this website is in an early draft stage,
it is being created for the EU-H2020 project Geners Bridge
(this website contains text - if you are not into reading go somewhere else)
“Quality is never an accident. It is always the result of intelligent effort.”
(John Ruskin 1819-1900)
Genetic resources management needs to be done well; once lost, genetic diversity is lost forever. Also, we depend on collaboration since no one country can do it alone. But to collaborate we need to be able to depend on each other; depend on the quality of the others’ work. Proper quality management allows us to do this.
Quality Management (QM) aims at ensuring that the quality of the products or services is consistent and complies with the set standards. To achieve this, generally four main components are considered: quality planning, quality assurance, quality control and quality improvement.
The procedures used by the organisation are described and documents showing that these procedures were actually followed are created. To assure that this is all properly done, usually an external auditor regularly checks the documents, and discusses them with the organisation. Quality improvement is usually based on feedback from people involved in the organisation or its ‘customers’. Properly collecting and processing this feedback is therefor often a part of quality management systems.
Methodology of quality management has been formalised in various domain specific systems, many of them also allowing certification. This certification proofs that the organisation (or at least the certified part of it) complies with the system. An overview of the systems relevant to genetic resources management is presented below.
Furthermore, to support collaboration it is helpful to adopt the same norms, use the same standards for the operations. As the different genetic resources domains (plant, animal and forest) have their own approaches and procedures, per domain, an overview will be created of the existing standards and quality management systems. Also an – per definition incomplete - overview of experiences of quality management in genetic resources will be presented per domain.
an overview of systems (possibly) relevant for genetic resources management
As the principles of quality management are the same for many organisations, some ‘standard systems’ have been created and published by the International Organisation for Standardization (ISO). These standards are reviewed every five years. The most relevant for genetic resources management are listed, plus some other systems.
“ISO 9001:2015 Quality management systems — Requirements”
This standard system followed the previous ISO 9001:2008 standard and is a generic system for QM. It uses the ‘Plan, Do, Check, Act cycle’ in a process-based approach and in addition encourages risk-based thinking. The purpose is to determine the conformity of the requirements, facilitate effective deployment and improve the quality management system. To quote the ISO website for this standard:
ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
“ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories”
This system is especially suitable for the laboratory component of genebanks (think of in-vitro plant genebanks and cryo preserved sperm). To quote the ISO website for this standard:
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
“ISO 20387:2018 Biotechnology — Biobanking — General requirements for biobanking”
A recent addition to the systems published by ISO relevant to QM in genebanks. Although there is little experience with this system, it seems relatively ‘high tech oriented’ as compared with many genebanks. To quote the ISO website for this standard (and especially the last sentence):
ISO 20387:2018 specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality. It is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms 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. This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
Other Systems
The ISO system provides international standards, but obviously for managing quality one doesn't need an international standard. In France the NF S96-900 standard serves as the system to manage the quality of their biological resources centres or to quote "Système de management d'un centre de ressources biologiques (CRB) et qualité des ressources biologiques".
Also the platform of genebanks in the Consultative Group on International Agricultural Research have adopted their own QMS (see in the section on PGR).
an overview of quality management standards, systems and their adoption in the PGR domain
QM in PGR - Existing standards
“Quality means doing it right when no one is looking. "
(Henry Ford 1863-1947)
Genebank Standards
The PGR community has been working on setting standards for a long time, some of the work was succesful, other less. One of the most successful standards is the Multi Crop Pasport Descriptor list (MCPD), used to exchange data between genebanks and databases such as EURISCO and Genesys. Also in the field of crop specific descriptors various organisations have worked on creating standards, such as ECPGR and Bioversity International and its predesessors. Here, however we'll concentrate on standards for genebank operations.
A good starting point when thinking about genbank operations, although it doesn't (try to) set any standards is 'A guide to effective management of germplasm collections' (Engels and Visser, 2003). It describes the context and operation of a PGR genebank in a structured way.
The first real attempt to set standards was by the FAO in collaboration with IPGRI in 1994. Although some publications had tackled various aspects of PGR management (the first in 1974 proposing standards for longterm seed storage), the booklet 'Genebank Standards' covered in short numbered paragraphs the details of PGR management and defined standards for seed storage and handling. In 2014 a completely revised version appeared. In this 'Genebank Standards for Plant Genetic Resources for Food and Agriculture' the FAO presented in a structured way the underlying principles of PGR conservation, not only for othodox seeds, but also for in vitro collections and field collections.
