§ 194.22 - Quality assurance.

§ 194.22 Quality assurance.

(a)

(1) As soon as practicable after April 9, 1996, the Department shall adhere to a quality assurance program that implements the requirements of ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c), and Section 17.1). (Incorporation by reference as specified in § 194.5.)

(2) Any compliance application shall include information which demonstrates that the quality assurance program required pursuant to paragraph (a)(1) of this section has been established and executed for:

(i) Waste characterization activities and assumptions;

(ii) Environmental monitoring, monitoring of the performance of the disposal system, and sampling and analysis activities;

(iii) Field measurements of geologic factors, ground water, meteorologic, and topographic characteristics;

(iv) Computations, computer codes, models and methods used to demonstrate compliance with the disposal regulations in accordance with the provisions of this part;

(v) Procedures for implementation of expert judgment elicitation used to support applications for certification or re-certification of compliance;

(vi) Design of the disposal system and actions taken to ensure compliance with design specifications;

(vii) The collection of data and information used to support compliance application(s); and

(viii) Other systems, structures, components, and activities important to the containment of waste in the disposal system.

(b) Any compliance application shall include information which demonstrates that data and information collected prior to the implementation of the quality assurance program required pursuant to paragraph (a)(1) of this section have been qualified in accordance with an alternate methodology, approved by the Administrator or the Administrator's authorized representative, that employs one or more of the following methods: Peer review, conducted in a manner that is compatible with NUREG-1297, “Peer Review for High-Level Nuclear Waste Repositories,” published February 1988 (incorporation by reference as specified in § 194.5); corroborating data; confirmatory testing; or a quality assurance program that is equivalent in effect to ASME NQA-1-1989 edition, ASME NQA-2a-1990 addenda, part 2.7, to ASME NQA-2-1989 edition, and ASME NQA-3-1989 edition (excluding Section 2.1 (b) and (c) and Section 17.1). (Incorporation by reference as specified in § 194.5.)

(c) Any compliance application shall provide, to the extent practicable, information which describes how all data used to support the compliance application have been assessed for their quality characteristics, including:

(1) Data accuracy, i.e., the degree to which data agree with an accepted reference or true value;

(2) Data precision, i.e., a measure of the mutual agreement between comparable data gathered or developed under similar conditions expressed in terms of a standard deviation;

(3) Data representativeness, i.e., the degree to which data accurately and precisely represent a characteristic of a population, a parameter, variations at a sampling point, or environmental conditions;

(4) Data completeness, i.e., a measure of the amount of valid data obtained compared to the amount that was expected; and

(5) Data comparability, i.e., a measure of the confidence with which one data set can be compared to another.

(d) Any compliance application shall provide information which demonstrates how all data are qualified for use in the demonstration of compliance.

(e) The Administrator will verify appropriate execution of quality assurance programs through inspections, record reviews and record keeping requirements, which may include, but may not be limited to, surveillance, audits and management systems reviews.