Know your processwithout making assumptions
We help you demonstrate your process is consistently delivering quality products.
Validation is a must to gain statistical control on your process, reduce the scraps and meet the market and regulatory requirements.
Our capabilities
- User requirements specification (URS)
- Technical requirements specification (TRS)
- Validation master plan
- Process mapping
- Process FMEA
- Equipment qualification
- Support to FAT/SAT
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Process validation procedure
- Statistical sampling procedure
- Measurement system analysis (MSA)
- Test method validation (TMV)
- Process Development
- Design of experiment (DoE)
- Six sigma
- Lean Manufacturing
- Software validation
- Design transfer and design control
- Packaging validation (ISO 11607)
- Support to clean room validation methods (ISO 14644)
- Support to sterilization validation methods (ISO 11135 - ISO 11137 - ISO 17665)
- Integration with customer quality management system (QMS)
Experience
- Injection moulding process validation
- Extrusion process validation
- Lean manufacturing implementation and training
- Packaging validation (ISO 11607)
- Leak test validation
- Dip moulding validation
- US welding validation
- Manual assembly validation
- UV gluing validation
- Hot melt and other dispensers validation
- Ovens and thermal treatments validation
- Cutting machines validation
- Custom assembly machine validation
- Thermoforming and filling machines validation
- Gage R&R and Attribute Agreement Analysis for Test Method Validation