As-built drawings

Right at the beginning of a project a policy decision must be taken to decide  

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Complete set of as-built drawings, including piping, electrical, and hydraulic calculations... 

Follow the drawings of the system to trace the actual constructed system and make an as built drawing. 

As-built drawings of the vacuum system within the plant should be available. The vacuum system should be installed in accordance with the set specifications. Records about maintenance repairs and modifications should be filed. 

As-built drawings (block diagrams, mechanical drawings, electrical schematics, wiring, and interconnection diagrams)... 

The as built drawings are kept when necessary or when contractually required. 

At this stage of a new installation it is possible that as-built drawings of the installation are still in a marked-up state. Marked-up drawings record the actual installation and should be submitted to the pharmaceutical manufacturer for review and approval before drawings are amended. The decision as to when to revise and reissue installation drawings can vary and will depend on the number of revisions, extent of revisions, and so on. A formal procedure is required to mark up drawings and control their use until drawings are updated and reissued. 

A set of design documentation, including as-built drawings, should be maintained for... 

Used shell-and-tube heat exchangers should be disassembled for inspection prior to purchase. Check that the tube-and-shell baffles coincide with the as-built drawing. 

All documentation furnished by the supplier should be available. User manuals, as-built drawings, instrument calibration records, and procedures for operation and maintenance (including calibration schedules) of the system should all be checked to verify that they are suitable. Supplier documentation should be reviewed for accuracy in its specifications of the various versions of software used and approved as fit for purpose. It is recommended that checks are made to verify that contingency plans, SOPs, and any Service Level Agreements (SLAs) are also in place. Any specific competencies supposed to be acquired before the IQ/OQ/PQ through training should also have been achieved — these records should be checked. 

The installation contractor should assist in the provision of as-built drawings that may be completed by others (e.g., the engineering design contractor) at the end of the contract. To assist in this exercise, the installation contractor must keep a set of printouts of all documentation that must be marked up as and when changes are agreed. 

Handover documentation (e.g., as-built drawings, electrical safety checks)... 

Complete successfully the post-construction noise survey. Complete "as-built" drawings and submit them to the Owner. Submit to the Owner copies of all engineering calculations and vendors information. 

Data on the total electricity load were collected and compiled using the as-built drawings for lighting loads and the nameplate capacity of the motors for the major equipment and the air-conditioning loads. A spreadsheet was developed using the data mentioned earlier to conduct analysis of peak loads and energy loads under various scenarios. 

A program to ensure control of critical system documentation will be established. The files will be controlled by QA. Validation and centralized for easy retrieval. Equipment validation data such as operating and service manuals, purchase orders, manufacturer specifications, as-built drawings and schematics, spare parts lists, and any other information pertaining to the system will be included in the file. Separate validation files for Facility, Systems, and Process validation of each product, including all related data, will be maintained. Procedures will be developed to create files for new equipment, update information for existing equipment, control, removal, and return of information, etc. 

Compressed air— Air which is classified as breathable should receive an intensive qualification effort especially with regard to the verification of as-built drawings, confirmation of proper identification, as well as any safety- and purity-related issues. The emphasis given to breathable air is due to the number of unnecessary deaths, which have occurred in the industry as a consequence of misidentified gas lines. Where air is utilized as a reactant in a BPC operation, it should be treated as described previously under process... 

Thermocouples. In order to obtain some information on the temper atures of the thermal and biological shields, thermocouples will be embedded at 47 points throughout the reactor structure. The locations of these 47 points are given in Table 2.8,A. As a factor of safety, two thermocouples will be attached to the steel or embedded in the concrete at these points. It should be noted that the locations given in Table 2.8.A are recommended best points, but construction difficulties may cause a shift in some of these locations. As built drawings should be consulted for final placement data. It is currently planned to bring out the thermocouple leads in small conduits to Junction boxes on the north and east faces of the reactor structure. 

Obtain as-built drawing of existing structures if possible. 

As-built drawings showing interface to exiting systems... 

Mechanical equipment installation verification of the authorized drawings (P IDs, system schematics, as-built drawings) and component lists including the verification that utilities are installed as required. 

All pipework and tubes (electricity, water, gasses, air ducts, etc.) should be documented by photographs before the wall is finally closed during construction. Those pictures can demonstrate later that the finished construction indeed does correspond with the as-built drawings. As-built drawings are the drawings that exactly represent the finally built constructive reality. At places where the wall should be loaded with objects to be mounted, the constructor should apply back styles. These are fortifications introduced in the wall,... 

Inform the user of the equipment and the operator of the location of hazards beneath the equipment set-up area (such as voids, tanks, utilities) if those hazards are identified in documents (such as site drawings, as-built drawings, and soil analyses) that are in the possession of the controlling entity (whether at the site or off-site) or the hazards are otherwise known to that controlling entity. 

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