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DOESTD107393
Design control measures should also provide for verifying or checking design adequacy. Such
measures would include performance of design reviews, by the use of alternate or simplified
calculational methods, or performance of a suitable testing program. The verifying or checking process
should be performed by individuals other than those who performed the original design, but who may
be from the same organization. Where a test program is used to verify adequacy of a specific design
feature in lieu of other verifying or checking processes, it should include suitable qualification testing of
a prototype unit under the most adverse design conditions.
Other design process controls that facilitate responsive, efficient, and effective design include
processing of requests for design changes, root cause determination of facility hardware problems,
development and selection of alternate solutions, cost/benefit evaluations of design changes,
conceptual design phase, project controls and planning of engineering design process work, and,
physical change tracking. These controls might or might not have a direct effect on the quality of the
design produced. These types of controls are largely administrative, and while they can be very
important to providing a responsive, efficient, and effective design, they are not required design
controls.
Design Authority vs. Design Agency. One of the more important aspects of design control is the
establishment of a single design authority, with defined relationships to the supporting design agencies.
The design authority is the organization responsible for establishing the design requirements and
ensuring that design output documents accurately reflect the design basis. The design authority is
responsible for design control and ultimate technical adequacy of the design process. These
responsibilities are applicable whether the process is conducted fully in-house, partially contracted to
outside organizations, or fully contracted to outside organizations. The design authority should be a
single organization within the owner/operator organization. The design authority may delegate design
work, but not its responsibilities. In a CM program context, the design authority assures that the design
requirements and design basis are fully identified and in a form compatible with needs. Policies and
procedures should clearly identify the design authority. Many facilities have policies and procedures
establishing the facility design authority; these should be retained and upgraded, if necessary, to better
support the CM program.
The design agency is the organization that performs the design activities, particularly those associated
with design analysis and calculations. The design authority can perform as the design agency. Other
organizations also can perform as the design agency for design work ranging from a given design to all
designs. The design agency performs design activities at the direction of and under the responsibility of
the design authority. For example, the organization performing DOE 4700.1 design work is a design
agency, but often not the design authority. The design agency should provide the content and format of
the design outputs and design basis, as well as the technical adequacy, according to the requirements
of the design authority.
Design interfaces should be identified and controlled, and design efforts coordinated among and within
participating organizations. Interface controls should include the assignment of responsibility and
establishment of procedures among participating design organizations. Formal interface controls
between the design authority and the design agency are necessary, even for the case where the design
agency is within the same corporate organization. In this case, the size of the organization influences
the degree of procedural controls necessary; the larger the organization, the greater the need for
procedural controls. In large matrixed organizations, support from other groups should be handled
formally through specifications, requisitions, and work control. In essence, the design authority treats
these matrixed organizations as outside vendors. For both vendor activities and these matrixed
organizations, the design authority should establish acceptance criteria to define satisfactory work
completion. The program management element provides further direction on programmatic and
organizational interfaces, and vendor control.
II-A-2


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