LABORATORY CERTIFICATION  DATA QUALITY

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Outline. IntroductionLaboratory Paper AuditLaboratory On-site AuditComplaint About Laboratory Data. OFFICE OF QUALITY ASSURANCE (OQA). Certify ~900 labs. worldwide who do environmental chemical and biological analyses in NJ; 25 Radiochem. LabsPerform management and technical audits of D

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LABORATORY CERTIFICATION DATA QUALITY

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1. LABORATORY CERTIFICATION & DATA QUALITY MICHAEL W. MILLER, Ph.D. NJ-DEP Office of Quality Assurance 609-292-3950 [email protected]

2. Outline Introduction Laboratory Paper Audit Laboratory On-site Audit Complaint About Laboratory Data

3. OFFICE OF QUALITY ASSURANCE (OQA) Certify ~900 labs. worldwide who do environmental chemical and biological analyses in NJ; 25 Radiochem. Labs Perform management and technical audits of DEP programs Review DEP project and program plans Provide technical assistance to DEP programs on data issues Conduct training OQA mandate is to ensure the department data is of high quality. The Office performs Data auditing functions. Lab. Cert. Discussed later. Other department programs are involved in data auditing. BEMQA, BEERAOQA mandate is to ensure the department data is of high quality. The Office performs Data auditing functions. Lab. Cert. Discussed later. Other department programs are involved in data auditing. BEMQA, BEERA

4. Laboratory certification ensures that the laboratory is capable of analyzing the sample and obtaining quality data. Certification does not ensure that a laboratory will obtain quality data on a specific sample.

5. NJ Has Two Certification Programs NJ Environmental Laboratory Certification Program (ELCP) Laboratory analyzes NJ samples Laboratory follows N.J.A.C. 7:18 National Environmental Laboratory Accreditation Program (NELAP) Laboratory analyzes NJ samples Laboratory follows NELAC standards Accreditation recognized in eleven states ELCP This program was established in the early 80’s. It has evolved into a program that emphasizes: EPA promulgated analytical methods QC Defined by the Method and NJAC 7:18 Lab SOPs Actual data review Lab successfully analyzes one PT per program/analyte/year NELAP national standards set by about 42 states & 5 Federal programs. Major input by private sector ((NELAC conference) Based on Quality System Approach International ISO standards ISO1725 Quality System entails extensive record keeping Lab SOPs Lab successfully analyzes two PT per program/analyte/year Program is an advantage to a Lab that analyzes samples from several states Data Quality of NJ labs should be the same INDEPENDENT OF THE PROGRAM ELCP This program was established in the early 80’s. It has evolved into a program that emphasizes: EPA promulgated analytical methods QC Defined by the Method and NJAC 7:18 Lab SOPs Actual data review Lab successfully analyzes one PT per program/analyte/year NELAP national standards set by about 42 states & 5 Federal programs. Major input by private sector ((NELAC conference) Based on Quality System Approach International ISO standards ISO1725 Quality System entails extensive record keeping Lab SOPs Lab successfully analyzes two PT per program/analyte/year Program is an advantage to a Lab that analyzes samples from several states Data Quality of NJ labs should be the same INDEPENDENT OF THE PROGRAM

6. DEP Certified Radiological Labs

7. Laboratory Paper Audit Review of Documents at OQA Personnel Qualifications Quality Systems Manual (QSM) Method SOPs Review of Performance Testing Results (PTs) Review of Demonstration of Capability Review of Minimum Detectable Activity (MDA) 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. MDA: count time, sample volume, interference, %solids total counts = counts/min. = Disintegrations/min. = pCi/LPerformed 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. MDA: count time, sample volume, interference, %solids total counts = counts/min. = Disintegrations/min. = pCi/L

8. Quality Systems Manual ELCP-Lab must have a QA/QC manual that describes procedures to implement QA. From sample receipt to data report NELAP- “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 requirements NELAC standards have very detailed requirements, 29 page check list ELCP- Program does not list the detailed requirements NELAC standards have very detailed requirements, 29 page check list

