Quality ManageMent With SaP eRP SAP Func PDF

SAP Functions in Detail
SAP ERP
Quality Management
with SAP® ERP
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
delivers 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.
CONTENT
4 To the Reader 38 Efficient Problem Management 58 Audit Management: Flexible

38 Improved Quality Through Tool for Planning, Execution,
5 Modern Quality Management: Targeted Problem Handling and Evaluation of Audits
An Integrated Management 38 Using Quality Notifications 58 Assessments: Methods for
Approach 39 Notification Processing Audit Criteria
5 Offering a Total Quality 39 Quality Notifications 58 Audit Processing: Evaluate
Management Solution 40 Elements of the Quality Risks and Confirm Information
6 Internal and External Integration Notification
40 Optimized Usage 60 Mapping SAP Solutions to
8 Quality Management with 41 Analysis of Items and Defects Your Six Sigma Initiatives
SAP ERP 41 Tasks
8 Take a Closed-Loop Approach 42 Support Functions 62 Service-Oriented Architecture
to Total Quality Management for Services-Based Business
9 The Planning Phase 43 Sustained Quality Control Solutions
11 The Implementation Phase Planning, Evaluation, and
16 The Usage Phase Direct Intervention 63 Appendix
43 Dynamic Modification of the 63 For More Information
18 Inspection Planning: Putting Inspection Scope 63 Key Terms
Quality Strategies into Action 44 On the Right Track with
18 Closed-Loop Inspection Plan- Statistical Process Control 64 Quick Facts
ning: Failure Mode and Effects 46 Vendor Evaluation: Permanent
Analysis and Control Plan and Objective Performance
20 Integrated Inspection Planning Monitoring
21 Basic Data for Inspection 47 Evaluations: Keeping You
Planning Up-to-Date
23 Planning Tools 50 Taking Control of Quality Costs
25 Quality Inspections: 51 Test Equipment Management

Achieving Reliable Results 51 Calibration Inspections and
25 Inspection Lot Processing SAP ERP
28 Inspection Results 51 Master Data in a Calibration
32 Sample Management Inspection
52 Planning a Calibration
34 Quality Certificates: Inspection
Guaranteed Reliability – 52 Calibration Inspection
Printed or on the Internet 54 Evaluations for Test Equipment
34 Certificate Processing in
Sales and Distribution 55 Enabling an Integrated
35 Certificate Creation – Enterprise Laboratory
Meeting Your Requirements Information Management
36 Certificate Processing at System with SAP ERP
Goods Receipt 55 The Enterprise LIMS Approach
37 Collaborative Business: 55 Stability Study – Supporting
Certificate Data for the Product Development and
Whole Company Product Improvement
56 Compliance and Quality Control
To the Reader
In today’s economy, you must invest in with ever-growing customer expecta-

business software in order to invest in tions and competitive pressures. In
your company’s future. It is important to short, you need to take a comprehen-
lay a trusted foundation for business sive approach to quality management –
excellence and innovation and to provide one that integrates information and
your organization with the enterprise processes across departments and
resource planning (ERP) functionality corporate boundaries and empowers
that is needed to gain strategic insight, both your employees and supply chain
competitive differentiation, increased partners to maintain and improve
productivity, and business agility. quality levels.
With the SAP® ERP application, SAP SAP ERP enables the comprehensive This document targets project plan-
has transferred its vision of increasing and efficient approach you need to ners, decision makers, and people
efficiency within an organization to soft- transform quality management into a interested in implementing QM with
ware for enterprise resource planning competitive advantage. SAP ERP deliv- SAP ERP. It explains how QM with SAP
that helps automate end-to-end busi- ers a wide range of integrated quality ERP is integrated in SAP Business
ness processes and extends those management functionality and supports Suite applications and service-oriented
processes to the entire business eco- collaborative business scenarios for architecture (SOA), powered by the
system, including customers, partners, cost-effectively ensuring the quality of SAP NetWeaver® technology platform.
and suppliers. With SAP ERP, you can your products and processes. As your It provides you with insight into the cur-
increase your employees’ productivity employees work throughout the entire rent functional scope of QM with SAP
and provide them with the insight product lifecycle along the supply ERP. It also shows how QM functions
needed to make decisions that set chain, SAP ERP helps ensure that qual- are integrated in SAP ERP and support
you apart from the competition. ity is efficiently built into your pro- the business processes of the supply
cesses, systems, and products, from chain.
Quality is a vital core competency for the shop floor to the top floor.
manufacturers industry-wide – and For detailed information about
given today’s complex and often global If you are considering implementing SAP ERP, visit our Web site at
production cycles, it cannot be treated or have already implemented quality www.sap.com/erp or visit the
as simply an afterthought. You have to management (QM) with SAP ERP in SAP Service Marketplace extranet
engineer quality into the design of prod- your company, and you want informa- at www.service.sap.com/erp
ucts and processes; you have to track tion on current functions and new (login is required).
quality through procurement, produc- developments, then this document
tion, and delivery; and you have to con- contains all the information you need.
stantly improve quality to keep pace
4 SAP Functions in Detail – Quality Management with SAP ERP

Modern Quality Management:
An Integrated Management
Approach
Offering a Total Quality Manage Audit Processes Stand Out at Quality Control
Management Solution The audit management functions of SAP ERP gives you quality control
SAP ERP let you plan, conduct, and functionality that supports strategic
The SAP® ERP application provides a evaluate audits throughout the enter- planning, continuous monitoring, and
single, powerful solution that lets you prise. You can perform internal or quick problem resolution. The applica-
take a comprehensive, broad-based external audits of systems, processes, tion lets you share quality information
approach to total quality management products, and environmental condi- and control quality processes across
(QM). Far more than a traditional iso- tions; conduct a range of assessments the supply chain. You can plan, con-
lated computer-aided quality system or and reviews; and monitor the effective- duct, and manage quality inspections –
a laboratory information management ness of all corrective and preventive and integrate them into processes
system, SAP ERP supports quality actions linked to quality notifications. throughout the product lifecycle. You
processes in any industry. All this helps you comply with legal can accurately track results and defect
requirements, support benchmarking data; record and charge inspection
Practice Continuous Improvement efforts, and uncover opportunities for costs; manage and maintain laboratory
You can quickly identify and analyze improvement. Audit management func- data related to samples, tests, and
problems, then rapidly eliminate their tions support a wide range of industry stability studies; automatically create
root causes. With the quality notifica- standards, such as ISO 9000:2000, quality certificates for customers and
tions functionality, for example, you can QS-9000, Good Manufacturing exchange that information with busi-
ensure that all problems and unplanned Practice (GMP), ISO 14011, and ness partners; and connect, monitor,
events are captured directly when they ISO 19011. and maintain test equipment to ensure
occur, that they are correctly assigned data accuracy.
and resolved, and that all actions are Deliver Quality-Related Information
monitored for maximum effectiveness. Where It’s Needed You can collect and analyze all the
A service-oriented approach allows Web-based enterprise portal technol- quality-related data needed to conduct
employees as well as business part- ogy and ready-made SAP content give Six Sigma projects. With the applica-
ners to create requests or notifications, your employees and your partners a tion’s built-in workflow functions, you
work together online to record informa- single point of access to all the infor- can automate and accelerate many of
tion, dispatch information, and track mation, applications, tools, and ser- your business processes. Meanwhile,
the processing status of requests – vices they need to collaborate on the SAP Manufacturing Integration
providing the full functionality needed quality initiatives. The intuitive, context- and Intelligence (SAP MII) application
to ensure corrective and preventive driven portal increases the reach of lets you rapidly integrate SAP ERP
actions. In addition, the analytic func- your quality management efforts to with other manufacturing software –
tionality of SAP ERP and the SAP include both everyday and occasional enabling production-line personnel to
NetWeaver® Business Warehouse users in quality processes. For exam- record inspection results directly from
(SAP NetWeaver BW) component ple, quality inspectors can work more the shop floor. Leveraging a service-
enables you to monitor quality perfor- efficiently by using the portal to access oriented architecture (SOA), SAP ERP
mance and adjust quality strategies to the specific work list they need to com- offers a wide range of enterprise ser-
eliminate problems. Using the flexible plete each inspection lot. vices for quality management. In an
QM cockpit for evaluations in SAP interconnected world, the ability to
ERP, for example, you can analyze both exchange data across applications and
online and archived quality manage- with various partners is rapidly becom-
ment data to support your company’s ing as important as statistical process
Six Sigma projects. control and test equipment interfaces.
SAP Functions in Detail – Quality Management with SAP ERP 5

SAP ERP is designed for easy integra- QM with SAP ERP is linked directly Using clearly defined roles, employees
tion with other SAP and non-SAP appli- to various functions that help you effi- can access their own work areas
cations for supply chain management, ciently manage your business pro- in SAP NetWeaver Portal. A role
customer relationship management, cesses. Examples of such functions describes a specific activity profile and
supplier relationship management, and include: groups together the corresponding
enterprise resource planning. As a • SAP Business Workflow tool for functions of that profile. Employees
result, it streamlines information shar- targeted process control can then target their involvement in
ing and supports true end-to-end Using SAP Business Workflow, you business processes. The flexible SAP
business processes. can establish a clearly defined infor- NetWeaver Portal allows you to adapt
mation and processing network to the roles to suit your individual needs.
Internal and External Integration quickly and efficiently process
inspection lots and quality
The openness of the SAP NetWeaver notifications.
technology platform and the seamless • SAP ArchiveLink® software for
integration of QM with SAP ERP into storing documents
a complete business solution support SAP ArchiveLink stores documents
you in total quality management and that are linked to application func-
satisfy the criteria for ISO 9000 or tions in an optical archive. Such
GMP. documents include quality records,
certificates, customer complaints,
In the integrated SAP Business Suite and other original internal or external
applications, SAP ERP functions are documents.
incorporated into other applications,
such as the SAP Supply Chain Man- In addition to SAP ERP, you can inte-
agement (SAP SCM) or SAP Cus- grate other SAP solutions in the SAP
tomer Relationship Management (SAP NetWeaver Portal component, such
CRM) application. You have software as SAP NetWeaver BW. You can also
support for all important processes. integrate non-SAP products. As a
result, you can adapt and enhance your
working environment to suit your own
requirements.

Service-Oriented
Architecture
Knowledge SAP
Management SCM
Sales and
Distribution
SAP External
NetWeaver® BW Customer Production URL
Service Planning
Plant Production Planning/

Maintenance Process Industries
Quality Planning Materials

Controlling
Quality Inspections Management
Quality Control
QM within Quality Certificates
SAP ERP Quality Improvement
Test Equipment Management
Classification SAP Business
Audit Management
Quality System Workflow Test Equipment
Manager Manager
Document
Office Management
Quality System Notification
Planner Engineering SAP Processor
Change ArchiveLink®
Management
Inspection Quality
Planner Inspector
Figure 1: Internal and External Integration of Quality Management with SAP® ERP

Quality Management with SAP ERP
Quality management with SAP ERP Take a Closed-Loop Approach

tightens control and contains costs. to Total Quality Management
Under current market conditions, many
Benefits:
organizations follow a twofold strategy: There is more to quality management • Increased customer
strive for continued growth and innova- than performing quality inspections
tion through competitive differentiation every now and then. Companies want
satisfaction through
and increase efficiency to meet the to focus on prevention of deficiencies, better product quality
enormous pressure to cut costs. In the continuous process improvement
end, you must be excellent in both to through collaboration, and sustainable
and enhanced com-
meet stakeholder expectations and quality control. You need to react plaint management
achieve financial success. You must immediately to unplanned quality-
reduce costs wherever possible, but related events, involve all affected
and tracking (correc-
avoid risks that might lead to unexpect- parties, and start follow-up actions tive and preventive
ed – and unbudgeted – expenditures. to solve or control an issue.
action)
QM with SAP ERP enables enterprises SAP ERP supports and helps ensure • Increased revenues
to manage quality in a highly efficient consistently high quality throughout the
way, differentiate their business, and supply chain. Companies can comply
by retaining custom
establish a reputation of excellence. continuously with legal requirements ers and strengthening
Conversely, mismanaging or ignoring and industry standards. Customer
quality issues negatively impacts a satisfaction goes up, as does overall
customer loyalty
company’s brand and products and product quality and customer service • Increased efficiency
impairs cost control. The best answer management.
is to put in place a comprehensive
through improved
approach to total quality manage- Because project management and asset utilization
ment along the entire supply chain. quality management functions are inte-
Enterprise-wide audit management, grated with the SAP ERP Corporate
quality engineering, quality assurance Services solution, you can run Six
and control, and continuous quality Sigma projects to further enhance
improvement are all aspects of it. By quality, improve processes, and reduce QM with SAP ERP supports you both
using QM with SAP ERP, organizations costs within your company. internally and externally. It provides
can comply with industry standards complete support, from product and
and legal requirements more easily, QM with SAP ERP supports key process planning in research and devel-
increase customer satisfaction, and business activities with a focus on opment (the planning phase); through
improve competitiveness. prevention of deficiencies, continuous procurement, production, and sales
process improvement through collabo- and distribution (the implementation
ration, and sustained quality control. phase); to service and usage (the
Comprehensive quality management usage phase), as shown in Figure 2.
functionality supports:
• Quality engineering
• Quality assurance and control
• Quality improvement
• Audit management

With the control plan, you can plan and
Disposal Market visualize all relevant inspections for a
research final product and all its components.
The control plan connects all informa-
tion from the related objects and is a
Maintenance Design basis for detailed inspection planning
for each step (in-process control,
goods-receipt inspections, and so on).
Testing
Usage Planning Document management
An important tool in SAP ERP is docu-
Shipping Production ment management. You can use docu-
planning ment management software to create
links between inspection outlines,
design drawings, technical delivery
terms, specifications, product specifi-
Implementation cations, inspection methods, and other
Warehousing Procurement quality-relevant documentation and
the corresponding master data. You
can manage data according to validity,
version, and status.
Final Production
inspection Master data management
During the implementation phase of
Figure 2: Quality Loop According to ISO 9004 your project, you specify product-
related settings that are required for
The Planning Phase process, a must for each supplier controlling quality-related processes in
in the automotive and other discrete the material master record in the quality
QM with SAP ERP supports the industries. management view of master data. For
process of quality management in the management of quality information
the planning phase. It comprises the SAP ERP provides tools for supporting related to materials, vendors, and cus-
following features and functions: this process; one is a tool for a failure tomers, and for the control of vendor
mode and effects analysis (FMEA) and and customer-related processes, you
Closed-loop inspection planning the other is the control plan. can maintain appropriate quality infor-
Closed-loop inspection planning means mation records. You can, for example,
integrated inspection planning for You can use the FMEA tool to perform assign quality assurance agreements
goods receipt inspections and for a risk analysis for a distinct object and perform model processing.
inspections during production, and it (material or operation) to identify possi-
starts at the very beginning of the ble defects of a process or a product. In material-related inspection plans, you
product development process for a By applying the given tools, you can can define either customer- or vendor-
new product. The international standard detect possible risks and eliminate specific inspection specifications and
ISO/TS16949 requires an advanced them by defining preventive actions multiple specifications related to further
product quality planning (APQP) at an early stage. objects. When you are performing an

inspection during production, these under controlled conditions for the within a problem notification can be
elements are integrated into the routing duration of the study. At specified transferred automatically to the
or recipe. intervals during the study, you remove organizational unit responsible.
these physical samples or parts of
You can make changes to the master these samples from the various condi- Quality costs
data centrally, and you can transfer the tions and test them according to You can enter, collect, and bill costs
data from one source system to one predefined inspection plans. You can related to the prevention of defects,
or more target systems. In addition, then use the results of these tests, inspections, and nonconformity to
there are tools available for research which have accumulated over the different account-assignment objects
and analysis of master data linked in course of the study, for example, to using orders in controlling.
a hierarchy, such as where-used lists check and confirm whether the desired
and the product structure browser. or guaranteed life expectancy of the Key figure analysis
product conforms to the predefined With its quality key figures, SAP
Engineering change management recommendations for storage. NetWeaver BW offers a wide range of
Central engineering change manage- possibilities for monitoring and control-
ment coordinates the changes you As a business process, the stability ling your quality processes.
make to master data. You can run such study is fully integrated in SAP ERP,
changes through an approval procedure using functions from the following Audit management
(for example, according to GMP areas: With integrated audit management
requirements). You can create different • Quality management: quality notifica- tools you can plan and process audits,
versions and then distribute them using tions, quality planning, and inspection grade audit objects, monitor corrective
workflow. You can also allocate a revi- lot processing and preventive actions that are based
sion level with regard to a specific valid- • Asset lifecycle management: mainte- on the findings, and document and ana-
from date when a change is made. nance planning and scheduling lyze audit data. Audit management, as
• Materials management: material part of SAP NetWeaver and thus also
Classification master, batch management, and bills part of SAP ERP, supports all apprais-
Using the integrated classification func- of materials als based on predefined criteria (audits,
tion, you can specify and assign data checks, inspections, reviews, and
that is available in SAP ERP (such as Authorization management examinations) and can subsequently
materials, documents, and inspection A central administration function is be used to valuate the object.
plans), in order to be able to locate this responsible for data security and
data later according to specific search protection. You can assign individual The audit management functionality
criteria (such as batch characteristics). authorizations for the processing of is very versatile and can be used for
master data and movement data. This various application areas. Examples
Stability study enables you, for example, to set up of audit usages are:
Stability studies or shelf-life studies are employees so that they have to provide • Quality management (system audit,
conducted to track and examine how a digital signature when performing process audit, or product audit) and
different environmental conditions (for certain operations. GMP
example, temperature, light, or mois- • Environment and hygiene
ture) affect a compound, a material, or Business workflow management
a batch over a specified period of time. You can use business workflow to con- • Safety and security management
Using features and functions in SAP trol certain complex processes and (facility safety, fire safety, or data
ERP, you create physical samples of the output associated with these pro- protection)
the material or batch and store them cesses. For example, corrective tasks

