VÄGEN TILL RÄTT KVALITET - på inköpta komponenter En fallstudie på Gambro Lundia AB Monitor Division

Sammanfattning: To avoid incorrectly manufactured components, the modern quality development focus towards preventive actions and process improvements. Therefore, a function as acceptance control is not of particular interest. This report treats the activities that have to take place at Gambro Lundia Monitor Division, GLAB MD, in order to get satisfactory quality of purchased components. The Incoming Inspection inspects the majority of components, but still most deviations are found in the Production. The purpose of this master thesis is therefore to propose how the Incoming Inspection should be changed, and suggest what kind of preventive activities that should be used. With this in mind, the defensive quality control, Incoming Inspection, is not a long-term solution. By way of introduction, a careful examination of the organisation and assignments of the Incoming Inspection has been performed. Furthermore, an overviewed study of interfaces of the department was made. In these studies interviews were especially applied. The interviewed actors were also asked about their opinions and were given the opportunity to suggest proposals for improvements. With a view to get further ideas for improvements, five other companies have been examined. One company that is carrying on a well functioning Incoming Inspection, and one that is only working with preventive activities. In the three last companies, both these aspects were studied, but not as thoroughly as in the other two companies. From the present situation at GLAB MD, five main shortcomings have been identified. Batches with incorrect located components, both functional errors as well as esthetical errors, can, when applying AQL, nevertheless be accepted. The procedure also obstructs continuous improvements. It is impossible to examine every parameter due to insufficient resources. Consequently it is important with decisive checkpoints in order to avoid an inefficient production due to an incorrect decision of the quality of the incoming batches. Even the handling of incorrect components is essential for how suppliers regard GLAB MD’s view of quality. Correct specifications are important when making accurate decisions, both for the suppliers and for the co-workers of the Incoming Inspection. Otherwise an inefficient production can occur. At last, but not least, insufficient use of quality tools, for example FMEA and capability study, lead to deteriorated knowledge of the supplier’s production. iv To achieve satisfactory quality of purchased components, our final conclusion is that two main activities have to take place. A reconstruction of GLAB MD’s Incoming Inspection must be carried out before any reduction can occur, in order to keep control of quality of the purchased components. At the same time preventive activities have to be carried out, because this process is long. We have found that GLAB MD have a great potential to improve these shortcomings, however it demands a genuine effort from all GLAB MD’s co-workers for this change. Our most important suggestions are stated below. − On the basis of a genuine analysis of risk, all components should be classified from A to C in order to concentrate the inspection where the biggest needs are. It is impossible to control every component equally due to insufficient resources. − AQL should not be applied since the application does not create an atmosphere where every deviation is an opportunity for corrective actions and improvements. Instead the sampling plans should be based on MIL-STD-1916, which means combining accept-zero with prevention procedures. − The four main areas; plastic, metallic, electronic and electro mechanics, should be considered when checkpoints are created. P-FMEA, both from suppliers and GLAB MD, and D-FMEA are among things that should be used in order to get decisive checkpoints. − The character of the deviation should decide when a complaint has to be performed. In order to get penetration at suppliers, batches or individual components should always be returned if located components are marred by functional errors, and located components with esthetical errors should be gathered before a complaint is made. Considering that, a plan of measure should always be required, because GLAB MD’s handling of incorrect components is now of great importance. − Capability studies, SPC and P-FMEA should always be demanded in order to, both in short-term and long-term, obtain knowledge if the supplier has ability to manufacture components that meet specified demands. The Incoming Inspection at GLAB MD thus gradually can be reduced.