pre-audit assessment report”

European Union Water Initiative Plus for the

Eastern Partnership Countries (EUWI+)

Result 2

“PRE-AUDIT ASSESSMENT REPORT”

Version 1.0; March 2021

Pre-Audit Assessment Report

2

Beneficiaries

Basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs, Vyshgorod

Laboratory of surface water pollution observations of the Central Geophysical Observatory (CGO)

Responsible EU member state consortium EUWI+ project leader

Mr Alexander Zinke, Umweltbundesamt GmbH (AT)

EUWI+ country representative in Ukraine

Ms Oksana Konovalenko

Responsible international thematic lead expert

Ms Cristina Trimbacher, Umweltbundesamt GmbH (AT)

Mr Michael Ghobrial, Umweltbundesamt GmbH (AT)

Responsible national thematic lead expert

Ms Natalia Osadcha, Ukrainian Hydrometrological Institute

Authors

Ms Cristina Trimbacher, Umweltbundesamt GmbH (AT)

Mr Michael Ghobrial, Umweltbundesamt GmbH (AT)

Disclaimer:

The EU-funded program European Union Water Initiative Plus for Eastern Partnership Countries (EUWI+) is im-

plemented by the United Nations Economic Commission for Europe (UNECE), the Organisation for Economic Co-

operation and Development (OECD), both responsible for the implementation of Result 1, and an EU Member

States Consortium comprising the Environment Agency Austria (UBA, Austria), the lead coordinator, and the In-

ternational Office for Water (IOW, France), both responsible for the implementation of Results 2 and 3. The pro-

gram is co-funded by Austria and France through the Austrian Development Agency (ADA) and the French

Artois-Picardie Water Agency.

This document was produced with the financial assistance of the European Union. The views expressed herein

can in no way be taken to reflect the official opinion of the European Union or of the Governments of the Eastern

Partnership Countries.

This document and any map included herein are without prejudice to the status of, or sovereignty over, any

territory, to the delimitation of international frontiers and boundaries, and to the name of any territory, city or

area.

Imprint

Owner and Editor: EU Member State Consortium

Umweltbundesamt GmbH

Spittelauer Lände 5

1090 Vienna, Austria

Office International de l’Eau (IOW)

21/23 rue de Madrid

75008 Paris, France

Responsible IOW Communication officer:

Ms Chloé Déchelette [email protected]

March, 2021


CONTENTS

1 Executive summary ............................................................................................................................ 5

2 Introduction ......................................................................................................................................... 6

3 Accreditation status ............................................................................................................................ 7

3.1 Scope of accreditation ................................................................................................................ 7

4 Accreditation Support Activities .......................................................................................................... 8

4.1 Trainings ..................................................................................................................................... 8

4.2 Facilities ...................................................................................................................................... 9

4.3 Equipment ................................................................................................................................... 9

4.4 Validity of results ....................................................................................................................... 10

4.5 Management System Documentation ...................................................................................... 11

4.6 Remote Audit ............................................................................................................................ 11

4.6.1 Audit findings .................................................................................................................. 11

4.7 Study Visit ................................................................................................................................. 12

5 Conclusion & Recommendations ..................................................................................................... 13


4

Abbreviations

ADA………………..Austrian Development Agency

AFS………………..Atomic Fluorescence Spectrometer

DoA ....................... Description of Action

DG NEAR ............. Directorate-General for Neighbourhood and Enlargement Negotiations

of the European Commission

EaP ....................... Eastern Partnership

EC ......................... European Commission

ENP………………..European Neighbourhood Policy

EU ......................... European Union

EU-MS .................. EU-Member States

EUWI+ .................. European Union Water Initiative Plus

QA/QC .................. Quality Assurance / Quality Control

QM…………………Quality Management

UBA ...................... Umweltbundesamt GmbH, Environment Agency Austria

WFD ...................... Water Framework Directive

Country Specific Abbreviations Ukraine

CGO laboratory of surface water pollution observations of the Central Geophysical Observatory

named after Boris Sreznevsky

NAAU National Accreditation Agency of Ukraine

SAWR State Agency of Water Resources of Ukraine


1 EXECUTIVE SUMMARY

The present pre-audit assessment report summarizes all project activities contributing to technical sup-

port for laboratory accreditation in Ukraine, especially for the main partner laboratory “Basin Laboratory

of the Interregional Office of Protective Arrays of Dnipro Reservoirs”.

