Presentation on theme: "Why Lab. Certification? Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality."— Presentation transcript:
1Why Lab. Certification?Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality data.Certification cannot guarantee that a laboratory will obtain quality data on a specific sample.
2NJ Has Two Certification Programs NJ Environmental Laboratory Certification Program (ELCP)Laboratory analyzes NJ samplesLaboratory follows N.J.A.C. 7:18National Environmental Laboratory Accreditation Program (NELAP)Laboratory follows NELAC standardsAccreditation recognized in eleven statesELCP This program was established in the early 80’s. It has evolved into a program that emphasizes:EPA promulgated analytical methodsQC Defined by the Method and NJAC 7:18Lab SOPsActual data reviewLab successfully analyzes one PT per program/analyte/yearNELAP national standards set by about 42 states & 5 Federal programs. Major input by private sector ((NELAC conference)Based on Quality System ApproachInternational ISO standards ISO1725Quality System entails extensive record keepingLab successfully analyzes two PT per program/analyte/yearProgram is an advantage to a Lab that analyzes samples from several statesData Quality of NJ labs should be the same INDEPENDENT OF THE PROGRAM
3Laboratory Paper Audit Review of Documents at OQA Personnel QualificationsQuality Systems Manual (QSM)Method SOPsReview of Performance Testing Results (PTs)Review of Demonstration of CapabilityReview of MDLsPerformed for new labs coming into the Program, Labs requesting new methods.For a new lab an onsite audit is scheduled after the successful paper audit.
4Categories of OQA Lab. Certification DWWPSHWCLPAirRadonRadiochemistryPerformed for new labs coming into the Program, Labs requesting new methods.For a new lab an onsite audit is scheduled after the successful paper audit.
5Types of Test Methods Inorganics Metals Organics Biologicals Performed for new labs coming into the Program, Labs requesting new methods.For a new lab an onsite audit is scheduled after the successful paper audit.
6Sources of Test Methods EPA (SM, SW-846)ASTMUSGSDSAMsPerformed for new labs coming into the Program, Labs requesting new methods.For a new lab an onsite audit is scheduled after the successful paper audit.
7Personnel Qualifications ELCP- Supervisors and bench operators must have specific experience and education; listed in 7:18.NELAP- Technical Directors (supervisors) must have specific experience and BS.When staff change instruments, they must re-qualify on new instrument before generating dataNeed qualified staff to obtain quality data.
8Quality Systems Manual ELCP-Lab must have a QA/QC manual that describes procedures to implement QA.From sample receipt to data reportNELAP- “A document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an organization, to ensure the quality of its product and the utility of its product to its user.”ELCP- Program does not list the detailed requirementsNELAC standards have very detailed requirements, 29 page check list
9Method SOPsMethod SOP must detail all the steps needed to successfully complete the analysis.The SOP must state what that lab. actually doesIf a published method has choices, the lab. must specify the choice used.Dated, numbered, revision, and signed by manager &/or QA personEPA guidance for Preparing SOPs EPA QA/G-www.epa.gov/quality/qs_docs/g6.final.pdfELCP- does not have any detailed instructions for SOPsNELAC QA chapter 5 has some instructions
10Performance Testing (PT) Samples ECLP-Lab successfully analyzes one PT per program/analyte/yearSeparate programs for DW, WP and SHWNELAP- Lab successfully analyzes two PT per program/analyte/yearIn addition; SDW One PT per method per yearPTs are an indication of the Lab ability to analyze the parameter, single blind.Should be analyzed as a sample.EPA DW requires One PT per method. ICP + GFAAPT failures are investigated at the onsite.
