Validation Process

Well-executed validation processes are key to our Quality Control.

Installation qualification (IQ)

All key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and recommendations of the supplier and the equipment are considered.

Operational qualification (OQ)

Process control limits and action levels result in devices meeting all predetermined requirements.

Performance qualification (PQ)

Process under anticipated conditions, consistently produces a device meeting all predetermined requirements.

Test method validation (TMV)

Documented verification proving test measurement is repeatable and reproducible; typically called Gage Repeatability and Reproducibility (GR&R).

Preventive Maintenance (PM)

Any maintenance that is required on a regular basis (weekly, monthly, and yearly) to ensure equipment produces optimal results.

Process Failure Mode and Effects Analysis (PFMEA)

Analytical technique employed to reasonably ensure that potential causes of process failure, and the associated mechanisms, have been identified and addressed.

Verification

Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.