CORBEL BBMRI-ERIC QM webinar slides

BBMRI-ERIC Quality Management Services for
basic and applied research on human specimens
Presenters: Andrea Wutte (BBMRI-ERIC)
Host:Vera Matser (EMBL-EBI)
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CORBEL Webinar Series

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AUDIENCE Q&A SESSION
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BACKGROUND
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Since 2015, thirteen ESFRI Research Infrastructures from the field
of BioMedical Science (BMS RI) joined their scientific capabilities
and services to transform the understanding of biological
mechanisms and accelerate its translation into medical care.
• biobanking & biomolecular
resources
• curated databases
• marine model organisms
• systems biology
• translational research
• functional genomics
• screening & medicinal
chemistry
• microorganisms
• clinical trials
• structural biology
• biological/medical imaging• plant phenotyping
• highly pathogenic
microorganisms

CORBEL MISSION
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Modern biological and biomedical research involves complex
projects and a variety of different technologies.
Some of the most important discoveries are made at the
interface between different disciplines.
CORBEL will harmonise access and services for complex
research projects involving more than one RI that offer:
• biological and medical technologies
• biological samples and
• data services

TODAY’S PRESENTER
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AndreaWutte has been leading the BBMRI-ERICQuality
Management Service since 2014.The service includes
Quality Management consultancy programmes for
biobank relevant standards and guidelines, monitoring
and audit programmes, training and education formats,
assessments and the initiation of improvement strategies,
respectively actions and accompanying measures. Andrea
holds a European Quality Manager and Lead Auditor EOQ
personnel certificate.
She acts as BBMRI-ERIC LiaisonOfficer to ISO/TC 276 Biotechnology and
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems and
CEN/TS 140 In vitro diagnostic medical devices. Andrea is a Biologist by
training.

BBMRI-ERIC QUALITY MANAGEMENT SERVICES FOR BASIC AND
APPLIED RESEARCH ON HUMAN SPECIMENS
ANDREA WUTTE
HEAD OF BBMRI-ERIC QM SERVICES
AW, December 06, 2018 CORBEL webinar 1

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WE ARE
Austria
Bulgaria
Belgium
Czech Republic
Estonia
Finland
France
Germany
Greece
Italy
Latvia
Malta
Netherlands
Norway
Poland
Sweden
United Kingdom
MEMBERS Switzerland
Cyprus
Turkey
IARC
OBSERVERS
AW, December 06, 2018 CORBEL webinar

THE WORLD‘S BIGGEST
BIOBANK DIRECTORY

WHAT WE
OFFER
WITH ETHICAL,
LEGAL AND SOCIETAL
ISSUES
SUPPORT
AND EXPERTISE
IT TOOLS
MANAGEMENT
SERVICES
QUALITY
4AW, December 06, 2018 CORBEL webinar

QUALITY
MANAGEMENT SERVICE
“If we want researchers to be able to
produce reliable findings, we need to
make sure that they have access to
samples and data of appropriate
defined quality.
As a European research
infrastructure, our ultimate goal is to
make samples comparable across
different countries and different
biobanking systems”

BIOBANKS IN PERSONALIZED MEDICINE
WORKFLOW
BIOBANK
QA/QC

PARTNER CHARTER
QM
All Partners should commit themselves to
implement quality management (QA / QC)
procedures compliant with applicable
European and International standards
OECD Best Practice Guidelines for Global
Biological Resource Centres Networks
WHO/IARC Guidelines Common Minimum
Technical Standards and Protocols for
Biobanks dedicated to Cancer Research
SOPs should be established and made publicly
available for all processes related to sample
collection, processing, storage, retrieval and
dispatch.

