Principle #6 - Properly Maintaining Facilities and Equipment

If you are a homeowner, you probably go to great lengths to protect the investment of your home and your appliances from deterioration and damage.  Since you live in your home and spend much of your time there, you probably want to keep it in good working order so that it will continue to protect you from the elements, and provide you with comfortable living space.  Termites and water damage are two examples of things from which you should protect your house in order to maintain it properly.  Additionally, you may engage in preventive maintenance for your furnace and air-conditioner, as they provide valuable services to you as a homeowner. 

Just like homeowners, businesses regulated by FDA must perform maintenance on their buildings and equipment to protect the investment made in the manufacturing process.  While you cannot control the size of your facility or the equipment at your disposal, the regulation requires that you make the best use of what is available.   Buildings which are not properly maintained can contaminate products (e.g. paint flaking off walls and getting into an in-process product.)  And equipment which is not properly maintained could fail to live up to specifications, causing the product to be considered contaminated.   These types of occurrences can be very costly for a company, causing waste, as such products cannot be released and sold.   If such products are accidentally released and sold, it can be even more costly, as recalls and potential litigation can come into play.

Therefore, it is important that your company have a maintenance schedule for buildings and equipment.  You must identify what areas require regular maintenance in order to prevent contaminations, mixups, and errors, and write procedures prescribing the maintenance.  Additionally, it is possible that an unexpected event (such as extreme weather) would cause deterioration of your facility and equipment and require emergency maintenance or repairs.  These must be immediately completed before production can resume if the damage could potentially contaminate your products.  

It is everyone's responsibility to follow established maintenance schedules, and to be on the lookout for new evidence of necessary maintenance.  By doing this you can help your company maintain its good image and stay profitable.