Faulty components in machines and vehicles can lead to recalls, which are expensive and damage the manufacturer’s image. That’s why high-quality products are a key competitive factor for companies in the automotive, high-tech, and mechanical and plant engineering sectors. Particularly for safety-related components like braking systems and airbags or medical devices such as endoscopes, seamless and comprehensively documented quality and risk management is a must. Manufacturers in the automotive industry demand their suppliers employ an APQP (Advanced Product Quality Planning) system in accordance with the international quality standard ISO/TS 16949, while manufacturers of medical devices are bound by the DIN EN ISO 14971 standard.
Systematically improving product and process quality
A closed-loop system for quality assurance and optimization helps companies to systematically and continually improve their products and manufacturing processes. SAP has therefore included two new applications for quality management in the Enhancement Package 3 for SAP ERP 6.0 – Failure Mode & Effects Analysis (FMEA) and Control Plan.
Failure Mode & Effects Analysis can be utilized across every industry sector and ensures preventive quality assurance. It enables potential defects and weaknesses in the development and manufacture of a product to be detected and analyzed early on so as to subsequently prevent defects through appropriate action. The Control Plan specifies how products and processes are monitored. It ensures seamless documentation of all quality assurance-related actions. The requirements for incoming and outgoing goods inspections, and inspections during manufacturing are recorded in the Control Plan.
The FMEA and Control Plan applications are an integral part of the ERP system, and complement existing functions and processes for quality assurance and improvement, such as the Inspection Plan, Statistical Process Control and quality notifications from the complaints management system. This enables the development of a quality optimization system, fully integrated in SAP ERP and conforming to ISO/TS 16949, without redundant data storage.
Forms are stored in both applications for the documentation of individual process steps. The form in the FMEA applications meets the VDA 96 and QS9000 industry standards, while the form in the Control Plan application conforms to the QS9000 industry standard. Thanks to the forms, users can print quality-related data and information as interactive forms based on Adobe technology, and either save these or send them as e-mail attachments.
Product structure based on modular principle
The FMEA application supports both product FMEAs and process FMEAs. The aim of the FMEA is to identify and prevent weaknesses and defects in the designed product and planned manufacturing process in the early stages of product development.
Using the FMEA, users can determine how products, such as windscreens or braking systems, behave when raw materials, bought-in semi-finished or finished components and manufacturing processes are defective. The examinations are based on functional nets. The products and their components are analyzed in terms of safety, reliability and compliance with legal requirements, among other factors, while production processes are additionally analyzed for their suitability and stability within the relevant manufacturing process.
Working on a modular principle, the FMEA application does not have to map the complete structure of a product, for example a six-gear transmission, but can instead focus on the critical assemblies or components. The benefit of this process is that standardized individual components also found in other products, like a five-gear transmission, only have to be captured once.
Closely analyzing risks
Saved defect catalogs and inspection characteristics can be utilized for defect description and defining inspection criteria. Defect descriptions are assigned codes in the defect catalogs to enable the consistent and evaluable description of defects. The inspection parameters specify the inspection criteria for materials, components and products. There are qualitative inspection parameters like “product color”, and quantitative parameters, for example “material density”.
The FMEA application also enables risk analyses to be performed on products, whereby the probability of the occurrence, detection and significance of the consequences of a defect are assessed on a scale from 1 (no risk) to 10 (high risk). The results are then multiplied to obtain a risk priority number, the maximum value being 1,000. The defects can then be graded according to the risk priority number. Preventive and detection measures are put in place and appropriately implemented to reduce the risk priority number.
All functions in the cockpit
The Failure Mode & Effects Analysis appears within the application in the form of a structure tree. The individual elements of an FMEA – such as the FMEA header, the defect or the actions – form the nodes in this structure tree. It is important that the FMEA header can be linked to all SAP ERP business objects, like “Material” or “Project”, and multiple assignments are also possible. The FMEA structure is thus based on the product structure, and the work and process steps, but is not however tied to concrete BOMs or routings.
Users can begin processing FMEAs and actions both via the FMEA Cockpit and the FMEA Monitor. The FMEA Cockpit offers central, simplified and easily navigable access to the application. The tree structure of an FMEA is depicted in the navigation area. The relevant detailed information for every structural element is available in the work area. The FMEA Monitor offers search and analysis functions to determine what detection or preventive actions are being processed.
End-to-end inspection in every production phase
The Control Plan comprises functions for end-to-end planning, seamless monitoring and documentation of all quality-assurance action throughout the entire value chain. Control Plans are utilized in three phases of the production process – prototype, pre-series production and series production.
The application provides pre-defined Control Plan structures for the individual phases and these can be customized. As there are frequently no BOMs and therefore no material numbers available during the prototype phase, development of the Control Plan is largely carried out manually. However, this is not the case during pre-series and in particular series production, where Control Plans can be created dynamically and largely automatically by utilizing the existing master data in SAP ERP, for example BOMs, material masters, routings and inspection plans. The Control Plan therefore offers a special view of the existing master data.
Direct access to Control Plan and FMEA
The Control Plan application is fully integrated in Failure Mode & Effects Analysis (FMEA), Routings (PP-BD-RTG), Inspection Planning (QM-PT-IP) and the quality notifications from the complaints management system. This means users can establish if inspection plans and routings for a product are available in SAP ERP. These are then transferred and integrated in the Control Plan. Users can also create and process their own routings or inspection plans via the Control Plan structure display.
Quality inspectors can simply drag and drop critical parameters from a Failure Mode & Effects Analysis to transfer these to the Control Plan, or inspection plans and routings. Consistency checks enable users to determine whether the parameters are included in the plans.
If a current complaint within a quality notification contains a material defect description, Quality Inspection can call up the Control Plan or FMEA for the material from the quality notification directly. This means users can immediately establish if the defect was considered within the FMEA. If it was not, it can be added or newly evaluated.
Companies can augment the FMEA and Control Plan with Business Add-Ins (BAdIs), enabling them to quickly and flexibly adapt the applications to their requirements. For instance, there are BAdIs for the FMEA which can be used to define types of action or create, modify and delete lists of questions. BAdIs in the Control Plan enable, among other things, the extension and modification of user interfaces and provide methods for consistency checks.
Quality management in a package
SAP supplies the new FMEA and Control Plan applications for quality management in Enhancement Package 3 in the Enterprise Business Function “OPS_QM_EXTENSION”. Its functional scope also includes add-ons for existing quality management processes, like adding digital signatures to quality notification. The business function is implemented by the SAP Enhancement Framework and activated by the SAP Switch Framework. This ensures cost-optimized, customized and modification-free provision of new functionality. The ERP platform therefore remains stable, and user companies can further develop it through an evolutionary approach.