Fortification of wheat flour with iron: development of a quality assurance system

Iron Deficiency Anaemia (IDA) has been identi­ fied as a problem of public health significance in Sri Lanka (1). As a part of its programme to com­ bat iron deficiency in the population, the Gov­ ernment of Sri Lanka (GOSL) has conducted a series of trials and studies on the feasibility of fortification of wheat flour with iron. These stud­ ies have been carried out under the iron fortifi­ cation of wheat flour project which began in 1994 jointly sponsored by the GOSL (2,3,4) (Ministry of Finance, Planning, Ethnic Affairs and National Integration) and USAID.


Introduction
Iron Deficiency Anaemia (IDA) has been identi fied as a problem of public health significance in Sri Lanka (1). As a part of its programme to com bat iron deficiency in the population, the Gov ernment of Sri Lanka (GOSL) has conducted a series of trials and studies on the feasibility of fortification of wheat flour with iron. These stud ies have been carried out under the iron fortifi cation of wheat flour project which began in 1994 jointly sponsored by the GOSL (2,3,4) (Ministry of Finance, Planning, Ethnic Affairs and National Integration) and USAID.
The GOSL under the project is currently imple menting an efficacy trial to demonstrate that for tification of wheat flour with iron could reduce the prevalence of iron deficiency anaemia in the population. There are favourable considerations and national interest on fortification of wheat flour with iron. With this prospect it is important to develop a proposal for a quality assurance sys tem for iron-fortified wheat flour which could be implemented once a national programme for fortification of wheat flour with iron gets under way. This is a summary of observations and recom mendations made in the report on the develop ment of a quality assurance system for fortifica tion of wheat flour with iron. The full report will be published by the Ministry.

Objectives and Scope
This study was undertaken as a part of the "Iron Fortification of Wheat Flour" project with the broad objective of developing a quality assurance system for application in the production of wheat flour fortified with iron for consumption by the Sri Lankan population. Specific objectives are; • Identification of quality aspects and crite ria for ingredients and processes involved.
• Identification of control points in the pro cessing, packaging and distribution, and to establish control and monitoring procedures at each control point.
• Develop a recording and verification system for the quality assurance and quality control activities.
The above aspects have been addressed with spe cific reference to the activities and processes in volved in the fortification of wheat flour with iron. The quality assurance activities required to secure the desired quality of wheat flour in the milling process such as cleaning of grain, blend ing, conditioning of grain for milling, sieving sift ing operations have not been specifically ad dressed. The quality assurance practices in place at present are considered adequate to achieve the required quality level as specified in the National Standards.
In this report the term "quality assurance" refers to all those planned and systematic actions nec essary to provide adequate confidence that a product or service will satisfy given requirements for quality. Quality control activities in operation at present includes the following; on protein content and protein quality, are blended to give the required protein content. Grain is tempered to aid in the milling process and achieve the required moisture content. The basic process for fortification of wheat flour with iron is as follows; The fortificant is first mixed with wheat flour in a ribbon blender in the ratio 1:1. This is to dilute the fortificant to facilitate the process of addition to the wheat flour bulk. The addition of pre-mix is direct to the wheat flour conveyor using volumetric feeders of suitable capacity. The product flow on lines are reported to be stable and uniform. There fore, the metering of pre-mix on to each of the five milling lines could be adjusted to a constant rate to give the desired rate of addition. Further mixing takes place as the product goes through several stages of conveyors and mixers.

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The required rate of addition of pre-mix (1:1) is 130 g per MT of flour produced to give an effec tive level of 65mg iron/kg flour. On this basis the daily requirment of pre-mix for 2500 MT of wheat flour is 325 kg. The ribbon blender of 80 kg capacity available at present is adequate for the production of pre-mix required for the total production of flour for all five lines. How ever, it is proposed that an additional Ribbon blender be provided to accomodate heavy work load and possible break downs.
Metering equipment for the addition of iron premix is now available only on one line (supplied under the project). This volumetric feeder is of adequate capacity and capability to achieve the required rate of feeding. It would therefore be necessary to provide 4 volumetric feeders of simi lar capacity for the 4 lines which are not equipped with feeders.

Quality issues in the fortification programme
Quality issues or factors relating to quality and safety which need to be addressed in a fortifica tion programme are highlighted in sections 1 to 6 below. For each of these aspects, possible con trol measures and mechanics for application of these measures are given in section 7 and pre sented in the form of a quality assurance plan (Schedule 2).

