Quality Management

Main Process

 

Inspection Planning

Identifies the inspection characteristics (tests) and inspection methods (procedures) and assigns it to various inspection operations of an inspections plan or material specification. SAP ERP offers advanced tools for inspection planning and the management of standard operation procedures. This includes the planning of multiple specifications for one inspection characteristic dependent on defined criteria, e.g. country, customer, or legal tolerances.

Advanced Product Quality Planning (APQP)

Segment of the QS 9000 standard, which describes an approach to product development in the discrete industry and is based on typical methods and tools for preventing defects. SAP Business Suite offers the cProjects component to support the phase-based product development process (Quality Gates).

Failure Mode & Effects Analysis (FMEA)

A procedure in which potential failure modes of an item are analyzed to determine the risks. FMEA can be used for root cause analysis in Six Sigma projects, risk assessment during product development and operational quality control and planning. FMEA supports compliance with ISO TS16949 (automotive industry).

Control Plan

The intent of a process control plan is to control the product characteristics and the associated proces variables to ensure capability (around the identified target or nominal) and stability of the product over time. The control plan in SAP ERP enables you to plan and visualize all relevant inspections for the final product and all its components. In addition, it connects all information from related objects. FMEA and control plan are processes intended to support a "closed loop inspection planning" as it is requested in the international standard ISO / TS 16949, which is especially important in the discrete industry.

Stability/Shelf-Life Study

Testing how well products will keep quality over predefined periods of time under controlled environmental conditions. SAP ERP offers a complete set of tools for planning and performing stability studies.

Sampling Procedure (ISO 2859, ISO 3951)

Indicates the sampling sizes and associated acceptance or rejection criteria to be used. SAP ERP supports standardized sampling systems such as ISO 2859 (attributive inspection) and ISO 3951 (variable inspection) as well as self-defined sampling procedures. Sampling plans according to ISO 2859-1 and ISO 3951 are available ready to be used. Dynamic modification of the sample size and skip lot is also supported. Modification rules according to ISO 2859-1 (normal - tightened # reduced inspection) and 2859-3 (varying skip rate) are available ready to be used.

Recipe & Trial Management

Used in the process industry during the development process. It supports structured product specifications and recipe definition from the first product idea down to the production-line-specific level.

Document Management

Creates, maintains, and retrieves documents in a safe and secure way. For quality documents, the document management solution of SAP ERP is an optimum choice, because of its strong integration into the supply chain master data.

Master Data & Change Management

Creates, maintains, and retrieves the master data needed for quality management. SAP ERP supports quality data, which are embedded in general master data such as material master or vendor master. Provides master data for quality inspection such as inspection method, inspection characteristic, and test equipment. Engineering change management is provided for these master data.   

Supplier Management

Ensures that the products of the supplier will be fit for use with minimal corrective action and inspection. According to J. M. Juran, there are nine primary activities needed: (1) define product and program quality requirements, (2) evaluate alternative suppliers, (3) select suppliers, (4) conduct joint quality planning, (5) cooperate with the supplier during the execution of the contract, (6) obtain proof of conformance to requirements, (7) certify qualified suppliers, (8) conduct quality improvement programs as required, and (9) create and use supplier quality ratings. SAP ERP supports all of these aspects. For example, by means of a data set, which is related to vendor and material, a vendor relationship can be initiated, released, or blocked; quality agreements can be handled.

Quality Manual (ISO 9000)

Documentation of a quality system according to the ISO 9000 standard. In the automotive industry, ISO 9000 is supplemented by standards such as QS 9000 and ISO TS 16949. In the food and drug industry, it is supplemented by so-called "Good Manufacturing Practice" and other rules (GxP). SAP ERP offers a variety of tools, such as knowledge warehouse or document management, to maintain a quality manual.

Quality Inspection

Measures, examines, tests, and gages one or more characteristics of a product or service and compares the results with specified requirements to determine whether conformity is achieved for each characteristic. Includes inspection lots of various origins. Provides results recording and defects recording (also web-enabled). Includes usage decision and release of the stock from being in quality inspection. Follow-up actions include batch classification and quality scoring.

Test Equipment Interfacing

SAP ERP offers a standardized interface (QM-IDI) for connecting measuring subsystems and for external control of inspection operations on shop floor level. In addition, simple measurement systems can be connected using RS232 interfaces, keyboard wedges, serial interfaces or file transfer methods.

Partner products for test equipment interfacing are also available.

Statistical Process Control (SPC)

SPC is the application of statistical techniques to control a process. The term statistical quality control (SQC) is often used interchangeably with statistical process control (SPC). SAP ERP supports Six Sigma approaches for analyzing measured values and non-conformance data, e.g., various quality control charts, Western Electric rules, capability indicators (cp, cpk), Pareto analysis, trend analysis, and exception analysis. It provides an interface (QM-STI) to external tools for statistical analysis, for example, if you need verification of a distribution or significance tests.

In addition, SAP xApp for Manufacturing Integration and Intelligence (SPA xMII) can be used as a front-end to visualize quality data from SAP ERP and execute statistical process control.

Laboratory Information Management (LIMS)

Facilitates the testing of samples that routinely pass through an analytical lab. Manages the complete routine from sample log-in and testing until final reporting. Organizes the inspection results into specific report formats to meet regulatory requirements. Quality management within SAP ERP includes functionality which can compete with best-of-breed LIMS vendors. Supporting the trend of shifting from isolated data islands to global information platforms, this Enterprise LIMS reaches far beyond the borders of traditional LIMS. Because of its tight integration in the supply chain components of SAP ERP, it offers functions for inventory control and batch tracking as well as problem handling and management of preventive and corrective actions (CAPA).

