QSM 5.1, QSAS 3.1, Errata Document Rev. 2 Joe Pardue Operations Team Lead and Laboratory Lead Pro2Serve ASP Workshop 2016 September 20, 2016

QSM, Revision 5.1 In conjunction with the U.S. Department of Defense (DoD), we have developed QSM Revision 5.1. DoD and DOECAP are finalizing the review comments and the final document will be finalized January 1, 2017. Due to existing laboratory contacts the document will also referenced as QSAS Revision 3.1. Alyssa Wingard and Fred McLean will address the specific changes during their presentation on Tuesday afternoon.

Errata Document Rev. 2 The Errata document was used last year to include necessary changes or updates to QSM 5.0 Maintaining thermal preservation Subcontracting Changes to the radiochemical requirements

Implementation Schedule QSM 5.1 DoD will begin accreditation using QSM 5.1 in Mid-2017. DOECAP will incorporate the updates and will use QSM 5.1 for the FY18 audits.

Partnering The development of QSM 5.1 was completed due to a great working relationship with the DoD. Our partnership demonstrates how to effectively work with other Federal agencies. Together we have addressed over 300 review comments. Rich Weiss and Dr. Bill Rogers also made significant improvements to the radiochemistry requirements.

Errata Document Revision 2 We will continue to use their requirements in the Errata Document in the FY17 audits. Due to a legal opinion by the DOE General Council and legal representation for Pro2Serve, we cannot approve corrective actions.

Errata Revision 2 The following with be used during the upcoming audits and has been included in the revision of the Errata Document: 4.11.8 DoD/DOE (Requirement) The laboratory shall have and use a record system for tracking corrective actions to completion and for analyzing trends to prevent the recurrence of the nonconformance. Corrective actions developed to address findings during DOECAP audits must be implemented. Any changes to reviewed corrective action plans must be reviewed by the DOECAP Operations Team, as appropriate.   4.11.8 DoD/DOE (Guidance) Willful avoidance of DOECAP reviewed corrective actions may result in a DOECAP Priority I finding.

Checklists Are Living Documents The DOECAP audit checklists are living documents. They provided to provide the majority of applicable requirements for each audit discipline. Auditors can modify the checklists if there are areas of review that are not covered by the lines of inquiry. The auditor should clearly indicate any additions made to the checklist.

Auditor Responsibilities All checklist LOIs should be addressed during the audit. If for some reason you do not address an LOI, indicate that on the checklist. Sufficient information should noted on the checklists. “Sufficient” means that the person looking at the checklists during the next audit can understand the status of the line of inquiry (i.e., which documents you reviewed, what activities you observed, and who you interviewed). Avoid making cryptic entries.

Auditor Responsibilities Use the legend for the lines of inquiry that is included on the second page of each checklist. We have observed that this legend is not used by some of the auditors. A = Acceptable NO = Not Observed U = Unsatisfactory O = Observations NA = Not Applicable F = Finding Auditors should complete their checklist(s) and provide the electronic file to the lead auditor at the end of the audit. The completed checklists, the audit report, and the corrective action plan are vital to the auditor performing the next audit.

Module 1, Quality Assurance The checklist will be revised to remove duplications and to consolidate the LOIs. The current checklists combines the QSM, the TNI standard, and ISO/IEC 17025 requirements. Changes will be made to the limited LIMS section to provide more complete references to the U.S. Environmental Protection Agency’s Good Automated Laboratory Practices (GALP) and the QSM.

Module 2, Organics No changes are needed to Module 2.

Module 3, Inorganic and Wet Chemistry Extensive changes have made to the Module 3 checklists based on the facility and auditor feedback that was received during the FY16 audits.

Module 4, Radiochemistry Specific changes that provide clarity will be included in the checklists. Completion of the revision will be based on review comments that were received during the FY16 audits and the revision of QSM 5.1.

Module 5, Laboratory Information Management Systems The changes will be consistent with the revision of the LIMS section in Module 1, Quality Assurance.

Module 6, Hazardous and Radioactive Materials Management No changes are anticipated.

Review Comments It is imperative that all auditors provide continuing feedback on the audit checklists The auditor and the facilities have the technical expertise in each audit discipline Accurate feedback will result in improved lines of inquiry

Questions