Accreditation and Technical Department

Florina Palada Head of Accreditation and Technical Department Rita Zecchinelli Chair of the ECOM-AWG July 2, Hyderabad, ISTA Congress

Outline

Department staff Audit programme Contracted auditors Statistics and feedback Quality assurance Workshops Continuous improvement

Department staff & audits • 2018 and 2019: Florina, Branka, Christine (60%) and Neelam • The selection process for a new SA at ISTA Secretariat is not

finalised

Year Accredited laboratories

Audits /year Type

2018 138 48 Total 30 – ISTA SA 18 – Contracted SA *Remote audit 2SAs/2TAs + 1 observer/advisor

Re-accreditation audits – 43 Accreditation audits: 5 including 1 Remote audit

2019 143 (30.06.2019)

Already in the plan 50 30 – ISTA SA 20 – Contracted SA

Re-accreditation audits – 47 Accreditation audits – 3 Possible a t leat 1 additional accreditation audit SA - System auditor, TA – Technical auditor

Audits - 2018 First audit ,incl. remote audit 5

(Remote audit) (1)

Second audit 1

Third audit 4

Fourth audit 9

Fifth audit 1

Sixth audit 3

Seventh audit 24

Eight audit 1

Total 48

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.

Remote audit Auditors team:

• 1 Lead/System auditor; 1 System auditor • 2 Technical auditors • 1 Observer/Advisor; SG supported the team

Step 1 • A simulation of a remote technical audit has been performed with the support of Valerie Cockerell at SASA, GB04 - ISTA accredited laboratory, on May 2018

Step 2

• System part evaluation – the laboratory representative visited ISTA Secretariat for two days: 21-22 November 2018 • Technical part evaluation: remote audit using web conference two days 11-12 December 2018 The laboratory is now accredited. Process finalised in June 2019.

Conclusion at the end of the process

• The remote audit is feasible with significant adjustment of the usual audit procedure (e.g. IT equipment, number of auditors, time consumed, trials before the audit to assure the suitability of the communication way…)

• The cost is similar with the cost of the classical audit

procedure

• Can be used in special cases to support the candidates for accreditation to achieve their scope when a classical audit cannot be performed

Contracted auditors 2018-2019 Contracted Auditors Total number Comments

Contracted SA&TA 2 Auditors with several years of experience

Contracted SA 3 2 already assigned to perform audits in 2018 and 1 assigned in 2019

SA in training 1 Exam in August

SA left 1 31 March 2019

Contracted TA

15 1 new TA for GMO only 1 new TA assigned for audits in 2019 2 TAs left the system in 2018

TA in training/ first contact 5/1 4 TA candidates (standard tests); 1 TA candidate for GMO and 1 for Seed Health SA - System auditor; TA - Technical auditor

New contracted auditors in training: Kenya, Hungary, Serbia, Canada

Auditors regional distribution

KE

RS, SE, HU,SK

CA

USA, CA

UK,IT,FR,NL, DE, DK, IL,

PL

IN

Active auditors

Auditors in training

Difficulties in the work with contracted System Auditors

• As they do not have access to ISTA Data Base, the information is provided/recorded by the ISTA Secretariat auditors and the audits administration

• Monitoring/follow-up for each audit to assure that all steps

are accomplished and to assure uniformity in reporting and Corrective Actions evaluation

• Final steps of the re-accreditation process is done by the

ISTA auditors (e.g. non-conformities categorised, audit documents storage, other records in the Data Base)

Accredited laboratories evolution

Statistics Key Performance Indicators

(KPIs) Time from audit (on-site assessment) to reporting Target: max 20 days - 2018

2 3 4 5 6 7 8 9 10 11 12 13 14 15 17

19 20

29

1 1 3 3 4 3 4 2 5 2 1 5 5 4 2 1 1 1 0

5

10

15

20

25

30

35

day audits remote audit

Statistics Key Performance Indicators

Time from (re)accreditation approval to (re)accreditation certificate Target 20 days - 2018

1 2 3 4 6 7 8 9 10 11

5

9 10 10

2

4 3

1 2

1

0

2

4

6

8

10

12

days certificates number

Statistics-KPIs Time from audit to (re)accreditation Target: 6 months after the audit date - 2018

0

20

40

60

80

100

120

140

160

180

200

num

ber o

f day

s

audits

Laboratories feedback, 2018 (number)

• Total audit 48, responses from 48 (100%) laboratories answered

Excellent + Very good

Excellent Very good Satisfactory Unsatisfactory

47

27

20

1 0

Laboratories feedback, 2018 (%) KPIs: ≥ 90% Excellent and very good; 0 unsatisfactory

Excellent + Very good

Excellent Very good Satisfactory Unsatisfactory

97.9

56.3

41.6

2.1 0

Overview – audits 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.