A series of workshops and trainings to enhance the needed competence and technical knowledge

of key staff was realized

New analytical equipment, auxiliary apparatus and consumables for strengthening the technical

capabilities was procured, purchased and delivered

Participation in proficiency testing schemes for selected WFD relevant groups of chemical sub-

stances to allow the monitoring of the measuring performance was enabled

Assistance in establishment and maintenance of an appropriate management system documenta-

tion was given

One study visit to Austria was organized

A remote audit with the Basin Laboratory of the Interregional Office of Protective Arrays of Dnipro

Reservoirs in Vyshgorod was conducted


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2 INTRODUCTION

The European Neighborhood Policy (ENP) provides a framework for closer relations between the EU

and its neighboring countries. The European Union Water Initiative Plus for Eastern Partnership Coun-

tries project (EUWI+) aims at further supporting the neighboring countries in improving their water quality

as well as the ecological status with special focus on transboundary river basin management in light of

the WFD principles.

One key challenge is still to further strengthening water monitoring capacity, both with geographical

coverage of monitoring networks, within the laboratories’ infrastructure and with the methodological ba-

sis for sampling, (physical-) chemical analyses and ecological as well as hydro morphological status

determination.

Monitoring and appropriate laboratory capacities play a key role in the implementation of the WFD.

Quality assurance, comparability and reliability of analytical results are duly addressed by the WFD’s

daughter directive on technical specifications for chemical analyses and monitoring of water status

(Commission Directive 2009/90/EC – QA/QC Directive). Accreditation provides government bodies and

regulators confidence in the technical competence, data quality and validity of results generated by

laboratories carrying out testing.

Ukraine has the largest territory of all of the six partnership countries under the EUWI+ east project with

the Ministry of Ecology and Natural Resources as main governmental body in water management. Au-

thorities within the Ministry are divided among various agencies and services with own laboratories on

state, oblast, regional and local level officially responsible for water quality monitoring, which made a

selection for technical support necessary.

Reflecting the distribution of competences defined in the new governmental resolution of the cabinet of

ministers of Ukraine for the State Monitoring System of Water Resources, and results of the on-site

assessments, the following partner laboratories for technical support for accreditation according to the

international standard EN ISO/IEC 17025:2017 “General requirements for the competence of testing

and calibration laboratories” have jointly been selected in priority order:

Basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs,

Vyshgorod

laboratory of surface water pollution observations of the Central Geophysical Observa-

tory (CGO) named after Boris Sreznevskyin Kyiv

In addition, laboratory experts from other authorities and laboratories involved in the national water mon-

itoring system participated in training activities provided by the EUWI+ project.

The current pre-audit assessment report summarizes the findings and achievements, which were jointly realized during the project. In addition, it gives recommendations for further actions where necessary.


3 ACCREDITATION STATUS

The basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs, situated in

Vyshgorod was the main partner laboratory in the framework of the EUWI+ project and thus involved in

all activities related to technical support for accreditation.

The laboratory is not yet accredited as testing laboratory according to the international standard EN

ISO/IEC 17025 at the national accreditation agency of Ukraine (NAAU). With the assistance of UBA

laboratory experts and a local QM expert the needed documentation was prepared, allowing the basin

laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs to start the application for

initial accreditation at NAAU in summer 2021.

3.1 Scope of accreditation

The selections process of analytical test methods and sampling methods for the first accreditation scope

is not fully completed. Most probably, the block of methods for determination of physical-chemical pa-

rameters in surface water and some AAS methods for the determination of elements in water (metals,

non-metals, heavy metals) are planned to be submitted for laboratory accreditation.


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4 ACCREDITATION SUPPORT ACTIVITIES

4.1 Trainings

It is a requirement of the 17025 international standard for laboratory accreditation, that the laboratory

shall have available the personnel to manage and perform its laboratory activities and that it has to

ensure that the personnel have the competence to perform laboratory activities for which they are re-

sponsible.