These 2014 Genebank Standards formed the basis of AQUAS, the QMS that was made for the AEGIS initiative, the European 'virtual genebank' of ECPGR. In this community it was decided that the 2014 Genebank Standards wree too general and needed specification per crop. This resulted in a number of crop specific 'Agreed Standards', defining (of only small) adjustments to the standards proposed by FAO.
Botanical Gardens
The botanical garden community also has created numerous relevant guidlines and standards. The Center for Plant Conservation (CPC) wrote a beautiful "Best Plant Conservation Practices to Support Species Survival in the Wild" with guidlines for 'seed banking'. The European Native Seed Conservation Network (ENSCONET) did something similar with its 'Curation Protocols & Recommendations'. In addition, the Millennium Seed Bank Partnership (MSBP) created a number of valueable documents such as the 'Seed Conservation Standards' and several others, all available on their 'resources'-page. Finally, Botanic Gardens Conservation International (BGCI) has a relevant 'Training and Resources'-page with many additional information sources.
Other Sources of Inspiration
Apart from these genebank or 'seed bank' specific standards, numerous standards can be relevant to plant genetic resources activities. An example is the standards defined by ISTA for germination testing (not freely available). These serve as important inspiration to genebanks, and can, for example, provide instructions on how to recognise a healty seedling. However, no genebank will use the 400 seeds that are required to meet the ISTA standard for germination testing.
QM in PGR - Adoption in the PGR community
Where it comes to PGR genebanks, it can be observed that "we are entering the age of quality management" (as someone put it in a recent meeting). An increasing number of genebanks, headed by the genebanks of the CGIAR, are taking quality seriously and are working on adopting a formal QMS.
Adoption Quality Management Systems
The first PGR genebank to adopt the ISO 9001 quality management system was the Centre for Genetic Resources, The Netherlands (CGN) in 2003, then certified by TÜV now by DNV-GL. By now, also some other genebanks have also adopted the ISO 9001 standard such as, most prominently, the genebank of the Leibniz Institute of Plant Genetics and Crop Plant Research (IPK) in Gatersleben, and some operations of the genebank of the International Maize and Wheat Improvement Center (CIMMYT).
International Potato Center (CIP) has ISO 17025 certification for its in vitro genebank.
Other QMS for Genebanks
The major initiative to develop a genebank specific alternative to the ISO systems is the Genebank Quality Management System as is being developed by, and (initially) for, the CGIAR Genebank Platform. Its basis is a detailed description of Standard Operationg Procedures (SOPs) for the main genebank oprations: acquisition, conservation, regeneration, characterisation and evaluation, distribution, safety duplication, information management and germplasm health. These operations are monitored with a number of performance indicators, and the proper adoption of the SOPs is reviewed by independent reviewers. Combined with appropriate attention for user satisfaction, safety and risks, and the work environement a complete QMS will be created. This system is relatively new and still under development (the first SOP based reviews were done in 2019) but might proof of great value also outside the CGIAR Genebank Platform.
On a lower ambition level, AQUAS was developed, the QMS for the AEGIS initiative, the European 'virtual genebank' of ECPGR. To quote the AQUAS website: The AEGIS Quality System is the set of policies, processes and procedures that are to be followed by all members of AEGIS to assure an appropriate quality of the activities in AEGIS, the virtual European genebank system. It provides participating genebanks with a template to document their operations, resulting in Genebank Manuals, that are published on the ECPGR website. In parallel crop specific operational standards are being produced by the ECPGR Crop Working Groups. The idea is that these two initiatives will be coupled with dedicated capacity building and a monitoring system (performance indicators and reviews), resulting in a non-bureaucratic QMS for European genebanks cooperating in AEGIS.
Within this ECPGR/AEGIS/AQUAS context the idea arose to organise peer reviews for genebanks: genebank experts of a few genebanks (initially three) visiting each other and reviewing each others genebank based on complete transparency and the Genebank Manual, and learning from each others expertise. The resulting report can be used for priority setting and fund raising. A pilot of this type of peer reviews has been organised in 2019 in the framework of Genres Bridge, reports of the pilot and the indivcidual visits were published on the ECPGR website, and the pilot was reported as a news item on the Genres Bridge website. The method of genebank peer rewiews has been picked up, and similar peer reviews will be done, as part of Genres Pridge, in 2020 in the AnGR domain, and more PGR genebank peer reviews will be done in the framework other EU Horizon 2020 projects.
