DoD-DOE QSM-AS Update :

1. DoD-DOE QSM-AS Update: • Presented to: • DOE ASP Workshop 2012 • Idaho Falls, Idaho • Fred McLean • Navy Laboratory Quality & Accreditation Office • Chair, DoD Quality Assurance Oversight Subgroup

2. DoD / DOE QSM-AS DoD QSM / DOE QSM-AS consolidation update: A “stand-alone” document has been created that requires ISO 17025 & 2009 TNI Standard for full compliance. Over 400 comments have been addressed and final edits will be sent to our contractor to create a final draft version. This final draft expected by 01 November 2012, at which time it will be ready for the signature cycle. Final document ready by the first of January, 2013, if possible. 2

3. DoD / DOE Participants Fred McLean, Chair – Navy Dr. Chung-Rei Mao – Army Corps. Dr. Seb Gillette – Air Force Joe Pardue – DOE Dr. Todd Hardt - DOE Alyssa Wingard – Navy Janice Willey – Navy Ed Corl – Navy Dr. Tom Georgian – Army Corps. Dr. Jan Dunker – Army Corps. Dr. Charles Stoner – Army Health Center Dr. Aurelie Soreefan – USAFSAM Christina Rousch – USAFSAM John Schwarz – Army CWA 3

4. Module 1 Proficiency Testing Will be Based on accreditation for PT providers as ISO Guide 17043 Will require PT samples for all analytes that are on a scope of accreditation Will require PT samples twice a year – except for Toxicity testing (once per year) Acceptance/Failure based on program(s) participated in by the PT provider Will allow for participation of other Federal programs such as DOE Mixed Analyte Performance Evaluation Program (MAPEP) 4

5. Module 2 General Quality Systems Global Changes – Based on review feedback Removed Terms “illegal” and “fraudulent” and replaced with “unethical” and “inappropriate” Changed “client” to “customer” Changed “documents” to “records” Changed “corrective action” to “corrections” Findings can be neutral as well as positive or negative Clarified electronic data as being acceptable – i.e. electronic signatures 5

6. Module 2 General Quality Systems Accepted changes based on comments received: Expiration dates – will follow the TNI standard; if the manufacturer does not assign a date, it will not be required. Calibration may not be forced through the origin: requirement removed from the standard. Quality Manager or designee can review and update as necessary quality documents. The laboratory does not have to notify the client prior to implementation of corrective action. The lab is now able to notify the client while implementing the corrective action. Written approval must be received prior to disposal of records. Changed to: for records less than 5 years old or less than contract limit, written approval must be obtained. 6

7. Module 2 General Quality Systems Clarifications based on comments received: Opening of sample coolers under or in a ventilation hood was clarified to mean opening in an area with adequate ventilation. Start and stop times for a batch was issued as guidance, “The start time/date for sampling is the moment that the sample is separated from the parent sample matrices, for preparation is the moment that the extraction solvent/solution touched the sample, for analysis is the moment that the sample is introduced to instrument.” “Logbooks” have been clarified to include the use of electronic logbooks. 7

8. Module 2 General Quality Systems Not Accepted comments received: ICAL – Some comments wanted to allow for failed calibration of non-detect analytes or report analytes without flagging under various cases of calibration failure. Quarterly verification of electronic temperature gauges – change to annualnot accepted. 8

9. Module 4 Chemistry Testing Surrogates – second source for surrogates will not be required, but LOD and LOQ verifications are still required. CCV failure (corrective action) – If a failure occurs immediately analyze two additional consecutive CCVs. If both pass, samples may be reported without reanalysis. If either fails, take correction action and re-calibrate then reanalyze all affected samples since the last acceptable CCV. “Immediate” defined as within the hour. ICV and CCV – at a minimum, the CCV criteria is as stringent as the ICV criteria. LOD and LOQ verification frequency will remain Quarterly. 9

10. Module 4 Chemistry Testing Grinding Blanks for Method 8330B – Grinding Blanks shall be collected prior to analysis; after every 10 samples; and at the end of the batchin lieu of between every sample. At least one grinding blank per batch must be analyzed (thus, all grinding blanks can be composited). All target analytes will still be required to be spiked into the LCS and MS/MSD. Control Charts (for trending) shall be monitored quarterly, at a minimum. 10

11. Unresolved Issues The client has specified incorrect, obsolete, or improper methods, the lab must notify the client. Many reviewers felt that a lab should not be responsible for this. DoD/DOE representatives understood the lab’s viewpoint, but tended to reject that argument. LCS – A laboratory must use its in-house statistically established LCS control limits for the purpose of batch control or Project specified LCS control limits, whichever is more stringent. The LCS criteria may change based on results from the LCS study. LOD and LOQs for infrequent tests and mobile facilities – Is one per batch acceptable? Many feel that CCVs need to be required at the end of the run for GC/MS analyses (with a different criteria, perhaps +/- 50%). 11