TSDF Pilot Checklist ProgramAlternative Audit Approach

Pete Yerace, DOE EMCBC

Objectives

• Historical perspective on DOECAP treatment, storage, and disposal facility (TSDF) audits

• Updated status of DOE Order 435.1 revision

• Refresh memory on proposed change to DOE Order 435.1 audit frequency language

• Overview of DOECAP TSDF Checklist Pilot Effort

• Detailed discussion on Pilot Effort- alternative audit approach

• Lessons Learned – Checklists and audit process

• Discuss DOECAP report write-up approach

• Discuss path forward for next year’s TSDF audits

TSDF Pilot Checklist Program

• Recognize DOECAP Operations Team

• Recognize George Detsis and Dr. Josh Silverman

• Recognize Audit Team

• Recognize EnergySolutions in Utah (ESU)

DOECAP TSDF Audits – New Perspective

Consolidated Approach•Efficient

•Cost effective

•Consistency

•Continuous improvement

•Regulatory interfaces are enhanced

Alternative Approach•More efficient

•Extremely cost effective

•More site-specific checklists/ lines of inquiry

•More ownership of site to integrate and improve their condition reporting process

•Minimize DOECAP findings

Current DOE 435.1 Language on Audit Frequency

a) Such non-DOE facilities shall:

1. Comply with applicable federal, state, and localrequirements;

2. Have the necessary permit(s), license(s), and approval(s) for the specific waste(s); and

3. Be determined by the Field Element Manager to be acceptable based on a review conducted

annually by DOE.

Current DOE Order 435.1 Status - Proposed Language on Audit Frequency

• Current DOE Order 435.1 status update

• Proposed DOE Order 435.1 revision states:

“Facilities must be authorized and qualified to perform the storage, treatment or disposal of the specified waste type(s), based on a DOE review of such facilities conducted prior to their first use by DOE, and biennially thereafter.”

• Initial reaction/feedback

• Developed TSDF Pilot effort based on last year’s feedback

Questionnaire Summary - Drivers for Pilot Approach

Audit Questionnaire in Support of DOE ASP Workshop

1. Performing audits every two years is acceptable

2. Perform focused audits or desk reviews

3. Regulatory focused audits should be considered

4. Reduce the size of checklists

5. Review ECHO Environmental Compliance History On-Line

6. Timeliness in corrective actions and number/severity of previous findings

7. Develop more site-specific checklists/lines of inquiry

Historical Small Site – Field Element Manager Feedback

1. Are you familiar with DOECAP and the annual TSDF audit reports? Yes

2. Do you rely on the current DOECAP TSDF Annual Reports as part of your annual

review of acceptability as required by DOE Order 435.1? How do you rely on the reports? Yes--we are a small site and rely on

DOECAP to conduct assessments.

Small Sites - Feedback (cont.)

3. If TSDF reviews of acceptability/audits were not required on an annual basis would you be comfortable sending waste to a facility that wasn’t audited on an annual basis? What would be some of your concerns? As a small site, we are sending waste to TSDFs that are used for disposal by other, larger DOE facilities, and that are the object of oversight by the DOE HQ waste group. Therefore, if HQ or other large sites do not have concerns about less than annual reviews, we as a small site are not concerned. However, if we were to seek to send waste to a little used or new facility, we would have a lower comfort level.

4. Do you have any thoughts on what circumstances would drive you to a more frequent TSDF acceptability review? New facilities, facilities with a poor compliance history, small facilities, facilities with little use by DOE complex.

Small Sites - Feedback (cont.)

5. Do you have any thoughts on what would provide you a level of comfort to not perform TSDF acceptability reviews annually? Mainly, we are a small site; if we are using facilities managing waste from the complex, including larger sites, that provides comfort.

6. Certain TSDF sites for the past couple years had no findings as part of the annual DOECAP audits. With the addition of a new facility at a site would you want to see an acceptability review performed this year before you sent waste or would you be comfortable with alternating a year? If not supportive of alternating a year what would you want the TSDF acceptability review to focus on this year? OK with alternating a year.

