Qualification Number: R685 04 Qualification Specification ...
Qualification: a risk based approach - Swisstransfusion · 2014-10-20 · Qualification: a risk...
Transcript of Qualification: a risk based approach - Swisstransfusion · 2014-10-20 · Qualification: a risk...
Swisstransfusion / 29.08.2014 / Lucerne Dr. Oliver Kürsteiner Locher Head of Qualitymanagement / Qualified Person (FvP) Blutspendedienst SRK Bern AG
Qualification: a risk based approach
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Qualification: a risk based approach
Qualification:
- For the inspector?
- For the Quality Manager?
- For the patient?
Qualification is not for the Inspector or the Quality Manager*
it is
FOR SAFETY REASONS (PATIENT & DONOR )
*C. Schärer, Swissmedic, ISBT Amsterdam 2013
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Qualification: a risk based approach
Process
Production
Transport
Disinfection
Assays
Serological assays
Molecular Biological assays
Quality control assays
Computer Systems
Software
Hardware
Fixes, Updates
Equipment / Infrastructure
Premises
Equipment
Systems
Validation policy
Process validation
Method validation
Computer system validation Qualification
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Qualification: a risk based approach
Regulations:
EU-GMP Guide
Critical steps of manufacturing processes and significant changes to the processes are validated.
(e.g. Annex 15: Qualification and Validation in revision)
PICS/S for Blood establishments
Equipment for collection, preparation and storage of blood and blood components should be dedicated to its use. New and repaired equipment should meet qualification requirements when installed and authorised before use. Qualification results should be documented.
Guide to the preparation, use and quality assurance of blood components, 17th edition
All validated processes must use qualified equipment. Qualification results must be documented.
Facilities and equipment need to be qualified prior to implementation. Systems, processes and tests all need to be validated.
Blutspende SRK Schweiz
Jeder Arbeitsablauf, jedes automatisierte System (einschliesslich Messgeräte und Informatiksysteme), Verbrauchsmaterial und kritische Methode muss vor der Inbetriebnahme nach einem vordefiniertenAblauf validiert werden
(Kapitel 13, in revision)
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Qualification: a risk based approach
General procedure:
ReQ PQ OQ IQ DQ RA URS
Definitions:
URS: User requirements specification
RA: Risk assessment
DQ: Design qualification
IQ: Installation qualification
OQ: Operational qualification
PQ: Performance qualification
ReQ: Re-Qualification
Formal documentation
URS: separate document
RA: risk assessment has to be documented
DQ, IQ, OQ, PQ:
• Plan: Definition of acceptance criteria's, test procedures
• Records: raw data
• Report: Evaluation whether criteria's are met, deviations,
changes to the test plan
• All documents have to be approved by QM
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Qualification: a risk based approach
Example 1 Example 2
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Qualification: a risk based approach
URS (User Requirement Specification) / Lastenheft
URS
The URS defines the specifications for your equipment /premises. The URS is your
reference document throughout the qualification life cycle.
Example 1: Example 2:
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Qualification: a risk based approach
URS - Examples
Example 1: Book shelf Example 2: Cold room
Cheap Cleaning with disinfection agent
Colour: White Surface: stainless steel
500 books, 75 DVDs, 15 binders Dimensions (500 blood bags , 5 shelfs)
length 60 cm, height 202 cm, width 28 cm Temperature: 2-6°C, empty and fully loaded
child safe Alarm management: doors, acoustic, visual, monitoring)
FSC-wood Calibrated sensors
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Qualification: a risk based approach
Risk assessment
RA
The risk assessment helps to define the critical elements of your equipment and to
establish the qualification parameters. The risk assessment defines the content of the
qualification.
Possible general risk bases approach:
• Each equipment is categorised with predefined qualification parameters
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Qualification: a risk based approach
Category Definition Examples Qualification approach
A
Simple Equipment No measurements possible, no sensor (no calibration possible) not used to control production / testing
Vortex (sample mixer) No qualification, but: • Log file • Equipment
documentation
B
Standard serial-equipment out-of-the-shelf indirectly used to control production / testing
Water bath, fridge, freezer • DQ • IQ (condensed) • OQ • (PQ)
C1
Complex serial-equipment out-of-the-shelf maybe used to control production / testing
Complex analytical systems, separators, apherese systems
• DQ • IQ (adjusted) • OQ • PQ
C2
Customised equipment Only made for you maybe used to control production / testing
Cold room, special analytical equipment
• DQ • IQ (comprehensive) • OQ • PQ
D
Not GMP relevant Fire alarm management
No qualification, but: • Log file • Equipment
documentation
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Qualification: a risk based approach
Design qualification
DQ
During the DQ the compliance of design with your specifications and GMP is demonstrated
and documented.
Example 1: Example 2:
• Floor plan with details
• Offers from builders with indications for
the materials planned to be used,
installations, alarms
• Technical documentation (wiring, P&ID
Schema)
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Qualification: a risk based approach
Installation qualification
IQ
During the IQ the verification of the correct installation is performed
Example 1: Example 2:
• Verification of construction (no damages, correct materials used, doors are tight, …)
• Temperature- and alarm-monitoring correctly installed
• Operating and working instructions are available
• Calibration of sensors
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Qualification: a risk based approach
Operational qualification
OQ
During the OQ the verification of the correct function is performed
Example 1: Example 2:
• Equipment file and SOP is available including cleaning procedures
• Temperature monitoring: empty, loaded (with monitoring including hot spots, cold spots)
• Alarm system testing
• Open door tests
• Shortage of power
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Qualification: a risk based approach
Performance qualification
PQ
During the PQ the verification of the correct function during routine conditions is
performed.
Example 1: Example 2:
• Temperature monitoring during one
week under real conditions
• Alarm monitoring: False alarms?
Wohnst Du noch oder lebst du schon?
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Qualification: a risk based approach
SUMMARY
Qualification of equipment in blood establishments should be seen as an excellent tool
to gain confidence in your equipment and procedures rather than a burden.
A risk based approach can standardise and minimise your qualification work to a useful and reliable extend
Qualification is not for the Inspector or the Quality Manager
it is
FOR SAFETY REASONS (PATIENTS / DONORS)
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Qualification: a risk based approach
Thanks to,
Arbeitsgruppe QM Blutspende SRK Schweiz
• Annette Koller, Blutspende SRK Schweiz
• Dominique Schenk, Blutspende SRK Schweiz
• Dominique Böhme, Blutspende SRK Ostschweiz
• Andreas Glauser, Blutspende Zürich
• Marianne Senn, Regionaler Blutspendedienst Aarau-Solothurn
• Ruth Seidlitz, Regionaler Blutspendedienst SRK Graubünden
• Irené Wäspe, Blutspendedienst Zentralschweiz SRK
Working Group Blood Quality Management EDQM • Marie-Laure Hecquet, EDQM Strasbourg, France
• Alex Aquilina, NBTC Malta, Malta
• Alina Mirella-Dobrota, Regional Blood Transfusion Centre Constanta, Romania
• Beate Rothe, Robert-Bosch Krankenhaus Stuttgart, Germany
• Martin Pisacka, UHKT Prague, Czech Rebublic
• Mariëlle van Roosmalen, Sanquin Nijmegen, The Netherlands