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Quality Systems for Analytical Services Revision 2.6 Joe Pardue

Quality Systems for Analytical Services Revision 2.6 Joe Pardue. ASP 2010 Workshop September 20-23, 2010 Seattle, Washington. Non-Destructive Assay Conesus Standard. In 2009, a draft standard was developed and was incorporated into Appendix E of the QSAS

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Quality Systems for Analytical Services Revision 2.6 Joe Pardue

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  1. Quality Systems for Analytical ServicesRevision 2.6Joe Pardue ASP 2010 Workshop September 20-23, 2010 Seattle, Washington

  2. Non-Destructive AssayConesus Standard • In 2009, a draft standard was developed and was incorporated into Appendix E of the QSAS • Associated draft checklists were developed and were used to conduct NDA audits of USEC Paducah and Portsmouth • Based on the information that was obtained by the two audits, a meeting will be conducted in Portsmouth on October 5, 2010

  3. NDA • Representatives from Oak Ride, Paducah, and Portsmouth will develop a consensus standard for NDA • The standard will be included in the QSAS and enhanced audit checklists will be developed prior to the FY2011 audit cycle

  4. Enhancements • Add requirements for binding and security locks for laboratory notebooks - QSAS 4.12 DOE-6 • Define daily verification requirements for dispensing devices - QSAS 5.5 DOE-6 • Add incubators in the examples for daily monitoring requirements – QSAS 5.5 DOE-4 • Developed reverification requirements for standards

  5. Analytical Balance Certification Requirements (5.5 DOE-4) • Certification requirements will be defined for independent or third party professional technicians that calibrated analytical balances • Requirements for entities that recertify Class 1 checks will be defined

  6. QSAS 6.0 Hazardous and Radioactive Management • Developed requirements for sending and receiving samples from a DOE site when the laboratory does not have a radiological materials license • Define training for the ES&H staff • Clarify the training requirements for the back-up Radiation Safety Officer • Add requirement for timely updates of the radiological material inventory

  7. Blank Acceptance Criteria – RADD.4 DOE-4 • Consideration will be given for the following: • Samples associated with any method blank result greater than the blanks MDC shall be redigested and reanalyzed • Exception – Where samples for which the measured concentration is greater than or equal the MB

  8. Reporting Radiochemistry ResultsQSAS D.4 DOE-27 • The Combined Standard Uncertainty shall include both systematic and random error.  Combined Standard Uncertainty is always 1 sigma.  Results should be reported at the 95% confidence level, which is 2 sigma.

  9. Sample Digestion and PreparationReinforce • Require that the sample digestion and preparation techniques that are used for the analysis of the MAPEP be also used without deviation for DOE client samples • Requirement will enforced unless there is documented release by each DOE client • There are many laboratories that use one preparation for MAPEP and another preparation for client matrices and analytes

  10. Future • The QSAS is organized to the structure of NELAC Standard 2003 Chapter 5 • Section 5,4 Management Requirements • Section 5.5 Technical Requirements • The revised TNI (The NELAC Institute) was adopted May 1, 2007 • The implementation date will be July 1, 2011

  11. Future • The implementation date will be determined as the state legislature of the accrediting bodies adopt the new standard • The QSAS will be rewritten in FY2011 to include the new standard • An expert committee will be assembled to develop the new standard

  12. QSAS Revision 3.0 • The implementation of QSAS Revision 3.0 will be prior to the FY2012 audit cycle

  13. Conclusion • Questions and Comments

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