LABORATORY CERTIFICATION & DATA QUALITY

MICHAEL W. MILLER, Ph.D.

NJ-DEP

Office of Quality Assurance

609-292-3950

mmiller1@dep.state.nj.us

Outline

• Introduction

• Laboratory Paper Audit

• Laboratory On-site Audit

• Complaint About Laboratory Data

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

• 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.

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

DEP Certified Radiological Labs

NELAP(P)

NELAP(S)

ELCP NEWJERSEY

Out ofState

Radio-chem.

2 12 4 3 15

Radon 0 1 14 5 10

Laboratory Paper AuditReview 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)

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.”

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

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

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

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

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

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

Complaints About Laboratory DataType

• Laboratory Not Certified for Analyte or Method• Wrong Method• Data Does Not Meet Regulatory Level• Not following the method• Incomplete QC• Holding Times

Complaints About Laboratory DataInvestigation

• 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