S.G. Wander, P.S.Z. Rogers, M.A. Gavett, and I.R. Triay
Chemical Sciences and Technology Division,

S.A. Robbins, D.P. Taggart, D.R. Yeamans, J.J. Vigil, S.E. Betts,
D.R. Janecky, C.P. Leibman, G.I. Vigil
Chemical Sciences and Technology Division

A.J. Montoya
Nuclear Materials Technology Division
Los Alamos National Laboratory, Los Alamos, NM 87545

The Los Alamos National Laboratory (LANL) achieved a national milestone on the road to shipment of transuranic (TRU) waste to the Waste Isolation Pilot Plant (WIPP) when it received certification authority on September 12, 1997. LANL earned the distinction of being the first TRU waste generator in the U.S. Department of Energy (DOE) complex to attain certification authority from the DOE Carlsbad Area Office (CAO). This paper describes not only the site process by which LANL gained this authority, but also valuable lessons learned from the process. These lessons learned will benefit other DOE sites as they prepare to receive their certification authorities.

Before a site is authorized to prepare TRU waste for shipment to the WIPP, it must prove that it has the capabilities and systems in place at quality levels that meet or exceed all of the requirements of the CAO TRU waste program. This includes the completion and determination by CAO that required site documents are adequate, effective, and implemented satisfactorily; satisfactory performance in the Performance Demonstration Program (PDP); completion of required personnel training; and a determination by the CAO that the site's quality assurance and technical programs are adequate and effectively implemented. The technical capabilities required for waste characterization include real time radiography, gamma spectroscopy, radionuclide assay, headspace gas sampling and analysis, visual examination, acceptable knowledge investigations, and data reduction and reconciliation. In addition, certification requires data handling and reporting capabilities, ability to use the WIPP Waste Information System (WWIS), and an approved transportation program. The quality assurance (QA) program includes audited procedures for all activities, quality control procedures, and a system and procedures for software validation and verification.

Over the past two years, LANL was subjected to three audits that evaluated these systems. Some of the expert participants on the audit review teams were from: the CAO, the U.S. Environmental Protection Agency (EPA), the State of New Mexico Environment Department (NMED), the New Mexico Environmental Evaluation Group (EEG), and additional organizations. Through the process of these audits, LANL completed necessary and required enhancements that allowed the CAO to grant certification authority for the site to certify LANL TRU legacy debris waste and to ship it in the TRUPACT-II shipping container to the WIPP.

The process used by LANL to complete each of these steps is described below, along with examples of lessons learned by LANL while implementing the required capabilities.

The National TRU Program has as its upper-tier requirements documents, five main documents that are issued by the CAO to the site as controlled documents. These are the Waste Acceptance Criteria¹ (WAC), the Transuranic Waste Characterization Quality Assurance Program Plan² (QAPP), the Transuranic Waste Characterization Sampling and Analysis Methods Manual³ (Methods Manual), the Quality Assurance Program Document⁴ (QAPD), and the TRUPACT-II Authorized Methods for Payload Control⁵ (TRAMPAC).

To pass the adequacy portion of the audit, all requirements must flow down from these upper-tier requirements documents into the site's specific program documents. Ensuring complete flowdown of all of the over 4,000 requirements is the main challenge for the QA staff in implementing a certification program. As the technical, data reporting, and QA aspects of a new certification program mature, the implementing procedures will change. It is almost impossible to implement all requirements without resorting to the seemingly endless and mundane task of listing in several large tables the upper-tier requirements, the section of the site-specific document in which they are addressed, and the sections of the procedures in which they are implemented. The tables listing requirements are an invaluable aid in ensuring that changes in procedures do not lead to inadvertent omission of a requirement. To provide this flowdown of requirements into site-specific documents, LANL developed a Quality Assurance Management Plan⁶ (QAMP), a Quality Assurance Project Plan⁷ (QAPjP), a Waste Certification Plan⁸, approximately 40 detailed technical procedures (DTPs), and approximately 35 quality procedures (QPs). The site document hierarchy is shown in Fig. 1.

The QAPjP was the first document prepared under the Transuranic Waste Characterization/Certification Program (TWCP) QA program; the WIPP WAC, QAPP, and the QAPD require it as a predecessor document. It must be approved by the DOE Los Alamos Area Office (LAAO) and the CAO. When LANL first submitted a draft site QAPjP for approval, references were made to the QAPP rather than reiterating the requirements, and sections within chapters were organized differently than in the QAPP. One of the lessons LANL learned from this was not to change the format of the QAPjP from that of the QAPP. LANL saved time, confusion, and frustration by modifying the QAPjP to match exactly the content and organization of the QAPP. In each section of the QAPjP, the requirements of the QAPP are reiterated in order and the implementing procedures or documents are listed. This results in a document that is essentially a listing of the QAPP requirements and their flowdown, even if it does mean some repetition of requirements. This allows scientific specialists to review their procedures against the QAPjP requirements without having to go back to the QAPP.

