If the design requirements for the proposed change are not available in the equipment
database, then the design authority may need to recover or generate those requirements
before the evaluation can proceed.
18.104.22.168 Independent Design Verifications
The provisions of 10 CFR 830.122(f) (4) require the contractor to use individuals or
groups other than those who performed the work to verify or validate the adequacy of any
changes to design products. Documentation of the independent design verification must
be included in the change control package. The independent design verification must
design inputs and constraints are correctly identified;
design analyses and calculations are complete and correct;
design outputs are complete and consistent;
the reasonable methods are used in the analysis and, where applicable, computer
programs are verified;
system interactions are considered appropriately;
the assumptions are reasonable; and
appropriate post-modification testing and acceptance criteria are established.
22.214.171.124 Interdisciplinary Technical Reviews
Unless the contractor determines that the proposed change does not need to be reviewed
through the change control process, the contractor must perform an interdisciplinary
technical review before proceeding with the proposed change. The technical review
should involve all potentially affected disciplines and organizations such as design,
operations, maintenance, training, radiation protection, fire protection, and security.
Often a change that does not appear to be significant can be assessed to have an impact to
another discipline. For example, the temporary removal of a door to facilitate a
maintenance activity could impact security or fire protection.
A change to a component also may impact system performance. Consequently, a
Cognizant System Engineer should be engaged in the review process. A change to a
component or system may impact nearby or interconnected components or systems. This
potential should be assessed in the review. The Cognizant System Engineers for nearby
or interfacing systems should be consulted as appropriate.
The technical review team must be aware of the potential impact of the change on safety
and reliability, as well as the design requirements. One of the challenges of change
control is to be cognizant of many ongoing changes--from proposal, through
development, to implementation--and to understand the integrated effect of the various
changes. The Cognizant System Engineer concept has been used in the commercial
nuclear industry to provide a technical focal point for each system. The Cognizant