The next time you walk the manufacturing floor, think about how many pieces of equipment you use for production, how many moving parts they have, and all the ways things could go terribly wrong.
Now, imagine an FDA investigator doing the same. If you don’t have all your equipment controls in place and being used effectively, the result could be a 483 or even a warning letter.
The FDA’s Quality System Regulation (QSR) is clear on the importance of equipment controls — you must have and follow procedures for installing, operating and maintaining all equipment used in your manufacturing processes. And that includes any ancillary equipment that affects production, such as environmental systems and contamination controls.
QSR says you must maintain, inspect and make adjustments to your equipment. What the nine-paragraph rule doesn’t say is how.
Three Phases of QSR-Compliant Equipment Control helps fill in the gaps. With this brief you’ll learn:
How to create the required maintenance schedule
Six strategies for determining the need for maintenance
How often to conduct internal audits
How OSHA regulations play into equipment installation and operation
How to include environmental systems and contamination control factors in equipment controls
How to evaluate your overall equipment effectiveness using three rate metrics: operating rate, performance rate and quality rate
Order Three Phases of QSR-Compliant Equipment Control and understand the QSR requirements for the installation, operation and maintenance of your manufacturing equipment.
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