Regulatory Interaction

There are no legal requirements that state that firms should review their proposed facility designs with regulators
prior to their construction. In the past, some firms announced their new facilities to inspectors upon physical
completion when they first sought approval to use them. In recent years it has become more common to hold some
form of review meeting with the regulatory bodies early in the project schedule to attempt to receive regulatory
approval while the design is still on paper. Where the firm has employed novelty in their design concepts, material
selections, or equipment features this interaction can be beneficial in obtaining regulatory “buy-in” well before
funds are committed. This type of interaction is best carried out by providing the regulatory body with copies of the
conceptual design information and validation master plan some time prior to a formal meeting. The meeting is used
to review the design and answer any questions regarding the facility by either the regulators or the firm. A
formalized approval is not granted; the firm merely comes away with an understanding of regulatory concerns
relative to the design and Validation that should be addressed prior to seeking approval to use the completed facility.

“As Built” Drawings

The qualification of constructed/assembled systems can be greatly aided by the preparation of “as built” drawings on
these systems. An “as built” drawing is prepared starting with the design P&ID drawings for the system. Trained
individuals (usually working as a team) compare the system as it exists in the field to the drawing. Discrepancies
between the actual system and the P&ID are noted directly on the drawing. This results in a marked up P&ID
sometimes called a “red-line drawing.” Once completed the red-line is critically reviewed. The owners design team
will then decide whether to modify the drawing to accurately document the system “as built” in the field or to
correct the system to match the original P&ID drawing. While one’s initial instinct is to modify the physical system
to match the P&ID, there may be little operational benefit to do so and a significant cost to make the change in the
system. Whatever the decision with regard to resolution of physical system–P&ID drawing differences, what is
essential is that a drawing be prepared that accurately reflects the final system as accepted by the firm from
the contractor. Depending upon the extent of the changes, this may mean preparation of an entirely new drawing, or
merely retention of the red-line as an accurate representation of the field installation. The decision not to update the
red-line into a controlled master drawing is one that should be made cautiously. If subsequent modifications are to
be made to the system, the mark-up of a red-line drawing is poor practice. Better to update (CAD is the normal
method) and to certify it as accurate as soon as possible.