Six Sigma cannot adhere strictly to customer and handles inspection certificates
Having SAP ERP and SAP Business specifications. and goods receipt inspections.
Suite in place in your company allows • Production. QM with SAP ERP inte-
you to implement your Six Sigma For this scenario enterprise services grates inspection specifications in
initiative. SAP ERP supports most of are also available to create and main- routings and recipes, allows inspec-
the elements that are essential for Six tain notifications in SAP ERP. tions during production and goods
Sigma, such as the definition of a receipt inspections for the manufac-
structured problem-solving road map Collaborative scenario: turing order to take place, monitors
such as DMAIC (define, measure, quality certificates the production process using control
analyze, improve, and control); a clear Working with your customers or ven- charts, and confirms quality, quantity,
setup of tasks and responsible persons dors, you use certificate profiles to and costs.
by using collaborative projects soft- plan exactly which characteristics are • Sales and distribution. QM with SAP
ware; the calculation of risks and costs; to appear on the certificate. This certifi- ERP manages customer-related mas-
the linking of related documents, notifi- cate data can be exchanged electroni- ter data, controls the sales and distri-
cations, inspections, and audits; the cally using quality data interchange bution process according to quality
determination of capability and perfor- (QDI), or it can be stored on the Inter- criteria, and handles inspection certif-
mance indicators, for example, from net. For example, you can store it as icates and inspections at goods
statistical process control (SPC) moni- a PDF document. issue.
toring of control charts and Cpk index;
and a failure mode and effects analysis. Collaborative scenario: Procurement
results recording Vendor evaluation
Process data can be extracted from You can record inspection results using Materials management provides infor-
the source and transferred into SAP the Internet or intranet. Results can be mation for the purchasing agent about
NetWeaver BW and an executive infor- recorded by external service providers a vendor’s delivery reliability, price
mation system for general analysis (for example, commercial analysts) and record, and service record. QM with
purposes. SAP NetWeaver BW and the internal inspectors (for example, in a SAP ERP provides the purchasing
executive information system provide source inspection) in their respective agent with information about quality
all the functions needed for calculating work centers. management used by the vendor and
key performance indicators (KPIs), the quality of previously delivered
feeding balanced scorecards, or other For this scenario enterprise services goods. To do this, SAP ERP summariz-
assessment techniques. are also available to trigger and record es quality scores from vendor audits,
inspection results in SAP ERP. goods receipt inspections, and com-
Collaborative scenario: plaints against the vendor.
quality notifications The Implementation Phase
In the product development stage, Vendor release
if you are working with customers or QM with SAP ERP helps ensure quality In some industry sectors, vendors must
partners, QM with SAP ERP offers you across the entire supply chain and have a quality management system in
the opportunity to initiate product ideas beyond company boundaries. It sup- their company. Such a system might, for
or changes to products using quality ports your quality management example, be required to be compliant
notifications. Customer complaints, department in the following activities: with the ISO 9000 series of standards.
which can be entered on the Internet, • Procurement. QM with SAP ERP Such vendors must have this system
can be used to determine product qual- manages vendor-related master data, certified by an accredited organization.
ity. Vendors can ask for permission to controls the purchasing process Your SAP ERP application checks if the
deviate from specifications if they according to certain quality criteria, quality management system used by the

vendor is adequate for certain materials Source inspection Goods receipt certificate
and then either releases or blocks the Occasionally, inspections can be per- If you have identified that a material
supply relationship accordingly. formed at the vendor’s premises to requires a certificate, the receipt of
replace a goods receipt inspection. this certificate must be confirmed.
You can limit the release of this supply If this occurs, the software takes the SAP ERP takes appropriate action if
relationship to a specific time frame target delivery deadline into account the certificate is missing (for example,
and a maximum delivery quantity. If the and creates an inspection lot in time posting the goods to blocked stock).
vendor has serious quality problems, for the source inspection. You can now SAP ERP supports the management
you can block requests for quotations, perform a source inspection at the of the certificate receipt process and
purchase orders, or goods receipts for vendor’s site, because it is possible sends reminders if necessary (see
specific materials supplied by this for you to access SAP ERP using Figure 3). You can manually create the
vendor. SAP NetWeaver Portal. This is possi- certificate and store it in the optical
ble even if the vendor does not use archive (SAP ArchiveLink), or you can
QM with SAP ERP also monitors the SAP ERP. send it in electronic form. Certificate
step-by-step release of a material. data can be transferred directly to the
Vendor deliveries must sequentially goods receipt inspection lot using elec-
pass through a series of customer- tronic quality data interchange.
defined statuses, such as model,
preliminary series, and production
series, using appropriately assigned
inspection plans.
In many industry sectors, suppliers Goods Receipt Reminder

are intermediaries (distributors), which
Certificate
means that the quality of produced Requirement
goods is dictated primarily by the Inspection Lot:
manufacturer rather than the vendor. Confirm receipt when or after
making usage decision
Consequently, you can apply the
following functions to a manufacturer: No
vendor release, inspection planning, No Inspection Lot:
dynamic modification of the inspection Post goods to blocked stock
scope, and complaints against the
vendor. Certificate
Included?
Quality assurance agreement,
technical delivery terms, and
Yes
certificate requirement
When the purchasing agent requests a Update Certificate Record
quotation and issues a purchase order,
vendors that are released receive infor-
mation automatically about the technical
delivery terms and the current quality
assurance agreement. Vendors may also
be required to include a quality certificate Figure 3: Certificate Processing at Goods Receipt
with the delivery.

Dynamic modification Recording inspection results Inspection completion
If the quality of a supply relationship is and defects The processing of an inspection lot
consistently high, you may want to You can record the results for the in QM with SAP ERP ends after the
waive the goods receipt inspection, goods receipt inspection in the form inspection is completed and the usage
particularly if the vendor has a certified of inspection characteristic values and decision is made (see Figure 4). The
QM system. For partial lots, you can defect data records or texts. If serious accepted inspection lot quantity is
set the software to inspect a goods problems arise during a goods receipt posted manually or automatically to
receipt only once for each purchase inspection, a quality notification can be unrestricted-use stock. Special stock
order, goods receipt, or batch. If you created automatically. Inspection results postings are available to you for
do not want to waive the goods receipt can also be recorded automatically rejected quantities, including posting
inspection completely, you can reduce using electronic measuring equipment. to blocked stock, transfer posting to a
the scope of the inspection as far as different material, returning to the ven-
the quality level allows. The reduction Appraisal costs dor, or posting to scrap. If the material
of the inspection scope may lead to a Costs are associated with every is handled in batches, the software
skip lot. If you allow a skip lot and an inspection and defect. Appraisal costs proposes a batch status that is com-
automatic usage decision for a materi- are determined using the activity patible with the usage decision.
al, the software processes skipped lots confirmations of the people involved
without intervention. It then immediate- in an inspection. You can allocate the Once the usage decision is made,
ly posts the inspection lot quantity to costs that are calculated on the basis SAP ERP updates the quality level and
unrestricted-use stock (ship to stock). of these confirmations for one or more the QM information system and makes
inspection lots in several QM orders, the quality score of the inspection lot
Receiving inspection and you can then pass them on to available for the vendor evaluation.
If the prerequisites for ship to stock the cost object. Costs associated SAP ERP also updates material and
are not fulfilled, SAP ERP automatically with defects are settled using quality vendor information in the quality data
triggers inspection lot processing upon notifications. record. For example, once the
goods receipt. In addition to the goods inspection lot has been completed,
receipt document, the application
also creates an inspection lot record,
selects an appropriate inspection plan,
and determines the sample size based Purchase
on the quality level. Order
No Quality
Physical-sample drawing Notification
If goods are delivered in containers, Goods
you can take samples in accordance Receipt
Inspection
with a sample-drawing procedure. The
documents you need (such as sample-
drawing instructions, sample labels, Stock in Quality Unrestricted-
and inspection instructions) are avail- Inspection Use Stock
Yes
able for printing immediately. You can
then proceed with the inspection. Figure 4: Inspection Lot Processing at Goods Receipt

the status of the supply relationship Production Inspection lots for an inspection during
can be updated from model delivery Materials planning production can be created in the follow-
to regular delivery. When you are inspecting raw materials ing ways:
or semifinished products, the planned • As an inspection lot during produc-
SAP ERP can trigger a series of user- duration of the receiving inspection is tion when a production order is
defined follow-up actions on the basis taken into account in materials released. This is not stock relevant.
of the usage decision. For example, planning. • As an early inspection lot at goods
you can print specific inspection receipt. This is stock relevant; in
reports. Inspection during production other words, the stock in the quality
QM with SAP ERP integrates quality inspection is managed using the
Invoice verification inspections into the production process usage decision for the inspection lot.
If invoices for the delivery of goods are (see Figure 5). It supports different • When goods are received from a
received before the usage decision is types of production, from order-related, subcontractor for external processing
made for the goods receipt inspection lot-based production and the assembly operations. This can be stock rele-
lot, you can prevent an automatic pay- process in mechanical engineering, vant, depending on software
ment during invoice verification. through repetitive manufacturing in the settings.
automotive industry, to batch-based
Complaints against the vendor process manufacturing in the chemi- Physical-sample drawing
Defects in delivered material that have cals, pharmaceutical, and food and The sample size is calculated, and shop
been caused by the vendor or manu- beverage industries. papers (such as sample drawing,
facturer can be documented in a quality inspection instructions, and sample
notification. You can use SAP Business You can initiate inspections on the labels) are printed at previously deter-
Workflow to pass this notification on to basis of different types of goods move- mined work centers after the valid
the processor responsible. The proces- ments. Inspection lots can be created routing or master recipe has been
sor can then initiate various tasks (such automatically when a material compo- selected.
as posting to blocked stock or sending nent is removed or when a product for
a complaint against the vendor). Com- the production or process order is pro- Digital signature
plaints can be entered on the vendor’s cessed at goods receipt. You can set the software to require a
Web site. digital signature (electronic signature)
from the employee who releases the
physical-sample drawing, records
Inspection Lot 1 Automatic results, or makes the usage decision,
4711 Defects
Recording
to ensure that this particular employee
has the appropriate authorization.
Inspection Point Quality Inspection results

Notification and defects recording
Characteristic Target Actual
Inspection results can be recorded
Length 50.0 mm 49.8 mm
for the following objects:
Width 30.0 mm 31.2 mm
• Inspection characteristics
Tasks
The results can be recorded in sum-
marized form, in classes, or as single
values.
Figure 5: Inspection During Production

• Inspection points the results of an initial run. If an action follow-up actions. QM with SAP ERP
Several inspections are performed limit is exceeded, messages and notifi- provides a digital signature for the
for each inspection characteristic. cations can be created. usage decision.
Inspection points can be user-
defined, and they can be planned Appraisal costs and production Sales and Distribution
in advance if necessary. They can quantity confirmations Quality assurance agreement
be related to production quantities When you are recording inspection and technical delivery terms
or production times (for example, results, you can also confirm produc- You can store customer-related quality
inspection of a wire basket or silo tion quantities and costs for the pro- documents in the quality information
once during each shift or every two duction order (see Figure 6). Such record for sales and distribution. In
hours). confirmations control the subsequent addition, you can use this quality infor-
• Physical samples production process (for example, the mation record to control the time and
These can be planned in advance release of inspection operations or type of a quality inspection.
using a sample-drawing procedure, subsequent work that has yet to be
or they can be unplanned. performed). Variant configuration
• Partial lots in the sales order
Production quantities of the same Inspection completion At the time of sales order creation,
quality can be grouped together. The inspection is completed when the customers can specify quality charac-
• Batches usage decision is made. Employees teristics for the desired variant. This
Inspection results can be used for with appropriate authorizations can information then flows into all inspec-
batch determination at a later stage; post stock quantities, classify charges tions during production in the form of
for example, they can be applied according to their quality, and perform inspection specifications.
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 control

The 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 Figure 6: Quantity Confirmation and Inspection Point Valuation

Batches determination Processing complaints Resource-related billing document
If you manage the stock of a material in and handling returns After the inspection results have been
batches, QM with SAP ERP allows you You can create customer complaints as confirmed, you can invoice the customer
to select suitable batches at delivery quality notifications on the Internet. You for the inspection costs.
using batch characteristics. These can document defects and tasks, and
characteristics can be populated with you can also perform various follow-up Inventory Management
quality results via valuation based on functions using the action box. For Stock categories
multiple specifications. example, you can process returns or Materials management categorizes
repair orders, enter costs, perform inventory by the following stock types:
Inspection for delivery stock postings, or trigger inspections. unrestricted use, blocked, and in quality
or for goods issue inspection. Usually the specified quanti-
Inspection lots can be created at the The Usage Phase ty of a received material is posted to
picking stage or at goods issue. After inspection stock for the duration of the
you have chosen a suitable inspection In the usage phase of the product life- goods receipt inspection. This stock
plan, the sample size is calculated and cycle, service providers can process can only undergo a transfer posting
shop papers (sample-drawing items, inspections (outsourcing) with QM with during inspection lot processing. For
inspection instructions, and sample SAP ERP. Service providers can use example, when the usage decision is
labels) are printed. When the inspec- SAP ERP to identify items, plan and made, it can be posted to unrestricted-
tion results have been recorded, the confirm services, and create invoices use stock. In the inspection lot, you can
inspection is completed with the usage for services rendered. view all of the posting documents that
decision. relate to the lot stock.
Service
Certificate at goods issue Variant configuration Warehouse management
At goods issue, you can use a quality in the sales order If you use warehouse management
certificate to document that the inspec- Inspection laboratories perform inspec- software, SAP ERP also manages the
tion results are in accordance with the tions as a service (commercial analy- inspection lot samples and units created
customer’s specifications. You can sis). When creating the sales order, due to the usage decision or while locat-
enter inspection characteristics from these laboratories can select the ing a storage bin. The inspection lot
the inspection plan and characteristics inspections requested by the customer identifies each unit and transfer require-
that were defined in the batch determi- from inspection plans and transfer ment. Using the strategy defined for
nation as inspection specifications on them into a service order. placement in storage, the software trig-
the certificate. The form, content, and gers the transport of samples and par-
means of output are customer-specific. Service order inspection tial quantities, and it posts the stock.
These are derived from the specifica- Inspections can be selected using vari-
tions made by the recipient of the cer- ant configuration in the sales order or Handling unit management
tificate at picking or at goods issue. by selecting inspection operations in You can use handling units as transport
the service order. Once the inspections units. A handling unit is a physical unit
Quality data interchange have been selected, inspection lots consisting of packaging and the goods
Formatted quality data contained in a can be created when the service order stored with or on this packaging. The
quality certificate can be sent electroni- is released. Then the inspection can software enables you to move these
cally and then automatically transferred begin, and inspection instructions and handling units, as opposed to just mov-
into an inspection lot at the customer sample-drawing items can be printed. ing the materials. Therefore, a quality
site. It is also possible to make this inspection can be performed with refer-
data available on the Internet. ence to handling units.

