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Technical Acceptance, QIU role and Complaints handling
Safe Injection EquipmentIndustry Consultation21st – 22nd April 2015
Stuart Turner, Quality Inspection Unit (QIU)
Discussion topics
• QAC Function
• Overall Technical Acceptance
• Safety Boxes
• SD Complaints
• Documentation Requirements
QAC Function
• The Quality Assurance Centre is a support
function to all UNICEF Procurement Teams
and Field Offices.
• We have separate reporting lines to ensure
Segregation of Duties.
• Consists of 4 Units
– Quality Inspection Unit (Pharma)
– Quality Inspection Unit
– Supplier Evaluation Unit
– Quality Management Unit
Three stages to technical acceptance
• Stage 1
– Technical review of tender technical documentation
• Review tender documents to determine if
product complies to specifications
• Stage 2
– QA evaluation of submitted samples
• Stage 3
– On Site Assessment of Quality Management
System (optional)
• Note – Commercial/Financial acceptance is a separate activity
Stage 1 – Technical Review
• Stage 1– Technical review of tender technical documentation
– will be discussed in detail in the next presentation
• Stage 2– QA evaluation of submitted samples
• Stage 3– On Site Assessment of Quality Management
System (optional)
Stage 2 – QA Review
• Stage 1
– Technical review of tender technical documentation
• Stage 2
– QA evaluation of submitted samples
• Stage 3
– On Site Assessment of Quality Management
System (optional)
Stage 2 – QA Review
• Submitted samples may be reviewed against the
following;
– Packaging
– Labeling
– I.F.U
– Functionality
• ‘Representative’ testing of
– Dead Space – Calculation, Calibrated Precision Scales.
– Cleanliness – Microscopy
– Needle – Microscopy
– AD Operation – Tensile Testing, programmed with ISO tests, calibrated
– Relevant ISO Standards (ISO 7864, ISO 7886 series),
WHO-PQS, etc.
Stage 2 – QA Review
• Any issues identified will be notified to
suppliers
• Dialogue will ensue between QA, Technical
and Suppliers, at the appropriate time.
• Independent third party testing to resolve any
conflicts…
Stage 3 – Manufacturing Site Visits
• Stage 1
– Technical review of tender technical documentation
• Stage 2
– QA evaluation of submitted samples
• Stage 3
– On Site Assessment of Quality Management
System.
Stage 3 – Manufacturing Site Visits
• QA Assessment of suppliers QMS (ISO 13485)
– Assess the quality management system under
which the relevant UNICEF products are
manufactured
– Focus on the manufacturing control aspects
– Visit Priorities
• 2016/17 LTA holders
• Technically Compliant Devices from RFP
• All other ad hoc requests from Technical Team
Safety Boxes
• Samples tested against WHO – PQS
standards…
– Discretion in certain areas
• UNICEF have started to look at the testing
methods in ISO 23907:2012 for the future.
• Working closely with WHO to develop future
testing methods
Complaints
• UNICEF operates an ISO 9001 compliant QMS.
• Complaints…– Database to manage the documented process
– Root Cause
– CAPA
– Review
• In Summary for last 3 years– 2012 – 7 Complaints
– 2013 – 4 Complaints
– 2014 – 4 Complaints
Documentation
• New Import/Export requirements in many countries for documentation.
• We will now request the following with each order, in addition to all normal shipping papers…
– Certificates of Origin
– Certificates of Sterility
• Electronic format – email address will be advised in PO