Quality Management With SAP ERP - Functions in Detail (US)

A comprehensive approach to quality management – one that integrates informa-tion and processes across departments and corporate boundaries – empowers your employees and supply chain partners to maintain and improve quality levels. The SAP® ERP application provides a single, powerful solution that lets you take a comprehensive, broad-based approach to total quality management. It de livers a wide range of inte-grated quality management functionality and supports collaborative business pro-cesses for cost-effectively ensuring the quality of your products and processes and transforming quality man-agement into a competitive advantage.

QUALITY MANAGEMENT WITH SAP® ERP

SAP Functions in DetailSAP ERP

4 To the Reader

5 Modern Quality Management: An Integrated Management Approach

5 Offering a Total Quality Management Solution 6 Internal and External Integration

8 Quality Management with SAP ERP

8 Take a Closed-Loop Approach to Total Quality Management

9 The Planning Phase 11 The Implementation Phase 16 The Usage Phase

18 Inspection Planning: Putting Quality Strategies into Action

18 Closed-Loop Inspection Plan-ning: Failure Mode and Effects Analysis and Control Plan

20 Integrated Inspection Planning 21 Basic Data for Inspection

Planning 23 Planning Tools

25 Quality Inspections: Achieving Reliable Results

25 Inspection Lot Processing 28 Inspection Results 32 Sample Management

34 Quality Certificates: Guaranteed Reliability – Printed or on the Internet

34 Certificate Processing in Sales and Distribution

35 Certificate Creation – Meeting Your Requirements

36 Certificate Processing at Goods Receipt

37 Collaborative Business: Certificate Data for the Whole Company

38 Efficient Problem Management 38 Improved Quality Through

Targeted Problem Handling 38 Using Quality Notifications 39 Notification Processing 39 Quality Notifications 40 Elements of the Quality

Notification 40 Optimized Usage 41 Analysis of Items and Defects 41 Tasks 42 Support Functions

43 Sustained Quality Control Planning, Evaluation, and Direct Intervention

43 Dynamic Modification of the Inspection Scope

44 On the Right Track with Statistical Process Control

46 Vendor Evaluation: Permanent and Objective Performance Monitoring

47 Evaluations: Keeping You Up-to-Date

50 Taking Control of Quality Costs

51 Test Equipment Management 51 Calibration Inspections and SAP

ERP 51 Master Data in a Calibration

Inspection 52 Planning a Calibration

Inspection 53 Calibration Inspection 54 Evaluations for Test Equipment

55 Enabling an Integrated Enter-prise Laboratory Information Management System with SAP ERP

55 The Enterprise LIMS Approach 55 Stability Study – Supporting

Product Development and Product Improvement

56 Compliance and Quality Control

58 Audit Management: Flexible Tool for Planning, Execution, and Evaluation of Audits

58 Assessments: Methods for Audit Criteria

58 Audit Processing: Evaluate Risks and Confirm Information

60 Mapping SAP Solutions to Your Six Sigma Initiatives

62 Enterprise Service-Oriented Architecture for Services-Based Business Solutions

63 Appendix 63 For More Information 63 Key Terms

64 Quick Facts

CONTENT

This document targets project plan-ners, decision makers, and people interested in implementing QM with SAP ERP. It explains how QM with SAP ERP is integrated in the SAP Business Suite family of business applications and enterprise service-oriented archi-tecture (enterprise SOA), powered by the SAP NetWeaver® technology plat-form. It provides you with insight into the current functional scope of QM with SAP ERP. It also shows how QM functions are integrated in SAP ERP and support the business processes of the supply chain.

For detailed information about SAP ERP, visit our Web site at www.sap.com/erp or visit the SAP Service Marketplace extranet at www.service.sap.com/erp(login is required).

In today’s economy, you must invest in business software in order to invest in your company’s future. It is important to lay a trusted foundation for business excellence and innovation and to provide your organization with the enterprise resource planning (ERP) functionality that is needed to gain strategic insight, competitive differen-tiation, increased productivity, and business agility.

With the SAP® ERP application, SAP has transferred its vision of increasing efficiency within an organization to soft-ware for enterprise resource planning (ERP) that helps automate end-to-end business processes and extends those processes to the entire business eco-system, including customers, partners, and suppliers. With SAP ERP, you can increase your employees’ productivity and provide them with the insight need-ed to make decisions that set you apart from the competition.

Quality is a vital core competency for manufacturers industry-wide – and given today’s complex and often global production cycles, it cannot be treated as simply an afterthought. You have to engineer quality into the design of prod-ucts and processes; you have to track quality through procurement, produc-tion, and delivery; and you have to con-

stantly improve quality to keep pace with ever-growing customer expecta-tions and competitive pressures. In short, you need to take a comprehen-sive approach to quality management – one that integrates information and processes across departments and corporate boundaries and empowers both your employees and supply chain partners to maintain and improve quality levels.

SAP ERP enables the comprehensive and efficient approach you need to transform quality management into a competitive advantage. SAP ERP deliv-ers a wide range of integrated quality management functionality and supports collaborative business scenarios for cost-effectively ensuring the quality of your products and processes. As your employees work throughout the entire product life cycle along the supply chain, SAP ERP ensures that quality is efficiently built into your processes, systems, and products, from the shop floor to the top floor.

If you are considering implementing or have already implemented quality management (QM) with SAP ERP in your company, and you want informa-tion on current functions and new developments, then this document contains all the information you need.

TO THE READER

4 SAP Functions in Detail – Quality Management with SAP ERP

Offering a Total Quality Management Solution

The SAP® ERP application provides a single, powerful solution that lets you take a comprehensive, broad-based approach to total quality management (QM). Far more than a traditional isolat-ed computer-aided quality system or a laboratory information management system, SAP ERP supports quality processes in any industry.

Practice Continuous ImprovementYou can quickly identify and analyze problems, then rapidly eliminate their root causes. With the quality notifica-tions functionality, for example, you can ensure that all problems and unplanned events are captured directly when they occur, that they are correctly assigned and resolved, and that all actions are monitored for maximum effectiveness. An enterprise service-oriented ap -proach allows employees as well as business partners to create requests or notifications, work together online to record information, dispatch informa-tion, and track the processing status of requests – providing the full function-ality needed to ensure corrective and preventive actions. In addition, the ana-lytic functionality of SAP ERP and the SAP NetWeaver® Business Intelligence (SAP NetWeaver BI) component enables you to monitor quality perfor-mance and adjust quality strategies to eliminate problems. Using the flexible QM cockpit for evaluations in SAP ERP, for example, you can analyze both online and archived quality manage-ment data to support your company’s Six Sigma projects.

Manage Audit ProcessesThe audit management functions of SAP ERP let you plan, conduct, and evaluate audits throughout the enter-prise. You can perform internal or external audits of systems, processes, products, and environmental condi-tions; conduct a range of assessments and reviews; and monitor the effective-ness of all corrective and preventive actions linked to quality notifications. All this helps you comply with legal requirements, support benchmarking efforts, and uncover opportunities for improvement. Audit management func-tions support a wide range of industry standards, such as ISO 9000:2000, QS-9000, Good Manufacturing Practice (GMP), ISO 14011, and ISO 19011.

Deliver Quality-Related Information Where It’s NeededWeb-based enterprise portal technolo-gy and ready-made SAP content give your employees and your partners a single point of access to all the infor-mation, applications, tools, and servic-es they need to collaborate on quality initiatives. The easy-to-use, context-driven portal increases the reach of your quality management efforts to include both everyday and occasional users in quality processes. For exam-ple, quality inspectors can work more efficiently by using the portal to access the specific work list they need to com-plete each inspection lot.

Stand Out at Quality ControlSAP ERP gives you quality control functionality that supports strategic planning, continuous monitoring, and quick problem resolution. The applica-tion lets you share quality information and control quality processes across the supply chain. You can plan, con-duct, and manage quality inspections – and integrate them into processes throughout the product life cycle. You can accurately track results and defect data; record and charge inspection costs; manage and maintain laboratory data related to samples, tests, and stability studies; automatically create quality certificates for customers and exchange that information with busi-ness partners; and connect, monitor, and maintain test equipment to ensure data accuracy.

You can collect and analyze all the quality-related data needed to conduct Six Sigma projects. With the applica-tion’s built-in workflow functions, you can automate and accelerate many of your business processes. Meanwhile, the SAP Manufacturing Integration and Intelligence (SAP MII) application lets you rapidly integrate SAP ERP with other manufacturing software – enabling production-line personnel to record inspection results directly from the shop floor. Leveraging an enter-prise service-oriented architecture (enterprise SOA), SAP ERP offers a wide range of enterprise services for quality management. In an intercon-nected world, the ability to exchange data across applications and with vari-ous partners is rapidly becoming as important as statistical process control

MODERN QUALITY MANAGEMENT: AN INTEGRATED MANAGEMENT APPROACH

5SAP Functions in Detail – Quality Management with SAP ERP

and test equipment interfaces. SAP ERP is designed for easy integration with other SAP and non-SAP applica-tions for supply chain management, customer relationship management, supplier relationship management, and enterprise resource planning. As a result, it enables the seamless sharing of information and true end-to-end business processes.

Internal and External Integration

The openness of the SAP NetWeaver technology platform and the seamless integration of QM with SAP ERP into a complete business solution support you in total quality management and satisfy the criteria for ISO 9000 or GMP.

In the integrated SAP Business Suite family of business applications, SAP ERP functions are incorporated into other applications, such as the SAP Supply Chain Management (SAP SCM) or SAP Customer Relationship Management (SAP CRM) applications. You have software support for all important processes.

QM with SAP ERP is linked directly to various functions that help you effi-ciently manage your business process-es. Examples of such functions include: • SAP Business Workflow tool for

targeted process control Using SAP Business Workflow, you

can establish a clearly defined infor-mation and processing network to quickly and efficiently process inspection lots and quality notifications.

• SAP ArchiveLink® software for stor-ing documents

SAP ArchiveLink stores documents that are linked to application func-tions in an optical archive. Such doc-uments include quality records, cer-tificates, customer complaints, and other original internal or external documents.

In addition to SAP ERP, you can inte-grate other SAP solutions in the SAP NetWeaver Portal component, such as SAP NetWeaver BI. You can also integrate non-SAP products. As a result, you can adapt and enhance your working environment to suit your own requirements.

Using clearly defined roles, employees can access their own work areas in SAP NetWeaver Portal. A role describes a specific activity profile and groups together the corresponding functions of that profile. Employees can then target their involvement in business processes. The flexible SAP NetWeaver Portal allows you to adapt the roles to suit your individual needs.


Enterprise Service-Oriented

Architecture

Figure 1: Internal and External Integration of Quality Management with SAP® ERP

QualityManager

KnowledgeManagement

SAPNetWeaver® BI

SAP®SCM

ExternalURL

QualityPlanner

InspectionPlanner

QualityInspector

NotificationProcessor

Test EquipmentManager

Sales andDistribution

CustomerService

PlantMaintenance

Controlling

ProductionPlanning

Production Planning/Process Industries

MaterialsManagement

ClassificationSystem

SAP BusinessWorkflow

Document Management

SystemOffice

EngineeringChange

Management

SAPArchiveLink®

Quality PlanningQuality InspectionsQuality ControlQuality CertificatesQuality ImprovementTest Equipment ManagementAudit Management

QM withinSAP ERP


QUALITY MANAGEMENT WITH SAP ERP

Quality management with SAP ERP tightens control and contains costs. Under current market conditions, many organizations follow a twofold strategy: strive for continued growth and innova-tion through competitive differentiation and increase efficiency to meet the enormous pressure to cut costs. In the end, you must be excellent in both to meet stakeholder expectations and achieve financial success. You must reduce costs wherever possible, but avoid risks that might lead to unexpect-ed – and unbudgeted – expenditures.

QM with SAP ERP enables enterprises to manage quality in a highly efficient way, differentiate their business, and establish a reputation of excellence. Conversely, mismanaging or ignoring quality issues negatively impacts a company’s brand and products and impairs cost control. The best answer is to put in place a comprehensive approach to total quality management along the entire supply chain. Enterprise-wide audit management, quality engineering, quality assurance and control, and continuous quality improvement are all aspects of it. By using QM with SAP ERP, organizations can comply with industry standards and legal requirements more easily, increase customer satisfaction, and improve competitiveness.

Take a Closed-Loop Approach to Total Quality Management

There is more to quality management than performing quality inspections every now and then. Companies want to focus on prevention of deficiencies, continuous process improvement through collaboration, and sustainable quality control. You need to react immediately to unplanned quality-related events, involve all affected parties, and start follow-up actions to solve or control an issue.

SAP ERP supports and ensures con-sistently high quality throughout the supply chain. Companies can comply continuously with legal requirements and industry standards. Customer satisfaction goes up, as does overall product quality and customer service management.

Because project management and quality management functions are inte-grated with the SAP ERP Corporate Services solution, you can run Six Sigma projects to further enhance quality, improve processes, and reduce costs within your company.

QM with SAP ERP supports key business activities with a focus on prevention of deficiencies, continuous process improvement through collabo-ration, and sustained quality control. Comprehensive quality management functionality supports:• Quality engineering• Quality assurance and control• Quality improvement• Audit management

QM with SAP ERP supports you both internally and externally. It provides complete support, from product and process planning in research and devel-opment (the planning phase); through procurement, production, and sales and distribution (the implementation phase); to service and usage (the usage phase), as shown in Figure 2.

Benefits:• Increased customer satisfaction through better product quality and enhanced complaint management and tracking (corrective and preventive action)• Increased revenues by retaining custo m - ers and strength- ening customer loyalty• Increased efficiency through improved asset utilization


The Planning Phase

QM with SAP ERP supports the process of quality management in the planning phase. It comprises the following features and functions:

Closed-loop inspection planningClosed-loop inspection planning means integrated inspection planning for goods receipt inspections and for inspections during production, and it starts at the very beginning of the product development process for a new product. The international standard ISO/TS16949 requires an advanced product quality planning (APQP)

process, a must for each supplier in the automotive and other discrete industries.

SAP ERP provides tools for supporting this process; one is a tool for a failure mode and effects analysis (FMEA) and the other is the control plan.

You can use the FMEA tool to perform a risk analysis for a distinct object (material or operation) to identify possi-ble defects of a process or a product. By applying the given tools, you can detect possible risks and eliminate them by defining preventive actions at an early stage.

With the control plan, you can plan and visualize all relevant inspections for a final product and all its components. The control plan connects all informa-tion from the related objects and is a basis for detailed inspection planning for each step (in-process control, goods-receipt inspections, and so on).

Document managementAn important tool in SAP ERP is docu-ment management. You can use docu-ment management software to create links between inspection outlines, design drawings, technical delivery terms, specifications, product specifi-cations, inspection methods, and other quality-relevant documentation and the corresponding master data. You can manage data according to validity, version, and status.

Master data managementDuring the implementation phase of your project, you specify product-related settings that are required for controlling quality-related processes in the material master record in the quality management view of master data. For the management of quality information related to materials, vendors, and cus-tomers, and for the control of vendor and customer-related processes, you can maintain appropriate quality infor-mation records. You can, for example, assign quality assurance agreements and perform model processing.

In material-related inspection plans, you can define either customer- or vendor-specific inspection specifications and multiple specifications related to further objects. When you are performing an

Figure 2: Quality Loop According to ISO 9004

Shipping

Maintenance

Disposal Marketresearch

Design

Testing

Productionplanning

Procurement

ProductionFinal inspection

Warehousing

Usage Planning

Implementation


inspection during production, these elements are integrated into the routing or recipe.

You can make changes to the master data centrally, and you can transfer the data from one source system to one or more target systems. In addition, there are tools available for research and analysis of master data linked in a hierarchy, such as where-used lists and the product structure browser.

Engineering change managementCentral engineering change manage-ment coordinates the changes you make to master data. You can run such changes through an approval procedure (for example, according to GMP requirements). You can create different versions and then distribute them using workflow. You can also allocate a revi-sion level with regard to a specific valid-from date when a change is made.

ClassificationUsing the integrated classification func-tion, you can specify and assign data that is available in SAP ERP (such as materials, documents, and inspection plans), in order to be able to locate this data later according to specific search criteria (such as batch characteristics).

Stability studyStability studies or shelf-life studies are conducted to track and examine how different environmental conditions (for example, temperature, light, or mois-ture) affect a compound, a material, or a batch over a specified period of time. Using features and functions in SAP ERP, you create physical samples of the material or batch and store them

under controlled conditions for the duration of the study. At specified intervals during the study, you remove these physical samples or parts of these samples from the various condi-tions and test them according to predefined inspection plans. You can then use the results of these tests, which have accumulated over the course of the study, for example, to check and confirm whether the desired or guaranteed life expectancy of the product conforms to the predefined recommendations for storage.

