Manfred Kindler Consultant PTB - · PDF file1 Case Officer of Acc. Body Special Guests of...

Kindler Berlin 2004 1

Proficiency Testingin the Accreditationof Testing Laboratoriesin Germany

Manfred KindlerConsultant PTB

Proficiency TestingProficiency Testingin in the Accreditationthe Accreditationof Testingof Testing LaboratoriesLaboratoriesin in GermanyGermany

Manfred KindlerManfred KindlerConsultant Consultant PTBPTB


DAP DAP GermanyGermany24 24 EmployeesEmployees

4 4 BoardsBoards80 80 MembersMembers

16 16 Technical CommitteesTechnical Committees350 350 MembersMembers

14 Partner 14 Partner InstitutionsInstitutions400 400 trained trained AssessorsAssessors

1.100 1.100 Technical ExpertsTechnical Expertsnational national and internationaland international ofof all all branchesbranches

Birth: 1989 as BAM-ASStart: 1994 as priv. DAP• 700 Accreditations of Testing Labs, Inspection Bodies, Certification Bodies for Products in 12 countries• 50 Proficiency Tests for 3.000 Labs in 30 countries


Proficiency TestingIn GermanyProficiency TestingProficiency TestingIn In GermanyGermany


Proficiency Tests in Germany:• Samples are water, soil, food, body fluids,steel bars etc.• Several times per year or period.• Mostly technique of split-sample testing is used.• Number of participants: 20-100, located in several countries.

Proficiency Proficiency Tests in Tests in GermanyGermany::•• Samples Samples are waterare water, , soilsoil, , foodfood,, body fluidsbody fluids,,steel bars steel bars etc.etc.•• Several times Several times per per year or periodyear or period..•• Mostly technique of splitMostly technique of split--samplesample testing is used testing is used..•• Number of participantsNumber of participants: 20-100,: 20-100, locatedlocated in in several countriesseveral countries..


Determination of assigned value:• Water, soil: Mixing constituents to base material• Asbestos, Blood, simple PTs: Use of Reference Laboratories• Steel, other: Use of Certified Reference Materials• Consensus Values: Chocolate Drink Powder etc.

DeterminationDetermination ofof assignedassigned valuevalue::•• WaterWater, , soilsoil: : Mixing constituentsMixing constituents to to base materialbase material•• AsbestosAsbestos, , BloodBlood, simple , simple PTsPTs: : Use of Reference Laboratories Use of Reference Laboratories•• Steel Steel, , otherother: : Use of CertifiedUse of Certified Reference Reference Materials Materials•• Consensus ValuesConsensus Values: : Chocolate Chocolate Drink Drink Powder Powder etc.etc.


Frequency of Proficiency Tests:• Water: 2-4x per year• Food: 2-4x per year• Clin.Diagnostics: 4x per year• Mechanics: 1x per year• other: 1–10x per 5 years offered by 150 PT-Providers

FrequencyFrequency ofof ProficiencyProficiency Tests: Tests:•• WaterWater: 2-4x per : 2-4x per yearyear•• Food Food: 2-4x per : 2-4x per yearyear•• Clin Clin..DiagnosticsDiagnostics: 4x per : 4x per yearyear•• MechanicsMechanics: 1x per : 1x per yearyear•• otherother: 1–10x per 5 : 1–10x per 5 years years offered by offered by 150 PT-150 PT-ProvidersProviders


Proficiency Test ChemistryInternal Requirements:• Minimum: 10 Laboratories• Range: 10 x Minimum• 3 Concentration Levels• 4 Parallel Measurements• 2 x per Year

ProficiencyProficiency Test Test ChemistryChemistryInternal RequirementsInternal Requirements::•• Minimum: 10 Minimum: 10 LaboratoriesLaboratories•• Range: 10 x Minimum Range: 10 x Minimum•• 3 3 ConcentrationConcentration LevelsLevels•• 4 Parallel 4 Parallel MeasurementsMeasurements•• 2 x per 2 x per YearYear


Teilnehmerzahlen


Proficiency TestingAt DAP GermanyProficiency TestingProficiency TestingAt At DAP DAP GermanyGermany


Advisory Board:1 Member of Technical Comm.1 Specialist for Statistics1 Representative of Labor1 Representative of Industry1 Representative of Ministry1 Case Officer of Acc. BodySpecial Guests of Partners