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 tracking
The 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.

Inspection Planning: Putting Quality
Strategies into Action
As inspection planner or quality all components, and is the basis for the FMEA is an analytical method for early
engineer, you implement predefined third step, maintaining the operational detection and elimination of possible
planning strategies in your company. inspection plans and routings. failures and issues in products and
This includes: processes. In the context of quality
• Performing closed-loop inspection As soon as the product is produced, management, this method is used for
planning with FMEA and control plans the supplier has to implement a closed- preventive failure avoidance. SAP ERP
• Defining the trigger, type, and scope loop process starting with a continuous offers tools for monitoring as well as a
of quality inspections improvement process. Each internal or cockpit for building an FMEA product
• Creating and managing task lists as external complaint must be checked or process structure. FMEA can be
the basis for quality inspections against the preventive actions, which used for root-cause analysis in Six Sig-
• Managing and processing the basic have been defined in the FMEA during ma projects, risk assessment during
data used in task lists the first step of the closed-loop inspec- product development, and operational
• Determining the procedure for statis- tion planning. One result of the com- quality control and planning. FMEA sup-
tical process control plaint could be to change the FMEA ports compliance with ISO/TS16949
and control plan as well as operational (automotive industry).
To complete these tasks, you can use plans.
the reusable basic data as building
blocks and a flexible planning tool.
Closed-Loop Inspection Planning: Specification FMEA

Failure Mode and Effects Analysis Defects Complaints Defects
(Product/
and Control Plan Characteristics Characteristics (8D-Method) Characteristics
Process)
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 CAD SPC
product development process for a Control Defects Defects
new product. Plan Characteristics Zero-Defect Characteristics
Stamping
Production
Typically the closed-loop inspection Characteristics
planning process comprises the follow-
ing steps:
The first step is to work in a team of

experts from different departments to Inspection Defects
create an FMEA. In doing so, the prod- Plan Characteristics
uct and process characteristics with
a high safety risk are pointed out. In 8D = eight disciplines
a second step, these characteristics CAD = computer-aided design
are transferred into a control plan. The FMEA = failure mode and effects analysis
SPC = statistical process control
control plan gives an overview about all
inspections for a final product, including Figure 7: Closed-Loop Inspection Planning According to ISO/TS 16949

The FMEA cockpit and monitor offer In addition to FMEA, there are func- Within the closed-loop inspection plan-
the possibility of a hierarchical display tions for managing a control plan to ning, you usually start an FMEA for a
of the object, machine, or system being ensure a closed-loop inspection plan- product to evaluate product- and
inspected for possible failures (see ning that is required as an international process-related characteristics with a
Figure 8). With the help of a hierarchical standard according to ISO/TS16949. high failure risk. These characteristics
or a linked structure, the entire chain of are transferred into the control plan.
failure mode, causes, and consequences A control plan is the description of the The control plan includes an overview
can be viewed and investigated. entire technical or functional system of all inspections that are relevant for
that is being monitored or checked for a particular product and all its compo-
With risk-priority numbers you can possible risks and defects. Fundamen- nents. This is the basis for developing
evaluate and estimate the defect cause tally, the control plan describes all the inspection plans and inspection opera-
of a failure. The necessary actions to actions that need to be performed in tions in the subsequent production
diminish or avoid a failure can be each phase of the process. This process.
managed with the FMEA tool as well. includes the inspection of the goods
Furthermore, there is a connection receipt, the goods shipment, and the Once a product is part of serialized or
between the FMEA of one element scheduled inspections and quality con- mass production, it is still necessary to
with the lists of those of subordinated trol activities that make sure all process check the previously defined risks as
and superordinated elements. Those results are controlled and documented well as the control plan itself. In the
lists contain not only the addressed (see Figure 9). course of the continuous improvement
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.
Figure 8: Example of FMEA with Structure

process, it may be necessary to adjust
the FMEA or the control plan.
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,
Figure 9: Example of Control Plan vendor assignment, or validity of
certain lot-size intervals.
Task List Group
Task List Structure
Inspection Plan 1 Inspection Plan 1 As shown in Figure 10, a task list con-
Material 1 sists of the task-list header, operation,
Inspection Plan 2 Material 2 characteristic, and test equipment.
Task List Header
Inspection Plan 3 Vendor 1 Task-list header

Operation 1 Vendor 2 You define the following information in
Inspection Plan 4 Operation 2 Customer 1
the task-list header:
Customer 2
• Material task-list assignments
Operation 3
Assignment of a task list to materials.
Inspection Plan 5
Characteristic 1 For example, you can assign several
materials to a task list. There can be
Inspection Plan 6 Characteristic 2 several task lists for one material.
Method 1 You can also assign inspection plans
Inspection Plan 7 Operation 4
to a vendor or customer, in addition
to the material.
Figure 10: Task List Structure

• Administrative data • Define multiple specifications for inspection characteristic master record
This type of data can include the additional objects (such as country) (master inspection characteristic). Mas-
validity date, change status, to determine the suitability of a prod- ter inspection characteristics can be:
responsible planner group, task-list uct or batch (for example, suitable for • Referenced in several task lists or
usage, and processing status. specific countries and not suitable for material specifications
• Control data a list of others) • Linked to characteristics with the
This type of data can include the • Specify with which equipment the classification function, for example,
dynamic modification rule for characteristic values must be to transfer inspection results for a
adapting the inspection scope. measured batch to the batch classification
Operation Basic Data for Inspection Planning Inspection Method

You can maintain the following informa- An inspection method describes how
tion for each inspection operation: Basic data consists of reusable building a characteristic is to be inspected.
• A description of the operation and blocks for inspection planning (see You can assign documents that are
control parameters for the operation Figure 11). To simplify your work as an stored in a document management
• Reference to a work center inspection planner, you should plan and system (such as drawings and descrip-
• Specifications for scheduling and include this data in your task lists. tions) to an inspection method. Inspec-
calculating the appraisal costs tion methods are assigned to master
• List of relevant test equipment, Inspection Characteristic inspection characteristics or inspection
documents, and production resource An inspection characteristic describes characteristics in task lists. You can
tools what should be inspected. You can cre- assign several inspection methods to
ate an inspection characteristic directly a master inspection characteristic.
Characteristic in a task list or predefine it as an
In the inspection characteristic, you
can:
• Specify the characteristic description
and define the control parameters for
Task List Header • Dynamic modification rule
results recording • Sample-drawing procedure
• Reference an inspection method,
sampling procedure, or a dynamic Material • Reference operation set
modification rule • Work center
Inspection
• Define qualitative or quantitative Operation • Material
specifications for the inspection and • Equipment
results recording, depending on the Test
Equipment • Other production resources and tools
characteristic type • Document
• Define individual specifications for Inspection
Characteristic • Master inspection characteristic
every task-list assignment to a • Inspection method
material, vendor, or customer. This • Sampling procedure
means you do not have to create • Dynamic modification rule
redundant inspection plans to modify • Catalog
customer- or material-dependent
target values and tolerances. Figure 11: Inspection Plan Structure and the Use of Master Data in Inspection Plans

You can plan independent and depen- inspection characteristics. You can also
dent multiple samples and record the assign a dynamic modification rule
inspection results from several samples to the inspection type in the material
for an inspection characteristic. Each master (inspection-type level) or at the
of these samples may contain several header or characteristic level in the
values, and each is valuated individually. task list.
On the basis of the individual sample
Catalog results, SAP ERP automatically deter- Test Equipment
A catalog is a summary of codes for mines the characteristic result (for Test equipment consists of fittings,
content-related terms. Catalogs can example, based on the worst-case objects, documents, or materials that
make it easy to uniformly describe qual- principle). are needed for a quality inspection.
itative data (for example, attributes for Test equipment can be fixed parts of
qualitative characteristics, defect types, Ready-to-use sampling schemes in a work center or consist of moveable
or usage decisions). For each catalog, accordance with ISO 2859-1 for quali- equipment. In the inspection plan, you
you can: tative inspections and ISO 3951 for can represent test equipment using
• Define code groups with codes and quantitative inspections are delivered various master records, such as
enter explanatory texts in different with SAP ERP and any upgrades. You production resource or tools (PRT),
languages can also create your own acceptable material, equipment, or documents.
• Select codes from one or more code quality level (AQL) sampling schemes
groups and combine them in a select- and define rules for automatic stage The PRT master record contains
ed set. This allows you to create a changes up to an inspection skip. You administrative data and information
value list that applies to a specific can also implement industry-specific relating to status, location, and a
situation. procedures. possible PRT group assignment. If
you use the classification function, you
Sampling Procedure Dynamic Modification Rule can define additional properties. In
and Sampling Scheme In a dynamic modification rule, you addition, you can reference document
The sampling procedure specifies how define the number of inspections and master records from the PRT master
the sample size is calculated and how skip stages, and the rules that control record or use document master
the inspection characteristic is valuated such stage changes, either in accor- records as test equipment in task lists.
(attributive, variable, or manual). You dance with appropriate standards such You can access drawings and other
assign sampling procedures in the as ISO 2859-3 or to suit your own documents using the document man-
material master or in the task list at requirements. The sample size may vary agement interfaces to computer-aided
characteristic level. between a 100% inspection and a skip. design (CAD) systems or to SAP
When you use a sampling scheme, the ArchiveLink.
QM with SAP ERP supports all common software switches between a normal,
sampling types (for example, 100% reduced, and tightened inspection, Work Center
inspection, sample based on percent- depending on the quality level. The work center specifies where an
age, fixed sample, and sample in accor- operation is to be performed and
dance with a sampling scheme). If the The inspection stage is then changed who should process it. The available
sampling types and valuation rules pro- depending on the inspection results for personnel and machine capacities are
vided with the standard software are inspection lots or characteristics. You also managed by the work center. You
not sufficient, you can supplement them can control the dynamic modification of provide the basis for capacity planning
with your own self-defined function the inspection stages either by accept- and scheduling of operations when you
modules. ing or rejecting the inspection lot or specify in task lists the work centers

in which the operations are to be • Generate work lists for processing • Display documents defined in a docu-
performed. data within task lists (for example, by ment management system in your
selecting task lists that use a certain own work area (for example, techni-
Each work center is assigned to a cost dynamic modification rule or sampling cal drawings)
center. The activities in a work center procedure)
are valuated using rates that are deter- • Process individual operations from Product Structure Browser
mined by cost centers and activity types different task lists in one work step Using the product structure browser,
(for example, working time or quantity). • Simultaneously process complex you can hierarchically display related
In a single step, you can record both task lists by selectively blocking objects in a product structure. During
inspection results and the activities per- objects (at task-list header or opera- inspection planning, for example, you
formed. You can also generate work tion level) can determine whether task lists or
lists for specific work centers when • Create where-used lists (for example, material specifications exist for a cer-
you record results or make a usage for PRT, dynamic modification rules, tain material. If you expand the product
decision. sampling procedures, sample- structure further, additional detailed
drawing procedures, and selected
Reference Operation Set sets)
In a reference operation set, you define
frequently required inspection opera- Operations Processing area Validity area Context block
tions and corresponding inspection overview • Change number • Key date
characteristics. A reference operation • Key date • Time frame
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, Structural Detail screens Integration into
display document
including the following:
management
Figure 12: Inspection Planning with the Engineering Workbench

information can be displayed (such as Stability Studies You can execute the process steps in a
inspection characteristics and SAP ERP provides a comprehensive stability study using follow-up functions
documents). planning tool for stability studies or in the quality notification’s action box.
shelf-life tests. You can readily enhance or modify
Where-Used Lists individual follow-up functions without
A where-used list shows you the task The special quality notification type making any software modifications.
lists in which master inspection charac- “stability study” is the central business Approximately 20 follow-up functions
teristics, inspection methods, and sam- object that represents a stability study are currently available for process
pling procedures are used. in the application. All of the following steps in a stability study.
objects created in the course of a
Mass Data Changes study are assigned to the quality
With the function for mass data chang- notification: Benefits:
es, you can adapt objects from the • Initial sample
where-used list (master inspection • Stability bill of material (BOM) • Integrated inspection
characteristics, inspection methods, or • Various documents planning
sampling procedures) to suit new con- • Inspection lot for initial test
ditions. You can also use this function • Physical samples (stability samples • Lighter workload as
to create and change inspection setup for storage conditions) a result of modular,
data in the material master. • Testing schedule for storage condi-
tions with corresponding inspection reusable basic data
Engineering Change Management plans • Efficient management
QM with SAP ERP maintains separate • Inspection lots for stability tests
engineering change statuses for each of inspection data
structural element in a task list. When You can assign other objects that are using mass process-
you make a change using a change defined as business objects in SAP
number, you can determine what was applications to the stability study. Using ing tools
contained in a plan at a specific date the document flow function for quality • Parallel task-list
and the date on which a change is to notifications, you can graphically dis-
become effective. play all objects assigned to a study and processing using
their relationship to one another. the engineering
Cross-System Transfer of Master Data
Using proprietary SAP technology for Based on this setup, you can trigger workbench
application link enabling, you can trans- various process steps that need to be • Time and money
fer specific basic data (for example, executed in the course of a stability
inspection setups, inspection methods, study, including the following: savings with cross-
inspection characteristics, and catalog • Creating and confirming the initial system data transfer
or code groups) from a source system sample
to one or more target systems. This • Assigning and processing the stabili- by means of applica-
means that it can be quick and easy to ty BOM tion link enabling
transfer basic data used in one plant to • Defining storage conditions
another plant. • Creating and maintaining the testing
schedule
• Starting the initial test

Quality Inspections:
Achieving Reliable Results
As a quality inspector, you are respon- Inspection Lot Processing There are different variants for inspec-
sible for proving that a material meets tion lot processing. In QM with SAP
predefined quality requirements. With Supported by quality planning specifi- ERP, these are defined as inspection
QM with SAP ERP, you can show that cations, inspections supply important types (for example, goods receipt
these requirements have been met. data for quality control purposes (see inspection and inspection during pro-
Inspections can be triggered for inspec- Figure 13). The inspection lot is the duction). The variants include:
tion points during production, for physi- central element for the quality inspec- • Inspection with or without a task list
cal samples in the process industry, tion in QM with SAP ERP. It contains or material specification
or automatically for goods movements. all information related to the quality • Recording of inspection characteris-
inspection, such as inspection specifi- tic results and defect data
Planned inspections in QM with cations, inspection results, and usage • Manual or automatic specification
SAP ERP can be used to document decisions. assignment, sample determination,
quality using quantitative and qualitative and usage decisions
inspection results. In addition, you • Control of inspection stock posting
can also create a record of unplanned
events in the form of defect data or
quality notifications.
Create inspection lot
For all quality inspection tasks, SAP Inspection Lot Select inspection specifications
ERP and SAP NetWeaver provide you Creation Determine samples
with the tools you require for the role of
Print shop papers
quality inspector, as well as the oppor-
tunity to customize the settings:
Confirm activities
• With SAP NetWeaver Portal you
have a role-based portal with work Complete inspection
Inspection
centers that are tailored specifically Record defect data
to the needs of the quality inspector
Request characteristic inspection results
for results and defects recording,
notification creation and processing,
Perform follow-up actions
confirmation processing for produc-
tion orders, and execution of quality Update QM information system
reports. Inspection Lot Update quality level
• With QM functions in SAP ERP you Completion
Determine quality score
have support for all the required
steps for recording and documenting Make usage decision
quality-related data as well as tools
for integrated processing and evalua- Figure 13: Stages in Inspection Lot Processing
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.

