TESTE DE

COMPETENTA

Ciprian Mihai Vatca

Account Manager

Octombrie 29, 2019

Iasi, Romania
 Ce sunt testele de competenta (PT)
Laboratoare de analiza si control

Schemele de competenta sunt o combinatie de servicii si

produse utilizate de organismele acreditate conform cerintelor ISO 17025

• Schemele de competenta sunt parte a sistemului de asigurare a calitatii rezultatelor

• Schemele se organizeaza dupa un program prestabilit si in varianta Quick Turn
• Rezultatele participantilor sunt evaluate si se emite un raport de evaluare
Ce sunt testele de Competenta (PT)

La ce folosesc?

“Scopul principal al schemelor de competenta este de a evalua performanta laboratoarelor.

Cele mai multe laboratoare lucreaza independent si nu au oportunitatea de a-si compara
valorile. In aceste conditii exista riscul de a genera rezultate eronate.

Organismele de acreditare solicita participari la astfel de scheme

Este o cerinta pentru laboratoarele acreditate conform cerintelor ISO 17025
Este un instrument critic pentru imbunatatirea continua a
managementului calitatii.
Ce sunt testele de Competenta (PT)

La ce folosesc?

Ce garanteaza faptul ca rezultatele generate de laborator sunt corecte?

➢ Metode validate

➢ Materiale de referinta certificate

➢ Sistem de management al calitatii implementat

➢ Acreditare conform cerintelor - ISO/IEC 17025

Ce sunt testele de Competenta (PT)
)
La ce folosesc?

Ce garanteaza faptul ca rezultatele generate de laborator sunt corecte?

➢ Metode validate

➢ Materiale de Referinta Certificate

Control Intern
➢ Sistem de management al calitatii

➢ Acreditare - ISO/IEC 17025

Participarea la PT = Control Extern

Ce sunt testele de Competenta (PT)
La ce folosesc ?

In timp, schemele de competenta ajuta la:

 Evaluarea performantelor analistilor

 Performantele instrumentelor

 Acuratetea metodelor si evaluarea tendintelor

 Performanta sistemului de management al calitatii.

Cum participam?
Laboratoarele participante trebuie:

• Sa aleaga studiul la care vor sa participe si probele de interes

• Sa comande probele (PT sau QC)
• Sa primeasca si sa receptioneze probele
• Sa le inregistreze si sa le puna in lucru in accord cu metodele utilizate si cu indicatiile
primite
• Sa raporteze rezultatele
• Sa primeasca raportul de evaluare
Etape:
Teste de Competenta

Procesul de desfasurare

1 2 3
Inregistrare & Comanda Livrare Studiu deschis
Inainte de prima comanda laboratoarele Se trimit probele catre beneficiar Fiecare laborator trebuie sa lucreze
trebuie sa obtina un cod de laborator probele lucrate.
care se obtine prin inscrierea
laboratorului pe portalul Sigma PT.

4 5 6
Raportatea rezultatelor Procesarea Datelor Raport de Evaluare
Laboratoarele trebuie sa introduca Sigma-Aldrich RTC proceseaza Rapoartele de evaluare sunt trimise in
rezultatele obtinute in portalul PT Sigma rezultatele primate si genereaza format PDF si sunt disponibile in Portalul
prelucrari statistice Sigma.
Inregistrare
Detalii:

Clientii noi se iregistreaza la

https://merck-
pt.com/user/login?destina
tion=/pt-participant
Aici isi pot seta parola pentru a
accesa portalul pentru raportare.

Site-ul se utilizeaza pentru

introducerea rezultatelor
Inregistrarea trebuie facuta inainte de lansarea
comenzii. Codul de laborator (LABCODE) se primeste
dupa ce se aproba inregistrarea (nu mai mult de 48 ore)
 Studii disponibile
Merck ofera:

Experienta ca furnizori de scheme de competenta de peste

20 ani

Probele din PT sunt produse la grad de MRC

Mai mult de 20’000 probe sunt disponibile
2’500
La scheme participa peste

laboratoare la nivel
global
www.sigma-aldrich.com/PT
Oferta de scheme de competenta:
Probe de mediu:
Matrici:
• Apa potabila - 116 probe, 4 runde pe an
• Apa Uzata - 139 probe, 6 runde pe an
• Sol - 37 probe, 4 runde pe an
• Aer - 23 probe, 2 runde pe an

