Compliance within cGMP (and really, any commercial) facilities can be affected by the choice of equipment and instrumentation numbering strategies. Numbering strategies can affect the convenience of implementation, traceability of documentation, implementation of tracking software, and can affect interdepartmental activities.
To clarify, by “numbering strategy”, I am referring to the manner in which numbers, (or other identifiers which may include text/numeric values), are assigned to equipment and instrumentation. Often, these are assigned to assist in traceability for accounting, calibration, validation, maintenance, and use as a general reference in drawings, standard operating procedures, batch records, etc. Of course, there are other numbering requirements as well, but these are some of the primary uses in cGMP facilities.
It is tempting to design a single numbering system that addresses all of these needs. This would have obvious apparent benefits of simplicity and uniformity, and thereby, improved compliance. For example, your tracking software and hard-copy files could all be organized by a single number scheme. In practice, the author has never seen a case where this approach has resulted in any of these benefits, and usually instead results in gaps and inconsistencies. The issues stem from the fact that the requirements for numbering are diverse. It is difficult, if not impossible, to design an efficient system that meets all requirements. The following table summarizes some of the variety of requirements for each system:
|Numbering System (Example)||Purpose||Equipment Affected||Timing||Primary Department Affected||Numbering Requirements||Information Required to Assign ID||ID Lifespan|
|Accounting (depreciation)||Equipment over a certain value||Assigned upon receipt||Accounting Dept|| |
|Value of equipment||ID is tied to the specific item. A replacement item is assigned a new ID.|
|Calibration Tracking||Calibrated Equipment and/or subcomponents of equipment||Assigned prior to routine calibration||Calibration Dept|| |
|Owner,usage, and whether it is calibratable||ID is tied to the specific item. A replacement item is assigned a new ID.|
|Maintenance Tracking||Equipment and/or subcomponents of equipment that require maintenance||Assigned prior to routine maintenance||Maintenance Dept|| |
|Owner, usage, and whether it requires maintenance||ID is tied to the specific item. A replacement item is assigned a new ID.|
|Validation Tracking||Equipment used for cGxP applications||Assigned prior to validation||Validation Dept|| |
|Owner, usage, and whether it requires validation||ID is tied to the specific item. A replacement item is assigned a new ID.|
|General Equipment ID|
|Identify equipment for general reference||Any equipment or component||Assigned prior to general use||All Depts||Describes Function, Uniqueness||Type of equipment/system and functionality||ID remains the same if item is replaced, so that documentation remains relevant.|
Review of the above table clarifies that the requirements for each type of ID are different and affect different pieces of equipment. In addition, different specialties are required to determine if a number is even required for some equipment. A few examples are presented below to identify some of the potential issues:
All of that said, it is possible to combine some numbering systems depending on how equipment is managed, and some of the above assumptions can be modified depending on the manner in which the document filing systems are set up and managed. However, Asset IDs are almost never a good substitute for any of the others because Asset IDs only cover high cost equipment; and General Equipment IDs are usually not a good substitute for Calibration IDs because if the equipment is replaced, the General Equipment ID usually stays the same and the Calibration ID is replaced to reflect a new calibration history.
Also, keep in mind that in any database the numbers are likely to be listed in an order determined by that database. More on this in a future post. Happy numbering!