022.01
SUBMISSION AND IMPLEMENTATION. Each quality assurance
program approval holder must:
(A) Submit 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 description must identify:
(i) The change;
(ii) Reason for the change; and
(iii) Basis for concluding the revised
program incorporating the change continues to satisfy the applicable
requirements of 180 NAC
13-021; and
(B) Not implement the change before receiving
Department approval.
022.02
PREVIOUSLY APPROVED
QUALITY ASSURANCE PROGRAM. Each quality assurance program approval
holder may change a previously approved quality assurance program without prior
Department approval, 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 must be submitted
to the Department every 24 months. In addition to quality assurance program
changes involving administrative improvements and clarifications, spelling
corrections, and nonsubstantive changes to punctuation or editorial items, the
following changes are not considered reductions in commitment:
(A) Use of a quality assurance standard
approved by the Department that is more recent than the quality assurance
standard in the licensee's current quality assurance program at the time of the
change;
(B) Use of generic
organizational position titles that clearly denote the position function,
supplemented as necessary by descriptive text, rather than specific titles,
provided there is no substantive change to either the functions of the position
or reporting responsibilities;
(C)
Use of generic organizational charts to indicate functional relationships,
authorities, and responsibilities, or alternatively, the use of descriptive
text, provided there is no substantive change to the functional relationships,
authorities, or responsibilities;
(D) 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; and
(E) Organizational revisions that ensure
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.
022.03
RECORDS. Each quality assurance program approval
holder must maintain records of quality assurance program changes.