As a business process, the stability study is fully integrated in SAP ERP, using functions from the following areas:• Quality management: quality notifica-

tions, quality planning, and inspection lot processing

• Asset life-cycle management: mainte-nance planning and scheduling

• Materials management: material master, batch management, and bills of materials

Authorization managementA central administration function is responsible for data security and protection. You can assign individual authorizations for the processing of master data and movement data. This enables you, for example, to set up employees so that they have to provide a digital signature when performing cer-tain operations.

Business workflow You can use business workflow to con-trol certain complex processes and the output associated with these process-es. For example, corrective tasks within

a problem notification can be trans-ferred automatically to the organiza-tional unit responsible.

Quality costs You can enter, collect, and bill costs related to the prevention of defects, inspections, and nonconformity to different account-assignment objects using orders in controlling.

Key figure analysis With its quality key figures, SAP NetWeaver BI offers a wide range of possibilities for monitoring and control-ling your quality processes.

Audit managementWith integrated audit management tools you can plan and process audits, grade audit objects, monitor corrective and preventive actions that are based on the findings, and document and ana-lyze audit data. Audit management, as part of SAP NetWeaver and thus also part of SAP ERP, supports all apprais-als based on predefined criteria (audits, checks, inspections, reviews, and examinations) and can subsequently be used to valuate the object.

The audit management functionality is very versatile and can be used for various application areas. Examples of audit usages are:• Quality management (system audit,

process audit, or product audit) and GMP

• Environment and hygiene management

• Safety and security management (facility safety, fire safety, or data protection)


Six SigmaHaving SAP ERP and SAP Business Suite in place in your company allows you to implement your Six Sigma initiative. SAP ERP supports most of the elements that are essential for Six Sigma, such as the definition of a structured problem-solving road map such as DMAIC (define, measure, analyze, improve, and control); a clear setup of tasks and responsible persons by using the Collaboration Projects (cProjects) application; the calculation of risks and costs; the linking of related documents, notifications, inspections, and audits; the determination of capa-bility and performance indicators, for example, from statistical process con-trol (SPC) monitoring of control charts and Cpk index; and a failure mode and effects analysis. Process data can be extracted from the source and transferred into SAP NetWeaver BI and an executive infor-mation system for general analysis purposes. SAP NetWeaver BI and the executive information system provide all the functions needed for calculating key performance indicators (KPIs), feeding balanced scorecards, or other assessment techniques.

Collaborative scenario: quality notifications In the product development stage, if you are working with customers or partners, QM with SAP ERP offers you the opportunity to initiate product ideas or changes to products using quality notifications. Customer complaints, which can be entered on the Internet, can be used to determine product qual-ity. Vendors can ask for permission to

deviate from specifications if they cannot adhere strictly to customer specifications.

For this scenario enterprise services are also available to create and main-tain notifications in SAP ERP.

Collaborative scenario: quality certificates Working with your customers or ven-dors, you use certificate profiles to plan exactly which characteristics are to appear on the certificate. This certifi-cate data can be exchanged electroni-cally using quality data interchange (QDI), or it can be stored on the Inter-net. For example, you can store it as a PDF document.

Collaborative scenario: results recording You can record inspection results using the Internet or intranet. Results can be recorded by external service providers (for example, commercial analysts) and internal inspectors (for example, in a source inspection) in their respective work centers.

For this scenario enterprise services are also available to trigger and record inspection results in SAP ERP.

The Implementation Phase

QM with SAP ERP ensures quality across the entire supply chain and beyond company boundaries. It sup-ports your quality management department in the following activities: • Procurement. QM with SAP ERP

manages vendor-related master data, controls the purchasing process

according to certain quality criteria, and handles inspection certificates and goods receipt inspections.

• Production. QM with SAP ERP inte-grates inspection specifications in routings and recipes, allows inspec-tions during production and goods receipt inspections for the manufac-turing order to take place, monitors the production process using control charts, and confirms quality, quantity, and costs.

• Sales and distribution. QM with SAP ERP manages customer-related mas-ter data, controls the sales and distri-bution process according to quality criteria, and handles inspection certif-icates and inspections at goods issue.

ProcurementVendor evaluationMaterials management provides infor-mation for the purchasing agent about a vendor’s delivery reliability, price record, and service record. QM with SAP ERP provides the purchasing agent with information about quality management used by the vendor and the quality of previously delivered goods. To do this, SAP ERP summariz-es quality scores from vendor audits, goods receipt inspections, and com-plaints against the vendor.

Vendor releaseIn some industry sectors, vendors must have a quality management sys-tem in their company. Such a system might, for example, be required to be compliant with the ISO 9000 series of standards. Such vendors must have this system certified by an accredited organization. Your SAP ERP application


checks if the quality management sys-tem used by the vendor is adequate for certain materials and then either releas-es or blocks the supply relationship accordingly.

You can limit the release of this supply relationship to a specific time frame and a maximum delivery quantity. If the vendor has serious quality problems, you can block requests for quotations, purchase orders, or goods receipts for specific materials supplied by this vendor.

QM with SAP ERP also monitors the step-by-step release of a material. Vendor deliveries must sequentially pass through a series of customer-defined statuses, such as model, preliminary series, and production series, using appropriately assigned inspection plans.

In many industry sectors, suppliers are intermediaries (distributors), which means that the quality of produced goods is dictated primarily by the manufacturer rather than the vendor. Consequently, you can apply the following functions to a manufacturer: vendor release, inspection planning, dynamic modification of the inspection scope, and complaints against the vendor.

Quality assurance agreement, technical delivery terms, and certificate requirementWhen the purchasing agent requests a quotation and issues a purchase order, vendors that are released receive infor-mation automatically about the techni-cal delivery terms and the current

quality assurance agreement. Vendors may also be required to include a quali-ty certificate with the delivery.

Source inspection Occasionally, inspections can be per-formed at the vendor’s premises to replace a goods receipt inspection. If this occurs, the software takes the target delivery deadline into account and creates an inspection lot in time for the source inspection. You can now perform a source inspection at the vendor’s site, because it is possible for you to access SAP ERP using SAP NetWeaver Portal. This is possi-ble even if the vendor does not use SAP ERP.

Goods receipt certificateIf you have identified that a material requires a certificate, the receipt of this certificate must be confirmed. SAP ERP takes appropriate action if the certificate is missing (for example, posting the goods to blocked stock). SAP ERP supports the management of the certificate receipt process and sends reminders if necessary (see Figure 3). You can manually create the certificate and store it in the optical archive (SAP ArchiveLink), or you can send it in electronic form. Certificate data can be transferred directly to the goods receipt inspection lot using elec-tronic quality data interchange.

Figure 3: Certificate Processing at Goods Receipt

Goods Receipt

CertificateRequirement

Reminder

Inspection Lot:Confirm receipt when or after

making usage decision

No

No Inspection Lot:Post goods to blocked stock

Update Certificate Record

Yes

Certificate Included?


Dynamic modification If the quality of a supply relationship is consistently high, you may want to waive the goods receipt inspection, particularly if the vendor has a certified QM system. For partial lots, you can set the software to inspect a goods receipt only once for each purchase order, goods receipt, or batch. If you do not want to waive the goods receipt inspection completely, you can reduce the scope of the inspection as far as the quality level allows. The reduction of the inspection scope may lead to a skip lot. If you allow a skip lot and an automatic usage decision for a materi-al, the software processes skipped lots without intervention. It then immediate-ly posts the inspection lot quantity to unrestricted-use stock (ship to stock).

Receiving inspection If the prerequisites for ship to stock are not fulfilled, SAP ERP automatically triggers inspection lot processing upon goods receipt. In addition to the goods receipt document, the application also creates an inspection lot record, selects an appropriate inspection plan, and determines the sample size based on the quality level.

Physical-sample drawing If goods are delivered in containers, you can take samples in accordance with a sample-drawing procedure. The documents you need (such as sample-drawing instructions, sample labels, and inspection instructions) are avail-able for printing immediately. You can then proceed with the inspection.

Recording inspection results and defects You can record the results for the goods receipt inspection in the form of inspection characteristic values and defect data records or texts. If serious problems arise during a goods receipt inspection, a quality notification can be created automatically. Inspection results can also be recorded automatically using electronic measuring equipment.

Appraisal costs Costs are associated with every inspection and defect. Appraisal costs are determined using the activity confirmations of the people involved in an inspection. You can allocate the costs that are calculated on the basis of these confirmations for one or more inspection lots in several QM orders, and you can then pass them on to the cost object. Costs associated with defects are settled using quality notifications.

Inspection completion The processing of an inspection lot in QM with SAP ERP ends after the inspection is completed and the usage decision is made (see Figure 4). The accepted inspection lot quantity is posted manually or automatically to unrestricted-use stock. Special stock postings are available to you for rejected quantities, including posting to blocked stock, transfer posting to a different material, returning to the ven-dor, or posting to scrap. If the material is handled in batches, the software proposes a batch status that is com-patible with the usage decision.

Once the usage decision is made, SAP ERP updates the quality level and the QM information system and makes the quality score of the inspection lot available for the vendor evaluation. SAP ERP also updates material and vendor information in the quality data record. For example, once the inspection lot has been completed,

Figure 4: Inspection Lot Processing at Goods Receipt

PurchaseOrder

No

Yes

Inspection

GoodsReceipt

Stock in Quality Inspection

QualityNotification

Unrestricted-Use Stock


the status of the supply relationship can be updated from model delivery to regular delivery.

SAP ERP can trigger a series of user-defined follow-up actions on the basis of the usage decision. For example, you can print specific inspection reports.

Invoice verificationIf invoices for the delivery of goods are received before the usage decision is made for the goods receipt inspection lot, you can prevent an automatic pay-ment during invoice verification.

Complaints against the vendorDefects in delivered material that have been caused by the vendor or manu-facturer can be documented in a quality notification. You can use SAP Business Workflow to pass this notification on to the processor responsible. The proces-sor can then initiate various tasks (such as posting to blocked stock or sending a complaint against the vendor). Com-plaints can be entered on the vendor’s Web site.

ProductionMaterials planning When you are inspecting raw materials or semifinished products, the planned duration of the receiving inspection is taken into account in materials planning.

Inspection during production QM with SAP ERP integrates quality inspections into the production process (see Figure 5). It supports different types of production, from order-related, lot-based production and the assembly process in mechanical engineering, through repetitive manufacturing in the automotive industry, to batch-based process manufacturing in the chemi-cals, pharmaceutical, and food and beverage industries.

You can initiate inspections on the basis of different types of goods move-ments. Inspection lots can be created automatically when a material compo-nent is removed or when a product for the production or process order is pro-cessed at goods receipt.

Inspection lots for an inspection during production can be created in the follow-ing ways: • As an inspection lot during produc-

tion when a production order is released. This is not stock relevant.

• As an early inspection lot at goods receipt. This is stock relevant; in other words, the stock in the quality inspection is managed using the usage decision for the inspection lot.

• When goods are received from a subcontractor for external processing operations. This can be stock rele-vant, depending on software settings.

Physical-sample drawing The sample size is calculated, and shop papers (such as sample drawing, inspection instructions, and sample labels) are printed at previously deter-mined work centers after the valid routing or master recipe has been selected.

Digital signature You can set the software to require a digital signature (electronic signature) from the employee who releases the physical-sample drawing, records results, or makes the usage decision, to ensure that this particular employee has the appropriate authorization.

Inspection results and defects recordingInspection results can be recorded for the following objects: • Inspection characteristics The results can be recorded in sum-

marized form, in classes, or as single values.

Figure 5: Inspection During Production

Inspection Lot 14711

Inspection Point

AutomaticDefects

Recording

CharacteristicLengthWidth

Target50.0 mm30.0 mm

QualityNotification

Tasks

Actual49.8 mm31.2 mm


• Inspection points Several inspections are performed

for each inspection characteristic. Inspection points can be user-defined, and they can be planned in advance if necessary. They can be related to production quantities or production times (for example, inspection of a wire basket or silo once during each shift or every two hours).

• Physical samples These can be planned in advance

using a sample-drawing procedure, or they can be unplanned.

• Partial lots Production quantities of the same

quality can be grouped together. • Batches Inspection results can be used for

batch determination at a later stage; for example, they can be applied when choosing products at the deliv-ery stage or when deciding which subcomponents to use for production.

• Serial numbers This applies if the inspection results

are to be assigned to a single unit. In this case, the serial numbers can be copied from the production order.

Defects can be recorded for inspection characteristics, inspection operations, or inspection lots.

Statistical process controlThe inspection results are the basis for statistical process control using control charts. A control chart can be valid for several inspection lots and production orders. The warning and action limits of a control chart are calculated using the most recent inspection results or

the results of an initial run. If an action limit is exceeded, messages and notifi-cations can be created.

Appraisal costs and production quantity confirmationsWhen you are recording inspection results, you can also confirm produc-tion quantities and costs for the pro-duction order (see Figure 6). Such confirmations control the subsequent production process (for example, the release of inspection operations or subsequent work that has yet to be performed).

Inspection completion The inspection is completed when the usage decision is made. Employees with appropriate authorizations can post stock quantities, classify charges according to their quality, and perform

follow-up actions. QM with SAP ERP provides a digital signature for the usage decision.

Sales and DistributionQuality assurance agreement and technical delivery terms You can store customer-related quality documents in the quality information record for sales and distribution. In addition, you can use this quality infor-mation record to control the time and type of a quality inspection.

Variant configuration in the sales order At the time of sales order creation, customers can specify quality charac-teristics for the desired variant. This information then flows into all inspec-tions during production in the form of inspection specifications.

Figure 6: Quantity Confirmation and Inspection Point Valuation


Resource-related billing document After the inspection results have been confirmed, you can invoice the custom-er for the inspection costs.

Inventory Management Stock categories Materials management categorizes inventory by the following stock types: unrestricted use, blocked, and in quality inspection. Usually the specified quanti-ty of a received material is posted to inspection stock for the duration of the goods receipt inspection. This stock can only undergo a transfer posting during inspection lot processing. For example, when the usage decision is made, it can be posted to unrestricted-use stock. In the inspection lot, you can view all of the posting documents that relate to the lot stock.

Warehouse management If you use warehouse management software, SAP ERP also manages the inspection lot samples and units creat-ed due to the usage decision or while locating a storage bin. The inspection lot identifies each unit and transfer requirement. Using the strategy defined for placement in storage, the software triggers the transport of samples and partial quantities, and it posts the stock.

Handling unit managementYou can use handling units as transport units. A handling unit is a physical unit consisting of packaging and the goods stored with or on this packaging. The software enables you to move these handling units, as opposed to just mov-ing the materials. Therefore, a quality inspection can be performed with refer-ence to handling units.

Processing complaints and handling returns You can create customer complaints as quality notifications on the Internet. You can document defects and tasks, and you can also perform various follow-up functions using the action box. For example, you can process returns or repair orders, enter costs, perform stock postings, or trigger inspections.

The Usage Phase

In the usage phase of the product life cycle, service providers can process inspections (outsourcing) with QM with SAP ERP. Service providers can use SAP ERP to identify items, plan and confirm services, and create invoices for services rendered.

ServiceVariant configuration in the sales order Inspection laboratories perform inspec-tions as a service (commercial analy-sis). When creating the sales order, these laboratories can select the inspections requested by the customer from inspection plans and transfer them into a service order.

Service order inspection Inspections can be selected using vari-ant configuration in the sales order or by selecting inspection operations in the service order. Once the inspections have been selected, inspection lots can be created when the service order is released. Then the inspection can begin, and inspection instructions and sample-drawing items can be printed.

Batches determinationIf you manage the stock of a material in batches, QM with SAP ERP allows you to select suitable batches at delivery using batch characteristics. These characteristics can be populated with quality results via valuation based on multiple specifications.

Inspection for delivery or for goods issueInspection lots can be created at the picking stage or at goods issue. After you have chosen a suitable inspection plan, the sample size is calculated and shop papers (sample-drawing items, inspection instructions, and sample labels) are printed. When the inspec-tion results have been recorded, the inspection is completed with the usage decision.

Certificate at goods issue At goods issue, you can use a quality certificate to document that the inspec-tion results are in accordance with the customer’s specifications. You can enter inspection characteristics from the inspection plan and characteristics that were defined in the batch determi-nation as inspection specifications on the certificate. The form, content, and means of output are customer-specific. These are derived from the specifica-tions made by the recipient of the cer-tificate at picking or at goods issue.

Quality data interchange Formatted quality data contained in a quality certificate can be sent electroni-cally and then automatically transferred into an inspection lot at the customer site. It is also possible to make this data available on the Internet.


Batch management Materials management can manage stocks for materials in batches, and it can recognize the difference between batches in unrestricted-use or blocked stock.

You can use QM with SAP ERP to monitor the shelf life of batches and deadlines for recurring inspections. In addition, you can change the batch status and perform stock postings automatically. For example, you can post to blocked stock when the expiry date is exceeded.