Determining
Creating Determining Printing shop
the inspection
inspection lot the sample papers
specifications
Figure 14: Inspection Lot Creation
Inspection Lot Creation Examples of shop papers and their con- Direct transfer of inspection results is
QM with SAP ERP generally creates tent include the following: possible if you link electronic test
inspection lots automatically (see • Sample-drawing instructions contain equipment to SAP ERP. You can also
Figure 14), but you can also create the information required for the record inspection results for serial
lots manually. Inspection lots may be physical-sample drawing and for numbers and batches, and you can
created as a result of the following: distributing samples to work centers transfer the inspection results recorded
• Goods movements (for example, or laboratories. in SAP ERP to batch classification.
goods receipt, goods issue, stock • Physical-sample labels are used to
transfer, and returns from a label samples. Flexible specifications
customer) • Inspection instructions list informa- Flexible specifications are used to influ-
• Deadline monitoring for batches tion about the test equipment and ence the specification data on creation
(recurring inspection) inspection characteristics for each of an inspection lot or during results
• Release of production orders, pro- inspection operation and specify the recording. Flexible inspection specifica-
cess orders, maintenance orders, inspection methods, specifications, tions allow you to select or deselect
service orders, and production and sample size for each inspection the relevant inspection characteristics
versions characteristic. Quality inspectors can and adjust the given specifications as
• Delivery creation in shipping record inspection results on the needed. As a standard setting in the
inspection instructions, if the layout SAP ERP application, the process is
For inspections with an inspection plan, is suitable. active for inspection lots related to a
SAP ERP selects the corresponding stability study. However, it can also
inspection specifications (for example, Inspection be of interest for other business sce-
the inspection plan or material specifi- During an inspection, you can: narios, where inspections cannot be
cation). If a customer has specific prod- • Record, valuate, and close inspection planned completely in advance, such
uct requirements, these can be copied results for characteristics as the following:
from variant configuration or batch • Record defect data and quality • Inspection performed as a service
determination to the inspection. Shop notifications • Inspection of a complaint
papers are printed, and inspection • Confirm activities • Inspection for a stability study
results are recorded on the basis of the
inspection specifications.

Authorization for the usage decision
The usage decision has significant
Making the Determining Updating the Performing consequences. Using material-specific
usage decision the quality score quality level follow-up actions authorizations and digital signatures,
you can ensure that only authorized
users can make the usage decision.
Figure 15: Inspection Lot Completion
Quality Inspection Engine
In all cases, an inspection plan or rout- the usage decision (for example, post- With the quality inspection engine, you
ing with inspection characteristics is ing to unrestricted-use stock or return can integrate quality inspections in vari-
the basis of a maximum plan, and dur- to vendor). ous SAP applications in SAP Business
ing a flexible specification the relevant Suite, as well as in non-SAP applica-
characteristics are selected. Quality score tions. The quality inspection engine
If the usage decision has been made, supplements the comprehensive quality
Note that the activation for additional SAP ERP determines the quality score management software supplied by SAP
processes, in addition to the stability for the inspection lot using a procedure ERP and was designed for use in a het-
study, is done via implementation of defined in the inspection setup for the erogeneous system landscape. The
corresponding business add-ins or material master record. It then updates services-oriented quality inspection
customer enhancements. the vendor evaluation. engine supports new processes, such
as the execution of inspections using
Inspection Lot Completion Quality level decentralized warehouse management
After results recording is completed or The quality level is updated, and based in SAP SCM.
the inspection is canceled, you make on the level, the inspection stages for
the usage decision for the inspection the next inspection are determined. In general, the quality inspection engine
lot (see Figure 15). An automatic usage is used by non-QM applications to per-
decision can be made if no inspection Follow-up actions form inspections. For example, quality
characteristics have been rejected and The usage decision can trigger a chain inspections can be performed in the
no defects are recorded. If a material of automatic follow-up actions, such as SAP Extended Warehouse Manage-
requires documentation, you must sending a message to purchasing if an ment application using functions in the
enter a comment for the usage deci- inspection lot is rejected. In addition, quality inspection engine. Inspection
sion if the inspection is canceled or the statistical data for the inspection data can then be forwarded to an
the usage decision differs from the lot is updated in the QM information application that provides enhanced
valuation for the inspection results. system. SAP ERP logs all user actions functions for quality inspections, such
using the name, date, and time. This as SAP ERP or a non-SAP QM applica-
Stock posting means that you have the ability to track tion or laboratory information manage-
If materials are posted to inspection all actions. You can also create an ment system running on either an
stock using an inspection lot, they can electronic batch record for materials internal or external system.
be posted from this stock only using that are managed in batches.

Inspection Results Characteristic Results • Classed values – number of results
You record and valuate characteristic within value classes
There are two types of inspection results according to inspection • Single values – such as several mea-
results in QM with SAP ERP (see specifications. sured values (In addition to single val-
Figure 16): ues, you can note the serial numbers
• Results for the planned inspection Characteristic types of the items to be inspected.)
of inspection characteristics (charac- You can record inspection results for
teristic inspection results) the following types of characteristics: Additional functions
• Unplanned defects defined during • Qualitative characteristics Within results recording, you can also:
the inspection (defect data) Nonnumerical characteristic values • Define unplanned characteristics
or variables stemming from these • Process conditional characteristics.
Characteristic inspection results are values This deals with planned characteris-
generally recorded for each operation. • Quantitative characteristics tics that must be inspected only if a
For this, inspection specifications must Measured values or variables stem- corresponding controlling characteris-
be assigned to the inspection lot, and ming from these values tic has either been accepted or
sample calculation must be completed. rejected.
You can record both characteristic Recording forms • Record inspection results for charac-
inspection results and defect data Depending on the detail you require, teristics that are in a skip stage
for an inspection lot with a task list. you can choose from the following • Calculate results using calculated
If characteristics are rejected, defect recording forms for a characteristic: characteristics. For calculated char-
data records can be created automati- • Summarized values – such as the acteristics, you calculate results
cally. Also, you can record defects in mean value and standard deviation using the results for other
an inspection without inspection of several measured values or an characteristics.
specifications. individual measured value
Samples
If the sampling procedure specifies
independent multiple samples, you can
Recording Inspection Results record results for more than one sam-
ple for each inspection characteristic.
The number of samples may then be
Unplanned Planned greater than the number specified in
the sampling procedure.
Defect Data Characteristic
Results In an attributive inspection, you can
Defect Data also plan dependent double and multi-
• Defect Type ple samples. If the result for the current
• Defect Location Qualitative Quantitative sample lies between the acceptance
• Cause Characteristic Characteristic and rejection numbers, the sample size
is increased according to the sampling
scheme. Once you have recorded the
Active Quality Quality results for this new sample, the sample
Notification Control is evaluated again using the updated
valuation parameters.
Figure 16: Types of Inspection Results

Valuation • Time-dependent (for example, one Process-Optimized Results Recording
You can confirm the characteristic inspection every hour) Work lists
inspection results recorded in different • Quantity-related (for example, an Personalized work lists provide you
inspection operations. During results inspection after 100 units have been with a flexible selection of inspection
recording, an inspection characteristic produced) lots. Examples of work lists include:
undergoes a series of status changes. • Freely defined (for example, one • Results recording for samples during
The authorization management function inspection per shift) laboratory inspections
controls who has the authorization to • Results recording for equipment or
record, valuate, or close results. To Distribution functions functional locations during calibration
fulfill special security requirements, for After results recording, the software inspections
example, GMP, a digital signature may determines the fraction of nonconform-
be required. ing units for all inspection characteristics Tabular results recording
and uses this information to estimate You can record inspection results in
You can use the following valuation the fraction of nonconforming units in tabular form as follows:
modes to accept or reject an inspec- the inspection lot. The most common • Processing characteristics for sev-
tion result: mathematical distribution methods are eral inspection lots
• Manual valuation supplied (normal, binomial, and Poisson You record results for inspection
• Attributive inspection based on the distribution). characteristics that occur in several
number of nonconforming units or inspection lots. In the recording table,
defects Statistics the inspection lots selected in the
• Decision based on the attribute You can display the following graphics work list are displayed in columns;
codes of qualitative characteristics in results recording: the characteristics are displayed in
• Decision based on the tolerance • Histogram illustrates the frequency rows.
range of quantitative characteristics distribution of the sample results in • Processing several inspection
• Variable inspection with single-sided the form of a bar chart. In this chart, points in an operation
or double-sided tolerance limits you can identify typical and extreme You record results for several inspec-
• Valuation based on the action limits values for a sample, as well as the tion points in an operation. In the
of a control chart location, dispersion range, and form recording table, the inspection char-
of the distribution. acteristics are displayed in columns;
Characteristics with independent, multi- • Run chart displays the run of mea- the corresponding inspection points
ple samples are valuated at the sample sured values for a characteristic over are displayed in rows.
level. For example, you might valuate a period of time as a line chart. You • Processing master inspection char-
such samples based on the worst-case can identify the dispersion and sys- acteristics for all inspection lots
principle, last-case principle, or best- tematic location changes. You can You record the results for a specific
case principle. You may also valuate also display trends. master inspection characteristic for
inspection points. • Control chart shows the time run of all inspection lots. In the recording
characteristic values in the produc- table, the inspection lots are dis-
Inspection points tion process with warning and action played in rows for the master inspec-
You can use inspection points to limits. tion characteristic that has been
perform several inspections on one selected.
characteristic. You can define various
inspection points in SAP ERP,
including:

Results Copy • Increases transparency and accuracy Dual Control Principle
The “copy inspection results” function: of inspection data The idea behind the dual control princi-
• Copies inspection results from a • Avoids manual errors through auto- ple is that the processing of an inspec-
source inspection lot into a target matic data transfer tion result should not – or even must
inspection lot • Guarantees tracking of copied data not – be made by only one person. For
• Is highly flexible and can be tailored (application log) example, the required process involves
to your needs one employee who enters the results
• Supports several business Input Processing for characteristics and a different
processes During results recording, a function for employee who validates and completes
• Is a requirement from various converting an entered value based on a the characteristics. This means that the
industries given procedure can be activated via a results need to be checked by at least
business add-in. Input processing must two different people. The dual control
This function is applicable for the trans- be planned in the master inspection principle can reduce the risk of failures
fer of results from precursors along the characteristic or in the inspection plan. or misuse and help you to comply with
production chain (parent-child relation- regulations.
ships) and for all types of recurring The input value can be processed, for
inspections, including the following: example, as follows: You can activate this function via imple-
• Periodic retests of batches • Output of a value calculated by per- mentation of a related business add-in
Only some characteristics need to be forming a formula conversion on the that offers the following functions:
reinspected, but all values from the original entry • Entry and analysis of results of an
initial inspection should be visible in • Output same as input inspection characteristic by two
every inspection lot. • Output of the significant rounded different users
• Calibration inspections value instead of the original entry • Possibility to force the completion
During inspections of equipment or • Output of the verification and deter- of a characteristic
functional locations, some values of mination limit instead of the original
the previous inspection lot should entry SAP offers a sample implementation
be taken as the new starting point. of this function that you can use as
• Stability studies The value that was entered originally delivered; or you can copy and modify
Some results from the initial test (including the decimal places entered) it to meet your needs.
should always be available when is also saved (original value).
scheduled inspections are carried Web-Based Approach to Quality
out. Operation Completion Control
• Inspections during production You can complete the operations in an The Internet provides you with several
Results of previous inspection points inspection lot individually and according possibilities for results recording. An
should be selected and copied to the to requirements. This allows you to doc- example of this is recording results
next inspection point. ument the exact inspection process for for source inspections. You provide
an inspection lot. After an operation has your vendor with access to a specific
The function for copying inspection been updated, follow-up actions can be Internet or intranet page, which
results supports you in your inspection triggered automatically, depending on requires special authorizations. The
process in the following ways: your application settings. The function vendor records inspection results
• Saves time during inspection can be activated via customizing. directly on the Web and saves the
processing data. As a result, this QM data can be
• Is applicable for a wide range of processed further by your SAP ERP
processes application.

In addition, SAP offers a role-based quality inspector in using graphic tools PC interface
portal (see Figure 17) with work to monitor and measure the most You can transfer inspection results
centers that are tailored specifically to important quality key figures. from a measuring device into the rele-
the needs of the quality inspector. It vant results fields in SAP ERP using file
supports a quality inspector’s most Connecting Measuring Devices transfer. You can trigger the results
important tasks: or External Systems transfer from external systems and also
• Results recording QM with SAP ERP offers interfaces to from within the results recording func-
• Defects recording connect to external systems for special tion in SAP ERP using driver programs.
• Notification creation and processing tasks within quality inspection. SAP provides examples for the driver
• Confirmation for production orders programs.
• Quality reports Keyboard interface
Keyboard interfaces convert the mea- Inspection data interface
Personalized work lists serve as trig- sured values into keyboard entries. You The QM inspection data interface
gers for the efficient completion of can link test equipment, such as elec- (QM-IDI) supports data exchange with
tasks. The role provides quick access tronic caliper gauges, bar-code read- external quality systems, such as
to all pertinent quality data and a simpli- ers, or laboratory balances, using a computer-aided quality assurance
fied user interface. Furthermore, it is keyboard wedge. Various interface box- (CAQ) systems and laboratory infor
possible to trigger alerting immediately es are available on the market, which mation management systems (LIMS).
when problems or exceptions are iden- differ in the number and type of test You use QM-IDI to process inspections
tified. In addition, the role supports the equipment that can be connected. 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 interface
The QM statistical interface (QM-STI)
links QM functionality with SAP ERP
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
Figure 17: Example for Portal Work Center for a Quality Inspector can use a format defined by SAP to

transfer recorded inspection results You can describe qualitative defect inspection lot. You define the following
from the quality management function data with the help of cataloged termi- information in the sample-drawing
in SAP ERP to the external evaluation nology (for example, defect type, procedure:
system. defect location, or defect cause) and • Type and number of samples
additional text. – Primary samples (one-stage
You can use QM-STI for manual statis- physical-sample drawing)
tical analysis of inspection results from A defect data record can be converted – Primary and pooled samples (two-
SAP ERP, or you can specify an auto- into a quality notification. As a result, stage physical-sample drawing)
matic start of predefined statistical the whole range of functions in notifica- – Reserve samples (to be stored for
analyses. tions can be used (for example, the link subsequent inspections)
to workflow). • Whether the application should calcu-
SAP Manufacturing Integration and late physical samples on the basis of
Intelligence Sample Management the lot container type or the lot
The SAP Manufacturing Integration and quantity
Intelligence application supports inte- When sample management is active in • Whether the drawing of the physical
gration of manufacturing systems with QM with SAP ERP, you can use the samples needs to be confirmed
SAP ERP. It enables you to integrate application to manage samples. To help separately
directly and provides functions for you manage samples effectively, a
Web-based user interfaces for access- unique physical-sample record is Processing Physical Samples
ing QM data in SAP ERP. For details, created for each physical sample. The Figure 18 depicts the types of planning
see the section “SAP Manufacturing physical-sample record contains the and processing for physical samples.
Integration and Intelligence for Quality following information for the sample:
Analytics.” • Physical-sample number Sample-drawing instruction
• Physical-sample type, such as sam- For a planned physical-sample drawing,
Defect Data ple from goods receipt, production, the application can print a sample-
Defects recording provides information or customer complaint drawing instruction at inspection lot
to control quality and optimize process- • Physical-sample category, such as creation. This instruction contains infor-
es. It enables Pareto analyses of defect primary sample, pooled sample, or mation from the inspection plan and
types and causes according to their reserve sample physical-sample drawing procedure
weighting or how frequently they occur. • Information for the physical-sample about drawing, processing, and distrib-
It provides empirical values for risk indi- drawing with data on the sample uting samples at work centers or
cators in FMEA. origin, such as material, batch, laboratories.
material document, and order
You record defects with reference to an • Detailed information about the physi- Physical-sample drawing
inspection lot, inspection operation, or cal sample, such as the inspection When the application creates the
inspection characteristic. To record lot or storage information physical-sample records for the
defects, you do not need inspection • Processing status of the physical inspection lot, it assigns a unique phys-
specifications. If an inspection plan is sample ical-sample drawing number. This num-
available, the defect data records can ber helps you identify the physical sam-
be assigned to an inspection character- When the inspection planner defines a ples that were drawn from the lot. You
istic contained in the plan. QM with sample-drawing procedure and assigns can also identify how many pooled and
SAP ERP then suggests the type of it to the inspection plan, routing, or reserve samples were formed. The fol-
defects recording that is suitable for master recipe, physical-sample records lowing functions are available for the
the material, work center, or user. are created automatically for the physical-sample drawing:

• Confirmation of the physical-sample Valuation Benefits:
drawing and release of the samples Once you have performed all inspec-
You can control whether or not the tion operations and have recorded the
• Integrates in the
physical-sample drawing must be inspection results, the physical sam- process of the
confirmed. A confirmation would ples must be valuated on the basis of
result in the release of all samples the operations (that is, accepted or
product lifecycle and
associated with the relevant physical- rejected). When all physical samples the supply chain
sample drawing. A digital signature in the inspection lot are valuated, you
may be required to make the confir- make the usage decision for the lot.
• Provides real-time
mation. This digital signature ensures data, transparent
that only people with the relevant Unplanned Samples
authorization can confirm a physical- It is possible to manage unplanned
for employees,
sample drawing. samples using QM with SAP ERP. You compliant with legal
• Label printing can perform the following tasks:
You can trigger label printing for • Create the physical samples manually
requirements
physical samples. The labels can be without reference to an existing
printed with bar codes. physical-sample drawing or inspec-
tion lot
Sample check • Supplement an existing physical-
The physical samples are displayed sample drawing by creating additional You must create inspection lots manu-
automatically in a work list for results physical samples ally to be able to record inspection
recording. You can process these • Create a new physical-sample results for unplanned physical samples.
samples immediately, provided that drawing manually, with reference to You can use this function to perform
they have the appropriate status. an existing inspection lot, production the following tasks:
order, process order, or production • Check the stability of reserve
version samples
• Inspect samples from competitors
• Inspect samples from a customer
complaint
Creation
Planned • Automatic creation of physical samples at

