DOECAP AUDITING Nile A. Luedtke DOECAP Operations Team ASP Workshop 2010 Seattle, Washington

1. DOECAP AUDITING Nile A. Luedtke DOECAP Operations Team ASP Workshop 2010 Seattle, Washington

2. Operations Team Goals To Perform Meaningful Audits To Clearly Communicate Audit Results To Assist in Identifying Appropriate Corrective Actions To Confirm Completion of Corrective Actions and Finding Closures Continuous Program Improvement

3. Basic Auditing Cycle • Pre-Audit • Facility Information • Auditor Preparation • Audit • Audit Activities • Report Development • Post Audit • Report Finalization • Corrective Action Plans • Finding Closures

4. Pre-Audit Facility Information • Quality Assurance Plan • Standard Operating Procedures • Corrective Action Plan Update • Operational Plans ( Health & Safety; Rad Control; etc.) • DOE Customers & Volume of Use

5. Pre-Audit Auditor Preparation • Review Last Audit Report • Review Facility CAP and CAP Update • Review SOPs and Operational Plans • Review Your DOE Site Specific • Contract Requirements • Facility Interactions and Performance • Review QSAS for Laboratories • Review TSDF Permits • Participate in Pre-Audit Team Call

6. Pre-Audit Concerns • Need Facility Information Earlier and More Promptly • Need Auditors To Do Their Homework • Need Mentors and Auditors-in-Training to Coordinate and Communicate • Need Leads To Be More Active in Getting the Team Coordinated • Need Auditors To Obtain Site Information Regarding Facility Performance

7. Auditing • Takes More Time When Not Prepared • DOECAP Checklists A Starting Point • Need to Add Individual Lines-of-Inquiry • Based on Your Pre-Audit Reviews • Based on Your Site Specific Information Regarding Facility Performance • Need To Use Time On-Site To Audit

8. Auditing • Continuing Audits Need to Build on Previous Audits • Do Not Need to Rehash All the Basics • Audit the Facility Systems While Maximizing Review of Performance • Audit Specific Technical Processes and Their Implementation (i.e., TSDF waste operations, Laboratory analytical methods, etc.)

9. Auditing • Focus On: • Personnel Interviews • Data Review and Direct Observation • SOP vs. Actual Facility Compliance • Facility Practices vs. Regulatory and Analytical Method Requirements • This Leads To: • Identifying Findings • Providing Observations • Producing a Report Narrative

10. Audit Documentation and Writing • Focus On: • Old Finding Closures or Non-Closures • New Finding Documentation • Observation Documentation and Rationale • Section Narrative • Checklist Completion • Priority I (Findings & Finding Closures) • Immediate Interaction with Lead, Facility, and DOECAP Management

11. Closing Findings • Finding: Requirements for on-site accumulation of hazardous waste are not being met. (CLOSED) Hazardous waste is stored in 90-day accumulation areas inside and outside of Building 15. Inspected waste containers were labeled with major risk(s) as required per the WAC. SOP was revised and implemented. Training for SOP was held on X, 2010 and Y, 2010. • Finding:Requirements for sampling of Bulk Processing Units and Baghouse ash are not being met. (CLOSED) SOP revision was completed on X, 2010 addressing the issues described by the finding and corrective action plan.

12. Closing Findings • Finding: Shipping procedures assign responsibilities to positions that do not currently exist. (CLOSED) During review of the SOP series, the two positions identified (shipping and manifesting supervisor and to the MW facility manager), have been appropriately removed from these procedures as they no longer exist. • Observation: Shipping procedures identify positions that are not currently staffed. NQA-1 requires all roles and responsibilities be clearly defined by management. The Facility Manager stated that SOP revisions have been approved; however, are not yet reflected in either document.

13. Closing Findings • Finding: Shipping containers received from DOE clients are not opened under a ventilation hood and radiation screening is not adequate. (CLOSED) SOP XXX has been revised to require that sample shipping containers from DOE will be surveyed on the bottom of the container and that all coolers will be opened under a ventilation hood. • There are many more examples where Findings were closed and the substantiating documentation to justify closure was not complete or provided in the original write-up.

14. Conflicting Closing/Opening • Old Finding: Laboratory SOPs do not correctly document formulas for calculating Combined Standard Uncertainty (CSU), including both systematic and random error. (CLOSED) Laboratory has revised all SOPs containing formulas for calculating CSU random and systematic error to address a non-zero CSU when the net activity is zero. • New Finding: Laboratory SOP XXX has not been revised to correctly document formulas for calculating CSU, including both systematic and random error.

15. New Finding vs. Open Finding • New Finding: Security seals are not attached to each individual sample container (or to a plastic bag that samples could be submitted in) nor are custody seals applied to sample shipping containers as required by the WAP when individual containers lack custody seals. • Old Finding: Sample custody is not maintained and/or properly documented for some waste samples collected for hazardous waste analysis. (OPEN)

16. Unclear Findings • Unclear Finding: SOPs for recertification of working check weight requirements conflict with each other. SOPs conflict in their requirements for recertification of working check weights: SOP XXX requires a recertification frequency of three years; however, the QAM, Section Y, requires recertification annually. SOP XXX, specifies every three years for “master” weights, yet QAM, Section Y specifies recertification of working weights yearly. The QSAS requirement is, “Class 1 certified check weights shall be verified every five years using recognized National Metrology Institute, such as NIST, traceable references when available.” These conflicts have caused exceedance of recertification of the check weights in the past.

17. Misdirected Findings • Misdirected Finding: Daily check weights must bracket the range used for weighing on the balances. The balance used in room 25 (XY401-S, “1 place” top loader) is checked at 30 g and 2 kg and used for preparation of scintillation vials for SOP ZZZ. The typical maximum weight used by this procedure is 5 g sometimes less that 1 g. Beyond weighing outside of checked range, these weights are not measured to a minimum of ±0.01 g.

18. Observation or Finding • Observation: The facility electronic database indicated two non-RCRA containers were currently stored on-site in building YY; however, these were actually shipped off-site to another facility for metal reclamation by a third party. Further research discovered the two containers were rejected by the recycling facility and returned to sister facility for eventual shipment back to facility. When the sister facility made the decision to return the two containers, they rejected them in the central electronic database, which in turn automatically updated the containers back to their last scanned facility storage location at building YY. This raises concern over complete reliability of the on-site inventory/location report in the electronic database.

19. Post-Audit, Audit Report Week Following Audit: Facility Review of Audit Report Audit Team Review of Audit Report Following Audit Report Submittal: Operations Team Review Auditors Respond to Questions Facility Notified of Finding/Obs. Changes DOECAP Management Review Report Distribution

20. Post-Audit, Corrective Action Facility Submits CAP Audit Team Reviews the CAP Facility Responds to Questions Operations Team Reviews the CAP Auditors Respond to Questions Changes Coordinated with Facility DOECAP Management Review CAP Finalization and Acceptance

21. Post-Audit, Corrective Action Causal Analysis Not expected to be a full Root Cause Analysis, but it needs to clearly identify the cause of the problem. Why Was There a Finding? What Caused the Deficiency? What Is the Basis for the Problem? Does the Deficiency have a Broader Context and Scope?

22. Post-Audit, Corrective Action Corrective Actions Will the Actions Fix the Problem? Will the Actions Correct the Deficiency Across Related Systems, Processes, and Methods? Will the Actions Prevent the Problem from Reoccurring? Facility – Auditors – Ops Team Need to Reach A Consensus on Actions

23. What Lies Beneath USS DOECAP