Sap QM

A comprehensive approach
to quality management
one that integrates informa-
tion and processes across
departments and corporate
boundaries empowers
your employees and supply
chain partners to maintain
and improve quality levels.
The SAP ERP application
provides a single, powerful
solution that lets you take
a comprehensive, broad-
based approach to total
quality management. It
de livers a wide range of inte-
grated quality management
functionality and supports
collaborative business pro-
cesses for cost-effectively
ensuring the quality of your
products and processes and
transforming quality man-
agement into a competitive
advantage.
QUALITY MANAGEMENT
WITH SAP ERP
SAP Functions in Detail
SAP ERP
4 To the Reader
5 Modern Quality Management:
An Integrated Management
Approach
5 Offering a Total Quality
Management Solution
6 Internal and External Integration
8 Quality Management with
SAP ERP
8 Take a Closed-Loop Approach
to Total Quality Management
9 The Planning Phase
11 The Implementation Phase
16 The Usage Phase
18 Inspection Planning: Putting
Quality Strategies into Action
18 Closed-Loop Inspection Plan-
ning: Failure Mode and Effects
Analysis and Control Plan
20 Integrated Inspection Planning
21 Basic Data for Inspection
Planning
23 Planning Tools
25 Quality Inspections:
Achieving Reliable Results
25 Inspection Lot Processing
28 Inspection Results
32 Sample Management
34 Quality Certificates:
Guaranteed Reliability
Printed or on the Internet
34 Certificate Processing in
Sales and Distribution
35 Certificate Creation
Meeting Your Requirements
36 Certificate Processing at
Goods Receipt
37 Collaborative Business:
Certificate Data for the
Whole Company
38 Efficient Problem Management
38 Improved Quality Through
Targeted Problem Handling
38 Using Quality Notifications
39 Notification Processing
39 Quality Notifications
40 Elements of the Quality
Notification
40 Optimized Usage
41 Analysis of Items and Defects
41 Tasks
42 Support Functions
43 Sustained Quality Control
Planning, Evaluation, and
Direct Intervention
43 Dynamic Modification of the
Inspection Scope
44 On the Right Track with
Statistical Process Control
46 Vendor Evaluation: Permanent
and Objective Performance
Monitoring
47 Evaluations: Keeping You
Up-to-Date
50 Taking Control of Quality Costs
51 Test Equipment Management
51 Calibration Inspections and
SAP ERP
51 Master Data in a Calibration
Inspection
52 Planning a Calibration
Inspection
52 Calibration Inspection
54 Evaluations for Test Equipment
55 Enabling an Integrated
Enterprise Laboratory
Information Management
System with SAP ERP
55 The Enterprise LIMS Approach
55 Stability Study Supporting
Product Development and
Product Improvement
56 Compliance and Quality Control
58 Audit Management: Flexible
Tool for Planning, Execution,
and Evaluation of Audits
58 Assessments: Methods for
Audit Criteria
58 Audit Processing: Evaluate
Risks and Confirm Information
60 Mapping SAP Solutions to
Your Six Sigma Initiatives
62 Service-Oriented Architecture
for Services-Based Business
Solutions
63 Appendix
63 For More Information
63 Key Terms
64 Quick Facts
CONTENT
This document targets project plan-
ners, decision makers, and people
interested in implementing QM with
SAP ERP. It explains how QM with SAP
ERP is integrated in SAP Business
Suite applications and service-oriented
architecture (SOA), powered by the
SAP NetWeaver technology platform.
It provides you with insight into the cur-
rent functional scope of QM with SAP
ERP. It also shows how QM functions
are integrated in SAP ERP and support
the business processes of the supply
chain.
For detailed information about
SAP ERP, visit our Web site at
www.sap.com/erp or visit the
SAP Service Marketplace extranet
at www.service.sap.com/erp
(login is required).

In todays economy, you must invest in
business software in order to invest in
your companys future. It is important to
lay a trusted foundation for business
excellence and innovation and to provide
your organization with the enterprise
resource planning (ERP) functionality
that is needed to gain strategic insight,
competitive differentiation, increased
productivity, and business agility.
With the SAP ERP application, SAP
has transferred its vision of increasing
efficiency within an organization to soft-
ware for enterprise resource planning
that helps automate end-to-end busi-
ness processes and extends those
processes to the entire business eco-
system, including customers, partners,
and suppliers. With SAP ERP, you can
increase your employees productivity
and provide them with the insight
needed to make decisions that set
you apart from the competition.
Quality is a vital core competency for
manufacturers industry-wide and
given todays complex and often global
production cycles, it cannot be treated
as simply an afterthought. You have to
engineer quality into the design of prod-
ucts and processes; you have to track
quality through procurement, produc-
tion, and delivery; and you have to con-
stantly improve quality to keep pace
with ever-growing customer expecta-
tions and competitive pressures. In
short, you need to take a comprehen-
sive approach to quality management
one that integrates information and
processes across departments and
corporate boundaries and empowers
both your employees and supply chain
partners to maintain and improve
quality levels.
SAP ERP enables the comprehensive
and efficient approach you need to
transform quality management into a
competitive advantage. SAP ERP deliv-
ers a wide range of integrated quality
management functionality and supports
collaborative business scenarios for
cost-effectively ensuring the quality of
your products and processes. As your
employees work throughout the entire
product lifecycle along the supply
chain, SAP ERP helps ensure that qual-
ity is efficiently built into your pro-
cesses, systems, and products, from
the shop floor to the top floor.
If you are considering implementing
or have already implemented quality
management (QM) with SAP ERP in
your company, and you want informa-
tion on current functions and new
developments, then this document
contains all the information you need.
TO THE READER
4 SAP Functions in Detail Quality Management with SAP ERP
Offering a Total Quality
Management Solution
The SAP ERP application provides a
single, powerful solution that lets you
take a comprehensive, broad-based
approach to total quality management
(QM). Far more than a traditional iso-
lated computer-aided quality system or
a laboratory information management
system, SAP ERP supports quality
processes in any industry.
Practice Continuous Improvement
You can quickly identify and analyze
problems, then rapidly eliminate their
root causes. With the quality notifica-
tions functionality, for example, you can
ensure that all problems and unplanned
events are captured directly when they
occur, that they are correctly assigned
and resolved, and that all actions are
monitored for maximum effectiveness.
A service-oriented ap proach allows
employees as well as business part-
ners to create requests or notifications,
work together online to record informa-
tion, dispatch information, and track
the processing status of requests
providing the full functionality needed
to ensure corrective and preventive
actions. In addition, the analytic func-
tionality of SAP ERP and the SAP
NetWeaver Business Warehouse
(SAP NetWeaver BW) component
enables you to monitor quality perfor-
mance and adjust quality strategies to
eliminate problems. Using the flexible
QM cockpit for evaluations in SAP
ERP, for example, you can analyze both
online and archived quality manage-
ment data to support your companys
Six Sigma projects.
Manage Audit Processes
The audit management functions of
SAP ERP let you plan, conduct, and
evaluate audits throughout the enter-
prise. You can perform internal or
external audits of systems, processes,
products, and environmental condi-
tions; conduct a range of assessments
and reviews; and monitor the effective-
ness of all corrective and preventive
actions linked to quality notifications.
All this helps you comply with legal
requirements, support benchmarking
efforts, and uncover opportunities for
improvement. Audit management func-
tions support a wide range of industry
standards, such as ISO 9000:2000,
QS-9000, Good Manufacturing
Practice (GMP), ISO 14011, and
ISO 19011.
Deliver Quality-Related Information
Where Its Needed
Web-based enterprise portal technol-
ogy and ready-made SAP content give
your employees and your partners a
single point of access to all the infor-
mation, applications, tools, and ser-
vices they need to collaborate on
quality initiatives. The intuitive, context-
driven portal increases the reach of
your quality management efforts to
include both everyday and occasional
users in quality processes. For exam-
ple, quality inspectors can work more
efficiently by using the portal to access
the specific work list they need to com-
plete each inspection lot.
Stand Out at Quality Control
SAP ERP gives you quality control
functionality that supports strategic
planning, continuous monitoring, and
quick problem resolution. The applica-
tion lets you share quality information
and control quality processes across
the supply chain. You can plan, con-
duct, and manage quality inspections
and integrate them into processes
throughout the product lifecycle. You
can accurately track results and defect
data; record and charge inspection
costs; manage and maintain laboratory
data related to samples, tests, and
stability studies; automatically create
quality certificates for customers and
exchange that information with busi-
ness partners; and connect, monitor,
and maintain test equipment to ensure
data accuracy.
You can collect and analyze all the
quality-related data needed to conduct
Six Sigma projects. With the applica-
tions built-in workflow functions, you
can automate and accelerate many of
your business processes. Meanwhile,
the SAP Manufacturing Integration
and Intelligence (SAP MII) application
lets you rapidly integrate SAP ERP
with other manufacturing software
enabling production-line personnel to
record inspection results directly from
the shop floor. Leveraging a service-
oriented architecture (SOA), SAP ERP
offers a wide range of enterprise ser-
vices for quality management. In an
interconnected world, the ability to
exchange data across applications and
with various partners is rapidly becom-
ing as important as statistical process
control and test equipment interfaces.
MODERN QUALITY MANAGEMENT:
AN INTEGRATED MANAGEMENT
APPROACH
SAP ERP is designed for easy integra-
tion with other SAP and non-SAP appli-
cations for supply chain management,
customer relationship management,
supplier relationship management, and
enterprise resource planning. As a
result, it streamlines information shar-
ing and supports true end-to-end
business processes.
Internal and External Integration
The openness of the SAP NetWeaver
technology platform and the seamless
integration of QM with SAP ERP into
a complete business solution support
you in total quality management and
satisfy the criteria for ISO 9000 or
GMP.
In the integrated SAP Business Suite
applications, SAP ERP functions are
incorporated into other applications,
such as the SAP Supply Chain Man-
agement (SAP SCM) or SAP Cus-
tomer Relationship Management (SAP
CRM) application. You have software
support for all important processes.
QM with SAP ERP is linked directly
to various functions that help you effi-
ciently manage your business pro-
cesses. Examples of such functions
include:
SAP Business Workflow tool for
targeted process control
Using SAP Business Workflow, you
can establish a clearly defined infor-
mation and processing network to
quickly and efficiently process
inspection lots and quality
notifications.
SAP ArchiveLink software for
storing documents
SAP ArchiveLink stores documents
that are linked to application func-
tions in an optical archive. Such
documents include quality records,
certificates, customer complaints,
and other original internal or external
documents.
In addition to SAP ERP, you can inte-
grate other SAP solutions in the SAP
NetWeaver Portal component, such
as SAP NetWeaver BW. You can also
integrate non-SAP products. As a
result, you can adapt and enhance your
working environment to suit your own
requirements.
Using clearly defined roles, employees
can access their own work areas
in SAP NetWeaver Portal. A role
describes a specific activity profile and
groups together the corresponding
functions of that profile. Employees
can then target their involvement in
business processes. The flexible SAP
NetWeaver Portal allows you to adapt
the roles to suit your individual needs.

Service-Oriented
Architecture
Figure 1: Internal and External Integration of Quality Management with SAP ERP
Quality
Manager
Knowledge
Management
SAP
NetWeaver BW
SAP
SCM
External
URL
Quality
Planner
Inspection
Planner
Quality
Inspector
Notification
Processor
Test Equipment
Manager
Sales and
Distribution
Customer
Service
Plant
Maintenance
Controlling
Production
Planning
Production Planning/
Process Industries
Materials
Management
Classification
System
SAP Business
Workflow
Document
Management
System
Office
Engineering
Change
Management
SAP
ArchiveLink
Quality Planning
Quality Inspections
Quality Control
Quality Certificates
Quality Improvement
Test Equipment Management
Audit Management
QM within
SAP ERP
QUALITY MANAGEMENT WITH SAP ERP
Quality management with SAP ERP
tightens control and contains costs.
Under current market conditions, many
organizations follow a twofold strategy:
strive for continued growth and innova-
tion through competitive differentiation
and increase efficiency to meet the
enormous pressure to cut costs. In the
end, you must be excellent in both to
meet stakeholder expectations and
achieve financial success. You must
reduce costs wherever possible, but
avoid risks that might lead to unexpect-
ed and unbudgeted expenditures.
QM with SAP ERP enables enterprises
to manage quality in a highly efficient
way, differentiate their business, and
establish a reputation of excellence.
Conversely, mismanaging or ignoring
quality issues negatively impacts a
companys brand and products and
impairs cost control. The best answer
is to put in place a comprehensive
approach to total quality manage-
ment along the entire supply chain.
Enterprise-wide audit management,
quality engineering, quality assurance
and control, and continuous quality
improvement are all aspects of it. By
using QM with SAP ERP, organizations
can comply with industry standards
and legal requirements more easily,
increase customer satisfaction, and
improve competitiveness.
Take a Closed-Loop Approach
to Total Quality Management
There is more to quality management
than performing quality inspections
every now and then. Companies want
to focus on prevention of deficiencies,
continuous process improvement
through collaboration, and sustainable
quality control. You need to react
immediately to unplanned quality-
related events, involve all affected
parties, and start follow-up actions
to solve or control an issue.
SAP ERP supports and helps ensure
consistently high quality throughout the
supply chain. Companies can comply
continuously with legal requirements
and industry standards. Customer
satisfaction goes up, as does overall
product quality and customer service
management.
Because project management and
quality management functions are inte-
grated with the SAP ERP Corporate
Services solution, you can run Six
Sigma projects to further enhance
quality, improve processes, and reduce
costs within your company.
QM with SAP ERP supports key
business activities with a focus on
prevention of deficiencies, continuous
process improvement through collabo-
ration, and sustained quality control.
Comprehensive quality management
functionality supports:
Quality engineering
Quality assurance and control
Quality improvement
Audit management
QM with SAP ERP supports you both
internally and externally. It provides
complete support, from product and
process planning in research and devel-
opment (the planning phase); through
procurement, production, and sales
and distribution (the implementation
phase); to service and usage (the
usage phase), as shown in Figure 2.
Benefits:
Increased customer
satisfaction through
better product quality
and enhanced com-
plaint management
and tracking (correc-
tive and preventive
action)
Increased revenues
by retaining custo m -
ers and strengthening
customer loyalty
Increased efficiency
through improved
asset utilization
The Planning Phase
QM with SAP ERP supports the
process of quality management in
the planning phase. It comprises the
following features and functions:
Closed-loop inspection planning
Closed-loop inspection planning means
integrated inspection planning for
goods receipt inspections and for
inspections during production, and it
starts at the very beginning of the
product development process for a
new product. The international standard
ISO/TS16949 requires an advanced
product quality planning (APQP)
process, a must for each supplier
in the automotive and other discrete
industries.
SAP ERP provides tools for supporting
this process; one is a tool for a failure
mode and effects analysis (FMEA) and
the other is the control plan.
You can use the FMEA tool to perform
a risk analysis for a distinct object
(material or operation) to identify possi-
ble defects of a process or a product.
By applying the given tools, you can
detect possible risks and eliminate
them by defining preventive actions
at an early stage.
With the control plan, you can plan and
visualize all relevant inspections for a
final product and all its components.
The control plan connects all informa-
tion from the related objects and is a
basis for detailed inspection planning
for each step (in-process control,
goods-receipt inspections, and so on).
Document management
An important tool in SAP ERP is docu-
ment management. You can use docu-
ment management software to create
links between inspection outlines,
design drawings, technical delivery
terms, specifications, product specifi-
cations, inspection methods, and other
quality-relevant documentation and
the corresponding master data. You
can manage data according to validity,
version, and status.
Master data management
During the implementation phase of
your project, you specify product-
related settings that are required for
controlling quality-related processes in
the material master record in the quality
management view of master data. For
the management of quality information
related to materials, vendors, and cus-
tomers, and for the control of vendor
and customer-related processes, you
can maintain appropriate quality infor-
mation records. You can, for example,
assign quality assurance agreements
and perform model processing.
In material-related inspection plans, you
can define either customer- or vendor-
specific inspection specifications and
multiple specifications related to further
objects. When you are performing an
Figure 2: Quality Loop According to ISO 9004
Shipping
Maintenance
Disposal Market
research
Design
Testing
Production
planning
Procurement
Production Final
inspection
Warehousing
Usage Planning
Implementation
inspection during production, these
elements are integrated into the routing
or recipe.
You can make changes to the master
data centrally, and you can transfer the
data from one source system to one
or more target systems. In addition,
there are tools available for research
and analysis of master data linked in
a hierarchy, such as where-used lists
and the product structure browser.
Engineering change management
Central engineering change manage-
ment coordinates the changes you
make to master data. You can run such
changes through an approval procedure
(for example, according to GMP
requirements). You can create different
versions and then distribute them using
workflow. You can also allocate a revi-
sion level with regard to a specific valid-
from date when a change is made.
Classification
Using the integrated classification func-
tion, you can specify and assign data
that is available in SAP ERP (such as
materials, documents, and inspection
plans), in order to be able to locate this
data later according to specific search
criteria (such as batch characteristics).
Stability study
Stability studies or shelf-life studies are
conducted to track and examine how
different environmental conditions (for
example, temperature, light, or mois-
ture) affect a compound, a material, or
a batch over a specified period of time.
Using features and functions in SAP
ERP, you create physical samples of
the material or batch and store them
under controlled conditions for the
duration of the study. At specified
intervals during the study, you remove
these physical samples or parts of
these samples from the various condi-
tions and test them according to
predefined inspection plans. You can
then use the results of these tests,
which have accumulated over the
course of the study, for example, to
check and confirm whether the desired
or guaranteed life expectancy of the
product conforms to the predefined
recommendations for storage.
As a business process, the stability
study is fully integrated in SAP ERP,
using functions from the following
areas:
Quality management: quality notifica-
tions, quality planning, and inspection
lot processing
Asset lifecycle management: mainte-
nance planning and scheduling
Materials management: material
master, batch management, and bills
of materials
Authorization management
A central administration function is
responsible for data security and
protection. You can assign individual
authorizations for the processing of
master data and movement data. This
enables you, for example, to set up
employees so that they have to provide
a digital signature when performing
certain operations.
Business workflow
You can use business workflow to con-
trol certain complex processes and
the output associated with these pro-
cesses. For example, corrective tasks
within a problem notification can be
transferred automatically to the
organiza tional unit responsible.
Quality costs
You can enter, collect, and bill costs
related to the prevention of defects,
inspections, and nonconformity to
different account-assignment objects
using orders in controlling.
Key figure analysis
With its quality key figures, SAP
NetWeaver BW offers a wide range of
possibilities for monitoring and control-
ling your quality processes.
Audit management
With integrated audit management
tools you can plan and process audits,
grade audit objects, monitor corrective
and preventive actions that are based
on the findings, and document and ana-
lyze audit data. Audit management, as
part of SAP NetWeaver and thus also
part of SAP ERP, supports all apprais-
als based on predefined criteria (audits,
checks, inspections, reviews, and
examinations) and can subsequently
be used to valuate the object.
The audit management functionality
is very versatile and can be used for
various application areas. Examples
of audit usages are:
Quality management (system audit,
process audit, or product audit) and
GMP
Environment and hygiene
management
Safety and security management
(facility safety, fire safety, or data
protection)
Six Sigma
Having SAP ERP and SAP Business
Suite in place in your company allows
you to implement your Six Sigma
initiative. SAP ERP supports most of
the elements that are essential for Six
Sigma, such as the definition of a
structured problem-solving road map
such as DMAIC (define, measure,
analyze, improve, and control); a clear
setup of tasks and responsible persons
by using collaborative projects soft-
ware; the calculation of risks and costs;
the linking of related documents, notifi-
cations, inspections, and audits; the
determination of capability and perfor-
mance indicators, for example, from
statistical process control (SPC) moni-
toring of control charts and Cpk index;
and a failure mode and effects analysis.

