The guidelines in DIN EN ISO 9001:2008 are ROFRA’s quality standards.
The quality assurance system covers the entire, closed process from checks on incoming raw material to the final inspection, taking in optoelectronic imaging and measurement to monitor machine production, in-line inspection using the most up-to-date of measuring and testing equipment, and checks on chemical composition.All the vital details are comprehensively recorded and are reproducible.
Check on incoming raw materials
ROFRA’s concern for quality starts with selection of suppliers.These are, without exception, approved, reputable and experienced companies.
Optoelectronic measuring systems
Computer-aided cameras at the heart of the process ensure uninterrupted measurement, monitoring and documentation in support of consistent manufacturing quality.
ROFRA’s own chemical laboratory carries out continues inspection and monitoring of production.
Final inspection and serial testing
- Continuous checking of pressure and friction resistance of printing on vials
- Vials tested for stability
- Tests carried out on resistance to discoloration (filled samples set aside)
The computerised quality assurance system ensures that all measured data can be called up, evaluated and tracked.Not until the quality assurance process has itself been examined is the product cleared for supply; a certificate of quality can then accompany it. In any case, the only products which will be passed for supply are those which meet the quality standard.