Data Quality in the Data Quality in the Modern Analytical LabModern Analytical Lab

Dr. Roy-Keith SmithDr. Roy-Keith Smith

Apichemical ConsultantsApichemical Consultants

East Lansing, MIEast Lansing, MI

1 May, 20071 May, 2007

General ConsiderationsGeneral Considerations

Legally defensible (Enforcement value of Legally defensible (Enforcement value of data)data)

Analytically valid (Analytical value of data) Analytically valid (Analytical value of data)

Common FoundationCommon Foundation

Approved methods by programApproved methods by program Necessary calibrated equipment and Necessary calibrated equipment and

suppliessupplies Trained personnelTrained personnel Quality Assurance PlanQuality Assurance Plan Certifications/ApprovalsCertifications/Approvals

Public LabsPublic Labs

Allocated funds from legislated budgetsAllocated funds from legislated budgets Slow response to changing regulations Slow response to changing regulations

and technologyand technology Ponderous personnel systems and salary Ponderous personnel systems and salary

restrictionsrestrictions Ample training opportunities and fundsAmple training opportunities and funds Time to do things right and repeat work if Time to do things right and repeat work if

neededneeded

Commercial LabsCommercial Labs

Rapid response to changing regulations Rapid response to changing regulations and technology (few decision makers)and technology (few decision makers)

Immediate hire and fire ability; generally Immediate hire and fire ability; generally higher salarieshigher salaries

Little money available for trainingLittle money available for training Things have to be done correctly the first Things have to be done correctly the first

timetime Over-riding consideration:Over-riding consideration:

Implications of $$$Implications of $$$

Analysis of environmental samples is Analysis of environmental samples is tedious and expensivetedious and expensive

Commercial labs concentrate on high Commercial labs concentrate on high dollar/high volume techniquesdollar/high volume techniques

Minimize services with high labor needs Minimize services with high labor needs and low profit marginand low profit margin

$ always generates the possibility of $ always generates the possibility of abuseabuse

Fiscal Common SenseFiscal Common Sense

Minimize overhead and expensesMinimize overhead and expenses Maximize sample through-putMaximize sample through-put Increase sales forceIncrease sales force Maximize profit marginMaximize profit margin This is difficult and the first area to be This is difficult and the first area to be

critically examined is Quality Assurancecritically examined is Quality Assurance

QA IssuesQA Issues

QA is EXPENSIVE!QA is EXPENSIVE! On the surface it’s non-revenue generatingOn the surface it’s non-revenue generating Trained QA personnel are expensiveTrained QA personnel are expensive Certifications are expensive and time-Certifications are expensive and time-

consuming to obtain and maintainconsuming to obtain and maintain Performance Evaluation samples are Performance Evaluation samples are

expensiveexpensive

Other expensesOther expenses

Initial and continuing calibration is Initial and continuing calibration is expensiveexpensive

Matrix spikes and Laboratory Control Matrix spikes and Laboratory Control samples are expensivesamples are expensive

Method Detection Limit studies are time-Method Detection Limit studies are time-consuming and expensiveconsuming and expensive

Initial Demonstrations of Competence are Initial Demonstrations of Competence are time-consuming and expensivetime-consuming and expensive

And when the QC results are And when the QC results are not acceptablenot acceptable

Time and supplies used are wasted while Time and supplies used are wasted while the situation is corrected and the samples the situation is corrected and the samples re-analyzed.re-analyzed.

Two Commercial AttitudesTwo Commercial Attitudes

The high roadThe high road The low roadThe low road Most commercial labs exist somewhere Most commercial labs exist somewhere

between the twobetween the two

High RoadHigh Road

Require a culture of QA in the laboratory Require a culture of QA in the laboratory and develop a reputation for high and develop a reputation for high standards and impeccable ethics.standards and impeccable ethics.

Accept a lower profit margin with the Accept a lower profit margin with the recognition that sometimes a loss is going recognition that sometimes a loss is going to be incurred.to be incurred.

Spend the money to hire and train Spend the money to hire and train professional analysts.professional analysts.

High Road (continued)High Road (continued)

Hire a high quality, expert QA supervisor.Hire a high quality, expert QA supervisor. Give them the power and flexibility to Give them the power and flexibility to

oversee a rigorous QA program.oversee a rigorous QA program. Continually examine and re-examine QC Continually examine and re-examine QC

procedures and results for each and every procedures and results for each and every test processtest process

Continually train lab personnel in QAContinually train lab personnel in QA Provide copies of QA ManualProvide copies of QA Manual

High Road (continued)High Road (continued)

Stand behind analytical results and Stand behind analytical results and answer all questions asked to the best of answer all questions asked to the best of your abilityyour ability

Offer complete results and QC data Offer complete results and QC data packages to clients even when not packages to clients even when not requested and at no extra costrequested and at no extra cost

Offer training to customers to help them Offer training to customers to help them understand analysis and QA, especially understand analysis and QA, especially those without chemistry backgroundsthose without chemistry backgrounds

High Road (continued)High Road (continued)

Seek to obtain and then maintain the Seek to obtain and then maintain the highest quality laboratory certifications highest quality laboratory certifications possible. NELAP is the beginning.possible. NELAP is the beginning.

Low RoadLow Road

And then there are the practices and And then there are the practices and symptoms of the low road, where the symptoms of the low road, where the objective is to maximize profits and trim all objective is to maximize profits and trim all “avoidable” expenses.“avoidable” expenses.

Badges, we don’t need no Badges, we don’t need no stinkin’ badgesstinkin’ badges

Concentrate on business that does not Concentrate on business that does not require any sort of laboratory require any sort of laboratory certification/approval. certification/approval.