Physical Samples inspection lot creation
• Manual creation of physical samples

Unplanned • Manual creation of physical-sample
Physical Samples drawing with reference to an inspection lot
• Manual creation of inspection lots for

Manual Inspection Lots existing physical samples
Figure 18: Types of Planning and Processing for Physical Samples

Quality Certificates:
Guaranteed Reliability –
Printed or on the Internet
Certificate Processing logo. You define required content in the predefined strategies. You can enhance
in Sales and Distribution certificate profile. Due to the flexible the data procurement functions and
interaction of the certificate profile and replacement strategies available in SAP
Your company produces high-quality form, you can meet multiple require- ERP by programming function modules.
products. As quality manager, it is your ments using just a few forms.
responsibility to provide evidence of The form master record allows you to
the quality of your goods for your cus- You specify the data origin for each tailor your certificates to your compa-
tomers. Whether you require certifi- characteristic in the certificate profile. ny’s needs. To simplify this process,
cates of analysis for the chemical or For each characteristic, you can include SAP ERP provides examples based on
pharmaceutical industry, or certificates texts (such as inspection methods) and SAPscript forms, a proprietary tool for
of conformity, test certificates, works- values (specification values and inspec- text management and form printing,
test certificates, or inspection certifi- tion results) in the certificate. and Adobe forms (PDF-based print
cates for material inspection laborato- form).
ries in the steel industry – the quality SAP ERP selects data from inspection
certificate fulfills all of your lots, batch specifications, or character- In addition to printing characteristics
requirements. istic master records. Texts for charac- that are directly linked to the product
teristics can also be obtained directly requiring the certificate, you can also
In addition to the usual output forms from the certificate profile. Only those define which characteristic data (from
for certificates (printer or fax), you can inspection lots that meet specific selec- raw materials and semifinished prod-
make certificates available to your tion criteria that have been defined in ucts used when creating the finished
customers on the Internet, or you can the certificate profile are considered for product) are printed on the certificate
transfer certificate data electronically data formatting. (see Figure 19).
for further processing.
Consequently, inspection lots that At this point, you can refer to inspec-
Flexible Certificate Planning have, for example, reached a pre- tions or batch classifications. SAP ERP
You define the layout and content of a defined quality score can be selected. selects batches for data formatting that
certificate in certificate planning. The If there is no inspection result for a are linked to one another by production
form determines the layout of the docu- characteristic due to a skip, SAP ERP orders, process orders, or production
ment – that is, the appearance and searches for other data sources using versions. The characteristic values for
Product: RAW01 Product: SEMI01 Product: RAW03 Product: FIN01

Batch: R1-1 Batch: S1-1 Batch: R3-1 Batch: F1-1
Char: R10 Char: R30 Char: F10
Char: R11 Product: SEMI3-1 Char: R11
Batch: S3-1
Char: S31
Char: S32
Product: RAW02 Product: SEMI02 Product: SEMI04 Product: R10
Batch: R2-2 Batch: R2-1 Batch: S4-1 Batch: S20
Char: R10 Char: S20 Char: S41 Char: S41
Char: R11 Char: S42 Char: F10
Figure 19: Example of a Quality Certificate for a Finished Product with Characteristic Values from Raw Materials and Semifinished Products

these materials in the production chain SAP ERP finds the correct certificate
can also be taken from other plants. profile, recipient, and shipping terms
with the help of the flexible condition
Apart from the characteristic data technique. The software can search for
defined in the certificate profile, you the address of the certificate recipient
can structure the certificate to contain by using, for example, the sold-to party,
all other information that is available at the ship-to party, delivery type, or ship-
certificate creation. Such information ping point. Then it decides whether the
might, for example, include data from certificate is to be issued in printed
the sales order. form, by fax, or electronically. Next, it
searches for the corresponding profile
Certificate Creation – for the material group, material, cus-
Meeting Your Requirements tomer, or a combination. All the infor-
mation required for these searches is
For single delivery items, certificates contained in data for the delivery.
are issued automatically when goods
are shipped, together with delivery As the final step, SAP ERP determines
notes. These certificates are then the contents of the certificate based on
included with goods deliveries. You can the requirements in the certificate pro-
create certificates at any stage of the file, such as characteristic values in
shipment process, as long as the data picking batches. It structures the infor-
required is accessible; for example, mation according to the specified form
when picking is completed or goods and transfers the resulting certificate to their output. You can create a print
are issued. If you want to make certifi- the output medium, and, if required, the preview to check the contents of the
cates available to customers before optical archive. certificate before it is finally issued. In
goods delivery, you can make them addition, the processing status of deliv-
accessible on the Internet or send them You can also manually trigger the ery item data is maintained consistently
electronically. creation of certificates for deliveries, so that you can always tell if a certifi-
inspection lots, or batches, and control cate was created properly.

Benefits:
• Easy creation
of certificates
• Automatic warnings if
a certificate is missing
at goods receipt
• Fewer errors by using
electronic data trans-
fer at goods receipt
• Time and money sav-
ings through using
individualized and fully
automatic certificate
creation for deliveries
• System-independent
access of certificates
on the Internet or Figure 20: Quality Certificate
intranet
Certificate Processing been received until the usage decision
• Multiple output at Goods Receipt is made for the incoming inspection lot.
formats: XML, PDF, If a certificate has not been received,
As a quality inspector, you are respon- SAP ERP may post the stock to
fax, or print sible for monitoring the receipt of certif- restricted-use stock.
• Electronic transfer icates during the procurement process.
If you have marked a material as requir- You can store certificates that have
of quality data to your ing a certificate, you must confirm that been received using SAP ArchiveLink.
business partners a quality certificate has been received You can also send reminders for miss-
for purchase orders or goods receipts. ing certificates and monitor reminder
statuses. In addition, you have the abili-
You generally confirm this information ty to process the receipt of certificates
at goods receipt. However, you can before the goods have actually been
wait to confirm that a certificate has received. This is often the case with

certificates that are sent electronically. Figure 20, via electronic data inter- Quality Data Exchange
If you receive an electronic certificate change (EDI). If you want to enable a recipient to use
with reference to a delivery, you can the quality data displayed on a certifi-
copy the quality data from the certifi- Certificate Access on the Internet cate, you must send the certificate
cate for further processing. As the vendor, you can allow your cus- electronically (using EDI) to the target
tomers to access SAP ERP over the system.
Collaborative Business: Certificate Internet and access a quality certificate
Data for the Whole Company for their purchased goods. Depending If the quality certificate refers to a deliv-
on their needs, it is possible for cus- ery to a customer, you can automatical-
You can make certificates available to tomers to access a certificate that is ly transfer the inspection results printed
your employees and business partners created when accessed or one that on the certificate to a goods receipt
over the Internet. In addition, you can was created for a delivery item and is inspection lot (see Figure 21). You can
send a certificate, like the one shown in already stored using SAP ArchiveLink. also manually copy the results to anoth-
er inspection lot, for example, a source
inspection lot.
Vendor Certificate data can be transferred to a

* IDOC = intermediate document
** EDI = electronic data interchange 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
SAP® ERP
also transfer data to your business
partners that do not use SAP software.
Certificate
Creation
Customer
IDOC* IDOC
Reference Data Reference Data Reference Data
EDI**
Certificate
Quality Data Quality Data
XML Record
Certificate (PDF) Other Certificate (PDF) Certificate (PDF)
Optical Archive
Figure 21: Quality Data Exchange

EFFICIENT PROBLEM MANAGEMENT
Improved Quality Through implement corrective tasks for quality quality notifications, you can deal with
Targeted Problem Handling improvement using the quality both simple problems and problems
notification. related to complex processes in the
To optimize business processes in logistics supply chain (for example,
your company, you must respond to In addition to the quality notification, complaints processing for deliveries
requests and problems quickly and effi- the following notifications are available or processing of returns), as shown
ciently. As the notification processor, to you: in Figure 22.
you coordinate the processing of • General notification for general
incoming requests or problem notifi requests or subjects (without a busi- Notification Types
cations and propose suitable tasks. ness assignment) The subjects defined in quality notifica-
You can ensure that all problems are • Maintenance notification for record- tions generally refer to exceptions in
assigned and solved correctly. You ing and processing problem notifica- everyday business processes. If you
are involved in the analysis, cause tions for technical objects create a notification, you use the notifi-
determination, and handling of prob- • Service notification for processing cation type to define the subject from
lems. You are also responsible for service activities a business viewpoint. The notification
checking the implemented tasks for • Feedback notification for requests type determines the process flow.
their effectiveness. or problems related to SAP ERP
• Claim for documenting deviations SAP ERP contains the following quality
Notifications in an SAP Environment from a project plan (for example, notification types (see Figure 23):
The integrated notification function schedule deviation or cost variance) • Customer complaint
supports you when you create and • Complaint against the vendor
process various issues and problems. Using Quality Notifications • Internal problem notification
As a special feature of QM with SAP
ERP, you can record quality problems, Notifications are an efficient tool for Requests or problems that cannot, at
document defects and causes, and processing exception situations. Using first, be assigned at a business level
Notification Processing
Unplanned Description/ Tasks/

Analysis Entering costs Solution
Event assignment activities
Internet/ Evaluations
Solution
intranet
Workflow database Action Status
box management
Figure 22: Notifications for Continuous Process Improvement

defects analysis for the individual
problems. You define the necessary
Customers Company Vendors corrective tasks and assign them to
the appropriate employees.
Customer Complaint
complaint against
the vendor
You complete the problem notification
after all tasks have been completed
successfully and their costs have been
Internal calculated. The steps you perform
problems mirror the status of the individual tasks
and the complete quality notification.
You can display the most significant
Figure 23: Quality Notification Types processing steps of a notification in
the action log.
are entered using the general notifica- are available in the enhanced view.
tion. As the responsible notification This view is particularly useful if the Quality Notifications
processor, you assign a suitable notifi- employee’s responsibility extends
cation type to a general notification, beyond the creation of the notification. You can adapt the structure and infor-
depending on the subject of the notifi- mation in a quality notification to meet
cation. The notification type controls If you are responsible for creating the your requirements. In addition to the
all further processing. notification, you must first describe the notification types supplied by SAP, you
subject in text form, then name a refer- can define your own notification types.
Quality notifications can be recorded ence object, if possible (for example, a For each notification type, you can:
manually or automatically: sales order or delivery), and assign an • Select a simple or enhanced pro-
• You can create a notification manually appropriate priority to the problem. QM cessing view
on the Internet, intranet, or directly in with SAP ERP copies the linked infor- • Determine screen areas and their
SAP ERP. mation to the notification. content
• For defects recording during inspec- • Structure notification data using tab
tion processing, a quality notification When you enter the notification, you pages
can be created automatically. can see immediately if, for example, • Include your own functions in an
notifications already exist for the same action box
Notification Processing material or customer. You can immedi- • Configure shop papers for printing
ately switch to one of these notifica- • Activate digital signature for distinct
If you manually enter and process gen- tions and access information about business transactions at header or
eral notifications, you can use simpli- how to solve the problem. task level
fied or enhanced processing views.
The simplified view is meant for As the responsible notification proces-
employees who do not require the sor, you are informed about notifica-
whole range of notification functions. tions using work lists or through work-
This view is used to quickly record flow. You can implement tasks and
problems. All notification functions record costs. You can also perform

Elements of the Quality Notification Item usage and control problem processing
Notification Individual problems or errors that have with regard to procedures. The action
occurred are documented as notifica- box includes typical tasks and activities
Figure 24 shows the layout of data in a tion items. They contain information for processing notifications. These tasks
quality notification. relating to defects analysis, such as or activities are known as follow-up
the defect type and location. You can functions and can be executed with a
Notification Header assign various causes to a notification mouse click. These follow-up functions
The header data record contains a item. You can access user-defined are available:
description of the subject matter and, catalogs to describe the defect type, • Creating letters of complaint or
depending on the notification type, location, and cause. eight-discipline (8D) reports for
assigns objects affected by the notifi- complaints against the vendor
cation (for example, purchase order, Tasks and Activities • Requesting permission to deviate
material, vendor, and inspection lot, or The tasks and activities used to correct from specifications
sales order, material, and customer). the defects are subordinate to the noti- • Creating a new quality notification
The priority and processing status are fication item. Tasks and activities can from an existing notification
documented in the notification header. be assigned to the notification header, • Sending decisions by e-mail, fax, or
You can also access other objects so that you can take the first steps print preview (for example, confirma-
linked to the notification in the notifica- to resolve a problem even before the tion of receipt, interim notice, or final
tion header, such as documents or analysis is available. notice)
QM orders used for recording costs. • Accessing the solution database
• Documenting calls related to the
notification
Quality Notification
The follow-up process is simplified
through the use of colors to mark the
processing statuses of follow-up func-
Partner Defect Item Activities Tasks tions and dependent follow-up func-
tions. In this way, you can recognize
immediately those follow-up functions
Activities Tasks Causes that have already been processed and
those that are outstanding.
Figure 24: Structure of a Quality Notification
Solution Database
Partners Optimized Usage Complaints must be processed quickly
The partners involved in the creation or and efficiently. With an integrated solu-
processing of a notification (for exam- SAP ERP has several useful functions tion database, you can quickly find
ple, vendors or customers) are listed in that optimize the use of quality notifica- solutions when processing notifica-
the notification. You can also include tions. In addition, several tools can tions. You access the solution data-
departments and people within your streamline notification processing. base from the action box and start a
company who are involved in notifica- free-text search in the database using
tion processing as partners. Action Box the entered problem description. You
You can use the action box to flexibly can quickly determine whether similar
enhance the functions in the notification problems have occurred in the past and
to suit your needs. You can simplify which tasks were used to solve them.

