Continually, we see in developing countries that Health Authorities are improving their laws and regulations towards more desirable and foreseeable improvements in the health and welfare of the populations. Nonetheless, in many instances, the legislation is enacted, but implementation and enforcement do not occur, mainly because of a lack of funds (e.g., personnel, training, facilities, etc.). This is also true for aspects of legislating the food and pharmaceutical industries; thus, it becomes obvious that self-regulation becomes paramount for the quality and safety of the products that enter export markets.

For those food enterprises that wish to export to U.S. markets, both the quality and safety of their products have become serious corporate issues, mainly because of the passing of the Food Safety Modernization Act (FSMA) of 2011. Their products must comply with this new law, which emphasizes safety of foodstuffs by contemplating prevention rather than detection.

The pursuit of quality is a universal concern; we are impacted by either good quality or lack of it of goods and services. Quality is a term that is frequently at the tip of our tongues, yet its precise meaning is not so clear (see Quality Terms below). Quality is associated with a certain status, that of luxury or prestige; it may also be related to price or value, but that is not appropriate here. A better definition of quality, one particularly useful in dealing with food production programs, is the concept of “fulfillment of what is promised.”

The quality of a food or the service that makes it available to the target population and fulfills its intended purpose is measured by the degree of satisfaction of expectations.

Quality, in synthesis, is fulfilling what is promised—all the time—and complying with specifications. In this sense, food safety becomes an integral part of quality, because the food manufactured must be wholesome and should not produce “harm” to the consumer.

Quality does not happen by chance; it is the result of a concerted effort of all relevant actors in the organization, from top management on down. The common belief that quality products can be obtained by applying controls or inspections at the end of the production line is simply not true. Quality must be considered at the very early stages of a project, that is, the product concept and its development; it needs to address the selection of appropriate ingredients and focus on the manufacturing process; and it must not forget packaging, distribution, handling and consumer acceptance. A particular emphasis should be placed on food safety;this regrettably—up to now—has not been a primary preoccupation of food manufacturing in developing countries. Nothing could be more irresponsible. The need to provide healthy and wholesome foods is an obligation of all manufacturers and is independent of the social or economic status of the consumer. Therefore, it is important to create a corporate culture that should include the fact that “quality is an investment,” and once it is treated that way, a return to that investment is expected and should be included in the objectives and job descriptions of all those involve in the process.

Investing in Quality
As mentioned above, quality as an investment requires the total participation of the enterprise, beginning with top-management commitment; specially,theparticipation of the highest-level officials in the organization’s quality improvement efforts. Their participation includes establishing and serving on a quality committee; establishing quality policies and goals; communicating those goals to lower levels of the organization; providing the resources and training for achieving them; participating in quality improvement teams; reviewing progress on a company-wide basis and recognizing those who have performed well. Top-management commitment is so vital that it can be said, without any hesitation, that without management commitment, most quality efforts will fail.

If only two determinants of quality could be considered, they would be: 1) company attitudes, including management commitment, and 2) looking after the interest of consumers. These are considered the “Pillars of Quality.”

The FSMA was signed into law by President Obama on January 4, 2011. It aims to ensure that the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. The emphasis is on prevention vs. detection,   terms used to contrast two types of quality activities. Prevention refers to those activities designed to prevent non-conformances in products and services. Detection refers to those activities designed to detect non-conformances already in products and services. Another term used to describe this distinction is “designing in quality vs. inspecting for quality.”

Unquestionably, both are important and should be properly understood. Additionally, foresight and prevention are mentioned; they are two considerations that are fundamental in satisfying customers and fulfilling the promise of quality. Foresight is formulating questions such as: What does my client needs from me? What can I do to satisfy my customer’s needs? These are important considerations for anyone who wants to succeed in the marketplace. Prevention may formulate questions such as: What could cause my client to be dissatisfied?  What can I do to prevent this from happening?

The above may have been OPTIONAL in the past, but under the new legislation, these actions become compulsory; those food manufacturers that ignore their importance and significance will not be successful in exporting foodstuffs to the U.S.

Quality Characteristics
Quality does not happen by chance, it is the result of a concerted effort, good planning and careful execution.

Quality can only “happen” in the right climate; this requires commitment and participation of the highest authority (management) in the emprise.

The pursuit of quality is everyone’s concern and is a full-time job.

People are the key players and are more meaningful than equipment, materials or installations.

Training and motivation are the basis for the good performance of personnel.

The search for quality is an ongoing process, not a finite program; continuous improvement is the road to excellence.

