Food Fortification Quality Control and Monitoring System

Abstract

• Name: Food Fortification Quality Control and Monitoring System
• Purpose: To enable food producers and law government enforcement agencies to set up and implement an effective QA/QC control system to regularly verify that the fortified product is manufactured and marketed within the legislated technical specifications, including micronutrient content, packing and labeling at production plants, market places and households.

• Type of Design: Cross-sectional use at production plants throughout the production cycle; random inspection of product packaging and labeling (eventually lab analysis and "quality audits") at distribution and market places. Periodic cross-sectional use for monitoring fortified foods in statistically representative samples of households.
• Sample Size: Various
• Where Used: Honduras, Guatemala, El Salvador

To survey tool

Basic Information

Food fortification is one of the most cost-effective intervention approaches to reducing micronutrient deficiencies. Universal fortification of food staples, particularly of sugar with vitamin A, wheat flour with iron and B complex vitamins, and salt with iodine, is at the core of micronutrient strategies in a number of developing countries. A critical issue in fortification programs is the need to have effective self-sustainable quality control and monitoring systems. While a quality control system is required for quality assurance (e.g. proper fortification levels) at production sites on a continue basis, an effective government monitoring system is needed to verify that fortified products reach the consumer at expected fortification levels and to estimate a program population coverage. Previous efforts toward development of such systems focused mainly on salt iodination.

OMNI developed a specific initiative, jointly with the Institute of Nutrition of Central America and Panama (INCAP), with initial support from OMNI Research, aimed at designing, field-testing and formally establishing quality assurance/control (QA/QC) and monitoring systems for three commonly fortified staple foods (sugar, wheat flour and salt). The systems were originally developed, field tested and established in Honduras, and then adapted to El Salvador and Guatemala. Although the systems were tailored to conditions prevalent in the Central America sub-region, they are flexible enough to be useful, with appropriate adaptations, in other countries and regions. Each of the three systems included in the inventory comprises a number of instruments to be used at production/fortification plants for (QA/QC) of fortified foods, as well as at distribution sites, market places, retail stores and households for program monitoring purposes.

Name: Food Fortification Quality Control and Monitoring System

Origin: Developed by the Institute of Nutrition of Central America and Panama (INCAP) with technical and financial support from OMNI. Field tested in Honduras in collaboration food producers and the Honduran Ministry of Health.

Ownership: INCAP/OMNI.

Basic Description: The four sets of instruments and their accompanying manuals are designed to be used by fortified staple food producers and government units responsible for food control to establish and maintain effective QA/QC and monitoring systems for fortified staple foods.

Country Applications: Honduras, Guatemala, El Salvador. To be used shortly in other LAC countries and in Zambia (for sugar).

Languages: Developed originally in Spanish, to be translated into other languages.

Technical Scope: Work at the fortified food production plants, distribution and market sites, and households, with the purpose of monitoring the quality and coverage of fortified staple foods in a country. Potential users include technical personnel at both food production plants and government units responsible for food fortification control and monitoring.

Purpose: Summative, quality control and program monitoring.

Type of methods: Mostly quantitative information to be gathered at food production or fortification plants, distribution sites, market places/retail stores and households.

Design: Cross-sectional use at production plants throughout the production cycle; random inspection of product packaging and labeling (eventually lab analysis and "quality audits") at distribution and market places. Periodic cross-sectional use for monitoring fortified foods in statistically representative samples of households.

The tools systems fall in the program implementation/monitoring category of the conceptual framework. They are organized into four main sections that are complemented with specific technical manuals:

• Quality control system for fortification of sugar with vitamin A.
• Quality control system for fortification of wheat flour with iron and B complex vitamins.
• Quality control system for salt iodination.
• Monitoring and surveillance systems for food fortification programs (in general).

Each of the first three sections, in turn, is divided in three or four parts, as follows:

• quality assurance/control system for food fortification at premix preparation (only for sugar fortification) and at production plants, an explicit responsibility of food producers;
• verification/inspection system for food fortification at production (or fortification) plants by government food control units (often the Food Control Division of the Ministry of Health);
• product monitoring at distribution and market places/retail stores by government food control units (often the Food Control Division of the Ministry of Health), as well as, eventually, by consumer protection groups; and
• product monitoring at the household level ("surveillance") by government food control units, consumer protection groups and/or other interested parties.

Frequency of Administration: Variable by instrument. Daily for QA/QC at premix preparation (only sugar) and food production plants, periodically or occasionally at distribution/market sites, annually for household monitoring.

Key Users of Information

Primary Users: Fortified staple food producers (sugar, wheat flour, salt) and technical personnel at production plants, as well as governments, particularly technical personnel responsible for quality control of fortified foods at production plants and program monitoring by government units, usually from the Ministry of Health.