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BBMRI.QM NET
Finland 11
Poland 4
Estonia 2
Austria 15
Czech Republic 2
Italy 9
Greece
Turkey 5
Sweden 4
Norway 8
Germany 13
United Kingdom 7
Netherlands 1
Belgium 11
France 6
Switzerland 2
Malta 6
IARC 1
Cyprus
Latvia 2
Bulgaria
bbmri-eric.eu/national-nodes/
109 Participants status 05.2018

BBMRI-ERIC QUALITY MANAGEMENT SERVICES
International standards (ISO
9001, ISO 20387, ISO 15189,
CEN Technical Specifications,
etc.)
Quality management in EU
funded projects
Quality management in national
and international research
projects
❖ Webinars, counseling
International biobanking
standards, Technical
Specifications
General quality management
systems
Integrated management systems
Interface management systems
❖ Online training (Members)
❖ Inhouse training, Workshops
❖ Summerschools, Master courses
FOR BASIC AND APPLIED RESEARCH
BBMRI-ERIC Self-
Assessment Survey for
biobanks / researchers
BBMRI-ERIC internal Audit
KNOWLEDGE HUB TRAINING & SUPPORT AUDITING

BBMRI.QM IN EU FUNDED PROJECTS
SPIDIA for Personalized Medicine –
Standardisation of generic Pre-analytical
procedures for Invitro DIAgnostics for
Personalized Medicine, SPIDIA4P
❖ Topic: SC1-HCO-02-2016
❖ Grant agreement: 733112
❖ Duration: 48 Month (2017-2021)
❖ Benefit/tasks for BBMRI-
ERIC: standards to biobanks and
reference centres, education and training
programmes, industry-academia
stakeholder workshop
EXAMPLES
SEE MORE http://www.bbmri-eric.eu/scientific-collaboration/

LIAISON TO ISO TECHNICAL COMMITTEES
ISO/TC 276
“Biotechnology”
--
ISO/TC 212
“Clinical laboratory
testing and in vitro
diagnostic test
systems”
--
CEN/TC 140
“In vitro diagnostic
medical devices -
European committees”
ISO A GLOBAL NETWORK OF NATIONAL STANDARDS BODIES (160 MEMBERS)
Reference: www.iso.org
June 22, 2018 Medical Science Summer School, Groningen 11AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria

ISO STANDARD FOR BIOBANKING
ISO 20387:2018
A working Group within the ISO/TC 276 Biotechnology
was established in December 2013
30 participating Member countries
14 Observer countries
7 Liaison organizations including BBMRI-ERIC
More than 150 experts contributed to the development of:
ISO 20387:2018 (E)
Biotechnology -- Biobanking -- General requirements for
biobanking

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WHERE TO GET THE STANDARD?
HTTPS://WWW.ISO.ORG/OBP/UI/#ISO:STD:ISO:20387:ED-1:V1:EN
Reference: www.iso.orgAW, December 06, 2018 CORBEL webinar

ISO 20387:2018
TABLE OF CONTENT
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Structural requirements
6 Resource requirements
7 Process requirements
8 Quality management system requirements
Annex A (normative) Documentation requirements
Annex B (informative) Implementation guidance for Annex A
Annex C (informative) Quality management system options
Bibliography
Reference: www.iso.org14AW, December 06, 2018 CORBEL webinar

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ISO 20387:2018
3 Terms and definitions
Examples:::
3.5 biobank
Legal entity or part of a legal entity that performs biobanking(3.6)
3.6 biobanking
Process of acquisition(3.2) and storing, together with some or all of the activities related to collection,
preparation,preservation,testing, analyzingand distributingdefined biologicalmaterialas well as related
information and data
3.7 biological material
Any substance derived or part obtainedfrom an organic entity such as a human, animal, plant,
microorganism(s) or multicellularorganism(s) that is (are) neither animalnor plant(e.g. brown seaweed, fungi)
Reference: www.iso.orgAW, December 06, 2018 CORBEL webinar

ISO 20387:2018
SCOPE
This document specifies general requirements including quality control requirements
for the competence, impartiality and consistent operation of biobanks to ensure
biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking activities,
including biobanking of human, animal, plant and microorganism resources for
research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies, and others can also use this document in confirming
or recognizing the competence of biobanks.

ISO 20387:2018
SCOPE
This document does not apply to biological material intended for food production or
therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply
to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used solely for diagnostic
and treatment purposes ISO 15189 and other clinical standards apply first and
foremost.