Overview Audits structure study

ECOM –AWG, ISTA SG and HoAT performed

the study on the audit structure in two steps: – Quality – Direct Cost

Audit structure study Quality

Factors considered • Total time spent for the on-site assessment • Time for travel and rest when needed

• Accreditation scope

• Time spent by the auditors for the audited

activities, during the on-site assessment • Auditors (availability, competence)

Audit structure study Quality

• 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

Total/average: 2011-2017; 321 audits; - time average 10.1 hrs - more than 1.5 working day

Audit structure study Quality

• Accreditation scope – proposed groups 1. Sampling Entities 2. Laboratories without sampling in the scope 3. Laboratories accredited for tree and shrubs only 4. Laboratories with "standard tests" in the scope: manual sampling, purity,

germination, viability, moisture, TSW 5. Laboratories with large scope: manual and automatic sampling, purity,

germination, viability, moisture, TSW, SH, Verification of variety, X-ray, vigour, size grading

6. Laboratories with Standard tests and GMO/VAR (PBA-SPBA) in the scope 7. Laboratories with large scope and GMO/VAR (PBA-SPBA) 8. Extension of the scope at the audit time – several tests and species crop

groups Proposal to be considered: duration based on scope. for example: - for 1, 2, 3, 4 – 1 day audit - for 5, 6, 7, 8 – 1.5 day to 2 days audit

Audit structure study Cost calculation

Cost calculation – average of 3 years period (direct costs

only) Cost calculation – “sampling” audits (direct costs only)

Audit structure study Cost calculation

2016 2017 2018

1 audit in a tour 11 17 9 2 audits in a tour 15 ( 15x2 = 30) 7 (7x2 = 14) 7 (2x7=14) 3 audits in a tour 3 (3x3 = 9) 2 (3x3 =9) 8 (8x3=24) 4 audits in a tour 0 1 (1x4=4) 1* remote audit

(4 days audit: 2 system +2 technical)

5 audits in a tour 0 1 (1x5=5) 0 Total 50 46 48

Average cost /1 audit = 11 744 CHF (overheads not included)

Cost calculation “sampling” audits

Audits /2018

1 audit in a tour, Secretariat SA (in Europe) 1 audit with a contracted SA (in Europe) 1 audit with an ISTA Secretariat SA (far from Europe) with one day for rest and audit preparation

2 audits - with an ISTA Secretariat SA (far from Europe); both auditors from Europe

2 audits - with a contracted SA (far from Europe); both auditors from Europe

2 audits - with a contracted SA (in Europe)

2 audits - with a ISTA Secretariat SA (in Europe + one contracted SA in training) with GMO in the scope 2 x 1.5 days

3 audits - with an ISTA Secretariat auditor (far from Europe )

3 audits - with a contracted SA (in Europe but TA from Europe)

3 audits - with a contracted SA (in Europe but TA far from Europe)

Average cost: 12 099 CHF (overheads not included)

Cost calculation

• 3 years audits, average cost (direct costs only) 11 744 CHF/audit

• Combinations of audits in a tour 2018, average cost (direct costs only)

12 099 CHF/audit

Conclusion

• To assure a service with high quality, to meet the expectations of the audited laboratories and also to meet auditing needs and improvements of the structures:

The most important factor is to increase the audit time for each activity – How?

• extend the audit to 1.5 day – 2 days for accreditation scope (see previous slide)

• ask in advance more documents to be translated 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 focused on specific aspects only

The costs of the actual audit structure is covered by the actual fee

PT Programme 2018

Shipment plan: April, August, December PT /Species Tests Type Comments

18-1 Lupinus angustifolius 18-1 Beta vulgaris coated seeds

G, MOI G, OIC Results cancelled

156 participants 180 participants

18-2 Daucus carota

P, OSD, G 180 participants

18-3, Oryza sativa Seed Mix organised by Purity COM

P, OSD, G, OIC

195 participants 5 warning letters

PT 18 SH 7-025, Aphelenchoides besseyi on Oryza sativa 7-007: Detection of Alternaria linicola, Botrytis cinerea and Colletotrichum lini in Linum usitatissimum

7-025: finalised – Reports sent out to participants 18.12.2018 7- 007 (postponed for 2019) shipment of the samples end of June

PT 22 GMO Brassica sp. finalised – Reports sent out to participants

Variety PT on Triticum DNA based methods

At the beginning of the process planning fase

Mini PT 2018-2019

PT Rounds Species Participants Tests performed

One round two species

2018

Triticum aestivum

11

P&OSD, G, Moi

Zea mays

11

P&OSD, G, Moi

One round one species

2019 Daucus carota 10 P&OSD, G

Results received in June

Quality assurance

Revision of the ISTA Accreditation Standard for seed Testing and Seed Sampling (version 6.2) Added at the field of application: • For the purpose of this standard, the term ISTA "accredited member" refers to the

accredited laboratory and accredited sampling entity. • Technologies new to the ISTA Rules are accepted, whether these are the basis of

new methods or new tools within existing methods, provided they can meet the specific requirements that are prescribed case by case.

