SAP-QM_2008_Ueberblick_ERP60_EN.pdf

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 todays economy, you must invest in business software in order to invest in your companys 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 todays 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 companys 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 Its 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-tions 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

SAPSCM

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 companys 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 vendors 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 vendors 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 vendors 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?

12 SAP Functions in Detail Quality Management with SAP ERP12

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 vendors 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 customers 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 notifications 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, whi

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