Advisory BoardAdvisory Board::1 1 Member of Technical CommMember of Technical Comm..1 1 Specialist for StatisticsSpecialist for Statistics1 1 Representative of Representative of LaborLabor1 1 Representative of IndustryRepresentative of Industry1 1 Representative of MinistryRepresentative of Ministry1 1 Case Officer of AccCase Officer of Acc. . BodyBodySpecial Guests of Special Guests of Partners Partners


Partners in PT-Schemes:• BAM, MPAs• Ministries• Universities• Test-Lab Associations• Industry• and other specialised Institutions of the Sector

Partners in PT-Partners in PT-SchemesSchemes::•• BAM, BAM, MPAsMPAs•• Ministries Ministries•• Universities Universities•• Test-Test-Lab AssociationsLab Associations•• Industry Industry•• and other specialised and other specialised Institutions of the Sector Institutions of the Sector


Design and Implementation• Proposal by Technical Comm.• Evaluation by Advisory Board• Decision by Head of Acc. Body• Cooperation with Partners• Design by Ad hoc Task Force• Implementation by Case Officer• Evaluation by Ad hoc Task Force• Control by Advisory Board

Design Design and and ImplementationImplementation•• Proposal by Technical CommProposal by Technical Comm..•• Evaluation by Advisory BoardEvaluation by Advisory Board•• Decision by Head of Acc Decision by Head of Acc. . BodyBody•• Cooperation with Cooperation with PartnersPartners•• Design Design by by Ad hoc Task ForceAd hoc Task Force•• Implementation Implementation by Case Officerby Case Officer•• Evaluation by Evaluation by Ad hoc Task ForceAd hoc Task Force•• Control by Advisory BoardControl by Advisory Board


Proficiency Testing:Problems in PracticeProficiency TestingProficiency Testing::Problems in Problems in PracticePractice


Problems in Practice:- Stability of Samples- Homogeneity of Samples- Cross effects in Matrix- Reference Laboratories- Used Methods and Units- Misunderstandings- „Subcontraction“- „Exchange of Experience“

Problems in Problems in PracticePractice::-- Stability of Stability of SamplesSamples-- Homogeneity of Homogeneity of SamplesSamples-- Cross effects Cross effects in Matrixin Matrix-- Reference LaboratoriesReference Laboratories-- Used Methods and UnitsUsed Methods and Units-- Misunderstandings Misunderstandings-- „„SubcontractionSubcontraction““-- „Exchange „Exchange of Experienceof Experience““


80

85

90

95

100

105

110

115

12012

.02.20

02

19.02

.2002

26.02

.2002

05.03

.2002

12.03

.2002

19.03

.2002

26.03

.2002

02.04

.2002

09.04

.2002

16.04

.2002

23.04

.2002

30.04

.2002

07.05

.2002

14.05

.2002

21.05

.2002

28.05

.2002

3- 3- Months EffectMonths EffectProblem:Problem:

„„Time is runningTime is running““AbsoluteValues

Date ofTesting


Reference Reference Labs Labs ??


# # ofof Samples Samples atat Subcontracted LabSubcontracted Lab

0

20

40

60

80

100

120

1 5 9 13 17 21 25 29 33 37 41 45 49 53

Week 2003

# of Samples


0

5

10

15

20

25

30

35

40

45

50

95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115

Distribution Distribution afterafter „ „SubcontractingSubcontracting““

Frequencies of Non SubcontractingLaboratories

Additional Frequencies ofSubcontractor

AbsoluteFrequency

AbsoluteValues


PT 600 In lb Torque Wre nch

290

295

300

305

310

315

13 3 11 14 5 4 2 7 8 9 10 6 19 Ref 20 1 17 15 16 18 12

PT 600 In lb Torque WrenchLab Mean SD Error

13 291,4 1,2 103 295,02 1,47 6,3811 295,7 0,6 5,714 295,8 1,2 5,65 296 2,96 5,44 298,42 1,47 2,982 298,5 3 2,97 299,8 4,5 1,68 299,86 1,07 1,549 300 1,5 1,410 300,02 2,79 1,386 300,1 4,5 1,319 300,87 9,89 0,53

Ref 301,4 1,57 020 301,8 1,2 -0,41 302,7 0,91 -1,317 302,7 0,91 -1,315 303,3 1,5 -1,916 303,4 1,2 -218 304,93 0,37 -3,5312 306 1,5 -4,6

