WAC 246-231-160
Quality assurance organization. (1) The
licensee,2 certificate holder, and applicant for a CoC shall be
responsible for the establishment and execution of the quality
assurance program. The licensee, certificate holder, and
applicant for a CoC may delegate to others, such as
contractors, agents, or consultants, the work of establishing
and executing the quality assurance program, or any part of
the quality assurance program, but shall retain responsibility
for the program. These activities include performing the
functions associated with attaining quality objectives and the
quality assurance functions.
2
While the term "licensee" is used in these criteria, the requirements are applicable to whatever design, fabrication,
assembly, and testing of the package is accomplished with respect to a package before the time a package approval is
issued.
(2) The quality assurance functions are:
(a) Assuring that an appropriate quality assurance
program is established and effectively executed; and
(b) Verifying, by procedures such as checking, auditing,
and inspection, that activities affecting the functions that
are important to safety have been correctly performed.
(3) The persons and organizations performing quality
assurance functions must have sufficient authority and
organizational freedom to:
(a) Identify quality problems;
(b) Initiate, recommend, or provide solutions; and
(c) Verify implementation of solutions.
(4) The persons and organizations performing quality
assurance functions shall report to a management level that
assures that the required authority and organizational
freedom, including sufficient independence from cost and
schedule, when opposed to safety considerations, are provided.
(5) Because of the many variables involved, such as the
number of personnel, the type of activity being performed, and
the location or locations where activities are performed, the
organizational structure for executing the quality assurance
program may take various forms, provided that the persons and
organizations assigned the quality assurance functions have
the required authority and organizational freedom.
(6) Irrespective of the organizational structure, the
individual(s) assigned the responsibility for assuring
effective execution of any portion of the quality assurance
program, at any location where activities subject to this
chapter are being performed, must have direct access to the
levels of management necessary to perform this function.