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The Sandia National Laboratories Nuclear Weapons Strategic Management Unit (NWSMU) is pursuing performance excellence, by focusing on compliance with the ISO 9001:2000 standard for quality management systems. The NWSMU also intends to achieve ISO Certification and eventually reach levels of performance excellence that are consistent with those of Malcolm Baldrige National Quality Award winners. In that context, this report documents a study undertaken to answer these questions: {sm_bullet} Would achieving ISO 9001:2000 compliance or certification help an organization prepare to achieve Baldrige-level performance excellence? {sm_bullet} Would pursuing Baldrige-based performance excellence help an organization achieve ISO certification? {sm_bullet} What are the areas where the Baldrige and ISO systems are most closely aligned? The study produced answers to those questions, as well as a number of comparisons and contrasts between the ISO standard and the Baldrige criteria.

This paper provides a summary of lessons learned from experiences on the Waste Isolation Pilot Plant (WJPP) Project in implementation of quality assurance controls surrounding inputs for performance assessment analysis. Since the performance assessment (PA) process is inherent in compliance determination for any waste repository, these lessons-learned are intended to be useful to investigators, analysts, and Quality Assurance (QA) practitioners working on high level waste disposal projects. On the WIPP Project, PA analyses for regulatory-compliance determination utilized several inter-related computer programs (codes) that mathematically modeled phenomena such as radionuclide release, retardation, and transport. The input information for those codes are the parameters that are the subject of this paper. Parameters were maintained in a computer database, which was then queried electronically by the PA codes whenever input was needed as the analyses were run.

The quality assurance requirements that apply to the effort to achieve safe transportation, storage, and disposal of high-level nuclear waste specify that ``design control`` be applied to design activities. That effort also involves extensive scientific investigation activities to, among other things, develop information that may be used in engineering design activities. Individuals who are charged with the implementation of such quality assurance requirements have come to a variety of conclusions about whether there is any firm linkage between design control and the conduct of scientific investigations. This paper contends that there is a reasonable and necessary linkage between ``design control`` and scientific activities, though not a connection that has traditionally been made and not one addressed in the QA standards for radioactive waste management programs.

The necessity to evaluate our participant Quality Assurance (QA) Program for the Yucca Mountain Site Characterization Project (YMP) against the Office of Civilian Radioactive Waste Management (OCRWM) Quality Assurance Requirements and Description (QARD) issued December 1992, presented an opportunity to improve the QA Program. For some time, the SNL YMP technical staff had complained that the QA requirements imposed on their work were cumbersome and inhibited their ability to perform investigations using scientific methods. There was some truth to this, since SNL had over the years developed some procedures with many detailed controls that were far beyond what was required by project QA requirements. This had occurred either as a result of responding to numerous audit findings with a ``make the auditor happy`` attitude or with an attempt to cover every contingency. Procedures affecting scientific work were authored by the technical staff in an effort to provide them with ownership of the process; unfortunately, there were problems. Procedures were inconsistent because of the varied writing styles and differing perceptions of the degree of QA controls required to implement the program. It was extremely difficult to get all of the technical staff to accept the QA program as it was intended. These issues were endemic to the program and resulted in the QARD, the actual requirements, being written by a team of QA professionals. Once new QARD requirements were issued, an opportunity to evaluate the QA Program and to revise it not only to meet the QARD, but also to make it more plausible and meaningful to the technical staff, was presented. The discussion that follows will describe how the program was changed, will present both the positive and negative experiences observed by SNL personnel during the QARD transition, and will provide some recommendations.