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

julian.smith@fera.gsi.gov.uk

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

julian.smith@fera.gsi.gov.uk

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