U.S. DEPARTMENT OF ENERGY

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT

OFFICE OF QUALITY ASSURANCE

AUDIT REPORT

OF

UNITED STATES GEOLOGICAL SURVEY

DENVER, COLORADO

AUDIT USGS-ARC-97-15

APRIL 28 - MAY 2, 1997

Prepared by:__________________________________________ Date:______________

Cynthia A. Humphries-Alder

Audit Team Leader

Office of Quality Assurance

Approved by:_________________________________________ Date:______________

Donald G. Horton

Director

Office of Quality Assurance

1.0 EXECUTIVE SUMMARY

As a result of Quality Assurance (QA) Audit USGS-ARC-97-15, the audit team determined that the U.S. Geological Survey (USGS) is satisfactorily implementing an adequate and effective QA program in accordance with the U.S. Department of Energy Office of Civilian Radioactive Waste Management (OCRWM) Quality Assurance Requirements and Description (QARD), DOE/RW-0333P, Revision 5 and the USGS=s implementing procedures for QA Program Elements 1.0, 2.0, 4.0, 5.0, 6.0, 7.0, 12.0, 15.0, 16.0, 17.0, 18.0 (surveillances only) and Supplements I, II, and III.

The audit team identified three deficiencies during the audit that resulted in the issuance of three Deficiency Reports (DRs) and USGS issued one DR detailed in Section 5.5.2. YM-97-D-039, the USGS-Yucca Mountain Project-Quality Management Procedure, (USGS-YMP-QMP)-3.16, AScientific Expert Elicitation,@ was implemented prior to the Project Plan being approved. YM-97-D-040, there has been no implementation of OCRWM Administrative Procedure, (AP)-17.1Q which became effective on November 22, 1996. YM-97-D-041, Nonconformance Reports (NCRs) are not being initiated at the time a nonconformance is identified. USGS-97-D-005 was issued as a result of upgrading an existing Performance Report (PR) to a DR after additional occurances of failure of obtain QA approval of procurement modifications were identified during the audit. Furthermore, there were four recommendations resulting from the audit, which are detailed in Section 6.0 of this report.

2.0 SCOPE

The audit was conducted to evaluate adequacy, compliance, and effectiveness of the OCRWM QA Program as described in the QARD and USGS=s implementing procedures.

The QA program elements/requirements evaluated during the audit are in accordance with the approved audit plan as follows:

QA PROGRAM ELEMENTS

1.0 Organization

2.0 Quality Assurance Program

4.0 Procurement Document Control

5.0 Implementing Documents

6.0 Document Control

7.0 Control of Purchased Items and Services

12.0 Control of Measuring and Test Equipment

15.0 Nonconformances

16.0 Corrective Action

17.0 Quality Assurance Records

18.0 Audits (Surveillances only)

Supplement I Software

Supplement II Sample Control

Supplement III Scientific Investigation

The following QA program elements/requirements were not reviewed during the audit because USGS has no activity for which these elements apply:

3.0 Design Control

8.0 Identification and Control of Items

9.0 Control of Special Processes

10.0 Inspection

11.0 Test Control

13.0 Handling, Storage, and Shipping

14.0 Inspection, Test and Operating Status

18.0 Audits

Supplement IV Field Surveying

Supplement V Control of the Electronic Management of Data

3.0 AUDIT TEAM

The following is a list of audit team members and their assigned areas of responsibility:

QA Program

Name/Title/Organization Element/Requirement

Cynthia A. Humphries-Alder, Audit Team Leader, OQA 2.0, 5.0, 6.0

James Blaylock, Auditor, OQA Supplements I, II, III

Henry T. Greene, Auditor, OQA 1.0, 15.0, 16.0, 18.0

Kristi A. Hodges, Auditor, OQA 4.0, 7.0, 12.0, 17.0

4.0 AUDIT MEETINGS AND PERSONNEL CONTACTED

The preaudit meeting was held at the USGS offices in Denver, Colorado, on April 28, 1997. Briefing and coordination meetings were held with the USGS management and staff on an as needed basis. Audit team meetings were also held daily to discuss issues and potential deficiencies. The audit was concluded with a postaudit meeting on May 2, 1997. A list of personnel contacted during the audit is found in Attachment 1 of this report. The list includes those who attended the preaudit and postaudit meetings.

Cooperation afforded to the audit team during the entire course of the audit was exceptional.

5.0 SUMMARY OF AUDIT RESULTS

5.1 Program Effectiveness

The audit team concluded that, overall, the USGS QA Program is adequate and is being satisfactorily implemented for the scope of this audit. The results for each program element evaluated are contained in Attachment 2, Summary Table of Audit Results for Procedural Compliance Evaluations.

5.2 Stop Work or Immediate Corrective Actions Taken

There were no Stop Work Orders, immediate corrective actions, or related additional items resulting from this audit.

5.3 QA Program Audit Activities

The Summary Table of Audit Results for Procedural Compliance Evaluations is provided in Attachment 2. The audit checklists contain the details of the audit evaluation along with identification of the objective evidence reviewed. The checklists are kept and maintained as QA Records.

5.4 Technical Audit Activities

There were no technical areas evaluated during this audit.

5.5 Summary of Deficiencies

The audit team issued three deficiencies during the audit. One additional condition, which had been previously documented and issued as a USGS PR, was upgraded and reissued as a USGS DR prior to the postaudit meeting. Synopses of deficiencies documented as DRs, are detailed in Section 5.5.2.

5.5.1 Corrective Action Requests (CARs)

None.