Batch trackingThe batch where-used list helps you determine which raw-material batches or semifinished products make up the batch of a finished product (top-down analysis) or, conversely, which batches of semifinished or finished products are made up of a particular batch of a raw material (bottom-up analysis). The where-used list also forms the basis for printing inspection results from the previous assembly stages (for example, semifinished products) for an end product on a quality certificate.


As inspection planner or quality engineer, you implement predefined planning strategies in your company. This includes: • Performing closed-loop inspection

planning with FMEA and control plans• Defining the trigger, type, and scope

of quality inspections • Creating and managing task lists as

the basis for quality inspections • Managing and processing the basic

data used in task lists • Determining the procedure for statis-

tical process control

To complete these tasks, you can use the reusable basic data as building blocks and a flexible planning tool.

Closed-Loop Inspection Planning: Failure Mode and Effects Analysis and Control Plan

Closed-loop inspection planning means an integrated inspection planning for goods receipt inspection and for inspection during production, and it starts at the very beginning of the product development process for a new product.

Typically the closed-loop inspection planning process comprises the follow-ing steps:

The first step is to work in a team of experts from different departments to create an FMEA. In doing so, the prod-uct and process characteristics with a high safety risk are pointed out. In a second step, these characteristics are transferred into a control plan. The control plan gives an overview about all inspections for a final product, including

all components, and is the basis for the third step, maintaining the operational inspection plans and routings.

As soon as the product is produced, the supplier has to implement a closed-loop process starting with a continuous improvement process. Each internal or external complaint must be checked against the preventive actions, which have been defined in the FMEA during the first step of the closed-loop inspec-tion planning. One result of the com-plaint could be to change the FMEA and control plan as well as operational plans.

FMEA is an analytical method for early detection and elimination of possible failures and issues in products and processes. In the context of quality management, this method is used for preventive failure avoidance. SAP ERP offers tools for monitoring as well as a cockpit for building an FMEA product or process structure. FMEA can be used for root-cause analysis in Six Sigma projects, risk assessment during prod-uct development, and operational quali-ty control and planning. FMEA supports compliance with ISO/TS16949 (auto-motive industry).

INSPECTION PLANNING: PUTTING QUALITY STRATEGIES INTO ACTION

Figure 7: Closed-Loop Inspection Planning According to ISO/TS 16949

Specification

CAD

DefectsCharacteristics



Characteristics

Stamping

Characteristics



8-D = eight disciplinesCAD = computer-aided designFMEA = failure mode and effects analysisSPC = statistical process control

FMEA(Product/Process)

Control Plan

Inspection Plan

Complaints(8D-Method)

SPC

Zero-DefectProduction


The FMEA cockpit and monitor offer the possibility of a hierarchical display of the object, machine, or system being inspected for possible failures (see Figure 8). With the help of a hierarchical or a linked structure, the entire chain of failure mode, causes, and consequenc-es can be viewed and investigated.

With risk-priority numbers you can evaluate and estimate the defect cause of a failure. The necessary actions to diminish or avoid a failure can be managed with the FMEA tool as well. Furthermore, there is a connection between the FMEA of one element with the lists of those of subordinated and superordinated elements. Those lists contain not only the addressed elements but also the addressed functions and failures.

This makes sure that the entire object, machine, or system is investigated regarding possible risks, since:• One function can be dependent on

the function of a subordinated element.

• The outage of one function can cause the outage of the function of a subordinated element.

With the integration of the FMEA tool into SAP ERP, it is possible to connect the FMEA with related functions and objects, for example, with catalogs of failure characteristics or inspection characteristics. Furthermore, you can directly connect the FMEA with a con-trol plan. You can archive FMEAs that are no longer in active use.

In addition to FMEA, there are func-tions for managing a control plan to

ensure a closed-loop inspection plan-ning that is required as an international standard according to ISO/TS16949.

A control plan is the description of the entire technical or functional system that is being monitored or checked for possible risks and defects. Fundamen-tally, the control plan describes all the actions that need to be performed in each phase of the process. This includes the inspection of the goods receipt, the goods shipment, and the scheduled inspections and quality con-trol activities that make sure all process results are controlled and documented (see Figure 9).

Within the closed-loop inspection plan-ning, you usually start an FMEA for a

product to evaluate product- and process-related characteristics with a high failure risk. These characteristics are transferred into the control plan. The control plan includes an overview of all inspections that are relevant for a particular product and all its compo-nents. This is the basis for developing inspection plans and inspection opera-tions in the subsequent production process.

Once a product is part of serialized or mass production, it is still necessary to check the previously defined risks as well as the control plan itself. In the course of the continuous improvement process, it may be necessary to adjust the FMEA or the control plan.

Figure 8: Example of FMEA with Structure


Integrated Inspection Planning

With integrated inspection planning, you can create and process different task-list types to adapt quality inspec-tions to suit the respective business processes: • Inspection plan for inspections during

goods movements • Routing for inspections during pro-

duction in discrete manufacturing • Rate routing for inspections during

production (repetitive manufacturing) • Master recipe for inspections in the

process industry • Material specification for simplified

inspection planning Task lists that differ only slightly in terms of content can be grouped together in task-list groups. The infor-mation that can differ within a task-list group may consist of task-list usage, vendor assignment, or validity of certain lot-size intervals.

Task List StructureAs shown in Figure 10, a task list con-sists of the task-list header, operation, characteristic, and test equipment.

Task-list header You define the following information in the task-list header: • Material task-list assignments Assignment of a task list to materials.

For example, you can assign several materials to a task list. There can be several task lists for one material. You can also assign inspection plans to a vendor or customer, in addition to the material.

Figure 9: Example of Control Plan

Figure 10: Task List Structure

Inspection Plan 1 Inspection Plan 1Material 1

Vendor 1

Task List Group

Characteristic 1

Inspection Plan 2

Inspection Plan 3

Inspection Plan 4

Inspection Plan 5

Inspection Plan 6

Inspection Plan 7

Material 2

Vendor 2

Customer 1Customer 2

Task List Header

Operation 1

Operation 2

Operation 3

Characteristic 2

Method 1Operation 4


• Administrative data This type of data can include the

validity date, change status, responsible planner group, task-list usage, and processing status.

• Control data This type of data can include the

dynamic modification rule for adapting the inspection scope.

Operation You can maintain the following informa-tion for each inspection operation: • A description of the operation and

control parameters for the operation • Reference to a work center • Specifications for scheduling and

calculating the appraisal costs • List of relevant test equipment,

documents, and production resource tools

Characteristic In the inspection characteristic, you can: • Specify the characteristic description

and define the control parameters for results recording

• Reference an inspection method, sampling procedure, or a dynamic modification rule

• Define qualitative or quantitative specifications for the inspection and results recording, depending on the characteristic type

• Define individual specifications for every task-list assignment to a material, vendor, or customer. This means you do not have to create redundant inspection plans to modify customer- or material-dependent target values and tolerances.

• Define multiple specifications for additional objects (such as country) to determine the suitability of a prod-uct or batch (for example, suitable for specific countries and not suitable for a list of others)

• Specify with which equipment the characteristic values must be measured

Basic Data for Inspection Planning

Basic data consists of reusable building blocks for inspection planning (see Figure 11). To simplify your work as an inspection planner, you should plan and include this data in your task lists.

Inspection Characteristic An inspection characteristic describes what should be inspected. You can cre-ate an inspection characteristic directly in a task list or predefine it as an

inspection characteristic master record (master inspection characteristic). Mas-ter inspection characteristics can be: • Referenced in several task lists or

material specifications • Linked to characteristics with the

classification function, for example, to transfer inspection results for a batch to the batch classification

Inspection Method An inspection method describes how a characteristic is to be inspected. You can assign documents that are stored in a document management system (such as drawings and descrip-tions) to an inspection method. Inspec-tion methods are assigned to master inspection characteristics or inspection characteristics in task lists. You can assign several inspection methods to a master inspection characteristic.

Figure 11: Inspection Plan Structure and the Use of Master Data in Inspection Plans

Task List Header

Material

InspectionOperation

TestEquipment

InspectionCharacteristic

• Dynamic modification rule• Sample-drawing procedure

• Reference operation set• Work center

• Material• Equipment• Other production resources and tools• Document

• Master inspection characteristic• Inspection method• Sampling procedure• Dynamic modification rule• Catalog


Catalog A catalog is a summary of codes for content-related terms. Catalogs make it easy to uniformly describe qualitative data (for example, attributes for qualita-tive characteristics, defect types, or usage decisions). For each catalog, you can: • Define code groups with codes and

enter explanatory texts in different languages

• Select codes from one or more code groups and combine them in a select-ed set. This allows you to create a value list that applies to a specific situation.

Sampling Procedure and Sampling SchemeThe sampling procedure specifies how the sample size is calculated and how the inspection characteristic is valuated (attributive, variable, or manual). You assign sampling procedures in the material master or in the task list at characteristic level.

QM with SAP ERP supports all com-mon sampling types (for example, 100% inspection, sample based on percentage, fixed sample, and sample in accordance with a sampling scheme). If the sampling types and val-uation rules provided with the standard software are not sufficient, you can supplement them with your own self-defined function modules.

You can plan independent and depen-dent multiple samples and record the inspection results from several samples for an inspection characteristic. Each of these samples may contain several values, and each is valuated individual-ly. On the basis of the individual sample results, SAP ERP automatically deter-mines the characteristic result (for example, based on the worst-case principle).

Ready-to-use sampling schemes in accordance with ISO 2859-1 for quali-tative inspections and ISO 3951 for quantitative inspections are delivered with SAP ERP and any upgrades. You can also create your own acceptable quality level (AQL) sampling schemes and define rules for automatic stage changes up to an inspection skip. You can also implement industry-specific procedures.

Dynamic Modification Rule In a dynamic modification rule, you define the number of inspections and skip stages, and the rules that control such stage changes, either in accor-dance with appropriate standards such as ISO 2859-3 or to suit your own requirements. The sample size may vary between a 100% inspection and a skip. When you use a sampling scheme, the software switches between a normal, reduced, and tight-ened inspection, depending on the quality level.

The inspection stage is then changed depending on the inspection results for inspection lots or characteristics. You can control the dynamic modification of the inspection stages either by accept-

ing or rejecting the inspection lot or inspection characteristics. You can also assign a dynamic modification rule to the inspection type in the material master (inspection-type level) or at the header or characteristic level in the task list.

Test Equipment Test equipment consists of fittings, objects, documents, or materials that are needed for a quality inspection. Test equipment can be fixed parts of a work center or consist of moveable equipment. In the inspection plan, you can represent test equipment using various master records, such as production resource or tools (PRT), material, equipment, or documents.

The PRT master record contains administrative data and information relating to status, location, and a possible PRT group assignment. If you use the classification function, you can define additional properties. In addition, you can reference document master records from the PRT master record or use document master records as test equipment in task lists. You can access drawings and other documents using the document man-agement interfaces to computer-aided design (CAD) systems or to SAP ArchiveLink.

Work Center The work center specifies where an operation is to be performed and who should process it. The available personnel and machine capacities are also managed by the work center. You provide the basis for capacity planning and scheduling of operations when you


• Display documents defined in a docu-ment management system in your own work area (for example, techni-cal drawings)

Product Structure Browser Using the product structure browser, you can hierarchically display related objects in a product structure. During inspection planning, for example, you can determine whether task lists or material specifications exist for a cer-tain material. If you expand the product structure further, additional detailed

• Generate work lists for processing data within task lists (for example, by selecting task lists that use a certain dynamic modification rule or sampling procedure)

• Process individual operations from different task lists in one work step

• Simultaneously process complex task lists by selectively blocking objects (at task-list header or opera-tion level)

• Create where-used lists (for example, for PRT, dynamic modification rules, sampling procedures, sample-drawing procedures, and selected sets)

specify in task lists the work centers in which the operations are to be performed.

Each work center is assigned to a cost center. The activities in a work center are valuated using rates that are deter-mined by cost centers and activity types (for example, working time or quantity). In a single step, you can record both inspection results and the activities performed. You can also gen-erate work lists for specific work cen-ters when you record results or make a usage decision.

Reference Operation Set In a reference operation set, you define frequently required inspection opera-tions and corresponding inspection characteristics. A reference operation set can be used as a part of inspection plans or routings, or as a template.

Planning Tools

The following sections discuss various planning tools provided by QM with SAP ERP. Such tools include the engi-neering workbench, product structure browser, and where-used lists.

Engineering Workbench The engineering workbench, shown in Figure 12, is an efficient tool that you can use to process several task lists simultaneously (routings, reference operation sets, and inspection plans). The data you require can be read from different task lists and restructured. You can perform a variety of tasks using the engineering workbench, including the following:

Figure 12: Inspection Planning with the Engineering Workbench

Processing area• Change number• Key date

Validity area• Key date• Time frame

Context blockOperations overview

Structuraldisplay

Detail screens Integration intodocumentmanagement


You can execute the process steps in a stability study using follow-up functions in the quality notification’s action box. You can easily enhance or modify individual follow-up functions without making any software modifications. Approximately 20 follow-up functions are currently available for process steps in a stability study.

Stability StudiesSAP ERP provides a comprehensive planning tool for stability studies or shelf-life tests.

The special quality notification type ”stability study” is the central business object that represents a stability study in the application. All of the following objects created in the course of a study are assigned to the quality notification:• Initial sample• Stability bill of material (BOM)• Various documents• Inspection lot for initial test• Physical samples (stability samples

for storage conditions)• Testing schedule for storage condi-

tions with corresponding inspection plans

• Inspection lots for stability tests

You can assign other objects that are defined as business objects in SAP applications to the stability study. Using the document flow function for quality notifications, you can graphically dis-play all objects assigned to a study and their relationship to one another.

Based on this setup, you can trigger various process steps that need to be executed in the course of a stability study, including the following:• Creating and confirming the initial

sample• Assigning and processing the stabili-

ty BOM• Defining storage conditions• Creating and maintaining the testing

schedule• Starting the initial test

information can be displayed (such as inspection characteristics and documents).

Where-Used Lists A where-used list shows you the task lists in which master inspection charac-teristics, inspection methods, and sam-pling procedures are used.

Mass Data Changes With the function for mass data chang-es, you can adapt objects from the where-used list (master inspection characteristics, inspection methods, or sampling procedures) to suit new con-ditions. You can also use this function to create and change inspection setup data in the material master.

Engineering Change Management QM with SAP ERP maintains separate engineering change statuses for each structural element in a task list. When you make a change using a change number, you can determine what was contained in a plan at a specific date and the date on which a change is to become effective.

Cross-System Transfer of Master Data Using proprietary SAP technology for application link enabling, you can trans-fer specific basic data (for example, inspection setups, inspection methods, inspection characteristics, and catalog or code groups) from a source system to one or more target systems. This means that it is quick and easy to trans fer basic data used in one plant to another plant.

Benefits:• Integrated inspection planning• Lighter workload as a result of modular, reusable basic data• Efficient management of inspection data using mass processing tools• Parallel task-list processing using the engineering workbench• Time and money savings with cross- system data transfer by means of application link enabling


There are different variants for inspec-tion lot processing. In QM with SAP ERP, these are defined as inspection types (for example, goods receipt inspection and inspection during pro-duction). The variants include:• Inspection with or without a task list

or material specification • Recording of inspection characteris-

tic results and defect data • Manual or automatic specification

assignment, sample determination, and usage decisions

• Control of inspection stock posting

As a quality inspector, you are respon-sible for proving that a material meets predefined quality requirements. With QM with SAP ERP, you can show that these requirements have been met. Inspections can be triggered for inspec-tion points during production, for physi-cal samples in the process industry, or automatically for goods movements.

Planned inspections in QM with SAP ERP can be used to document quality using quantitative and qualitative inspection results. In addition, you can also create a record of unplanned events in the form of defect data or quality notifications.

For all quality inspection tasks, SAP ERP and SAP NetWeaver provide you with the tools you require for the role of quality inspector, as well as the oppor-tunity to customize the settings:• With SAP NetWeaver Portal you

have a role-based portal with work centers that are tailored specifically to the needs of the quality inspector for results and defects recording, notification creation and processing, confirmation processing for produc-tion orders, and execution of quality reports.

• With QM functions in SAP ERP you have support for all the required steps for recording and documenting quality-related data as well as tools for integrated processing and evalua-tion of the data.

• With support for collaborative busi-ness, your internal and external busi-ness partners can record inspection results on an intranet or the Internet.

QUALITY INSPECTIONS: ACHIEVING RELIABLE RESULTS

Inspection Lot Processing

Supported by quality planning specifi-cations, inspections supply important data for quality control purposes (see Figure 13). The inspection lot is the central element for the quality inspec-tion in QM with SAP ERP. It contains all information related to the quality inspection, such as inspection specifi-cations, inspection results, and usage decisions.

