IQ OQ: Installation Qualification, Operational Qualification. |
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Tags: Installation Qualification. Inspection. Operational Qualification. Manufacturing. Medical Device. MiniTab. System Testing. |
| Situation: |
The customer is an S&P 500 manufacturer of Class III life sustaining medical devices. The manufacturing process includes use of laser optics vision inspection instruments containing embedded software. As part of capacity expansion the inspection instruments are being moved to a new building. The instruments have been previously validated. The contracted work involves updating IQ (Installation Qualification) and OQ (Operational Qualification) protocols, executing testing, creating reports, and getting all deliverables signed off through the EDMS (Electronic Document Management System). |
| Obstacles: |
| The current validation method uses a gauge pin affixed to a glass plate. It is very set up technique sensitive. Preliminary tests which are analyzed with MiniTab statistical software show borderline pass / fail. |
| Actions: |
| Created a set up method that improves the fixturing of the gauge pin. Recognized ambient light as a key source of variation. Modified the procedure to allow adjusting orientation to minimize it. |
| Results: |
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