GxP Compliance

Acronym for Good Clinical/Laboratory/Manufacturing Practice (GCP, GLP, GMP). Includes guidelines for enterprises that are regulated by the Federal Drug Administration (FDA). SAP ERP provides all the functions that are necessary to fulfil such requirements. For example, it supports FDA document control (corresponding to 21 CFR Part 11), digital signature, audit trail, batch traceability, and electronic batch record (EBR). SAP's development and service organizations are certified according to ISO 9000.

Sample Management

Allows you to plan and automatically generate samples (physical samples, pooled samples, and/or reserve samples) at goods receipt or in production. You can create individual sample master records for all kinds of sample types, for example, goods receipt samples, environmental samples, and competitor samples.

Batch Management and Traceability

Required if products may vary in quality or if they originate from different production runs. SAP ERP can provide identification, classification, and inventory management for different batches of a material. Bottom-up as well as top-down analyses are offered in order to show into which final products a batch of raw material has flown or which batches of raw materials have flown into a final product. It might even be necessary to show the life cycle of individual items. In this case, traceability is achieved via serial numbers. Moreover, process data can be stored in an order record and in an optical archive (electronic batch record).

Certificate of Analysis

Is related to an inspection lot, a batch or a delivery, in order to document that it meets the quality requirements. SAP ERP supports the creation of all types of certificates that may be sent to customers, e.g., as suggested by European standard EN 10204. Form, contents, recipients, language, and the delivery form of a certificate are automatically selected depending on material, customer, or other criteria.

Outgoing certificates are usually created at delivery time. Structured and textual certificate data can be transmitted to the recipient via a quality data interchange (QDI). Quality certificates for delivery or batches enable customers to obtain a quality certificate over the Internet for goods delivered. The customer can either retrieve a certificate that is created instantly or access one that is stored using ArchiveLink.

SAP ERP also supports the management of incoming certificates, which are delivered together with supplied material. Exchanging quality certificate data offers easy access to the quality data in certificates. You can send the certificate to the target system in electronic form. If the quality certificate relates to a delivery to the customer, the inspection results on the certificate can be automatically transferred to a goods receipt inspection lot or manually to another inspection lot type.  

Gage Calibration (ISO 10012)

Includes the comparison of a measurement instrument of unverified accuracy to a standard instrument of known accuracy to detect any deviation from the accuracy specification. SAP ERP supports the complete calibration process, especially the calibration inspection, in accordance with ISO 10012 and other standards. It supports the generation of equipment calibration orders on a regular basis, it provides the calibration instruction, it enables results recording, and it can adjust the status of the equipment depending on the inspection result.

Quality Costs

Includes the cost associated with inspecting a product to ensure it meets the internal or external customer's needs and requirements; this is an appraisal cost. Includes the costs associated with providing poor quality products or services. There are four categories of costs: internal failure costs (costs associated with defects found before the customer receives the product or service), external failure costs (costs associated with defects found after the customer receives the product or service), appraisal costs (costs incurred to determine the degree of conformance to quality requirements), and prevention costs (costs incurred to keep failure and appraisal costs to a minimum).

Problem/Complaint Management

Provides the notification and analysis of nonconformities, defects, and failures that are related to products, processes, or services. SAP ERP supports problem management with its very flexible and powerful quality notification tool.It is possible to record quality notifications using variable templates depending on the scenario. Notifications are a flexible tool for recording, processing, and monitoring all unplanned events in an organization, e.g. complaints against vendors, customer complaints, or internal problems. 

Corrective and Preventive Action (CAPA) and 8D Report

Includes the implementation of solutions resulting in the elimination of an identified problem and all activities taken to improve a process to prevent future occurrences. SAP ERP quality notification supports the necessary corrective action. Corrective measures can be related to the problem in general and to individual nonconformities or deviations in particular.

Especially for automotive suppliers, a complete 8D process can be implemented using quality notifications.   

Solution Database

Contains information to describe an action or process that is intended to eliminate a symptom and the problem indicated by the symptom. Its design allows you to define a solution using various information sources (e.g., free-text description, basic data and classification, actions that must be performed, attachments, or linked symptoms). 

Quality Information Management

Includes vendor evaluations, Balanced Scorecards, and web reporting on inspection lots, inspection results and quality notification data (defects, tasks, actions, causes, etc.)  using SAP Business Intelligence.

In addition, SAP ERP provides a powerful tool for flexible ad-hoc reporting and evaluations on inspection lot data (new transaction QGA4).

Six Sigma Improvement Projects (Future Focus)

The Six Sigma methodology can be applied to all kind of improvement projects. The quality management application in SAP ERP and the cProjects component provide a perfect basis to define, measure, analyze, improve, and control such projects.

In addition, SAP xApp for Manufacturing Integration and Intelligence (SAP xMII) can be used as platform to set up lean six sigma projects to investigate and improve manufacturing processes. Partner products are also available.

An audit is a systematic examination used to determine to what extend an object meets previously specified criteria. Audits are usually performed using question lists which represent the criteria. Audit management means to plan and process audits, grade the audit objects, monitor corrective and preventive actions that were based on the findings, and analyse audit data. You can trigger a quality notification out of an audit finding for further processing. Evaluation of audit results can be executed using SAP Business Intelligence.

The Audit Management component is very versatile can support various audit types that are performed on the basis of previously specified criteria. Examples of usages are:

• Quality Management (system audit, process audit, product audit), Good Manufacturing Practises
• Environment Management, Hygiene Management
• Safety & Security Management (facility safety, fire safety, data protection)