ISO 20387:2018
TABLE OF CONTENT
4 General requirements
4.1 General
4.2 Impartiality
4.3 Confidentiality
5 Structural requirements
6 Resource requirements
6.1 General
6.2 Personnel
6.2.1 General
6.2.2 Competence and competence assessment
6.2.3 Training
6.3 Facilities/dedicated areas and environmental conditions
6.4 Externally provided processes, products and services
6.5 Equipment

ISO 20387:2018
TABLE OF CONTENT
7.1 General
7.2 Collection of biological material and associated data
7.2.1 Documented information requirements
7.2.2 Pre-acquisition information
7.2.3 Collection procedure 🔎🔎 CEN/TS, ISO/TS pre-examination processes
7.3 Reception and distribution of biological material and associated data
7.3.1 Access principles
7.3.2 Reception
7.3.3 Distribution
7.4 Transport of biological material and associated data

ISO 20387:2018
TABLE OF CONTENT
7.5 Traceability of biological material and associated data
7.6 Preparation and preservation of biological material
7.7 Storage of biological material
7.8 Quality control of biological material and associated data
7.8.1 General
7.8.2 Quality control of processes
7.8.3 Quality control of data
7.9 Validation and verification of method
7.9.1 General
7.9.2 Validation
7.9.3 Verification
7.10 Management of information and data

ISO 20387:2018
TABLE OF CONTENT
7.11 Nonconforming output
7.11.1 General
7.11.2 Control of nonconforming output
7.12 Report requirements
7.12.1 General
7.12.2 Content of the report
7.13 Complaints

ISO 20387:2018
TABLE OF CONTENT
8 Quality management system requirements
8.1 Options
8.1.1 General
8.1.2 Option A
8.1.3 Option B
8.2 Documented information for the quality management system (Option A)
8.3 Control of quality management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective action for nonconforming output (Option A)
8.8 Internal audits (Option A)
8.9 Quality management reviews (Option A)
22AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria

ISO 20387:2018
TABLE OF CONTENT
7.1 General
7.2 Collection of biological material and associated data
7.2.1 Documented information requirements
7.2.2 Pre-acquisition information
7.2.3 Collection procedure 🔎🔎 CEN/TS, ISO/TS pre-examination
processes

May 24, 2018 MC&AoM meeting, Bologna 24
PRE-ANALYTICAL ERRORS
“Pre-analyticalerrors still accountfor nearly 60% - 70% of all problems occurring in laboratorydiagnostics,
most of them attributableto mishandlingprocedures during collection,handling,preparing or storing the
specimens”.
Lippi G. et al. Pre-analytical quality improvement:from dream to reality. Clin Chem Lab Med. 2011 Jul; 49(7):1113-26.

QUALITY OF SPECIMENS
PUBLISHED COMPLAINTS
Lippi G. et al. Preanalytical quality improvement: from dream to reality
Clin Chem Lab Med. 2011 Jul; 49(7):1113-26.).
Stephen A Bustin. The reproducibility of biomedical research: sleepers
awake! Biomolecular Detection and Quantification 2014, pp. 35-42
Freedman LP et al. The Economics of Reproducibility in Preclinical
Research. Plos Biol. 2015 Jun 9;13(6):e1002165.

CEN TECHNICAL SPECIFICATIONS (CEN/TS)
PRE-EXAMINATION PROCESSES / SAMPLE HANDLING PROCEDURES
CEN/TS 16826-1, snap frozen tissue – Part 1: Isolated RNA
CEN/TS 16826-2, snap frozen tissue – Part 2: Isolated proteins
CEN/TS 16827-1, FFPE tissue – Part 1: Isolated RNA
CEN/TS 16827-2, FFPE tissue – Part 2: Isolated proteins
CEN/TS 16827-3, FFPE tissue – Part 3: Isolated DNA
CEN/TS 16835-1, venous whole blood – Part 1: Isolated cellular RNA
CEN/TS 16835-2, venous whole blood – Part 2: Isolated genomic DNA
CEN/TS 16835-3, venous whole blood – Part 3: Isolated circ. cell-free DNA from plasma
CEN/TS 16945 metabolomics in urine, serum and plasma
cen.eu or bbmri-eric.eu