Process data can be extracted from
the source and transferred into SAP
NetWeaver BW and an executive infor-
mation system for general analysis
purposes. SAP NetWeaver BW and the
executive information system provide
all the functions needed for calculating
key performance indicators (KPIs),
feeding balanced scorecards, or other
assessment techniques.
Collaborative scenario:
quality notifications
In the product development stage,
if you are working with customers or
partners, QM with SAP ERP offers you
the opportunity to initiate product ideas
or changes to products using quality
notifications. Customer complaints,
which can be entered on the Internet,
can be used to determine product qual-
ity. Vendors can ask for permission to
deviate from specifications if they
cannot adhere strictly to customer
specifications.
For this scenario enterprise services
are also available to create and main-
tain notifications in SAP ERP.
quality certificates
Working with your customers or ven-
dors, you use certificate profiles to
plan exactly which characteristics are
to appear on the certificate. This certifi-
cate data can be exchanged electroni-
cally using quality data interchange
(QDI), or it can be stored on the Inter-
net. For example, you can store it as
a PDF document.
results recording
You can record inspection results using
the Internet or intranet. Results can be
recorded by external service providers
(for example, commercial analysts) and
internal inspectors (for example, in a
source inspection) in their respective
work centers.
For this scenario enterprise services
are also available to trigger and record
inspection results in SAP ERP.
The Implementation Phase
QM with SAP ERP helps ensure quality
across the entire supply chain and
beyond company boundaries. It sup-
ports your quality management
department in the following activities:
Procurement. QM with SAP ERP
manages vendor-related master data,
controls the purchasing process
according to certain quality criteria,
and handles inspection certificates
and goods receipt inspections.
Production. QM with SAP ERP inte-
grates inspection specifications in
routings and recipes, allows inspec-
tions during production and goods
receipt inspections for the manufac-
turing order to take place, monitors
the production process using control
charts, and confirms quality, quantity,
and costs.
Sales and distribution. QM with SAP
ERP manages customer-related mas-
ter data, controls the sales and distri-
bution process according to quality
criteria, and handles inspection certif-
icates and inspections at goods
issue.
Procurement
Vendor evaluation
Materials management provides infor-
mation for the purchasing agent about
a vendors delivery reliability, price
record, and service record. QM with
SAP ERP provides the purchasing
agent with information about quality
management used by the vendor and
the quality of previously delivered
goods. To do this, SAP ERP summariz-
es quality scores from vendor audits,
goods receipt inspections, and com-
plaints against the vendor.
Vendor release
In some industry sectors, vendors must
have a quality management system in
their company. Such a system might, for
example, be required to be compliant
with the ISO 9000 series of standards.
Such vendors must have this system
certified by an accredited organization.
Your SAP ERP application checks if the
quality management sys tem used by the
vendor is adequate for certain materials
and then either releases or blocks the
supply relationship accordingly.
You can limit the release of this supply
relationship to a specific time frame
and a maximum delivery quantity. If the
vendor has serious quality problems,
you can block requests for quotations,
purchase orders, or goods receipts for
specific materials supplied by this
vendor.
QM with SAP ERP also monitors the
step-by-step release of a material.
Vendor deliveries must sequentially
pass through a series of customer-
defined statuses, such as model,
preliminary series, and production
series, using appropriately assigned
inspection plans.
In many industry sectors, suppliers
are intermediaries (distributors), which
means that the quality of produced
goods is dictated primarily by the
manufacturer rather than the vendor.
Consequently, you can apply the
following functions to a manufacturer:
vendor release, inspection planning,
dynamic modification of the inspection
scope, and complaints against the
vendor.
Quality assurance agreement,
technical delivery terms, and
certificate requirement
When the purchasing agent requests a
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
with the delivery.
Source inspection
Occasionally, inspections can be per-
formed at the vendors premises to
replace a goods receipt inspection.
If this occurs, the software takes the
target delivery deadline into account
and creates an inspection lot in time
for the source inspection. You can now
perform a source inspection at the
vendors site, because it is possible
for you to access SAP ERP using
SAP NetWeaver Portal. This is possi-
ble even if the vendor does not use
SAP ERP.
Goods receipt certificate
If you have identified that a material
requires a certificate, the receipt of
this certificate must be confirmed.
SAP ERP takes appropriate action if
the certificate is missing (for example,
posting the goods to blocked stock).
SAP ERP supports the management
of the certificate receipt process and
sends reminders if necessary (see
Figure 3). You can manually create the
certificate and store it in the optical
archive (SAP ArchiveLink), or you can
send it in electronic form. Certificate
data can be transferred directly to the
goods receipt inspection lot using elec-
tronic quality data interchange.
Figure 3: Certificate Processing at Goods Receipt
Goods Receipt
Certificate
Requirement
Reminder
Inspection Lot:
Confirm receipt when or after
making usage decision
No
No Inspection Lot:
Post goods to blocked stock
Update Certificate Record
Yes
Certificate
Included?
12 SAP Functions in Detail Quality Management with SAP ERP 12
Dynamic modification
If the quality of a supply relationship is
consistently high, you may want to
waive the goods receipt inspection,
particularly if the vendor has a certified
QM system. For partial lots, you can
set the software to inspect a goods
receipt only once for each purchase
order, goods receipt, or batch. If you
do not want to waive the goods receipt
inspection completely, you can reduce
the scope of the inspection as far as
the quality level allows. The reduction
of the inspection scope may lead to a
skip lot. If you allow a skip lot and an
automatic usage decision for a materi-
al, the software processes skipped lots
without intervention. It then immediate-
ly posts the inspection lot quantity to
unrestricted-use stock (ship to stock).
Receiving inspection
If the prerequisites for ship to stock
are not fulfilled, SAP ERP automatically
triggers inspection lot processing upon
goods receipt. In addition to the goods
receipt document, the application
also creates an inspection lot record,
selects an appropriate inspection plan,
and determines the sample size based
on the quality level.
Physical-sample drawing
If goods are delivered in containers,
you can take samples in accordance
with a sample-drawing procedure. The
documents you need (such as sample-
drawing instructions, sample labels,
and inspection instructions) are avail-
able for printing immediately. You can
then proceed with the inspection.
Recording inspection results
and defects
You can record the results for the
goods receipt inspection in the form
of inspection characteristic values and
defect data records or texts. If serious
problems arise during a goods receipt
inspection, a quality notification can be
created automatically. Inspection results
can also be recorded automatically
using electronic measuring equipment.
Appraisal costs
Costs are associated with every
inspection and defect. Appraisal costs
are determined using the activity
confirmations of the people involved
in an inspection. You can allocate the
costs that are calculated on the basis
of these confirmations for one or more
inspection lots in several QM orders,
and you can then pass them on to
the cost object. Costs associated
with defects are settled using quality
notifications.
Inspection completion
The processing of an inspection lot
in QM with SAP ERP ends after the
inspection is completed and the usage
decision is made (see Figure 4). The
accepted inspection lot quantity is
posted manually or automatically to
unrestricted-use stock. Special stock
postings are available to you for
rejected quantities, including posting
to blocked stock, transfer posting to a
different material, returning to the ven-
dor, or posting to scrap. If the material
is handled in batches, the software
proposes a batch status that is com-
patible with the usage decision.
Once the usage decision is made,
SAP ERP updates the quality level and
the QM information system and makes
the quality score of the inspection lot
available for the vendor evaluation.
SAP ERP also updates material and
vendor information in the quality data
record. For example, once the
inspection lot has been completed,
Figure 4: Inspection Lot Processing at Goods Receipt
Purchase
Order
No
Yes
Inspection
Goods
Receipt
Stock in Quality
Inspection
Quality
Notification
Unrestricted-
Use Stock
the status of the supply relationship
can be updated from model delivery
to regular delivery.
SAP ERP can trigger a series of user-
defined follow-up actions on the basis
of the usage decision. For example,
you can print specific inspection
reports.
Invoice verification
If invoices for the delivery of goods are
received before the usage decision is
made for the goods receipt inspection
lot, you can prevent an automatic pay-
ment during invoice verification.
Complaints against the vendor
Defects in delivered material that have
been caused by the vendor or manu-
facturer can be documented in a quality
notification. You can use SAP Business
Workflow to pass this notification on to
the processor responsible. The proces-
sor can then initiate various tasks (such
as posting to blocked stock or sending
a complaint against the vendor). Com-
plaints can be entered on the vendors
Web site.
Production
Materials planning
When you are inspecting raw materials
or semifinished products, the planned
duration of the receiving inspection is
taken into account in materials
planning.
Inspection during production
QM with SAP ERP integrates quality
inspections into the production process
(see Figure 5). It supports different
types of production, from order-related,
lot-based production and the assembly
process in mechanical engineering,
through repetitive manufacturing in the
automotive industry, to batch-based
process manufacturing in the chemi-
cals, pharmaceutical, and food and
beverage industries.
You can initiate inspections on the
basis of different types of goods move-
ments. Inspection lots can be created
automatically when a material compo-
nent is removed or when a product for
the production or process order is pro-
cessed at goods receipt.
Inspection lots for an inspection during
production can be created in the follow-
ing ways:
As an inspection lot during produc-
tion when a production order is
released. This is not stock relevant.
As an early inspection lot at goods
receipt. This is stock relevant; in
other words, the stock in the quality
inspection is managed using the
usage decision for the inspection lot.
When goods are received from a
subcontractor for external processing
operations. This can be stock rele-
vant, depending on software
settings.
The sample size is calculated, and shop
papers (such as sample drawing,
inspection instructions, and sample
labels) are printed at previously deter-
mined work centers after the valid
routing or master recipe has been
selected.
Digital signature
You can set the software to require a
digital signature (electronic signature)
from the employee who releases the
physical-sample drawing, records
results, or makes the usage decision,
to ensure that this particular employee
has the appropriate authorization.
Inspection results
and defects recording
Inspection results can be recorded
for the following objects:
Inspection characteristics
The results can be recorded in sum-
marized form, in classes, or as single
values.
Figure 5: Inspection During Production
Inspection Lot 1
4711
Inspection Point
Automatic
Defects
Recording
Characteristic
Length
Width
Target
50.0 mm
30.0 mm
Quality
Notification
Tasks
Actual
49.8 mm
31.2 mm
Inspection points
Several inspections are performed
for each inspection characteristic.
Inspection points can be user-
defined, and they can be planned
in advance if necessary. They can
be related to production quantities
or production times (for example,
inspection of a wire basket or silo
once during each shift or every two
hours).
Physical samples
These can be planned in advance
using a sample-drawing procedure,
or they can be unplanned.
Partial lots
Production quantities of the same
quality can be grouped together.
Batches
Inspection results can be used for
batch determination at a later stage;
for example, they can be applied
when choosing products at the deliv-
ery stage or when deciding which
subcomponents to use for
production.
Serial numbers
This applies if the inspection results
are to be assigned to a single unit.
In this case, the serial numbers can
be copied from the production order.
Defects can be recorded for inspection
characteristics, inspection operations,
or inspection lots.
Statistical process 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
the results of an initial run. If an action
limit is exceeded, messages and notifi-
cations can be created.
Appraisal costs and production
quantity confirmations
When you are recording inspection
results, you can also confirm produc-
tion quantities and costs for the pro-
duction order (see Figure 6). Such
confirmations control the subsequent
production process (for example, the
release of inspection operations or
subsequent work that has yet to be
performed).
Inspection completion
The inspection is completed when the
usage decision is made. Employees
with appropriate authorizations can
post stock quantities, classify charges
according to their quality, and perform
follow-up actions. QM with SAP ERP
provides a digital signature for the
usage decision.
Sales and Distribution
Quality assurance agreement
and technical delivery terms
You can store customer-related quality
documents in the quality information
record for sales and distribution. In
addition, you can use this quality infor-
mation record to control the time and
type of a quality inspection.
Variant configuration
in the sales order
At the time of sales order creation,
customers can specify quality charac-
teristics for the desired variant. This
information then flows into all inspec-
tions during production in the form of
inspection specifications.
Figure 6: Quantity Confirmation and Inspection Point Valuation
Resource-related billing document
After the inspection results have been
confirmed, you can invoice the customer
for the inspection costs.
Inventory Management
Stock categories
Materials management categorizes
inventory by the following stock types:
unrestricted use, blocked, and in quality
inspection. Usually the specified quanti-
ty of a received material is posted to
inspection stock for the duration of the
goods receipt inspection. This stock
can only undergo a transfer posting
during inspection lot processing. For
example, when the usage decision is
made, it can be posted to unrestricted-
use stock. In the inspection lot, you can
view all of the posting documents that
relate to the lot stock.
Warehouse management
If you use warehouse management
software, SAP ERP also manages the
inspection lot samples and units created
due to the usage decision or while locat-
ing a storage bin. The inspection lot
identifies each unit and transfer require-
ment. Using the strategy defined for
placement in storage, the software trig-
gers the transport of samples and par-
tial quantities, and it posts the stock.
Handling unit management
You can use handling units as transport
units. A handling unit is a physical unit
consisting of packaging and the goods
stored with or on this packaging. The
software enables you to move these
handling units, as opposed to just mov-
ing the materials. Therefore, a quality
inspection can be performed with refer-
ence to handling units.
Processing complaints
and handling returns
You can create customer complaints as
quality notifications on the Internet. You
can document defects and tasks, and
you can also perform various follow-up
functions using the action box. For
example, you can process returns or
repair orders, enter costs, perform
stock postings, or trigger inspections.
The Usage Phase
In the usage phase of the product life-
cycle, service providers can process
inspections (outsourcing) with QM with
SAP ERP. Service providers can use
SAP ERP to identify items, plan and
confirm services, and create invoices
for services rendered.
Service
Variant configuration
in the sales order
Inspection laboratories perform inspec-
tions as a service (commercial analy-
sis). When creating the sales order,
these laboratories can select the
inspections requested by the customer
from inspection plans and transfer
them into a service order.
Service order inspection
Inspections can be selected using vari-
ant configuration in the sales order or
by selecting inspection operations in
the service order. Once the inspections
have been selected, inspection lots
can be created when the service order
is released. Then the inspection can
begin, and inspection instructions and
sample-drawing items can be printed.
Batches determination
If you manage the stock of a material in
batches, QM with SAP ERP allows you
to select suitable batches at delivery
using batch characteristics. These
characteristics can be populated with
quality results via valuation based on
multiple specifications.
Inspection for delivery
or for goods issue
Inspection lots can be created at the
picking stage or at goods issue. After
you have chosen a suitable inspection
plan, the sample size is calculated and
shop papers (sample-drawing items,
inspection instructions, and sample
labels) are printed. When the inspec-
tion results have been recorded, the
inspection is completed with the usage
decision.
Certificate at goods issue
At goods issue, you can use a quality
certificate to document that the inspec-
tion results are in accordance with the
customers specifications. You can
enter inspection characteristics from
the inspection plan and characteristics
that were defined in the batch determi-
nation as inspection specifications on
the certificate. The form, content, and
means of output are customer-specific.
These are derived from the specifica-
tions made by the recipient of the cer-
tificate at picking or at goods issue.
Quality data interchange
Formatted quality data contained in a
quality certificate can be sent electroni-
cally and then automatically transferred
into an inspection lot at the customer
site. It is also possible to make this
data available on the Internet.
Batch management
Materials management can manage
stocks for materials in batches, and it
can recognize the difference between
batches in unrestricted-use or blocked
stock.
You can use QM with SAP ERP to
monitor the shelf life of batches and
deadlines for recurring inspections. In
addition, you can change the batch
status and perform stock postings
automatically. For example, you can
post to blocked stock when the expiry
date is exceeded.
Batch 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.