Therefore, one key element of the technical support for laboratory accreditation was a series of work-

shops and trainings to enhance the needed competence and technical knowledge of key staff in the

partner laboratories. The following training activities were realized with active participation of all partici-

pants:

As an implication of the global Covid-19 pandemic, method trainings with new equipment, procured and

purchased within the EUWI+ project could not be carried out according to plan. Effects of the worldwide

Covid-19 pandemic make a timely accomplishment of these trainings highly unlikely in the course of the

EUWI+ project.

For the new Atomic Fluorescence Spectrometer (AFS), a guidance document, the “AFS cookbook” for

the determination of mercury according to the standard ISO 17852:2006 Water quality -- Determination

2018

Workshop on laboratory basics and

fundamentals of ISO Quality

Management Standards

harmonising and improving knowledge on

fundamentals (principles and terminology) of

quality management in laboratories and

accreditation requirements (basis is ISO 17025)

• Clarification of fundamentals of the EN ISO/IEC

17025 standard for laboratory accreditation

• Clarification of terms and basic information for

uniform use and understanding of terms such as

calibration, standards, work range, reference,

validation, verification, statistics, EN ISO/IEC

17025 s umbrella

Kyiv

2018

Determination of organochlorine

compounds and PCBs according to

EN ISO 6468

developement/adaption/professionalization of

analytical methods according EN ISO 6468

sample preparation, sample cleanup techniques

for water/biota/sediments,

Analysis of the samples & troubleshooting

Quantitative determination, evaluation and

interpretation of results, Quality assurance

UBA Lab

Vienna

2018The new revision of the EN ISO/IEC

17025: 2017

understanding of the main changes, new structure

and requirements for laboraotry actvities and QM

documentation for the enivsaged accreditation

requirements to testing laboratories according to

EN ISO/IEC 17025:2017

EUWI+ project

office, Kyiv

2019

Method verification & validation,

measurement uncertainty and

metrological traceability acc. to EN

ISO 17025:2017

harmonizing & improving knowledge on method

verification & validation for WFD relevant types of

chemical testing, measurement uncertainty and

metrological traceability

technical requirements from the EN/ISO

17025:2017 & practical exercisesKyiv

2019

Training for internal auditors acc. to

ISO 19011 guideline and EN ISO

17025:2017

Professionalization of audit techniques & reporting

Audit principles; audit program planning &

implementation; conduct of individula audits,

competences of auditors; communication skills;

group works and communcation exercises

Kyiv

2019

Addressing riks & opportunites acc.

To EN ISO/IEC 17025:2017

standard for laboratory accreditation

harmonization and improvement of knowledge and

understanding of the risk based approach of the

new version of the EN ISO/IEC 17025:2017 and

options for implementation in the laboratory QM

system

• Risk based approach from the En ISO/IEC

17025:2017 international standard for

laboratories

• Terms & definitions

• Risk identification

• Risk assessment - FMEA tool as example

Kyiv

Training

Year Title Objective/Target Content Venue


of mercury -- Method using atomic fluorescence spectrometry was prepared and provided by UBA ex-

perts. The cookbook is intended to provide guidance for chemical analysis according to the specifica-

tions of the standard and the specific instrumental conditions to allow the set-up of the analytical method

in the Vyshgorod basin laboratory by the laboratory staff.

4.2 Facilities

Part of the requirements of the EN ISO/IEC 17025 international standard for laboratory accreditation is

that facilities and environmental conditions shall be suitable for the laboratory activities and shall not

adversely affect the validity of results.

As the conditions of the premises and infrastructure of the basin laboratory of the Interregional Office of

Protective Arrays of Dnipro Reservoirs were far from fulfilling the needed requirements to allow techni-

cally competent testing and producing reliable results, one major aspect within the EUWI+ project was

to technically support and give guidance to the Ukraine partner laboratory in terms of achieving appro-

priate laboratory facilities.

The Basin Laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs in Vyshgorod

was completely refurbished by the State Agency of Water Resources of Ukraine (SAWR) between

September 2018 and September 2019, based on the recommendations provided by UBA.

Refurbishment included installation of gas pipelines (argon, nitrogen, helium, etc.) and external gas

storage cabinets, new electricity lines, ventilation system (exhaust, air condition), floor and wall tiles,

separation of office and laboratory rooms (individual sample preparation and measuring rooms) and

new appropriate laboratory furniture. Three UBA expert missions on-site accompanied the process of

refurbishment. The official opening of the laboratory took place 22nd of March 2021.

