For those food enterprises exporting to U.S. markets, both the quality and safety of their products are serious corporate issues. The following list addresses several subjects or broad activities that can be considered subsystems of an overall “quality system.” The term “system” in this context conforms to its definition: “an orderly and comprehensive assemblage of facts, principles, methods and executions in a particular field, directed to obtain a defined goal.”

Elements of a Quality Assurance (QA) system:

• Quality management
• Product development control
• Purchase material control
• Process development and manufacturing control
• Quality measurement
• Quality data programs
• Human resources
• Customer relations

Each of the subsystems listed has a variety of activities, which are by no means exhaustive or unique; some elements may be modified and expanded, according to the needs of each organization.

Quality management
This subsystem embodies all the activities that set the quality policy, overview and support its implementation, evaluate its performance and report results. The elements of this subsystem are given in a logical sequence for an organization that accepts seriously the quality commitment.

Product development control
It is important to note that one of the dimensions of quality is quality of design; products must be conceived having the requirements of the final user in mind. This will become the target during manufacturing and distributing. No quality could ever be obtained only by inspections; this is quality compliance, which means to meet established standards.

Purchase material control
This subsystem is intended to increase satisfaction of the purchasing activities. This is aimed at minimizing quality costs and improving service. Commercial aspects of purchasing involve reasonable price contracting and deliveries on time. From a quality point of view, it should be understood that no matter how low the price of an item may be, it is too expensive if it does not perform properly.

Process development and manufacturing control
A well-conceived product development should include the corresponding manufacturing process, where the precise procedure should be established. Each process has points or steps that are essential to the success of the operation. It has also certain points where trouble may arise and affect quality adversely. These are the so called Critical Control Points (CCPs), which the Hazard Analysis and Critical Control Points (HACCP) system for food safety has popularized. The principles of HACCP are not an exclusivity of food safety; they are a logical approach to insure satisfactory and consistent performance of the manufacturing function. CCPs should be identified and their corresponding controls established. A close cooperation of groups such as R&D, manufacturing and QA is essential in establishing a CCP program.

Quality measurement and control equipment
The purpose of this subsystem is to insure that suitable and well-calibrated equipment is available for the needed measurements in quality control.

Quality data programs
Careful consideration should be given to the collection of data. In medium to large organizations, there is a tendency to accumulate data for its own sake. This often has little value. Evaluation of what data are really necessary should be done by QA and those who need the information, for example, manufacturing, purchasing, R&D and management. Data that are not needed for taking action or act on its information is generally superfluous.

Human Resources
This subsystem deals with the need to obtain full commitment from all personnel to support and participate in the quality system. It has been said that no matter how hard they try, quality control personnel cannot “make quality happen.” Quality is the result of concern, well-planned and judiciously executed actions by all members of the organization and appropriately, it starts with top management. Top management commitment, participation and example, followed then by delegation, assure success. Just a command to establish a quality program or deployment of some resources is insufficient and will not provide lasting and satisfactory results. To attain a quality system, considerable development and training of personnel is needed.

Customer relations
This is the final and definitive element of a quality system. We are faced with the need to evaluate how well was the job done. Are we meeting the goals proposed? What is the level of accomplishment? What can be done better? These are all pertinent questions, and we may use a few tools to appraise the situation.

Quality should not be left to chance; it must be the result of a carefully planned design and the responsible execution of required actions.

Establishing the program requires assistance of an individual with experience, and this person can be an employee or a consultant of the company. It is important to have very clear objectives beforehand, and a document should be developed that will include the responsibilities, objectives and goals of all those that are expected to participate. There are many books, manuals and articles (see Bibliography) in which specific information on the preparation and implementation of these programs can be found.

The initial “planning document” cannot foresee all possible situations and conditions; thus, it should be kept flexible and reviewed as many times as necessary and modified accordingly.

A specific example that the author wishes to emphasize is that related to documentation. This, in his experience is one of the areas—together with personal hygiene—that require the most attention and education. For example, the following are some considerations that must be included in the area of documentation of each function (quality control in this case):

• The operation needs to document actions in the implementation of the quality program to monitor its progress and thus give confidence to its management.

• Various functional groups, purchasing, production, and marketing, need information about quality control actions. Well-kept records are invaluable in case of an internal or external investigation of incidents that question or challenge the quality of products, whether prompted by customer dissatisfaction or government actions.