As inspection planner or quality
engineer, you implement predefined
planning strategies in your company.
This includes:
Performing closed-loop inspection
planning with FMEA and control plans
Defining the trigger, type, and scope
of quality inspections
Creating and managing task lists as
the basis for quality inspections
Managing and processing the basic
data used in task lists
Determining the procedure for statis-
tical process control
To complete these tasks, you can use
the reusable basic data as building
blocks and a flexible planning tool.
Closed-Loop Inspection Planning:
Failure Mode and Effects Analysis
and Control Plan
Closed-loop inspection planning means
an integrated inspection planning for
goods receipt inspection and for
inspection during production, and it
starts at the very beginning of the
product development process for a
new product.
Typically the closed-loop inspection
planning process comprises the follow-
ing steps:
The first step is to work in a team of
experts from different departments to
create an FMEA. In doing so, the prod-
uct and process characteristics with
a high safety risk are pointed out. In
a second step, these characteristics
are transferred into a control plan. The
control plan gives an overview about all
inspections for a final product, including
all components, and is the basis for the
third step, maintaining the operational
inspection plans and routings.
As soon as the product is produced,
the supplier has to implement a closed-
loop process starting with a continuous
improvement process. Each internal or
external complaint must be checked
against the preventive actions, which
have been defined in the FMEA during
the first step of the closed-loop inspec-
tion planning. One result of the com-
plaint could be to change the FMEA
and control plan as well as operational
plans.
FMEA is an analytical method for early
detection and elimination of possible
failures and issues in products and
processes. In the context of quality
management, this method is used for
preventive failure avoidance. SAP ERP
offers tools for monitoring as well as a
cockpit for building an FMEA product
or process structure. FMEA can be
used for root-cause analysis in Six Sig-
ma projects, risk assessment during
product development, and operational
quality control and planning. FMEA sup-
ports compliance with ISO/TS16949
(automotive industry).
INSPECTION PLANNING: PUTTING QUALITY
STRATEGIES INTO ACTION
Figure 7: Closed-Loop Inspection Planning According to ISO/TS 16949
Specification
CAD
Defects
Characteristics
Defects
Characteristics
Defects
Characteristics
Characteristics
Stamping
Characteristics
Defects
Characteristics
Defects
Characteristics
8D = eight disciplines
CAD = computer-aided design
FMEA = failure mode and effects analysis
SPC = statistical process control
FMEA
(Product/
Process)
Control
Plan
Inspection
Plan
Complaints
(8D-Method)
SPC
Zero-Defect
Production
The FMEA cockpit and monitor offer
the possibility of a hierarchical display
of the object, machine, or system being
inspected for possible failures (see
Figure 8). With the help of a hierarchical
or a linked structure, the entire chain of
failure mode, causes, and consequences
can be viewed and investigated.
With risk-priority numbers you can
evaluate and estimate the defect cause
of a failure. The necessary actions to
diminish or avoid a failure can be
managed with the FMEA tool as well.
Furthermore, there is a connection
between the FMEA of one element
with the lists of those of subordinated
and superordinated elements. Those
lists contain not only the addressed
elements but also the addressed
functions and failures.
This makes sure that the entire object,
machine, or system is investigated
regarding possible risks, since:
One function can be dependent on
the function of a subordinated
element.
The outage of one function can
cause the outage of the function
of a subordinated element.
With the integration of the FMEA tool
into SAP ERP, it is possible to connect
the FMEA with related functions and
objects, for example, with catalogs of
failure characteristics or inspection
characteristics. Furthermore, you can
directly connect the FMEA with a con-
trol plan. You can archive FMEAs that
are no longer in active use.
In addition to FMEA, there are func-
tions for managing a control plan to
ensure a closed-loop inspection plan-
ning that is required as an international
standard according to ISO/TS16949.
A control plan is the description of the
entire technical or functional system
that is being monitored or checked for
possible risks and defects. Fundamen-
tally, the control plan describes all the
actions that need to be performed in
each phase of the process. This
includes the inspection of the goods
receipt, the goods shipment, and the
scheduled inspections and quality con-
trol activities that make sure all process
results are controlled and documented
(see Figure 9).
Within the closed-loop inspection plan-
ning, you usually start an FMEA for a
product to evaluate product- and
process-related characteristics with a
high failure risk. These characteristics
are transferred into the control plan.
The control plan includes an overview
of all inspections that are relevant for
a particular product and all its compo-
nents. This is the basis for developing
inspection plans and inspection opera-
tions in the subsequent production
process.
Once a product is part of serialized or
mass production, it is still necessary to
check the previously defined risks as
well as the control plan itself. In the
course of the continuous improvement
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,
vendor assignment, or validity of
certain lot-size intervals.
Task List Structure
As shown in Figure 10, a task list con-
sists of the task-list header, operation,
characteristic, and test equipment.
Task-list header
You define the following information in
the task-list header:
Material task-list assignments
Assignment of a task list to materials.
For example, you can assign several
materials to a task list. There can be
several task lists for one material.
You can also assign inspection plans
to a vendor or customer, in addition
to the material.
Figure 9: Example of Control Plan
Figure 10: Task List Structure
Inspection Plan 1
Inspection Plan 1
Material 1
Vendor 1
Task List Group
Characteristic 1
Inspection Plan 2
Inspection Plan 3
Inspection Plan 4
Inspection Plan 5
Inspection Plan 6
Inspection Plan 7
Material 2
Vendor 2
Customer 1
Customer 2
Task List Header
Operation 1
Operation 2
Operation 3
Characteristic 2
Method 1
Operation 4
Administrative data
This type of data can include the
validity date, change status,
responsible planner group, task-list
usage, and processing status.
Control data
This type of data can include the
dynamic modification rule for
adapting the inspection scope.
Operation
You can maintain the following informa-
tion for each inspection operation:
A description of the operation and
control parameters for the operation
Reference to a work center
Specifications for scheduling and
calculating the appraisal costs
List of relevant test equipment,
documents, and production resource
tools
Characteristic
In the inspection characteristic, you
can:
Specify the characteristic description
and define the control parameters for
results recording
Reference an inspection method,
sampling procedure, or a dynamic
modification rule
Define qualitative or quantitative
specifications for the inspection and
results recording, depending on the
characteristic type
Define individual specifications for
every task-list assignment to a
material, vendor, or customer. This
means you do not have to create
redundant inspection plans to modify
customer- or material-dependent
target values and tolerances.
Define multiple specifications for
additional objects (such as country)
to determine the suitability of a prod-
uct or batch (for example, suitable for
specific countries and not suitable for
a list of others)
Specify with which equipment the
characteristic values must be
measured
Basic Data for Inspection Planning
Basic data consists of reusable building
blocks for inspection planning (see
Figure 11). To simplify your work as an
inspection planner, you should plan and
include this data in your task lists.
Inspection Characteristic
An inspection characteristic describes
what should be inspected. You can cre-
ate an inspection characteristic directly
in a task list or predefine it as an
inspection characteristic master record
(master inspection characteristic). Mas-
ter inspection characteristics can be:
Referenced in several task lists or
material specifications
Linked to characteristics with the
classification function, for example,
to transfer inspection results for a
batch to the batch classification
Inspection Method
An inspection method describes how
a characteristic is to be inspected.
You can assign documents that are
stored in a document management
system (such as drawings and descrip-
tions) to an inspection method. Inspec-
tion methods are assigned to master
inspection characteristics or inspection
characteristics in task lists. You can
assign several inspection methods to
a master inspection characteristic.
Figure 11: Inspection Plan Structure and the Use of Master Data in Inspection Plans
Task List Header
Material
Inspection
Operation
Test
Equipment
Inspection
Characteristic
Dynamic modification rule
Sample-drawing procedure
Reference operation set
Work center
Material
Equipment
Other production resources and tools
Document
Master inspection characteristic
Inspection method
Sampling procedure
Dynamic modification rule
Catalog
Catalog
A catalog is a summary of codes for
content-related terms. Catalogs can
make it easy to uniformly describe qual-
itative data (for example, attributes for
qualitative characteristics, defect types,
or usage decisions). For each catalog,
you can:
Define code groups with codes and
enter explanatory texts in different
languages
Select codes from one or more code
groups and combine them in a select-
ed set. This allows you to create a
value list that applies to a specific
situation.
Sampling Procedure
and Sampling Scheme
The sampling procedure specifies how
the sample size is calculated and how
the inspection characteristic is valuated
(attributive, variable, or manual). You
assign sampling procedures in the
material master or in the task list at
characteristic level.
QM with SAP ERP supports all common
sampling types (for example, 100%
inspection, sample based on percent-
age, fixed sample, and sample in accor-
dance with a sampling scheme). If the
sampling types and valuation rules pro-
vided with the standard software are
not sufficient, you can supplement them
with your own self-defined function
modules.
You can plan independent and depen-
dent multiple samples and record the
inspection results from several samples
for an inspection characteristic. Each
of these samples may contain several
values, and each is valuated individually.
On the basis of the individual sample
results, SAP ERP automatically deter-
mines the characteristic result (for
example, based on the worst-case
principle).
Ready-to-use sampling schemes in
accordance with ISO 2859-1 for quali-
tative inspections and ISO 3951 for
quantitative inspections are delivered
with SAP ERP and any upgrades. You
can also create your own acceptable
quality level (AQL) sampling schemes
and define rules for automatic stage
changes up to an inspection skip. You
can also implement industry-specific
procedures.
Dynamic Modification Rule
In a dynamic modification rule, you
define the number of inspections and
skip stages, and the rules that control
such stage changes, either in accor-
dance with appropriate standards such
as ISO 2859-3 or to suit your own
requirements. The sample size may vary
between a 100% inspection and a skip.
When you use a sampling scheme, the
software switches between a normal,
reduced, and tightened inspection,
depending on the quality level.
The inspection stage is then changed
depending on the inspection results for
inspection lots or characteristics. You
can control the dynamic modification of
the inspection stages either by accept-
ing or rejecting the inspection lot or
inspection characteristics. You can also
assign a dynamic modification rule
to the inspection type in the material
master (inspection-type level) or at the
header or characteristic level in the
task list.
Test Equipment
Test equipment consists of fittings,
objects, documents, or materials that
are needed for a quality inspection.
Test equipment can be fixed parts of
a work center or consist of moveable
equipment. In the inspection plan, you
can represent test equipment using
various master records, such as
production resource or tools (PRT),
material, equipment, or documents.
The PRT master record contains
administrative data and information
relating to status, location, and a
possible PRT group assignment. If
you use the classification function, you
can define additional properties. In
addition, you can reference document
master records from the PRT master
record or use document master
records as test equipment in task lists.
You can access drawings and other
documents using the document man-
agement interfaces to computer-aided
design (CAD) systems or to SAP
ArchiveLink.
Work Center
The work center specifies where an
operation is to be performed and
who should process it. The available
personnel and machine capacities are
also managed by the work center. You
provide the basis for capacity planning
and scheduling of operations when you
specify in task lists the work centers
Display documents defined in a docu-
ment management system in your
own work area (for example, techni-
cal drawings)
Product Structure Browser
Using the product structure browser,
you can hierarchically display related
objects in a product structure. During
inspection planning, for example, you
can determine whether task lists or
material specifications exist for a cer-
tain material. If you expand the product
structure further, additional detailed
Generate work lists for processing
data within task lists (for example, by
selecting task lists that use a certain
dynamic modification rule or sampling
procedure)
Process individual operations from
different task lists in one work step
Simultaneously process complex
task lists by selectively blocking
objects (at task-list header or opera-
tion level)
Create where-used lists (for example,
for PRT, dynamic modification rules,
sampling procedures, sample-
drawing procedures, and selected
sets)
in which the operations are to be
performed.
Each work center is assigned to a cost
center. The activities in a work center
are valuated using rates that are deter-
mined by cost centers and activity types
(for example, working time or quantity).
In a single step, you can record both
inspection results and the activities per-
formed. You can also generate work
lists for specific work centers when
you record results or make a usage
decision.
Reference Operation Set
In a reference operation set, you define
frequently required inspection opera-
tions and corresponding inspection
characteristics. A reference operation
set can be used as a part of inspection
plans or routings, or as a template.
Planning Tools
The following sections discuss various
planning tools provided by QM with
SAP ERP. Such tools include the engi-
neering workbench, product structure
browser, and where-used lists.
Engineering Workbench
The engineering workbench, shown in
Figure 12, is an efficient tool that you
can use to process several task lists
simultaneously (routings, reference
operation sets, and inspection plans).
The data you require can be read from
different task lists and restructured.
You can perform a variety of tasks
using the engineering workbench,
including the following:
Figure 12: Inspection Planning with the Engineering Workbench
Processing area
Change number
Key date
Validity area
Key date
Time frame
Context block Operations
overview
Structural
display
Detail screens Integration into
document
management
You can execute the process steps in a
stability study using follow-up functions
in the quality notifications action box.
You can readily enhance or modify
individual follow-up functions without
making any software modifications.
Approximately 20 follow-up functions
are currently available for process
steps in a stability study.

