Accreditation and Technical

Department

Annual Meeting 2018

Dr. Florina Palada, Head of Accreditation and Technical Department

Outline

Department staff

Audit programme

Contracted auditors

Statistics and feedback

Quality assurance Workshops

Continous improvment

Department staff • 2017: Florina, Branka, Christine (60%) and for the audit administration

Sejal, Andreea (part time); since October 2017, Neelam

• 2018: Florina, Branka, Christine (60%) and Neelam

2017

2018

Audit Programme

Year Accredited

laboratories

Audits /year Type

2017 137 46 Total

34 – ISTA SA

12 - Contracted SA

Re-accreditation audits - 39

Accreditation audit - 6

- 4 Laboratories

- 2 Sampling Entities

Scope extension, Sampling -1

2018 138

31.05.2018

46 Total actual plan

26 – ISTA SA

20 – Contracted SA

Re-accreditation audits – 44

Accreditation audits – 2

Possible 5 additional accreditation

audits

SA - System auditor

Audits - 2017 First audit 6

Second audit 7

Third audit 5

Fourth audit 4

Fifth audit 3

Sixth audit 8

Seventh audit 12 Scope extension Sampling 1

Total 46

Contracted auditors 2018 Contracted

Auditors

Total number Comments

Contracted SA&TA 3 Senior auditors

Contracted SA (new) 2 Approved in 2017

Already assigned to perform audits in 2018

SA in training/ first

contact

1/1 Exam in July/ waiting for the acceptance to start

the training

SA rejected/not active 1/1 SA contract terminated 28 February 2018/

SA not active

Contracted TA

15 1 TA the contract terminated on 31 August 2018;

1 TA will resign at the end of 2018

TA in training/ first

contact

3/2 1 TA candidate (standard tests); 2 TA candidates

(for GMO) training 2018;

TA with SH, Variety competence – in process

/ waiting for an answer

SA - System auditor; TA - Technical auditor

New contracted auditors/ in training: France, Germany, Italy, The Netherlands, Hungary

First contact with a new candidate: Kenya, Israel, Brazil

Audit structure study

ECOM Decision no. 18014/ February 2018

The ECOM decided to start a study with the aim to improve

the audit structure, looking in particular at the duration, the

number of auditors and the other factors affecting the

performance of the assessment.

The Accreditation and Technical Department will lead the

study in collaboration with the ECOM/AWG. The first

results of the study to be presented at the ECOM Meeting

in June 2018.

Audit structure study

• An AWG meeting took place in March 2018 and the

discussion were continued by emails.

• It was decided that the existing information collected at

audits will be used to improve the quality of the ISTA

audits

• The cost will be considered as a separate study.

Audit structure study Factors considered

• Total time spent for the on-site assessment

• Time for travel and rest when needed

• Laboratory accreditation scope

• Time spent by the auditors for the audited activities, during the on-site

assessment (system and technical)

• Number of auditors

• Other factors ( e.g. with/without translation, time for opening and closing

meeting, breaks, travel to/from laboratory, travel for sampling demonstration)

Audit structure study

• Time spent for the on-site assessment

Type First

audit (hrs)

Second

Audit (hrs)

Third

Audit (hrs)

Fourth

Audit (hrs)

Fifth

Audit (hrs)

Sixth

Audit (hrs)

Seventh

audit (hrs)

Time

average

On site

assessment

10.4

Min 7.30

Max 11.20

10.5

Min 8.30

Max 12.30

10.0

Min 8.00

Max 12.30

9.9

Min 7.50

Max 11.20

10.3

Min 8.00

Max 12.00

10.4

Min 8.00

Max 13.15

9.5

Min 8.00

Max 10.45

Period 2011-2017; Total 321 audits;

- time average 10.1 hrs

- more than 1.5 working day

Proposals • To assure a service with high quality and to meet the expectations

of the audited laboratories and also to meet auditing needs and improvements of the structures:

The most important factor is the duration of the audit

• Correlate the duration with the scope; extend the audit to 1.5 day – 2 days for a part of the accredited laboratory

• ask in advance more documents and records to be evaluated

• a combination of two of them

• assign one auditor for the system part and more than one for the technical aspects

• audit focus on specific aspects only

• other options can be considered

Remote audit (special cases only) Definition: audit performed without auditors being physically present

at the facility under audit.

• ECOM Decision no. 17072/ June 2017

The Accreditation working group will investigate the possible solutions that will enable an audit acceptable to ISTA to take place when a physical audit is not possible.

Special case:

• ISTA auditors are not allowed to travel to perform ISTA audits in any country where they are advised against travel by the Swiss official site Federal Department of Foreign Affairs, and/or the country which the ISTA auditors belong to, due to unpredictable security situations.

What is already done?

Feasibility study

• A remote audit is considered in the valid version of

the International Standard ISO 19011, Guidelines for

auditing management systems.

What is already done?