PT 600 In lb Torque WrenchLab Mean SD Error

13 291,4 1,2 103 295,02 1,47 6,3811 295,7 0,6 5,714 295,8 1,2 5,65 296 2,96 5,44 298,42 1,47 2,982 298,5 3 2,97 299,8 4,5 1,68 299,86 1,07 1,549 300 1,5 1,410 300,02 2,79 1,386 300,1 4,5 1,319 300,87 9,89 0,53

Ref 301,4 1,57 020 301,8 1,2 -0,41 302,7 0,91 -1,317 302,7 0,91 -1,315 303,3 1,5 -1,916 303,4 1,2 -218 304,93 0,37 -3,5312 306 1,5 -4,6

Laboratory

„Exchange „Exchange of Experienceof Experience““


Phenomenon„Mafia Labs“PhenomenonPhenomenon„Mafia „Mafia LabsLabs““


Phenomenon „Mafia-Lab“:- Rumour on the market- Excellent equipment and facilities- No obvious non-conformities- Share of the market: increasing- Order books are well filled- „Customer-focused“ results (Meet the expectations of clients)- Litigious, “Powered with Money”- Dumping prices (sometimes)

Phenomenon „Mafia-Lab“:Phenomenon „Mafia-Lab“:-- RumourRumour on the market on the market-- Excellent equipment and facilitiesExcellent equipment and facilities-- No obvious non-conformities No obvious non-conformities-- Share of the market: increasing Share of the market: increasing-- Order books are well filled Order books are well filled-- „Customer-focused“ results „Customer-focused“ results (Meet the expectations of clients) (Meet the expectations of clients)-- Litigious, “Powered with Money” Litigious, “Powered with Money”-- Dumping prices (sometimes) Dumping prices (sometimes)


Distribution of test-results on the market

0,0

0,5

1,0

1,5

2,0

2,5

3,0

1 11 21 31 41 51 61 71 81 91 101

"Bad" test-results

"Good" test-results Mean-

Value


0,00

0,50

1,00

1,50

2,00

2,50

3,00

1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 67 70 73 76 79 82 85 88 91 94 97 100

"Mafia-Hill"

"Mafia-Hole"

Mean-Value on this

"Mafia-Lab"

Mean-Value on the Market

Distribution Distribution of of „Mafia-„Mafia-LabsLabs““


Proficiency Testing„Asbestos Analytics“Proficiency TestingProficiency Testing„„Asbestos AnalyticsAsbestos Analytics““


PT “Asbestos Analytics”- Use of asbestos was mandatory for fire protection in 70s- In 90s threshold values defined- Huge market for refurbishments- Run of labs for asbestos testing- Used method: Scanner Microscopy- Creation of cartel agreements- Dumping prices and bankruptcies- Boom of accreditations

PT “Asbestos Analytics”PT “Asbestos Analytics”-- Use of asbestos was mandatory Use of asbestos was mandatory for fire protection in 70s for fire protection in 70s-- In 90s threshold values defined In 90s threshold values defined-- Huge market for refurbishments Huge market for refurbishments-- Run of labs for asbestos testing Run of labs for asbestos testing-- Used method: Scanner Microscopy Used method: Scanner Microscopy-- Creation of cartel agreements Creation of cartel agreements-- Dumping prices and bankruptcies Dumping prices and bankruptcies-- Boom of accreditations Boom of accreditations


0

10

20

30

40

50

60

70

80

-50 -45 -40 -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 40 45 50

Problem: Problem: AsbestosAsbestos--AnalyticsAnalytics

Expected DistributionAllowedLimit

"Bad" test-results:High contamination

"Good" test-results:Low contamination


0

5

10

15

20

25

30

35

40

45

50

-50 -45 -40 -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 40 45 50

Distribution of a „Mafia-Lab“


AllowedLimit

"Mafia-Hole"


0

10

20

30

40

50

60

70

80

-50 -45 -40 -35 -30 -25 -20 -15 -10 -5 0 5 10 15 20 25 30 35 40 45 50

Fictive Clients

Client-Group A:Owner of buildings

Client-Group B:Disposal companies



PT “Asbestos Analytics”- 2 years, 30 participants, 4 plates- 4 reference laboratories- Advisory board with representative of Standardisation body- Problem 1: Stability, damages- Problem 2: Homogeneity- Problem 3: Statistical evaluation- Problem 4: Personal resources- Problem 5: Financial resources