Analiti:
 Metale
 PAHs
 Poluanti
 Pesticide
 Micro-Organisme
www.sigma-aldrich.com/PT
Oferta Scheme de Competenta
Merck ofera: Flexibilitate
&
Incredere
Teste de competenta:

- Acreditate de ACLASS conform cerintelor ISO/IEC

17043: 2010 (Certificat Nr. AP-1469)
- Recunoscute de toate organismele de acreditare la nivel
global
Scheme de competenta WP - pentru probe de apa uzata
Cum se aleg probele: WS - pentru probe de apa potabila
Domeniile de concentratii ale
Apa Potabila vs. Apa uzata micropoluantilor sunt diferite.
Scheme de competenta Certificatele de analiza sunt disponibile
Cum se aleg probele: pentru descarcare pe site
sigmaaldrich.com.

Probele PT incep cuSPE sau PE

Porbele QC incep cu SQC sau QC
Teste de competenta
vs. materiale de referinta

Certificatele de analiza pentru materialele de referinta sunt

disponibile online
Scheme de competenta
Alegerea probelor

Studii programate:

• Portofoliu extins

• Raportul de evaluare se obtine in 21 zile

Quick Turns:

• Utilizate ca actiuni corrective

• Raportul de evaluare se obtine in 48-72 ore

Etape:
Teste de Competenta

Procesul de desfasurare

1 2 3
Inregistrare & Comanda Livrare Studiu deschis
Inainte de prima comanda laboratoarele Se trimit probele catre beneficiar Fiecare laborator trebuie sa lucreze
trebuie sa obtina un cod de laborator probele lucrate.
care se obtine prin inscrierea
laboratorului pe portalul Sigma PT.

4 5 6
Raportatea rezultatelor Procesarea Datelor Raport de Evaluare
Laboratoarele trebuie sa introduca Sigma-Aldrich RTC proceseaza Rapoartele de evaluare sunt trimise in
rezultatele obtinute in portalul PT Sigma rezultatele primate si genereaza format PDF si sunt disponibile in Portalul
prelucrari statistice Sigma.
Ce sunt testele de competenta(PT)
Ce contine o proba pentru testele de competenta?

O proba care contine analitul/analitii de interes, intr-o matrice, imbogatita la o anumita

concentratie.
Probele sunt analizate si caracterizate de Sigma-Aldrich RTC inainte de a fi introduse in
scheme avand pentru fiecare analit in parte o valoare atribuita.
Ce sunt testele de competenta (PT)
Ce alte informatii primim odata cu probele?

Un pachet de raportare contine toate instructiunile de pregatire a

probelor, modul de raportare a rezultatelor, domeniul de concentratie in
care se afla analitul de interes si orice alta informatie necesara pentru
buna desfasurare a analizei.
Aceste informatii sunt transmise clientului si pe adresa de mail
inregistrata in portalul PT.
Etape:
Teste de competenta

Procesul de desfasurare

1 2 3
Inregistrare & Comanda Livrare Studiu deschis
Inainte de prima comanda laboratoarele Se trimit probele catre beneficiar Fiecare laborator trebuie sa lucreze
trebuie sa obtina un cod de laborator probele lucrate
care se obtine prin inscrierea
laboratorului pe portalul Sigma PT.

4 5 6
Raportatea rezultatelor Procesarea Datelor Raport de Evaluare
Laboratoarele trebuie sa introduca Sigma-Aldrich RTC proceseaza Rapoartele de evaluare sunt trimise in
rezultatele obtinute in portalul PT Sigma rezultatele primate si genereaza format PDF si sunt disponibile in Portalul
prelucrari statistice Sigma.
.
Scheme de Competenta– Raportul

Raportul este trimis in format PDF si contine:

• Un raport de evaluare pentru fiecare studiu

• Scorul Z pentru fiecare valoare raportata cu recomandarile noastre:

