the production manager and line supervisors. We go through all of these materials to make sure they have a basic grasp of all the applicable rules and regulations pertaining to food safety. When an inspector arrives at the plant, we want our personnel to be well-versed in this area.

"At the end of the day, it is critical that the food processor's documentation--of the product formulations and your actual processing systems, of sanitation efforts and GMP compliance--is available in such a way as to show evidence of your company's compliance with food safety rules and regulations."

4. Quality Control
The quality control (QC) program consists of measures and procedures pertaining to physical, chemical or organoleptic attributes of food products to ensure the cost-effective production of uniform and consistent products. A typical QC program involves establishing product performance criteria and supplier specifications, setting critical limits and instituting product- and process-specific controls that are applied at the point of production in a particular processing environment.

In terms of food safety, the basic elements of today's QC programs serve as a way for food processors to achieve both quality assurance and safety requirements. With the advent of new in-process intervention technologies that reduce the incidence of microbiological, chemical and physical contaminants, improved processing equipment design and placement within facilities, and automated data monitoring systems, processors are better positioned to ensure a higher degree of confidence that products are produced, packaged, distributed and reach consumers in the highest quality and safest state possible.

As William Sperber, Ph.D., Corporate Microbiologist with Cargill, Inc., has stated, "Quality control must be built into the system. Operators cannot assure the safety (which they are required to do by law) and quality (which is what sells their product) of products by simply testing finished product. Operators are realizing that it is more efficient and economical to build quality programs into the system, and are many have adopted quality programs in which on- or at-line quality monitoring and control play a crucial role. Without control, monitoring operations are a waste of time. Without control, operators might as well revert to the old belief that quality can be inspected into the product. The key to monitoring and control is to collect samples or evaluate the process and make corrections in "real time." Making corrections to a process that has begun to go "out-of-control" saves both time and money, since a substandard product must be destroyed, reworked or sold at a loss."

"For most processors, HACCP has become the core of the food safety program, the pillar upon which other programs and strategies rest," says Joe Meyer, who, as Section Manager, Microbiology and Food Safety Group, provides leadership and direction for HACCP systems within Kraft Foods North American businesses. "Although prerequisite programs, good GMPs, and sanitary hygiene programs have to be in place and working for HACCP to be effective, this program really has become the point at which all of these other programs connect."


Indeed, although this seven-principle, science-based approach for ensuring food safety is not mandatory for food manufacturers outside of meat and poultry, seafood and juice operations, it has been voluntarily and widely adopted throughout the industry, becoming an essential component of many companies' food safety efforts. The internationally accepted HACCP concept involves risk identification and the development of specific controls and countermeasures to mitigate or eliminate microbiological, chemical and physical hazards. The seven HACCP principles are:

1. Conduct a hazard analysis of microbiological, chemical and physical hazards.

2. Identify the critical control points (CCPs) in the process.

3. Establish critical limits for preventative measures associated with each identified CCP.

4. Establish CCP monitoring requirements.

5. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.

6. Establish effective recordkeeping procedures that document the HACCP system.

7. Establish procedures for verification that the HACCP system is working correctly.

The HACCP model places emphasis on proactive prevention, control and corrective actions. The processor is responsible to identify and control food hazards, to keep records that document the system's effectiveness, and to routinely and continuously verify that the system is working. If monitoring data exposes a hazard or isolates a weakness at a critical control point, the processor is able to take immediate corrective actions.

The widespread adoption of this food safety approach, says Kraft's Meyer, is the best indication that HACCP has proved an effective and long-term control strategy for the industry. "There are so many resources available today that help manufacturers to plan and implement a HACCP program, from a variety of "cookbook" type manuals in which you can customize the steps to your specific facility, to HACCP training and certification workshops and seminars, to planning and implementation materials on websites and in publications of several scientific and industry organizations. Information on HACCP is fairly easy to find."

How does the food company maintain an effective HACCP program once it is in place? Meyer responds that retraining is probably one of the most important aspects of a successful HACCP program. "The company's commitment to training and the retraining really becomes the key element for HACCP success today. I always tell people that back in the old days, you brought a new employee in and trained him the first day and you were good to go for 30 years. Well, that's not a good way to gain consistency or to improve food safety systems and programs. The key is to provide ongoing training to keep people maintaining the consistent application of good protocols over time."