In order to integrate the concepts of quality and food safety, the concept of Total Quality Management is one that is particularly appealing. The author has applied this concept in various countries in Latin America and Asia; it is based on the tenet that all the many sections and activities that constitute the enterprise must be seen as a wholeand that each one of them is responsible for good or bad performance. In the whole enterprise or any of its parts, we can identify sequences of dependency, where groups provide or receive services, in a true relationship of supplier/customer. For instance, the purchasing department provides a service to manufacturing that, in turn, provides a product to the sales department that supplies outside customers.

If we understand the concept of quality as the fulfillment of what is promised and we use the concept of dependency or the supplier/customer relationship between departments, all we have to do is insure that each customer, internal or external, is satisfied.

Examples of Supplier/Customer Relationships
R&D designs products that meet marketing and safety briefs, which desirably should satisfy consumer’s expectations.

Purchasing acquires materials that fit what was specified by R&D—including safety concerns—and keeps the factory supplied in the correct quantities and at expected times.

Manufacturing produces safe products in compliance with product specifications and in quantities requested by marketing and sales.

Marketing and sales aim to satisfy the final consumer and insure that the goals of the program—including the safety of the consumers—are met.

If we look at operations in the enterprise as a chain of interrelated steps and events, it is clear that a failure in one-step or event will affect others down the line. Quality considerations should not be the concern of only the people in the quality assurance (QA) and quality control (QC) departments. Quality must be everybody's concern and responsibility, thus, the importance of top-management involvement. The safeguard and pursuit of quality should become a way of life, a philosophy, not a mere program suggested by the management of the moment, assigned to QC personnel. Experience has demonstrated that when quality becomes a way of life, the company gains in productivity, workers morale improves, satisfaction of customers and profitability are achieved and the livelihood of the company is assured. The accomplishment of these objectives and implementation of this course of action will include all the necessary steps to assure the safetyof exportable foodstuffs. In as much as the “importer” is now responsible (to the U.S. Food and Drug Administraion as well as the U.S. Department of Agriiculture) of the food quality/safety of the imported products, the agreement or contract for such importation would include product definitions assuring compliance to specifications and therefore with the “safety” of the foods.

As part of the total quality management (TQM) program mentioned before, a systematic QA approach offers, in the author’s estimation, the best possible way to establish a comprehensive and logical program, one that will improve quality of products and services and the performance of the enterprise.

Integration of the aspects of food safety into the TQM system requires a preliminary analysis of where the enterprise is. A preliminary food safety review aims at establishing the current business position with regard to food safety and determining needs and opportunities for improvement. The review would include the following:

• The identification of relevant food safety issues

• The production, processing, distribution and consumption conditions, and their potential impact on food safety, in all operating conditions

• The current safety procedures and practical level of control

• The information gained from investigations of past problems

• An inventory of constraints, in particular legal and regulatory requirements for control (e.g., performance objectives, microbiological criteria)

• Other professional, legal or contractual requirements (e.g., codes, guidance documents, requirements for certification), as well as market constraints (economic issues and costs, e.g., of raw materials)

• An assessment of performance against expressed internal or external criteria

• An overview of opportunities (e.g., product development, process innovation, new markets)

• Current management control practices for chemical and physical hazards

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, a TQM system must be implemented, revised and updated constantly, and top managements’ involvement not only with the necessary resources but with 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.

Read the sidebar: Quality Terms

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

Crosby, P.B. 1995. Quality without tears: The art of hassle-Free management. New York: McGraw-Hill.
Ishikawa, K. 1988. What is total quality control? The Japanese way (Business Management). Upper Saddle River, New Jersey: Prentice Hall.
Heldt, J.J. and D.J. Costa. 1988. Quality pays: Increasing profits through quality cost analysis. Wheaton, IL: Hitchcock Publishing Company.


Quality Terms
These definitions are presented with the intention of making them known to all and to clarify concepts. We place this section ahead in order to have a better understanding.

Quality: Refers to the conditions of a product or service that make it acceptable. Quality can be measured by the degree of fulfillment of promises or manifestations made by the seller to consumers. Engineers use the term fit for use that is how close it meets the specifications for its intended use.

Quality Assurance/Quality Control: Two terms that have many interpretations because of the multiple definitions for the words “assurance” and “control.” For example, “assurance” can mean the act of giving confidence, the state of being certain, or the act of making certain; “control” can mean an evaluation to indicate needed corrective responses, the act of guiding, or the state of a process. Thus:

Quality Assurance (QA) is all the planned and systematic activities implemented within the quality system that can be demonstrated to provide confidence that a product or service will fulfill quality requirements. It has to do with setting up policies, objectives, and means of obtaining them and controls to insure that they are reached. It sets up a road map and considers all the elements that can impact quality (and safety); it will focus on the design of products and procedures, specifications, methods of analysis and acceptance levels.