4.3 Equipment

Part of the requirements of the 17025 international standard for laboratory accreditation is that the la-

boratory shall have available and access to appropriate equipment for a correct performance of its la-

boratory activities. Equipment includes measuring instruments, software, measurement standards, ref-

erence materials, reference data, reagents, consumables or auxiliary apparatus.

Therefore, one project activity focused on the procurement of new equipment, purchase of needed con-

sumables as well as rehabilitation and upgrade of existing equipment to strengthen the technical capac-

ities. As indicated in the DOA, this activity focused on a long-term and sustainable capacity building.

For the basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs in Vyshgo-

rod the following equipment was procured, purchased and delivered:

One Gas Chromatograph tandem mass spectrometer (GC-MS/MS) for determination of

a wide range of organic pollutants

One Atomic Absorption Spectrometer (AAS) for determination of inorganic pollutants

(metals, heavy metals)

One Atomic Fluorescence Spectrometer (AFS) for determination of mercury in very low

concentration ranges

One Microwave Digestion System for inorganic sample preparation

One Water Purification System

One Solid Phase Extraction System for organic sample preparation

One Solvent Evaporation System for organic sample preparation (concentration of ex-

tracts)


10

Kjeldahl Analyzer for determination of total (Kjeldahl) nitrogen

Rotavapor for concentration of sample extracts

Laboratory dishwasher

Magnetic stirrers

Various consumables, e.g.: chemical standard solutions, certified reference materials,

solvents, reagents, glassware

ISO standards for analytical test methods

For the laboratory of surface water pollution observations of the Central Geophysical Observatory (CGO)

named after Boris Sreznevsky in Kyiv one thermoreactor and one Kjeldahl Analyzer for determination

of total (Kjeldahl) nitrogen was procured, purchased and delivered.

4.4 Validity of results

The international standard 17025 for laboratory accreditation has been developed to promote confi-

dence in the operation of laboratories. Laboratories, which comply with the requirements of this stand-

ard, are able to generate valid results. To ensure the validity of results, the validity shall be regularly

monitored. This monitoring includes among other measures the participation in interlaboratory compar-

isons and proficiency testing schemes. This external quality control measure allows laboratories to mon-

itor their performance by comparing their data with other laboratories.

Therefore, one project activity allowed the partner laboratories to participate in proficiency testing (PT)

schemes organized by UBA for selected groups of chemical compounds in surface waters. UBA is ac-

credited proficiency testing provider according to EN ISO/IEC 17043 “Conformity assessment — Gen-

eral requirements for proficiency testing” since 2017 for the area of air quality, since 2020 in addition for

the area of chemical testing in water.

Partner laboratories from Ukraine participated in the following proficiency testing schemes for chemical

analysis in water:

Date Name

of PT Parameters submitted parameters

Feb

2018

M140 Al, As, Pb, Cd, Cr, Fe, Cu, Mn, Ni,

Hg, Se, U, Zn

Ukrainian Hydrometeorological

Institute: Pb, Fe,Cu, Ni, Zn

Feb

2018

N140 Total hardness, alkalinity, electrical

conductivity (25°C), HCO3-, Ca2+,

Mg2+, Na+, K+, NO3-, NO2

-, NH4+, Cl-,

SO42-, o-PO4

3-, B, DOC, total-P

(dissolved), pH, total-N

No results submitted

Due to technical problems, the participation in the 2nd round of proficiency tests in 2020 could not be

realized.


4.5 Management System Documentation

In order to facilitate consistent laboratory operations, the establishment and maintenance of an appro-

priate management system documentation is required by the 17025 international standard for laboratory

accreditation.

The basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs is not accred-

ited yet as testing laboratory according to the international standard EN ISO/IEC 17025 at the national

accreditation agency of Ukraine (NAAU). With the assistance of UBA laboratory experts and a local QM

expert the needed documentation was prepared, allowing the basin laboratory to start the application

for initial accreditation at NAAU in summer 2021.