The video below was made for the Crop Trust and describes the principles of the Genebank Quality Management System as it is being developed by the CGIAR Genebank Platform and the workshops that the Crop Trust organises to improve the operational standards in genebanks.
an overview of quality management standards, systems and their adoption in the AnGR domain
QM in AnGR - Existing standards
Genebank Standards
The FAO Guidelines – Cryoconservation of animal genetic resources, published by the FAO in 2012, is the global standard for establishing and implementing a cryopreservation programme for animal genetic resources.
The development and operation of a gene bank for cryoconservation of animal genetic resources requires technical capacity in genetics, reproductive physiology, cryobiology and data management. Coordination among a wide group of stakeholders is also essential. The FAO Guidelines are intended to serve as a decision aid with respect to the various cryoconservation options that are available, and to provide technical guidance on the design and establishment of animal gene banks. The guidelines are written under the assumption that a decision has already been taken that cryoconservation will make a valuable contribution to a programme for conserving the animal genetic resources of interest. The advice provided is intended to be relevant to all species of domestic livestock, but species-specific guidance is given where appropriate. Much of the information may also be relevant to cryoconservation of wild relatives of livestock and to other wildlife species.
Before the global FAO Guidelines were published and endorsed by the global community, a Working Group of the European Regional Focal Point for Animal Genetic Resources (ERFP) already published cryoconservation guidelines in 2003. These ERFP Guidelines were the result of 12 months dedicated, collaborative work of European National Co-ordinators and researchers expert in cryopreservation from 11 European countries. As the FAO’s First Report on the State of the World’s AnGR for Food and Agriculture process gained momentum and countries throughout Europe began to develop new or existing national action plans for the conservation and sustainable use of their breeds of livestock, the question of ex situ conservation of those breeds arose. These ERFP Guidelines became an early relevant reference document for all those considering setting up or renewing gene banks whether policy makers, NGOs, research institutes or private organisations.
More recently, in 2019, the Working Group Ex Situ Conservation and the ABS Task Force of ERFP have been working on the development of Guidelines for the Development of Material Acquisition Agreements (MAA) and Material Transfer Agreements (MTA) for their Genebanks. These guidelines provide a potential set of elements, which could be incorporated in a MAA and/or MTA.
The FAO Guidelines for (ex situ in vitro) cryo-conservation were complemented by the FAO Guidelines on in vivo conservatiion, published by FAO in 2013, one year after the initial guidlines.
QM in AnGR - Adoption in the AnGR community
Within the framework of the EU Horizon 2020 funded IMAGE project a quality management gap analysis was carried out. The general aim of IMAGE is to enhance the use of genetic collections and to upgrade animal gene bank management.
The objectives of the quality management gap analysis were the following: 1) to identify key factors and processes associated with quality assurance in animal gene banking; 2) to develop a tool for gene bank managers to use to self-assess their quality management; and 3) to apply this tool to European animal gene banks to identify current areas of strengths and gaps in quality management. An on-line survey consisting of 54 questions on different aspects of quality management was distributed to gene bank managers.
Approximately 30% of the banks reported having a quality management system, 15 of which involved formal certification. Many other banks have plans to implement formal quality management. A general conclusion from the survey was that more emphasis is placed on procedures related to acquisition and entering the material into the gene banks, and less on distribution of material and utilization. Almost all respondents reported specific standard operating procedures for processing and freezing, while a minority had policies regarding access to their gene bank material..
The results of the quality management gap analysis have been submitted for publication by Zomerdijk et al. (2019) "Quality management practices of gene banks for livestock: a global review."
an overview of quality management standards, systems and their adoption in the FGR domain
QM in FGR - Existing standards
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QM in FGR - Adoption in the FGR community
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Contributors
This site was created and is maintained Theo van Hintum, content and corrections were provided by Janny van Beem Suzanne Sharrock, Hoijka Kraigher, Rachel Davis, Audrey Didier, Imke Thorman, Sipke-Joost Hiemstra, Milena Savi Ivanov