Monitoring the Product

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:

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:

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:

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. Wholesale and Retail Monitoring* • “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

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 AssurancePremix 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