Process validation – the most efficient cornerstone of your product process reliability
According to ISO 13485, all production processes whose results are not verified by subsequent monitoring or measurement, must be validated. This means that defects may only become apparent after the product has already been used.
PKT validates the serial production of your products at your request. All the necessary steps are carried out and documented, from tool design, tool construction and tool sampling to series release. The scope can be tailored to meet your requirements and consists of the following main phases:
Validation Master Plan (VMP)
- Contact details of project members
- Define customer requirements and scope of validation
Design Qualification (DQ)
- Verification of development inputs and results as well as required tests and approvals
Installation Qualification (IQ)
- Verification of the correct installation of tools and equipment as well as correct identification and labelling
Operational Qualification (OQ)
- Tool installation and commissioning on machine (FOT)
- Process determination and test (zero setting, DoE, optimum setting, corner points)
- Measurement system analysis, first sample inspection and proof of capability
Performance qualification (PQ)
- Training of production staff and pilot production
- Part testing and proof of capability
All processes at PKT are consistently and continously optimised – for greater effectiveness and efficiency. You can profit from our proven process too.