Tool Validation

Process Optimisation & Validation (ISO13485)

The key to our service is a detailed validation plan covering various levels of optimisation and qualification, all of which is overseen by a Senior Process Engineer. This process takes into account all of the known variables across defined areas such as; materials, mould tooling, moulding machines and settings – ensuring the tool and process achieve the correct level of capability.

The plan will typically cover:

  • • Process Optimisation
  • • Installation Qualification (IQ)
  • • Operational Qualification (OQ)
  • • Performance Qualification (PQ)

Once validated, the corresponding documentation will be released for further analysis by the client.

Prototyping and Pre-production Testing

We can also use the mould tool to create pilot and pre-production samples of your component(s) in accordance with the validation protocol. These can be supplied with measurement reports covering; Key Process Indicators (KPI), Critical to Function (CtF) values or Process Capability Index (Cpk) analysis.

Re-Validation of Mould Tools

Taking a mould tool from one environment and expecting it to work ‘out of the box’ is not always possible. Hymid’s expert tooling team can take client-supplied tools and validate them for use in our production process. We can also handle the re-validation process following modifications or improvements to a mould tool. This is often the case when the component has been through a necessary change or planned revision.