11Demonstration of Capability (DOC) DOC- NELAC term for Precision and Accuracy (P&A) StudyLAB Control Sample (LCS)- Lab Spiked BlanksInitial Four Samples per analyte per methodDetermine RSD and %RNELAC requires DOC for each analystELCP requires only one set of P & A for labEstablishes the performance of the method & analystEvaluated against the method values.Used to establish initial Lab QC values for LCS and MS
12Method Detection Level (MDL) MDL based on the 40 CFR 136 app. BEvaluated against the method valuesMust be generated for each certified method annuallyLabs. Must evaluate their reporting level (RLs) against their calculated MDLsDEP auditors look at this information while conducting on-site audits
13Laboratory On-site Audit NELAC labs. are looked at every 2 yearsELCP Labs. every 3-5 years, or when a DEP program asks us to review specific informationOQA staff have expertise in every area of analytical testing; multiple staff participate in most auditsEvery two yearsNew lab in the programLab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MSLab adds a new code, microbiology,Complaint
14Laboratory On-site Audit Review records for QSMSample Receiving (Track a sample)Check analytical method used vs. SOPCheck Method QCInterview AnalystReview bench recordsReview raw dataPT resultsCorrective actions from previous auditEvery two yearsNew lab in the programLab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MSLab adds a new code, microbiology,Complaint
15Sample Receiving and Custody Must show that the lab. follows the SOPProper use of sample containersProper sample entry logComplete chain of custodySample preservation documented (pH, Temp.)Internal sample tracking system (analysts cannot check out samples themselves)Select samples to track through the lab.Entry log- book or computer, Contains Key sample information:client ID, Lab ID, sampling time & date, Analysis needed, preservationCOC check several for completeness:Preservation Checks recorded. Includes bottles if provided by lab.Internal Tracking:sample custodian must sign sample release. Location and analyst of sample must be documented.Formal internal COC available by contract or request of customer.
16The Bench Audit Interview Analyst Compare operation to the official SOPQuestion analyst about their knowledge of the methodEvaluate QC used vs. Method-required QCExamine laboratory dataCheck appropriate use of all reagentsVerify data reporting and reviewThis is where you find out what is happeningAnalyst my not have current SOP or may have made changesDoes the lab have current control chartsBench records very important for classical chem. Not computerizedSample Data:Methods On GC/MS, check manual intergrations
17Recordkeeping Examine how data is reviewed and reported Insure that records (paper & electronic) are securely stored and can be retrieved if neededLaboratories must demonstrate capability to produce specific reports and/or forms (e.g., CLP)This is where you find out what is happeningAnalyst my not have current SOP or may have made changesDoes the lab have current control chartsBench records very important for classical chem. Not computerizedSample Data:Methods On GC/MS, check manual intergrations
18Typical Complaints About Laboratory Data Not Certified for Analyte or MethodWrong MethodReporting Level of Data Does Not Meet Regulatory LevelNot following the methodIncomplete or Wrong QCSample Custody ViolatedHolding Times ExceededUnder most circumstances data is reviewed at OQA.Check methods requested vs OQA data base and method actually used by looking at data summaries.
19Complaints About Laboratory Data: Investigation and Follow-Up Request documents from Lab. for OQA reviewChain of CustodyCustomer data reportData, Calibration and QC summariesFull Data package after preliminary reviewConduct On-site AuditNeed to interview analyst & QA OfficerProblem may be larger than one sample set
20Investigation and Follow-Up: Next Steps OQA will issue a Letter of Deficiency that can be shared with interested DEP program(s)Lab. has 60 days to perform required remedial actionEnforcement actions (fines, loss of cert.) can result if remedies are not madeFor repeat offenders, subsequent follow-up audits, often unannounced, can be scheduled
21How to Choose a Laboratory NJDEP Certified?Is Lab. certified for required methods?Review laboratory quality systemsWhat is OQAs history with this lab.?Will lab. provide all requested documentation?Can lab.Meet project data quality objectives?Provide required data deliverable?Provide timely results?
22How to Communicate With Your Lab. Provide all information on the nature of the samples to be analyzedIf there are specific DQOs, tell the lab. in advance of sample collectionBe specific on what your data reporting needs areFind a lab. contact you are comfortable with and maintain open communicationIf you have any issues, let the lab. know ASAP!