When LANL submitted its QAPjP to the CAO for review, LANL also submitted copies of all variances that had been issued and referenced in the QAPjP, which made it obvious to CAO that LANL had received approval for those variances (and hopefully would not open those variances up for discussion again).

The requirements in Chapters 1 through 4 of the QAPP contain many, but not all of the QA requirements of the QAPD (the QAPD contains no technical requirements). To track the flowdown of these additional requirements to procedures, LANL wrote an additional site-specific document, the QAMP. The QAMP includes reference to training, assessment, and graded approach procedures. Initially, a graded approach was not used by LANL, under the assumption that all certification activities would fall under Level 1. However, a graded approach procedure is required by the QAPD, and the DOE Field Office and the CAO must approve it. LANL developed a graded approach procedure that uses two basic levels; most activities related to the TRU Waste Program are considered Level 1 and require application of all of the QA elements. Activities related to the facilities are considered Level 2, where some less stringent QA elements may be applied.

A procedures matrix also is required by the QAPD, and must be approved by the LAAO and the CAO. The matrix shows the flowdown of requirements into site-specific documents, all the way down to the implementing procedures. As with the QAPP, it is critical that all applicable QAPD requirements have flowed into the appropriate plan or procedure. CAO determines if adequacy has been met prior to commencing the certification audit.

The Sampling Plan⁹ was the second document prepared by LANL. It is required by the QAPP and must be approved by the Site Project Manager. Even though the CAO recommends that the Sampling Plan be included with the QAPjP, LANL's Sampling Plan is a separate document. This allows for revision of its information separate from having to revise the entire QAPjP. The Sampling Plan outlines the contents of the LANL legacy waste inventory and the strategy to be used in the sampling of TRU waste that will be shipped to the WIPP. No procedures are contained within the Sampling Plan. Instead, sampling procedures are independent and referenced directly in the QAPjP.

LANL prepared approximately 40 detailed technical procedures addressing activities to be implemented to meet the requirements outlined in the Waste Certification Plan and the QAPjP. Each technical activity had its share of learning experiences during implementation. Problems common to the implementation of technical activities typically occurred in requirements flowdown and at the interfaces of different activities. Initially, technical staff often followed the requirements of the Methods Manual but neglected the QAPP requirements in their procedures. This problem was solved by having the QA staff pay special attention to the requirements flowdown matrix developed from the QAPjP while reviewing technical procedures and working with the technical staff to incorporate missed requirements.

The most serious and confusing problems occurred at the interfaces between activities, particularly in data review and in the coordination of related characterization activities. For example, technical staff implemented the general review requirements of Chapter 3 of the QAPP using technical terms, wording, and references to data quality objectives (DQOs) specific to their activities. Many auditors were not able to determine the correspondence between the technical questions and the general review criteria of the QAPP. This problem persisted until we required each technical specialist to include, in their data review procedure, a matrix showing the correspondence between the technical and data generation QA review checklists and the requirements of Chapter 3 of the QAPP.

Two examples of problems encountered in bridging the interface between activities are of general interest to other sites, particularly those intending to use contract characterization services. In the use of radioassay for determining radionuclide content, the ratios of the concentrations of each radionuclide must be known from acceptable knowledge (AK) or must be determined, typically using gamma spectroscopy. LANL AK was determined by a CAO audit not to provide sufficient information of radionuclide ratios, so that gamma spectroscopy was required. In turn, the gamma spectrum deconvolution results obtained experimentally must be reconciled with the original AK information as a method of improving waste AK. A procedure clearly explaining the flow of information from AK, to gamma spectroscopy, to radioassay, and back to AK reconciliation is necessary to document these activities. Similarly, for use in radiography, LANL did not have sufficient information on waste packaging practices to provide a table correlating waste packaging volumes with waste material weights. An additional requirement to measure the volume of each waste item weighed during visual examination was added to the visual examination procedure, the radiography procedure was changed to allow the estimation of volumes only. An additional procedure was written to document the use of the visual examination data to develop a volume-to-weight correlation table and its subsequent use in calculating the waste material parameter weights from radiography information.

The WIPP WAC requires each site to develop and implement plans that address TRU waste characterization, certification, packaging, and transportation requirements. As previously discussed, waste characterization requirements are based on the CAO QAPP, general site QA program requirements are based on the CAO QAPD, and the QA/quality control (QC) elements for analytical laboratories and testing facilities are based on requirements in both the CAO QAPD, the CAO QAPP, and the Methods Manual.

