Section 120.793 - Quality Assurance Program(A) The licensee shall establish, at the earliest practicable time consistent with the schedule for accomplishing the activities, a quality assurance program that complies with the requirements of 105 CMR 120.791 through 120.797. The licensee shall document the quality assurance program by written procedures or instructions and shall carry out the program in accordance with those procedures throughout the period during which the packaging is used. The licensee shall identify the material and components to be covered by the quality assurance program, the major organizations participating in the program, and the designated functions of these organizations.(B) The licensee shall base the requirements and procedures of its quality assurance program on the following considerations concerning the complexity and proposed use of the package and its components: (1) The impact of malfunction or failure of the item to safety;(2) The design and fabrication complexity or uniqueness of the item;(3) The need for special controls and surveillance over processes and equipment;(4) The degree to which functional compliance can be demonstrated by inspection or test; and(5) The quality history and degree of standardization of the item.(C) The licensee shall provide for indoctrination and training of personnel performing activities affecting quality, as necessary to assure that suitable proficiency is achieved and maintained. The licensee shall review the status and adequacy of the quality assurance program at established intervals. Management of other organizations participating in the quality assurance program shall review regularly the status and adequacy of that part of the quality assurance program they are executing.Amended by Mass Register Issue 1307, eff. 2/26/2016.Amended by Mass Register Issue 1373, eff. 9/7/2018.Amended by Mass Register Issue 1480, eff. 10/14/2022.