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