• +/- 3 pentru apa uzata si sol

• +/- 2 pentru probe de apa potabila

• Explicatii despre prelucrarea statistica a rezultatelor

• Informatii despre acreditarea confor cerintelor ISO 17043

Interpretarea rezultatelor:
Date statistice importante

Valoarea atribuita: Valoarea utilizata pentru evaluarea schemelor

σPT: deviatia standard a schemei

Scorul Z oferta informatii cu privire la rezultatul obtinut care poate sa fie mai mare
sau mai mica decat valoarea atribuita. Dar oferta informatii si despre performanta
laboratorului care se poate evalua astfel: pentru un scor z mai mic de 2 rezultatul este
acceptat; pentru o valoare intre 2 si 3 rezultatul este considerat discutabil dar totusi
metoda este tinuta sub control; un scor z mai mare de 3 este considerat
nesatisfacator. Pentru studiile de apa potabila puteti stabili un criteriu mai strans
considerand ca valori z mai mari de 2 sunt nesatisfacatoare.
Teste de competenta
Detalii raport Schema de Competenta:
Studii Quick-Turn (QT) – Scheme de competenta la cerere

Cand un larorator trebuie sa participe la o schema de competenta avand la dispozitie o

perioada scurta de timp, sunt disponibile schemele Quick-Turn.

Studiile Quick-Turns sunt furnizate la aceleasi costuri ca si probele din schemele programate.

In cele mai multe cazuri laboratoarele utilizeaza aceste probe pentru:

• Validarea metodei
• Un instrument pentru actiuni corective
• Pentru instruirea personalului nou angajat
Cum functioneaza studiile Quick-Turn:

1. Gasiti proba potrivita pentru nevoile dumneavoastra care au mentiunea Quick-Turn

2. Probele sunt trimise in cel mai scurt timp posibil

3. Aveti la dispozitie 45 zile de la trimiterea probelor si pana la raportarea rezultatelor

4. Daca obtineti rezultatele mai repede de 45 zile puteti incarca rezultatele in portal. In ziua
in care ati transmis rezultatele studiul se incheie.

5. In 48-72 ore de la transmiterea rezultatelor veti primi raportul de evaluare

 Raportul Final!

Raportul final se trimite catre toate adresele de

email introduse in sistem
Scheme de competenta
Site-ul EPTIS

• Site-ul ajuta la gasirea de scheme de competenta acreditate

• Sigma-Aldich RTC este recunoscut si present pe EPTIS
• Schemele de competenta sunt reinnoite periodic
http://www.eptis.org/
Noutati pentru 2019
Noul portal PT

Noutati:
• Rapoarte detaliate incluzand si prelucrari grafice
• Analiza tendintelor
• Metode noi salvate in portal
• Timp de incarcare mai rapid pentru introducerea
datelor
• Data lansarii nu a fost inca fixata
Multumesc pentru atentie!
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption

The European Commission adopted the draft revised DWD on 1 February. The Council of the
EU has already met three times during the past two months and a policy debate by Ministers
is scheduled for the Environment Council on 25 June

The evaluation identified four areas with room for improvement:

• the list of parameters;
• the use of the risk-based approach;
• increased transparency on water-related issues and giving consumers access to up-to-
date information
• materials in contact with drinking water
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption
1. Parameters that the WHO recommended be removed from Annex I
Because of their low occurrence in drinking water, usually due to pollution incidents, the
WHO report recommended that five parameters be removed from the Directive:
– benzene,
– cyanide,
– 1,2-dichloroethane,
– mercury, and
– polycyclic aromatic hydrocarbons (PAHs).
The WHO justified removing these parameters by explaining that they could still be
monitored where necessary by Member States on the basis of the WHO guidance value.
Stakeholders, and in particular Member States’ authorities, strongly advocated not to
remove them for health reasons and also because of the necessity to have a binding value
set at EU level. It was therefore decided to keep them in Annex I. However, the risk-
based approach set out in the Directive allows water suppliers to remove a parameter from
the list of substances to be monitored under certain conditions; water suppliers therefore
have the right not to monitor those parameters if they are irrelevant in a supply zone. Last
but not least, the treatment plants needed to meet these limit values have already been
built.
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption

