Quality

Through continuous improvements, we at Unimec strive to meet our customers’ requirements for cost, safety, delivery and quality.

At Unimec, we have built our quality system to meet, and in many cases exceed, the general expectations of the industry.

Customers are not the same, which means we as a supplier must be able to adapt our deliveries.

All our customers share one expectation: the delivery must be of high quality.

Through a flexible and scalable Project Stage/Gate Model, we are able to manage project execution in all phases and, through methods such as risk assessment, adjust the necessary activities to ensure that deliveries meet the customer’s needs.

We use FMEA (Failure Mode and Effect Analysis) as an integrated part of our development projects.

In the pharmaceutical industry, we follow the current GAMP (Good Automation Manufacturing Practice) guidelines and ensure that our employees receive the necessary training in, for example, GDP (Good Documentation Practics).

In collaboration with the customer, a Project and Quality Plan is prepared to ensure that the required quality level is defined and implemented as a natural part of project execution.

Projects involving Qualification activities are carried out according to the V-model (GAMP) and include the following elements:

–URS (User Requirement Specificaitons) and the corresponding traceability matrix

–DQ (Design Qualification)

–RA (Risk Assesment)

–IQ (Installation Qualification)

–OQ (Operational Qualification)

We also provide necessary support in connection with validation (PQ).