During missions and training activities, numerous tools and guidance documents have been provided

by the EUWI+ project to help the partner laboratories in implementing the new aspects and requirements

of the new edition, e.g.:

EN ISO/IEC 17025:2017 transition plan

Competence matrix

Failure Mode Effects Analysis (FMEA) worksheet for risk identification and assessment

Templates and examples for specific topics from the UBA laboratory management system documenta-

tion were provided and shared, where requested by the partner laboratories. In addition, either during

missions, carried out by UBA laboratory and quality management experts or via e-mail, various aspects

and possibilities of practical implementation in the laboratories daily working routine were discussed with

the basin laboratory of the Interregional Office of Protective Arrays of Dnipro Reservoirs.

4.6 Remote Audit

One Pre-Audit Assessment Report for each of the six EUWI+ partner countries is defined as deliverable

in the DOA. The originally planned audit missions for an on-site audit were cancelled due to the world-

wide Covid-19 pandemic and related restrictions and containment measures. Instead, one remote audit

with representatives from the basin laboratory of the Interregional Office of Protective Arrays of Dnipro

Reservoirs in Vyshgorod, the local QM expert and UBA laboratory experts was held on 14th of December

2020.

Prior to this remote audit, the UA partner laboratory completed an audit checklist, which was used as

starting point for the audit questions and selection of evidence for implementation.

4.6.1 Audit findings

The quality management system documentation follows the structure of the new standard edition EN

ISO/IEC 17025:2017 and comprises all needed quality and technical procedures as well as records

requested by the standard.

All documents are finalized and will be officially approved by the Head of the Interregional Office of

Protective Arrays of Dnipro Reservoirs in January 2021. After selection of test methods for the envisaged

scope of accreditation, all application documents can be submitted at NAAU for the initial accreditation,

which is envisaged for summer 2021.


12

4.7 Study Visit

A one week study visit to Austria in October 2019, organized by UBA, offered the opportunity for intense

exchange of experience of different aspects and requirements of quality management and accreditation

for the EUWI+ partner laboratories, responsible for the WFD compliant national water monitoring.

Objective of this study visit was to demonstrate the practical hydro-chemical implementation of the Water

Framework Directive (WFD) in Austria related to accreditation according EN ISO/IEC 17025. Two par-

ticipants of each designated partner laboratory from Armenia, Azerbaijan, Belarus, Georgia, Moldova,

and Ukraine, in particular laboratory personnel responsible for the implementation of a WFD-compliant

water quality monitoring joint the study visit.

Main topics:

Information about the implementation of WFD in Austria (from sampling to data reporting)

Practical implementation of the WFD monitoring in Austria

Field trips and visits of accredited partner laboratories

Practical implementation of the EN ISO/IEC 17025 requirements in selected laboratories in Austria

The Study Visit Report is published under https://euwipluseast.eu/en/component/content/article/445-all-

activities/activites-global-project-2/all-reports-global-project/781-study-visit-report-aspects-of-labora-

tory-accreditation-and-implications-in-the-day-to-day-practice?Itemid=397

https://euwipluseast.eu/en/component/content/article/445-all-activities/activites-global-project-2/all-reports-global-project/781-study-visit-report-aspects-of-laboratory-accreditation-and-implications-in-the-day-to-day-practice?Itemid=397




5 CONCLUSION & RECOMMENDATIONS

For the successful passing of the external accreditation audit, planned to be carried out by NAAU, the

national accreditation body of Ukraine in summer 2021, all needed documentation according to the re-

quirements of the ISO/IEC 17025:2017 international standard including analytical test methods shall be

completed and approved.

In order to enhance the technical capabilities especially for WFD relevant priority substances, it is rec-

ommended, to gradually expand the analytical scope.

Any emerging problems or comments can still be addressed to the UBA experts or will become subject

of the future EU support.

The collaboration between the UA partner laboratories and UBA experts during the EUWI+ project ac-

tivities was characterized by a trusted relationship, which allowed open and fruitful discussions and an

open dialogue.

The installation, acceptance and commissioning of the new equipment, procured under the EUWI+ pro-

ject shall be completed, accompanied by instrument and software trainings by the supplier.

Still pending specific method trainings with new equipment, originally planned as huge project activity in

the EUWI+ project, shall be conducted in a follow-up project. At present, the existing restrictions and

containment measures due to the Corona Pandemic make the planning of these trainings highly uncer-

tain.

www.euwipluseast.eu

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