Figure 13: Stages in Inspection Lot Processing

Create inspection lot

Inspection Lot Creation

Select inspection specifications

Determine samples

Print shop papers

Confirm activities

Complete inspection

Record defect data

Request characteristic inspection results

Perform follow-up actions

Update QM information system

Update quality level

Determine quality score

Make usage decision

Inspection

Inspection Lot Completion


Direct transfer of inspection results is possible if you link electronic test equipment to SAP ERP. You can also record inspection results for serial numbers and batches, and you can transfer the inspection results recorded in SAP ERP to batch classification.

Flexible specificationsFlexible specifications are used to influ-ence the specification data on creation of an inspection lot or during results recording. Flexible inspection specifica-tions allow you to select or deselect the relevant inspection characteristics and adjust the given specifications as needed. As a standard setting in the SAP ERP application, the process is active for inspection lots related to a stability study. However, it can also be of interest for other business sce-narios, where inspections cannot be planned completely in advance, such as the following:• Inspection performed as a service • Inspection of a complaint• Inspection for a stability study

Examples of shop papers and their con-tent include the following: • Sample-drawing instructions contain

the information required for the physical-sample drawing and for distributing samples to work centers or laboratories.

• Physical-sample labels are used to label samples.

• Inspection instructions list informa-tion about the test equipment and inspection characteristics for each inspection operation and specify the inspection methods, specifications, and sample size for each inspection characteristic. Quality inspectors can record inspection results on the inspection instructions, if the layout is suitable.

InspectionDuring an inspection, you can: • Record, valuate, and close inspection

results for characteristics • Record defect data and quality

notifications• Confirm activities

Inspection Lot Creation QM with SAP ERP generally creates inspection lots automatically (see Figure 14), but you can also create lots manually. Inspection lots may be created as a result of the following: • Goods movements (for example,

goods receipt, goods issue, stock transfer, and returns from a customer)

• Deadline monitoring for batches (recurring inspection)

• Release of production orders, pro-cess orders, maintenance orders, service orders, and production versions

• Delivery creation in shipping

For inspections with an inspection plan, SAP ERP selects the corresponding inspection specifications (for example, the inspection plan or material specifi-cation). If a customer has specific prod-uct requirements, these can be copied from variant configuration or batch determination to the inspection. Shop papers are printed, and inspection results are recorded on the basis of the inspection specifications.

Figure 14: Inspection Lot Creation

Creatinginspection lot

Determiningthe inspectionspecifications

Determiningthe sample

Printing shop papers


Authorization for the usage decision The usage decision has significant consequences. Using material-specific authorizations and digital signatures, you can ensure that only authorized users can make the usage decision.

Quality Inspection EngineWith the quality inspection engine, you can integrate quality inspections in various SAP applications in the SAP Business Suite, as well as in non-SAP applications. The quality inspection engine supplements the comprehen-sive quality management software sup-plied by SAP ERP and was designed for use in a heterogeneous system landscape. The services-oriented quality inspection engine supports new processes, such as the execution of inspections using decentralized warehouse management in SAP SCM.

In general, the quality inspection engine is used by non-QM applications to per-form inspections. For example, quality inspections can be performed in the SAP Extended Warehouse Manage-ment application using functions in the quality inspection engine. Inspection data can then be forwarded to an application that provides enhanced functions for quality inspections, such as SAP ERP or a non-SAP QM applica-tion or laboratory information manage-ment system running on either an internal or external system.

the usage decision (for example, post-ing to unrestricted-use stock or return to vendor).

Quality score If the usage decision has been made, SAP ERP determines the quality score for the inspection lot using a procedure defined in the inspection setup for the material master record. It then updates the vendor evaluation.

Quality level The quality level is updated, and based on the level, the inspection stages for the next inspection are determined.

Follow-up actionsThe usage decision can trigger a chain of automatic follow-up actions, such as sending a message to purchasing if an inspection lot is rejected. In addition, the statistical data for the inspection lot is updated in the QM information system. SAP ERP logs all user actions using the name, date, and time. This means that you have the ability to track all actions. You can also create an electronic batch record for materials that are managed in batches.

In all cases, an inspection plan or rout-ing with inspection characteristics is the basis of a maximum plan, and dur-ing a flexible specification the relevant characteristics are selected.

Note that the activation for additional processes, in addition to the stability study, is done via implementation of corresponding business add-ins or customer enhancements.

Inspection Lot Completion After results recording is completed or the inspection is canceled, you make the usage decision for the inspection lot (see Figure 15). An automatic usage decision can be made if no inspection characteristics have been rejected and no defects are recorded. If a material requires documentation, you must enter a comment for the usage deci-sion if the inspection is canceled or the usage decision differs from the valuation for the inspection results.

Stock posting If materials are posted to inspection stock using an inspection lot, they can be posted from this stock only using

Figure 15: Inspection Lot Completion

Making the usage decision

Determiningthe quality score

Updating the quality level

Performing follow-up actions


• Classed values – number of results within value classes

• Single values – such as several mea-sured values (In addition to single val-ues, you can note the serial numbers of the items to be inspected.)

Additional functions Within results recording, you can also: • Define unplanned characteristics • Process conditional characteristics.

This deals with planned characteris-tics that must be inspected only if a corresponding controlling characteris-tic has either been accepted or rejected.

• Record inspection results for charac-teristics that are in a skip stage

• Calculate results using calculated characteristics. For calculated char-acteristics, you calculate results using the results for other characteristics.

SamplesIf the sampling procedure specifies independent multiple samples, you can record results for more than one sam-ple for each inspection characteristic. The number of samples may then be greater than the number specified in the sampling procedure.

In an attributive inspection, you can also plan dependent double and multi-ple samples. If the result for the current sample lies between the acceptance and rejection numbers, the sample size is increased according to the sampling scheme. Once you have recorded the results for this new sample, the sample is evaluated again using the updated valuation parameters.

Characteristic Results You record and valuate characteristic results according to inspection specifications.

Characteristic types You can record inspection results for the following types of characteristics: • Qualitative characteristics Nonnumerical characteristic values

or variables stemming from these values

• Quantitative characteristics Measured values or variables stem-

ming from these values

Recording forms Depending on the detail you require, you can choose from the following recording forms for a characteristic: • Summarized values – such as the

mean value and standard deviation of several measured values or an individual measured value

Inspection Results

There are two types of inspection results in QM with SAP ERP (see Figure 16):• Results for the planned inspection

of inspection characteristics (charac-teristic inspection results)

• Unplanned defects defined during the inspection (defect data)

Characteristic inspection results are generally recorded for each operation. For this, inspection specifications must be assigned to the inspection lot, and sample calculation must be completed. You can record both characteristic inspection results and defect data for an inspection lot with a task list. If characteristics are rejected, defect data records can be created automati-cally. Also, you can record defects in an inspection without inspection specifications.

Figure 16: Types of Inspection Results

Unplanned

Defect Data

Recording Inspection Results

Active Quality Notification

Planned

Defect Data• Defect Type• Defect Location• Cause

Characteristic Results

Quality Control

QualitativeCharacteristic

QuantitativeCharacteristic


Process-Optimized Results Recording Work lists Personalized work lists provide you with a flexible selection of inspection lots. Examples of work lists include:• Results recording for samples during

laboratory inspections • Results recording for equipment or

functional locations during calibration inspections

Tabular results recording You can record inspection results in tabular form as follows: • Processing characteristics for sev-

eral inspection lots You record results for inspection

characteristics that occur in several inspection lots. In the recording table, the inspection lots selected in the work list are displayed in columns; the characteristics are displayed in rows.

• Processing several inspection points in an operation

You record results for several inspec-tion points in an operation. In the recording table, the inspection char-acteristics are displayed in columns; the corresponding inspection points are displayed in rows.

• Processing master inspection char-acteristics for all inspection lots

You record the results for a specific master inspection characteristic for all inspection lots. In the recording table, the inspection lots are dis-played in rows for the master inspec-tion characteristic that has been selected.

• Time-dependent (for example, one inspection every hour)

• Quantity-related (for example, an inspection after 100 units have been produced)

• Freely defined (for example, one inspection per shift)

Distribution functions After results recording, the software determines the fraction of nonconform-ing units for all inspection characteris-tics and uses this information to esti-mate the fraction of nonconforming units in the inspection lot. The most common mathematical distribution methods are supplied (normal, binomi-al, and Poisson distribution).

Statistics You can display the following graphics in results recording: • Histogram illustrates the frequency

distribution of the sample results in the form of a bar chart. In this chart, you can identify typical and extreme values for a sample, as well as the location, dispersion range, and form of the distribution.

• Run chart displays the run of mea-sured values for a characteristic over a period of time as a line chart. You can identify the dispersion and sys-tematic location changes. You can also display trends.

• Control chart shows the time run of characteristic values in the produc-tion process with warning and action limits.

Valuation You can confirm the characteristic inspection results recorded in different inspection operations. During results recording, an inspection characteristic undergoes a series of status changes. The authorization management function controls who has the authorization to record, valuate, or close results. To fulfill special security requirements for example, GMP, a digital signature may be required.

You can use the following valuation modes to accept or reject an inspec-tion result: • Manual valuation • Attributive inspection based on the

number of nonconforming units or defects

• Decision based on the attribute codes of qualitative characteristics

• Decision based on the tolerance range of quantitative characteristics

• Variable inspection with single-sided or double-sided tolerance limits

• Valuation based on the action limits of a control chart

Characteristics with independent, multi-ple samples are valuated at the sample level. For example, you might valuate such samples based on the worst-case principle, last-case principle, or best-case principle. You may also valuate inspection points.

Inspection points You can use inspection points to perform several inspections on one characteristic. You can define various inspection points in SAP ERP, including:


Dual Control PrincipleThe idea behind the dual control princi-ple is that the processing of an inspec-tion result should not – or even must not – be made by only one person. For example, the required process involves one employee who enters the results for characteristics and a different employee who validates and completes the characteristics. This means that the results need to be checked by at least two different people. The dual control principle can reduce the risk of failures or misuse and help you to comply with regulations.

You can activate this function via imple-mentation of a related business add-in that offers the following functions:• Entry and analysis of results of an

inspection characteristic by two different users

• Possibility to force the completion of a characteristic

SAP offers a sample implementation of this function that you can use as delivered; or you can copy and modify it to meet your needs.

Web-Based Approach to Quality ControlThe Internet provides you with several possibilities for results recording. An example of this is recording results for source inspections. You provide your vendor with access to a specific Internet or intranet page, which requires special authorizations. The vendor records inspection results directly on the Web and saves the data. As a result, this QM data can be processed further by your SAP ERP application.

• Increases transparency and accuracy of inspection data

• Avoids manual errors through auto-matic data transfer

• Guarantees tracking of copied data (application log)

Input ProcessingDuring results recording, a function for converting an entered value based on a given procedure can be activated via a business add-in. Input processing must be planned in the master inspection characteristic or in the inspection plan.

The input value can be processed, for example, as follows:• Output of a value calculated by per-

forming a formula conversion on the original entry

• Output same as input• Output of the significant rounded val-

ue instead of the original entry• Output of the verification and deter-

mination limit instead of the original entry

The value that was entered originally (including the decimal places entered) is also saved (original value).

Operation CompletionYou can complete the operations in an inspection lot individually and according to requirements. This allows you to document the exact inspection process for an inspection lot. After an operation has been updated, follow-up actions can be triggered automatically, depend-ing on your application settings. The function can be activated via customizing.

Results CopyThe “copy inspection results” function:• Copies inspection results from a

source inspection lot into a target inspection lot

• Is highly flexible and can be tailored to your needs

• Supports several business processes

• Is a requirement from various industries

This function is applicable for the trans-fer of results from precursors along the production chain (parent-child relation-ships) and for all types of recurring inspections, including the following:• Periodic retests of batches Only some characteristics need to be

reinspected, but all values from the initial inspection should be visible in every inspection lot.

• Calibration inspections During inspections of equipment or

functional locations, some values of the previous inspection lot should be taken as the new starting point.

• Stability studies Some results from the initial test

should always be available when scheduled inspections are carried out.

• Inspections during production Results of previous inspection points

should be selected and copied to the next inspection point.

The function for copying inspection results supports you in your inspection process in the following ways:• Saves time during inspection

processing• Is applicable for a wide range of

processes


tronic caliper gauges, bar-code read-ers, or laboratory balances, using a keyboard wedge. Various interface box-es are available on the market, which differ in the number and type of test equipment that can be connected.

PC interface You can transfer inspection results from a measuring device into the rele-vant results fields in SAP ERP using file transfer. You can trigger the results transfer from external systems and also from within the results recording func-tion in SAP ERP using driver programs. SAP provides examples for the driver programs.

Inspection data interfaceThe QM inspection data interface (QM-IDI) supports data exchange with external quality systems, such as computer-aided quality assurance (CAQ) systems and laboratory infor-mation management systems (LIMS). You use QM-IDI to process inspections in an external system.

During inspection planning, you decide in which system an inspection opera-tion should be processed. The inspec-tion specifications are transferred to the external system during inspection lot creation in SAP ERP. After results are recorded in the external system, the inspection results or usage deci-sions are confirmed in SAP ERP. You can protect your IT investment by requiring that the external system is certified for the interface.

Statistical interfaceThe QM statistical interface (QM-STI) links QM functionality with SAP ERP

possible to trigger alerting immediately when problems or exceptions are iden-tified. In addition, the role supports the quality inspector in using graphic tools to monitor and measure the most important quality key figures.

Connecting Measuring Devices or External SystemsQM with SAP ERP offers interfaces to connect to external systems for special tasks within quality inspection.

Keyboard interface Keyboard interfaces convert the mea-sured values into keyboard entries. You can link test equipment, such as elec-

In addition, SAP offers a role-based portal (see Figure 17) with work centers that are tailored specifically to the needs of the quality inspector. It supports a quality inspector’s most important tasks:• Results recording• Defects recording• Notification creation and processing• Confirmation for production orders• Quality reports

Personalized work lists serve as trig-gers for the efficient completion of tasks. The role provides quick access to all pertinent quality data and a simpli-fied user interface. Furthermore, it is

Figure 17: Example for Portal Work Center for a Quality Inspector


• Processing status of the physical sample

When the inspection planner defines a sample-drawing procedure and assigns it to the inspection plan, routing, or master recipe, physical-sample records are created automatically for the inspection lot. You define the following information in the sample-drawing procedure: • Type and number of samples

– Primary samples (one-stage physical-sample drawing)

– Primary and pooled samples (two-stage physical-sample drawing)

– Reserve samples (to be stored for subsequent inspections)

• Whether the application should calcu-late physical samples on the basis of the lot container type or the lot quantity

• Whether the drawing of the physical samples needs to be confirmed separately

Processing Physical Samples Figure 18 depicts the types of planning and processing for physical samples.

Sample-drawing instruction For a planned physical-sample drawing, the application can print a sample-drawing instruction at inspection lot creation. This instruction contains infor-mation from the inspection plan and physical-sample drawing procedure about drawing, processing, and distrib-uting samples at work centers or laboratories.

Physical-sample drawing When the application creates the physical-sample records for the

specifications. If an inspection plan is available, the defect data records can be assigned to an inspection character-istic contained in the plan. QM with SAP ERP then suggests the type of defects recording that is suitable for the material, work center, or user.

You can describe qualitative defect data with the help of cataloged termi-nology (for example, defect type, defect location, or defect cause) and additional text.

A defect data record can be converted into a quality notification. As a result, the whole range of functions in notifica-tions can be used (for example, the link to workflow).

Sample Management

When sample management is active in QM with SAP ERP, you can use the application to manage samples. To help you manage samples effectively, a unique physical-sample record is created for each physical sample. The physical-sample record contains the following information for the sample: • Physical-sample number • Physical-sample type, such as sam-

ple from goods receipt, production, or customer complaint

• Physical-sample category, such as primary sample, pooled sample, or reserve sample

• Information for the physical-sample drawing with data on the sample origin, such as material, batch, material document, and order

• Detailed information about the physi-cal sample, such as the inspection lot or storage information

to external evaluation systems. As a result, you can perform evaluations that are not supported by the statistical functions in SAP ERP for results recording (control charts, histograms, and process capability indexes). You can use a format defined by SAP to transfer recorded inspection results from the quality management function in SAP ERP to the external evaluation system.

You can use QM-STI for manual statis-tical analysis of inspection results from SAP ERP, or you can specify an auto-matic start of predefined statistical analyses.

SAP Manufacturing Integration and IntelligenceThe SAP Manufacturing Integration and Intelligence application supports inte-gration of manufacturing systems with SAP ERP. It enables you to integrate directly and provides functions for Web-based user interfaces for access-ing QM data in SAP ERP. For details, see the section “SAP Manufacturing Integration and Intelligence for Quality Analytics.”

Defect Data Defects recording provides information to control quality and optimize process-es. It enables Pareto analyses of defect types and causes according to their weighting or how frequently they occur. It provides empirical values for risk indi-cators in FMEA.

