Europlaz can help ensure successful
validation of your product

Quality Control Validation

Validation ensures all devices and processes are reliable and fit for purpose

Europlaz Technologies Ltd. offers design, tool, process and equipment validation options to meet  customer needs.

Master Validation Plans: used for more complex validations to present an overview of the entire validation operation, organisational structure, content and planning.

Validation Protocols: used to describe the procedure and the steps within the procedure that will be followed in order to validate the process, providing a high level description of the overall philosophy, intention and approach.

Process Failure Mode and Effects Analysis (pFMEA): helps to identify potential failure modes based on past experience with similar products or processes, enabling action to be taken to design those failures out of the system at the earliest possible stage of the project, minimizing effort, resource and expenditure, thereby reducing development time and costs.

Installation qualification (IQ): provides objective evidence to demonstrate all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and the recommendations of the supplier of the equipment are suitably considered.

Design of Experiments (DOE): allows for multiple input factors to be manipulated determining their effect on a desired output (response). By manipulating multiple inputs at the same time, DOE can identify important interactions that may be missed when experimenting with one factor at a time. All possible combinations can be investigated (full factorial) or only a portion of the possible combinations (fractional factorial).

Operational qualification (OQ): provides objective evidence to demonstrate, when operated at the extremes of the established process control limits, the product meets all of the pre-determined requirements.

Performance qualification (PQ): provides objective evidence to demonstrate the process, under anticipated conditions, consistently produces a product that meets all pre-determined requirements.

Product Characteristics Evaluation: provides objective evidence by way of a full dimensional report to confirm the tooling is capable of producing product within specification.  The report is conditionally formatted to provide a clear visual indicator to show where the measured dimension fits within the specified tolerance.

Gauge R&R / Measurement system analysis (MSA): provides objective evidence of the capability of the measurement system.
If you don’t measure it, you can’t ‘Manage’ it! If you do measure it, but don’t know how good or bad your measurement system is,  you aren’t ‘Managing’ it!