1. Monitoring the Product Production, Import, Wholesale and Retail Level Monitoring

2. Different Levels of Monitoring The Product: Iodized Salt At production facilities At import sites At wholesale depots At retail shops

3. For Each Level: What information is needed? Why is this information important? Who is responsible for collecting and using this information? How is the information collected and managed? When is the information collected?

4. Aspects of Production Level Monitoring Internal Monitoring: Quality assurance, quality control measures done by producer External Monitoring: Confirmation of adherence to standards, done by government (ie: Sanitary Epidemiologic Service)

5. Internal monitoring is done at production facilities, and thus not in Moldova External monitoring includes: –Monitoring at import sites –Monitoring at wholesale facilities –Monitoring at retail shops

6. Monitoring the product ensures that salt reaching consumers provides adequate iodine, and meets government standards Monitoring the product is a joint responsibility of producers and the government

7. * *from Omar Dary, MOST

8. Overview of Internal Monitoring at Production Facilities

9. Internal Monitoring at Production Level: What?% of samples within acceptable range (ppm iodine) Why?To conform to specification of orders received Who?Quality assurance team How?QA procedures, spot test kit, titration or alternative When?Daily

10. Quality Assurance * Definition –All matters and activities that individually and collectively influence the quality of a product. –Applies to equipment, product design, processing, supplies, logistics, management and human resources –Salt fortification: Includes review of feeders, premix, packaging, labeling, sampling plans etc *adapted from Quentin Johnson, MI

11. Quality Control * Definition –Part of the Good Manufacturing Practice (GMP) –Concerned with sampling, testing and specifications, and with the organization, documentation and procedures for release of product –Ensures that tests are carried out and that products are not released until quality standards are met *adapted from Quentin Johnson, MI

12. What Does Industry Do for Quality Assurance? * Purchases equipment and premix supplies for quality assurance procedures Routinely inspects processing equipment Validates the mixing process for consistency Monitors salt ready for distribution Keeps adequate records Provides records for government review *adapted from Quentin Johnson, MI

13. Feeder Problems * (examples from flour fortification) For salt iodization, nozzle clogging *adapted from Quentin Johnson, MI

14. External Monitoring of Production Facilities, and for Imported Products

15. External Monitoring: Production Sites * Auditing: Examination of the quality assurance activities. Routine periodic sampling: Periodic sampling to confirm (corroborate) compliance. Full Inspection: Verification of legal compliance on products based on quantitative assays and statistical sampling (conformity assessment). *adapted from Omar Dary, MOST

16. Auditing (Checking the process) * Storage and Management of Micronutrient Mix: At least two months stock and FIFO policies. Production/micronutrient mixing: Checks on production line Feeder Calibration. QA/QC Records. Presence of “daily-composite- samples” in the “history-room”. Contract with an External Reference Laboratory (if salt is sent out for quantitative analysis) *adapted from Omar Dary, MOST

17. Example of Sample Size for Routine and Conformity Assessment Inspections * Routine Visits: 5 to 10 samples of 250 g, including at least one “daily-composite” from the “history- room”. Conformity Assessment: As statistically recommended. Three sealed replicates of 250 g: one for the reference laboratory, another for food control department, and another for the factory. *adapted from Omar Dary, MOST

18. External Monitoring at Import Level: What?% of samples conforming to government standard (ppm iodine) Why?To ensure adequate iodine intake in population; to limit availability of non-iodized salt in market Who?Customs How?Batch sampling When?Per shipment

19. External Monitoring: Imported Product * Certification of Conformity: Document that states that the batch fulfills the standards. Routine periodic sampling: A right of the food control authorities to check for compliance. Batch Inspection: If routine sampling demonstrates a problem, importers might request an official conformity assessment of the lot. *adapted from Omar Dary, MOST

20. External Monitoring at the Wholesale and Retail Levels

21. External Monitoring at Wholesale and Retail Levels: What?% of samples conforming to government standard (ppm iodine) Why?To ensure adequate iodine intake in population; to review availability in the marketplace Who?Sanitary Epidemiologic Service How?Selective sampling When?Periodically throughout year

22. Wholesale and Retail Monitoring * Verification of Legal Compliance: Presence of micronutrients, packaging, exact weight, labeling. Warning “alarm” (triggers intensified auditing with increased diligence at customs). Coordinated effort between local governmental personnel and food control departments. Limited by the large workload of small number of inspectors *adapted from Omar Dary, MOST

23. “Educative” and external pressure through large consumers and sellers. Application of sanctions (supported with technical auditing and quantitative assays) following procedures approved by the food control department—requires strong food laws and regulations. Retention of lot if clear proofs of health risks or non-authorized brands. *adapted from Omar Dary, MOST Wholesale and Retail Monitoring *

24. Example of Sample Size for Inspection in Retail Stores * Two complete sample (if packaged individually), or at least two 250 g, of each brand. Examine quality of the unused bags to ensure origin of the product. Depending on household coverage, some estimate of national availability at retail level may be needed. *adapted from Omar Dary, MOST

25. Analytical Methods * Qualitative in place (spot-test): Presence of iodine. (for “educative” purposes only) Quantitative in authorized lab: To justify recommendation of more intense inspections to the production sites, or application of legal actions. *adapted from Omar Dary, MOST

26. For small group work, at each level: What is the minimum information to be collected? Who is responsible for collecting it? How will it be collected, and how often? How will the information be processed and used? What specifics are needed in the legal environment to permit these monitoring activities?

27. Considerations: Considering the current situation in Moldova, what is working well, and what needs improvement? Are the recommendations realistic: are they conceptual, or are they actually likely to happen without stressing the system? If the information is collected as recommended, will it all actually be used to improve the program?

28. Thank you

29. Quality Assurance: Technical Details * Feeder/dosifier calibration Feed rate calculations Process controls –Check weighing, standards and sampling schedule –Salt iodine qualitative spot testing (using salt test kit) Record keeping Laboratory analysis –Quantitative test for iodine by titration *adapted from Quentin Johnson, MI

30. Quality Assurance: Premix Requirements * Specifications –Ingredients: Purity by government and international standards –Type of iodine (potassium iodate, potassium iodide) Dosage levels Storage conditions for premix: Cool, dry Stock rotation using FIFO (first in, first out) Certificate of Analysis (provided by supplier) *adapted from Quentin Johnson, MI

31. Quality Assurance Premix Control Records * TO VERIFY THAT PREMIX IS BEING ADDED AT CORRECT LEVELS USING INVENTORY CONTROL SYSTEM. *adapted from Quentin Johnson, MI

32. SAMPLING NUMBER FOR INSPECTION * (Codex Alimentarius, volume 13) Example, bag weight larger than 4.5 kg (10 pounds) *adapted from Omar Dary, MOST