Stability Studies
SAP ERP provides a comprehensive
planning tool for stability studies or
shelf-life tests.
The special quality notification type
stability study is the central business
object that represents a stability study
in the application. All of the following
objects created in the course of a
study are assigned to the quality
notification:
Initial sample
Stability bill of material (BOM)
Various documents
Inspection lot for initial test
Physical samples (stability samples
for storage conditions)
Testing schedule for storage condi-
tions with corresponding inspection
plans
Inspection lots for stability tests
You can assign other objects that are
defined as business objects in SAP
applications to the stability study. Using
the document flow function for quality
notifications, you can graphically dis-
play all objects assigned to a study and
their relationship to one another.
Based on this setup, you can trigger
various process steps that need to be
executed in the course of a stability
study, including the following:
Creating and confirming the initial
sample
Assigning and processing the stabili-
ty BOM
Defining storage conditions
Creating and maintaining the testing
schedule
Starting the initial test
information can be displayed (such as
inspection characteristics and
documents).
Where-Used Lists
A where-used list shows you the task
lists in which master inspection charac-
teristics, inspection methods, and sam-
pling procedures are used.
Mass Data Changes
With the function for mass data chang-
es, you can adapt objects from the
where-used list (master inspection
characteristics, inspection methods, or
sampling procedures) to suit new con-
ditions. You can also use this function
to create and change inspection setup
data in the material master.
Engineering Change Management
QM with SAP ERP maintains separate
engineering change statuses for each
structural element in a task list. When
you make a change using a change
number, you can determine what was
contained in a plan at a specific date
and the date on which a change is to
become effective.
Cross-System Transfer of Master Data
Using proprietary SAP technology for
application link enabling, you can trans-
fer specific basic data (for example,
inspection setups, inspection methods,
inspection characteristics, and catalog
or code groups) from a source system
to one or more target systems. This
means that it can be quick and easy to
trans fer basic data used in one plant to
another plant.
Benefits:
Integrated inspection
planning
Lighter workload as
a result of modular,
reusable basic data
Efficient management
of inspection data
using mass process-
ing tools
Parallel task-list
processing using
the engineering
workbench
Time and money
savings with cross-
system data transfer
by means of applica-
tion link enabling
There are different variants for inspec-
tion lot processing. In QM with SAP
ERP, these are defined as inspection
types (for example, goods receipt
inspection and inspection during pro-
duction). The variants include:
Inspection with or without a task list
or material specification
Recording of inspection characteris-
tic results and defect data
Manual or automatic specification
assignment, sample determination,
and usage decisions
Control of inspection stock posting
As a quality inspector, you are respon-
sible for proving that a material meets
predefined quality requirements. With
QM with SAP ERP, you can show that
these requirements have been met.
Inspections can be triggered for inspec-
tion points during production, for physi-
cal samples in the process industry,
or automatically for goods movements.
Planned inspections in QM with
SAP ERP can be used to document
quality using quantitative and qualitative
inspection results. In addition, you
can also create a record of unplanned
events in the form of defect data or
quality notifications.
For all quality inspection tasks, SAP
ERP and SAP NetWeaver provide you
with the tools you require for the role of
quality inspector, as well as the oppor-
tunity to customize the settings:
With SAP NetWeaver Portal you
have a role-based portal with work
centers that are tailored specifically
to the needs of the quality inspector
for results and defects recording,
notification creation and processing,
confirmation processing for produc-
tion orders, and execution of quality
reports.
With QM functions in SAP ERP you
have support for all the required
steps for recording and documenting
quality-related data as well as tools
for integrated processing and evalua-
tion of the data.
With support for collaborative busi-
ness, your internal and external busi-
ness partners can record inspection
results on an intranet or the Internet.
QUALITY INSPECTIONS:
ACHIEVING RELIABLE RESULTS
Inspection Lot Processing
Supported by quality planning specifi-
cations, inspections supply important
data for quality control purposes (see
Figure 13). The inspection lot is the
central element for the quality inspec-
tion in QM with SAP ERP. It contains
all information related to the quality
inspection, such as inspection specifi-
cations, inspection results, and usage
decisions.
Figure 13: Stages in Inspection Lot Processing
Create inspection lot
Inspection Lot
Creation
Select inspection specifications
Determine samples
Print shop papers
Confirm activities
Complete inspection
Record defect data
Request characteristic inspection results
Perform follow-up actions
Update QM information system
Update quality level
Determine quality score
Make usage decision
Inspection
Inspection Lot
Completion
Direct transfer of inspection results is
possible if you link electronic test
equipment to SAP ERP. You can also
record inspection results for serial
numbers and batches, and you can
transfer the inspection results recorded
in SAP ERP to batch classification.
Flexible specifications
Flexible specifications are used to influ-
ence the specification data on creation
of an inspection lot or during results
recording. Flexible inspection specifica-
tions allow you to select or deselect
the relevant inspection characteristics
and adjust the given specifications as
needed. As a standard setting in the
SAP ERP application, the process is
active for inspection lots related to a
stability study. However, it can also
be of interest for other business sce-
narios, where inspections cannot be
planned completely in advance, such
as the following:
Inspection performed as a service
Inspection of a complaint
Inspection for a stability study
Examples of shop papers and their con-
tent include the following:
Sample-drawing instructions contain
the information required for the
physical-sample drawing and for
distributing samples to work centers
or laboratories.
Physical-sample labels are used to
label samples.
Inspection instructions list informa-
tion about the test equipment and
inspection characteristics for each
inspection operation and specify the
inspection methods, specifications,
and sample size for each inspection
characteristic. Quality inspectors can
record inspection results on the
inspection instructions, if the layout
is suitable.
Inspection
During an inspection, you can:
Record, valuate, and close inspection
results for characteristics
Record defect data and quality
notifications
Confirm activities
Inspection Lot Creation
QM with SAP ERP generally creates
inspection lots automatically (see
Figure 14), but you can also create
lots manually. Inspection lots may be
created as a result of the following:
Goods movements (for example,
goods receipt, goods issue, stock
transfer, and returns from a
customer)
Deadline monitoring for batches
(recurring inspection)
Release of production orders, pro-
cess orders, maintenance orders,
service orders, and production
versions
Delivery creation in shipping
For inspections with an inspection plan,
SAP ERP selects the corresponding
inspection specifications (for example,
the inspection plan or material specifi-
cation). If a customer has specific prod-
uct requirements, these can be copied
from variant configuration or batch
determination to the inspection. Shop
papers are printed, and inspection
results are recorded on the basis of the
inspection specifications.
Figure 14: Inspection Lot Creation
Creating
inspection lot
Determining
the inspection
specifications
Determining
the sample
Printing shop
papers
Authorization for the usage decision
The usage decision has significant
consequences. Using material-specific
authorizations and digital signatures,
you can ensure that only authorized
users can make the usage decision.
Quality Inspection Engine
With the quality inspection engine, you
can integrate quality inspections in vari-
ous SAP applications in SAP Business
Suite, as well as in non-SAP applica-
tions. The quality inspection engine
supplements the comprehensive quality
management software supplied by SAP
ERP and was designed for use in a het-
erogeneous system landscape. The
services-oriented quality inspection
engine supports new processes, such
as the execution of inspections using
decentralized warehouse management
in SAP SCM.
In general, the quality inspection engine
is used by non-QM applications to per-
form inspections. For example, quality
inspections can be performed in the
SAP Extended Warehouse Manage-
ment application using functions in the
quality inspection engine. Inspection
data can then be forwarded to an
application that provides enhanced
functions for quality inspections, such
as SAP ERP or a non-SAP QM applica-
tion or laboratory information manage-
ment system running on either an
internal or external system.
the usage decision (for example, post-
ing to unrestricted-use stock or return
to vendor).
Quality score
If the usage decision has been made,
SAP ERP determines the quality score
for the inspection lot using a procedure
defined in the inspection setup for the
material master record. It then updates
the vendor evaluation.
Quality level
The quality level is updated, and based
on the level, the inspection stages for
the next inspection are determined.
Follow-up actions
The usage decision can trigger a chain
of automatic follow-up actions, such as
sending a message to purchasing if an
inspection lot is rejected. In addition,
the statistical data for the inspection
lot is updated in the QM information
system. SAP ERP logs all user actions
using the name, date, and time. This
means that you have the ability to track
all actions. You can also create an
electronic batch record for materials
that are managed in batches.
In all cases, an inspection plan or rout-
ing with inspection characteristics is
the basis of a maximum plan, and dur-
ing a flexible specification the relevant
characteristics are selected.
Note that the activation for additional
processes, in addition to the stability
study, is done via implementation of
corresponding business add-ins or
customer enhancements.
Inspection Lot Completion
After results recording is completed or
the inspection is canceled, you make
the usage decision for the inspection
lot (see Figure 15). An automatic usage
decision can be made if no inspection
characteristics have been rejected and
no defects are recorded. If a material
requires documentation, you must
enter a comment for the usage deci-
sion if the inspection is canceled or
the usage decision differs from the
valuation for the inspection results.
Stock posting
If materials are posted to inspection
stock using an inspection lot, they can
be posted from this stock only using
Figure 15: Inspection Lot Completion
Making the
usage decision
Determining
the quality score
Updating the
quality level
Performing
follow-up actions
Classed values number of results
within value classes
Single values such as several mea-
sured values (In addition to single val-
ues, you can note the serial numbers
of the items to be inspected.)
Additional functions
Within results recording, you can also:
Define unplanned characteristics
Process conditional characteristics.
This deals with planned characteris-
tics that must be inspected only if a
corresponding controlling characteris-
tic has either been accepted or
rejected.
Record inspection results for charac-
teristics that are in a skip stage
Calculate results using calculated
characteristics. For calculated char-
acteristics, you calculate results
using the results for other
characteristics.
Samples
If the sampling procedure specifies
independent multiple samples, you can
record results for more than one sam-
ple for each inspection characteristic.
The number of samples may then be
greater than the number specified in
the sampling procedure.
In an attributive inspection, you can
also plan dependent double and multi-
ple samples. If the result for the current
sample lies between the acceptance
and rejection numbers, the sample size
is increased according to the sampling
scheme. Once you have recorded the
results for this new sample, the sample
is evaluated again using the updated
valuation parameters.
Characteristic Results
You record and valuate characteristic
results according to inspection
specifications.
Characteristic types
You can record inspection results for
the following types of characteristics:
Qualitative characteristics
Nonnumerical characteristic values
or variables stemming from these
values
Quantitative characteristics
Measured values or variables stem-
ming from these values
Recording forms
Depending on the detail you require,
you can choose from the following
recording forms for a characteristic:
Summarized values such as the
mean value and standard deviation
of several measured values or an
individual measured value
Inspection Results
There are two types of inspection
results in QM with SAP ERP (see
Figure 16):
Results for the planned inspection
of inspection characteristics (charac-
teristic inspection results)
Unplanned defects defined during
the inspection (defect data)
Characteristic inspection results are
generally recorded for each operation.
For this, inspection specifications must
be assigned to the inspection lot, and
sample calculation must be completed.
You can record both characteristic
inspection results and defect data
for an inspection lot with a task list.
If characteristics are rejected, defect
data records can be created automati-
cally. Also, you can record defects in
an inspection without inspection
specifications.
Figure 16: Types of Inspection Results
Unplanned
Defect Data
Recording Inspection Results
Active Quality
Notification
Planned
Defect Data
Defect Type
Defect Location
Cause
Characteristic
Results
Quality
Control
Qualitative
Characteristic
Quantitative
Characteristic
Process-Optimized Results Recording
Work lists
Personalized work lists provide you
with a flexible selection of inspection
lots. Examples of work lists include:
Results recording for samples during
laboratory inspections
Results recording for equipment or
functional locations during calibration
inspections
Tabular results recording
You can record inspection results in
tabular form as follows:
Processing characteristics for sev-
eral inspection lots
You record results for inspection
characteristics that occur in several
inspection lots. In the recording table,
the inspection lots selected in the
work list are displayed in columns;
the characteristics are displayed in
rows.
Processing several inspection
points in an operation
You record results for several inspec-
tion points in an operation. In the
recording table, the inspection char-
acteristics are displayed in columns;
the corresponding inspection points
are displayed in rows.
Processing master inspection char-
acteristics for all inspection lots
You record the results for a specific
master inspection characteristic for
all inspection lots. In the recording
table, the inspection lots are dis-
played in rows for the master inspec-
tion characteristic that has been
selected.
Time-dependent (for example, one
inspection every hour)
Quantity-related (for example, an
inspection after 100 units have been
produced)
Freely defined (for example, one
inspection per shift)
Distribution functions
After results recording, the software
determines the fraction of nonconform-
ing units for all inspection characteristics
and uses this information to estimate
the fraction of nonconforming units in
the inspection lot. The most common
mathematical distribution methods are
supplied (normal, binomial, and Poisson
distribution).
Statistics
You can display the following graphics
in results recording:
Histogram illustrates the frequency
distribution of the sample results in
the form of a bar chart. In this chart,
you can identify typical and extreme
values for a sample, as well as the
location, dispersion range, and form
of the distribution.
Run chart displays the run of mea-
sured values for a characteristic over
a period of time as a line chart. You
can identify the dispersion and sys-
tematic location changes. You can
also display trends.
Control chart shows the time run of
characteristic values in the produc-
tion process with warning and action
limits.
Valuation
You can confirm the characteristic
inspection results recorded in different
inspection operations. During results
recording, an inspection characteristic
undergoes a series of status changes.
The authorization management function
controls who has the authorization to
record, valuate, or close results. To
fulfill special security requirements, for
example, GMP, a digital signature may
be required.
You can use the following valuation
modes to accept or reject an inspec-
tion result:
Manual valuation
Attributive inspection based on the
number of nonconforming units or
defects
Decision based on the attribute
codes of qualitative characteristics
Decision based on the tolerance
range of quantitative characteristics
Variable inspection with single-sided
or double-sided tolerance limits
Valuation based on the action limits
of a control chart
Characteristics with independent, multi-
ple samples are valuated at the sample
level. For example, you might valuate
such samples based on the worst-case
principle, last-case principle, or best-
case principle. You may also valuate
inspection points.
Inspection points
You can use inspection points to
perform several inspections on one
characteristic. You can define various
inspection points in SAP ERP,
including:
Dual Control Principle
The idea behind the dual control princi-
ple is that the processing of an inspec-
tion result should not or even must
not be made by only one person. For
example, the required process involves
one employee who enters the results
for characteristics and a different
employee who validates and completes
the characteristics. This means that the
results need to be checked by at least
two different people. The dual control
principle can reduce the risk of failures
or misuse and help you to comply with
regulations.
You can activate this function via imple-
mentation of a related business add-in
that offers the following functions:
Entry and analysis of results of an
inspection characteristic by two
different users
Possibility to force the completion
of a characteristic
SAP offers a sample implementation
of this function that you can use as
delivered; or you can copy and modify
it to meet your needs.
Web-Based Approach to Quality
Control
The Internet provides you with several
possibilities for results recording. An
example of this is recording results
for source inspections. You provide
your vendor with access to a specific
Internet or intranet page, which
requires special authorizations. The
vendor records inspection results
directly on the Web and saves the
data. As a result, this QM data can be
processed further by your SAP ERP
application.
Increases transparency and accuracy
of inspection data
Avoids manual errors through auto-
matic data transfer
Guarantees tracking of copied data
(application log)
Input Processing
During results recording, a function for
converting an entered value based on a
given procedure can be activated via a
business add-in. Input processing must
be planned in the master inspection
characteristic or in the inspection plan.
The input value can be processed, for
example, as follows:
Output of a value calculated by per-
forming a formula conversion on the
original entry
Output same as input
Output of the significant rounded
value instead of the original entry
Output of the verification and deter-
mination limit instead of the original
entry
The value that was entered originally
(including the decimal places entered)
is also saved (original value).
Operation Completion
You can complete the operations in an
inspection lot individually and according
to requirements. This allows you to doc-
ument the exact inspection process for
an inspection lot. After an operation has
been updated, follow-up actions can be
triggered automatically, depending on
your application settings. The function
can be activated via customizing.
Results Copy
The copy inspection results function:
Copies inspection results from a
source inspection lot into a target
inspection lot
Is highly flexible and can be tailored
to your needs
Supports several business
processes
Is a requirement from various
industries
This function is applicable for the trans-
fer of results from precursors along the
production chain (parent-child relation-
ships) and for all types of recurring
inspections, including the following:
Periodic retests of batches
Only some characteristics need to be
reinspected, but all values from the
initial inspection should be visible in
every inspection lot.
Calibration inspections
During inspections of equipment or
functional locations, some values of
the previous inspection lot should
be taken as the new starting point.
Stability studies
Some results from the initial test
should always be available when
scheduled inspections are carried
out.
Inspections during production
Results of previous inspection points
should be selected and copied to the
next inspection point.
The function for copying inspection
results supports you in your inspection
process in the following ways:
Saves time during inspection
processing
Is applicable for a wide range of
processes
PC interface
You can transfer inspection results
from a measuring device into the rele-
vant results fields in SAP ERP using file
transfer. You can trigger the results
transfer from external systems and also
from within the results recording func-
tion in SAP ERP using driver programs.
SAP provides examples for the driver
programs.
Inspection data interface
The QM inspection data interface
(QM-IDI) supports data exchange with
external quality systems, such as
computer-aided quality assurance
(CAQ) systems and laboratory infor-
mation management systems (LIMS).
You use QM-IDI to process inspections
in an external system.
During inspection planning, you decide
in which system an inspection opera-
tion should be processed. The inspec-
tion specifications are transferred to
the external system during inspection
lot creation in SAP ERP. After results
are recorded in the external system,
the inspection results or usage deci-
sions are confirmed in SAP ERP. You
can protect your IT investment by
requiring that the external system is
certified for the interface.
Statistical 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
can use a format defined by SAP to
quality inspector in using graphic tools
to monitor and measure the most
important quality key figures.
Connecting Measuring Devices
or External Systems
QM with SAP ERP offers interfaces to
connect to external systems for special
tasks within quality inspection.
Keyboard interface
Keyboard interfaces convert the mea-
sured values into keyboard entries. You
can link test equipment, such as elec-
tronic caliper gauges, bar-code read-
ers, or laboratory balances, using a
keyboard wedge. Various interface box-
es are available on the market, which
differ in the number and type of test
equipment that can be connected.
In addition, SAP offers a role-based
portal (see Figure 17) with work
centers that are tailored specifically to
the needs of the quality inspector. It
supports a quality inspectors most
important tasks:
Results recording
Defects recording
Notification creation and processing
Confirmation for production orders
Quality reports
Personalized work lists serve as trig-
gers for the efficient completion of
tasks. The role provides quick access
to all pertinent quality data and a simpli-
fied user interface. Furthermore, it is
possible to trigger alerting immediately
when problems or exceptions are iden-
tified. In addition, the role supports the
Figure 17: Example for Portal Work Center for a Quality Inspector
inspection lot. You define the following
information in the sample-drawing
procedure:
Type and number of samples
Primary samples (one-stage
physical-sample drawing)
Primary and pooled samples (two-
stage physical-sample drawing)
Reserve samples (to be stored for
subsequent inspections)
Whether the application should calcu-
late physical samples on the basis of
the lot container type or the lot
quantity
Whether the drawing of the physical
samples needs to be confirmed
separately
Processing Physical Samples
Figure 18 depicts the types of planning
and processing for physical samples.
Sample-drawing instruction
For a planned physical-sample drawing,
the application can print a sample-
drawing instruction at inspection lot
creation. This instruction contains infor-
mation from the inspection plan and
physical-sample drawing procedure
about drawing, processing, and distrib-
uting samples at work centers or
laboratories.
When the application creates the
physical-sample records for the
inspection lot, it assigns a unique phys-
ical-sample drawing number. This num-
ber helps you identify the physical sam-
ples that were drawn from the lot. You
can also identify how many pooled and
reserve samples were formed. The fol-
lowing functions are available for the
physical-sample drawing:
You can describe qualitative defect
data with the help of cataloged termi-
nology (for example, defect type,
defect location, or defect cause) and
additional text.
A defect data record can be converted
into a quality notification. As a result,
the whole range of functions in notifica-
tions can be used (for example, the link
to workflow).
Sample Management
When sample management is active in
QM with SAP ERP, you can use the
application to manage samples. To help
you manage samples effectively, a
unique physical-sample record is
created for each physical sample. The
physical-sample record contains the
following information for the sample:
Physical-sample number
Physical-sample type, such as sam-
ple from goods receipt, production,
or customer complaint
Physical-sample category, such as
primary sample, pooled sample, or
reserve sample
Information for the physical-sample
drawing with data on the sample
origin, such as material, batch,
material document, and order
Detailed information about the physi-
cal sample, such as the inspection
lot or storage information
Processing status of the physical
sample
When the inspection planner defines a
sample-drawing procedure and assigns
it to the inspection plan, routing, or
master recipe, physical-sample records
are created automatically for the
transfer recorded inspection results
from the quality management function
in SAP ERP to the external evaluation
system.
You can use QM-STI for manual statis-
tical analysis of inspection results from
SAP ERP, or you can specify an auto-
matic start of predefined statistical
analyses.
SAP Manufacturing Integration and
Intelligence
The SAP Manufacturing Integration and
Intelligence application supports inte-
gration of manufacturing systems with
SAP ERP. It enables you to integrate
directly and provides functions for
Web-based user interfaces for access-
ing QM data in SAP ERP. For details,
see the section SAP Manufacturing
Integration and Intelligence for Quality
Analytics.
Defect Data
Defects recording provides information
to control quality and optimize process-
es. It enables Pareto analyses of defect
types and causes according to their
weighting or how frequently they occur.
It provides empirical values for risk indi-
cators in FMEA.
You record defects with reference to an
inspection lot, inspection operation, or
inspection characteristic. To record
defects, you do not need inspection
specifications. If an inspection plan is
available, the defect data records can
be assigned to an inspection character-
istic contained in the plan. QM with
SAP ERP then suggests the type of
defects recording that is suitable for
the material, work center, or user.
You must create inspection lots manu-
ally to be able to record inspection
results for unplanned physical samples.
You can use this function to perform
the following tasks:
Check the stability of reserve
samples
Inspect samples from competitors
Inspect samples from a customer
complaint
Valuation
Once you have performed all inspec-
tion operations and have recorded the
inspection results, the physical sam-
ples must be valuated on the basis of
the operations (that is, accepted or
rejected). When all physical samples
in the inspection lot are valuated, you
make the usage decision for the lot.
Unplanned Samples
It is possible to manage unplanned
samples using QM with SAP ERP. You
can perform the following tasks:
Create the physical samples manually
without reference to an existing
physical-sample drawing or inspec-
tion lot
Supplement an existing physical-
sample drawing by creating additional
physical samples
Create a new physical-sample
drawing manually, with reference to
an existing inspection lot, production
order, process order, or production
version
Confirmation of the physical-sample
drawing and release of the samples
You can control whether or not the
physical-sample drawing must be
confirmed. A confirmation would
result in the release of all samples
associated with the relevant physical-
sample drawing. A digital signature
may be required to make the confir-
mation. This digital signature ensures
that only people with the relevant
authorization can confirm a physical-
sample drawing.
Label printing
You can trigger label printing for
physical samples. The labels can be
printed with bar codes.
Sample check
The physical samples are displayed
automatically in a work list for results
recording. You can process these
samples immediately, provided that
they have the appropriate status.