Secondary Users: Private sector interested groups, including NGOs/PVOs, consumer protection groups. USAID's missions, Cooperating Agencies (CAs), and other international donors (WHO, UNICEF).

Objectives and Scope of Tool

Objective: Gather information needed for QA/QC of fortified staple foods, including verification by government units of the QA/QC system implemented by food producers at production/fortification plants, as well as for government monitoring at distribution and market places, and at households.

Scope: The tools collect and analyze information on the fortification premix (sugar only) and the fortified food which is of relevance for QA/QC and program monitoring as a basis for technical decisions by food producers and government regulatory and enforcement units.

Key Monitoring Needs and Evaluation Questions Tool Seeks to Address

The following questions are to be answered:

At the food production/fortification plant level:

For sugar only:

• is the fortification premix timely and adequately prepared, stored and distributed

• to food production plants according to the established technical specifications ?
• is there a quality assurance/control (QA/QC) system in place and operating regularly during the premix preparation period, by which the producers periodically verify the quality of the premix prepared ?
• is the fortification premix appropriately stored and systematically added to the food on a regular basis, at the right place and in adequate amounts according with technical specifications ?

For sugar, wheat flour and salt:

• is there a QA/QC system in place and operating regularly which systematically monitors the quality of fortification at the plant by the food producers or fortifiers?
• are the results of random verification of nutrient content in the fortified food by government inspectors similar to those obtained by the producers/fortifiers quality control system ?.
• is the fortified food adequately packed, labeled and, eventually, stored separated from any non fortified food ?

At distribution/market sites/retail stores:

• Is the fortified food available to the consumer properly packed and labeled according to the regulations ?
• are there packages of the presumably fortified food that are not properly labeled ?
• if samples of presumably fortified food are taken for lab analysis, do they comply with the established technical specifications ?

At the household level:

• what is the specific nutrient level and distribution in samples of the presumably fortified food taken from a nationally representative sample of households ?

Key Indicators

Premix preparation, packing and distribution (for sugar only):

• Timely availability (before harvest begins) of equipment and materials required for premix preparation and quality control.
• Quantity of fortificant used per unit of premix prepared.
• Number and frequency of samples of premix analyzed by the plant QA/QC system.
• Mean and distribution of specific nutrient levels in samples of premix analyzed by the plant QA/QC system.
• Mean and distribution of specific nutrient levels in samples of premix analyzed by government inspectors.
• Time (days before initiation f sugar production) and quantity of fortification premix distributed to production plants.
• Percentage of the premix needed by each production plant that is timely met by the premix distribution system.

Quality/coverage of fortification at production/fortification plants:

• Proportion of the total food production of the plant that is fortified according to producers QA/QC system.
• Ratio of premix used over food produced/fortified per unit of time (daily, weekly,
• monthly).
• Mean and distribution of specific nutrient levels in food samples analyzed by the plant QA/QC system.
• Mean and distribution of specific nutrient levels in food samples analyzed by government inspectors.
• Proportion of the fortified food that is adequately fortified, packed, labeled and, eventually, stored separated from any non fortified food.

Quality of fortification at distribution/market sites:

• Number of monthly visits to distribution sites, market places and retail stores by government inspectors.
• Proportion of retail food packages that are properly labeled.
• If food samples are taken from distribution sites, market places and/or retail stores, mean and distribution of specific nutrient levels in those samples.

Quality/coverage of fortification at households:

• Mean and distribution of specific nutrient content in samples of presumably fortified food taken from households.
• Proportion of households consuming adequately fortified foods.

Research Design

The systems are designed following a standard format. However, while the sugar and wheat flour industries are relatively modern, well equipped and sophisticated, the salt industry in many countries is still rudimentary, production plants are ill equipped and marketing not well organized, thus QA/QC standard procedures are less feasible and monitoring more complex; therefore, the QA/QC and monitoring system for iodinated salt is somewhat simpler and less rigid.

As salt is often fortified in especial facilities other than production plants, QA/QC of iodinated salt is more often implemented at fortification facilities, rather than at production plants. The standard system at production plants calls for QA/QC procedures implemented by the producers, using composite "Lot quality Assurance Sampling" (LQAS) and quantitative laboratory assays, and for inspection visits for verification of the QA/QC system operation through observation, random sample collection and laboratory assays by government units.

Data collection at distribution sites, market places and retail stores is limited, as observational visits by government inspectors focus on verifying proper packaging and labeling of fortified foods and have more enforcement than monitoring purposes. Periodic monitoring of fortified food at households, usually once per year, call for statistically representative samples of households at the national level and, eventually, at district level; this is often done by piggy-backing periodic multipurpose household surveys implemented by the health or other sectors.