Avoid possible situations where outsiders Avoid possible situations where outsiders conduct a detailed examination of conduct a detailed examination of laboratory procedures and practices.laboratory procedures and practices.

Refuse to produce any data related to Refuse to produce any data related to possible QC results.possible QC results.

Badges (continued)Badges (continued)

QA Manual consists of price list and a QA Manual consists of price list and a notarized statement stating “We do good notarized statement stating “We do good work”work”

Slash and BurnSlash and Burn

The business plan depends upon a steady The business plan depends upon a steady flow of new customersflow of new customers

Repeat business is acceptable, however if Repeat business is acceptable, however if a customer asks questions of any sort, a customer asks questions of any sort, drop them like a hot rock.drop them like a hot rock.

For the client who develops regulatory For the client who develops regulatory problems the lab pulls a vanishing act.problems the lab pulls a vanishing act.

I’ll show you mine, if you I’ll show you mine, if you show me yoursshow me yours

Performance Evaluation results can make Performance Evaluation results can make or break a lab. or break a lab.

Labs share preliminary PE sample Labs share preliminary PE sample answers. Examination of a variety of answers. Examination of a variety of answers for the sample(s) allows one to answers for the sample(s) allows one to chose the best values to submit to the chose the best values to submit to the sponsor.sponsor.

Water, wastewater, solid Water, wastewater, solid waste, it’s all the samewaste, it’s all the same

Particularly prevalent in large laboratories Particularly prevalent in large laboratories - GC, GCMS, HPLC, ICP, and ICPMS are - GC, GCMS, HPLC, ICP, and ICPMS are only set up for one method, most only set up for one method, most commonly a SW-846 method, and then all commonly a SW-846 method, and then all samples are processed using the method.samples are processed using the method.

The most common rationalization is that The most common rationalization is that the SW-846 methods are the most modern the SW-846 methods are the most modern and thus the best, and the other methods and thus the best, and the other methods are not as good.are not as good.

All the same (continued)All the same (continued)

This ignores differences in sample prep, This ignores differences in sample prep, surrogates, calibration, target analyte list, surrogates, calibration, target analyte list, etc.etc.

QA Manual? It’s around here QA Manual? It’s around here somewhere.somewhere.

A comprehensive and annually revised QA A comprehensive and annually revised QA Manual is a major component of a QA Manual is a major component of a QA Program. It is also tedious and expensive Program. It is also tedious and expensive to write and update. Inability to produce a to write and update. Inability to produce a QA Manual is a good sign the lab lacks a QA Manual is a good sign the lab lacks a QA Program.QA Program.

Bubba here just got promoted Bubba here just got promoted to QA Managerto QA Manager

In smaller labs, randomly assigning the In smaller labs, randomly assigning the position of QA Manager to anybody, is a position of QA Manager to anybody, is a common practice. Often they are a common practice. Often they are a relative or good friend of the owner. This relative or good friend of the owner. This is in addition to other duties such as sales is in addition to other duties such as sales rep, or field services manager.rep, or field services manager.

A little bit doesn’t mean A little bit doesn’t mean anythinganything

Laboratory contamination in blanks and Laboratory contamination in blanks and samplessamples

Methylene chloride in the volatiles labMethylene chloride in the volatiles lab Phthalates in the semivolatiles labPhthalates in the semivolatiles lab Falsified blanks and blank correctionFalsified blanks and blank correction Any results must be rejected where blank Any results must be rejected where blank

contamination is suspectedcontamination is suspected

Sale TODAY ONLY, hurry Sale TODAY ONLY, hurry down for the best pricesdown for the best prices

Sales people exist to sell. They will do Sales people exist to sell. They will do most anything to complete the sale. They most anything to complete the sale. They are generally incapable of answering are generally incapable of answering technical and QA questions. Avoid labs technical and QA questions. Avoid labs where you can only talk to the sales where you can only talk to the sales people, rather than the people actually people, rather than the people actually doing the analysis.doing the analysis.

Bottom LineBottom Line

Buyer Beware.Buyer Beware. You the client bear the regulatory burden You the client bear the regulatory burden

when results/methods are not acceptable.when results/methods are not acceptable. The environmental services industry is The environmental services industry is

essentially immune to regulatory action.essentially immune to regulatory action. Do not award analytical services contracts Do not award analytical services contracts

based solely on lowest price based solely on lowest price

Bottom LineBottom Line

Write bid specifications to include a Write bid specifications to include a rigorous QA Program, PE sample result rigorous QA Program, PE sample result submission, and an on-site inspection.submission, and an on-site inspection.

You know what is required for legally You know what is required for legally defensible and analytically valid data defensible and analytically valid data within your program. Insist that your within your program. Insist that your Contract Laboratory have the same Contract Laboratory have the same knowledge and dedication.knowledge and dedication.

ReferencesReferences

Smith, R-K, 1995, Smith, R-K, 1995, Water and Wastewater Water and Wastewater Laboratory TechniquesLaboratory Techniques, WEF, Alexandria VA; , WEF, Alexandria VA; 1999, 1999, Lectures on Wastewater Analysis & Lectures on Wastewater Analysis & InterpretationInterpretation, , Handbook of Environmental Handbook of Environmental Analysis (4th Ed.)Analysis (4th Ed.); 2000, ; 2000, Interpretation of Interpretation of Organic DataOrganic Data; ; 20012001, Interpretation of Inorganic , Interpretation of Inorganic Data; Data; 20032003, Guide to Environmental Analytical , Guide to Environmental Analytical Methods, 5th Edition, Methods, 5th Edition, Genium Publishing, New Genium Publishing, New Amsterdam NYAmsterdam NY