9. Method SOPs Method SOP must detail all the steps needed to successfully complete the analysis. The SOP applies to the specific Lab. If a published method has choices the Lab must specify the choice used. Dated, numbered, revision, and signed by manager &/or QA person EPA guidance for Preparing SOPs EPA QA/G-6: www.epa.gov/quality/qs_docs/g6.final.pdf ELCP- does not have any detailed instructions for SOPs NELAC QA chapter 5 has some instructions Radiation rules for: SDW 40CFR 141 & 142 WPP 40CFR 136 Radio chem. methods: EPA 60014-80-032 SHW SW 846 manual Radon Air methods; EPA 402-R-92-004 (15 methods) ELCP- does not have any detailed instructions for SOPs NELAC QA chapter 5 has some instructions Radiation rules for: SDW 40CFR 141 & 142 WPP 40CFR 136 Radio chem. methods: EPA 60014-80-032 SHW SW 846 manual Radon Air methods; EPA 402-R-92-004 (15 methods)

10. Performance Testing Results ECLP-Lab successfully analyzes one PT per program/analyte/year NELAP- Lab successfully analyzes two PT per program/analyte/year In addition; SDW One PT per method per year At this time ERA only Rad. PT provider PTs are an indication of the Lab ability to analyze the parameter, single blind. Must be analyzed as a sample. EPA DW requires One PT per method. Gross Alpha: Proportional, co-PPT PT failures are investigated at the onsite.PTs are an indication of the Lab ability to analyze the parameter, single blind. Must be analyzed as a sample. EPA DW requires One PT per method. Gross Alpha: Proportional, co-PPT PT failures are investigated at the onsite.

11. Demonstration of Capability (DOC) DOC- NELAC term for Precision and Accuracy Study LAB Control Sample (LCS)- Lab Spiked Blanks Initial Four Samples per analyte per method Determine RSD and %R NELAC requires DOC for each analyst ELCP requires only one set of P & A for lab Establishes the performance of the method & analyst Evaluated against the method values. Used to establish initial Lab QC values for LCS and MSEvaluated against the method values. Used to establish initial Lab QC values for LCS and MS

12. Laboratory On-site Audit Review records for QSM Sample Receiving (Track a sample) Check analytical method used vs. SOP Check Method QC Interview Analyst Review bench records Review raw data PT results Corrective actions from previous audit Every two years New lab in the program Lab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MS Lab adds a new code, microbiology, Radiochemistry Complaint Method QC: Blank, LCS, MS/MSDEvery two years New lab in the program Lab wants to add a technology to Certification. i.e. ICP, GC/MS, ICP/MS Lab adds a new code, microbiology, Radiochemistry Complaint Method QC: Blank, LCS, MS/MSD

13. Quality System Manual NELAC 29 page checklist to validate the implementation of the QSM ELCP systematic review of Lab’s operational procedures Staff implements QSM NELAP- Check that the records discussed in the QSM are present and complete ECLP- Check refrigerator, balances, instrument maintenance, standard preparation logs, QC records, corrective actionsNELAP- Check that the records discussed in the QSM are present and complete ECLP- Check refrigerator, balances, instrument maintenance, standard preparation logs, QC records, corrective actions

14. The Bench Audit Interview Analyst Compare operation to the official SOP QC used vs. Method QC Bench Records Actual sample data Look at the data system NJDEP data or PT data This is where you find out what is happening Analyst my not have current SOP or may have made changes Does the lab have current control charts Bench records very important for non computerized instrumentation. Sample Data:This is where you find out what is happening Analyst my not have current SOP or may have made changes Does the lab have current control charts Bench records very important for non computerized instrumentation. Sample Data:

15. Complaints About Laboratory Data Type Laboratory Not Certified for Analyte or Method Wrong Method Data Does Not Meet Regulatory Level Not following the method Incomplete QC Holding Times Under most circumstances data is reviewed at OQA. Check methods requested Vs OQA data base and method actually used by looking at data summaries.Under most circumstances data is reviewed at OQA. Check methods requested Vs OQA data base and method actually used by looking at data summaries.

16. Complaints About Laboratory Data Investigation Request documents from Lab. for OQA review Chain of Custody Customer data report Data, Calibration and QC summaries Full Data package after preliminary review Conduct On-site Audit Need to interview analyst Problem may be larger than one sample set

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