Why ISO Accreditation Matters; Not just to the Laboratory and its Immediate Client But to All Stakeholders

Transcription

1 16 th Annual Conference, Gatineau, PQ 2014 October 27 to 29 Why ISO Accreditation Matters; Not just to the Laboratory and its Immediate Client But to All Stakeholders Klas Ohman, Ph.D., P.Eng. Ken Middlebrook, M.Sc.

2 Presentation Overview Why is ISO Relevant? What happens without accreditation? What s with all the terminology & reporting? What about the samples? What about on-line vs laboratory data Does uncertainty really matter? What do I do about U.S. data? Why should I care

3 Why is ISO Relevant?

4 Walkerton Event (May, 2000) Justice Dennis O Connor Walkerton Report of 2002 (Part Two Chapter 9) What about Milwaukee (1993)? Or North Battleford (2001)? But it wasn t the laboratory, was it? Did you not hear about Sydney, Australia (1998)???? Why this is important

5 Another wake up call? North Battleford guilty, fined for water records non-compliance Sloppy water quality record keeping has the City of North Battleford in trouble with environment officials. The City entered a guilty plea Thursday to a charge under the Environmental Management and Protection Act of failing to comply with a Permit to Operate. The City failed to conduct specified sampling and/or monthly reviews, provide turbidity trending data and maintain operational records or logs, contrary to section 23(6) and 74(2) of the Environmental Management and Protection Act, Why this is important March 30, 2012 to Aug. 01, 2013

6 Why is ISO Relevant? Ppqd-level measurements becoming the norm Regulatory changes On-line instrumentation Laboratory accreditation Can save you/client $$$ and embarrassment Fox can t look after the henhouse

7 What Happens without Accreditation?

8 What Happens Without Accreditation? Not the following: Technical & logistical qualifications QMS & Qualification System Documentation Data Review Procedures Subcontracts Assessments Parameter analyses accredited? By who? Potential for Consistent Multi-facility Lab. Analysis Proficiency Testing (perhaps)

9 What s with the Terminology and Reporting?

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11 What s with the Terminology and Reporting? What to look for?? Turnaround time Method % Recovery QA/QC Report Trend information Duplicates Knowledge of Account Manager Where the analyses was undertaken So.who is checking to see this is all correct?

12 What s with the Terminology and Reporting? Document Control This is what it s about What about Assessments? How often? What s involved? What about the laboratory? What are they providing - is there a value add?

13 What s with the Terminology and Reporting? ISO Do your clients really know, and do they appreciate what it provides them with? Or Not?? Say and Do It s about showing that you do what you say you do and what if you don t?

14 What about the samples?

15 Representative Samples Grab samples Flow or time composited samples Composited samples Physical/chemical/micro. makeup and preservation Solids Groundwater

16 Much depends on the knowledge and conscientiousne of the sampler An analysis is only as good as the sample taken

17 What about on-line vs. laboratory information?

18 On-line Information Used extensively in water supply and wastewater system systems Trust level in the instrumentation can vary depending on the operator Typically the cleaner the matrix, the more trusted the on-line value; dirtier the matrix the less trust Which is better?

19 Does Uncertainty Really Matter?

20 Uncertainty & Accreditation Uncertainty is contentious! Significant effort spent to address analysis uncertainty 1=2 for certain analytes $M s in client expenditures can hang in the balance

21 Accreditation Accreditation only CALA, SCC and CEAEQ accredit laboratories to the ISO standard in Canada Ontario unique accreditation requirements, and undergo assessments from CALA/SCC

22 Ontario Drinking Water Process Laboratories Different protocols Two MOE inspections a year, one announced & one unannounced Licensed by MOE (not accredited) Regulatory compliance focus Accreditation agency (CALA/SCC) required to report a regulatory noncompliance to MOE

23 Accreditation SCC, CALA and QMPLS are all ILAC signatory. CEAEQ is not

24 What do I do about US data?

25 USA vs. Canadian Laboratories USA: Accreditation system more fractured At least 8 different accreditation agencies ties to ILAC Over 50 agencies accredit to ISO Clients assume accreditation = quality and accuracy (is this really the case??) Is this a problem in a global economy??

26 Why should I care?

27 Terminology & Reports A Typical Report: What to look for Analyte Info. (Geosmin) Sample Rec d Date and Time Analysis Approval Date Analysis Start Date Analysis Finish Date % Rec. Method M.D.L. (ppt) Location Sampled (Treated) Lab. A (ppt) Location Sampled (Treated) Lab. B (ppt) Cost Sample Date and Time Finished Finished Trace Organic Anallyte (A) (B) (A) (B) (A) (B) SM-6040D SM-6040D(M) <5.0 < <10.0 $ $350.00

28 Saving $$$ Many regulations linked to analytical info. Lab. mistakes and misinterpretation can lead to $$$$ s.. (lots of them). Examples.

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36 Some caution In the data set, non-accredited labs will have a higher proportion of very small labs and industrial labs; they may have less sensitive equipment; nevertheless their performance may perfectly suit their needs. Users of laboratory data need to make themselves aware of their lab s performance history.

37 Acknowledgements All CALA Staff and Colleagues as well as Rick Wilson, former CEO of CALA

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39 Is this data real or not?

40 Is this data real or not?

41 USA vs. Canadian Laboratories Canada: Only CALA and SCC accredit laboratories to a ISO standard ISO only applies to labs ISO 17025: all labs are not equal

42 Terminology & Reports MDL Method Detection Limit Result <MDL analyte not detected LOQ Limit of Quantitation Limit where quantitative results may be obtained with a certain level of confidence

43 Terminology & Reports RDL Reportable Detection Limit Usually 2 X the MDL, but not always PQL Practical Quantitation Limit Normally 3 to 10 times the MDL and is considered the lowest concentration that can be accurately measured (compared to detected). Percent Recovery % R - %- recovery for an analyte based on a spiked sample

44 Terminology & Reports Blanks Identify contamination 5 different types: Equipment Blank Field Blank Trip Blank Method Blank Instrument Blank

45 Terminology & Reports Data Validation QMS Frequency varies - used to evaluate lab performance for a specific analyte A lab s quality management system

46 Terminology & Reports Duplicate Frequency varies - used by the laboratory to evaluate their performance for a particular analytical method Can be from one client or many clients

47 Terminology & Reports PT Proficiency Tests Spikes Determined for individual labs, for specific tests Spiked samples with known quantity of analyte used to determine % recovery

48 On-line Information Ensure calibration checks are followed Always have a way of ensuring laboratory back-up for on-line instruments Province/Territory may require analytical info from an ISO accredited lab

49 Is this data real or not?

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