TSDF Pilot Site Selected

• ESU agreed to participate in a voluntary pilot program supporting integration of the DOECAP checklists/lines of inquiry into the self-assessment that ESU performed to prepare for the DOECAP audit.

• DOECAP initiated the pilot program as part of the Program’s efforts to prepare for the changes that are expected from the upcoming revision to DOE Order 435.1.

• DOECAP provided the blank TSDF audit checklists to ESU six weeks prior to the DOECAP audit.

TSDF Pilot Checklist

• ESU integrated the lines of inquiry from the checklists into its annual corporate quality assurance (QA) and facility-level assessments.

• ESU submitted the completed TSDF checklists to the DOECAP Operations Team as part of its pre-audit document package.

TSDF Site’s Condition Reporting Process

• Emphasize importance of a TSDF maintaining mature condition reporting process

• Discuss TSDF internal assessment reviews integrating DOECAP checklists/lines of inquiry.

Pilot Process and Results

• During its self-assessment and completion of the TSDF checklists, ESU self-identified issues and documented each issue and the associated condition report in ESU’s mature condition reporting system.

• ESU developed a corrective action plan (CAP) for each issue.

• Prior to the start of the DOECAP audit, ESU had closed several of the self-identified issues and posted the CAP and closure evidence in the ESU corrective action tracking system.

Pilot Process and Results

• During the DOECAP audit, the team verified the objective evidence and concurred with ESU’s closure of the self-identified issues. Self-identified issues that remain open are listed in this year’s report.

• As agreed for the pilot program, ESU is expected to submit copies of its internal CAPs for the open self-identified issues with the CAP that it develops for the new findings issued by DOECAP.

• ESU’s self-identified issues will be evaluated for closure as part of the next DOECAP annual audit, consistent with ESU’s corrective actions.

DOECAP Pilot Report Process

• The facility must develop a CAP for each self-identified issue.

• Any self-identified issues that are still open when the DOECAP audit begins are listed in the audit report as self-identified issues (e.g., SIQA-140611-A) and placed below the new observations in the appropriate section of the report (e.g., QA, waste operations).

Pilot Effort Audit Report Format

• The audited facility’s self-identified issues that were not closed prior to the DOECAP audit are identified by the letters “SI” preceding the DOECAP identifier for the item (e.g., SIOQA-YYMMDD-XXX).

• DOECAP added a new issue category in this report—audited facility self-identified issue—to accommodate the TSDF checklist pilot project results. The definition is provided on next slide.

Pilot Effort Audit Report Process

• Audited Facility Self-Identified Issue: In a DOECAP audit report, a self-identified issue refers to an issue identified by the audited facility during advance completion of DOECAP audit checklists.

• The Operations Team sends the blank checklists to the facility at least six weeks in advance, and the facility sends the completed checklists and the list of newly identified issues back to the Operations Team at least two weeks prior to the audit.

TSDF Pilot Checklist Lessons Learned

Item Numbe

r

Lines of Inquiry Status

Response/CommentFrom the Facility

Status

Response/Comment From the Auditor

1.0 Quality Assurance Program        

Pilot Effort Lessons Learned

• Give audit facility more time to complete the checklists

• Ensure auditors have time to review completed checklists from the TSDF prior to the audit

• Work on site-specific checklists• Revise the checklist form as previously

discussed• Validate objective evidence packages and have

them prepared by TSDF• Audit report format agreed upon by DOECAP

Pilot Effort Lessons Learned and Suggestions

• Future off-year assessments could rely on completed checklists and TSDF condition reporting review.

• Auditors or TSDF Input

• Others

Other Audit Approach Suggestions

Group Discussion – Capture feedback on flip chart

Path Forward / Questions?

• Summarize Pilot Effort issues and concerns

• Continue to engage Field Element Managers and obtain feedback regarding the TSDF Pilot

• Continue to provide data to DOECAP Operations Team and Headquarters

• Discuss performing this pilot approach at other TSDFs

• Recommend working group to solidify alternative approach (site-specific checklists/procedure)

Most Challenging Issue - Travel

“ I’m not bringing my lunch, I’m not sharing a room with another auditor, and I’m not driving my car to the East Coast”

THANK YOU