6. Allergen Control
In recent years, there has been a dramatic rise in the number of product recalls due to unlabeled allergens and reports from the medical community indicating an increase in the number of food-allergic patients in the U.S. According to the Food Allergy & Anaphylaxis Network, six to seven million Americans suffer from food allergy, accounting for an estimated 30,000 emergency room visits and 2,000 hospitalizations each year. It is estimated that as many as 200 people die each year from food allergy-related reactions. The "Big 8"--peanuts, tree nuts, fish, shellfish, eggs, milk, soy and wheat--account for 90% of these allergic reactions.

These statistics have made food allergens a high food safety priority in many food processing and handling operations. The critical elements of the allergen control program include preventive management approaches such as the identification of all allergenic ingredients in products (including sub-components of ingredients) and the dedication of processing systems to either allergen-free or allergen-containing products only (including process equipment, employees, ingredient receipt, storage and transfer, packaging materials and maintenance equipment).

When process line or system dedication is not an option, the processor must have an effective sanitation program in place to ensure that no allergen residues remain on equipment or product contact surfaces and to prevent inadvertent cross-contamination of common surfaces with which both allergen-containing products and non-allergen-containing products come into contact.

Effectively managing the allergen risk requires the company to schedule products that do not contain allergens at the start of a production run and follow with the allergen-containing product at the end of the production run. A typical allergen control program also includes measures to control ingredient sources, storage and handling and to control movement of product through the plant, as well as the use of allergen detection tests to verify that cleaning procedures have been effective.

7. Testing & Verification
For all food and beverage producers, some type of testing and verification strategy is employed as a tool to support established food safety programs. Depending on the type of processing operation, the testing program typically includes some combination of microbiological, chemical and physical contaminant testing. Under the regulatory compliance program, for example, a company may be required to incorporate microbiological testing of product to detect, identify or enumerate specific pathogens. Under the sanitation program, an environmental hygiene testing strategy often is implemented to verify that equipment and plant facilities have been adequately cleaned and sanitized and are free of chemical or microbiological residues. Testing is also a valuable component of the HACCP validation program.

Whether the company is conducting finished product testing, in-process testing, ingredient testing and/or environmental monitoring, or some combination of these, says Kraft's Hall, the decision on what, when, where and how to test "will be a function of the type of product you're producing and the quantity you're producing. To be effective, the food testing program must be put into the context of your company's overall approach to managing the safety of your process and the understanding of your process."

"For example, any time we're talking about testing as a component of a food safety program, we have to talk about the sampling plan and how meaningful that sampling plan is. Without a good sampling plan, a test result that is negative just gives you a false sense of security. You can't just take a grab sample here or there and expect to have any level of assurance. In order to create a good sampling plan, you have to know your operation inside and out."

To get meaningful data, Hall says, the company must have a good understanding of its testing in the context of the sampling plan. "Let's say that you are testing the environment for verification. The types of swabs you are running--individual or composite--the number of swabs, and the sites in the plant that you're actually sampling will impact the test results. You have to have a good understanding of these elements because they are going to significantly impact your interpretation of the data. You can't take testing out of context of the sampling plan."

8. Auditing
All five of the fundamental food safety program areas--GMPs, Sanitation, Regulatory Compliance, Quality Control and HACCP--should include auditing as an essential component of evaluating and verifying that established systems and processes are working effectively. In-house auditing of the company's own processes and systems can be conducted either by management and plant operations personnel who have been trained to look for adherence to established standards and protocols, or by third-party auditing organizations.

Conducting external audits, such as evaluations of the company's suppliers and contract manufacturing operations, has become an important tool in the manufacturing supply chain's food safety arsenal. Tammy Smith, Food Safety Manager with PepsiCo Beverages and Foods, says that even though the company's units--Quaker, Pepsi and Tropicana--each use third-party auditing and develop their own checklists for certain processing, food groups and processing parameters, PepsiCo views supplier auditing as a critical part of any good food safety program.

