UNICEF Supply Division Copenhagen QA for LN Procurement by UNICEF Supply Division Jolanta Wozniak Quality Assurance Centre
Agenda The UNICEF Supply Division Model UNICEF QA Introduction Inspections Regulatory Framework UNICEF Quality Assurance of LN / different aspects Inspection Guidelines Questions
QAC ORGANISATION CHART Centre Chief Admin Assistant Quality Inspection Unit Pharma Quality Inspection Unit Non-Pharma S. Turner Supplier Evaluation Unit Quality Management Unit
Inspections Factory / Supplier Inspection Goods Receipt Pre Delivery Inspection (PDI) Post Delivery Inspection (Goods Receipt) Bid Sample Evaluation
Definition of Needs Budgeting and Planning Sample Evaluation The Supply Chain Where QA Inspections fit In Procurement Delivery and Clearance Inspection Factory/ Supplier Inspection PDI Goods Receipt and QC Supplier Evaluation Warehousing Distribution and Re Order Utilisation by Beneficiary Fit for Purpose Monitoring and Evaluation
Inspections Factory / Supplier Inspection Assurance that QMS system is in place (if applicable) Assurance QMS is Working Provide Advice and Guidance on Quality Assurance Reduces Risk to SD Business Units New standard approach using weighted scoring to ensure consistency between inspections Goods Receipt conducted at receiving warehouse or destination
Inspections Pre Delivery Inspection (PDI) Managed by the QIU Normally conducted by Third Party Agents (4 LTA s in place) Effective to remedy any identified problems at this time Supervision of loading Can be done together with PDI Post Delivery Inspection (Goods Receipt) Normally done at SD warehouse Sample Check on 100% incoming stock Can Result in 100% Rejection of Consignment by UNICEF based on inspection agency report It is important to understand that passing a PDI does not absolve suppliers from their contractual liability if product quality is found to be not acceptable under designed use.
Inspections Bid Sample Evaluation Conducted in house to ensure that technically compliant bids meet all the detailed specifications Four aspects to be considered: Conformity to specification Quality and workmanship of product Durability and functionality of product Compatibility of product (when it is a set of parts, items..)
Regulatory Framework UNICEF sources bids only from suppliers of products that are WHOPES Recommended. The products require to be registered with the appropriate legal bodies in the receiving country. It is the Suppliers responsibility to complete the in country Registration Process. Registration status is reviewed during the UNICEF bid evaluation process. The current list of approved insecticide products is available on the WHO website http://www.who.int/whopes/en/.
Quality Assurance of LN PDI conducted at manufacturing site on 100% of orders Physical inspection of sample (sample size determined by ISO 2859) Samples sent to lab for mechanical and chemical test (PSB Singapore, TUV owned, WHO prequalified ) Items released immediately by UNICEF QA if physical inspection passes to prevent bottleneck Lab test results received 10 days later All issues, if any, communicated to supplier to promote continual improvement process
Quality Assurance of LN A few statistics 2011 81 PDIs, inspected 13.5 Million nets (33.3 Million in 2009) Inspection Cost - $80K Laboratory tests - 81 Lab Testing Cost - $45K 2012 (to date) 71 PDIs, inspected approx. 12 Million nets Inspection Cost - $30K Laboratory tests - 71 Lab Testing Cost - $33K
Quality Assurance of LN New and improved Inspection Guidelines have been created in partnership with industry and inspection agency input. Used to ensure all inspection agencies have a standard approach to defect classification Small scale trial has been successful, the document will be launched and used in every UNICEF PDI from today. PSI and the GF (amongst others) looking at adopting the guidelines and use this as good practice. This provides industry with a common approach from all major LN procurers to inspection Cuts costs and inspection time
Quality Assurance of LN UNICEF use ISO 2859 as guidance in setting Inspection sample sizes The level of inspection The Acceptable Quality Levels (AQL) 4.0 and 6.5 for major and minor defects respectively. This is a change from our previous inspection AQL of 1.0 and 2.5 and was done after consultation with industry and research of the textile industry in general We are considering making ISO 2859 contractual
Quality Assurance of LN We encourage suppliers of nets to implement QMS (Quality Management System) compliant to ISO 9001 standard as well as to implement other tools (e.g. six sigma). It is to ensure in addition to WHOPES prequalification for product, a consistent quality of product.. at the end of manufacturing line!
Quality Assurance of LN We encourage suppliers to implement systems which will help to utilize/ reuse rejected products
Quality Assurance of LN F4P we have established F4P strategy / guideline to be implemented soon - promotes systematic approach to F4P studies, - promotes importance of implementation of results of F4P studies Current Focus.How to get involved third parties? LTAs
Quality Assurance of LN Complaints handling process - to systematically deal with problems we apply problem solving techniques - Problem definition, - Root cause analysis, - Root cause statement, CAPA (Corrective Action Preventive Action ) process - to address problems via CAs and PAs - We apply CA to avoid problem reoccurrence, - We apply PA to avoid problem occurrence.
Questions?
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