Qa/ Qc Implementation / Proposal for a Questionnaire to Ms

Contact: [email protected]

QA/ QC IMPLEMENTATION / PROPOSAL FOR A QUESTIONNAIRE TO MS

AIM : Exchange of current practices and approaches to implement QA/QC directive .

Some aspects of the directive need to be clarified or at least harmonized in view of comparability at European level.

DEADLINE FOR COMMENT ON QUESTIONNAIRE : 21 December, 2010

Planning : January 2011-Mid February : Answer collection

March 2011: Report with needs and recommendations.

COUNTRY : Sweden…………………………………….

NAME: …………………………………….

Organisation: Swedish EPA and Geological Survey of Sweden…………………………………….

Do you think this could help your country to implement QA/QC: YES or NO

Depends on the time frame. In the initial faze dealing with getting the formal regulation in place, this activity and questionnaire probably comes to late. But in the longer run this initiative could be of help concerning issues like review/development of national guidance and manual documents.

If YES, would you like to be active in this activity (Conference call meeting in a small group):

In general positive but to early to say because of several reasons, one being that a new agency for water related issues is forming in Sweden. This makes the responsibility of future QA/QC related work unclear at the moment.

NAME and mail address: General aspects of the QA/QC Directive Topic Question(s) Answer(s)

Scope of QA/QC From your understanding, what are the Sweden’s interpretation of the QA/QC directive is that it concerns parameters concerned with this directive? 1) For surface water, monitoring of chemical status, i.e. the daughter directives to directive 76/464/EEG, (directive 2008/105/EG and directives 2006/44/EG (previously 78/659/EEG) and 2006/113/EG (previously 79/923/EEG) and that article 4.1 thus concerns only these EU common environmental quality standards. Sweden has regulated the river basin specific pollutants under ecological status.

In connection to this we also wonder what article 4.2 in the directive intends to regulate?

2) For groundwater, parameters concerned are regulated by directive 2006/118/EG. That means all relevant parameters that are causing GWB to be at risk for not meeting WFD Article 4 objectives or good groundwater chemical status.

Quality Management What type of quality management Do this refer to the laboratories or to the management level? System system(s) in your country will be implemented in order to follow QA/QC In general we will revise our necessary national regulations in order to directive? fulfil the requirements in the directive.

If there will be no change to the current Today the laboratories involved with monitoring for WFD compliance situation, could you explain briefly the already have demands (not legally binding) on accreditation via national current system that exists? How will the contract and/or procurements. These labs are thereby followed up by the directive requirements be checked? Swedish accreditation body accordingly.

Organization in MS Are the operational activities ‘sampling Water monitoring programs (WFD) can be contracted to both private labs and analysis” for water monitoring and/or public and university institutes. program (WFD) contracted to private labs or public institutes (one or more)?

Aspects of sampling under the QA/QC Directive Topic Question(s) Answer(s)

Do you in your country consider No. Relevance for sampling sampling to be covered by this directive?

In case you have a quality management No, not for quality management system, but some part of sampling are system for sampling, describe it briefly. Is however covered by sampling laboratories accredited to ISO 17025. it organised through ISO 17025? In Sweden, guides in form of investigation methods to national monitoring are central to the quality assurance. They are designed to be useful also for monitoring at the local level and in sectoral, voluntary and other contexts. A guide will cover central aspects of the quality assurance Sampling and QA/QC process, such as recommendations on the planning and implementation of monitoring as well as specifics of study design, sampling methods and techniques. The guides include references to standard methods, in the case of sampling for example: ISO 5667-1:2006 Water quality – Sampling – Part 1: Guidance on the design of sampling programmes and sampling techniques. ISO 5667-11 (1991) Water quality – Sampling – Part 11: Guidance on sampling of groundwater’s. (International standard) Sampling by externals In case that sampling is done by external The Swedish EPA no longer holds any own labs or field personnel. organisations, who is responsible for the Sampling (as analysis) are therefore done by contracted parties (i.e. results? Illustrate briefly this aspect. private consultants, university institutes, county administrative boards, etc.) Personnel performing sampling shall be “certified” accordingly.

National/regional clients (i.e. EPA, water authorities, SGU) are responsible for the results when published.

Limit of quantification (LQ) and Limit of detection (LQ) under the QA/QC Directive Topic Question(s) Answer(s)

LQ The definition of LQ (limit of No definition yet. Sweden are in faze of drafting the formal regulation at quantification) indicates an « acceptable » the moment. level of accuracy and precision. Which level will be defined in your country?

Best available techniques How do you define the concept of “best No definition yet. Sweden are in faze of drafting the formal regulation at available techniques not entailing the moment.. excessive costs” in view of the required minimum limit of quantification?

Who is responsible to define this concept?

How do you decide that a given LQ is not achievable?

Limit of detection Do you think that LD is needed in the No when it comes to EU reporting under the WFD in order to follow the reporting format? Why? directive.

Yes when it comes to national reporting to our data hosts, for trend monitoring and trend analysis, statistical evaluation of data, etc.

Below LQ Do you consider calculation of the mean No specific guidelines yet. Sweden are in faze of drafting the formal with LQ/2 is only applicable if analytical regulation at the moment. performance criteria (LQ

concept?

On which criteria?

Field measurements Topic Question(s) Answer(s)

Field measurements and Do you consider that field measurements No. See answer to “Scope of QA/QC directive” ISO 17025 (pH, Oxygen, etc…) have to be undertaken through ISO 17025

How is it organised on site? In some cases measured by laboratories accredited (ISO 17025) for on site analysis and sampling. Otherwise measured by sampling personnel.

Proficiency testing (PT) schemes and the QA/QC Directive

Topic Question(s) Answer(s)

Compatibility of PT How do you assure that PT schemes Via today’s accreditation. schemes samples are compatible with monitoring samples in terms of concentration? In terms of matrices?

Accreditation Have you some requirements concerning The demand of accreditation for PT provider is written in the drafts of the the quality management system of PT formal regulations. providers? Should they be accredited? However, the PT-provider in Sweden today, follows quality management systems but are not formally accredited (by the Swedish accreditation body). This is still an outstanding issue whether this or any other organisation will be accredited (for ISO 17043) or not. If not, our labs would have to use international accredited PT providers/network (PT- WFD).

Do you implement criteria Accredited laboratories use requirements and guidelines from European co-operation for Accreditation and ILAC. Criteria for PT schemes - for laboratory results to PT Schemes?

- for annual participation frequency?

Do you have some requirement for No, but will be according ISO 13528. PT scheme scoring system of PT scheme scoring?