•Well-kept records of pertinent information, when properly analyzed, help to detect trends and establish corrective actions, for instance, changes in compliance of suppliers, variation in quality of competitive products and deterioration in workmanship practices in a unit or shifts in production yields. Error prevention, based on a study of historical data and trends, is a particularly worthwhile application of data gathering.

Reporting As an Established and Necessary Managerial Procedure
In the documentation example, the program must include the design of reporting forms, for laboratory work (i.e., time of sampling, sample size, weight, result of test, method used, etc.), manufacturing conditions (i.e., time, temperature, batch weight, product, etc.) and all other operations that are to be documented.

Under the above context and systematic development of a quality policy and total quality program for the enterprise, an eventual verification is required to assure that the program fits the needs of the exporter and that the controls and costs are adequate to maintain quality and safety of products to be exported. Normally, this can only be accomplished once the operation is underway and should be considered as a “reality check.” In performing such evaluations, a series of inspections must take place, be it by members of the enterprise or external individuals who are knowledgeable in the process and have the appropriate tools to identify and report problems encountered. Especially at the beginning of operations, these problems should be discussed and actions taken immediately to resolve the issues and allow production to begin. Once the export flow of products is accomplished, the inspections should be at random and if anomalies are noted they also should be corrected.

However, audits/inspections and auditors/inspectors are not created equal. How effective a third-party inspection will be and whether it will “find the skeletons in the closet” depends upon the auditor/inspector and the inspection format being used. The individual who conducts the inspection has to have a level of expertise in the particular operation that will support credibility in his/her findings. Because of this, many companies are utilizing the audit schemes that the Global Food Safety Initiative (GFSI) has approved or the incorporation of the ISO 22000 principles into their food quality/safety management program. The six schemes currently approved under GFSI are the British Retail Consortium (BRC), Safe Quality Food (SQF), International Food Standard (IFS), Dutch HACCP, Food Safety System Certification (FSSC) 22000 and Synergy 22000; most technical personnel—in the food industries in the USA and the EU—believe that the adoption of these audits have enhanced food quality and safety, and reduced recalls. Of course, the question regarding qualified auditors still remains. A good auditor is not simply someone who has attended a course and passed a test. The best auditors have extensive experience with different products, processes and plants, and they understand not only what can create problems but the means for preventing them.

The above paragraphs have been included in this paper, because, the Food Safety Modernisation Act (FSMA), by putting the responsibility of the product’s safety in the hands of the importers, has presumed that the “foreign” producing entities will be audited/inspected periodically. Even though these audits/inspections can be performed by local or foreign third-party personnel, their qualifications and expertise should be clearly ascertained.

As a last note, most industrial concerns and many food companies are now integrating all of their “operations” (e.g., manufacturing, marketing, sales, advertising and promotion, logistics, human resources, etc.) and reviewing what is the total impact on the enterprise in our environment. They are creating a corporate environmental policy, a written statement of a company’s objectives concerning the management of the effects of its operations on the environment. It is not currently compulsory to have an environmental policy but an increasing number of businesses are opting to have one.

In order to be effective and not just a paper exercise, the policy must be implemented at a senior management level and should contain targets and methods for measuring the improvement of environmental performance. And, in the authors’ opinion is the picture of what is to come!

Conclusion and Recommendations
Compliance with the FSMA for food products that are to be exported to the U.S. is a fact. The best way to assure success is to produce and deliver a product that meets specifications. In order to assure this, it becomes paramount that a total quality management system is implemented, revised and updated constantly, and top management’s involvement, not only the necessary resources but also time and presence, is fundamental to the success and profitability of the operation.

In the writing of this document, many of the concepts and ideas mentioned were used from the authors’ publications and presentations, as well as from colleagues who have participated with him in seminars and courses, such as William Saenz, Omar Dary, Ph.D., Richard (Rick) Stier and others.

Herbert Weinstein, Ph.D., earned his chemical engineering degree from the Universidad Nacional Autonoma de Mexico and his M.Sc. and Ph.D. in Food Science and Technology from Massachusetts Institute of Technology. He has 45+ years of industrial and consulting experience (General Foods, now Kraft Foods, and Unilever) specifically as an expert in Product Development, Quality Control and Quality Assurance and Food Safety. He has traveled extensively to countries where he has been responsible for all technical aspects of food manufacturing, distribution, logistics, product development, quality control, quality assurance and management, both as top manager for his employers, as well as consultant for various clients, governments and United Nations agencies. Food Safety and Food Security have been major topics of his latest assignments as these aspects of global food commerce have become more in the front lines of concern. Today he is a consultant working out of Arlington, VA. He can be contacted at

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