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Why Lab. Certification? Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality.

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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:

1 Why 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.

2 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 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 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

3 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 MDLs 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.

4 Categories of OQA Lab. Certification
DW WP SHW CLP Air Radon Radiochemistry 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.

5 Types 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.

6 Sources of Test Methods
EPA (SM, SW-846) ASTM USGS DSAMs 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.

7 Personnel 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 data Need qualified staff to obtain quality data.

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

9 Method SOPs Method SOP must detail all the steps needed to successfully complete the analysis. The SOP must state what that lab. actually does 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-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

10 Performance Testing (PT) Samples
ECLP-Lab successfully analyzes one PT per program/analyte/year Separate programs for DW, WP and SHW NELAP- Lab successfully analyzes two PT per program/analyte/year In addition; SDW One PT per method per year PTs 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 + GFAA PT failures are investigated at the onsite.

11 Demonstration of Capability (DOC)
DOC- NELAC term for Precision and Accuracy (P&A) 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 MS

12 Method Detection Level (MDL)
MDL based on the 40 CFR 136 app. B Evaluated against the method values Must be generated for each certified method annually Labs. Must evaluate their reporting level (RLs) against their calculated MDLs DEP auditors look at this information while conducting on-site audits

13 Laboratory On-site Audit
NELAC labs. are looked at every 2 years ELCP Labs. every 3-5 years, or when a DEP program asks us to review specific information OQA staff have expertise in every area of analytical testing; multiple staff participate in most audits 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, Complaint

14 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, Complaint

15 Sample Receiving and Custody
Must show that the lab. follows the SOP Proper use of sample containers Proper sample entry log Complete chain of custody Sample 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, preservation COC 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.

16 The Bench Audit Interview Analyst
Compare operation to the official SOP Question analyst about their knowledge of the method Evaluate QC used vs. Method-required QC Examine laboratory data Check appropriate use of all reagents Verify data reporting and review 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 classical chem. Not computerized Sample Data: Methods On GC/MS, check manual intergrations

17 Recordkeeping Examine how data is reviewed and reported
Insure that records (paper & electronic) are securely stored and can be retrieved if needed Laboratories must demonstrate capability to produce specific reports and/or forms (e.g., CLP) 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 classical chem. Not computerized Sample Data: Methods On GC/MS, check manual intergrations

18 Typical Complaints About Laboratory Data
Not Certified for Analyte or Method Wrong Method Reporting Level of Data Does Not Meet Regulatory Level Not following the method Incomplete or Wrong QC Sample Custody Violated Holding Times Exceeded Under most circumstances data is reviewed at OQA. Check methods requested vs OQA data base and method actually used by looking at data summaries.

19 Complaints About Laboratory Data: Investigation and Follow-Up
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 & QA Officer Problem may be larger than one sample set

20 Investigation 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 action Enforcement actions (fines, loss of cert.) can result if remedies are not made For repeat offenders, subsequent follow-up audits, often unannounced, can be scheduled

21 How to Choose a Laboratory
NJDEP Certified? Is Lab. certified for required methods? Review laboratory quality systems What 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?

22 How to Communicate With Your Lab.
Provide all information on the nature of the samples to be analyzed If there are specific DQOs, tell the lab. in advance of sample collection Be specific on what your data reporting needs are Find a lab. contact you are comfortable with and maintain open communication If you have any issues, let the lab. know ASAP!


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