Flexible Work Lists Document Flow Tasks
Work lists are available to you for pro- You can display all documents that are
cessing quality notifications, defect linked to the notification in a list or as a A task is a processing step that is per-
items, tasks, and activities. In particu- graphic. formed during notification processing.
lar, for notifications or tasks, you can You can track the processing status of
select and process objects that you: Digital Signature the task with a status sequence that
• Created By activating the digital signature for you define. You can specify the dead-
• Processed last notifications, you can request a digital line for completion and the person
• Are responsible for processing or signature for selected process steps responsible for each task. SAP ERP
which are within your area of when processing a notification; for manages the status of each task and
responsibility example, when setting a status such as allows you to complete a quality notifi-
• Are responsible for processing “released.” The activation can be done cation only when all the tasks have
within a specific partner function at the header or task level for any busi- been processed. The structure of the
ness transaction and notification type. quality notification differentiates
Workflow Signature strategies can be applied. between immediate and corrective
If you use SAP Business Workflow, tasks.
all parties involved in notification pro- Analysis of Items and Defects
cessing are informed about their tasks. Immediate Task
Depending on the status of notifica- Quality notifications are designed to The purpose of an immediate task is
tions or tasks, work items are entered analyze defects. There is one notifica- to provide an immediate response to
in the mailbox of the responsible tion item (defect data record) for each the problem that produced the quality
parties. defect that has been recorded. In this notification and to prevent any further
record, you can describe the defect damage from occurring. These types
You can access the necessary pro- type and location, and you can use of tasks are assigned to the quality
cessing functions directly from a work company-specific codes to document notification header and can be imple-
item. If the responsible processor is the problem. These codes can later be mented without specifying a defect or
unable to complete the task within evaluated. Additional input fields are defect cause. Examples of immediate
the deadline, workflow forwards the available for each notification item, tasks include the following:
operation to a department or employee including fields for defective quantities • Blocking warehouse stock
responsible for urgent outstanding and a field for a quantitative defect • Triggering an additional inspection
tasks. This is also referred to as valuation. • Sending a confirmation letter
escalation.
Using the classification function, you Corrective Task
Response Profile can classify defects, define additional The purpose of a corrective task is
Depending on the priority of the notifi- defect characteristics, specify value to eliminate the defect and its cause
cation, you can define a sequence of ranges for these characteristics, and and to prevent it from recurring. You
standard tasks using a response pro- record characteristic values. In addi- assign corrective tasks to an individual
file. These tasks can then be proposed tion, you can enhance defect analysis notification item (defect). Examples of
on request in the notification; they must by documenting the causes of the corrective tasks include the following:
be completed within a specified period defects and by defining corrective • Changing a work instruction
of time. tasks. • Implementing training
• Modifying a routing

Follow-Up Actions • Triggering multiple internal service
You can link tasks with automatic processes
follow-up actions. As a result, you can, • Forwarding the notification to the per-
for example, initiate inspections, block son responsible for processing using Benefits:
supply relationships, or create a SAP Business Workflow
purchase order for a return delivery.
• Rapid processing
Sending faxes and e-mails of unplanned events
Activities When processing a notification, you
You can define activities to document can send information to an internal or
• Active participation
that a specific action has been external address as a fax or by e-mail. by employees in the
implemented.
Storage and Documentation
continuous improve-
Support Functions Shop papers ment of processes
Although SAP ERP supports paper-free
Additional functions are available to processing of quality notifications, it is
• Easy communication
support quality notifications. You can sometimes useful to have printed shop and work processing
make notification recording available papers to present the information in the
to business partners on the Internet. form of a fax or to store in a file. QM
by using the Inter-
In addition, you can archive quality with SAP ERP provides the following net or intranet –
notifications using SAP ArchiveLink. shop papers:
• Notification overview
independently of
Communication • Notification items the application
Notifications on the Internet and • Complaint report
intranet • Confirmation report
• Time and money
Using an Internet connection for quality • Interim notice savings because
notifications, you can reduce the • Final report
resources and time needed for record- • 8D report
of the optimal control
ing a complaint, thereby improving notifi- of subsequent
cation processing. A customer records If required, you can create your own
a problem on the Internet. QM with SAP shop papers and structure them with the
processes
ERP then triggers internal operations help of the SAPscript text-processing
using the workflow function. The cus- function or Adobe PDF function. You can
tomer can display the processing status use the examples delivered with SAP archive and manage printed or electron-
of the notification at any time on the ERP as models for designing your own. ically transmitted documents. Outgoing
Internet. documents, printed or transmitted by
Assignment of documents fax, are stored in an optical archive.
If notifications are created for general Using the document management func- Incoming documents can be recorded
requests or problems from an employ- tion, you can assign documents, such with SAP ArchiveLink and assigned to
ee’s working environment, the Internet as CAD drawings, Word documents, a new or an existing quality notification.
service request is the medium for find- and HTML documents, to a notification. If processing is to start immediately, a
ing solutions quickly and through which These documents are then available to workflow can be triggered when the
the following are performed: you during notification processing. incoming document is recorded. The
• Recording different issues workflow function forwards tasks to
• Searching for solutions using the Storage with SAP ArchiveLink the partner responsible for processing
integrated solution database Using SAP ArchiveLink, which is acces- work items using the business work-
sible in the quality notification, you can place function.

Sustained Quality Control
Planning, Evaluation, and Direct
Intervention
Quality control involves strategic plan- QM with SAP ERP takes the quality • Tightening or reducing the inspection
ning, continuous monitoring, and rapid level into account when determining the scope based on the results of a pre-
intervention to deal with unexpected inspection scope and defining the vious inspection is controlled either
events. SAP offers you a complete set inspection specifications in the inspec- by the valuation of the inspection lot
of tools for this purpose. tion instruction. Inspection lots are (dynamic modification by lot) or by
• The role of quality manager in SAP summarized in a quality level according the valuations of the individual
NetWeaver Portal provides the basis to specific criteria. For example, inspec- inspection characteristics (dynamic
for your quality control–related tasks, tion lots in production are summarized modification by characteristic).
which range from strategic planning according to material, plant, and task
to monitoring and evaluating inspec- list, while inspection lots for goods When several lots of the same material
tions and notifications. receipt inspections are summarized are to be inspected simultaneously,
• iViews (portlets) provide an overview according to material, vendor, manufac- there are two times when the software
of all important key figures and evalu- turer, plant, and task list. can dynamically modify the inspection
ations in QM with SAP ERP. As a scope:
result, you can continuously evaluate Figure 25 shows how master data and • The inspection scope is modified in
your quality strategy and modify it on transaction data interact during dynam- advance by assuming that all open
the fly if a problem arises. ic modification of the inspection scope. characteristics will be accepted. If a
• An intuitive data warehouse, which is The main features of this interaction are lot is rejected unexpectedly as a
included in SAP NetWeaver BW, as follows: result of an inspection, the inspection
brings related data together to give • Dynamic modification rules apply scope will be updated again after the
you the reliable company key figures uniformly for all inspection character- usage decision has been made.
you need. istics of a task list, individually for • The inspection scope is modified
certain inspection characteristics, or after the usage decision for the cur-
Dynamic Modification of the generally for the inspection type that rent inspection lot has been made.
Inspection Scope is active for the material.
Dynamic modification controls the

Transactional Data Lot level
inspection scope (based on inspection
Quality level
characteristics and sample sizes) for a Characteristic level
series of inspection lots to achieve a
predetermined quality goal. General Inspection lot creation Sampling Characteristic
Task list selection Inspection instruction inspection result
technical rules, such as the sampling Inspection scope Quality inspection Usage decision
standards of ISO 2859-1 and ISO
Inspection Lot Processing
3951, follow this principle. QM with
SAP ERP contains a complete set of
Master Data
sampling tables for these standards.
Inspection Plan
• Header
To help you reach your quality goal, • Characteristic
SAP ERP determines inspection stages
for the next inspection lot after each Sampling Procedure Dynamic Modification Rule
Assignment
usage decision. It uses the dynamic • Sampling plan • Stage change
modification rule in the task list to Acceptable Sampling Scheme Inspection
determine inspection stages and then Quality Level Sampling Plans Based on Lot Size Stages
writes them to a quality-level data
record. Figure 25: Dynamic Modification of the Inspection Scope

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.
Figure 26: Illustration of an X-Bar/S Control Chart
Types of Control Charts
QM with SAP ERP provides the follow- You can show the mean value and the share of scrap of the process. The
ing types of control charts: standard deviation of a characteristic limits of these charts are extended if a
• Mean value with tolerances (accep- on one control chart with two tracks. long-term reduction in the process vari-
tance chart) ance is achieved.
• Mean value without tolerances In addition to the control variable, each
(Shewhart chart) track also contains control limits. If If you are using a Shewhart chart, the
• Standard deviation (Shewhart chart) these limits are exceeded, you have the limits become tighter as a result of a
• Range (Shewhart chart) ability to intervene in the process. For long-term reduction in the process vari-
• Moving average some control chart types, you can pre- ance. These charts only take internal
• Exponentially weighted moving define warning limits or a centerline. process parameters into account, not
average The limits are determined using statisti- external tolerance specifications. They
• Individual moving range for sample cal methods from the current process use a continuously recurring statistical
size n=1 data or from the results of an initial run. test to check that the controlled status
• Charts for qualitative characteristics You can also enter them manually on of the process has not changed.
(np-, p-, u- and c-chart) the basis of existing data. You can use
various algorithms for the calculation. As an inspection planner, you deter-
Normal distribution is used for quantita- mine whether a quality control chart is
tive characteristics; Poisson distribution Acceptance charts are based on your to be maintained for a given inspection
is used for qualitative characteristics. predefined tolerances. They determine characteristic. The charts may include

several inspection lots or production • 4 of 5 consecutive points outside 1/3 • You want to view a list of control
orders. SAP ERP creates the quality of the control limits charts from which you can choose
control charts when preparing the quali- • 8 consecutive points above or below individual control charts to be
ty inspection and updates them when the centerline (run) checked.
you record results. As a quality inspec- • 15 consecutive points within 1/3 of
tor, you can display the charts when the control limits Violations of Western Electric Rules
you are recording results and, if you • 6 consecutive points in ascending or are displayed in a list along with the
have the appropriate authorization, you descending order (trend) chart number, track, and sample num-
can use them to calculate intervention ber. From this list, you can branch to
and warning limits. If necessary, you On the selection screen of the related the inspection results to display
can change the algorithms. work-list transaction, you can decide detailed information on the individual
whether: inspections and to view the control
You can evaluate inspection results • You want to immediately carry out a chart.
using the quality control chart. QM with check according to Western Electric
SAP ERP contains a valuation rule that Rules. In this case, all control charts In the mean-value chart, you can
rejects a sample as soon as any limit is that correspond to the selection crite- display the process capability indexes
exceeded. When this occurs, the work- ria are checked. Cp and Cpk in a second window (see
flow automatically notifies the depart- Figure 27).
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

You can use a histogram evaluation to content-based examples of how to inte- Quality Scores
display the frequency distribution of grate business processes supported Quality scores for inspection lots are a
measured values in a bar chart. This by SAP ERP with shop floor–related proven tool for quality control. QM with
allows you to recognize typical and processes using SAP MII transactional SAP ERP provides you with several
extreme values of a sample, as well as techniques. For example, there is ways of determining the quality score.
to judge the location, dispersion, and sample software for an intuitive, Web- It uses information from the following
form of the distribution. You can blend based results recording function based sources:
the histogram out and replace it with a on SAP MII. Shop-floor operators • Usage decision
normal distribution if required. would use it for in-process control. • Estimated fraction of nonconforming
units in the lot
The histogram contains the following SAP MII enables real-time, preconfig- • Estimated fraction of nonconforming
data: ured transactional integration between units for characteristics
• All valid results for the sample plant-floor and enterprise (SAP ERP) – Maximum share of defects
• Upper and lower specification limits applications through the following: – Weighted average share of defects
• Target value • Universal connectivity to the data, • Quality score of the characteristic
• Distribution function and statistical functionality, and processes of exist- defect classes
values ing plant-floor systems through busi- – Minimum (worst) quality score
ness logic for creating automated – Weighted average quality score
If the inspection results are already events, KPIs, and alerts
divided into classes, SAP ERP uses • Workflow to synchronize plant and Vendor Evaluation: Permanent and
these classes to display the histogram. enterprise business processes Objective Performance Monitoring
Otherwise, it divides the existing values • Manufacturing intelligence with a
into appropriate classes. You can near-real-time analytics engine that When procuring materials, you can use
increase or decrease the number of aggregates and delivers unified visu- the vendor evaluation function to select
classes using the zoom function. alization of events, alerts, KPIs, and a suitable vendor. This function pro-
decision support to production vides you (as the purchaser) with a
SAP Manufacturing Integration and personnel summarized score that has been calcu-
Intelligence for Quality Analytics lated for the vendor according to main
For integrating systems, databases, or In addition to this, SAP MII provides a and subcriteria (see Figure 28).
other external applications (especially connector framework to establish or
on the shop floor) and also for perform- develop connectivity to various produc-
ing comprehensive analytics on quality tion and test devices. SAP is building a
data, SAP offers SAP Manufacturing partner ecosystem around SAP MII.
Integration and Intelligence. Integration For more information on SAP MII, go to
templates in the application provide www.sap.com/solutions/manufacturing
/manufacturing-intelligence-software
/index.epx.

These tools complement each other.
Procurement Main Criteria Subcriteria Weighting Report lists primarily evaluate operative
Weighting data. SAP NetWeaver BW and the QM
information system, however, analyze
A1 Price level % summarized data that can be stored for
Price 30% A2 Price behavior % a long period of time.
A3 Other %
A1 Goods receipt inspection % Results History

A2 Complaint % With the help of the results history,
Quality 40%
A3 Audit % you can analyze single values that
Vendor A4 Other %
Evaluation were recorded for a characteristic in
the results recording function and
A1 On-time delivery performance %
A2 Quality reliability % when you made the usage decision.
Delivery 20% You define the period of time to be
A3 Uniform shipping instructions %
A4 Other % analyzed. You can prepare the data in
list form and graphically represent the
A1 Technology % progression of values over a period
Service 10% A2 Other %
of time using a run chart. With the help
of a trend analysis you can represent
the predicted course of the values.
A Determined automatically Exporting the data, for example, to a
Microsoft Excel file provides additional
Figure 28: Vendor Evaluation in SAP® ERP options for processing the data.
The subcriteria for quality, the main Evaluations: Keeping You QM Cockpit for Evaluations
criterion, come from the following Up-to-Date With the help of the QM cockpit for
sources: evaluations, you can analyze quality-
• Goods receipt inspection – the aver- The following evaluation tools are related data based on inspection lots,
age of the quality scores of all goods available in QM with SAP ERP: defects, and quality notifications (see
receipt lots from the vendor for a • Results history of mean and single Figure 29). Batch where-used lists pro-
specific time period values with integrated analysis of vide quality-related data of components
• Complaints – the number of com- trends or preliminary products. During the
plaints received in relation to total • QM cockpit for evaluations with SAP analysis you can use tables or informa-
sales or total revenue, for example ERP for online and archived QM data tive graphics to visualize the results.
• QM audit – either the average quality • SAP NetWeaver BW with integrated These graphics can be adjusted to suit
score of all audits executed during a business content your requirements. Multiple graphics
specified time period or the quality • QM information system can be displayed at the same time, for
score of the most recent audit • SAP MII for integrated quality analyt- example, with reference to an inspec-
ics based on disparate systems tion lot, to facilitate comparisons. You
You define the criteria and their relative • Report lists programmed using the can calculate key figures, which you
weighting according to your company ABAP™ programming language can define to meet your needs.
requirements. – Predefined SAP reports
– Logical databases as the basis for
customer-specific reports

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 Figure 29: Evaluation of Components Using the QM Cockpit
inspection results for several
characteristics. Since the QM information system is company key figures using formulas.
part of the logistics information system, Even if you have no programming expe-
In the cockpit you can create different you can combine evaluations with infor- rience, you can create reports quickly
types of control charts without any mation from other areas of logistics, using flexible analysis.
preparation in the related inspection such as production or purchasing. Out-
characteristics. You can analyze put data is displayed in list form or as Early warning system
defects together with inspection lots or a graphic and can be sent as an e-mail An “early warning system” helps you
as notifications. A new graphic type is attachment. Other features are activity- identify problems at an early stage by
available for the visualization of defect based costing and portfolio analyses. warning you if an exception situation
frequencies. Additional key figures for Using the standard query tools, you occurs. You can define the exception
defect risks are also available. Notifica- can freely define your own evaluations situations. When an exception situation
tions can be analyzed together with and reports. arises, you are informed immediately
defect causes. For components, you via e-mail or workflow. An exception
can analyze and visualize inspection Standard analyses situation can, for example, occur if the
lots, notifications, or defects from the The QM information system contains quality score of a vendor falls below 90
production cycle. a selection of standard evaluations for points. You define exception analyses
your materials, vendors, and custom- using standard information structures
Quality Management ers, including key figures such as pro- or your self-defined structures. You can
Information System cess capability indexes, defects fre- also use mathematical algorithms or
Inspection results and quality notifica- quencies, or skip quotas. You can tailor set the software to recognize threshold
tions are summarized on the basis of both the presentation and content of values or trends.
time, plant, or work center and updated the QM information system to suit your
in the QM information system. You can needs. Report Lists Using ABAP Query
decide whether you want the update to You can create evaluations that are
be performed on the basis of material, Flexible analyses not available as standard with a simple
material and vendor, or material and You can configure your own reports mouse click using the ABAP query
customer. on the basis of standard information tool or predefined logical databases.
structures or self-defined structures. The link to printing and presentation
You can also link your key figures to functions occurs automatically.

