BB Electronics received the assistance of FORCE Technology for a validation project that opens up new perspectives on the world market.
”It was a customer’s wish to validate the process involved in manufacturing their products that really got us started on a concrete validation project. We thought that we were pretty good at validation, but when we, in collaboration with FORCE Technology, took a closer look at our procedures, we immediately realized that a different and more methodical approach was required,” says Quality Manager Birthe Drachmann from BB Electronics.
The American market
BB Electronics supplies equipment to customers operating in the American medico market where requirements regarding documentation and validation have been tightened. BB Electronics wanted the validation expertise to be a skill in the company, and they contacted FORCE Technology to get the validation project started.
FORCE Technology has validated the production of BB Electronics.
Role of process consultant
”We have acted as a process consultant throughout the implementation phase, and we have trained various BB Electronics key employees in the validation technique. We have focused on providing insight into the actual validation process and on incorporating various forms of reporting and documentation as an every day routine,” says Project Manager Karin Alnor Ulrich from FORCE Technology.
The actual validation process follows a specific procedure where the company prepares a risk analysis to find critical elements in the production process from arrival of the raw materials and until the finished product leaves the company. The risk analysis leads to a ValidationMasterPlan that describes the processes and areas to be validated.
Karin Alnor Ulrich says: ”Based on the ValidationMasterPlan the company prepares requirement specifications, and the subsequent tests and measuring methods are described in the relevant protocols. The last step in the validation process is reporting, where a conclusion is made as to whether the test results are valid in relation to the requirement specifications. A comprehensive process where accuracy is of the essence.”
BB Electronics has now acquired the skill to validate customer products and uses it actively in its marketing. The new knowledge about validation has become a competition parameter for the company.
”Customers and authorities all over the world demand an increasing amount of documentation. We have, so to speak, learned to think and talk in terms of validation. We master the terminology, the structure, the method and the tools in the process. Therefore, we offer our customers full validation of our deliveries. Validation has become a platform for our expansion,” concludes Quality Manager Birthe Drachmann.