Embed Size (px)
DESCRIPTION
Citation preview
A Quality Framework for Plant Breeding
GCP 2011 General Research Meeting
21–25 September 2011
Hyderabad, India David Galsworthy
Derek Tomlinson
Julian Smith
International Development
1-Quality@GCP – a feasibility
analysis
Asked to review the opportunity for
positioning a quality system „about‟ the GCP
Agreed to map out some of the top tier
process that describe a generic plant
breeding pipeline and to see what controls
might be appropriate
To identify some „low hanging‟ and/or „high
impact‟ opportunities
The message of this talk
Why
What
How
[The Why and What could be reversed, but to
capture attention it has to be this way]
The why – a justification for
quality assured ways
Some high level benefits of a
QA system
Increased competitiveness within the market
Succession of knowledge within the institute
over time
Improved institutional resource management
and net increase in efficiency
Reduced vulnerability to customer disputes
Improved basis for outsourcing and
partnerships for deliverables requested by an
external party – strengths the „community‟
IBS Workshop feedback
Quality systems need
upfront inputs to put in place
And cost extra to maintain
The first is true, but the latter
is a debatable point
Especially in developing
countries: staff vs
consumables costs reversed
Do we recognise this scenario
Plant breeders are a community, but are
competitive, which is good
Projects won on institutional reputation for
research excellence and project management
The better scientists are attracted to the elite
institutes
Funds follow previous funding
A status quo is reached
Is this an optimal model
For innovation
For motivating
For developing emerging institutions,
especially amongst the national programmes
Quality systems can demonstrate
equivalence or comparative advantage
between institutions
The what (in brief)
Quality Assurance
“all those planned and systematic actions
necessary to provide adequate confidence
that a product or service will satisfy given
requirements for quality.....”
And meet the expectation of the customer
Quality = meets expectation
About demonstrated competence
Those applicable to plant
breeding
ISO 9001 - is a generic quality standard application in
all situations and is designed to help organisations
ensure they meet the needs of customers and other
stakeholders. The standard has the potential for
superior operational performance by driving through
better practices and efficacy improvements.
ISO 17025 - is the main quality standard used by
testing laboratories.
The how
Examples to draw from
Crop pesticide production
Crop pesticide production
Comparable stages to plant breeding
– Idea formation and iteration
– Resource inventorying
– Bioactive generation
– Screening, stages
– Field trials
– Registration and release
– Post release monitoring
Crop pesticides production and
QA
Health and environmental concerns are high and this
has motivated legislation
In Europe production has to comply with REACH
(Registration, Evaluation, Authorisation and restriction
on Chemicals) that sets standards
Regulation is recognised in the UK by ORETO that
provides for „officially recognised testing facilities‟
FERA is a registered with ORETO so that it can win
business in this area
UK hand book on pesticide development and meeting
EU regulatory norms (Expectations) is over substantial
Plant germplasms and freeness
from pests
Plant germplasms and freeness
from pests
International Potato Centre is accredited to ISO
17025 for named pests of quarantine concern and
associated with in vitro production. Involved:
– Document control systems
– Training and training records
– Equipment records
– Validation of data for test methods
– Evidence of operation of the quality control system
Crop Genebank Knowledge Base. A well intended
website for best practices, but not a quality system.
No measure of adoption or use
CIP example
The CGIAR centres have a
unique position as the
repository of germplasms
Act as a primary conduit for
germplasms and breeding
Responsibility for ensuring
the safe movement of
germplasms
In 2007-2008 CIP
implemented a quality system
to support the supply of in-
vitro potato and sweet potato
CIP and motivation for adopting
QA
CIP employed a seed systems specialist (from
FERA) that was familiar with quality systems and
how they could leverage change and raise
standards
There was concern that the TC germplasm was
not tested to be free of pests; infection with a
quarantine organism was been reported by US
causing „embarrassment‟
A combination of „institutional hurt‟ and individual
knowledge or culture for QA brought about
change
Proficiency Testing Schemes
Widely used in many
commercial sectors
A metric of
competence
Accreditation for DNA
extraction
Basis for support and
learning
PT Scheme for CBSV
Adoption
The major imperative to
adoption
For QA to be adopted there has to be
incentives and consequences for success
and failure
Currently these are not sufficiently in place
Who is most likely to champion
a plant breeding quality frame?
Expectations and driver strength
Stakeholder Incentive Driver
strength
Researcher Improved quality of research
Science publication
Esteem
Low
Research institute Increased efficacy of direct costs and staff time
Higher success rate in winning project funding through
demonstration of competitive advantage over competitors
Moderate /
High
Variety registering
body
Greater acceptance of data provided by variety developers
Greater comparability of data on variety performance over
time and between regulatory bodies
Reduced time and cost for variety performance assessment
and recommendation
Moderate
Commercial
partner
Cost saving due to improved efficiency over pipeline and in
time required to have varieties registered for commercial sale
High
Donor Greater likelihood in success of projects funded
Defendable choice of partners selected for funding
Quality of data increases scope for sharing data between
projects, realising synergy of data and securing legacy of data
High
Setting the expectation along a
pipeline
Critical questions about:
– Idea validation
– Minimum resourcing: natural, human, infrastructure
– Experimental design and compliance checks
– Data management for traceability
– Partnerships brokering
Idea validation, collection of resources
Progeny generation
1st 2nd 3rd germplasm screening
Approval and release
Field trials (Biosafety trials if GMO)
Owner of these expectations
GCP
CGIAR
CRP
Alliance of CGIAR
Donors
Other!
A quality frame for plant
breeding
Meeting the expectation
At the researcher and institute level:
– Document control systems
– Training and training records
– Equipment records
– Data management tools and services
– Validation of data for test methods
– Evidence of operation of the quality control
system
Approach for implementation of
ISO 17025
Mainly the below generic stages will fit for the
majority of needs, but the detail for each will
be institute specific
– Stage 1: Design and process setting
– Stage 2: Developing the system
documentation
– Stage 3: Training in System Requirements
– Stage 4: Evidence of implementation
– Stage 5: Internal Auditing
•
Inputs and outcomes
The special case of
development
In times of emergency response we need
solutions before the full validation is
undertaken
Work with partners of diverse capabilities and
access to recourses, to raise that capacity
These factors needs to be „understood‟ and
built into the deliverables
Situations to consider
Cassava Brown Streak Disease
Two species (CBSV
an UCBSV)
Both present in Ke,
Tz and Ug
Only UCBSV in Br,
Rw and DRC
(currently)
Disparate lab
capacities
Breeding and field
trials ongoing
Nucleic acid data – ICRISAT
example
World class
genomic capacity
Internal research
Outsourcing
services
Would the
outsourcing win
more business if
accreditated?
Summary
What will make me want to move from here to there?
Currently a absence of consequence about non-
compliance
No natural owner of a quality system
GCP has capital in a Community of Partners
GCP has a wealth of Best Practice tools; their use
will contribute to a quality assured system
But be caution of opportunistic adages of systems
designed for other reasons
Not everything available will fit the expectation when
that is set
Thank you
First name Last name Institution
Jeffrey Ehlers UC-R ; University of California Riverside
Pooran Gaur ICRISAT - International Crops Research
Institute for the Semi-Arid Tropics
Marie Noelle Ndjiondjop WARDA - Africa Rice Center
Emmanuel Okogbenin National Root Crops Research Institute
Chunlin He GCP
Breeding services Manger
Arvind Kumar IRRI
Richard Trethowan Sydney University