• at 2. Definitions • Risk: effect of uncertainty • Laboratory: entity performing: a) seed testing and sampling or b) seed testing

only paragraphs: 1.2 and 7.1: new technologies

Quality assurance Revision of the ISTA Accreditation Standard for seed Testing and Seed Sampling (version 6.2) 10.11 Action to address risk and opportunity • The laboratory must establish a policy and procedures to address risks and

opportunities. 8.6 An ISTA Certificates is the property of the client and must be kept confidential.

replaced by: The results reported on any ISTA Certificate must be kept confidential

In the text, "accredited sampling entities and laboratories" replaced by "accredited

members" excepting 7.1

Quality assurance

• Acc-D-01 Termination, Suspension and Withdrawal of ISTA Accreditation, revised

• Acc-F-09 Application Form for (Re)Accreditation

• Confidentiality agreement with the Contracted Auditors

• Technical auditor checklist – under revision, System auditor checklist will follow Flexibility to select the necessary fields and delete what is not in the scope. • After the remote audit is finalised, the related procedures will be revised (based

on the experience accumulated)

• Seed Health Guidline for Auditors; support from Valerie Grimault and Valerie Cockerell

• A policy on how the „comparative test“ need to be organised

• ISTA Secretariat QMS documents for ISO 9001, Certification maintenance

Quality assurance • Auditors monitoring – ongoing

• Auditors/BSC Meeting – October 2018

– Automatic sampling (asked additional clarification after the WS) – The non-conformities identified by the ISTA auditors in 2018 were discussed;

some actions points were identified

• Dress code for the auditors

• Optimisation of the Accreditation Data Base – almost finalised

• GMO Accreditation scope: work with the GMO COM to align the events name and to have a more appropriate Accreditation scope posted on the website

Quality assurance Workshops (WS)

• 2018 • June 2018, Tsukuba/Japan, Quality Assurance WS for begginers, Sampling

was included

• November 2018, Montevideo/Uruguay, Quality Assurance WS for advanced laboratories

• October 2018, Lund and Svalov/Sweden, Sampling WS, with focus on automatic sampling (technical auditors supported by ISTA to participate)

• 2019

• March 2019, Bologna/Italy, DNA WS for the ISTA auditors (supported by Enrico Noli, LaRas- IT01 and Rita Zecchinelli CREA - IT03 and coordinated by the chair and vice-chair of the VAR Com)

• April 2019, Pejë/ Kosovo, Quality Assurance WS for beginners, Sampling was

included • December 2019 Bangalore/India, Quality Assurance WS for beginners

Challenges

• New ISTA website – Accreditation aspects • How to support the Proficiency Tests (PTs) Commitee to

improve the PTs process? • Support to the GER COM in organising Comparative

tests for Beta vulgaris • New Technologies at ISTA (revision of the Accreditation

standard; a Guidline for the auditors will be produced)

• Interactive Certificates in connection with the procedure “ How to complete an ISTA Certificate“

Interactive Certificates • Goal 1 Create an online interactive training tool on how to fill in

ISTA Certificates correctly with some predefined examples which were created by the ISTA Accreditation and Technical Department

• Goal 2 Create a template (e.g. word or pdf) for the laboratories to

fill in their own results with matching text boxes to have precise layout on the laboratory printed paper Certificates.

Storyboard interactive ISTA Certificate

• Domain name: www.LEARN-ista.org (password protected)

• Webdesign Bytekultur started programming

• Design of ISTA Certificate will be used with selection options for types of Certificates and different analysis

• An example with data and text of ISTA Certificate will be displayed

Stamp

Flower Seed Trade, Bond Street 1, 8000 Malver, United Kingdom Checkb

ox Radio

button 1

Seed testing station Rumex, Euston Road 5, 7000 Derby, United Kingdom, GB21

Checkbox

Radio button

2 Individual lot mark e.g. ISTA 2000 PAR Checkbox

Radio button

4

Checkbox

Radio button

3

20 2018-12-10

2018-12-11 Drop

down, tree

analysis 5

Derby, United Kingdom

Checkbox

Radio button

6

Species

Triticum aestivum

Beta vulgaris uncoated

coated Brassica napus, Lolium perenne,

Glycine max

Sampling conducted by

Seed testin station Rumex GB21

Official seed testing station Taraxacum GB25

Type of seal

Seal

Stich

ISTA Lab Code

Status

Original

Dublicate

Provisional

Status

Original

Dublicate

Provisional

Job title

Authorised signature

Head of laboratory

QM, or other position

International representation 2018

Head of the Accreditation and Technical Department participation to: • MONSANTO Symposium • ILAC meeting • Myanmar WSP • Myanmar, 4th National Seed Sector Platform • Myanmar laboratory visit • Vegetables Seed Industry WG – ongoing

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

Thank You for Your Attention!

.