You record defects with reference to an inspection lot, inspection operation, or inspection characteristic. To record defects, you do not need inspection


• Supplement an existing physical-sample drawing by creating additional physical samples

• Create a new physical-sample drawing manually, with reference to an existing inspection lot, production order, process order, or production version

You must create inspection lots manu-ally to be able to record inspection results for unplanned physical samples. You can use this function to perform the following tasks: • Check the stability of reserve

samples • Inspect samples from competitors • Inspect samples from a customer

complaint

Sample check The physical samples are displayed automatically in a work list for results recording. You can process these samples immediately, provided that they have the appropriate status. Valuation Once you have performed all inspec-tion operations and have recorded the inspection results, the physical sam-ples must be valuated on the basis of the operations (that is, accepted or rejected). When all physical samples in the inspection lot are valuated, you make the usage decision for the lot.

Unplanned SamplesIt is possible to manage unplanned samples using QM with SAP ERP. You can perform the following tasks: • Create the physical samples manually

without reference to an existing physical-sample drawing or inspec-tion lot

inspection lot, it assigns a unique phys-ical-sample drawing number. This num-ber helps you identify the physical sam-ples that were drawn from the lot. You can also identify how many pooled and reserve samples were formed. The following functions are available for the physical-sample drawing: • Confirmation of the physical-sample

drawing and release of the samples You can control whether or not the

physical-sample drawing must be confirmed. A confirmation would result in the release of all samples associated with the relevant physical-sample drawing. A digital signature may be required to make the confir-mation. This digital signature ensures that only people with the relevant authorization can confirm a physical-sample drawing.

• Label printing You can trigger label printing for

physical samples. The labels can be printed with bar codes.

Figure 18: Types of Planning and Processing for Physical Samples

Creation

Planned Physical Samples

Unplanned Physical Samples

Manual Inspection Lots

• Automatic creation of physical samples at inspection lot creation

• Manual creation of physical samples• Manual creation of physical-sample

drawing with reference to an inspection lot

• Manual creation of inspection lots for existing physical samples

Benefits:• Integrates in the process of the product life cycle and the supply chain• Provides real-time data, transparent for employees, com - pliant with legal requirements


logo. You define required content in the certificate profile. Due to the flexible interaction of the certificate profile and form, you can meet multiple require-ments using just a few forms.

You specify the data origin for each characteristic in the certificate profile. For each characteristic, you can include texts (such as inspection methods) and values (specification values and inspec-tion results) in the certificate.

SAP ERP selects data from inspection lots, batch specifications, or character-istic master records. Texts for charac-teristics can also be obtained directly from the certificate profile. Only those inspection lots that meet specific selec-tion criteria that have been defined in the certificate profile are considered for data formatting.

Consequently, inspection lots that have, for example, reached a pre-defined quality score can be selected. If there is no inspection result for a characteristic due to a skip, SAP ERP searches for other data sources using

Certificate Processing in Sales and Distribution

Your company produces high-quality products. As quality manager, it is your responsibility to provide evidence of the quality of your goods for your cus-tomers. Whether you require certifi-cates of analysis for the chemical or pharmaceutical industry, or certificates of conformity, test certificates, works-test certificates, or inspection certifi-cates for material inspection laborato-ries in the steel industry – the quality certificate fulfills all of your requirements.

In addition to the usual output forms for certificates (printer or fax), you can make certificates available to your customers on the Internet, or you can transfer certificate data electronically for further processing.

Flexible Certificate Planning You define the layout and content of a certificate in certificate planning. The form determines the layout of the docu-ment – that is, the appearance and

QUALITY CERTIFICATES: GUARANTEED RELIABILITY – PRINTED OR ON THE INTERNET

predefined strategies. You can enhance the data procurement functions and replacement strategies available in SAP ERP by programming function modules.

The form master record allows you to tailor your certificates to your compa-ny’s needs. To simplify this process, SAP ERP provides examples based on SAPscript forms, a proprietary tool for text management and form printing, and Adobe forms (PDF-based print form).

In addition to printing characteristics that are directly linked to the product requiring the certificate, you can also define which characteristic data (from raw materials and semifinished prod-ucts used when creating the finished product) are printed on the certificate (see Figure 19).

At this point, you can refer to inspec-tions or batch classifications. SAP ERP selects batches for data formatting that are linked to one another by production orders, process orders, or production versions. The characteristic values for

Figure 19: Example of a Quality Certificate for a Finished Product with Characteristic Values from Raw Materials and Semifinished Products

Product:Batch:Char:Char:

RAW01R1-1R10R11


RAW02R2-2R10R11

Product:Batch:

SEMI01S1-1

Product:Batch:Char:

SEMI02R2-1S20


SEMI3-1S3-1S31S32

Product:Batch:Char:

RAW03R3-1R30


SEMI04S4-1S41S42


FIN01F1-1F10R11


R10S20S41F10


their output. You can create a print pre-view to check the contents of the cer-tificate before it is finally issued. In addition, the processing status of deliv-ery item data is maintained consistently so that you can always tell if a certifi-cate was created properly.

SAP ERP finds the correct certificate profile, recipient, and shipping terms with the help of the flexible condition technique. The software can search for the address of the certificate recipient by using, for example, the sold-to party, the ship-to party, delivery type, or ship-ping point. Then it decides whether the certificate is to be issued in printed form, by fax, or electronically. Next, it searches for the corresponding profile for the material group, material, cus-tomer, or a combination. All the infor-mation required for these searches is contained in data for the delivery.

As the final step, SAP ERP determines the contents of the certificate based on the requirements in the certificate pro-file, such as characteristic values in picking batches. It structures the infor-mation according to the specified form and transfers the resulting certificate to the output medium, and, if required, the optical archive.

You can also manually trigger the cre-ation of certificates for deliveries, inspection lots, or batches, and control

these materials in the production chain can also be taken from other plants.

Apart from the characteristic data defined in the certificate profile, you can structure the certificate to contain all other information that is available at certificate creation. Such information might, for example, include data from the sales order.

Certificate Creation – Meeting Your Requirements

For single delivery items, certificates are issued automatically when goods are shipped, together with delivery notes. These certificates are then included with goods deliveries. You can create certificates at any stage of the shipment process, as long as the data required is accessible; for example, when picking is completed or goods are issued. If you want to make certifi-cates available to customers before goods delivery, you can make them accessible on the Internet or send them electronically.


been received until the usage decision is made for the incoming inspection lot. If a certificate has not been received, SAP ERP may post the stock to restricted-use stock.

You can store certificates that have been received using SAP ArchiveLink. You can also send reminders for miss-ing certificates and monitor reminder statuses. In addition, you have the abili-ty to process the receipt of certificates before the goods have actually been received. This is often the case with

Certificate Processing at Goods Receipt

As a quality inspector, you are respon-sible for monitoring the receipt of certif-icates during the procurement process. If you have marked a material as requir-ing a certificate, you must confirm that a quality certificate has been received for purchase orders or goods receipts.

You generally confirm this information at goods receipt. However, you can wait to confirm that a certificate has

Benefits:• Easy creation of certificates• Automatic warnings if a certificate is missing at goods receipt• Fewer errors by using electronic data transfer at goods receipt• Time and money savings through using individualized and fully automatic certificate creation for deliveries• System-independent access of certificates on the Internet or intranet• Multiple output formats: XML, PDF, fax, or print• Electronic transfer of quality data to your business partners

Figure 20: Quality Certificate


was created for a delivery item and is already stored using SAP ArchiveLink.

Quality Data Exchange If you want to enable a recipient to use the quality data displayed on a certifi-cate, you must send the certificate electronically (using EDI) to the target system.

If the quality certificate refers to a deliv-ery to a customer, you can automatical-ly transfer the inspection results printed on the certificate to a goods receipt inspection lot (see Figure 21). You can also manually copy the results to anoth-er inspection lot, for example, a source inspection lot.

Certificate data can be transferred to a recipient system for further processing without a link to a specific delivery. In such cases, the certificate data refers to the inspection lot or batch. You can also transfer data to your business partners that do not use SAP software.

send a certificate, like the one shown in Figure 20, via electronic data inter-change (EDI).

Certificate Access on the InternetAs the vendor, you can allow your cus-tomers to access SAP ERP over the Internet and access a quality certificate for their purchased goods. Depending on their needs, it is possible for cus-tomers to access a certificate that is created when accessed or one that

certificates that are sent electronically. If you receive an electronic certificate with reference to a delivery, you can copy the quality data from the certifi-cate for further processing.

Collaborative Business: Certificate Data for the Whole Company

You can make certificates available to your employees and business partners over the Internet. In addition, you can

Figure 21: Quality Data Exchange

Vendor

Optical Archive

SAP® ERP

CertificateCreation

IDOC*Reference Data

Quality Data

Certificate (PDF)

EDI**

XML

Other

IDOCReference Data

Quality Data

Certificate (PDF)

Reference Data

Certificate Record

Certificate (PDF)

Customer

* IDOC = intermediate document** EDI = electronic data interchange


quality notifications, you can deal with both simple problems and problems related to complex processes in the logistics supply chain (for example, complaints processing for deliveries or processing of returns), as shown in Figure 22.

Notification Types The subjects defined in quality notifica-tions generally refer to exceptions in everyday business processes. If you create a notification, you use the notifi-cation type to define the subject from a business viewpoint. The notification type determines the process flow.

SAP ERP contains the following quality notification types (see Figure 23): • Customer complaint • Complaint against the vendor • Internal problem notification

Requests or problems that cannot, at first, be assigned at a business level

implement corrective tasks for quality improvement using the quality notification.

In addition to the quality notification, the following notifications are available to you: • General notification for general

requests or subjects (without a busi-ness assignment)

• Maintenance notification for record-ing and processing problem notifica-tions for technical objects

• Service notification for processing service activities

• Feedback notification for requests or problems related to SAP ERP

• Claim for documenting deviations from a project plan (for example, schedule deviation or cost variance)

Using Quality Notifications

Notifications are an efficient tool for processing exception situations. Using

Improved Quality Through Targeted Problem Handling

To optimize business processes in your company, you must respond to requests and problems quickly and effi-ciently. As the notification processor, you coordinate the processing of incoming requests or problem notifi-cations and propose suitable tasks. You can ensure that all problems are assigned and solved correctly. You are involved in the analysis, cause determination, and handling of prob-lems. You are also responsible for checking the implemented tasks for their effectiveness.

Notifications in an SAP EnvironmentThe integrated notification function supports you when you create and process various issues and problems. As a special feature of QM with SAP ERP, you can record quality problems, document defects and causes, and

EFFICIENT PROBLEM MANAGEMENT

Figure 22: Notifications for Continuous Process Improvement

UnplannedEvent

Description/assignment Analysis SolutionTasks/

activities Entering costs

Internet/intranet

Notification Processing

WorkflowSolutiondatabase Action

boxStatus

management

Evaluations


flow. You can implement tasks and record costs. You can also perform defects analysis for the individual problems. You define the necessary corrective tasks and assign them to the appropriate employees.

You complete the problem notification after all tasks have been completed successfully and their costs have been calculated. The steps you perform mirror the status of the individual tasks and the complete quality notification. You can display the most significant processing steps of a notification in the action log.

Quality Notifications

You can adapt the structure and infor-mation in a quality notification to meet your requirements. In addition to the notification types supplied by SAP, you can define your own notification types. For each notification type, you can: • Select a simple or enhanced pro-

cessing view • Determine screen areas and their

content • Structure notification data using tab

pages • Include your own functions in an

action box • Configure shop papers for printing • Activate digital signature for distinct

business transactions at header or task level

problems. All notification functions are available in the enhanced view. This view is particularly useful if the employee’s responsibility extends beyond the creation of the notification.

If you are responsible for creating the notification, you must first describe the subject in text form, then name a refer-ence object, if possible (for example, a sales order or delivery), and assign an appropriate priority to the problem. QM with SAP ERP copies the linked infor-mation to the notification.

When you enter the notification, you can see immediately if, for example, notifications already exist for the same material or customer. You can immedi-ately switch to one of these notifica-tions and access information about how to solve the problem.

As the responsible notification proces-sor, you are informed about notifica-tions using work lists or through work-

are entered using the general notifica-tion. As the responsible notification processor, you assign a suitable notifi-cation type to a general notification, depending on the subject of the notifi-cation. The notification type controls all further processing.

Quality notifications can be recorded manually or automatically: • You can create a notification manually

on the Internet, intranet, or directly in SAP ERP.

• For defects recording during inspec-tion processing, a quality notification can be created automatically.

Notification Processing

If you manually enter and process gen-eral notifications, you can use simpli-fied or enhanced processing views. The simplified view is meant for employees who do not require the whole range of notification functions. This view is used to quickly record

Customers

Customercomplaint

Company

Complaint against

the vendor

Vendors

Internalproblems

Figure 23: Quality Notification Types


fy usage and control problem process-ing with regard to procedures. The action box includes typical tasks and activities for processing notifications. These tasks or activities are known as follow-up functions and can be execut-ed with a mouse click. These follow-up functions are available: • Creating letters of complaint or

eight-discipline (8-D) reports for complaints against the vendor

• Requesting permission to deviate from specifications

• Creating a new quality notification from an existing notification

• Sending decisions by e-mail, fax, or print preview (for example, confirma-tion of receipt, interim notice, or final notice)

• Accessing the solution database • Documenting calls related to the

notification

The follow-up process is simplified through the use of colors to mark the processing statuses of follow-up func-tions and dependent follow-up func-tions. In this way, you can recognize immediately those follow-up functions that have already been processed and those that are outstanding.

Solution Database Complaints must be processed quickly and efficiently. With an integrated solu-tion database, you can quickly find solutions when processing notifica-tions. You access the solution data-base from the action box and start a free-text search in the database using the entered problem description. You can quickly determine whether similar problems have occurred in the past and which tasks were used to solve them.

Notification Item Individual problems or errors that have occurred are documented as notifica-tion items. They contain information relating to defects analysis, such as the defect type and location. You can assign various causes to a notification item. You can access user-defined catalogs to describe the defect type, location, and cause.

Tasks and Activities The tasks and activities used to correct the defects are subordinate to the noti-fication item. Tasks and activities can be assigned to the notification header, so that you can take the first steps to resolve a problem even before the analysis is available.

Optimized Usage

SAP ERP has several useful functions that optimize the use of quality notifica-tions. In addition, several tools can streamline notification processing.

Action Box You can use the action box to flexibly enhance the functions in the notifica-tion to suit your needs. You can simpli-

Elements of the Quality Notification

Figure 24 shows the layout of data in a quality notification.

Notification HeaderThe header data record contains a description of the subject matter and, depending on the notification type, assigns objects affected by the notifi-cation (for example, purchase order, material, vendor, and inspection lot, or sales order, material, and customer). The priority and processing status are documented in the notification header. You can also access other objects linked to the notification in the notifica-tion header, such as documents or QM orders used for recording costs.

Partners The partners involved in the creation or processing of a notification (for exam-ple, vendors or customers) are listed in the notification. You can also include departments and people within your company who are involved in notifica-tion processing as partners.

Figure 24: Structure of a Quality Notification

Partner Activities Tasks

Activities Tasks Causes

Quality Notification

Defect Item


line for completion and the person responsible for each task. SAP ERP manages the status of each task and allows you to complete a quality notifi-cation only when all the tasks have been processed. The structure of the quality notification differentiates between immediate and corrective tasks.

Immediate Task The purpose of an immediate task is to provide an immediate response to the problem that produced the quality notification and to prevent any further damage from occurring. These types of tasks are assigned to the quality notification header and can be imple-mented without specifying a defect or defect cause. Examples of immediate tasks include the following: • Blocking warehouse stock • Triggering an additional inspection • Sending a confirmation letter

Corrective Task The purpose of a corrective task is to eliminate the defect and its cause and to prevent it from recurring. You assign corrective tasks to an individual notification item (defect). Examples of corrective tasks include the following: • Changing a work instruction • Implementing training • Modifying a routing

Follow-Up Actions You can link tasks with automatic follow-up actions. As a result, you can, for example, initiate inspections, block supply relationships, or create a purchase order for a return delivery.

Digital SignatureBy activating the digital signature for notifications, you can request a digital signature for selected process steps when processing a notification; for example, when setting a status such as “released.” The activation can be done at the header or task level for any busi-ness transaction and notification type. Signature strategies can be applied.

Analysis of Items and Defects

Quality notifications are designed to analyze defects. There is one notifica-tion item (defect data record) for each defect that has been recorded. In this record, you can describe the defect type and location, and you can use company-specific codes to document the problem. These codes can later be evaluated. Additional input fields are available for each notification item, including fields for defective quantities and a field for a quantitative defect valuation.

Using the classification function, you can classify defects, define additional defect characteristics, specify value ranges for these characteristics, and record characteristic values. In addi-tion, you can enhance defect analysis by documenting the causes of the defects and by defining corrective tasks.