Figure 18: Types of Planning and Processing for Physical Samples
Creation
Planned
Physical Samples
Unplanned
Physical Samples
Manual Inspection Lots
Automatic creation of physical samples at
inspection lot creation
Manual creation of physical samples
Manual creation of physical-sample
drawing with reference to an inspection lot
Manual creation of inspection lots for
existing physical samples
Benefits:
Integrates in the
process of the
product lifecycle and
the supply chain
Provides real-time
data, transparent
for employees,
compliant with legal
requirements
logo. You define required content in the
certificate profile. Due to the flexible
interaction of the certificate profile and
form, you can meet multiple require-
ments using just a few forms.
You specify the data origin for each
characteristic in the certificate profile.
For each characteristic, you can include
texts (such as inspection methods) and
values (specification values and inspec-
tion results) in the certificate.
SAP ERP selects data from inspection
lots, batch specifications, or character-
istic master records. Texts for charac-
teristics can also be obtained directly
from the certificate profile. Only those
inspection lots that meet specific selec-
tion criteria that have been defined in
the certificate profile are considered for
data formatting.
Consequently, inspection lots that
have, for example, reached a pre-
defined quality score can be selected.
If there is no inspection result for a
characteristic due to a skip, SAP ERP
searches for other data sources using
Certificate Processing
in Sales and Distribution
Your company produces high-quality
products. As quality manager, it is your
responsibility to provide evidence of
the quality of your goods for your cus-
tomers. Whether you require certifi-
cates of analysis for the chemical or
pharmaceutical industry, or certificates
of conformity, test certificates, works-
test certificates, or inspection certifi-
cates for material inspection laborato-
ries in the steel industry the quality
certificate fulfills all of your
requirements.
In addition to the usual output forms
for certificates (printer or fax), you can
make certificates available to your
customers on the Internet, or you can
transfer certificate data electronically
for further processing.
Flexible Certificate Planning
You define the layout and content of a
certificate in certificate planning. The
form determines the layout of the docu-
ment that is, the appearance and
QUALITY CERTIFICATES:
GUARANTEED RELIABILITY
PRINTED OR ON THE INTERNET
predefined strategies. You can enhance
the data procurement functions and
replacement strategies available in SAP
ERP by programming function modules.
The form master record allows you to
tailor your certificates to your compa-
nys needs. To simplify this process,
SAP ERP provides examples based on
SAPscript forms, a proprietary tool for
text management and form printing,
and Adobe forms (PDF-based print
form).
In addition to printing characteristics
that are directly linked to the product
requiring the certificate, you can also
define which characteristic data (from
raw materials and semifinished prod-
ucts used when creating the finished
product) are printed on the certificate
(see Figure 19).
At this point, you can refer to inspec-
tions or batch classifications. SAP ERP
selects batches for data formatting that
are linked to one another by production
orders, process orders, or production
versions. The characteristic values for
Figure 19: Example of a Quality Certificate for a Finished Product with Characteristic Values from Raw Materials and Semifinished Products
Product:
Batch:
Char:
Char:
RAW01
R1-1
R10
R11
Product:
Batch:
Char:
Char:
RAW02
R2-2
R10
R11
Product:
Batch:
SEMI01
S1-1
Product:
Batch:
Char:
SEMI02
R2-1
S20
Product:
Batch:
Char:
Char:
SEMI3-1
S3-1
S31
S32
Product:
Batch:
Char:
RAW03
R3-1
R30
Product:
Batch:
Char:
Char:
SEMI04
S4-1
S41
S42
Product:
Batch:
Char:
Char:
FIN01
F1-1
F10
R11
Product:
Batch:
Char:
Char:
R10
S20
S41
F10
their output. You can create a print
preview to check the contents of the
certificate before it is finally issued. In
addition, the processing status of deliv-
ery item data is maintained consistently
so that you can always tell if a certifi-
cate was created properly.
SAP ERP finds the correct certificate
profile, recipient, and shipping terms
with the help of the flexible condition
technique. The software can search for
the address of the certificate recipient
by using, for example, the sold-to party,
the ship-to party, delivery type, or ship-
ping point. Then it decides whether the
certificate is to be issued in printed
form, by fax, or electronically. Next, it
searches for the corresponding profile
for the material group, material, cus-
tomer, or a combination. All the infor-
mation required for these searches is
contained in data for the delivery.
As the final step, SAP ERP determines
the contents of the certificate based on
the requirements in the certificate pro-
file, such as characteristic values in
picking batches. It structures the infor-
mation according to the specified form
and transfers the resulting certificate to
the output medium, and, if required, the
optical archive.
You can also manually trigger the
creation of certificates for deliveries,
inspection lots, or batches, and control
these materials in the production chain
can also be taken from other plants.
Apart from the characteristic data
defined in the certificate profile, you
can structure the certificate to contain
all other information that is available at
certificate creation. Such information
might, for example, include data from
the sales order.
Certificate Creation
Meeting Your Requirements
For single delivery items, certificates
are issued automatically when goods
are shipped, together with delivery
notes. These certificates are then
included with goods deliveries. You can
create certificates at any stage of the
shipment process, as long as the data
required is accessible; for example,
when picking is completed or goods
are issued. If you want to make certifi-
cates available to customers before
goods delivery, you can make them
accessible on the Internet or send them
electronically.
been received until the usage decision
is made for the incoming inspection lot.
If a certificate has not been received,
SAP ERP may post the stock to
restricted-use stock.
You can store certificates that have
been received using SAP ArchiveLink.
You can also send reminders for miss-
ing certificates and monitor reminder
statuses. In addition, you have the abili-
ty to process the receipt of certificates
before the goods have actually been
received. This is often the case with
Certificate Processing
at Goods Receipt
As a quality inspector, you are respon-
sible for monitoring the receipt of certif-
icates during the procurement process.
If you have marked a material as requir-
ing a certificate, you must confirm that
a quality certificate has been received
for purchase orders or goods receipts.
You generally confirm this information
at goods receipt. However, you can
wait to confirm that a certificate has
Benefits:

Easy creation
of certificates

Automatic warnings if
a certificate is missing
at goods receipt

Fewer errors by using
electronic data 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
intranet

Multiple output
formats: XML, PDF,
fax, or print

Electronic transfer
of quality data to your
business partners
Figure 20: Quality Certificate
Quality Data Exchange
If you want to enable a recipient to use
the quality data displayed on a certifi-
cate, you must send the certificate
electronically (using EDI) to the target
system.
If the quality certificate refers to a deliv-
ery to a customer, you can automatical-
ly transfer the inspection results printed
on the certificate to a goods receipt
inspection lot (see Figure 21). You can
also manually copy the results to anoth-
er inspection lot, for example, a source
inspection lot.
Certificate data can be transferred to a
recipient system for further processing
without a link to a specific delivery. In
such cases, the certificate data refers
to the inspection lot or batch. You can
also transfer data to your business
partners that do not use SAP software.
Figure 20, via electronic data inter-
change (EDI).
Certificate Access on the Internet
As the vendor, you can allow your cus-
tomers to access SAP ERP over the
Internet and access a quality certificate
for their purchased goods. Depending
on their needs, it is possible for cus-
tomers to access a certificate that is
created when accessed or one that
was created for a delivery item and is
already stored using SAP ArchiveLink.
certificates that are sent electronically.
If you receive an electronic certificate
with reference to a delivery, you can
copy the quality data from the certifi-
cate for further processing.
Collaborative Business: Certificate
Data for the Whole Company
You can make certificates available to
your employees and business partners
over the Internet. In addition, you can
send a certificate, like the one shown in
Figure 21: Quality Data Exchange
Vendor
Optical Archive
SAP ERP
Certificate
Creation
IDOC*
Reference Data
Quality Data
Certificate (PDF)
EDI**
XML
Other
IDOC
Reference Data
Quality Data
Certificate (PDF)
Reference Data
Certificate
Record
Certificate (PDF)
Customer
* IDOC = intermediate document
** EDI = electronic data interchange
quality notifications, you can deal with
both simple problems and problems
related to complex processes in the
logistics supply chain (for example,
complaints processing for deliveries
or processing of returns), as shown
in Figure 22.
Notification Types
The subjects defined in quality notifica-
tions generally refer to exceptions in
everyday business processes. If you
create a notification, you use the notifi-
cation type to define the subject from
a business viewpoint. The notification
type determines the process flow.
SAP ERP contains the following quality
notification types (see Figure 23):
Customer complaint
Complaint against the vendor
Internal problem notification
Requests or problems that cannot, at
first, be assigned at a business level
implement corrective tasks for quality
improvement using the quality
notification.
In addition to the quality notification,
the following notifications are available
to you:
General notification for general
requests or subjects (without a busi-
ness assignment)
Maintenance notification for record-
ing and processing problem notifica-
tions for technical objects
Service notification for processing
service activities
Feedback notification for requests
or problems related to SAP ERP
Claim for documenting deviations
from a project plan (for example,
schedule deviation or cost variance)
Using Quality Notifications
Notifications are an efficient tool for
processing exception situations. Using
Improved Quality Through
Targeted Problem Handling
To optimize business processes in
your company, you must respond to
requests and problems quickly and effi-
ciently. As the notification processor,
you coordinate the processing of
incoming requests or problem notifi-
cations and propose suitable tasks.
You can ensure that all problems are
assigned and solved correctly. You
are involved in the analysis, cause
determination, and handling of prob-
lems. You are also responsible for
checking the implemented tasks for
their effectiveness.
Notifications in an SAP Environment
The integrated notification function
supports you when you create and
process various issues and problems.
As a special feature of QM with SAP
ERP, you can record quality problems,
document defects and causes, and
EFFICIENT PROBLEM MANAGEMENT
Figure 22: Notifications for Continuous Process Improvement
Unplanned
Event
Description/
assignment
Analysis Solution
Tasks/
activities
Entering costs
Internet/
intranet
Notification Processing
Workflow
Solution
database
Action
box
Status
management
Evaluations
defects analysis for the individual
problems. You define the necessary
corrective tasks and assign them to
the appropriate employees.
You complete the problem notification
after all tasks have been completed
successfully and their costs have been
calculated. The steps you perform
mirror the status of the individual tasks
and the complete quality notification.
You can display the most significant
processing steps of a notification in
the action log.
Quality Notifications
You can adapt the structure and infor-
mation in a quality notification to meet
your requirements. In addition to the
notification types supplied by SAP, you
can define your own notification types.
For each notification type, you can:
Select a simple or enhanced pro-
cessing view
Determine screen areas and their
content
Structure notification data using tab
pages
Include your own functions in an
action box
Configure shop papers for printing
Activate digital signature for distinct
business transactions at header or
task level
are available in the enhanced view.
This view is particularly useful if the
employees responsibility extends
beyond the creation of the notification.
If you are responsible for creating the
notification, you must first describe the
subject in text form, then name a refer-
ence object, if possible (for example, a
sales order or delivery), and assign an
appropriate priority to the problem. QM
with SAP ERP copies the linked infor-
mation to the notification.
When you enter the notification, you
can see immediately if, for example,
notifications already exist for the same
material or customer. You can immedi-
ately switch to one of these notifica-
tions and access information about
how to solve the problem.
As the responsible notification proces-
sor, you are informed about notifica-
tions using work lists or through work-
flow. You can implement tasks and
record costs. You can also perform
are entered using the general notifica-
tion. As the responsible notification
processor, you assign a suitable notifi-
cation type to a general notification,
depending on the subject of the notifi-
cation. The notification type controls
all further processing.
Quality notifications can be recorded
manually or automatically:
You can create a notification manually
on the Internet, intranet, or directly in
SAP ERP.
For defects recording during inspec-
tion processing, a quality notification
can be created automatically.
Notification Processing
If you manually enter and process gen-
eral notifications, you can use simpli-
fied or enhanced processing views.
The simplified view is meant for
employees who do not require the
whole range of notification functions.
This view is used to quickly record
problems. All notification functions
Customers
Customer
complaint
Company
Complaint
against
the vendor
Vendors
Internal
problems
Figure 23: Quality Notification Types
usage and control problem processing
with regard to procedures. The action
box includes typical tasks and activities
for processing notifications. These tasks
or activities are known as follow-up
functions and can be executed with a
mouse click. These follow-up functions
are available:
Creating letters of complaint or
eight-discipline (8D) reports for
complaints against the vendor
Requesting permission to deviate
from specifications
Creating a new quality notification
from an existing notification
Sending decisions by e-mail, fax, or
print preview (for example, confirma-
tion of receipt, interim notice, or final
notice)
Accessing the solution database
Documenting calls related to the
notification
The follow-up process is simplified
through the use of colors to mark the
processing statuses of follow-up func-
tions and dependent follow-up func-
tions. In this way, you can recognize
immediately those follow-up functions
that have already been processed and
those that are outstanding.
Solution Database
Complaints must be processed quickly
and efficiently. With an integrated solu-
tion database, you can quickly find
solutions when processing notifica-
tions. You access the solution data-
base from the action box and start a
free-text search in the database using
the entered problem description. You
can quickly determine whether similar
problems have occurred in the past and
which tasks were used to solve them.
Notification Item
Individual problems or errors that have
occurred are documented as notifica-
tion items. They contain information
relating to defects analysis, such as
the defect type and location. You can
assign various causes to a notification
item. You can access user-defined
catalogs to describe the defect type,
location, and cause.
Tasks and Activities
The tasks and activities used to correct
the defects are subordinate to the noti-
fication item. Tasks and activities can
be assigned to the notification header,
so that you can take the first steps
to resolve a problem even before the
analysis is available.
Optimized Usage
SAP ERP has several useful functions
that optimize the use of quality notifica-
tions. In addition, several tools can
streamline notification processing.
Action Box
You can use the action box to flexibly
enhance the functions in the notification
to suit your needs. You can simplify
Elements of the Quality
Notification
Figure 24 shows the layout of data in a
quality notification.
Notification Header
The header data record contains a
description of the subject matter and,
depending on the notification type,
assigns objects affected by the notifi-
cation (for example, purchase order,
material, vendor, and inspection lot, or
sales order, material, and customer).
The priority and processing status are
documented in the notification header.
You can also access other objects
linked to the notification in the notifica-
tion header, such as documents or
QM orders used for recording costs.
Partners
The partners involved in the creation or
processing of a notification (for exam-
ple, vendors or customers) are listed in
the notification. You can also include
departments and people within your
company who are involved in notifica-
tion processing as partners.
Figure 24: Structure of a Quality Notification
Partner Activities Tasks
Activities Tasks Causes
Quality Notification
Defect Item
Tasks
A task is a processing step that is per-
formed during notification processing.
You can track the processing status of
the task with a status sequence that
you define. You can specify the dead-
line for completion and the person
responsible for each task. SAP ERP
manages the status of each task and
allows you to complete a quality notifi-
cation only when all the tasks have
been processed. The structure of the
quality notification differentiates
between immediate and corrective
tasks.
Immediate Task
The purpose of an immediate task is
to provide an immediate response to
the problem that produced the quality
notification and to prevent any further
damage from occurring. These types
of tasks are assigned to the quality
notification header and can be imple-
mented without specifying a defect or
defect cause. Examples of immediate
tasks include the following:
Blocking warehouse stock
Triggering an additional inspection
Sending a confirmation letter
Corrective Task
The purpose of a corrective task is
to eliminate the defect and its cause
and to prevent it from recurring. You
assign corrective tasks to an individual
notification item (defect). Examples of
corrective tasks include the following:
Changing a work instruction
Implementing training
Modifying a routing
Document Flow
You can display all documents that are
linked to the notification in a list or as a
graphic.
Digital Signature
By activating the digital signature for
notifications, you can request a digital
signature for selected process steps
when processing a notification; for
example, when setting a status such as
released. The activation can be done
at the header or task level for any busi-
ness transaction and notification type.
Signature strategies can be applied.
Analysis of Items and Defects
Quality notifications are designed to
analyze defects. There is one notifica-
tion item (defect data record) for each
defect that has been recorded. In this
record, you can describe the defect
type and location, and you can use
company-specific codes to document
the problem. These codes can later be
evaluated. Additional input fields are
available for each notification item,
including fields for defective quantities
and a field for a quantitative defect
valuation.
Using the classification function, you
can classify defects, define additional
defect characteristics, specify value
ranges for these characteristics, and
record characteristic values. In addi-
tion, you can enhance defect analysis
by documenting the causes of the
defects and by defining corrective
tasks.
Flexible Work Lists
Work lists are available to you for pro-
cessing quality notifications, defect
items, tasks, and activities. In particu-
lar, for notifications or tasks, you can
select and process objects that you:
Created
Processed last
Are responsible for processing or
which are within your area of
responsibility
Are responsible for processing
within a specific partner function
Workflow
If you use SAP Business Workflow,
all parties involved in notification pro-
cessing are informed about their tasks.
Depending on the status of notifica-
tions or tasks, work items are entered
in the mailbox of the responsible
parties.
You can access the necessary pro-
cessing functions directly from a work
item. If the responsible processor is
unable to complete the task within
the deadline, workflow forwards the
operation to a department or employee
responsible for urgent outstanding
tasks. This is also referred to as
escalation.
Response Profile
Depending on the priority of the notifi-
cation, you can define a sequence of
standard tasks using a response pro-
file. These tasks can then be proposed
on request in the notification; they must
be completed within a specified period
of time.
archive and manage printed or electron-
ically transmitted documents. Outgoing
documents, printed or transmitted by
fax, are stored in an optical archive.
Incoming documents can be recorded
with SAP ArchiveLink and assigned to
a new or an existing quality notification.
If processing is to start immediately, a
workflow can be triggered when the
incoming document is recorded. The
workflow function forwards tasks to
the partner responsible for processing
work items using the business work-
place function.

