Quality control is the process of inspecting products and services to ensure conformance with valid quality standards (ISO). Quality measurement is a continuous process and takes place before, during, and at the end of every operation process. Stryker developed appropriate guiding principles that all employees have strictly to follow. Quality control is an integral part of production process. It is the responsibility of each to employ prescribed applications to sort out conform parts from bad parts.
Quality control procedures for: - raw materials / forge
- stems
- cups
- total hip implant
Once arrived to the production facility, the raw materials are first tested before used for manufacturing. This includes the identification of the components, their valid certifications, their correct dimensions and their proper quality. Only materials featuring perfect quality are then brought to forging process. The correct adjustment of the parameters for the forging is been conducted with the help of standard tables. For proper documentation, the operator is listing the parameters on an individual protocol sheet. The forged stems are the checked on correct dimensions with predefined stem-templates (sizes 1 to 8).
After the manufacturing process of ABG™II stems, the operator is first checking the stems for surface failures (holes, cracks, imperfections, etc) by visual control. In addition, “penetrant testing”, a non-destructive method used to detect surface breaking defects, is applied to ensure best quality. This control procedure is taking place for all stems produced at stryker. Finally, the employee is verifying the dimensions of the forged stems with the help of predefined stem-templates (sizes 1 to 8).
After the the cups are being produced, the quality control process starts with the verification of several documents. It is to verify that all manufacturing processes have been conducted and that the cup corresponds to the specifications described in the documents. Similar to the stem, the cup is then checked for correct dimensions. This entails the inspection of correct inside and outside diameter, correct tapping and the accurate analysis of the cup's detents. The operator is supported with several standardized instruments (templates). In the end, he is properly controlling the cup’s surface properties by eye.
The hip implant is undergoing a last quality control procedure. After identifying the product and verifying its manufacturing steps, the ABG™II implant is tested on its functionality. For the ABG™II modular prosthesis, the operator is first looking at the intrusion of modular necks and inspects their correct positioning. It is obviously that this step is missing for the Standard ABG™II implant. For both type of implants, different heads are then screwed on to check the implant's thread. Finally, the implant is checked a last time regarding correct dimensions and perfect surface properties.
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