Tasks

A task is a processing step that is per-formed during notification processing. You can track the processing status of the task with a status sequence that you define. You can specify the dead-

Flexible Work Lists Work lists are available to you for pro-cessing quality notifications, defect items, tasks, and activities. In particu-lar, for notifications or tasks, you can select and process objects that you: • Created • Processed last • Are responsible for processing or

which are within your area of responsibility

• Are responsible for processing within a specific partner function

Workflow If you use SAP Business Workflow, all parties involved in notification pro-cessing are informed about their tasks. Depending on the status of notifica-tions or tasks, work items are entered in the mailbox of the responsible parties.

You can access the necessary pro-cessing functions directly from a work item. If the responsible processor is unable to complete the task within the deadline, workflow forwards the operation to a department or employee responsible for urgent outstanding tasks. This is also referred to as escalation.

Response ProfileDepending on the priority of the notifi-cation, you can define a sequence of standard tasks using a response pro-file. These tasks can then be proposed on request in the notification; they must be completed within a specified period of time.

Document Flow You can display all documents that are linked to the notification in a list or as a graphic.


fax, are stored in an optical archive. Incoming documents can be recorded with SAP ArchiveLink and assigned to a new or an existing quality notification. If processing is to start immediately, a workflow can be triggered when the incoming document is recorded. The workflow function forwards tasks to the partner responsible for processing work items using the business work-place function.

Sending faxes and e-mails When processing a notification, you can send information to an internal or external address as a fax or by e-mail.

Storage and Documentation Shop papers Although SAP ERP supports paper-free processing of quality notifications, it is sometimes useful to have printed shop papers to present the information in the form of a fax or to store in a file. QM with SAP ERP provides the following shop papers: • Notification overview • Notification items • Complaint report • Confirmation report • Interim notice • Final report • 8-D report

If required, you can create your own shop papers and structure them with the help of the SAPscript text-processing function or Adobe PDF function. You can use the examples delivered with SAP ERP as models for designing your own.

Assignment of documents Using the document management func-tion, you can assign documents, such as CAD drawings, Word documents, and HTML documents, to a notification. These documents are then available to you during notification processing.

Storage with SAP ArchiveLink Using SAP ArchiveLink, which is acces-sible in the quality notification, you can archive and manage printed or electron-ically transmitted documents. Outgoing documents, printed or transmitted by

Activities You can define activities to document that a specific action has been implemented.

Support Functions

Additional functions are available to support quality notifications. You can make notification recording available to business partners on the Internet. In addition, you can archive quality notifications using SAP ArchiveLink.

Communication Notifications on the Internet and intranet Using an Internet connection for quality notifications, you can reduce the resources and time needed for record-ing a complaint, thereby improving noti-fication processing. A customer records a problem on the Internet. QM with SAP ERP then triggers internal operations using the workflow function. The customer can display the process-ing status of the notification at any time on the Internet.

If notifications are created for general requests or problems from an employ-ee’s working environment, the Internet service request is the medium for find-ing solutions quickly and through which the following are performed: • Recording different issues• Searching for solutions using the

integrated solution database • Triggering multiple internal service

processes • Forwarding the notification to the per-

son responsible for processing using SAP Business Workflow

Benefits:• Rapid processing of unplanned events• Active participation by employees in the continuous improvement of processes• Easy communication and work processing by using the Internet or intranet – independently of the application• Time and money savings because of the optimal control of subsequent processes


• Tightening or reducing the inspection scope based on the results of a pre-vious inspection is controlled either by the valuation of the inspection lot (dynamic modification by lot) or by the valuations of the individual inspection characteristics (dynamic modification by characteristic).

When several lots of the same material are to be inspected simultaneously, there are two times when the software can dynamically modify the inspection scope:• The inspection scope is modified in

advance by assuming that all open characteristics will be accepted. If a lot is rejected unexpectedly as a result of an inspection, the inspection scope will be updated again after the usage decision has been made.

• The inspection scope is modified after the usage decision for the cur-rent inspection lot has been made.

QM with SAP ERP takes the quality level into account when determining the inspection scope and defining the inspection specifications in the inspec-tion instruction. Inspection lots are summarized in a quality level according to specific criteria. For example, inspec-tion lots in production are summarized according to material, plant, and task list, while inspection lots for goods receipt inspections are summarized according to material, vendor, manufac-turer, plant, and task list.

Figure 25 shows how master data and transaction data interact during dynam-ic modification of the inspection scope. The main features of this interaction are as follows: • Dynamic modification rules apply

uniformly for all inspection character-istics of a task list, individually for certain inspection characteristics, or generally for the inspection type that is active for the material.

Quality control involves strategic plan-ning, continuous monitoring, and rapid intervention to deal with unexpected events. SAP offers you a complete set of tools for this purpose. • The role of quality manager in SAP

NetWeaver Portal provides the basis for your quality control–related tasks, which range from strategic planning to monitoring and evaluating inspec-tions and notifications.

• iViews (portlets) provide an overview of all important key figures and evalu-ations in QM with SAP ERP. As a result, you can continuously evaluate your quality strategy and modify it on the fly if a problem arises.

• An easy-to-use data warehouse, which is included in SAP NetWeaver BI, brings related data together to give you the reliable company key figures you need.

Dynamic Modification of the Inspection Scope

Dynamic modification controls the inspection scope (based on inspection characteristics and sample sizes) for a series of inspection lots to achieve a predetermined quality goal. General technical rules, such as the sampling standards of ISO 2859-1 and ISO 3951, follow this principle. QM with SAP ERP contains a complete set of sampling tables for these standards.

To help you reach your quality goal, SAP ERP determines inspection stages for the next inspection lot after each usage decision. It uses the dynamic modification rule in the task list to determine inspection stages and then writes them to a quality-level data record.

SUSTAINED QUALITY CONTROL PLANNING, EVALUATION, AND DIRECT INTERVENTION

Figure 25: Dynamic Modification of the Inspection Scope

Master Data

Transactional DataLot levelQuality levelCharacteristic level

Inspection lot creationTask list selectionInspection scope

Sampling SchemeSampling Plans Based on Lot Size

SamplingInspection instructionQuality inspection

Characteristicinspection resultUsage decision

Inspection Plan• Header• Characteristic

Sampling Procedure• Sampling plan

Dynamic Modification Rule• Stage change

AcceptableQuality Level

InspectionStages

Assignment

Inspection Lot Processing


the share of scrap of the process. The limits of these charts are extended if a long-term reduction in the process vari-ance is achieved.

If you are using a Shewhart chart, the limits become tighter as a result of a long-term reduction in the process vari-ance. These charts only take internal process parameters into account, not external tolerance specifications. They use a continuously recurring statistical test to check that the controlled status of the process has not changed.

As an inspection planner, you deter-mine whether a quality control chart is to be maintained for a given inspection characteristic. The charts may include

You can show the mean value and standard deviation of a characteristic on one control chart with two tracks.

In addition to the control variable, each track also contains control limits. If these limits are exceeded, you have the ability to intervene in the process. For some control chart types, you can pre-define warning limits or a centerline. The limits are determined using statisti-cal methods from the current process data or from the results of an initial run. You can also enter them manually on the basis of existing data. You can use various algorithms for the calculation.

Acceptance charts are based on your predefined tolerances. They determine

On the Right Track with Statistical Process Control

Statistical process control allows you to monitor, regulate, and improve the quality of processes.

Quality Control Chart The most important tool for statistical process control is the quality control chart, a graphic tool for documenting, analyzing, and controlling processes (see Figure 26). You can use this chart in an inspection during production and during the procurement or shipping process.

You choose one or more control vari-ables for the relevant characteristic, determine their values at regular inter-vals by taking samples during the process, and enter them in the chart in chronological order.

Types of Control ChartsQM with SAP ERP provides the follow-ing types of control charts: • Mean value with tolerances (accep-

tance chart) • Mean value without tolerances

(Shewhart chart) • Standard deviation (Shewhart chart) • Range (Shewhart chart) • Moving average • Exponentially weighted moving

average • Individual moving range for sample

size n=1 • Charts for qualitative characteristics

(np-, p-, u- and c-chart)

Normal distribution is used for quantita-tive characteristics; Poisson distribution is used for qualitative characteristics.

Figure 26: Illustration of an X-Bar/S Control Chart


• You want to view a list of control charts from which you can choose individual control charts to be checked.

Violations of Western Electric Rules are displayed in a list along with the chart number, track, and sample num-ber. From this list, you can branch to the inspection results to display detailed information on the individual inspections and to view the control chart.

In the mean-value chart, you can display the process capability indexes Cp and Cpk in a second window (see Figure 27).

• 4 of 5 consecutive points outside 1/3 of the control limits

• 8 consecutive points above or below the center line (run)

• 15 consecutive points within 1/3 of the control limits

• 6 consecutive points in ascending or descending order (trend)

On the selection screen of the related work-list transaction, you can decide whether: • You want to immediately carry out a

check according to Western Electric Rules. In this case, all control charts that correspond to the selection crite-ria are checked.

several inspection lots or production orders. SAP ERP creates the quality control charts when preparing the quali-ty inspection and updates them when you record results. As a quality inspec-tor, you can display the charts when you are recording results and, if you have the appropriate authorization, you can use them to calculate intervention and warning limits. If necessary, you can change the algorithms.

You can evaluate inspection results using the quality control chart. QM with SAP ERP contains a valuation rule that rejects a sample as soon as any limit is exceeded. When this occurs, the work-flow automatically notifies the depart-ment (as long as the defect class has been set appropriately in the defect code of the task-list characteristic).

You can view all of the control charts you are responsible for in a work list. If you are working in the quality manager role, an iView (portlet) shows you all charts where control limits have been exceeded.

Western Electric Rules Apart from showing where control lim-its were exceeded, control charts can indicate that a process may be running out of control on the basis of unusual patterns (for example, runs or trends). The criteria you use to detect such pat-terns are referred to as Western Elec-tric Rules. In the work list for control charts, you can check the stability of processes according to the following criteria: • 1 point outside of control limits • 2 of 3 consecutive points outside 2/3

of the control limits Figure 27: Process Capability Index Cpk


Quality Scores Quality scores for inspection lots are a proven tool for quality control. QM with SAP ERP provides you with several ways of determining the quality score. It uses information from the following sources: • Usage decision • Estimated fraction of nonconforming

units in the lot • Estimated fraction of nonconforming

units for characteristics – Maximum share of defects – Weighted average share of defects

• Quality score of the characteristic defect classes – Minimum (worst) quality score – Weighted average quality score

Vendor Evaluation: Permanent and Objective Performance Monitoring

When procuring materials, you can use the vendor evaluation function to select a suitable vendor. This function pro-vides you (as the purchaser) with a summarized score that has been calcu-lated for the vendor according to main and subcriteria (see Figure 28).

content-based examples of how to inte-grate business processes supported by SAP ERP with shop floor–related pro-cesses using SAP MII transactional techniques. For example, there is sam-ple software for an easy-to-use, Web-based results recording function based on SAP MII. Shop-floor operators would use it for in-process control.

SAP MII enables real-time out-of-the box transactional integration between plant-floor and enterprise (SAP ERP) applications through the following:• Universal connectivity to the data,

functionality, and processes of exist-ing plant-floor systems through busi-ness logic for creating automated events, KPIs, and alerts

• Workflow to synchronize plant and enterprise business processes

• Manufacturing intelligence with a near-real-time analytics engine that aggregates and delivers unified visu-alization of events, alerts, KPIs, and decision support to production personnel

In addition to this, SAP MII provides a connector framework to establish or develop connectivity to various produc-tion and test devices. SAP is building a partner ecosystem around SAP MII. For more information on SAP MII, go to www.sap.com/solutions/xapps/xmii.

You can use a histogram evaluation to display the frequency distribution of measured values in a bar chart. This allows you to recognize typical and extreme values of a sample, as well as to judge the location, dispersion, and form of the distribution. You can blend the histogram out and replace it with a normal distribution if required.

The histogram contains the following data: • All valid results for the sample • Upper and lower specification limits • Target value • Distribution function and statistical

values

If the inspection results are already divided into classes, SAP ERP uses these classes to display the histogram. Otherwise, it divides the existing values into appropriate classes. You can increase or decrease the number of classes using the zoom function.

SAP Manufacturing Integration and Intelligence for Quality AnalyticsFor integrating systems, databases, or other external applications (especially on the shop floor) and also for perform-ing comprehensive analytics on quality data, SAP offers SAP Manufacturing Integration and Intelligence. Integration templates in the application provide


These tools complement each other. Report lists primarily evaluate operative data. SAP NetWeaver BI and the QM information system, however, analyze summarized data that can be stored for a long period of time.

Results History With the help of the results history, you can analyze single values that were recorded for a characteristic in the results recording function and when you made the usage decision. You define the period of time to be analyzed. You can prepare the data in list form and graphically represent the progression of values over a period of time using a run chart. With the help of a trend analysis you can represent the predicted course of the values. Exporting the data, for example, to a Microsoft Excel file provides additional options for processing the data.

QM Cockpit for EvaluationsWith the help of the QM cockpit for evaluations, you can analyze quality-related data based on inspection lots, defects, and quality notifications (see Figure 29). Batch where-used lists pro-vide quality-related data of components or preliminary products. During the analysis you can use tables or informa-tive graphics to visualize the results. These graphics can be adjusted to suit your requirements. Multiple graphics can be displayed at the same time, for example, with reference to an inspec-tion lot, to facilitate comparisons. You can calculate key figures, which you can define to meet your needs.

Evaluations: Keeping You Up-to-Date

The following evaluation tools are available in QM with SAP ERP: • Results history of mean and single

values with integrated analysis of trends

• QM cockpit for evaluations with SAP ERP for online and archived QM data

• SAP NetWeaver BI with integrated business content

• QM information system• SAP MII for integrated quality analyt-

ics based on disparate systems• Report lists programmed using the

ABAP™ programming language– Predefined SAP reports – Logical databases as the basis for

customer-specific reports

The subcriteria for quality, the main criterion, come from the following sources: • Goods receipt inspection – the aver-

age of the quality scores of all goods receipt lots from the vendor for a specific time period

• Complaints – the number of com-plaints received in relation to totals sales or total revenue, for example

• QM audit – either the average quality score of all audits executed during a specified time period or the quality score of the most recent audit

You define the criteria and their relative weighting according to your company requirements.

Vendor Evaluation

Procurement Main Criteria Weighting

Price 30%

Subcriteria Weighting

Quality 40%

Figure 28: Vendor Evaluation in SAP® ERP

Delivery 20%

Service 10%

A1A2A3

A1A2A3A4

A1A2A3A4

A1A2

Price levelPrice behaviorOther

Goods receipt inspectionComplaintAuditOther

On-time delivery performanceQuality reliabilityUniform shipping instructionsOther

TechnologyOther

%%%

%%%%

%%%%

%%

A Determined automatically


company key figures using formulas. Even if you have no programming expe-rience, you can create reports quickly and easily using flexible analysis.

Early warning systemAn “early warning system” helps you identify problems at an early stage by warning you if an exception situation occurs. You can define the exception situations. When an exception situation arises, you are informed immediately via e-mail or workflow. An exception situation can, for example, occur if the quality score of a vendor falls below 90 points. You define exception analyses using standard information structures or your self-defined structures. You can also use mathematical algorithms or set the software to recognize threshold values or trends.

Report Lists Using ABAP QueryYou can create evaluations that are not available as standard with a simple mouse click using the ABAP query tool or predefined logical databases. The link to printing and presentation functions occurs automatically.

Since the QM information system is part of the logistics information system, you can combine evaluations with infor-mation from other areas of logistics, such as production or purchasing. Out-put data is displayed in list form or as a graphic and can be sent as an e-mail attachment. Other features are activity-based costing and portfolio analyses. Using the standard query tools, you can freely define your own evaluations and reports.

Standard analyses The QM information system contains a selection of standard evaluations for your materials, vendors, and custom-ers, including key figures such as pro-cess capability indexes, defects fre-quencies, or skip quotas. You can tailor both the presentation and content of the QM information system to suit your needs.

Flexible analyses You can configure your own reports on the basis of standard information structures or self-defined structures. You can also link your key figures to

QM-STI enables the export of data for additional statistical evaluations, which can be visualized directly integrated in the QM cockpit for evaluations.

According to the selection of the object type, such as inspection lot, notifica-tion, or component, different selections and grouping layouts are offered. Via the grouping layout, you can easily decide which information is relevant for you and which aggregation level is needed. You can evaluate both current and archived data and compare the inspection results for several characteristics.

In the cockpit you can create different types of control charts without any preparation in the related inspection characteristics. You can analyze defects together with inspection lots or as notifications. A new graphic type is available for the visualization of defect frequencies. Additional key figures for defect risks are also available. Notifica-tions can be analyzed together with defect causes. For components, you can analyze and visualize inspection lots, notifications, or defects from the production cycle.

Quality Management Information SystemInspection results and quality notifica-tions are summarized on the basis of time, plant, or work center and updated in the QM information system. You can decide whether you want the update to be performed on the basis of material, material and vendor, or material and customer.