Triggering multiple internal service
processes
Forwarding the notification to the per-
son responsible for processing using
SAP Business Workflow
Sending faxes and e-mails
When processing a notification, you
can send information to an internal or
external address as a fax or by e-mail.
Storage and Documentation
Shop papers
Although SAP ERP supports paper-free
processing of quality notifications, it is
sometimes useful to have printed shop
papers to present the information in the
form of a fax or to store in a file. QM
with SAP ERP provides the following
shop papers:
Notification overview
Notification items
Complaint report
Confirmation report
Interim notice
Final report
8D report
If required, you can create your own
shop papers and structure them with the
help of the SAPscript text-processing
function or Adobe PDF function. You can
use the examples delivered with SAP
ERP as models for designing your own.
Assignment of documents
Using the document management func-
tion, you can assign documents, such
as CAD drawings, Word documents,
and HTML documents, to a notification.
These documents are then available to
you during notification processing.
Storage with SAP ArchiveLink
Using SAP ArchiveLink, which is acces-
sible in the quality notification, you can
Follow-Up Actions
You can link tasks with automatic
follow-up actions. As a result, you can,
for example, initiate inspections, block
supply relationships, or create a
purchase order for a return delivery.
Activities
You can define activities to document
that a specific action has been
implemented.
Support Functions
Additional functions are available to
support quality notifications. You can
make notification recording available
to business partners on the Internet.
In addition, you can archive quality
notifications using SAP ArchiveLink.
Communication
Notifications on the Internet and
intranet
Using an Internet connection for quality
notifications, you can reduce the
resources and time needed for record-
ing a complaint, thereby improving notifi-
cation processing. A customer records
a problem on the Internet. QM with SAP
ERP then triggers internal operations
using the workflow function. The cus-
tomer can display the processing status
of the notification at any time on the
Internet.
If notifications are created for general
requests or problems from an employ-
ees working environment, the Internet
service request is the medium for find-
ing solutions quickly and through which
the following are performed:
Recording different issues
Searching for solutions using the
integrated solution database
Benefits:
Rapid processing
of unplanned events
Active participation
by employees in the
continuous improve-
ment of processes
Easy communication
and work processing
by using the Inter-
net or intranet
independently of
the application
Time and money
savings because
of the optimal control
of subsequent
processes
Tightening or reducing the inspection
scope based on the results of a pre-
vious inspection is controlled either
by the valuation of the inspection lot
(dynamic modification by lot) or by
the valuations of the individual
inspection characteristics (dynamic
modification by characteristic).
When several lots of the same material
are to be inspected simultaneously,
there are two times when the software
can dynamically modify the inspection
scope:
The inspection scope is modified in
advance by assuming that all open
characteristics will be accepted. If a
lot is rejected unexpectedly as a
result of an inspection, the inspection
scope will be updated again after the
usage decision has been made.
The inspection scope is modified
after the usage decision for the cur-
rent inspection lot has been made.
QM with SAP ERP takes the quality
level into account when determining the
inspection scope and defining the
inspection specifications in the inspec-
tion instruction. Inspection lots are
summarized in a quality level according
to specific criteria. For example, inspec-
tion lots in production are summarized
according to material, plant, and task
list, while inspection lots for goods
receipt inspections are summarized
according to material, vendor, manufac-
turer, plant, and task list.
Figure 25 shows how master data and
transaction data interact during dynam-
ic modification of the inspection scope.
The main features of this interaction are
as follows:
Dynamic modification rules apply
uniformly for all inspection character-
istics of a task list, individually for
certain inspection characteristics, or
generally for the inspection type that
is active for the material.
Quality control involves strategic plan-
ning, continuous monitoring, and rapid
intervention to deal with unexpected
events. SAP offers you a complete set
of tools for this purpose.
The role of quality manager in SAP
NetWeaver Portal provides the basis
for your quality controlrelated tasks,
which range from strategic planning
to monitoring and evaluating inspec-
tions and notifications.
iViews (portlets) provide an overview
of all important key figures and evalu-
ations in QM with SAP ERP. As a
result, you can continuously evaluate
your quality strategy and modify it on
the fly if a problem arises.
An intuitive data warehouse, which is
included in SAP NetWeaver BW,
brings related data together to give
you the reliable company key figures
you need.
Dynamic Modification of the
Inspection Scope
Dynamic modification controls the
inspection scope (based on inspection
characteristics and sample sizes) for a
series of inspection lots to achieve a
predetermined quality goal. General
technical rules, such as the sampling
standards of ISO 2859-1 and ISO
3951, follow this principle. QM with
SAP ERP contains a complete set of
sampling tables for these standards.

To help you reach your quality goal,
SAP ERP determines inspection stages
for the next inspection lot after each
usage decision. It uses the dynamic
modification rule in the task list to
determine inspection stages and then
writes them to a quality-level data
record.
SUSTAINED QUALITY CONTROL
PLANNING, EVALUATION, AND DIRECT
INTERVENTION
Figure 25: Dynamic Modification of the Inspection Scope
Master Data
Transactional Data
Lot level
Quality level
Characteristic level
Inspection lot creation
Task list selection
Inspection scope
Sampling Scheme
Sampling Plans Based on Lot Size
Sampling
Inspection instruction
Quality inspection
Characteristic
inspection result
Usage decision
Inspection Plan
Header
Characteristic
Sampling Procedure
Sampling plan
Dynamic Modification Rule
Stage change
Acceptable
Quality Level
Inspection
Stages
Assignment