PT “Asbestos Analytics”PT “Asbestos Analytics”-- 2 years, 30 participants, 4 plates 2 years, 30 participants, 4 plates- 4 reference laboratories- 4 reference laboratories-- Advisory board with representative Advisory board with representative of of StandardisationStandardisation body body-- Problem 1: Stability, damages Problem 1: Stability, damages-- Problem 2: Homogeneity Problem 2: Homogeneity-- Problem 3: Statistical evaluation Problem 3: Statistical evaluation-- Problem 4: Personal resources Problem 4: Personal resources-- Problem 5: Financial resources Problem 5: Financial resources


PT “Asbestos Analytics” - Results- Evaluation time: 8 months- Validation of modified statistical method was necessary- Specialized software was developed - Hugh costs for personal and meetings (at least 30 specialists involved)- Since 1998 not any new PT Asbestos has started in Germany

PT “Asbestos Analytics” - ResultsPT “Asbestos Analytics” - Results-- Evaluation time: 8 months Evaluation time: 8 months-- Validation of modified statistical Validation of modified statistical method was necessary method was necessary-- Specialized software was developed Specialized software was developed -- Hugh costs for personal and meetings Hugh costs for personal and meetings (at least 30 specialists involved) (at least 30 specialists involved)-- Since 1998 not any new PT Asbestos Since 1998 not any new PT Asbestos has started has started in Germanyin Germany


Proficiency TestingIn MetallographyProficiency TestingProficiency TestingIn In MetallographyMetallography


DecisionmakingDecisionmaking


OrganisationOrganisation


PartnersPartners


PT-PT-GroupsGroups


ISO 17025 vs.ISO 17025 vs.EN 45001EN 45001


2 2 PTs PTs in 1in 1


Problem:Problem:„„Time is runningTime is running““

Photos Photos asas Samples Samples


Proficiency TestingSome EffectsProficiency TestingProficiency TestingSome EffectsSome Effects


Cusum Analysis

-7,0%

-6,0%

-5,0%

-4,0%

-3,0%

-2,0%

-1,0%

0,0%

1,0%

2,0%

3,0%

4,0%

5,0%

6,0%

7,0%

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

diff%cusum %

Crom

Random Error

SystematicError

SystematicError


Calcio

-20%

-15%

-10%

-5%

0%

5%

10%

15%

20%

Dez

98

Mrz

99

Jun

99

Sep

99

Dez

99

Mrz

00

Jun

00

Sep

00

Dez

00

Mrz

01

Jun

01

Sep

01

Dez

01

Mrz

02

Jun

02

Sep

02

Dez

02

Mrz

03

Jun

03

ImprovementImprovement

New Equipment


Fosfato

-30%

-20%

-10%

0%

10%

20%

30%

Dez

98

Mrz

99

Jun

99

Sep

99

Dez

99

Mrz

00

Jun

00

Sep

00

Dez

00

Mrz

01

Jun

01

Sep

01

Dez

01

Mrz

02

Jun

02

Sep

02

Dez

02

Mrz

03

Jun

03

PersonnelPersonnel

Maternity


Proteinas

-12%

-10%

-8%

-6%

-4%

-2%

0%

2%

4%

6%

8%

10%

12%

Dez

98

Mrz

99

Jun

99

Sep

99

Dez

99

Mrz

00

Jun

00

Sep

00

Dez

00

Mrz

01

Jun

01

Sep

01

Dez

01

Mrz

02

Jun

02

Sep

02

Dez

02

Mrz

03

Jun

03

LongtimeLongtime Trends Trends

Aging Effects? PT-Provider?


Creatinina

y = 0,0524x - 0,1627R2 = 0,5647

-25%

-20%

-15%

-10%

-5%

0%

5%

10%

15%

20%

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

ConcentrationConcentrationNegative Bias

Positive Bias

Random Error

CONCENTRATION


Calcio

y = 0,0085x - 0,0295R2 = 0,1459

-4%

-2%

0%

2%

4%

6%

8%

10%

12%

14%

8,0 9,0 10,0 11,0 12,0 13,0 14,0

UncertaintyUncertainty??

CONCENTRATION


-5 %

0 %

5 %

10 %

15 %

-5 % % 5 % 10 % 15 % 20 % 25 % 30 % 35 %

Extended Uncertainty %

Diffe

renc

e %

to R

efer

ence

Ni Ni PECd Cd PECu Cu PECr Cr PEPb PE Zn PE Cd

Pb PE

Cu

Ni

Cr

Ni PE

Cu PE

Cr PE

Zn PE

Cd PE

?

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Manfred Kindler Consultant PTB - · PDF file1 Case Officer of Acc. Body Special Guests of...

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