Figure 29: Evaluation of Components Using the QM Cockpit


management, scrap and rework quanti-ties in production, or returns in sales. This information is integrated in the business content and can be linked with key figures from SAP ERP, thereby providing you with a complete picture of quality in your company.

QM-STI for External Evaluations QM-STI is an open interface used for evaluating inspection results in external systems. You configure it in customiz-ing and trigger the external application by simply clicking a button in one of the following QM functions with SAP ERP:• Results recording • Usage decision • Control chart • Results history

Search for Quality DataThe SAP NetWeaver Enterprise Search application provides SAP applications with numerous services for searching, classifying, and text mining in large col-lections of documents (unstructured data) as well as for searching in and aggregating business objects (struc-tured data).

In QM with SAP ERP, the search func-tion is available for quality-related data such as:• Master inspection characteristic• Inspection method• Supplier information record• Quality notification

The search function is offered during data entry within change and display transactions for a given object; a sim-ple and an extended search function are provided.

transferred to SAP NetWeaver BI. In this way, you receive summarized or detailed information regarding the noti-fication process, with an emphasis on reference objects such as customer, vendor, material, or assembly. On the organizational side, the emphasis is placed on purchasing and sales divi-sions, material groups, or the country of origin of your customers.

Among the key figures, you can obtain the number of notifications, cumulative or average processing time, defective and returned quantities, and proportion of notifications completed on time. In addition, you can get information on new, outstanding, and successfully completed tasks.

Defects, defect locations, causes, activities, and tasks Using QM with SAP ERP, you docu-ment defects in the inspection lot or as notification items. SAP NetWeaver BI shows you which defect types occurred, where they occurred, and what caused them. Activities and tasks associated with the notification are also extracted. The same reference objects as in quality notifications are available to you in the form of naviga-tional attributes. All coding is also avail-able. For example, you can determine which defects occur regularly in a specific location.

Many key figures used by the quality manager are based on information obtained from internal systems running non-SAP software as well as external systems. Examples of this information include the vendor evaluation in pur-chasing, returned quantities in stock

SAP NetWeaver Business IntelligenceSAP NetWeaver BI offers data ware-housing that fits effortlessly into the IT landscape of SAP ERP and other soft-ware applications. It contains preconfig-ured business content for your role of quality manager or quality planner. Business content includes data extrac-tion, metadata and information models, and ready-made templates for tables and graphs in Microsoft Excel or HTML.

Inspection results The specifications and results of your quality inspections can be evaluated down to the sample level of an individu-al characteristic. The spectrum of key figures ranges from the number of inspected or rejected samples to indi-cators for process capability, such as Cp and Cpk. You can interactively analyze quality using criteria such as material, vendor, or work center.

Inspection lots Inspection lots can be transferred to SAP NetWeaver BI once the usage decision has been made. You can obtain information in graphic or tabular form on the frequency of individual usage decisions, the number of inspected and skipped lots, the actual inspected quantity, the percentage of nonconforming units, or the quality score. For example, you can consoli-date the information and sort it accord-ing to vendor or purchasing organization.

Quality notifications Quality notifications reflect unplanned events that occur during the quality process. For every notification, a selec-tion of attributes and key figures is


for costs such as those relating to a warranty, to scrapping, or to the settle-ment of activities performed. You can also assign rework orders to this cost collector account. This allows you to debit all costs for a quality notification to the appropriate personnel and ana-lyze the costs.

Appraisal Costs Appraisal cost orders are stored in the material master and assigned by SAP ERP as cost collectors to individual inspection lots. If, however, a special settlement is required for an inspec-tion, that settlement takes precedence. This can happen, for example, when the lot belongs to a production order or when it comes from a goods receipt for a purchase order that is assigned to a cost center account.

SAP ERP calculates appraisal costs using the activities that you, as the inspector, confirm. You can confirm activities, for example, on the basis of the hours worked. Accounting fixes the types of activities, such as setup or inspection time, and the valid charges for the cost center that performs the activity. The activities performed for inspection lots are logged during results recording or when the usage decision is made. Activities performed for inspections during production are confirmed when confirmations for pro-duction orders are made. Other inspec-tion costs, such as material usage, are settled to the order in which you con-firm the inspection activity.

Nonconformity Costs To settle nonconformity costs for a quality notification, you create a QM order when processing a notification. You assign the order to the notification header and use it as a cost collector

Even when the entry is imprecise or the entered search string contains typing errors, results can be found using a “fuzzy search.” Depending on the set-ting of the search criteria in customiz-ing, you can search for notifications of one special type, for example, only for quality notifications.

Taking Control of Quality Costs

With SAP ERP, the controlling function plans, collects, and evaluates all costs incurred by a company. These costs include quality-related costs. In QM with SAP ERP, you record appraisal costs originating from quality inspec-tions or nonconformity costs originat-ing from quality notifications. Quality costs from other applications (for example, human resource manage-ment) can be included in the cost calculation.

The controlling component uses QM orders to manage quality costs. The following types of QM orders are provided in SAP ERP: • Appraisal costs order

– For individual settlement – For collective settlement

• Nonconformity costs order

You can also define your own specific order types. When creating an inspec-tion lot or a quality notification, you can create or assign a corresponding QM order.

Benefits:• Use dynamic modification to reduce your appraisal costs • Monitor processes continuously using quality control charts• Access important company key figures and evaluations immediately


Master Data in a Calibration Inspection

Several master data records are used during a calibration inspection: equip-ment master data, maintenance plan, and maintenance task list.

Equipment In SAP ERP, your company’s test equipment data is stored in an equip-ment master record. This master record contains all of the data relevant to test equipment (such as acquisition value and date, manufacturer, work center, cost center, and location).

To organize your test equipment and make it easier to locate, you can: • Combine similar test equipment into

groups • Use the classification function to cat-

egorize test equipment according to technical features

• Assign test equipment to a construc-tion type (material)

Using the results history, you can verify the suitability of each piece of equip-ment and the accuracy of the inspec-tions performed using this equipment.

Tracking Test EquipmentSAP ERP provides you with test equip-ment tracking functions. During a cali-bration inspection, you might notice that a piece of test equipment is no longer fit for use. In this case, you can check in the test equipment history to see which inspection lots and charac-teristics were inspected using this piece of equipment. You are then able to initiate the appropriate actions.

Monitoring Technical InstallationsIn addition to calibration inspections, you can use inspection lots created for maintenance orders for the extended recording of measured values in plant maintenance (for example, to monitor technical installations where critical val-ues have to be recorded on a regular basis). Consequently, you can record inspection results for functional loca-tions as well as for test equipment.

As a test equipment manager, you are responsible for managing, monitoring, calibrating, and maintaining test equip-ment. Test equipment management involves the following activities: • Planning and performing calibration

inspections • Releasing or blocking test equipment • Documenting the calibration history • Creating trend analyses • Determining calibration costs • Tracking test equipment with usage

lists

Calibration Inspections and SAP ERP

As shown in Figure 30, test equipment management in SAP ERP combines important planning and processing functions from QM with SAP ERP that are needed for master data manage-ment and for planning and performing calibration inspections.

Releasing Test EquipmentYou can use the inspection results to decide whether a piece of test equip-ment can be released for further use.

TEST EQUIPMENT MANAGEMENT

Figure 30: Functions of Test Equipment Management

UsageList Master Data

Link Insp.Char. & Msmt.

Pnts

CalibrationIntervals

Notifications

Calibration Planning

Calibration Inspection

OrderProcessing

InspectionDecisions

CalibrationOrders

TrendAnalysis

ResultsHistory

WorkLists


have the option of defining a mainte-nance cycle (single-cycle plan) at the maintenance plan level that is valid for all operations of the maintenance task list.

You define inspection intervals based either on time or performance. A time-based inspection interval might, for example, consist of an annual calibra-tion on a key date. A performance-based inspection interval may involve a calibration after 1,000 uses of a piece of equipment. You can combine time- and performance-based calibrations in a multiple counter plan (for example, inspect after 6 months or, at the latest, after 1,000 uses of the equipment).

To plan a calibration inspection, you must: • Create master data You need master data such as equip-

ment master records, maintenance plan, master inspection characteris-tics, and the maintenance task list. You define operations and the char-acteristics associated with these operations in the maintenance task list.

• Define inspection specifications Quantitative and qualitative inspec-

tion characteristics contain the inspection specifications (such as tar-get values, tolerances, and codes for attributive valuations), and they deter-mine how results are to be recorded.

• Define inspection intervals You can define inspection intervals

using a central maintenance strategy that can apply to several maintenance plans. You can use maintenance strategies, for example, to define dif-ferent intervals for each operation within a maintenance task list. You

Maintenance Plan The maintenance plan is the central planning object in which you assign the list of equipment to be inspected, the maintenance task list, and the calibra-tion schedule.

The maintenance plan specifies which types of activities must be performed periodically and how often they are to be performed. In the maintenance plan, you can enter time-based or performance-based intervals for per-forming these activities. When mainte-nance deadlines are reached, SAP ERP automatically creates maintenance orders.

Maintenance Task List In the task list, you plan the recurring work processes in a standardized form. To perform a calibration inspection, you can include inspection characteristics in the maintenance task list. In turn, you can include a maintenance task list in a maintenance plan. The task list speci-fies the activities to be performed for individual maintenance deadlines.

Planning a Calibration Inspection

The automatic or manual scheduling of a maintenance plan triggers calibration inspections that are to be performed at regular intervals. When a maintenance plan is scheduled, SAP ERP creates a maintenance order; when this mainte-nance order is released, an inspection lot is created. The inspection lot con-tains all data required for the calibration inspection, such as a list of equipment to be inspected and the inspection specifications (see Figure 31).

Test Equipment(Equipment

Master Records)

Maintenance Task List

Maintenance Strategy Cycle

Maintenance Item

Figure 31: Objects in a Calibration Inspection

MaintenanceOrder

Maintenance Plan

InspectionCharacteristics


make the usage decision for the inspection lot. As a result of the usage decision, SAP ERP can perform certain follow-up actions (see Figure 32):• Update equipment status SAP ERP manages a status for each

item of test equipment in the equip-ment master record. This status determines whether a piece of test equipment is released for use or blocked. On the basis of the equip-ment valuation, SAP ERP proposes the future status. This status can be updated in the equipment master record. If a piece of test equipment is blocked, you are alerted to this fact when the next order is released.

• Change inspection interval If an inspection shows that a piece

of test equipment is still fit for use, but maintenance is due before the next inspection date, you can change the cycle modification factor when you make the usage decision. This has the effect of reducing the length of the next inspection interval.

• Recording results You can record results in the work list

for the equipment and use the char-acteristic types and recording func-tions of QM with SAP ERP.

During a calibration inspection, you are able to make confirmations for the maintenance order; for example, to record costs for activities performed or for materials that were required for the calibration inspection. In addition, additional order processing functions are available, such as capacity planning or external assignment. If characteris-tics are rejected, you can create main-tenance notifications, start corrective tasks, and document the success of these corrective tasks.

Once you have recorded all the results for the equipment in each operation, you make an equipment valuation for the test equipment (accept or reject). When all the test equipment for an inspection lot has been valuated, you

Calibration Inspection

A calibration inspection covers the fol-lowing activities: • Scheduling the maintenance plan

and creating the maintenance order and inspection lot

The maintenance plan is usually scheduled automatically using a peri-odically run program. When this pro-gram is run, SAP ERP creates calls and converts these calls into orders when they become due. You can select a setting that releases orders directly, causing the inspection lots to be created.

• Inspecting and calibrating test equipment

You can use various criteria to create a work list of the calibration inspec-tions that are planned for a specific period. Such criteria might include, for example, all test equipment to be calibrated in the next week or test equipment sorted by cost center or work center. You can use this infor-mation to identify and prepare the test equipment for inspection. When a maintenance order is released, SAP ERP automatically creates an inspection lot. All orders that have been released and all inspection lots that are to be processed appear in a work list for results recording and can be processed in any sequence. If test equipment unexpectedly fails during use, you can create a maintenance notification (malfunction report). Within this maintenance notification, you can manually create a mainte-nance order to schedule a calibration inspection.

Release or Block Equipment

Figure 32: Follow-Up Actions When Making the Usage Decision

Updateequipment status

Usage Decision

Inspection Lot

EquipmentNo. 12345

Reduce/IncreaseInspection Interval

DocumentInspection Result

Adjustcycle modification factor

Updatemeasurement documents


Evaluations for Test Equipment

Results historyYou use the results history to display the results of previous inspections for specific characteristics of a piece of test equipment.

Trend analysis using run chartIf you display inspection results for an inspection characteristic as a run chart using the time axis in the results history, SAP ERP can indicate a trend (regres-sion line) for the run of values. This provides you with an indication of when a tolerance limit will be exceeded.

Usage listsThe usage list for test equipment allows you to determine the cost center of the test equipment, its current or previous location, or the work center in which it was used.

Test equipment historyUsing the test equipment history, you can determine which inspection lots and characteristics were inspected with a specific piece of test equipment. This is important when, for example, during a calibration inspection you determine that a piece of test equipment should no longer be in use (test equipment tracking).

• Create measurement documents If you have defined measuring points

for your test equipment, SAP ERP can create measurement documents automatically for each measuring point. When this follow-up action is executed, the results of the cali-bration inspection are entered automatically in new measurement documents. You can access these documents in the equipment history.

• Complete maintenance order You can set the software to automati-

cally complete the calibration order when the calibration inspection has been completed.

In addition to the follow-up actions described above, you can also define your own follow-up actions, such as printing self-adhesive calibration labels specifying the date of the next calibra-tion inspection.

Benefits:• Guaranteed quality and reliability of your test equipment • Safe production process because of early forecasting of possible weak points in technical installations• Ability to track your test equipment


Stability Study – Supporting Product Development and Product Improvement

Functionality for stability studies is an important feature to enable the use of quality management with SAP ERP as a LIMS. Stability studies, also known as shelf-life studies, are carried out for self-produced or externally procured goods, especially in the chemical, phar-maceutical, cosmetic, and food indus-tries. Such studies are required to determine expiration dates during the development of new products (in research and development), and they are mandatory in order to obtain legal approvals for products.

This integrated approach means that quality management functions can be embedded easily into business processes such as procurement, manu-facturing, or controlling, helping to eliminate redundant data and increasing information transparency throughout the organization. On a more technical level, integration means having fewer systems and interfaces to maintain. Overall, the simplicity of SAP ERP as a LIMS can help companies reduce costs and increase profits and customer satisfaction.

The SAP ERP application supports all essential functions in a LIMS, including those shown in Figure 33.

The Enterprise LIMS Approach

Over the years, LIMS have evolved from custom-developed in-house sys-tems used to track data in quality labs to proprietary commercial products. More recently, LIMS have evolved into standards-based systems. As a result, companies are beginning to think in terms of “enterprise LIMS” that not only support the full range of functions within the laboratory, but are integrated with systems throughout the company.

The challenges labs face as they man-age quality are related to turnaround time of lab tests, access to results data, accuracy of analyses, resource utilization, data exchange, record keep-ing, and productivity. With SAP ERP, a full range of quality management func-tions addresses these challenges in both commercial and industrial labora-tories. In addition, SAP ERP offers an integrated LIMS as part of a larger, more comprehensive quality manage-ment solution, simplifying implemen-tation and integration as well as streamlining quality processes. And SAP ERP is more than just another LIMS. Unlike traditional LIMS, it offers seamless integration into the supply chain and other key areas within the enterprise. By enabling companies to take an enterprise approach to LIMS, SAP ERP does the following:• Provides a standard basis for inte-

grating quality management process-es across the enterprise

• Enables visibility of quality data throughout the organization

• Enhances communication among quality groups and other departments

ENABLING AN INTEGRATED ENTERPRISE LABORATORY INFORMATION MANAGEMENT SYSTEM WITH SAP ERP

• Audit management• Bar coding and labeling• Batch management (batch traceability and

electronic batch record)• Calculations and formulas• Calibration of instruments• Certificates of analysis• Change management (audit trail)• Complaint and problem management and

corrective and preventive action• Data retrieval and archiving• Digital signatures• Document management• Engineering change management (audit

trail)• Flexible inspections• Goods receipt inspections• Information system and reporting• In-process control• Inspection plan maintenance• Interfaces (inspection data and statistical

data)• Inventory control• Invoicing and billing of analysis• Laboratory statistics

• Master data maintenance• Multiple specifications• Nonconformance reporting and processing• Notification processing• Order management• Post-process control• Problem solving and event handling• Quality assurance• Quality planning• Quality data interchange• Recurring inspections• Results recording and copy• Returns inspections• Sample management (unplanned and

planned samples)• Skip-lot functionality• Specification management• Stability (shelf-life) studies• Statistical process control• Statistical quality control• Test equipment interfacing• Quality cost tracking• Vendor evaluation• Web services• Work lists and workflow

Figure 33: Overview of LIMS Functionality with SAP® ERP


introduce their products into the U.S. market with a detailed, complete, and traceable description of their production process. This includes all operations affecting product quality performed during the manufacture and distribution of a particular drug. The requirements for computerized systems with respect to electronic records are described in the U.S. Code of Federal Regulations (CFR), volume 21, part 11.