– The ISTA SOP on how to perform a remote audit

and the related forms are created (first draft)

– A list of resources is now in progress

– A simulation of a remote technical audit has

been performed with the support of Valerie

Cockerell at SASA, ISTA accredited laboratory,

on 31 May 2018

Remote audit Conclusion:

– auditors to be skilled (fully trained) including operating the video conference and specific options (e.g. sharing the screen, sharing the documents, switching on/off microphones)

– 1 technical auditor and 1 system auditor in the ISTA office

– 1 auditor leading the audit and giving clear guidance to the auditee on who is speaking at a time and to whom the question is asked

– short and clear questions

– ensure transparency and clarity

Remote audit Conclusion:

– System audit should take place in the ISTA office before the

technical remote audit

– At the system audit, a trial will be made with the laboratory for checking if the laboratory equipment works

– Technical auditor will make on-desk assessment of records (e.g. equipment control/calibration records), prior to the remote audit

– new adapted technical audit documentation ( e.g. more suitable checklists, SOPs) need to be created

– guidelines for auditors and auditees need to be created

– One audit will be carried out exceptionally; experience will be analysed

PT Programme 2017 Shipment plan: April, August, December

PT Species Tests Type Participants Dispatched

Final results

17-1

MIX

Festuca

arundinacea

P, OSD, G

Training

135

150

July 2017

January 2018

17-1

Brassica napus Vigor

57 May 2017

August 2017

17-2 Trifolium repens P, OSD, G, M 149 July 2017

January 2018

17-3 Lolium perenne P, OSD, G, TZ,

OIC

136 November 2017

April 2018

Gypsophila

elegans

G 104 November 2017

April 2018

Picea abies G 46 February 2018

May 2018

Mini PT 2017/2018 PT Rounds Species Participants Tests

performed

Dispatched

Final results

One round

3 species

2017

Helianthus annuus 10

Germination May

August

Sinapis alba 10

Germination

May

August

Origanum

majorana 10

Germination

May

August

One round

2 species

2018

Triticum aestivum 11

P, OSD, GER,

MOI

January 2018

March 2018

Zea mays 11

P, OSD, GER,

MOI

January 2018

March 2018

No other Mini PT round organised for 2018

SH and GMO PTs 2017

Seed Health Proficiency Test

• The results for the seed health proficiency test on Cucurbits viruses

have been reported to participants.

• Phaseolus vulgaris for detection of Xanthomonas axonopodis pv.

phaseoli and Pseudomonas savastanoi pv. phaseolicola (ISTA methods

7-021 and 7-023). The results are closed to finalisation.

GMO Proficiency Test

Round

Species

Event

Status

PT 21

40 participants

Zea mays NK603, MON88017 Results were

reported

PT Programme 2018 PT /Species Tests Type Comments

18-1 Lupinus angustifolius

18-1 Beta vulgaris

coated seeds

G, MOI

G, OIC

Shipment in April 2018

18-2 Daucus carota

P, OSD, G Shipment in August 2018

18-3, Lolium perenne

P, OSD, G, OIC

Shipment in December

2018

PT 18 SH 7-025, Aphelenchoides besseyi on

Oryza sativa

7-007: Detection of Alternaria linicola,

Botrytis cinerea and Colletotrichum lini in

Linum usitatissimum

Samples preparation

PT 22 GMO Brassica sp Samples preparation

Variety PT on Triticum

DNA based methods

Disussed with the chair of Variety

COM

Planning

Quality Assurance workshops

• 2017

– No Quality Assurance WSs organised

• 2018 – Japan, Quality Assurance WS for begginers – June

– Uruguay, Quality Assurance WS for advanced laboratories – November

• 2019 – India, Quality Assurance WS for advanced laboratories

(proposal for June)

Quality assurance • Revision of the ISTA Accreditation Standard for seed Testing and Seed

Sampling (version 6.1)

• ISTA Accreditation Standard for seed Testing and Seed Sampling, version 6.1, French and Spanish translation posted on the website; German translation is at the final check; Italian translation is available at the ISTA Secretariat. Translation in other languages: if available, please contact ISTA

• Acc-P-07, How to complete ISTA Certificates version 3.0, posted on the website

• Acc-D-01-Termination-Suspension-Withdrawal of accreditation - revised

• ISTA internal policy to assign an auditor for a specific audit – revised

Quality assurance QMS at ISTA Secretariat

• Ongoing revision of the internal quality documents for the

maintainance of the ISTA Secretariat Certification, ISO

9001:2015 ; Surveillance audit on 1 June 2018

• Support in creation of the ISTA Secretariat HR Policy

• Support for the revision of some SOPs related to the

administration of the PTs

• Part of the internal audits

Quality assurance

Accreditation Department • Auditors monitoring – in progress

• Auditors/BSC Meeting – 2017

– Focused on Automatic sampling

– The need for a WS focused on Automatic sampling has been identified

• Workshops :

– Automatic sampling, October 2018 in Sweden

– DNA based methods, March 2019 in Italy

• Dressing code for the auditors

• Optimisation of the Accreditation DB; checking of the records from the DB if they match with the records in Navision.

• GMO DB connected with the Accreditation DB

International representation

Head of the Accreditation and Technical Department

• 2017 – ISF Congress

– ABRATES Congress

– VDLUFA Congress

• 2018 ILAC Meeting in Frankfurt

An excellent opportunity to meet people and to promote ISTA/ISTA accreditation

Acknowledgments

• Executive Committee Members

• Accreditation Working Group

• Technical Committee chairs and members

• ISTA Secretary General and the Secretariat colleagues

• Accredited Laboratories and Sampling Entities

• ISTA auditors

• ISTA members and accredited laboratories

Thank You

for your Attention!