If this is a production fixture, it falls under 820.70 equipment and should be qualified to perform its intended use. Especially those equipments that are manually operated by production personnel cannot be "validated".
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 05-Apr-2019 13:43
From: Anonymous Member
Subject: Test Fixture Validation
This message was posted by a user wishing to remain anonymous
Hi All,
For PCB manufacturing with in-process testing that utilizes a test fixture, can the test fixture be validated with a single sample to validate that the PCB fixture produces accurate and consistent results as intended, rather than utilizing many samples since this in not necessarily a typical test method validation (similar to Gauge R&R)?
Note: The fixture itself will be used for a very low volume of production PCBs so testing with many samples is not feasible.
Thanks!