Compliance and Quality Control

GxP is an acronym for Good Clinical/Laboratory/Manufacturing Practice (GCP, GLP, and GMP) and refers to exacting requirements for regulated industries, such as the pharmaceutical, food, and beverage industries. For example, the U.S. Food and Drug Administration (FDA) requires compa-nies in the pharmaceutical industry to

In addition, stability studies are an important tool for continuously improv-ing products and processes. In general, stability studies are conducted for the following reasons:• Monitor and study the effects of

storage conditions (for example, temperature, light, and humidity) on a substance over a defined period of time

• Provide evidence of the effectiveness or shelf life of a product under con-trolled environmental conditions

To perform a stability study, you must draw physical samples from a material or batch and store them under specific environmental conditions. You then remove the samples from storage at specified intervals and test them according to a predefined testing schedule.

To meet the demands of various international legal requirements and regulations such as GMP, SAP has developed software to support stability studies as part of quality management with the SAP ERP application (see Figure 34). Quality management with SAP ERP supports research and devel-opment processes and has been avail-able since the release of SAP R/3® Enterprise software (functionality now found in the SAP ERP application). Sta-bility study functionality with SAP ERP is also linked to the SAP Recipe Man-agement application, which is an impor-tant cornerstone of the overall new-product development and introduction (NPDI) process.

Figure 34: Example for Stability Study


The following functions of the digital signature for inspection lots and physi-cal samples have been enhanced in the most recent release: • Use of signature strategies• Multistage signatures• Detailed documentation• Possibility to print information about

the signature

Within extended customizing you can define strategies for signatures, which means that in a multistage process multiple persons have to sign the results in a predefined order. To realize this scenario, it is possible to process inspection lots for which signatures already have been created. If results need to be inspected and signed by multiple users, the inspection charac-teristic does not get the status “com-pleted” immediately. Instead, this status is set once the entire signature process for this characteristic is fin-ished. For more detailed documenta-tion, you can save or print data that is related to the signature.

In the work list for results recording, the status of a signature process is dis-played with icons and can be requested by the user. As new functionality in SAP ERP for notifications, such as quality notifications and maintenance notifications, you can now include a digital signature for single processing steps. In customizing for notifications you can define the notice type, the level (header or operation), and the business process for which a digital signature is necessary. You can also use signature strategies in this context.

GxP compliance plays a decisive role in data acquisition and validation, espe-cially in analytical laboratories. Accura-cy and clarity of data, as well as consistent change documents (who did what, when, where, and why) are crucial for regulatory compliance.

Quality management with SAP ERP supports these GxP requirements, pro-viding complete audit trail functions and digital signatures in results recording, sample or product release, and notifica-tion processing. These functions also support change management, electron-ic batch records, and integrated docu-ment management to store all relevant documents, such as standard operating procedures.

One added benefit is the optimized data flow that results from eliminating interfaces between systems. The use of SAP ERP as an integrated enterprise LIMS can lead to improved data accu-racy and consistency, which, in turn, can lead to better – and easier – regula-tory compliance.

For more information about compliance of SAP ERP with GxP requirements in general, refer to the SAP white paper Complying with U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry.

Digital SignatureThe digital signature serves the same function for the processing of digital data as a handwritten signature serves for paper documents. Its purpose is to guarantee within an authorization pro-cedure that the individual who signs a digital document really is who he or she claims to be.

Benefits:• Reduced workload for system administration, less training, and fewer upgrades by not using numerous frag mented systems • Better processes with standardization, increased efficiency, and ease of collaboration• Better product quality, fewer defects, and less rework and waste• Increased accuracy and security of data, which reduces costs associated with regulatory compliance• Improved data quality and visibility because data is consistent, transparent, and available throughout the company


audits, revisions, or inspections can be performed using the audit management functionality. The process phases are based on the standard ISO 19011.

The audit management functionality supports all phases of auditing – from the planning of a comprehensive audit program and of the individual audits, through the definition of the audit crite-ria or question lists, to the actual audit-ing process and the assessment of the audit object in the audit report. It also supports you in defining and monitoring corrective and preventive actions. Audit management functionality also provides effective tools for the evaluation of all audit data.

A typical process includes the following phases and tasks:• Planning audit criteria Planning of general question lists

(general criteria), depending on rele-vant standards, regulations, or rules of the application area

• Planning the audit program Definition of a scheme, for example,

in the form of an annual schedule, taking into consideration the scope, object, and date of the audits

• Preparing the individual audits Determination of the individual audit

question lists and of the partners involved in the audit, distribution of roles, and preparing the required documents

environment, and industrial safety, in one integrated management applica-tion. Combined audits can greatly reduce expenses.

Audit objects can be freely defined by groups of fields; for example, audits can be performed with reference to organizations, enterprise areas, prod-ucts, and vendors. If an audit object is described using data elements from the application repository, for example, by the combination vendor and material, the information related to these data elements is available – a clear advan-tage of integration.

The versatility of the audit management functionality stems from being able to customize the properties of the audit components (audit plan, question list, audit, and action) as well as the proce-dures for assessing the criteria and grading the audit object. For example, employees can provide question lists with hierarchical tree structures to suit their own requirements.

Audit Processing: Evaluate Risks and Confirm Information

To keep the process description that follows as simple as possible, the example is based on a quality system audit performed in accordance with ISO 9000. However, if regarded in a broader sense, the example below can also show you how various other

Assessments: Methods for Audit Criteria

An audit is a systematic examination used to determine to what extent an object meets previously specified crite-ria. 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 find-ings, and document and analyze audit data. Audit management supports all appraisals based on predefined criteria (audits, checks, inspections, reviews, and examinations) and can subsequent-ly be used to valuate the object.

The audit management functionality is very versatile and can be used for various application areas. Examples of audit usages are:• Quality management (system audit,

process audit, and product audit) and GMP

• Environment management and hygiene management

• Safety and security management (facility safety, fire safety, and data protection)

Suitability for a wide variety of audit usages meets the need of companies to unify different management systems, for example, for quality assurance,

AUDIT MANAGEMENT: FLEXIBLE TOOL FOR PLANNING, EXECUTION, AND EVALUATION OF AUDITS


processes, or products, while taking the relevant standards into consider-ation. You can perform any kind of review or survey, based on checklists. Audit management functionality in SAP ERP also helps you fulfill legal require-ments and enables various scenarios for benchmarking.

• Audit processing Release of the audit, invitation to par-

ticipants, provision of the documents, examination of the audit object with regard to the criteria (questioning and viewing), and recording of findings (statements and documents)

• Assessment Valuation of the criteria (question list

items), rating and grading of the audit object, and creation of an audit report (draft and final report with signature)

• Follow-up actions Determination of a subsequent audit;

corrective, preventive, and improve-ment actions and the persons responsible; monitoring of the subse-quent steps; and verification of the effectiveness of all actions

• Analysis and evaluation Overview of the entire audit program

or of selected groups of audits, of audit questions and results, of find-ings and actions as well as feedback of audit results to audit planning

To summarize: audit management is an easy-to-use, yet powerful tool that you can use to manage your audit process-es. Regardless of your industry sector, this tool supports you throughout the entire audit process, from the planning phase, through audit execution and valuation, to the evaluation phase. This is a highly flexible tool with open inter-faces, such as the cockpit shown in Figure 35. It allows you to perform internal or external audits of systems,

Figure 35: Audit Cockpit


A structured DMAIC problem-solving road map comprising five steps – define, measure, analyze, improve, and control – is commonly regarded as the core of every Six Sigma project. In SAP ERP, procedures like these can be

Of all the ERP and dedicated QM soft-ware solutions, SAP Business Suite is an excellent choice for implementing Six Sigma methodologies. In particular, SAP ERP supports most of the ele-ments that are essential for Six Sigma.

The Six Sigma approach to quality improvement focuses on reducing pro-cess variations and eliminating noncon-formities, resulting in better quality, lower costs, and increased customer satisfaction.

MAPPING SAP SOLUTIONS TO YOUR SIX SIGMA INITIATIVES

Figure 36: Sample Process According to Six Sigma

Define

Management(Sponsor Champion)

Measure

Analyze

Improve

Control

Project Lead(Black Belt, MBB)

Statistician(Green Belt)

Project Member(Inspector, Analyst)

Management of Six Sigma projects as an integrated and structured application providing tools to achieve breakthrough improvements

Comprehensive tools to calculate samples and capture data for critical characteristics

Sophisticated analysis to control KPIs and monitor continuous improvement


managed easily using the cProjects application, which provides all the func-tions you need in collaborative projects.

Using cProjects, you define the five DMAIC phases of your Six Sigma proj-ect and the related tasks for every phase (see Figure 36). You define crite-ria and checklists for passing the quali-ty gates between one phase and the next. You plan the resources (employ-ees, black belt, and so on) needed for executing the tasks. You can also use graphical tools to schedule and visual-ize the relations between the project tasks and find critical paths.

In your collaborative Six Sigma project you can use supplementary SAP ERP functions, which are linked with cProjects. For example, you can calcu-late project costs, and you can link directly to related documents, notifica-tions, inspections, and audits. In this way you get access to various capabili-ty and performance indicators, for example, from SPC (control charts, Cpk, and so on) and FMEA. Process data can be extracted from the source and transferred into SAP NetWeaver BI and an executive information system for general analysis purposes. SAP NetWeaver BI and the executive infor-mation system provide all the functions needed for calculating KPIs, feeding balanced scorecards, or other assess-ment techniques.


The enterprise services supplied by this bundle can be used by quality inspectors, operators, and lab technicians who are executing quality analyses and entering inspection data manually or transferring data from elec-tronic test devices. It is also applicable for production supervisors or quality managers who want to perform analy-sis on this data.

This bundle requires the use of QM in SAP ERP. The services expose func-tionality of QM business objects such as inspection lot, physical sample, and quality notification, and can interoper-ate with an external QM solution.

In the future, SAP will offer additional enterprise services in the area of inspection planning.

For more information about enterprise services, see the wiki documentation at http://wiki.sdn.sap.com/wiki/x/kww and information about enterprise ser-vices in the Enterprise Services Work-place site at www.sdn.sap.com/irj/sdn/esworkplace.

level. It can be used to exchange data between LIMS and CAQ systems and SAP ERP directly, with more flexibility that is provided by existing interfaces.

IQM can be used to integrate LIMS and CAQ systems via composite applica-tions. Integration with SAP ERP can be achieved by using the enterprise ser-vices provided in this bundle. SAP MII can consume the services to enable entry of quality data and visualization without having external QM systems connected.

This bundle does not supply or assume a dedicated user interface. It is intended as a way to integrate other applications that provide front-end functionality. A dedicated user-interface template based on the supplied services could be created using SAP MII or the Web Dynpro development environment, the SAP NetWeaver Visual Composer tool, or Adobe technology.

The enterprise services bundle “Inte-gration of Quality Management Sys-tems” (IQM) provides enterprise ser-vices for the exchange of inspection lot data, inspection results, and quality notification data between SAP ERP 6.0 and external quality management systems.

In comparison to the existing QM-IDI, the enterprise services bundle “Inte-gration of Quality Management Sys-tems” adds the following benefits and advantages:• New XML-based technology

(Web services)• Greater flexibility (a subset of ser-

vices can be deployed)• Enhanced functionality (quality notifi-

cations and unplanned inspection points, for example)

The IQM enterprise services bundle bridges data from the quality planning level to the inspection data level and right down to the instrument recording

ENTERPRISE SERVICE-ORIENTED ARCHITECTURE FOR SERVICES-BASED BUSINESS SOLUTIONS


www.sdn.sap.com/irj/sdn/esworkplace

SAP® Business SuiteThe SAP Business Suite is a compre-hensive family of adaptive business applications that provide industry-specific functionality. The software is built for complete application integra-tion, scalability, and easy collaboration over the Internet. SAP Business Suite applications help to manage critical business processes and form a tightly integrated business application suite that adds value to every facet of an organization and the external value chain. SAP Business Suite applications are based on the SAP NetWeaver® technology platform, an integration and application platform that supports the evolution of SAP Business Suite applications to a services-based architecture.

SAP ERPThe SAP ERP application is integrated business management software that includes the functionality and methods that are needed to effectively plan and manage a business. QM functions are seamlessly integrated.

SAP NetWeaverSAP NetWeaver is a Web-based tech-nology platform that serves as a foun-dation for enterprise SOA and enables the integration and alignment of people, information, and business processes across business and technology bound-aries. By using open standards, it can integrate with information and applica-tions from virtually any source or technology.

SAP NetWeaver PortalThe SAP NetWeaver Portal component unifies the applications, information, and services existing in an enterprise into one platform and includes a portal, content management, and business intelligence.

Key Terms

CAPACorrective and preventive action (CAPA) is an instrument for compliance management in terms of systematic processing of quality deficiencies, errors, and malfunctions. Its aim is to document the entire process of solving the issue and providing appropriate corrective actions and further preven-tive actions to avoid a recurrence of an issue in the future.

CAQComputer-aided quality assurance (CAQ) is the application of computers and computer-controlled machines for the definition and inspection of the quality of products.

collaborative businessCollaborative business occurs between companies using a regulated exchange of information and data on the Internet.

enterprise service-oriented architecture (enterprise SOA)Enterprise SOA is a software architec-ture that uses policies, practices, and frameworks that enable application functionality to be provided and con-sumed as services. These services are published at a level of granularity relevant to service consumers.

LIMSA laboratory information management system (LIMS) is computer software that is used in the laboratory for the management of samples, laboratory users, instruments, standards, and other laboratory functions such as invoicing, plate management, and work flow automation.

For More Information

To find out more, refer to the following:• For general information about the

SAP® ERP application, visit the SAP Service Marketplace extranet at www.service.sap.com/erp (login is required).

• For general information about the quality management (QM) functional-ity with SAP ERP and QM as an enterprise laboratory information management system, visit www.service.sap.com/qm (login is required).

• For online documentation (SAP Library) for SAP applications, visit SAP Help Portal at http://help.sap.com. The following link is an example of the online documentation available for quality management: http://help.sap.com/saphelp_erp2005vp/helpdata/en/a0/df293581dc1f79e10000009b38f889/content.htm.

• For information about electronic records (SAP audit trail functions, table logging, and change docu-ments), refer to online documentation (SAP Library) at http://help.sap.com/saphelp_erp2005vp/helpdata/en/7c/fb0f3a57b38c0fe10000000a11402f/frameset.htm.

• For information about enterprise services, see wiki documentation at http://wiki.sdn.sap.com/wiki/x/kww and go to the Enterprise Services Workplace site at www.sdn.sap.com/irj/sdn/esworkplace.

• To coordinate visits or phone calls with companies using SAP ERP, con-tact your SAP sales representative.

APPENDIX


http://help.sap.com

http://help.sap.com/saphelp_erp2005vp/helpdata/en/a0/df293581dc1f79e10000009b38f889/content.htm

http://help.sap.com/saphelp_erp2005vp/helpdata/en/7c/fb0f3a57b38c0fe10000000a11402f/frameset.htm

www.sdn.sap.com/irj/sdn/esworkplace

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These materials are subject to change without notice. These materials are provided by SAP AG and its affi liated companies (“SAP Group”) for informational purposes only, without representation or warranty of any kind, and SAP Group shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP Group products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.

Summary The SAP® ERP application provides a single, powerful solution that lets you take a compre-hensive, broad-based approach to total quality management. It delivers a wide range of integrated quality management functionality and supports collaborative business processes for cost-effectively ensuring the quality of your products and processes and transforming quality management into a competitive advantage.

Challenges • Gain visibility into complex and global production cycles• Engineer quality into the design of new products and business processes• Track quality through procurement, production, and delivery• Keep pace with customer expectations and competitive pressures

Supported Business Processes and Software Functions• Inspection planning – Put quality strategies into action with integrated data and planning

tools• Quality inspections – Achieve and document reliable results while automating and

streamlining inspection activities• Problem management – Improve quality with targeted quality notifications and follow-up

actions• Test equipment management – Automate the calibration of critical equipment and main-

tain ongoing evaluations• Audit management – Continuously check processes, products, and systems and trigger

corrective actions

Business Benefi ts • Increased customer satisfaction and loyalty – Provide better product quality and

enhanced complaint management and tracking (corrective and preventive action)• Accelerated employee performance – Increase efficiency with automated tasks that

guide employees through key steps• Greater transparency – Make quality decisions based on reliable, integrated, traceable,

and accurate data• Enhanced collaboration – Integrate employees and business partners in your entire prod-

uct life cycle and the supply chain

For More InformationFor detailed information about SAP ERP, visit our Web site at www.sap.com/erp or contact your SAP representative.

Quality Management With SAP ERP - Functions in Detail (US)

Documents

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