Quality and purity of fortificant -
The fortificant used should conform to specifications covering quality and purity requirements. These would cover nature of material, par ticle size, iron content and associated impuri ties. Possible contamination arising from damage to containers during transit and stor age should be considered and steps taken to avoid use of such material. 6. Storage of wheat flour and distribution -It is necessary to ensure that iron fortified flour is consumed within a targeted period of three months (maximum) since it has been shown that iron fortification reduces the shelf life of wheat flour. The present distribution system is such that the flour reaches the retail points within six weeks and are consumed within three months.

Quality assurance plan
Based on the quality issues discussed in sections 1 to 6 (above) the control points at which the quality parameters could be controlled have been identified. The following have been iden tified for each control point (CP) and presented as a Quality Assurance Plan in Schedule 2.

CP3(a)-Labelling of pre-mix packages-
It is recommended that the pre-mix be packed in standard quantities and prop erly labelled to avoid any risk of mistaken identity.

CP3(b)-Storage of pre-mix-
This would be required, based on the prac tical production schedules adopted for pre-mix. Since studies on stability of pre mix has not been carried out, it is recom mended that storage time be restricted to seven days. At the rate of consumption of 325 kg per day of pre-mix, the maximum bulked quantity should not exceed 2400 kg (7 days requirement).

CP4(a)-Identification of pre-mix packages before addition-
This control activity is a preventive mea sure for any possible mix-up of packages of pre-mix and prevent use of pre-mix stored for periods beyond the specified limit. The daily requirement of pre-mix would be approx. 325kg for 2500 MT of flour.

CP4(b)-Quantity of pre-mix added-
It is desirable that the pre-mix package is of standard quantity which can be added at once to the hopper at feeder point. It will then be possible to record the quan tity added with time of addition. This

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infomation would he used for the control activity at CP4(d), where daily records would be scrutinized.

CP4(c)-Visual checks on the feeder
Volumetric feeders are used. The correct feeding rate need to be worked out with tolerances to give a feeding rate of 130 ± 5g of pre-mix per 1MT of wheat flour. The meter readings should be checked regularly by line operators.

This analysis should be carried out daily in-house. Daily samples of flour are anal ysed in the in-house laboratoty at Prima
Ltd. Therefore, Fe determination should be carried out once a day on the samples collected.

Verification procedures
Verification procedures form an integral part of a Quality Assurance Plan. Verification activities should be carried out on a planned basis accord ing to a scheduled programme. The following aspects should be covered in a verification pro cess: The first aspect of verification should be, to en sure that the QA plan at the mill is functioning effectively. A properly functioning QA plan re quires little end product sampling and testing since appropriate safeguards for assuring qual ity are built into the process. This part of the verification process should involve the verifica tion that the QA plan is correctly followed at dif ferent levels and the review of records at each

CP as indicated in the QA plan. This verification of records at CP's should be carried out by inter nal staff (internal audits) at least once in three months. Records of such internal audits should be maintained for verification.
The second aspect is the performance of an ex ternal audit to verify that the QA plan is imple mented in a proper manner. It is recommended that a surveillance audit of the QA system be carried out once in six months by a team of audi tors nominated by GOSL (MFPEANI).
In addition to such verification procedure, inde pendent monitoring and surveillance through testing of final product is recommended. These activities should be carried out as indicated un der CP 6 in the QA plan. It is the responsibility of the QC unit of The Food Department to arrange for these tests. Adequate funds should be made available for this purpose.

Conclusion
Iron fortification of wheat flour has been consid ered favourably by the GOSL as a means to com bat iron deficiency in the Sri Lankan population. Adherence to general principles for addition of nutrients to food and related good manufactur ing practices is essential to assure safety and derive full benefits from such a fortification programme. Assuring safety and quality of such fortified foods is the responsibility of all stake holders and interested groups involved in the process. A properly designed QA system should be installed and implemented with the participa tion of all concerned to assure safety and quality of the fortified food.
The quality system recommended in this report could be implemented by effectively integrating with the present QC system. Installing and imple menting the QA system will be the responsibil ity of the mill management. However, it would be the responsibility of the GOSL and the rel evant regulatory authorities to see that adequate and effective systems are installed and practised to assure safety and quality of products. Sufficent financial resources should be made available by the GOSL for the implementation of this QA programme in the event a positive decision is made to implement the programmne for fortifi cation of wheat flour with iron.