"If you're not spending time and money auditing to know your suppliers and contract manufacturers, their products, programs, run strategies, line set up and operations, and how well they know their suppliers, then there's a big gap in your food safety system," says Smith. "It is critical to know who our suppliers are and what they do from the standpoint of allergens, regulatory compliance and HACCP because if you don't have that information, you really can't have good assurance of how effective their control is over their own system."

Smith adds that getting good value from your investment in in-house, contract manufacturer or supplier auditing programs requires that auditors spend more time walking the plant than in the office. "Auditing is essentially verifying that what has been written in procedures and practices is actually what an operation is doing. The biggest mistake auditors make is to spend 70 percent of the time reviewing manuals, rather than walking the plant floor. That percentage should be the other way around. You want more percentage of the time spent on the floor, not in the office."

9. Employee Training & Education
Like the auditing function, employee training and education is an element underpinning all other food safety programs and strategies in the total food protection program, from HACCP to There are a plethora of training materials and approaches available for use by food companies, notes John Butts of Land O'Frost, but the key to each food safety program's success is to make training accessible and understandable to employees.

"Employee training is the last component that we execute when we create any process or improve upon any process control program," says Butts. "If you don't finish the job with good employee training, the gains that you've worked so hard to attain will be lost with the next set of turnovers at the operator or supervisory levels.

"We have to make the training programs indelible to our process to prevent placing untrained employees in situations where they are asked by management to operate or manage the process. This means that we must have training materials deliverable and in formats that transcend the language barriers employees often face in this industry. It means making materials understandable to all education levels of our employees. Lengthy text documents probably are not tools that we can use to deliver meaningful content to the majority of employees. In the era of digital cameras and PowerPoint annotations, there are many tools to help use achieve this, and many food companies are using these formats to help employees reach a solid understanding of their role in keeping food safe."

Joe Meyer of Kraft adds that that promoting this understanding among employees is the single most important aspect of the success of any food safety programs in the plant. "It is about personal integrity--people want to do the right thing," he states. "The line workers want to do the right thing and it is a matter of training and gaining understanding. When employees understand the impact that their practices can have on food safety, they will bend over backwards to work to do the right thing."


10. Biosecurity
Today, food safety and food security strategies comprise the two-pronged foundation of a total food protection program. As Specialty Brands' Mike Cramer notes, "The events of Sept. 11, 2001 raised food business biosecurity awareness to a greater level than any time in the past. Because food and agriculture businesses represent a significant part of the American economy, over $1 trillion in 1999, we are a particularly compelling target to terrorists. Companies must now implement biosecurity programs to prevent their facilities or their products from becoming targets of terrorism, both domestic and foreign."

The U.S. government has been actively developing guidance and support systems for the industry on food security issues since 9/11, which has been funded to record levels. According to the U.S. Department of Health and Human Services, a $96 million increase in the agency's food security budget in fiscal years 2002 and 2003 enabled FDA to hire 655 new field personnel that work almost exclusively on food security and food safety. President Bush's FY 2004 budget requests another $116.3 million to further protect the nation's food supply.

Since last year's passage of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the DHHS has proposed four regulations to implement provisions of the act, including required registration of food facilities and advance notice of food imports and improved record-keeping for imported foods, and FDA has issued a series of guidance documents that recommend measures that food companies can take to minimize biosecurity risks. In July 2003, DHHS Secretary Tommy Thompson announced $5 million in funding to support a new food security research program designed to develop new biosecurity prevention and mitigation technologies and to improve the ability to assess foods for contamination with chemical, biological and radiological agents.

Cramer adds that the food industry is aware of the importance of adding security measures as part of its operational strategies. "Just as with food safety, biosecurity is a process that requires focus, discipline and execution. Food processors will need to include four elements when implementing a biosecurity program: threat assessment to determine who might pose a threat and how; surveillance to identify areas of vulnerability; deterrence and prevention through the use of multiple hurdles; and crisis management in the event of a successful terrorist attack against the company. These elements will assist the industry in achieving comprehensive food protection goals."