The site-specific Waste Certification Plan is used to show flowdown of requirements for certification and is approved by the DOE Field Office and the CAO. The certification technical requirements are contained in the WIPP WAC, while certification QA requirements are based on the CAO QAPD. As with the QAPjP, LANL organizes the Certification Plan to match the organization of the technical requirements listed in the WIPP WAC. LANL met the CAO QA requirements, not by preparing a separate structure and document, but by using the QA structure that was already established through the QAMP and QAPjP. For clarity and simplification, the QA chapter of the LANL Certification Plan simply contains a matrix referencing where the QA requirements of the WIPP WAC are met in the QAMP, QAPjP, and implementing procedures.

LANL's TRAMPAC and associated QA plan are both included in the site TRU Waste Certification Plan. The LAAO and the CAO must approve these elements of certification. The TRAMPAC describes how compliance with requirements of the Safety Analysis Report for the TRUPACT-II Shipping Package¹⁰ (SARP) and the Certificate of Compliance¹¹ (C of C) will be met. LANL's TRAMPAC states the requirement, states how we intend to comply, and states how we will verify that we have complied. The procedures that are used for this compliance are all referenced and summarized in tabular format. LANL found that, by combining the TRAMPAC and its associated QA plan with the site TRU Waste Certification Plan, it has produced a user friendly plan that provides all requirements and references to implementing procedures in one document.

The packaging QA plan is the document which demonstrates that LANL's packaging activities for the TRUPACT-II meet the requirements of 10 Code of Federal Regulations (CFR) 71¹² (Subpart H) and the C of C. The LAAO must approve the packaging QA plan. LANL met this requirement, not by preparing a separate document, but by using the QA structure that was already established and referencing, in a matrix, how these elements relate to the requirements in Subpart H. For activities specifically related to transportation, the detailed procedures that were developed were documented and distributed as a transportation implementation procedure manual.

Some personnel positions in the LANL TRU Waste Program require specific qualifications and training, which are outlined in documents such as the QAPP, QAPD, and Methods Manual. The steps used to build the training and qualification program at LANL are listed in Table I. LANL has consolidated these training requirements into a TRU Waste Program Training Matrix, which details the position by job function, shows the qualifications necessary, and shows the training (either through reading procedures, attending classes, or conducting on-the-job exercises) necessary to meet the requirements. An example of the training matrix (for procedures) is shown in Fig. 2. All TWCP personnel have received the required training, and each individual has a training file that details this training.

A challenge for LANL was keeping the training up to date, especially when implementing procedures were being revised at such a fast rate that there was minimal time to train (and document that training) to the revised procedure. LANL addressed that by including a statement on the document receipt acknowledgment from which, by signing, documents that the recipient has read and understood the revised procedure. LANL also supplemented the read-and-sign procedures with self-assessments that were distributed with the procedures. Personnel are not allowed to work on TWCP tasks prior to completing their training.

To demonstrate to the CAO that the characterization activities for radioassay, headspace gas, and Resource Conservation and Recovery Act (RCRA) analysis of solidified waste successfully meet the QA objectives of the QAPP, LANL participates in the PDPs for these characterization activities. To date, LANL has passed all cycles of the PDPs for each activity (two per year; soon to be once per year per activity), showing that LANL maintains effective characterization capabilities. Participation in each PDP cycle requires dedication of about six person-weeks of effort for each characterization activity.

The WIPP Waste Information System (WWIS) is the system through which the characterization, certification, and shipping data is sent to the WIPP for approval prior to releasing a payload assembly for shipment. The WWIS (software, user manual, and training) was introduced to LANL by the CAO, and LANL personnel implemented the system by developing a procedure entitled Data Entry to WWIS. Until the entire data process is electronic at LANL, this procedure allows for development of spreadsheets that are used to enter data manually into WWIS. Data are collected from the various characterization activities (e.g., radiography, radioassay, headspace gas analysis, and visual examination) and are reviewed, verified, and validated at the data generation phase, at the project level, and at the CAO level.

At the data generation level, a technical reviewer, a QA reviewer, and a supervisor review the data. At the project level, the Site Project QA Officer and the Site Project Manager review the data. At the CAO level, the Data Manager at WIPP reviews the data after they are entered into the Characterization Module of WWIS. Each container is approved on a separate basis in the Characterization Module of WWIS before the container can be transferred into the Certification Module of WWIS. The Waste Stream Profile Form (WSPF) is completed and submitted to the CAO for review and approval before any waste can be approved as ready to ship. This WSPF approval is tied into the WWIS review and approval of information. Data cannot be transferred from the Characterization Module to the Certification Module of the WWIS without the WSPF approval and waste stream number entry into WWIS. Information that is required for completion of the WSPF includes the detailed AK Summary Report, which provides detailed information on the processes used to produce the waste.