Inspection Lot Processing
the share of scrap of the process. The
limits of these charts are extended if a
long-term reduction in the process vari-
ance is achieved.
If you are using a Shewhart chart, the
limits become tighter as a result of a
long-term reduction in the process vari-
ance. These charts only take internal
process parameters into account, not
external tolerance specifications. They
use a continuously recurring statistical
test to check that the controlled status
of the process has not changed.
As an inspection planner, you deter-
mine whether a quality control chart is
to be maintained for a given inspection
characteristic. The charts may include
You can show the mean value and
standard deviation of a characteristic
on one control chart with two tracks.
In addition to the control variable, each
track also contains control limits. If
these limits are exceeded, you have the
ability to intervene in the process. For
some control chart types, you can pre-
define warning limits or a centerline.
The limits are determined using statisti-
cal methods from the current process
data or from the results of an initial run.
You can also enter them manually on
the basis of existing data. You can use
various algorithms for the calculation.
Acceptance charts are based on your
predefined tolerances. They determine
On the Right Track with Statistical
Process Control
Statistical process control allows you
to monitor, regulate, and improve the
quality of processes.
Quality Control Chart
The most important tool for statistical
process control is the quality control
chart, a graphic tool for documenting,
analyzing, and controlling processes
(see Figure 26). You can use this chart
in an inspection during production and
during the procurement or shipping
process.
You choose one or more control vari-
ables for the relevant characteristic,
determine their values at regular inter-
vals by taking samples during the
process, and enter them in the chart
in chronological order.
Types of Control Charts
QM with SAP ERP provides the follow-
ing types of control charts:
Mean value with tolerances (accep-
tance chart)
Mean value without tolerances
(Shewhart chart)
Standard deviation (Shewhart chart)
Range (Shewhart chart)
Moving average
Exponentially weighted moving
average
Individual moving range for sample
size n=1
Charts for qualitative characteristics
(np-, p-, u- and c-chart)
Normal distribution is used for quantita-
tive characteristics; Poisson distribution
is used for qualitative characteristics.
Figure 26: Illustration of an X-Bar/S Control Chart
You want to view a list of control
charts from which you can choose
individual control charts to be
checked.
Violations of Western Electric Rules
are displayed in a list along with the
chart number, track, and sample num-
ber. From this list, you can branch to
the inspection results to display
detailed information on the individual
inspections and to view the control
chart.
In the mean-value chart, you can
display the process capability indexes
Cp and Cpk in a second window (see
Figure 27).
4 of 5 consecutive points outside 1/3
of the control limits
8 consecutive points above or below
the centerline (run)
15 consecutive points within 1/3 of
the control limits
6 consecutive points in ascending or
descending order (trend)
On the selection screen of the related
work-list transaction, you can decide
whether:
You want to immediately carry out a
check according to Western Electric
Rules. In this case, all control charts
that correspond to the selection crite-
ria are checked.
several inspection lots or production
orders. SAP ERP creates the quality
control charts when preparing the quali-
ty inspection and updates them when
you record results. As a quality inspec-
tor, you can display the charts when
you are recording results and, if you
have the appropriate authorization, you
can use them to calculate intervention
and warning limits. If necessary, you
can change the algorithms.
You can evaluate inspection results
using the quality control chart. QM with
SAP ERP contains a valuation rule that
rejects a sample as soon as any limit is
exceeded. When this occurs, the work-
flow automatically notifies the depart-
ment (as long as the defect class has
been set appropriately in the defect
code of the task-list characteristic).
You can view all of the control charts
you are responsible for in a work list. If
you are working in the quality manager
role, an iView (portlet) shows you all
charts where control limits have been
exceeded.
Western Electric Rules
Apart from showing where control lim-
its were exceeded, control charts can
indicate that a process may be running
out of control on the basis of unusual
patterns (for example, runs or trends).
The criteria you use to detect such pat-
terns are referred to as Western Elec-
tric Rules. In the work list for control
charts, you can check the stability of
processes according to the following
criteria:
1 point outside of control limits
2 of 3 consecutive points outside 2/3
of the control limits Figure 27: Process Capability Index Cpk
Quality Scores
Quality scores for inspection lots are a
proven tool for quality control. QM with
SAP ERP provides you with several
ways of determining the quality score.
It uses information from the following
sources:
Usage decision
Estimated fraction of nonconforming
units in the lot
Estimated fraction of nonconforming
units for characteristics
Maximum share of defects
Weighted average share of defects
Quality score of the characteristic
defect classes
Minimum (worst) quality score
Weighted average quality score
Vendor Evaluation: Permanent and
Objective Performance Monitoring
When procuring materials, you can use
the vendor evaluation function to select
a suitable vendor. This function pro-
vides you (as the purchaser) with a
summarized score that has been calcu-
lated for the vendor according to main
and subcriteria (see Figure 28).
content-based examples of how to inte-
grate business processes supported
by SAP ERP with shop floorrelated
processes using SAP MII transactional
techniques. For example, there is
sample software for an intuitive, Web-
based results recording function based
on SAP MII. Shop-floor operators
would use it for in-process control.
SAP MII enables real-time, preconfig-
ured transactional integration between
plant-floor and enterprise (SAP ERP)
applications through the following:
Universal connectivity to the data,
functionality, and processes of exist-
ing plant-floor systems through busi-
ness logic for creating automated
events, KPIs, and alerts
Workflow to synchronize plant and
enterprise business processes
Manufacturing intelligence with a
near-real-time analytics engine that
aggregates and delivers unified visu-
alization of events, alerts, KPIs, and
decision support to production
personnel
In addition to this, SAP MII provides a
connector framework to establish or
develop connectivity to various produc-
tion and test devices. SAP is building a
partner ecosystem around SAP MII.
For more information on SAP MII, go to
www.sap.com/solutions/manufacturing
/manufacturing-intelligence-software
/index.epx.
You can use a histogram evaluation to
display the frequency distribution of
measured values in a bar chart. This
allows you to recognize typical and
extreme values of a sample, as well as
to judge the location, dispersion, and
form of the distribution. You can blend
the histogram out and replace it with a
normal distribution if required.
The histogram contains the following
data:
All valid results for the sample
Upper and lower specification limits
Target value
Distribution function and statistical
values
If the inspection results are already
divided into classes, SAP ERP uses
these classes to display the histogram.
Otherwise, it divides the existing values
into appropriate classes. You can
increase or decrease the number of
classes using the zoom function.
SAP Manufacturing Integration and
Intelligence for Quality Analytics
For integrating systems, databases, or
other external applications (especially
on the shop floor) and also for perform-
ing comprehensive analytics on quality
data, SAP offers SAP Manufacturing
Integration and Intelligence. Integration
templates in the application provide
These tools complement each other.
Report lists primarily evaluate operative
data. SAP NetWeaver BW and the QM
information system, however, analyze
summarized data that can be stored for
a long period of time.
Results History
With the help of the results history,
you can analyze single values that
were recorded for a characteristic in
the results recording function and
when you made the usage decision.
You define the period of time to be
analyzed. You can prepare the data in
list form and graphically represent the
progression of values over a period
of time using a run chart. With the help
of a trend analysis you can represent
the predicted course of the values.
Exporting the data, for example, to a
Microsoft Excel file provides additional
options for processing the data.
QM Cockpit for Evaluations
With the help of the QM cockpit for
evaluations, you can analyze quality-
related data based on inspection lots,
defects, and quality notifications (see
Figure 29). Batch where-used lists pro-
vide quality-related data of components
or preliminary products. During the
analysis you can use tables or informa-
tive graphics to visualize the results.
These graphics can be adjusted to suit
your requirements. Multiple graphics
can be displayed at the same time, for
example, with reference to an inspec-
tion lot, to facilitate comparisons. You
can calculate key figures, which you
can define to meet your needs.
Evaluations: Keeping You
Up-to-Date
The following evaluation tools are
available in QM with SAP ERP:
Results history of mean and single
values with integrated analysis of
trends
QM cockpit for evaluations with SAP
ERP for online and archived QM data
SAP NetWeaver BW with integrated
business content
QM information system
SAP MII for integrated quality analyt-
ics based on disparate systems
Report lists programmed using the
ABAP programming language
Predefined SAP reports
Logical databases as the basis for
customer-specific reports
The subcriteria for quality, the main
criterion, come from the following
sources:
Goods receipt inspection the aver-
age of the quality scores of all goods
receipt lots from the vendor for a
specific time period
Complaints the number of com-
plaints received in relation to total
sales or total revenue, for example
QM audit either the average quality
score of all audits executed during a
specified time period or the quality
score of the most recent audit
You define the criteria and their relative
weighting according to your company
requirements.
Vendor
Evaluation
Procurement
Main Criteria
Weighting
Price 30%
Subcriteria Weighting
Quality 40%
Figure 28: Vendor Evaluation in SAP ERP
Delivery 20%
Service 10%
A
1
A
2
A
3
A
1
A
2
A
3
A
4
A
1
A
2
A
3
A
4
A
1
A
2
Price level
Price behavior
Other
Goods receipt inspection
Complaint
Audit
Other
On-time delivery performance
Quality reliability
Uniform shipping instructions
Other
Technology
Other
%
%
%
%
%
%
%
%
%
%
%
%
%
A Determined automatically
company key figures using formulas.
Even if you have no programming expe-
rience, you can create reports quickly
using flexible analysis.
Early warning system
An early warning system helps you
identify problems at an early stage by
warning you if an exception situation
occurs. You can define the exception
situations. When an exception situation
arises, you are informed immediately
via e-mail or workflow. An exception
situation can, for example, occur if the
quality score of a vendor falls below 90
points. You define exception analyses
using standard information structures
or your self-defined structures. You can
also use mathematical algorithms or
set the software to recognize threshold
values or trends.
Report Lists Using ABAP Query
You can create evaluations that are
not available as standard with a simple
mouse click using the ABAP query
tool or predefined logical databases.
The link to printing and presentation
functions occurs automatically.
Since the QM information system is
part of the logistics information system,
you can combine evaluations with infor-
mation from other areas of logistics,
such as production or purchasing. Out-
put data is displayed in list form or as
a graphic and can be sent as an e-mail
attachment. Other features are activity-
based costing and portfolio analyses.
Using the standard query tools, you
can freely define your own evaluations
and reports.
Standard analyses
The QM information system contains
a selection of standard evaluations for
your materials, vendors, and custom-
ers, including key figures such as pro-
cess capability indexes, defects fre-
quencies, or skip quotas. You can tailor
both the presentation and content of
the QM information system to suit your
needs.
Flexible analyses
You can configure your own reports
on the basis of standard information
structures or self-defined structures.
You can also link your key figures to
QM-STI enables the export of data for
additional statistical evaluations, which
can be visualized directly integrated in
the QM cockpit for evaluations.
According to the selection of the object
type, such as inspection lot, notifica-
tion, or component, different selections
and grouping layouts are offered. Via
the grouping layout, you can easily
decide which information is relevant
for you and which aggregation level is
needed. You can evaluate both current
and archived data and compare the
inspection results for several
characteristics.
In the cockpit you can create different
types of control charts without any
preparation in the related inspection
characteristics. You can analyze
defects together with inspection lots or
as notifications. A new graphic type is
available for the visualization of defect
frequencies. Additional key figures for
defect risks are also available. Notifica-
tions can be analyzed together with
defect causes. For components, you
can analyze and visualize inspection
lots, notifications, or defects from the
production cycle.
Quality Management
Information System
Inspection results and quality notifica-
tions are summarized on the basis of
time, plant, or work center and updated
in the QM information system. You can
decide whether you want the update to
be performed on the basis of material,
material and vendor, or material and
customer.
Figure 29: Evaluation of Components Using the QM Cockpit
ties in production, or returns in sales.
This information is integrated in the
business content and can be linked
with key figures from SAP ERP, thereby
providing you with a complete picture
of quality in your company.
QM-STI for External Evaluations
QM-STI is an open interface used for
evaluating inspection results in external
systems. You configure it in customiz-
ing and trigger the external application
by simply clicking a button in one of the
following QM functions with SAP ERP:
Results recording
Usage decision
Control chart
Results history
Search for Quality Data
The SAP NetWeaver Enterprise Search
application provides SAP applications
with numerous services for searching,
classifying, and text mining in large col-
lections of documents (unstructured
data) as well as for searching in and
aggregating business objects (struc-
tured data).
In QM with SAP ERP, the search func-
tion is available for quality-related data
such as:
Master inspection characteristic
Inspection method
Supplier information record
Quality notification
The search function is offered during
data entry within change and display
transactions for a given object; a sim-
ple and an extended search function
are provided.
In this way, you receive summarized or
detailed information regarding the noti-
fication process, with an emphasis on
reference objects such as customer,
vendor, material, or assembly. On the
organizational side, the emphasis is
placed on purchasing and sales divi-
sions, material groups, or the country
of origin of your customers.
Among the key figures, you can obtain
the number of notifications, cumulative
or average processing time, defective
and returned quantities, and proportion
of notifications completed on time. In
addition, you can get information on
new, outstanding, and successfully
completed tasks.
Defects, defect locations, causes,
activities, and tasks
Using QM with SAP ERP, you docu-
ment defects in the inspection lot or as
notification items. SAP NetWeaver BW
shows you which defect types
occurred, where they occurred, and
what caused them. Activities and tasks
associated with the notification are
also extracted. The same reference
objects as in quality notifications are
available to you in the form of naviga-
tional attributes. All coding is also avail-
able. For example, you can determine
which defects occur regularly in a
specific location.
Many key figures used by the quality
manager are based on information
obtained from internal systems running
non-SAP software as well as external
systems. Examples of this information
include the vendor evaluation in pur-
chasing, returned quantities in stock
management, scrap and rework quanti-
SAP NetWeaver Business Warehouse
SAP NetWeaver BW offers data ware-
housing that fits effortlessly into the IT
landscape of SAP ERP and other soft-
ware applications. It contains preconfig-
ured business content for your role
of quality manager or quality planner.
Business content includes data extrac-
tion, metadata and information models,
and ready-made templates for tables
and graphs in Microsoft Excel or HTML.
Inspection results
The specifications and results of your
quality inspections can be evaluated
down to the sample level of an individual
characteristic. The spectrum of key fig-
ures ranges from the number of inspect-
ed or rejected samples to indicators for
process capability, such as Cp and Cpk.
You can interactively analyze quality
using criteria such as material, vendor,
or work center.
Inspection lots
Inspection lots can be transferred to
SAP NetWeaver BW once the usage
decision has been made. You can obtain
information in graphic or tabular form
on the frequency of individual usage
decisions, the number of inspected and
skipped lots, the actual inspected quan-
tity, the percentage of nonconforming
units, or the quality score. For example,
you can consolidate the information and
sort it according to vendor or purchas-
ing organization.
Quality notifications
Quality notifications reflect unplanned
events that occur during the quality
process. For every notification, a selec-
tion of attributes and key figures is
transferred to SAP NetWeaver BW.
for costs such as those relating to a
warranty, to scrapping, or to the settle-
ment of activities performed. You can
also assign rework orders to this cost
collector account. This allows you to
debit all costs for a quality notification
to the appropriate personnel and ana-
lyze the costs.

Appraisal Costs
Appraisal cost orders are stored in the
material master and assigned by SAP
ERP as cost collectors to individual
inspection lots. If, however, a special
settlement is required for an inspec-
tion, that settlement takes precedence.
This can happen, for example, when
the lot belongs to a production order or
when it comes from a goods receipt for
a purchase order that is assigned to a
cost center account.
SAP ERP calculates appraisal costs
using the activities that you, as the
inspector, confirm. You can confirm
activities, for example, on the basis
of the hours worked. Accounting fixes
the types of activities, such as setup or
inspection time, and the valid charges
for the cost center that performs the
activity. The activities performed for
inspection lots are logged during
results recording or when the usage
decision is made. Activities performed
for inspections during production are
confirmed when confirmations for pro-
duction orders are made. Other inspec-
tion costs, such as material usage, are
settled to the order in which you con-
firm the inspection activity.
Nonconformity Costs
To settle nonconformity costs for a
quality notification, you create a QM
order when processing a notification.
You assign the order to the notification
header and use it as a cost collector
Even when the entry is imprecise or the
entered search string contains typing
errors, results can be found using a
fuzzy search. Depending on the set-
ting of the search criteria in customiz-
ing, you can search for notifications of
one special type, for example, only for
quality notifications.
Taking Control of Quality Costs
With SAP ERP, the controlling function
plans, collects, and evaluates all costs
incurred by a company. These costs
include quality-related costs. In QM
with SAP ERP, you record appraisal
costs originating from quality inspec-
tions or nonconformity costs originat-
ing from quality notifications. Quality
costs from other applications (for
example, human resource manage-
ment) can be included in the cost
calculation.
The controlling component uses QM
orders to manage quality costs. The
following types of QM orders are
provided in SAP ERP:
Appraisal costs order
For individual settlement
For collective settlement
Nonconformity costs order
You can also define your own specific
order types. When creating an inspec-
tion lot or a quality notification, you can
create or assign a corresponding QM
order.
Benefits:
Use dynamic modifi-
cation to reduce your
appraisal costs
Monitor processes
continuously using
quality control charts
Access important
company key figures
and evaluations
immediately
Master Data in a
Calibration Inspection
Several master data records are used
during a calibration inspection: equip-
ment master data, maintenance plan,
and maintenance task list.
Equipment
In SAP ERP, your companys test
equipment data is stored in an equip-
ment master record. This master
record contains all of the data relevant
to test equipment (such as acquisition
value and date, manufacturer, work
center, cost center, and location).
To organize your test equipment and
make it easier to locate, you can:
Combine similar test equipment into
groups
Use the classification function to cat-
egorize test equipment according to
technical features
Assign test equipment to a construc-
tion type (material)
Using the results history, you can verify
the suitability of each piece of equip-
ment and the accuracy of the inspec-
tions performed using this equipment.
Tracking Test Equipment
SAP ERP provides you with test equip-
ment tracking functions. During a cali-
bration inspection, you might notice
that a piece of test equipment is no
longer fit for use. In this case, you can
check in the test equipment history to
see which inspection lots and charac-
teristics were inspected using this
piece of equipment. You are then able
to initiate the appropriate actions.
Monitoring Technical Installations
In addition to calibration inspections,
you can use inspection lots created for
maintenance orders for the extended
recording of measured values in plant
maintenance (for example, to monitor
technical installations where critical val-
ues have to be recorded on a regular
basis). Consequently, you can record
inspection results for functional loca-
tions as well as for test equipment.
As a test equipment manager, you are
responsible for managing, monitoring,
calibrating, and maintaining test equip-
ment. Test equipment management
involves the following activities:
Planning and performing calibration
inspections
Releasing or blocking test equipment
Documenting the calibration history
Creating trend analyses
Determining calibration costs
Tracking test equipment with usage
lists
Calibration Inspections
and SAP ERP
As shown in Figure 30, test equipment
management in SAP ERP combines
important planning and processing
functions from QM with SAP ERP that
are needed for master data manage-
ment and for planning and performing
calibration inspections.
Releasing Test Equipment
You can use the inspection results to
decide whether a piece of test equip-
ment can be released for further use.
TEST EQUIPMENT MANAGEMENT
Figure 30: Functions of Test Equipment Management
Usage
List
Master Data
Link Insp.
Char. & Msmt.
Pnts
Calibration
Intervals
Notifications
Calibration Planning
Order
Processing
Inspection
Decisions
Calibration
Orders
Trend
Analysis
Results
History
Work
Lists
(single-cycle plan) at the maintenance
plan level that is valid for all operations
of the maintenance task list.
You define inspection intervals based
either on time or performance. A time-
based inspection interval might, for
example, consist of an annual calibra-
tion on a key date. A performance-
based inspection interval may involve a
calibration after 1,000 uses of a piece
of equipment. You can combine time-
and performance-based calibrations in
a multiple counter plan (for example,
inspect after 6 months or, at the latest,
after 1,000 uses of the equipment).
A calibration inspection covers the fol-
lowing activities:
Scheduling the maintenance plan
and creating the maintenance order
and inspection lot
The maintenance plan is usually
scheduled automatically using a peri-
odically run program. When this
To plan a calibration inspection, you
must:
Create master data
You need master data such as equip-
ment master records, maintenance
plan, master inspection characteris-
tics, and the maintenance task list.
You define operations and the char-
acteristics associated with these
operations in the maintenance task
list.
Define inspection specifications
Quantitative and qualitative inspec-
tion characteristics contain the
inspection specifications (such as tar-
get values, tolerances, and codes for
attributive valuations), and they deter-
mine how results are to be recorded.
Define inspection intervals
You can define inspection intervals
using a central maintenance strategy
that can apply to several maintenance
plans. You can use maintenance strat-
egies, for example, to define different
intervals for each operation within a
maintenance task list. You have the
option of defining a maintenance cycle
Maintenance Plan
The maintenance plan is the central
planning object in which you assign the
list of equipment to be inspected, the
maintenance task list, and the calibra-
tion schedule.
The maintenance plan specifies which
types of activities must be performed
periodically and how often they are to
be performed. In the maintenance
plan, you can enter time-based or
performance-based intervals for per-
forming these activities. When mainte-
nance deadlines are reached, SAP ERP
automatically creates maintenance
orders.
Maintenance Task List
In the task list, you plan the recurring
work processes in a standardized form.
To perform a calibration inspection, you
can include inspection characteristics in
the maintenance task list. In turn, you
can include a maintenance task list in
a maintenance plan. The task list speci-
fies the activities to be performed for
individual maintenance deadlines.
Planning a Calibration Inspection
The automatic or manual scheduling of
a maintenance plan triggers calibration
inspections that are to be performed at
regular intervals. When a maintenance
plan is scheduled, SAP ERP creates a
maintenance order; when this mainte-
nance order is released, an inspection
lot is created. The inspection lot con-
tains all data required for the calibration
inspection, such as a list of equipment
to be inspected and the inspection
specifications (see Figure 31).
Test Equipment
(Equipment
Master Records)
Maintenance Task
List
Maintenance
Strategy Cycle
Maintenance
Item
Figure 31: Objects in a Calibration Inspection
Maintenance
Order
Maintenance Plan
Inspection
Characteristics
the future status. This status can be
updated in the equipment master
record. If a piece of test equipment is
blocked, you are alerted to this fact
when the next order is released.
Change inspection interval
If an inspection shows that a piece
of test equipment is still fit for use,
but maintenance is due before the
next inspection date, you can change
the cycle modification factor when
you make the usage decision. This
has the effect of reducing the length
of the next inspection interval.
Create measurement documents
If you have defined measuring points
for your test equipment, SAP ERP
can create measurement documents
automatically for each measuring
point. When this follow-up action
is executed, the results of the cali-
bration inspection are entered
automatically in new measurement
documents. You can access these
documents in the equipment history.
the calibration inspection. In addition,
additional order processing functions
are available, such as capacity planning
or external assignment. If characteris-
tics are rejected, you can create main-
tenance notifications, start corrective
tasks, and document the success of
these corrective tasks.
Once you have recorded all the results
for the equipment in each operation,
you make an equipment valuation for
the test equipment (accept or reject).
When all the test equipment for an
inspection lot has been valuated, you
make the usage decision for the
inspection lot. As a result of the usage
decision, SAP ERP can perform certain
follow-up actions (see Figure 32):
Update equipment status
SAP ERP manages a status for each
item of test equipment in the equip-
ment master record. This status
determines whether a piece of test
equipment is released for use or
blocked. On the basis of the equip-
ment valuation, SAP ERP proposes
program is run, SAP ERP creates
calls and converts these calls into
orders when they become due. You
can select a setting that releases
orders directly, causing the inspec-
tion lots to be created.
Inspecting and calibrating test
equipment
You can use various criteria to create
a work list of the calibration inspec-
tions that are planned for a specific
period. Such criteria might include,
for example, all test equipment to be
calibrated in the next week or test
equipment sorted by cost center or
work center. You can use this infor-
mation to identify and prepare the
test equipment for inspection. When
a maintenance order is released,
SAP ERP automatically creates an
inspection lot. All orders that have
been released and all inspection lots
that are to be processed appear in a
work list for results recording and can
be processed in any sequence. If test
equipment unexpectedly fails during
use, you can create a maintenance
notification (malfunction report).
Within this maintenance notification,
you can manually create a mainte-
nance order to schedule a calibration
inspection.
Recording results
You can record results in the work list
for the equipment and use the char-
acteristic types and recording func-
tions of QM with SAP ERP.
During a calibration inspection, you are
able to make confirmations for the
maintenance order; for example, to
record costs for activities performed
or for materials that were required for
Release or Block
Equipment
Figure 32: Follow-Up Actions When Making the Usage Decision
Update
equipment status
Usage Decision
Inspection Lot
Equipment
No. 12345
Reduce/Increase
Inspection Interval
Document
Inspection Result
Adjust
cycle modification factor
Update
measurement documents
Trend analysis using run chart
If you display inspection results for an
inspection characteristic as a run chart
using the time axis in the results history,
SAP ERP can indicate a trend (regres-
sion line) for the run of values. This
provides you with an indication of when
a tolerance limit will be exceeded.
Usage lists
The usage list for test equipment
allows you to determine the cost center
of the test equipment, its current or
previous location, or the work center in
which it was used.
Test equipment history
Using the test equipment history, you
can determine which inspection lots
and characteristics were inspected with
a specific piece of test equipment. This
is important when, for example, during
a calibration inspection you determine
that a piece of test equipment should
no longer be in use (test equipment
tracking).