5.5.2 Deficiency Reports (DRs)

YM-97-D-039

YMP-USGS-QMP-3.16 requires a Project Plan to be approved prior to the implementation of the Scientific Elicitation process. Contrary to the procedure, implementation was initiated on or before October, 1996; however, the Project Plan was not approved until April 30, 1997. In addition, the attestation of qualifications had not been documented for many of the participants in the process.

YM-97-D-040

OCRWM AP-17.1Q, was issued with an effective date of November 22, 1996. Furthermore, on that same date a letter was transmitted from the Director, Office of Human Resources and Administration, and the Yucca Mountain Site Characterization Office Assistant Manager for Administration and Asset Management directing the implementation of AP-17.1Q and the cancellation of existing record source procedures within 90 days, i.e., February 20, 1997. To date, the USGS has not implemented this procedure, nor has it canceled its existing record source procedure.

YM-97-D-041

Yucca Mountain Administrative Procedure (YAP)-15.1Q, AControl of Nonconformances,@ requires an NCR to be initiated at the time a nonconformance is identified. Contrary to the procedure, a review of past and current NCRs revealed that several had been initiated and documented months after identification of the nonconformance.

USGS-97-D-005

An existing PR, USGS-97-P-002, had been issued to document failure to obtain QA approval of procurement modifications. This PR was closed and reissued as DR USGS-97-D-005 when an additional occurance was identified during the audit.

5.5.3 Performance Report (PRs)

None

5.5.4 Deficiencies Corrected During the Audit

None

5.5.5 Follow-up of Previously Identified CARs and DRs

Two corrective action verifications were performed during the audit and are as follows:

CAR YM-96-004

CAR YM-96-004 documented a significant breakdown in the USGS procurement process. After a collaborated effort by the USGS and OQA to correct the CAR condition, all but one of the individual findings within the CAR were verified to have been corrected. The one finding and two additional issues associated with the USGS Procurement Action Plan are the subjects of three open USGS DRs. A determination was made to resolve and track the remaining actions via the open DRs. Based on the verification results, it is recommended that CAR YM-96-004 be closed.

YM-96-D-051

During the audit, corrective action for DR YM-96-D-051 was verified. The DR, which documented lost or misplaced records, identified 51 record packages that were assembled and transmitted to the Records Processing Center (RPC). Twelve of 51 record packages were verified as having been transferred; those packages were in order. It is recommended that YM-96-D-051 be closed.

6.0 RECOMMENDATIONS

The following recommendations resulted from the audit and are presented for USGS management consideration:

1. It is recommended that YMP-USGS-QMP-4.01, AProcurement Document Control,@ or a superseding procedure, include provisions for a supplier to notify the USGS when its QA program has been revised/changed. Currently, it is left to the annual supplier evaluation to discover program changes. In view of the fact that the USGS has recently base-lined its suppliers, the QA program manuals indicated in the OCRWM Qualified Suppliers List are assumed current; however, for future procurements, this provision needs to be added to the procurement documentation.

2. Intergovernmental Personnel Assignment (IPA) agreements, which are rarely used by YMP-USGS, are not considered by YMP-USGS to be procurement documents. However, based on review of the only open IPA, it serves essentially the same purpose as a procurement document; i.e., to attain a specified service, and is tracked on the USGS procurement log. To ensure application of appropriate quality requirements, it is recommended that IPAs be incorporated into YMP-USGS-QMP-4.02, AControl of Agreements,@ or any superseding procedure.

3. During the audit, Scientific Notebook (SN)-0034 was examined and found to be an inactive scientific notebook. The SN was initiated to control pore water extraction; this was done and two technical procedures were written, Hydrologic Procedure (HP)-223, AMethod for Pore Water Extraction Using One-Dimensional Compression,@ and HP-249, Method for Pore Water Extraction Using High-Pressure One-Dimensional Compression@. The last entry in the SN was December, 1994. The USGS should close this SN and submit it to the RPC. Likewise, the other existing SNs should be reviewed to determine if there are others that can be closed and submitted to the RPC.

4. The USGS initiated a formal Expert Elicitation (EE) process during October, 1996 under the auspices of the QA Program using NUREG-1563, ABranch Technical Position on the Use of Expert Elicitation in the High-Level Radioactive Waste Program,@ as the guide. Currently, the QARD does not address the EE process. The USGS internally approved their EE procedure, YMP-USGS-QMP-3.16, during October, 1996. The USGS has a milestone that is due in early 1998 that is dependent on the EE process.

The DOE reviewed the USGS QMP using the NUREG for developing the review criteria. The latest letter, dated April 16, 1997, outlines significant differences between DOE expectations and the USGS procedure. There has been little conveyance since October, 1996 in gaining OQA acceptance of the procedure - yet the process continues unabated. The primary areas of contention between the USGS and DOE deal with the use and status of unqualified data and software. OQA will soon find itself in the position of identifying the product as having shortcomings since the product was not in full compliance with a future QARD revision. Due to other commitments, many of the experts on the panels will be unavailable by the time these issues are resolved. This could impact and limit the action that the USGS would be able to accomplish in responding to corrective actions. It is imperative that the DOE define expectations for the EE process and that the USGS comply with DOE expectations.

7.0 LIST OF ATTACHMENTS

Attachment 1: Personnel Contacted During the Audit

Attachment 2: Summary Table of Audit Results for Procedural Compliance Evaluations

ATTACHMENT 1

ATTACHMENT 2

Summary of Audit Results

For Procedural Compliance Evaluations

LEGEND:

ADEQUACY Requirements in Procedure meet QARD N/I Not Implemented

CDA Corrected During the Audit OVERALL Summary of Element

COMPLIANCE Procedures Implemented REC Recommendation

N None SAT Satisfactory

N/A Not Applicable UNSAT Unsatisfactory