Implementing QCSPC Software for Medical Device Manufacturing Plants

 

The medical device industry demands the highest standards of quality, as every component directly impacts human health. Facilities manufacturing items such as syringes, IV tubing, ventilator housings, and sample trays are required to comply with GMP and ISO 13485 standards.

 

We have successfully supplied and implemented QCSPC software for numerous medical device companies.

 

Specific characteristics of medical device manufacturing:

 

Production takes place in Class 7 and Class 8 cleanrooms.

Products are made of transparent plastic and must be free from burrs, black spots, and shrinkage.

Full traceability is required for every batch, covering raw materials, injection molding machines, shifts, and operators.

Immediate generation of SPC and Cpk reports is required during audits by the FDA or EU clients.

QCSPC solutions provided:

 

Cleanroom control: Data collection occurs directly at the QC station within the cleanroom, eliminating the need to transport paper records outside.

Medical visual defect control: Statistical tracking of defects such as black spots, air bubbles, short shots, and edge chips using P-charts.

Functional dimension control: Measurement of cylinder diameters and seal integrity using digital calipers connected directly to the QCSPC system.

GMP traceability: Each product tray is assigned a lot ID; scanning the QR code instantly retrieves the complete SPC chart for that specific lot.

Results:

Defect rates decreased by 60%, and audit documentation preparation time was reduced from three days to 15 minutes.