SAP NetWeaver Business Warehouse In this way, you receive summarized or ties in production, or returns in sales.
SAP NetWeaver BW offers data ware- detailed information regarding the noti- This information is integrated in the
housing that fits effortlessly into the IT fication process, with an emphasis on business content and can be linked
landscape of SAP ERP and other soft- reference objects such as customer, with key figures from SAP ERP, thereby
ware applications. It contains preconfig- vendor, material, or assembly. On the providing you with a complete picture
ured business content for your role organizational side, the emphasis is of quality in your company.
of quality manager or quality planner. placed on purchasing and sales divi-
Business content includes data extrac- sions, material groups, or the country QM-STI for External Evaluations
tion, metadata and information models, of origin of your customers. QM-STI is an open interface used for
and ready-made templates for tables evaluating inspection results in external
and graphs in Microsoft Excel or HTML. Among the key figures, you can obtain systems. You configure it in customiz-
the number of notifications, cumulative ing and trigger the external application
Inspection results or average processing time, defective by simply clicking a button in one of the
The specifications and results of your and returned quantities, and proportion following QM functions with SAP ERP:
quality inspections can be evaluated of notifications completed on time. In • Results recording
down to the sample level of an individual addition, you can get information on • Usage decision
characteristic. The spectrum of key fig- new, outstanding, and successfully • Control chart
ures ranges from the number of inspect- completed tasks. • Results history
ed or rejected samples to indicators for
process capability, such as Cp and Cpk. Defects, defect locations, causes, Search for Quality Data
You can interactively analyze quality activities, and tasks The SAP NetWeaver Enterprise Search
using criteria such as material, vendor, Using QM with SAP ERP, you docu- application provides SAP applications
or work center. ment defects in the inspection lot or as with numerous services for searching,
notification items. SAP NetWeaver BW classifying, and text mining in large col-
Inspection lots shows you which defect types lections of documents (unstructured
Inspection lots can be transferred to occurred, where they occurred, and data) as well as for searching in and
SAP NetWeaver BW once the usage what caused them. Activities and tasks aggregating business objects (struc-
decision has been made. You can obtain associated with the notification are tured data).
information in graphic or tabular form also extracted. The same reference
on the frequency of individual usage objects as in quality notifications are In QM with SAP ERP, the search func-
decisions, the number of inspected and available to you in the form of naviga- tion is available for quality-related data
skipped lots, the actual inspected quan- tional attributes. All coding is also avail- such as:
tity, the percentage of nonconforming able. For example, you can determine • Master inspection characteristic
units, or the quality score. For example, which defects occur regularly in a • Inspection method
you can consolidate the information and specific location. • Supplier information record
sort it according to vendor or purchas- • Quality notification
ing organization. Many key figures used by the quality
manager are based on information The search function is offered during
Quality notifications obtained from internal systems running data entry within change and display
Quality notifications reflect unplanned non-SAP software as well as external transactions for a given object; a sim-
events that occur during the quality systems. Examples of this information ple and an extended search function
process. For every notification, a selec- include the vendor evaluation in pur- are provided.
tion of attributes and key figures is chasing, returned quantities in stock
transferred to SAP NetWeaver BW. management, scrap and rework quanti-

Even when the entry is imprecise or the Appraisal Costs
entered search string contains typing Appraisal cost orders are stored in the
errors, results can be found using a material master and assigned by SAP
“fuzzy search.” Depending on the set- ERP as cost collectors to individual
ting of the search criteria in customiz- inspection lots. If, however, a special
ing, you can search for notifications of settlement is required for an inspec-
one special type, for example, only for tion, that settlement takes precedence.
quality notifications. This can happen, for example, when
the lot belongs to a production order or
Taking Control of Quality Costs when it comes from a goods receipt for
a purchase order that is assigned to a
With SAP ERP, the controlling function cost center account. Benefits:
plans, collects, and evaluates all costs
incurred by a company. These costs SAP ERP calculates appraisal costs • Use dynamic modifi-
include quality-related costs. In QM using the activities that you, as the cation to reduce your
with SAP ERP, you record appraisal inspector, confirm. You can confirm
costs originating from quality inspec- activities, for example, on the basis appraisal costs
tions or nonconformity costs originat- of the hours worked. Accounting fixes • Monitor processes
ing from quality notifications. Quality the types of activities, such as setup or
costs from other applications (for inspection time, and the valid charges continuously using
example, human resource manage- for the cost center that performs the quality control charts
ment) can be included in the cost activity. The activities performed for
calculation. inspection lots are logged during • Access important
results recording or when the usage company key figures
The controlling component uses QM decision is made. Activities performed
orders to manage quality costs. The for inspections during production are and evaluations
following types of QM orders are confirmed when confirmations for pro- immediately
provided in SAP ERP: duction orders are made. Other inspec-
• Appraisal costs order tion costs, such as material usage, are
– For individual settlement settled to the order in which you con-
– For collective settlement firm the inspection activity. for costs such as those relating to a
• Nonconformity costs order warranty, to scrapping, or to the settle-
Nonconformity Costs ment of activities performed. You can
You can also define your own specific To settle nonconformity costs for a also assign rework orders to this cost
order types. When creating an inspec- quality notification, you create a QM collector account. This allows you to
tion lot or a quality notification, you can order when processing a notification. debit all costs for a quality notification
create or assign a corresponding QM You assign the order to the notification to the appropriate personnel and ana-
order. header and use it as a cost collector lyze the costs.

Test Equipment Management
As a test equipment manager, you are Using the results history, you can verify Master Data in a
responsible for managing, monitoring, the suitability of each piece of equip- Calibration Inspection
calibrating, and maintaining test equipment and the accuracy of the inspec-
ment. Test equipment management tions performed using this equipment. Several master data records are used
involves the following activities: during a calibration inspection: equip-
• Planning and performing calibration Tracking Test Equipment ment master data, maintenance plan,
inspections SAP ERP provides you with test equip- and maintenance task list.
• Releasing or blocking test equipment ment tracking functions. During a cali-
• Documenting the calibration history bration inspection, you might notice Equipment
• Creating trend analyses that a piece of test equipment is no In SAP ERP, your company’s test
• Determining calibration costs longer fit for use. In this case, you can equipment data is stored in an equip-
• Tracking test equipment with usage check in the test equipment history to ment master record. This master
lists see which inspection lots and charac- record contains all of the data relevant
teristics were inspected using this to test equipment (such as acquisition
Calibration Inspections piece of equipment. You are then able value and date, manufacturer, work
and SAP ERP to initiate the appropriate actions. center, cost center, and location).
As shown in Figure 30, test equipment Monitoring Technical Installations To organize your test equipment and
management in SAP ERP combines In addition to calibration inspections, make it easier to locate, you can:
important planning and processing you can use inspection lots created for • Combine similar test equipment into
functions from QM with SAP ERP that maintenance orders for the extended groups
are needed for master data manage- recording of measured values in plant • Use the classification function to cat-
ment and for planning and performing maintenance (for example, to monitor egorize test equipment according to
calibration inspections. technical installations where critical val- technical features
ues have to be recorded on a regular • Assign test equipment to a construc-
Releasing Test Equipment basis). Consequently, you can record tion type (material)
You can use the inspection results to inspection results for functional loca-
decide whether a piece of test equip- tions as well as for test equipment.
ment can be released for further use.
Inspection Order
Results
Decisions Processing
History
Usage
List Work
Master Data
Lists
Calibration Planning
Calibration
Orders Calibration Inspection Notifications
Trend Link Insp. Calibration

Analysis Char. & Msmt. Intervals
Pnts
Figure 30: Functions of Test Equipment Management

Maintenance Plan
The maintenance plan is the central Maintenance Task
planning object in which you assign the List
list of equipment to be inspected, the Maintenance
maintenance task list, and the calibra- Strategy Cycle
Test Equipment Maintenance
tion schedule. (Equipment Maintenance
Item Order
Master Records)
The maintenance plan specifies which
types of activities must be performed
Maintenance Plan
periodically and how often they are to
be performed. In the maintenance
Inspection
plan, you can enter time-based or
Characteristics
performance-based intervals for per-
forming these activities. When mainte-
nance deadlines are reached, SAP ERP Figure 31: Objects in a Calibration Inspection
automatically creates maintenance
orders. To plan a calibration inspection, you (single-cycle plan) at the maintenance
must: plan level that is valid for all operations
Maintenance Task List • Create master data of the maintenance task list.
In the task list, you plan the recurring You need master data such as equip-
work processes in a standardized form. ment master records, maintenance You define inspection intervals based
To perform a calibration inspection, you plan, master inspection characteris- either on time or performance. A time-
can include inspection characteristics in tics, and the maintenance task list. based inspection interval might, for
the maintenance task list. In turn, you You define operations and the char- example, consist of an annual calibra-
can include a maintenance task list in acteristics associated with these tion on a key date. A performance-
a maintenance plan. The task list speci- operations in the maintenance task based inspection interval may involve a
fies the activities to be performed for list. calibration after 1,000 uses of a piece
individual maintenance deadlines. • Define inspection specifications of equipment. You can combine time-
Quantitative and qualitative inspec- and performance-based calibrations in
Planning a Calibration Inspection tion characteristics contain the a multiple counter plan (for example,
inspection specifications (such as tar- inspect after 6 months or, at the latest,
The automatic or manual scheduling of get values, tolerances, and codes for after 1,000 uses of the equipment).
a maintenance plan triggers calibration attributive valuations), and they deter-
inspections that are to be performed at mine how results are to be recorded. Calibration Inspection
regular intervals. When a maintenance • Define inspection intervals
plan is scheduled, SAP ERP creates a You can define inspection intervals A calibration inspection covers the fol-
maintenance order; when this mainte- using a central maintenance strategy lowing activities:
nance order is released, an inspection that can apply to several maintenance • Scheduling the maintenance plan
lot is created. The inspection lot con- plans. You can use maintenance strat- and creating the maintenance order
tains all data required for the calibration egies, for example, to define different and inspection lot
inspection, such as a list of equipment intervals for each operation within a The maintenance plan is usually
to be inspected and the inspection maintenance task list. You have the scheduled automatically using a peri-
specifications (see Figure 31). option of defining a maintenance cycle odically run program. When this

program is run, SAP ERP creates
calls and converts these calls into Update
orders when they become due. You equipment status Release or Block
Usage Decision
can select a setting that releases Equipment
orders directly, causing the inspec-
tion lots to be created. Adjust
• Inspecting and calibrating test cycle modification factor Reduce/Increase
Inspection Lot
equipment Inspection Interval
You can use various criteria to create
a work list of the calibration inspec- Update
tions that are planned for a specific Equipment measurement documents Document
period. Such criteria might include, No. 12345 Inspection Result
for example, all test equipment to be
calibrated in the next week or test
equipment sorted by cost center or Figure 32: Follow-Up Actions When Making the Usage Decision
work center. You can use this infor-
mation to identify and prepare the the calibration inspection. In addition, the future status. This status can be
test equipment for inspection. When additional order processing functions updated in the equipment master
a maintenance order is released, are available, such as capacity planning record. If a piece of test equipment is
SAP ERP automatically creates an or external assignment. If characteris- blocked, you are alerted to this fact
inspection lot. All orders that have tics are rejected, you can create main- when the next order is released.
been released and all inspection lots tenance notifications, start corrective • Change inspection interval
that are to be processed appear in a tasks, and document the success of If an inspection shows that a piece
work list for results recording and can these corrective tasks. of test equipment is still fit for use,
be processed in any sequence. If test but maintenance is due before the
equipment unexpectedly fails during Once you have recorded all the results next inspection date, you can change
use, you can create a maintenance for the equipment in each operation, the cycle modification factor when
notification (malfunction report). you make an equipment valuation for you make the usage decision. This
Within this maintenance notification, the test equipment (accept or reject). has the effect of reducing the length
you can manually create a mainte- When all the test equipment for an of the next inspection interval.
nance order to schedule a calibration inspection lot has been valuated, you • Create measurement documents
inspection. make the usage decision for the If you have defined measuring points
• Recording results inspection lot. As a result of the usage for your test equipment, SAP ERP
You can record results in the work list decision, SAP ERP can perform certain can create measurement documents
for the equipment and use the char- follow-up actions (see Figure 32): automatically for each measuring
acteristic types and recording func- • Update equipment status point. When this follow-up action
tions of QM with SAP ERP. SAP ERP manages a status for each is executed, the results of the cali
item of test equipment in the equip- bration inspection are entered
During a calibration inspection, you are ment master record. This status automatically in new measurement
able to make confirmations for the determines whether a piece of test documents. You can access these
maintenance order; for example, to equipment is released for use or documents in the equipment history.
record costs for activities performed blocked. On the basis of the equip-
or for materials that were required for ment valuation, SAP ERP proposes

• Complete maintenance order Trend analysis using run chart
You can set the software to automati- If you display inspection results for an
cally complete the calibration order inspection characteristic as a run chart
when the calibration inspection has using the time axis in the results history,
been completed. SAP ERP can indicate a trend (regres-
sion line) for the run of values. This
In addition to the follow-up actions provides you with an indication of when
described above, you can also define a tolerance limit will be exceeded.
your own follow-up actions, such as
printing self-adhesive calibration labels Usage lists
specifying the date of the next calibra- The usage list for test equipment
tion inspection. allows you to determine the cost center
of the test equipment, its current or
Evaluations for Test Equipment previous location, or the work center in Benefits:
which it was used.
Results history • Guaranteed quality
You use the results history to display Test equipment history and reliability of your
the results of previous inspections for Using the test equipment history, you
specific characteristics of a piece of can determine which inspection lots test equipment
test equipment. and characteristics were inspected with • Safe production pro-
a specific piece of test equipment. This
is important when, for example, during cess because of early
a calibration inspection you determine forecasting of possi-
that a piece of test equipment should
no longer be in use (test equipment ble weak points in
tracking). technical installations
• Ability to track your
test equipment

Enabling an Integrated
Enterprise Laboratory
Information Management
System with SAP ERP
The Enterprise LIMS Approach This integrated approach means that Stability Study – Supporting
quality management functions can Product Development and
Over the years, LIMS have evolved be embedded into business processes Product Improvement
from custom-developed in-house sys- such as procurement, manufacturing, or
tems used to track data in quality labs controlling, helping to eliminate redun- Functionality for stability studies is an
to proprietary commercial products. dant data and increasing information important feature to enable the use of
More recently, LIMS have evolved into transparency throughout the organiza- quality management with SAP ERP as
standards-based systems. As a result, tion. On a more technical level, integra- a LIMS. Stability studies, also known
companies are beginning to think in tion means having fewer systems and as shelf-life studies, are carried out for
terms of “enterprise LIMS” that not interfaces to maintain. Overall, the sim- self-produced or externally procured
only support the full range of functions plicity of SAP ERP as a LIMS can help goods, especially in the chemical,
within the laboratory, but are integrated companies reduce costs and increase pharmaceutical, cosmetic, and food
with systems throughout the company. profits and customer satisfaction. industries. Such studies are required
to determine expiration dates during
The challenges labs face as they man- The SAP ERP application supports all the development of new products (in
age quality are related to turnaround essential functions in a LIMS, including research and development), and they
time of lab tests, access to results those shown in Figure 33. are mandatory in order to obtain legal
data, accuracy of analyses, resource approvals for products.
utilization, data exchange, record keep-
ing, and productivity. With SAP ERP, a
full range of quality management func- • Audit management • Master data maintenance
tions addresses these challenges in • Bar coding and labeling • Multiple specifications
both commercial and industrial labora- • Batch management (batch traceability • Nonconformance reporting and processing
and electronic batch record) • Notification processing
tories. In addition, SAP ERP offers an • Calculations and formulas • Order management
integrated LIMS as part of a larger, • Calibration of instruments • Post-process control
more comprehensive quality manage- • Certificates of analysis • Problem solving and event handling
ment solution, simplifying implemen • Change management (audit trail) • Quality assurance
tation and integration as well as • Complaint and problem management • Quality planning
and corrective and preventive action • Quality data interchange
streamlining quality processes. And • Data retrieval and archiving • Recurring inspections
SAP ERP is more than just another • Digital signatures • Results recording and copy
LIMS. Unlike traditional LIMS, it offers • Document management • Returns inspections
tight integration into the supply chain • Engineering change management • Sample management (unplanned and
and other key areas within the enter- (audit trail) planned samples)
• Flexible inspections • Skip-lot functionality
prise. By enabling companies to take • Goods receipt inspections • Specification management
an enterprise approach to LIMS, SAP • Information system and reporting • Stability (shelf-life) studies
ERP does the following: • In-process control • Statistical process control
• Provides a standard basis for integrat- • Inspection plan maintenance • Statistical quality control
ing quality management processes • Interfaces (inspection data and • Test equipment interfacing
statistical data) • Quality cost tracking
across the enterprise • Inventory control • Vendor evaluation
• Enables visibility of quality data • Invoicing and billing of analysis • Web services
throughout the organization • Laboratory statistics • Work lists and workflow
• Enhances communication among
quality groups and other departments Figure 33: Overview of LIMS Functionality with SAP® ERP