Quality Control (QC) is a more specific activity, the operational techniques and activities used to fulfill requirements for quality. It will typically involve inspections, sampling and analyses and approval or rejection of samples according to specifications. It answers more to the “hows” of the quality system. Its area of action is primarily in the manufacturing facility, but QC cooperates with QA in monitoring suppliers and the distribution chain. Often, regrettably, QA and QC are used interchangeably, when referring to the actions performed to ensure the quality of a product, service, or process.

Quality Audit: A systematic, independent examination and review to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives. It should not be confused with random occasional spot checks of product characteristics.

Prevention vs. Detection: Terms used to contrast two types of quality activities. Prevention refers to those activities designed to prevent non-conformances in products and services. Detection refers to those activities designed to detect non-conformances already in products and services. Another term used to describe this distinction is “designing in quality vs. inspecting for quality.” Unquestionably, both are important and should be properly understood.

Total Quality: A set of principles and methods organized as a comprehensive strategy, with the goal of mobilizing the whole enterprise, in order to achieve the greatest customer satisfaction, at the lowest cost.

Food Safety: A scientific discipline that describes handling, preparation and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards. Food can transmit disease from person to person as well as serve as a growth medium for bacteria that can then cause food poisoning. It also includes all the measures necessary to insure the safety, soundness and wholesomeness of foodstuffs at all stages of the food chain from production, and manufacturing, to distribution and consumption

Top-management Commitment: Participation of the highest-level officials in their organization’s quality improvement efforts. Their participation includes establishing and serving on a quality committee; establishing quality policies and goals; communicating those goals to lower levels of the organization; providing the resources and training for achieving them; participating in quality improvement teams; reviewing progress on a company-wide basis and recognizing those who have performed well. Top-management commitment is so vital that it can be said, without any hesitation, that without management commitment most quality efforts will fail.

Quality Policy: It is a manifestation and commitment of the company (enterprise) that states the general principles and intentions that the company has in the search for quality and how they will discharge their responsibilities in front of consumers and the society at large. It is a frame of reference and a guide to all the actors in the company.

Company Culture: Is the sum of values, traditions, behavior and practices that a company has that give it its own identity. The behavior of employees, their interrelations their approach in dealing with customers and suppliers and the way they look at the company products depend of this culture.

Total Quality Management (TQM): A style of quality management based on a systematic approach using practices, tools and training methods that allow the company to provide consumer satisfaction, through quality products and services.

Hazard Analysis of Critical Control Points (HACCP): HACCP is a common-sense technique to control food safety hazards. It is a preventive system of hazard control rather than a reactive one. It is not a zero risk system, but is designed to minimize the risk of food safety hazards. HACCP is not a stand-alone program but is one part of a larger quality system. The concept is based on logical reasoning: foresee what hazards could appear in a process; define means of controlling them and verify that the corrections were effective. It can also be adapted to general quality management.

Good Manufacturing Practices (GMPs): GMPs are a collection of guidelines, precepts and requirements necessary to insure that foods are manufactured and handled in conditions that will promote and insure food safety and quality of products. Most countries have GMPs incorporated in their food regulations. 

Supplier QA: This involves establishing the confidence that a supplier’s product or service will fulfill its customers’ needs. This confidence is achieved by creating a relationship between the customer and supplier that ensures the product will be fit for use with minimal corrective action and inspection. According to Juran, there are nine primary activities needed: 1) define product and program quality requirements, 2) evaluate alternative suppliers, 3) select suppliers, 4) conduct joint quality planning, 5) cooperate with the supplier during the execution of the contract, 6) obtain proof of conformance to requirements, 7) certify qualified suppliers, 8) conduct quality improvement programs as required, and 9) create and use supplier quality ratings (see resource list).

Continuous Improvement: This the constant pursuit of quality, an ongoing process. Continuous improvement corrects errors in the operations and draws lessons and guidance for the prevention of future problems. The goals of yesterday become today’s standards. It is the road to excellence.

Quality system. We understand by system a process by which conditions are set up, needs are defined, resources are deployed and actions are taken to obtain the intended results. It can be said that the quality system is the combination of all actions that must be executed in order to guarantee that the company policies on quality are fulfilled.