Data entered into the WWIS are reviewed and verified to contain correct information at several different steps, and the entire WWIS process is documented and verified. The main challenge in this process is maintaining adequate tracking of WWIS entries all the way back to the original, raw data. An example (just one of several pages) of the WWIS data and the source document for that information that is used at LANL for the spreadsheet input is shown in Table II. LANL demonstrated effective use of the system during its certification audit in September 1997. However, LANL does not recommend manual entry of data into the WWIS because of the time required. LANL is in the process of implementing electronic data transfer.

LANL had three audits in two years. The last two were the main certification audits that addressed the areas of waste characterization, certification, packaging, and transportation activities. The audits included evaluating the effectiveness and adequacy of LANL's implementation of the LANL QA program. The QA Program includes both the site-specific TRU waste QA program and implementation procedures and the QA programs and procedures for LANL generators/storage site(s) as they apply to TRU waste activities. The audit teams determined that the implementation of the QA program was adequate, satisfactorily implemented, and effective. In planning for certification audits, sites must be prepared to operate systems during the audit. All documents (e.g., plans and procedures) must be approved and implemented prior to the audit and sites must be able to show evidence of program implementation (at least 30 days) prior to the audit.

After the follow-up on the certification audits, LANL received a letter from the CAO (September 12, 1997)¹³ that gave LANL certification and transportation authority for characterization, certification, and shipping of combustible legacy debris waste. This was the first such letter sent to a site in the DOE Complex and is milestone on the road to WIPP.

LANL has proven that it has the capabilities and systems in place at quality levels that meet or exceed all of the requirements of the CAO TRU waste program. The major steps in developing this effective program were:

• Preparing site documents for waste characterization, certification, and transportation that addressed all requirements;
• Addressing interfaces between activities to ensure consistency and to avoid discrepancies;
• Assembling a comprehensive worker qualification matrix to identify and track necessary training; and
• Developing a system which allows traceability of data from the WWIS entry back to the original raw data.

Finally, LANL proposes that the lessons it learned during the certification process be considered by other DOE sites so that receipt of their certification authorities may be accelerated.

1. Waste Acceptance Criteria For The Waste Isolation Pilot Plant. Revision 5. DOE/WIPP-069 Carlsbad, New Mexico, U.S. DOE Carlsbad Area Office (1996).
2. Transuranic Waste Characterization Quality Assurance Program Plan, Revision 0. CA0-94-1010, Carlsbad, New Mexico, Carlsbad Area Office, U.S. Department of Energy (1995).
3. Transuranic Waste Characterization, Sampling and Analysis Methods Manual. DOE/WIPP-91-043, Rev. 1, Carlsbad, New Mexico, Carlsbad Area Office, U.S. Department of Energy (1996).
4. QAPD Quality Assurance Program Description. CAO-94-1012, Current Revision, Carlsbad, New Mexico, Carlsbad Area Office, U.S. Department of Energy (1994).
5. TRUPACT-II Authorized Methods for Payload Control. Appendix 1.3.7 of Safety Analysis Report for the TRUPACT-II Shipping Package (Condensed), Revision 14. Carlsbad, New Mexico, U.S. DOE Carlsbad Area Office (1994).
6. Los Alamos National Laboratory Transuranic Waste Quality Assurance Management Plan. Revision 0. TWCP-PLAN-0.2.6-001,R.0, Los Alamos, New Mexico, Los Alamos National Laboratory (1997).
7. Los Alamos National Laboratory Transuranic Waste Characterization Quality Assurance Project Plan. Revision 0. CSTDO-PLAN-002,R.0, Los Alamos, New Mexico, Los Alamos National Laboratory (1995).
8. Los Alamos National Laboratory Transuranic Waste Certification Plan. Revision 0. PLAN-CSTDO-004,R.0, Los Alamos, New Mexico, Los Alamos National Laboratory (1996).
9. Los Alamos National Laboratory Transuranic Waste Sampling Plan. Revision 0. CSTDO-PLAN-003,R.0, Los Alamos, New Mexico, Los Alamos National Laboratory (1995).
10. Safety Analysis Report for the TRUPACT-II Shipping Package (Condensed), Revision 14. Carlsbad, New Mexico, U.S. DOE Carlsbad Area Office (1994).
11. TRUPACT-II Certificate of Compliance, Revision 7. Docket number 71-9218, U.S. Nuclear Regulatory Commission (1996).
12. 10 CFR 71, Packaging and Transportation of Radioactive Materials, Code of Federal Regulations, Washington, D.C., Office of the Federal Register, National Archives and Records Administration.
13. Letter from George E. Dials, Carlsbad Area Office, to G. Thomas Todd, Los Alamos Area Office, on Site Certification of Los Alamos National Laboratory, dated September 12, 1997.

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