2. Parametric values that the WHO recommended be raised

The WHO report recommended updating the value for antimony (up from 5 to 20 μg/l),
boron (up from 1 to 2.4 mg/l) and selenium (up from 10 to 40 μg/l) based on their
latest available health-based guideline values as published in the first addendum to the
fourth edition of the WHO Guidelines. However, since the current values have been in place
for decades, it is assumed that there will be no increased costs as treatment techniques to
meet these limit values are already in place. In any event, the risk-based approach allows
water suppliers to remove a parameter from the list to be monitored under certain
conditions. Therefore original, stricter, values have been maintained in Annex I to the
Directive. Concerning boron more specifically, some national derogations were granted in
regions of high boron-baring rocks where boron occurs naturally in groundwater. Requests to
revise the value for boron also came from the European Parliament (E-9146/2016, P-
0848/2016, E-10 109/2014). Although there is no recent official opinion, the European Food
Safety Authority has in the past recommended52 that — to protect all age groups — natural
mineral water should not contain more than 1.5 mg boron.
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption

3. New parameters recommended for inclusion by the WHO

3.1 Chlorate and chlorite
The WHO report recommended including chlorate (ClO3) and chlorite (ClO2) as new
parameters and to set a value of 0.7 mg/l for both. Both are predominantly disinfection
byproducts using hypochlorite. The WHO recognised that this value may be too high, and
remarked that, if it is feasible to meet lower values.

Therefore, the Commission considers that it is justified to set the value for chlorate and
chlorite at the stricter level of 0.25 mg/l, which is around 3 times lower than
proposed by
the WHO.
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption

3.2 Perfluorinated compounds

The WHO report recommended adopting parametric values for two individual perfluorinated
substances: perfluorooctanesulfonic acid (PFOS) should have a value of 0.4 μg/l and
perfluorooctanoic acid (PFOA) a value of 4 μg/l.

PFOS and PFOA are persistent, bioaccumulative and toxic substances. PFOS was originally
included in the list of restricted substances in Annex XVII to the REACH Regulation54, but is
now regulated as a persistent organic pollutant under Regulation (EC) No 850/200455. PFOA
its salts and PFOA-related substances were added to the list of restricted substances in
Annex XVII to the REACH Regulation on 14 June 201756 as the Commission considered that
manufacturing, using or selling them leads to an unacceptable risk to human health and the
environment.

The proposal is to regulate the group of PFASs, as defined by the OECD60, and to suggest
values of 0.1 μg/l for individual PFAS and 0.5 μg/l for PFASs in total, as is done for
pesticides.
Drinking Water Directive
Draft revised DWD on 1 February
Council Directive 98/83/EC on the quality of water intended for human consumption
4. Endocrine disrupting compounds
The WHO did not propose guideline values for endocrine disrupting compounds (EDCs) but
suggested that - since aquatic life is much more sensitive to the effects of oestrogenic EDCs
than mammals, including humans - it would be possible to use precautionary benchmark
values which are close to existing or possible future environmental quality standards, for the protection
of aquatic life.

The following three representative EDCs and benchmark values were proposed by the WHO:
– beta-estradiol: 0.001 μg/l;
– nonylphenol: 0.3 μg/l;
– bisphenol A: 0.01 μg/l

The three substances were chosen as benchmarks because they are known to be present in
surface water sources impacted by treated sewage effluent and other discharges.

These compounds are relatively insoluble in water and are effectively removed by conventional
adsorption treatment methods (e.g. bank filtration, coagulation, ozonation, granular activated carbon).
The compounds will therefore be considered as any other chemical parameter under the Directive,
meaning, as mentioned above, that water suppliers have the possibility to remove these parameters
from the list to be monitored under certain conditions, if a risk assessment concludes they are irrelevant
Drinking Water Directive
Draft revised DWD on 1 February

Council Directive 98/83/EC on the quality of water intended for human consumption

5. Chromium and lead

The WHO report recommends maintaining the current parametric value of 10 μg/l for lead
and of 50 μg/l for chromium total.
The WHO remarks that lead is one of few substances known to cause direct health impacts
through drinking water, and that concentrations should be therefore as low as reasonably
practical. To that end, the Commission therefore proposes lowering the value to 5 μg/l
10 years after the entry into force of the Directive. During this transitional 10-year period,
the current value of 10 μg/l will be maintained.

The WHO remarks that the value for chromium remains under review. Ongoing discussions
with many toxicologists suggest introducing a lower value for chromium, and in particular for
the more toxic Chromium VI. The Commission will therefore apply to chromium the same
approach taken for lead. It proposes reducing the value by 50 % to 25 μg/l after a
transition period of 10 years after the entry into force of the Directive.