In addition, stability studies are an Compliance and Quality Control introduce their products into the
important tool for continuously improv- U.S. market with a detailed, complete,
ing products and processes. In general, GxP is an acronym for Good Clinical/ and traceable description of their
stability studies are conducted for the Laboratory/Manufacturing Practice production process. This includes all
following reasons: (GCP, GLP, and GMP) and refers to operations affecting product quality
• Monitor and study the effects of exacting requirements for regulated performed during the manufacture and
storage conditions (for example, industries, such as the pharmaceutical, distribution of a particular drug. The
temperature, light, and humidity) on food, and beverage industries. For requirements for computerized systems
a substance over a defined period example, the U.S. Food and Drug with respect to electronic records are
of time Administration (FDA) requires compa- described in the U.S. Code of Federal
• Provide evidence of the effectiveness nies in the pharmaceutical industry to Regulations (CFR), volume 21, part 11.
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

GxP compliance plays a decisive role The following functions of the digital Benefits:
in data acquisition and validation, espe- signature for inspection lots and physi- • Reduced workload for
cially in analytical laboratories. Accura- cal samples have been enhanced in the
cy and clarity of data, as well as most recent release: system administration,
consistent change documents (who • Use of signature strategies less training, and fewer
did what, when, where, and why) are • Multistage signatures
crucial for regulatory compliance. • Detailed documentation upgrades by not using
• Possibility to print information about numerous fragmented
Quality management with SAP ERP the signature
supports these GxP requirements, pro- systems
viding complete audit trail functions and Within extended customizing you can • Better processes
digital signatures in results recording, define strategies for signatures, which
sample or product release, and notifica- means that in a multistage process with standardization, in-
tion processing. These functions also multiple persons have to sign the creased efficiency, and
support change management, electron- results in a predefined order. To realize
ic batch records, and integrated docu- this scenario, it is possible to process ease of collaboration
ment management to store all relevant inspection lots for which signatures • Better product quality,
documents, such as standard operating already have been created. If results
procedures. need to be inspected and signed by fewer defects, and
multiple users, the inspection charac- less rework and waste
One added benefit is the optimized teristic does not get the status “com-
data flow that results from eliminating pleted” immediately. Instead, this • Increased accuracy
interfaces between systems. The use status is set once the entire signature and security of data,
of SAP ERP as an integrated enterprise process for this characteristic is fin-
LIMS can lead to improved data accu- ished. For more detailed documenta- which reduces costs
racy and consistency, which, in turn, tion, you can save or print data that is associated with
can lead to better – and easier – regula- related to the signature.
tory compliance. regulatory compliance
In the work list for results recording, • Improved data quality
For more information about compliance the status of a signature process is dis-
of SAP ERP with GxP requirements in played with icons and can be requested and visibility because
general, refer to the SAP white paper by the user. As new functionality in data is consistent,
Complying with U.S. FDA Title 21 CFR SAP ERP for notifications, such as
Part 11 for the Life Sciences Industry. quality notifications and maintenance transparent, and
notifications, you can now include a available throughout
Digital Signature digital signature for single processing
The digital signature serves the same steps. In customizing for notifications the company
function for the processing of digital you can define the notice type, the
data as a handwritten signature serves level (header or operation), and the
for paper documents. Its purpose is to business process for which a digital
guarantee within an authorization pro- signature is necessary. You can also
cedure that the individual who signs a use signature strategies in this context.
digital document really is who he or she
claims to be.

Audit Management: Flexible Tool
for Planning, Execution,
and Evaluation of Audits
Assessments: Methods for environment, and industrial safety, in audits, revisions, or inspections can be
Audit Criteria one integrated management applica- performed using the audit management
tion. Combined audits can greatly functionality. The process phases are
An audit is a systematic examination reduce expenses. based on the standard ISO 19011.
used to determine to what extent an
object meets previously specified crite- Audit objects can be freely defined by The audit management functionality
ria. Audits are usually performed using groups of fields; for example, audits supports all phases of auditing – from
question lists, which represent the can be performed with reference to the planning of a comprehensive audit
criteria. organizations, enterprise areas, prod- program and of the individual audits,
ucts, and vendors. If an audit object is through the definition of the audit crite-
Audit management means to plan and described using data elements from the ria or question lists, to the actual audit-
process audits, grade the audit objects, application repository, for example, by ing process and the assessment of the
monitor corrective and preventive the combination vendor and material, audit object in the audit report. It also
actions that were based on the find- the information related to these data supports you in defining and monitoring
ings, and document and analyze audit elements is available – a clear advan- corrective and preventive actions. Audit
data. Audit management supports all tage of integration. management functionality also provides
appraisals based on predefined criteria effective tools for the evaluation of all
(audits, checks, inspections, reviews, The versatility of the audit management audit data.
and examinations) and can subsequent- functionality stems from being able to
ly be used to valuate the object. customize the properties of the audit A typical process includes the following
components (audit plan, question list, phases and tasks:
The audit management functionality audit, and action) as well as the proce- • Planning audit criteria
is very versatile and can be used for dures for assessing the criteria and Planning of general question lists
various application areas. Examples of grading the audit object. For example, (general criteria), depending on rele-
audit usages are: employees can provide question lists vant standards, regulations, or rules
• Quality management (system audit, with hierarchical tree structures to suit of the application area
process audit, and product audit) and their own requirements. • Planning the audit program
GMP Definition of a scheme, for example,
• Environment management and Audit Processing: Evaluate in the form of an annual schedule,
hygiene management Risks and Confirm Information taking into consideration the scope,
• Safety and security management object, and date of the audits
(facility safety, fire safety, and data To keep the process description that • Preparing the individual audits
protection) follows as simple as possible, the Determination of the individual audit
example is based on a quality system question lists and of the partners
Suitability for a wide variety of audit audit performed in accordance with involved in the audit, distribution of
usages meets the need of companies ISO 9000. However, if regarded in a roles, and preparing the required
to unify different management systems, broader sense, the example below can documents
for example, for quality assurance, also show you how various other

• 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

intuitive, yet powerful tool that you can
use to manage your audit processes. Figure 35: Audit Cockpit
Regardless of your industry sector, this
tool supports you throughout the entire products, while taking the relevant
audit process, from the planning phase, standards into consideration. You can
through audit execution and valuation, perform any kind of review or survey,
to the evaluation phase. This is a highly based on checklists. Audit manage-
flexible tool with open interfaces, such ment functionality in SAP ERP also
as the cockpit shown in Figure 35. It helps you fulfill legal requirements and
allows you to perform internal or exter- enables various scenarios for
nal audits of systems, processes, or benchmarking.

Mapping SAP Solutions to
Your Six Sigma Initiatives
Management Project Lead Statistician Project Member

(Sponsor Champion) (Black Belt, MBB) (Green Belt) (Inspector, Analyst)
Define Management of Six Sigma projects as an integrated
and structured application providing tools to achieve
breakthrough improvements
Measure
Comprehensive tools to calculate samples and

capture data for critical characteristics
Analyze
Improve
Control
Sophisticated analysis to control KPIs and monitor
continuous improvement
Figure 36: Sample Process According to Six Sigma
The Six Sigma approach to quality Of all the ERP and dedicated QM soft- A structured DMAIC problem-solving
improvement focuses on reducing pro- ware solutions, SAP Business Suite is road map comprising five steps – define,
cess variations and eliminating noncon- an excellent choice for implementing measure, analyze, improve, and control
formities, resulting in better quality, Six Sigma methodologies. In particular, – is commonly regarded as the core of
lower costs, and increased customer SAP ERP supports most of the ele- every Six Sigma project. Procedures
satisfaction. ments that are essential for Six Sigma. like these can be managed readily using

the collaboration software in SAP ERP,
which provides the functions you need
in collaborative projects.
Using collaborative projects software,

you define the five DMAIC phases of
your Six Sigma project and the related
tasks for every phase (see Figure 36).
You define criteria and checklists for
passing the quality gates between
one phase and the next. You plan the
resources (employees, black belt, and
so on) needed for executing the tasks.
You can also use graphical tools to
schedule and visualize 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 collab-
orative projects software. For example,
you can calculate project costs, and
you can link directly to related docu-
ments, notifications, inspections, and
audits. In this way you get access to
various capability 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 BW and an executive
information system for general analysis
purposes. SAP NetWeaver BW and the
executive information system provide
all the functions needed for calculating
KPIs, feeding balanced scorecards, or
other assessment techniques.

Service-Oriented Architecture
for Services-Based Business
Solutions
The enterprise services bundle “Integra- level. It can be used to exchange data The enterprise services supplied by
tion of Quality Management Systems” between LIMS and CAQ systems and this bundle can be used by quality
(IQM) provides enterprise services for SAP ERP directly, with more flexibility inspectors, operators, and lab
the exchange of inspection lot data, that is provided by existing interfaces. technicians who are executing quality
inspection results, and quality notifica- analyses and entering inspection data
tion data between SAP ERP 6.0 and IQM can be used to integrate LIMS and manually or transferring data from elec-
external quality management systems. CAQ systems via composite applica- tronic test devices. It is also applicable
tions. Integration with SAP ERP can be for production supervisors or quality
In comparison to the existing QM-IDI, achieved by using the enterprise ser- managers who want to perform analy-
the enterprise services bundle “Inte- vices provided in this bundle. SAP MII sis on this data.
gration of Quality Management Sys- can consume the services to enable
tems” adds the following benefits and entry of quality data and visualization This bundle requires the use of QM in
advantages: without having external QM systems SAP ERP. The services expose func-
• New XML-based technology connected. tionality of QM business objects such
(Web services) as inspection lot, physical sample, and
• Greater flexibility (a subset of ser This bundle does not supply or assume quality notification, and can interoper-
vices can be deployed) a dedicated user interface. It is intended ate with an external QM solution.
• Enhanced functionality (quality notifi- as a way to integrate other applications
cations and unplanned inspection that provide front-end functionality. In the future, SAP will offer additional
points, for example) A dedicated user-interface template enterprise services in the area of
based on the supplied services could inspection planning.
The IQM enterprise services bundle be created using SAP MII or the Web
bridges data from the quality planning Dynpro development environment, the For more information about enterprise
level to the inspection data level and SAP NetWeaver Visual Composer tool, services, see the wiki documentation
right down to the instrument recording or Adobe technology. 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.

Appendix
For More Information Key Terms a tightly integrated business application

suite that adds value to every facet of an
To find out more, refer to the following: CAPA organization and the external value chain.
• For general information about the Corrective and preventive action SAP Business Suite applications are
SAP® ERP application, visit the (CAPA) is an instrument for compliance based on the SAP NetWeaver® technol-
SAP Service Marketplace extranet at management in terms of systematic ogy platform, an integration and applica-
www.service.sap.com/erp (login is processing of quality deficiencies, tion platform that supports the evolution
required). errors, and malfunctions. Its aim is to of SAP Business Suite applications to a
• For general information about the document the entire process of solving services-based architecture.
quality management (QM) functional- the issue and providing appropriate
ity with SAP ERP and QM as an corrective actions and further preven- SAP ERP
enterprise laboratory information tive actions to avoid a recurrence of The SAP ERP application is integrated
management system, visit an issue in the future. business management software that
www.service.sap.com/qm (login is includes the functionality and methods
required). CAQ that are needed to effectively plan and
• For online documentation (SAP Computer-aided quality assurance manage a business. QM functions are
Library) for SAP applications, visit SAP (CAQ) is the application of computers seamlessly integrated.
Help Portal at http://help.sap.com. and computer-controlled machines
The following link is an example of the for the definition and inspection of the SAP NetWeaver
online documentation available for quality of products. SAP NetWeaver is a Web-based tech-
quality management: nology platform that serves as a founda-
http://help.sap.com/erp2005 collaborative business tion for SOA and enables the integration
_ehp_05/helpdata/en/a6 Collaborative business occurs between and alignment of people, information,
/df293581dc1f79e10000009b38f889 companies using a regulated exchange and business processes across busi-
/frameset.htm. of information and data on the Internet. ness and technology boundaries. By
• For information about electronic using open standards, it can integrate
records (SAP audit trail functions, LIMS with information and applications from
table logging, and change docu- A laboratory information management virtually any source or technology.
ments), refer to online documentation system (LIMS) is computer software
(SAP Library) at http://help.sap.com that is used in the laboratory for the SAP NetWeaver Portal
/saphelp_erp2005/helpdata/EN/02 management of samples, laboratory The SAP NetWeaver Portal component
/05cce0e4b0c34cb485de7246093ce8 users, instruments, standards, and unifies the applications, information,
/frameset.htm. other laboratory functions such as and services existing in an enterprise
• For information about enterprise invoicing, plate management, and work into one platform and includes a portal,
services, see wiki documentation at flow automation. content management, and business
http://wiki.sdn.sap.com/wiki/x/kww intelligence.
and go to the Enterprise Services SAP® Business Suite
Workplace site at www.sdn.sap.com SAP Business Suite is a comprehensive service-oriented architecture (SOA)
/irj/sdn/esworkplace. family of adaptive business applications SOA is a software architecture that
• To coordinate visits or phone calls that provide industry-specific functional- uses policies, practices, and frame-
with companies using SAP ERP, con- ity. The software is built for complete works that enable application function-
tact your SAP sales representative. application integration, scalability, and ality to be provided and consumed as
collaboration over the Internet. SAP services. These services are published
Business Suite applications help to man- at a level of granularity relevant to ser-
age critical business processes and form vice consumers.

Quick facts www.sap.com /contactsap
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.
Business 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
Key Features
• 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
maintain ongoing evaluations
• Audit management – Continuously check processes, products, and systems and trigger
corrective actions
Business Benefits
• 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 50 058 498 (11/11)
• Greater transparency – Make quality decisions based on reliable, integrated, traceable, ©2011 SAP AG. All rights reserved.
and accurate data SAP, R/3, SAP NetWeaver, Duet, PartnerEdge, ByDesign,
SAP BusinessObjects Explorer, StreamWork, SAP HANA, and other
• Enhanced collaboration – Integrate employees and business partners in your entire SAP products and services mentioned herein as well as their respec-
product lifecycle and the supply chain tive logos are trademarks or registered trademarks of SAP AG in
Germany and other countries.
For More Information Business Objects and the Business Objects logo, BusinessObjects,
Crystal Reports, Crystal Decisions, Web Intelligence, Xcelsius, and
For detailed information about SAP ERP, visit our Web site at www.sap.com/erp or contact other Business Objects products and services mentioned herein
your SAP representative. as well as their respective logos are trademarks or registered trade
marks of Business Objects Software Ltd. Business Objects is an
SAP company.
Sybase and Adaptive Server, iAnywhere, Sybase 365, SQL Anywhere,

and other Sybase products and services mentioned herein as well
as their respective logos are trademarks or registered trademarks of
Sybase, Inc. Sybase is an SAP company.
All other product and service names mentioned are the trademarks of
their respective companies. Data contained in this document serves
informational purposes only. National product specifications may vary.
These materials are subject to change without notice. These materials

are provided by SAP AG and its affiliated 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 prod-
ucts 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.

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SAP Functions in Detail

4 To the Reader 38 Efficient Problem Management 58 Audit Management: Flexible

25 Quality Inspections: 51 Test Equipment Management

In today’s economy, you must invest in with ever-growing customer expecta-

4 SAP Functions in Detail – Quality Management with SAP ERP

SAP Functions in Detail – Quality Management with SAP ERP 5

6 SAP Functions in Detail – Quality Management with SAP ERP

Plant Production Planning/

Quality Planning Materials

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Quality management with SAP ERP Take a Closed-Loop Approach

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In many industry sectors, suppliers Goods Receipt Reminder

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Inspection Point Quality Inspection results

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Defects can be recorded for inspection

Statistical process control

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You can use QM with SAP ERP to

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Closed-Loop Inspection Planning: Specification FMEA

Closed-loop inspection planning means

The first step is to work in a team of

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This makes sure that the entire object,

With the integration of the FMEA tool

Figure 8: Example of FMEA with Structure

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Integrated Inspection Planning

With integrated inspection planning,

Inspection Plan 3 Vendor 1 Task-list header

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Operation Basic Data for Inspection Planning Inspection Method

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The following sections discuss various

Figure 12: Inspection Planning with the Engineering Workbench

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Figure 14: Inspection Lot Creation

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During inspection planning, you decide

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Planned • Automatic creation of physical samples at

• Manual creation of physical samples

• Manual creation of inspection lots for

Figure 18: Types of Planning and Processing for Physical Samples

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Product: RAW01 Product: SEMI01 Product: RAW03 Product: FIN01

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