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Additionally, packaging integrity verification activities must
be reviewed for every inspection during which sterilization
is covered. This review of the control and monitoring ac-
tivities should be done on the shop floor by reviewing work
instructions, product acceptance procedures, control charts,
etc.
While on the shop floor, make note of one piece of signifi-
cant sterilization process equipment and one significant
piece of inspection, measuring or test equipment (prefer-
ably from a finished device acceptance activity). Prior to
concluding the inspection, confirm that the applicable main-
tenance activities (preventive maintenance, cleaning and
adjustment, etc.) are performed as scheduled for the cho-
sen piece of sterilization process equipment. Also, confirm
that the piece of inspection, measuring, and test equipment
was controlled and calibrated.
After you have reviewed the process control and monitor-
ing activities on the shop floor, use the sampling tables and
select for review a number of Device History Records
(DHRs, including monitoring and control records, accep-
tance testing records, etc.) from recent production runs. If
the process is run over more than one shift, your review
should include DHRs from all shifts. Verify that the product
was sterilized in accordance with the DMR. Your review of
the selected records should include all applicable verifica-
tion activities (see above) including records of process pa-
rameter monitoring, and in-process and final device accep-
tance activities and results.
Your evaluation must also include a review of the firm’s
purchasing controls and receiving acceptance activities
regarding at least one component, material or service.
Examples include: the sterilant, sterilization indicators, and
services provided by contract sterilizers or contract labora-
tories. In addition, review environmental and contamina-