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alexandrabuga replied to the topic Discussion Topic: Playing with IQ, OQ, PQ in the forum Process Validation and Process Risk 7 years, 3 months ago
Since the previous devices’ IQ, OQ, and PQs have been explained in great detail, what would the IQ, OQ and PQ look like for other devices? For example a femoral implant?
IQ- Femoral molding equipment meets the specs, working parts, can be installed, operated and maintained, has a maintenance schedule. Includes limitations and tolerances that are known to operator. SOPs or Work Instructions, calibration schedule, meets OSHA standards and training for personnel.
OQ-Femoral molding machine has optimal parameters including temperature, pressure, molding size, curing time, and cooling time. The process is reproducible, upper and lower limits of the process are found and control limits for the process are set.
PQ-Femoral implants are reproducible and are identical in size, structure, durability. The implants are checked for variations including; defects, weight, appearance, packaging against the spec. Raw materials are tested from primary, secondary, and tertiary vendors to ensure that production scale runs successfully.