Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
QUALITY ASSURANCE
Section 120.794 - Changes to Quality Assurance Program

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.794

Current through Register 1531, September 27, 2024

(A) Each quality assurance program approval holder shall submit, in accordance with 105 CMR 120.013, a description of a proposed change to its Agency-approved quality assurance program that will reduce commitments in the program description as approved by the Agency. The quality assurance program approval holder shall not implement the change before receiving Agency approval. The description of a proposed change to the Agency-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 105 CMR 120.791 through 120.797.

(B) Each quality assurance program approval holder may change a previously approved quality assurance program without prior Agency approval, if the change does not reduce the commitments in the quality assurance program previously approved by the Agency. Changes to the quality assurance program that do not reduce the commitments shall be submitted to the Agency every 24 months, in accordance with 105 CMR 120.013. 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:

(1) The use of a quality assurance standard approved by the Agency that is more recent than the quality assurance standard in the applicant's current quality assurance program at the time of the change;

(2) 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;

(3) 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;

(4) 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; and

(5) 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.

(C) Each quality assurance program approval holder shall maintain records of quality assurance program changes.

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