Implementation

Implementation of QA/QC systems requires full cooperation of the food industry and the government enforcement units, which is best ensured when a strong public-private sector partnership has been developed since the early stages of program planning. As QA/QC systems for purposes other than fortification are operational in most sugar and wheat flour production plants, it is usually not difficult to add a specific fortification component to them, provided that producers are firmly committed to fortification. The additional cost is expected to be relatively low (less than 5% of fortification costs), although it has not been specifically estimated. Establishing QA/QC systems at salt production or iodination plants is usually more difficult, particularly in small to medium size production plants not using modern manufacturing practices.

Verification of existing QA/QC systems at production or fortification plants and monitoring at market places and households by government units is often hampered by financial and technical limitations. Major restrictions affecting government's control and monitoring capacity are lack of laboratory equipment and trained technicians; insufficient number and distribution of inspectors; not enough budgetary allocations for transportation, per-diem, laboratory equipment and supplies; and organizational and management problems. Therefore, in addition to technical assistance and specific training for both industry and government personnel, cooperative agencies often engage in policy dialogue, budgetary and institutional strengthening activities. Government costs of maintaining the monitoring systems are relatively low, yet they have not been formally established in many countries.

Analysis

Data analysis of the quantitative information is relatively simple. At the plant level, it involves simple comparisons of means and distribution levels of specific nutrients in the premix (for sugar only) and straight forward calculations of quantities of premix, food and fortificant used, compared with food produced. Qualitative information is gathered through inspection and observation at production plants, distribution sites, market places and retail stores, for law enforcement rather than monitoring purposes. Data from household monitoring basically entails micronutrient content of food samples, of which mean and distributions by district and for the total country are estimated and compared with expected levels at households, on the bases of the existing technical specifications; percent coverage estimations of the population by the fortified food can also be made.

Reporting

The results of the food producers/fortifiers own QA/QC system are routinely kept at production/fortification plants and become available for inspection by government officers; they are not formally reported as they belong to each particular food producer's own system. Reports of the QA/QC verification visits, including laboratory results, are prepared by government officers immediately after each visit, using standard instruments, and shared with both food producers and government law enforcement units for appropriate follow-up.

Results of government inspections to distribution and market places are submitted to the central offices for action, as the proposed system does not provide inspectors with law enforcement authority to make decisions on site (to prevent corrupted practices); "quality audits" may be recommended. An annual report of household monitoring is formally prepared which provides overall program quality and coverage estimations, to be shared with food producers, government authorities, consumer groups and donors. A formal annual meeting to discuss the monitoring results, identify problems and define corrective actions is regularly scheduled.

Dissemination of Results

Routine dissemination of results, as they become available, occurs among government units, food producers and, eventually, consumer protection groups and international donors. Except for general annual government reports, there is limited dissemination of fortification QA/QC verification and monitoring results by law enforcement authorities, food producers and, eventually, consumer protection groups.

Manuals and Guidelines

Technical manuals and guidelines describing the QA/QC and monitoring systems and providing guidance on implementation, including the use of the different instruments and standard procedures, are available in Spanish. They are currently used in three countries and will soon be used in other countries of the LAC region. Versions in other languages may be locally adapted and used elsewhere.

References

Dary O, Guamuch M, MartRnez C, Chinchilla D. Manual de un Sistema de GarantRa de Calidad de los Programas de Fortificaci\n deAlimentos para PaRses en Desarrollo. Parte 2. Sistema de GarantRa de Calidad de la Fortificaci\n de Azdcar con Vitamina A. ICAP/OMNI. (manuscript, 1998).

Dary O, Guamuch M, MartRnez C, Chinchilla D. Manual de un Sistema de GarantRa de Calidad de los Programas de Fortificaci\n deAlimentos para PaRses en Desarrollo. Parte 3. Sistema de GarantRa de Calidad de la Fortificaci\n de Harina de Trigo con Hierro y Vitaminas B. ICAP/OMNI (manuscript, 1998).

Dary O, Guamuch M, MartRnez C, Chinchilla D. Manual de un Sistema de GarantRa de Calidad de los Programas de Fortificaci\n deAlimentos para PaRses en Desarrollo. Parte 4. Sistema de GarantRa de Calidad del Programa de Yodaci\n de Sal Comdn. INCAP/OMNI (manuscript, 1998).

Other

At present, there is no other prototype instrument available for QA/QC and monitoring of staple food fortification in developing countries. The systems and instruments developed, field-tested and successfully implemented in Central America will be used, with local adaptations, in other countries of the region, and may be useful elsewhere. The manual and guidelines will eventually be translated into other languages (English, French).