QA-QC of vitamin A & D Fortfication of oil.pptx

Oil Fortification with Vitamin A and D- QA QC Program

1. QUALITY ASSURANCE AND QUALITY CONTROL EDIBLE OIL/GHEE FORTIFICATION

2. QA/QC Activities To ensure that the fortified food products meet the requirements set in food regulations and standards from production to the market. It also ensures that fortification programs are implemented correctly so that their public health impact is effective to help achieve nutritional targets. The Quality Assurance is process orientated and focuses on defect prevention. Quality control is product orientated and focuses on defect identification.  QA/QC for oil/ghee fortification does not require new program in factories, but only to incorporate a few practices into the ongoing QA/QC procedures.

3. Quality Assurance (QA) Quality Assurance is process orientated approach and focuses on defect prevention. QA planned and systematic pattern of all necessary actions to ensure that the product conforms to technical standards. Main objective of QA is to ensure that products meet quality standards for their intended use. Quality Control (QC)  QC is product orientated approach and focuses on defect identification An overall system to measure and control the quality of a product to ensure that it adheres to the specifications and meet user requirements. An integral part of the overall quality assurance processes and are undertaken by the staff of government food regulatory authorities. QA/QC Activities

4.  V ital to ensure that the fortified oil/ghee meets the requirements QA/QC systems help to identify the causes of non-compliance and implement corrective and preventive actions (CAPA).  QA/QC protocols are essential to ensure that adequate level of vitamins is present in the finished product to improve nutrition of the target population. The HACCP system is a method used to ensure food safety by identifying potentially unsafe links in the food processing chain. It recommends checking the raw materials; monitoring the critical parts of the process and ensure that the finished product remains intact until its expiry date. Importance of QA/QC System in Edible Oil/Ghee Fortification

5. Control Point Industry Regulator Premix supply √ √ Premix importation   √ Premix arrival at production facility √   Premix movement at production facility √   Premix addition – process control √   Finished product inspection √   Inspection and internal audit √   Inspection and external audit   √ Inspection of fortified imports   √ Inspection of market samples √ √ Key control points, and responsibilities

6.  Provision of spot test kits to the mills Provision of iCheck to a cluster of 6 to 8 edible oil/ghee mills for quantitative testing at production level iCheck at the divisional level High Performance Liquid Chromatography (HPLC) at provincial headquarters for testing of vitamin A in oil/ghee. Vitamin A results as proxy indicator for vitamin D3 QA/QC Mechanism Under FFP

7. Samples Representative sample Sample taking, and compositing and retention are critical. Sampling could be taken every hour to every shift depending on mill internal risk system A composite sample is generated - be it by day, week or month – by taking the same quantity (for example 10 ml) from every sample taken and producing the daily composite. IMPORTANT NOTE – ensure a composite is generated for each type of oil the mill produces and that samples are not cross contaminated. Coding/recording samples – Unique Code on the sample container and recorded in sample book Properly store samples refrigerator or in a cool dark place or in a closed cupboard Such samples be made available to inspectors (any third party analysis). Samples older than one month – not recommended for analysis (though some mills do use composites of quarterly samples) Sampling techniques and management of samples

8. A retention sample is one taken by the production facility and stored under its control on its own premises under the required storage conditions i.e. in a cool dry place out of direct sunlight. The point of retention samples is that if the Regulator queries non-compliance based on a market based sample, the production facility can offer the inspector the opportunity to test a sample from the same day to see if that is also non-complaint. If it proves complaint then the inspector can start investigating the distribution chain, for which they are responsible. If that sample is also non-compliant then the investigator can then start to identify why – was it not fortified in the first place, was the premix a problem i.e. fit for purpose, or some other reason. Retention Sample

9. Type of Quality Check Edible Oil/Ghee Frequency Responsibility Internal – QA (at production level) Spot Test Kit (e.g. BASF test kit) Every batch Miller iCheck Chroma 3 (placed at a central location of 7 mills as an average) Fortnightly Miller / FFP Extender External – QC   iCheck Chroma 3 (placed at divisional level) Monthly Govt. Food Inspector High Performance Liquid Chromatography (HPLC) at provincial level Monthly Govt. Food Inspector Analytical Methodology

10. Rapid Qualitative Trichloroacitic acid and Trichoromethane ( Corrosive ) Semi Quantitative Rapid Semi Quantitative (BASF Test Kit) Quantitative iCheck Chroma 3 Qualitative vs Quantitative Tests

11. Uncertainty of measurement sampling protocol, analysis type, analyst and multiple other factors Control Charts Interpretation of Test Result: Recognizing limitations of Laboratory Analysis

12. In a stable process three characteristics are evident: Most points are near the average A few points are near the control limits No points are beyond the control limits Control chart differentiate special from common causes of variation as shown on here. Two points are outside the control limits. In such a case action should be taken to find the special cause and permanently remove it from the process. Reading Control Chart

13. Trends are much more easily noticed. In the plots on the left all of the processes are OUT of control even though the upper control limit has not been activated. The important part is that multiple points following a recognisable pattern are not normal in nature. In the top left the process is consistently above average In the top right the opposite is illustrated. In the bottom plots the system is ABOUT to go out of control so an early warning has been sent for imminent action. Reading Control Chart

14. The systems Approach has already been mentioned earlier (and attached a separate component of the manual) but the system relies on: Only authorised suppliers of pre-mix Suppliers and PSQCA held “accountable” for pre-mix components being of required standard. Storing fortificant well protected from exposure to light or under the conditions laid down by the manufacturer. It is ideal to keep fortification mixes in their original containers. Once opened, exposure to the light and air should be minimised to prevent product degradation. Record Keeping

15. Obtaining and keeping on record a certificate of compliance (CoA) for every batch of fortification mix. Employing, and adhering to, strict stock rotation procedures so as to prevent old stock losing potency and to comply with the shelf life expiry date. It is recommended to employ and implement the first in, first out (FIFO) system for this purpose. Keep records of inputs and outputs. Keep records of raw material procurement; Keep records of fortification mix inventory and usage; Keep production records of the amount of fortified product produced; Keep monthly records of the amount of fortification mixes used every month. These records should correspond with the monthly production records; Ensure that all critical stages of the manufacturing process are monitored to ensure the correct dosage levels are maintained through the following measures: Record Keeping

16. In continuous dosing checking of the dosers to ensure they are delivering the correct quantities of diluted premix. This can be done by measuring the weight of diluted premix discharged over a specific time (1 or 2 minutes) and comparing the measurements with the target weight of diluted premix. In batch mixing establishing a system to ensure each batch is fortified i.e. two person approach Performing frequent visual checks to ensure diluted premix is being used and that no blockages have occurred, and keeping a record of this. Performing regular rapid tests on the finished product. Record Keeping

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