NEW CEN/TS AND ISO STANDARDS
IN THE PIPELINE UNTIL 2020
4 CEN/TS for venous whole blood circulating Tumor and Organ Cells (DNA, RNA, Proteins,
staining procedures)
1 CEN/TS for Venous Whole Blood Exosomes / cell-free circulating RNA
1 CEN/TS for Saliva (DNA)
1 CEN/TS for Frozen Tissues (DNA)
1 CEN/TS for Urine and other body fluids (cell-free DNA)
3 CEN/TS for Fine Needle Aspirates (RNA, DNA, Proteins)
1 CEN/TS for Saliva and Stool Microbiomes (DNA)
1 CEN/TS for FFPE Tissues (in-situ staining procedures)
H2020 ProjectSPIDIA4P,GANo. 733112

CEN/TS
“This Technical Specification gives recommendations for the
handling, documentation and processing of xxx specimens
intended for xxx analysis during the pre-analytical phase
before a molecular assay is performed. This Technical
Specification is applicable to molecular in vitro diagnostic
examinations (e.g., in vitro diagnostic laboratories,
laboratory customers, developers and manufacturers of in
vitro diagnostics, institutions and commercial organizations
performing biomedical research, biobanks, and regulatory
authorities)“ Reference CEN/TS page 5, cen.eu
SCOPE

CEN/TS
GENERAL CONTENTS
Scope, Normative reference, Terms and definitions
Outside the laboratory
− Primary specimen collection manual, sample donor, sample
processing, transport,
Inside the laboratory
− Sample reception, fixation, evaluation of the pathology, post
fixation, processing of embedding, aliquoting, storage, isolation
processes (RNA, DNA, Proteins..), using commercial kits,
laboratories’ own protocols, Quantity and quality assessment,
storage of isolated RNA, DNA, ccfDNA, Proteins..
Quality control of RNA, DNA, Proteins…, impact of preanalytical
workflow steps on specimen quality, time dependencies of
analyte integrity

INTEGRATED MANAGEMENT
SYSTEMS (IMS)
QUALITY MANAGEMENT
SYSTEMS -
REQUIREMENTS
ISO 9001:2015
COMBINES MULTIPLE
MANAGEMENT SYSTEM
STANDARDS
IMS
GENERAL
REQUIREMENTS FOR
BIOBANKING
ISO 20387:2018
ISO 15189:2015
MEDICAL
LABORATORIES
REQUIREMENTS FOR
QUALITY AND
COMPETENCE
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INCREASING THE VISIBILITY
OF BIOBANKS AND SAMPLE COLLECTIONS

CEN/TS TO SELF-ASSESSMENT
BBMRI-ERIC SELF-ASSESSMENT SURVEYS (IT-BASED)
IT-based SAS

ACCESS TO BBMRI-SAS
WEBSITE
www.bbmri-eric.eu/services/self-assessment-survey/

ASSESSMENT PROCESS
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ACCESS
COMPLETE
SURVEY(S)
REMOTE AUDIT
REPORT
SELF-
ASSESSMENT
granted by
BBMRI-ERIC BBMRI-ERIC
DIRECTORY
✓

REMOTE AUDIT
independent evaluation based on self-
assessment
remote audit in cooperaton with trained
auditor (e.g. TelCo, SkypeConf, etc.)
triggered by SAS survey → report sent to
BBMRI-ERIC
support quality improvement by external
expertise
for biobankers and researchers
− with and without ISO certification

BBMRI-SAS TO DIRECTORY

BBMRI-ERIC QUALITY MANAGEMENT SERVICES
Principles of auditing
Managing the audit
Performing an audit
Competence and evaluation of
BBMRI auditors
FOR BASIC AND APPLIED RESEARCH
AUDITING
SERVICE 2019

CONTACT
KNOWLEDGE HUB TRAINING & SUPPORT AUDITING
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Co-funded within ADOPT BBMRI-ERIC, a project that has received funding from the
European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550.
Co-funded within SPIDIA4P, a project that has received funding from the
European Union’s Horizon 2020 research and innovation programme under grant agreement No 733112.
Andrea Wutte – andrea.wutte@bbmri-eric.eu
http://www.bbmri-eric.eu/services/quality-management/

Questions?
BBMRI-ERIC Quality Management Services for basic
and applied research on human specimens
AndreaWutte (BBMRI-ERIC)

MERRY CHRISTMAS
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We will be going on a winter break, the CORBEL webinar series
will resume in January 2019
Registration and details
http://www.corbel-project.eu/webinars

CORBEL BBMRI-ERIC QM webinar slides

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