Presentation on theme: "Why Lab. Certification? 4 Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality."— Presentation transcript:
Why Lab. Certification? 4 Laboratory certification tries to insure that the laboratory is qualified and capable of analyzing the sample and obtaining quality data. 4 Certification cannot guarantee that a laboratory will obtain quality data on a specific sample.
NJ Has Two Certification Programs 4 NJ Environmental Laboratory Certification Program (ELCP) –Laboratory analyzes NJ samples –Laboratory follows N.J.A.C. 7:18 4 National Environmental Laboratory Accreditation Program (NELAP) –Laboratory analyzes NJ samples –Laboratory follows NELAC standards –Accreditation recognized in eleven states
Laboratory Paper Audit Review of Documents at OQA 4 Personnel Qualifications 4 Quality Systems Manual (QSM) 4 Method SOPs 4 Review of Performance Testing Results (PTs) 4 Review of Demonstration of Capability 4 Review of MDLs
Categories of OQA Lab. Certification 4 DW 4 WP 4 SHW 4 CLP 4 Air 4 Radon 4 Radiochemistry
Types of Test Methods 4 Inorganics 4 Metals 4 Organics 4 Biologicals
Sources of Test Methods 4 EPA (SM, SW-846) 4 ASTM 4 USGS 4 DSAMs
Personnel Qualifications 4 ELCP- Supervisors and bench operators must have specific experience and education; listed in 7:18. 4 NELAP- Technical Directors (supervisors) must have specific experience and BS. 4 When staff change instruments, they must re- qualify on new instrument before generating data
Quality Systems Manual 4 ELCP-Lab must have a QA/QC manual that describes procedures to implement QA. –From sample receipt to data report 4 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.
Method SOPs 4 Method SOP must detail all the steps needed to successfully complete the analysis. 4 The SOP must state what that lab. actually does 4 If a published method has choices, the lab. must specify the choice used. 4 Dated, numbered, revision, and signed by manager &/or QA person 4 EPA guidance for Preparing SOPs EPA QA/G-
Performance Testing (PT) Samples 4 ECLP-Lab successfully analyzes one PT per program/analyte/year –Separate programs for DW, WP and SHW 4 NELAP- Lab successfully analyzes two PT per program/analyte/year 4 In addition; SDW One PT per method per year
Demonstration of Capability (DOC) 4 DOC- NELAC term for Precision and Accuracy (P&A) Study 4 LAB Control Sample (LCS)- Lab Spiked Blanks –Initial Four Samples per analyte per method –Determine RSD and %R 4 NELAC requires DOC for each analyst 4 ELCP requires only one set of P & A for lab 4 Establishes the performance of the method & analyst
Method Detection Level (MDL) 4 MDL based on the 40 CFR 136 app. B 4 Evaluated against the method values 4 Must be generated for each certified method annually 4 Labs. Must evaluate their reporting level (RLs) against their calculated MDLs 4 DEP auditors look at this information while conducting on-site audits
Laboratory On-site Audit 4 NELAC labs. are looked at every 2 years 4 ELCP Labs. every 3-5 years, or when a DEP program asks us to review specific information 4 OQA staff have expertise in every area of analytical testing; multiple staff participate in most audits
Laboratory On-site Audit 4 Review records for QSM 4 Sample Receiving (Track a sample) 4 Check analytical method used vs. SOP 4 Check Method QC 4 Interview Analyst 4 Review bench records 4 Review raw data 4 PT results 4 Corrective actions from previous audit
Sample Receiving and Custody 4 Must show that the lab. follows the SOP 4 Proper use of sample containers 4 Proper sample entry log 4 Complete chain of custody 4 Sample preservation documented (pH, Temp.) 4 Internal sample tracking system (analysts cannot check out samples themselves) 4 Select samples to track through the lab.
The Bench Audit 4 Interview Analyst 4 Compare operation to the official SOP 4 Question analyst about their knowledge of the method 4 Evaluate QC used vs. Method-required QC 4 Examine laboratory data 4 Check appropriate use of all reagents 4 Verify data reporting and review
Recordkeeping 4 Examine how data is reviewed and reported 4 Insure that records (paper & electronic) are securely stored and can be retrieved if needed 4 Laboratories must demonstrate capability to produce specific reports and/or forms (e.g., CLP)
Typical Complaints About Laboratory Data 4 Not Certified for Analyte or Method 4 Wrong Method 4 Reporting Level of Data Does Not Meet Regulatory Level 4 Not following the method 4 Incomplete or Wrong QC 4 Sample Custody Violated 4 Holding Times Exceeded
Complaints About Laboratory Data: Investigation and Follow-Up 4 Request documents from Lab. for OQA review –Chain of Custody –Customer data report –Data, Calibration and QC summaries –Full Data package after preliminary review 4 Conduct On-site Audit –Need to interview analyst & QA Officer –Problem may be larger than one sample set
Investigation and Follow-Up: Next Steps 4 OQA will issue a Letter of Deficiency that can be shared with interested DEP program(s) 4 Lab. has 60 days to perform required remedial action 4 Enforcement actions (fines, loss of cert.) can result if remedies are not made 4 For repeat offenders, subsequent follow-up audits, often unannounced, can be scheduled
How to Choose a Laboratory 4 NJDEP Certified? 4 Is Lab. certified for required methods? 4 Review laboratory quality systems 4 What is OQAs history with this lab.? 4 Will lab. provide all requested documentation? 4 Can lab. –Meet project data quality objectives? –Provide required data deliverable? –Provide timely results?
4 Provide all information on the nature of the samples to be analyzed 4 If there are specific DQOs, tell the lab. in advance of sample collection 4 Be specific on what your data reporting needs are 4 Find a lab. contact you are comfortable with and maintain open communication 4 If you have any issues, let the lab. know ASAP! How to Communicate With Your Lab.