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

Qualification: a risk based approach / Swisstransfusion / Lucerne / 29.08.2014 2


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



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



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)



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



Example 1 Example 2



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:



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



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



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



Design qualification

DQ

During the DQ the compliance of design with your specifications and GMP is demonstrated

and documented.


• Floor plan with details

• Offers from builders with indications for

the materials planned to be used,

installations, alarms

• Technical documentation (wiring, P&ID

Schema)



Installation qualification

IQ

During the IQ the verification of the correct installation is performed


• 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

http://www.google.ch/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=vz1BgqPTu6XnyM&tbnid=WZHioW3rC7LcaM:&ved=0CAUQjRw&url=http://inordnungblog.blogspot.com/2013_12_01_archive.html&ei=RJrkU_qCDMjDPJ3BgPgP&bvm=bv.72676100,d.bGQ&psig=AFQjCNHTbDybscuZcnCqm5Mz6myIa2bYbQ&ust=1407576950650112



Operational qualification

OQ

During the OQ the verification of the correct function is performed


• 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

http://www.google.ch/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=GRNupGJIGxwP4M&tbnid=BTEmQ8osWliyBM:&ved=0CAUQjRw&url=http://www.wand-und-beet.de/wohnen/einrichten/wohnzimmer/billy-oder-ivar-welcher-ikea-regal-typ-sind-sie&ei=F5zkU8WAE4eYO4PXgOAJ&bvm=bv.72676100,d.bGQ&psig=AFQjCNEaRQwh8Fc5YICi8fYKQpRH2Lcd4A&ust=1407577467874706



Performance qualification

PQ

During the PQ the verification of the correct function during routine conditions is

performed.


• Temperature monitoring during one

week under real conditions

• Alarm monitoring: False alarms?

Wohnst Du noch oder lebst du schon?



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)



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

Qualification: a risk based approach - Swisstransfusion · 2014-10-20 · Qualification: a risk...

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