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Laboratory Quality Systems

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Laboratory Quality Systems for Chesapeake Bay Monitoring Mary E. Ley, QA Coordinator September 21, 2007 NELAC Gap Assessment for Chesapeake Bay Program Labs ... – PowerPoint PPT presentation

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Title: Laboratory Quality Systems


1
Laboratory Quality Systems
  • for
  • Chesapeake Bay Monitoring

Mary E. Ley, QA Coordinator September 21, 2007
2
NELAC Gap Assessment for Chesapeake Bay Program
Labs
  • Objectives
  • Compare lab practices to NELAC requirements
  • Effectiveness of CBP QA Policies
  • External Review
  • Scope
  • Five Labs CBL, DCLS, ODU, DHMH, VIMS
  • CBP Guidelines
  • QAPPs for MDNR and VDEQ CBP Monitoring
  • Status
  • Four Lab Reports Final
  • Overall Recommendations Report (Draft)

3
Recommendations for CBPO
  • Update CBP Guidelines for Sampling Analysis
  • Quality System Elements
  • Clear and Consistent Requirements
  • Training in Quality Management Systems
  • Program Laboratory Personnel
  • Improve Process to
  • Update documents, change requirements
  • Communicate requirements
  • Adopt a formal corrective action program
  • Consider policy for traceability to national
    standards

4
Recommendations for Labs
  • Develop a Quality System consistent with NELAC or
    ISO 17025
  • Update QA Manuals and SOPs
  • Document control system - historical
    reconstruction of the test method
  • Identify standards reagents for each batch
    (bench sheets)
  • Unique sample IDs, Test ID (bench sheets)
  • Second source standards for calibration
    verification
  • Procedures for data verification and corrective
    actions
  • Procedures for out of control data
  • Procedures for calibration and support equipment
  • Consistent with CBP Guidelines and State QAPPs

5
Recommendations for Labs (cont.)
  • 3. Document and report changes to SOPs and QA
    Manual
  • Conduct internal audits
  • Document personnel education, training and
    capabilities
  • Ethics Program
  • 7. Review of State contract requirements
  • How changes will be reported
  • Review of State QAPPs

6
State Responsibilities
  1. Consistency of lab operations with CBP Guidelines
    and QAPPs
  2. Report changes and deviations to CBPO within 30
    days (field lab)
  3. Track changes in method and laboratory changes
    over years
  4. Results of data validation

7
Current CBP Guidelines for Lab QA Manuals (p.
II-21)
  • Procedures to
  • Maintain data integrity, validity and usability
  • Ensure that analytical systems are stable and
    reproducible
  • Document all aspects of system to provide data
    that are technically sound legally defensible
  • Detect problems through data assessment
  • Establish corrective action procedures...

8
Current CBP SOP Guidelines (II-25)
  • Traceability of stds., equip., samples, data
  • SOPs reviewed updated annually
  • Deviations justified, documented, approved
  • Submit within 30 days after the last cruise
    (II-7)

9
CBP SOP Guidelines (cont.)
  • SOP sections to include
  • Calibration
  • QC Limits
  • Internal Review
  • Corrective Action
  • Calculations
  • Document Control
  • and more

10
Revising the CBP Guidelines
  • QA Manuals (II-21)
  • SOPs (p. II-24)
  • Documentation/Document Control (II-26)
  • Control Limits (II-15)
  • Calibration Curves Methods (IV-20)

11
Calibration Issues
  • Dropping Calibration Stds. from Curve
  • (Unless document reason)
  • Calibration Verification from 2nd Source
  • Control Sample (LCS) every 20 samples
  • Method Blank every 20 samples
  • Field Filtered?

12
New Specifications for
  • Corrective Action Protocols
  • Support Equipment Calibration Logs
  • Freezers, balances, glassware
  • Internal Audits
  • Unique sample IDs
  • Tracking Standards

13
QC Practices
  • MDL Procedure
  • Proficiency Samples
  • NELAC QC ??
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