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OBJECTIVEOBJECTIVE
Definition of QAOverview of QA methodology &
procedures required to deliver quality Focus on QA w.r.t salt iodization
QA is a wide-ranging concept which covers QA is a wide-ranging concept which covers all matters which individually or all matters which individually or
collectively influence the quality of a collectively influence the quality of a product. It applies to equipment, product product. It applies to equipment, product
design, supplies and logistics, management design, supplies and logistics, management and human resource development, and all and human resource development, and all elements designed to ensure that products elements designed to ensure that products
are of the quality required for their intended are of the quality required for their intended use. use.
TOPICS TO BE COVERED TOPICS TO BE COVERED Dispersion Iodizing plant capability Production lot size & sampling plans Monitoring product quality
– Interpretation of QC results– Criteria for acceptance
Communication & information flow Documentation Customer Service
IODIZING PLANT IODIZING PLANT CAPABILITYCAPABILITY
Validation of Process– Minimum of 5 sample means from repeated tests– Variance < 2%– Relative Standard Deviation < 3%
Range of iodine < mandatory limits
Typical Process Control ChartTypical Process Control Chart
TYPICAL CONTROL CHART
0
10
20
30
40
50
60
70
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Time Intervals hrs
Iodi
ne C
onte
nt p
pm
Upper Control Limit Iodine Level ppmLow er Control Limit Upper Spec. LimitLow er Spec. Limit
PRODUCTION LOT SIZE & PRODUCTION LOT SIZE & SAMPLING PLANSAMPLING PLAN
Suitable for non-homogeneous bulk materialProduction lot size daily output of packed
product– truck size, no. of bags etc.
Minimum of 3 to 5 samples per production lot for analysis of iodine
Erroneous results from 1 sample/batch
MONITORING PRODUCT MONITORING PRODUCT QUALITYQUALITY
Frequency of sampling Handling of composite samplesRecording of samplesAnalysis of samplesAcceptance Criteria - statistical
– U - Ks or L + Ks Acceptance Criteria - range
COMMUNICATION & COMMUNICATION & INFORMATION FLOWINFORMATION FLOW
Short channels - small producersRouting of QC report
– Record corrective action
Use of packaging– Production lot no.– Nominal iodine content
DOCUMENTATIONDOCUMENTATION
Available for reviewRecord of QC data by sample
no./dates/production lotHolding of samplesQC Reports - larger producers
– Indicate acceptance/rejection
CUSTOMER SERVICECUSTOMER SERVICE
Customer confidence builds businessComplaints handling procedure
– Promotes supplier responsibility
Open house relationship
SUMMARY OF QA SUMMARY OF QA PRINCIPLESPRINCIPLES
Set quality standardsValidate Plant Capability & MaintainDelegate responsibility for performanceMeasure output against standardsApply acceptance criteriaDefine corrective action for non-complianceFocus on quality
INCREASING AVAILABILITY INCREASING AVAILABILITY OF IODIZED SALTOF IODIZED SALT
Information required re current status by country– Problem of no or low monitoring– Lack of government resources
Surveys required to determine current status– Contract out if necessary– Example of RSA
Formulate action plan to bring non-iodizing companies