DHS 157.94(6)(f)1.1. Each quality assurance program approval holder shall submit to the department a description of a proposed change to its department-approved quality assurance program that will reduce commitments in the program description as approved by the department. The quality assurance program approval holder shall not implement the change before receiving the department’s approval. The description of a proposed change to the department-approved quality assurance program must identify the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the applicable requirements of 10 CFR 71 subpart H.

DHS 157.94(6)(f)2.2. Each quality assurance program approval holder may change a previously approved quality assurance program without the prior approval of the department, if the change does not reduce the commitments in the quality assurance program previously approved by the department. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the department every 24 months. In addition to quality assurance program changes involving administrative improvements and clarifications, spelling corrections, and non-substantive changes to punctuation or editorial items, the following changes are not considered reductions in commitment:

DHS 157.94(6)(f)2.a.a. The use of a quality assurance standard approved by the department that is more recent than the quality assurance standard in the certificate holder’s or applicant’s current quality assurance program at the time of the change.

DHS 157.94(6)(f)2.b.b. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles, provided that there is no substantive change to either the functions of the position or reporting responsibilities.

DHS 157.94(6)(f)2.c.c. The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternatively, the use of descriptive text, provided that there is no substantive change to the functional relationships, authorities, or responsibilities.

DHS 157.94(6)(f)2.d.d. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which the quality assurance program approval holder has committed to on record.

DHS 157.94(6)(f)2.e.e. Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

DHS 157.94(6)(f)3.3. Each quality assurance program approval holder shall maintain records of quality assurance program changes.

DHS 157.94(6)(g)(g) The licensee, certificate holder, and applicant for a certificate of compliance shall maintain sufficient written records to describe the activities affecting quality.

DHS 157.94(6)(g)1.1. The records shall include the following:

DHS 157.94(6)(g)1.b.b. The documented instructions, procedures, or drawings of a type appropriate to the circumstances to prescribe quality assurance activities including appropriate quantitative and qualitative acceptance criteria for determining that activities important to quality have been satisfactorily accomplished.

DHS 157.94(6)(g)1.d.d. the instructions or procedures which establish a records retention program that is consistent with applicable regulations and designates factors such as duration, location, and assigned responsibility.

DHS 157.94(6)(g)2.2. The licensee, certificate holder, and applicant for a certificate of compliance shall retain these records for 3 years beyond the date when the licensee, certificate holder, and applicant for a certificate of compliance last engages in the activity for which the quality assurance program was developed. If any portion of the quality assurance program, written procedures or instructions is superseded, the licensee, certificate holder, and applicant for a certificate of compliance shall retain the superseded material for 3 years after it is superseded.

DHS 157.94(7)(7) Assumptions as to unknown properties of fissile material. When the isotopic abundance, mass, concentration, degree of irradiation, degree of moderation, or other pertinent property of fissile material in any package is not known, the licensee shall package the fissile material as if the unknown properties have credible values that will cause the maximum neutron multiplication.

DHS 157.94(8)(8) Preliminary determinations. Prior to the first use of any packaging for the shipment of radioactive material a licensee shall ascertain that the determination requirements in 10 CFR 71.85 (a) through (c) have been made.

DHS 157.94 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (2) (b) Register October 2006 No. 610, eff. 11-1-06; CR 16-078: r. and recr. (3), am. (5) (a), cr. (5) (am), am. (5) (c) 4., (d) to (f), r. and recr. (6), renum. (8) (intro.) to (8) and am., r. (8) (a) to (d) Register January 2018 No. 745, eff. 2-1-18; correction in (2) (b), (5) (b) 3. a., b., (6) (b), (d), (g) (intro.), 2. made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (5) (d), (6) (c), renum. (6) (f) 1. (intro.) to (6) (f) and am., r. (6) (f) 1. a., b., am. (6) (f) 2. (intro.), a. Register June 2023 No. 810, eff. 7-1-23.

DHS 157.95(3)(3) The community water system obtains all water from, but is not owned or operated by, a public water system to which the rules of this subchapter apply.