As part of a company’s quality management system, there must be consideration for the equipment used within the facility. According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.” They also have the requirement that all inspection, measuring and test equipment is suitable for the intended use and that it will produce the desired results.
What this translates to is that any tools and equipment used during production must be under control. All controls and maintenance activities must be defined and proceduralized. When tools and equipment are not properly maintained, their performance can be affected. This, in turn, can have an impact on the product being manufactured. In the procedure(s), you will need to address required maintenance activities, documentation requirements, and who is responsible for those activities.
These procedures will then need to be readily available to operators of the tools and equipment. The individuals using and/or maintaining the equipment will need to be trained, qualified and have the appropriate skills to operate them. Equipment should be maintained and controlled, and if there is a safety risk, a measure of precaution should be implemented for the user’s protection.
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