Manufacturing Equipment Qualification, Part 1, Overview
Equipment, FDA, Installation Qualification, IQ, Manufacturing, QSR, Requirements
The FDA QSR requires that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use. For large, permanently installed or semi-permanently installed equipment this is often done using an Installation Qualification (IQ – part of the 3-part IQ-OQ-PQ process). But the QSR requirement also applies to portable benchtop equipment such as Oscilloscopes, Digital Multimeters (DMM’s) and thermal pouch/bag sealers.
So here’s the tip:
Determine and document the requirements for any piece of Manufacturing Equipment before you select or design that equipment.
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For specific-use equipment (such as, say pneumatic crimper for a specific crimp terminal) it is straightforward to define and document the requirements:
- The Crimper shall be able to properly crimp Molex P/N 02-09-5142 to 18-22 AWG wire.
For somewhat general purpose equipment (such as, say a curing oven) one might define the requirements as:
- The Oven shall be able to maintain a temperature from 140-200 deg. F within +/- 5 deg. F. or
- The Oven shall have a minimum internal volume of 12”H x 16”W x 10”D.
For general purpose controlled process equipment (such as, say a thermal pouch/bag sealer) one might define the requirements as:
- The Sealer shall be able to thermally seal pouches up to 18” width and 1/6” thick, or
- The Sealer shall be able to thermally for pouch seals up to 3/8” width, or
- The Sealer shall be able to apply a temperature up to 450 deg. F. or
- The Sealer shall be able to thermally seal Mylar, Polypropylene, Polyethylene or Polyurethane pouches, or
- The Sealer shall be able to control sealing temperature from xx to yy deg. F +/- zz deg. F, or
- The Sealer shall be able to control sealing pressure from xx to yy +/- zz, or
- The Sealer shall be able to control sealing time from xx to yy seconds +/- zz seconds.
For general benchtop measuring equipment such as a Digital Multimeter (DMM), one needs to narrow the full range of measuring capabilities to those that the DMM will be used for in a given application. For instance:
- The DMM shall be able to measure DC voltage from 0-20 VDC at 0.01VDC precision and +/- 0.1% accuracy, or
- The DMM shall be able to measure DC current from 0-100 mA at 0.1mA precision and +/- 0.4% accuracy.
These do not need to be the specifications of a particular DMM, but the requirements of the DMM in a specified application. This will make it easier to demonstrate that the “equipment … meets specified requirements”, and also make it easier to find another piece of equipment that meets the same specified requirements, without it necessarily being the same make and model that was qualified originally.