The purpose of this article is to stress the importance of and to provide guidance on how to classify and to communicate the applicable maintenance protocol when performing maintenance on different classifications of equipment and/or work areas.
Pharmaceutical laboratory research, manufacturing, pilot plants
Amusement Parks (Mobile/Fixed)
Changing belts and lubricating an exhaust fan on the roof of a pilot plant, where dangerous life threatening gases might be flowing out of the equipment, needs a different maintenance protocol than when the same fan is located on a typical office building.
Changing the propeller blade on a commercial airplane that holds many people is a different situation than changing the propeller blade on a Hollywood photography drone. A different maintenance protocol needs to be followed in these cases.
Locking out an exhaust fan for a room in a pharmaceutical vivarium containing animals with extremely dangerous contagious diseases is different than when shutting down an exhaust fan for a bathroom.
Moving a freezer containing a $1,000,000 of experimental medicines calls for a different maintenance protocol than when moving a lunch freezer containing frozen pizza. Will the circuit breaker properly handle the power spike when three freezer compressors decide to kick simultaneously at 1am on Saturday? Are you going to discover on Monday morning that your company just lost $3,000,000 worth of experimental medicine? Being lazy and/or penny wise and pound foolish can lead to one unfortunate incident that can cost a company many times its entire annual maintenance budget.
A different maintenance protocol needs to be followed when replacing an electric motor on a machine that puts an enteric coating on medicine than for an exhaust fan sitting on the roof of a typical office building. The enteric coating causes the medicine to break down in a person’s intestines rather than in the stomach. If the enteric coating is too thin, numerous patients can start complaining about serious stomach pains which can easily lead to an unscheduled FDA audit. Not following proper maintenance protocols in a pharmaceutical factory can quickly lead to FDA citations and forced factory closures.
The importance of classifying equipment and/or work areas varies depending upon the industry and the structuring of a maintenance department. When all the equipment and work areas are subject to the same maintenance protocol, classifying equipment into different maintenance protocols is obviously not needed. It is when maintenance workers are subject to multiple maintenance protocols that clear guidelines need to be set on how equipment and customer areas are to be classified and how the proper maintenance protocol will be clearly communicated to your workers.
We recommend that a Standard Operating Procedure (SOP) be created for each specific maintenance protocol which may need to be followed by your maintenance workers. Each SOP should be signed by the maintenance manager and possibly by the managers in your customer department, quality control department and/or safety department.
Where you have different maintenance protocols in place, you need to implement an SOP to how to handle new equipment installations and how to handle when existing equipment is moved. This SOP must require proper managerial oversight of the maintenance protocol classification for each piece of equipment. This SOP should be signed by the maintenance manager and possibly your customer managers, quality control manager and safety manager.
Communicating the Maintenance Protocol
When your workers are subject to different maintenance protocols, it is critically important to have a computerized maintenance management system that clearly communicates to your workers which maintenance protocol needs to be followed on both the printed work orders and/or when viewing them electronically.