QA for LN Procurement by UNICEF Supply

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UNICEF Supply Division
Copenhagen
QA for LN Procurement
by UNICEF
Supply Division
Jolanta Wozniak
Quality Assurance Centre
Agenda
The UNICEF Supply Division Model
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UNICEF QA Introduction
Inspections
Regulatory Framework
UNICEF Quality Assurance of LN / different
aspects
• Inspection Guidelines
• Questions
QAC ORGANISATION CHART
Admin Assistant
Centre Chief
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
The Supply Chain
Where QA
Inspections fit In
Definition of Needs
Budgeting and Planning
Sample
Evaluation
Procurement
Delivery and Clearance
Factory/
Supplier
Inspection
PDI
Inspection
Warehousing
Distribution and Re
Order
Utilisation by Beneficiary
Fit for
Purpose
Monitoring and
Evaluation
Goods
Receipt
and QC
Supplier
Evaluation
Inspections
• Factory / Supplier Inspection
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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)
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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)
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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?
Thank You
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