Complete maintenance order
You can set the software to automati-
cally complete the calibration order
when the calibration inspection has
been completed.
In addition to the follow-up actions
described above, you can also define
your own follow-up actions, such as
printing self-adhesive calibration labels
specifying the date of the next calibra-
tion inspection.
Evaluations for Test Equipment
Results history
You use the results history to display
the results of previous inspections for
specific characteristics of a piece of
test equipment.
Benefits:
Guaranteed quality
and reliability of your
test equipment
Safe production pro-
cess because of early
forecasting of possi-
ble weak points in
technical installations
Ability to track your
test equipment
Stability Study Supporting
Product Development and
Product Improvement
Functionality for stability studies is an
important feature to enable the use of
quality management with SAP ERP as
a LIMS. Stability studies, also known
as shelf-life studies, are carried out for
self-produced or externally procured
goods, especially in the chemical,
pharmaceutical, cosmetic, and food
industries. Such studies are required
to determine expiration dates during
the development of new products (in
research and development), and they
are mandatory in order to obtain legal
approvals for products.
This integrated approach means that
quality management functions can
be embedded into business processes
such as procurement, manufacturing, or
controlling, helping to eliminate redun-
dant data and increasing information
transparency throughout the organiza-
tion. On a more technical level, integra-
tion means having fewer systems and
interfaces to maintain. Overall, the sim-
plicity of SAP ERP as a LIMS can help
companies reduce costs and increase
profits and customer satisfaction.
The SAP ERP application supports all
essential functions in a LIMS, including
those shown in Figure 33.
The Enterprise LIMS Approach
Over the years, LIMS have evolved
from custom-developed in-house sys-
tems used to track data in quality labs
to proprietary commercial products.
More recently, LIMS have evolved into
standards-based systems. As a result,
companies are beginning to think in
terms of enterprise LIMS that not
only support the full range of functions
within the laboratory, but are integrated
with systems throughout the company.
The challenges labs face as they man-
age quality are related to turnaround
time of lab tests, access to results
data, accuracy of analyses, resource
utilization, data exchange, record keep-
ing, and productivity. With SAP ERP, a
full range of quality management func-
tions addresses these challenges in
both commercial and industrial labora-
tories. In addition, SAP ERP offers an
integrated LIMS as part of a larger,
more comprehensive quality manage-
ment solution, simplifying implemen-
tation and integration as well as
streamlining quality processes. And
SAP ERP is more than just another
LIMS. Unlike traditional LIMS, it offers
tight integration into the supply chain
and other key areas within the enter-
prise. By enabling companies to take
an enterprise approach to LIMS, SAP
ERP does the following:
Provides a standard basis for integrat-
ing quality management processes
across the enterprise
Enables visibility of quality data
throughout the organization
Enhances communication among
quality groups and other departments
ENABLING AN INTEGRATED
ENTERPRISE LABORATORY
INFORMATION MANAGEMENT
SYSTEM WITH SAP ERP
Audit management
Bar coding and labeling
Batch management (batch traceability
and electronic batch record)
Calculations and formulas
Calibration of instruments
Certificates of analysis
Change management (audit trail)
Complaint and problem management
and corrective and preventive action
Data retrieval and archiving
Digital signatures
Document management
Engineering change management
(audit trail)
Flexible inspections
Goods receipt inspections
Information system and reporting
In-process control
Inspection plan maintenance
Interfaces (inspection data and
statistical data)
Inventory control
Invoicing and billing of analysis
Laboratory statistics
Master data maintenance
Multiple specifications
Nonconformance reporting and processing
Notification processing
Order management
Post-process control
Problem solving and event handling
Quality assurance
Quality planning
Quality data interchange
Recurring inspections
Results recording and copy
Returns inspections
Sample management (unplanned and
planned samples)
Skip-lot functionality
Specification management
Stability (shelf-life) studies
Statistical process control
Statistical quality control
Test equipment interfacing
Quality cost tracking
Vendor evaluation
Web services
Work lists and workflow
Figure 33: Overview of LIMS Functionality with SAP ERP
introduce their products into the
U.S. market with a detailed, complete,
and traceable description of their
production process. This includes all
operations affecting product quality
performed during the manufacture and
distribution of a particular drug. The
requirements for computerized systems
with respect to electronic records are
described in the U.S. Code of Federal
Regulations (CFR), volume 21, part 11.
Compliance and Quality Control
GxP is an acronym for Good Clinical/
Laboratory/Manufacturing Practice
(GCP, GLP, and GMP) and refers to
exacting requirements for regulated
industries, such as the pharmaceutical,
food, and beverage industries. For
example, the U.S. Food and Drug
Administration (FDA) requires compa-
nies in the pharmaceutical industry to
In addition, stability studies are an
important tool for continuously improv-
ing products and processes. In general,
stability studies are conducted for the
following reasons:
Monitor and study the effects of
storage conditions (for example,
temperature, light, and humidity) on
a substance over a defined period
of time
Provide evidence of the effectiveness
or shelf life of a product under con-
trolled environmental conditions
To perform a stability study, you must
draw physical samples from a material
or batch and store them under specific
environmental conditions. You then
remove the samples from storage at
specified intervals and test them
according to a predefined testing
schedule.
To meet the demands of various
international legal requirements and
regulations such as GMP, SAP has
developed software to support stability
studies as part of quality management
with the SAP ERP application (see
Figure 34). Quality management with
SAP ERP supports research and devel-
opment processes and has been avail-
able since the release of SAP R/3
Enterprise software (functionality now
found in the SAP ERP application). Sta-
bility study functionality with SAP ERP
is also linked to the SAP Recipe Man-
agement application, which is an impor-
tant cornerstone of the overall new-
product development and introduction
(NPDI) process.
Figure 34: Example for Stability Study
The following functions of the digital
signature for inspection lots and physi-
cal samples have been enhanced in the
most recent release:
Use of signature strategies
Multistage signatures
Detailed documentation
Possibility to print information about
the signature
Within extended customizing you can
define strategies for signatures, which
means that in a multistage process
multiple persons have to sign the
results in a predefined order. To realize
this scenario, it is possible to process
inspection lots for which signatures
already have been created. If results
need to be inspected and signed by
multiple users, the inspection charac-
teristic does not get the status com-
pleted immediately. Instead, this
status is set once the entire signature
process for this characteristic is fin-
ished. For more detailed documenta-
tion, you can save or print data that is
related to the signature.
In the work list for results recording,
the status of a signature process is dis-
played with icons and can be requested
by the user. As new functionality in
SAP ERP for notifications, such as
quality notifications and maintenance
notifications, you can now include a
digital signature for single processing
steps. In customizing for notifications
you can define the notice type, the
level (header or operation), and the
business process for which a digital
signature is necessary. You can also
use signature strategies in this context.
GxP compliance plays a decisive role
in data acquisition and validation, espe-
cially in analytical laboratories. Accura-
cy and clarity of data, as well as
consistent change documents (who
did what, when, where, and why) are
crucial for regulatory compliance.
Quality management with SAP ERP
supports these GxP requirements, pro-
viding complete audit trail functions and
digital signatures in results recording,
sample or product release, and notifica-
tion processing. These functions also
support change management, electron-
ic batch records, and integrated docu-
ment management to store all relevant
documents, such as standard operating
procedures.
One added benefit is the optimized
data flow that results from eliminating
interfaces between systems. The use
of SAP ERP as an integrated enterprise
LIMS can lead to improved data accu-
racy and consistency, which, in turn,
can lead to better and easier regula-
tory compliance.
For more information about compliance
of SAP ERP with GxP requirements in
general, refer to the SAP white paper
Complying with U.S. FDA Title 21 CFR
Part 11 for the Life Sciences Industry.

Digital Signature
The digital signature serves the same
function for the processing of digital
data as a handwritten signature serves
for paper documents. Its purpose is to
guarantee within an authorization pro-
cedure that the individual who signs a
digital document really is who he or she
claims to be.
Benefits:
Reduced workload for
system administration,
less training, and fewer
upgrades by not using
numerous frag mented
systems
Better processes
with standardization, in-
creased efficiency, and
ease of collaboration
Better product quality,
fewer defects, and
less rework and waste
Increased accuracy
and security of data,
which reduces costs
associated with
regulatory compliance
Improved data quality
and visibility because
data is consistent,
transparent, and
available throughout
the company
audits, revisions, or inspections can be
performed using the audit management
functionality. The process phases are
based on the standard ISO 19011.
supports all phases of auditing from
the planning of a comprehensive audit
program and of the individual audits,
through the definition of the audit crite-
ria or question lists, to the actual audit-
ing process and the assessment of the
audit object in the audit report. It also
supports you in defining and monitoring
corrective and preventive actions. Audit
management functionality also provides
effective tools for the evaluation of all
audit data.
A typical process includes the following
phases and tasks:
Planning audit criteria
Planning of general question lists
(general criteria), depending on rele-
vant standards, regulations, or rules
of the application area
Planning the audit program
Definition of a scheme, for example,
in the form of an annual schedule,
taking into consideration the scope,
object, and date of the audits
Preparing the individual audits
Determination of the individual audit
question lists and of the partners
involved in the audit, distribution of
roles, and preparing the required
documents
environment, and industrial safety, in
one integrated management applica-
tion. Combined audits can greatly
reduce expenses.
Audit objects can be freely defined by
groups of fields; for example, audits
can be performed with reference to
organizations, enterprise areas, prod-
ucts, and vendors. If an audit object is
described using data elements from the
application repository, for example, by
the combination vendor and material,
the information related to these data
elements is available a clear advan-
tage of integration.
The versatility of the audit management
functionality stems from being able to
customize the properties of the audit
components (audit plan, question list,
audit, and action) as well as the proce-
dures for assessing the criteria and
grading the audit object. For example,
employees can provide question lists
with hierarchical tree structures to suit
their own requirements.
Audit Processing: Evaluate
Risks and Confirm Information
To keep the process description that
follows as simple as possible, the
example is based on a quality system
audit performed in accordance with
ISO 9000. However, if regarded in a
broader sense, the example below can
also show you how various other
Assessments: Methods for
Audit Criteria
An audit is a systematic examination
used to determine to what extent an
object meets previously specified crite-
ria. Audits are usually performed using
question lists, which represent the
criteria.
Audit management means to plan and
process audits, grade the audit objects,
monitor corrective and preventive
actions that were based on the find-
ings, and document and analyze audit
data. Audit management supports all
appraisals based on predefined criteria
(audits, checks, inspections, reviews,
and examinations) and can subsequent-
ly be used to valuate the object.
is very versatile and can be used for
various application areas. Examples of
audit usages are:
Quality management (system audit,
process audit, and product audit) and
GMP
Environment management and
hygiene management
Safety and security management
(facility safety, fire safety, and data
protection)
Suitability for a wide variety of audit
usages meets the need of companies
to unify different management systems,
for example, for quality assurance,
AUDIT MANAGEMENT: FLEXIBLE TOOL
FOR PLANNING, EXECUTION,
AND EVALUATION OF AUDITS
products, while taking the relevant
standards into consideration. You can
perform any kind of review or survey,
based on checklists. Audit manage-
ment functionality in SAP ERP also
helps you fulfill legal requirements and
enables various scenarios for
benchmarking.

Audit processing
Release of the audit, invitation to par-
ticipants, provision of the documents,
examination of the audit object with
regard to the criteria (questioning and
viewing), and recording of findings
(statements and documents)
Assessment
Valuation of the criteria (question list
items), rating and grading of the audit
object, and creation of an audit report
(draft and final report with signature)
Follow-up actions
Determination of a subsequent audit;
corrective, preventive, and improve-
ment actions and the persons
responsible; monitoring of the subse-
quent steps; and verification of the
effectiveness of all actions
Analysis and evaluation
Overview of the entire audit program
or of selected groups of audits, of
audit questions and results, of find-
ings and actions as well as feedback
of audit results to audit planning
To summarize: audit management is an
intuitive, yet powerful tool that you can
use to manage your audit processes.
Regardless of your industry sector, this
tool supports you throughout the entire
audit process, from the planning phase,
through audit execution and valuation,
to the evaluation phase. This is a highly
flexible tool with open interfaces, such
as the cockpit shown in Figure 35. It
allows you to perform internal or exter-
nal audits of systems, processes, or
Figure 35: Audit Cockpit
A structured DMAIC problem-solving
road map comprising five steps define,
measure, analyze, improve, and control
is commonly regarded as the core of
every Six Sigma project. Procedures
like these can be managed readily using
Of all the ERP and dedicated QM soft-
ware solutions, SAP Business Suite is
an excellent choice for implementing
Six Sigma methodologies. In particular,
SAP ERP supports most of the ele-
ments that are essential for Six Sigma.
The Six Sigma approach to quality
improvement focuses on reducing pro-
cess variations and eliminating noncon-
formities, resulting in better quality,
lower costs, and increased customer
satisfaction.
MAPPING SAP SOLUTIONS TO
YOUR SIX SIGMA INITIATIVES
Figure 36: Sample Process According to Six Sigma
Define
Management
(Sponsor Champion)
Measure
Analyze
Improve
Control
Project Lead
(Black Belt, MBB)
Statistician
(Green Belt)
Project Member
(Inspector, Analyst)
Management of Six Sigma projects as an integrated
and structured application providing tools to achieve
breakthrough improvements
Comprehensive tools to calculate samples and
capture data for critical characteristics
Sophisticated analysis to control KPIs and monitor
continuous improvement
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.
The enterprise services supplied by
this bundle can be used by quality
inspectors, operators, and lab
technicians who are executing quality
analyses and entering inspection data
manually or transferring data from elec-
tronic test devices. It is also applicable
for production supervisors or quality
managers who want to perform analy-
sis on this data.
This bundle requires the use of QM in
SAP ERP. The services expose func-
tionality of QM business objects such
as inspection lot, physical sample, and
quality notification, and can interoper-
ate with an external QM solution.
In the future, SAP will offer additional
enterprise services in the area of
inspection planning.
For more information about enterprise
services, see the wiki documentation
at http://wiki.sdn.sap.com/wiki/x/kww
and information about enterprise ser-
vices in the Enterprise Services Work-
place site at www.sdn.sap.com/irj/sdn
/esworkplace.

level. It can be used to exchange data
between LIMS and CAQ systems and
SAP ERP directly, with more flexibility
that is provided by existing interfaces.
IQM can be used to integrate LIMS and
CAQ systems via composite applica-
tions. Integration with SAP ERP can be
achieved by using the enterprise ser-
vices provided in this bundle. SAP MII
can consume the services to enable
entry of quality data and visualization
without having external QM systems
connected.
This bundle does not supply or assume
a dedicated user interface. It is intended
as a way to integrate other applications
that provide front-end functionality.
A dedicated user-interface template
based on the supplied services could
be created using SAP MII or the Web
Dynpro development environment, the
SAP NetWeaver Visual Composer tool,
or Adobe technology.
The enterprise services bundle Integra-
tion of Quality Management Systems
(IQM) provides enterprise services for
the exchange of inspection lot data,
inspection results, and quality notifica-
tion data between SAP ERP 6.0 and
external quality management systems.
In comparison to the existing QM-IDI,
the enterprise services bundle Inte-
gration of Quality Management Sys-
tems adds the following benefits and
advantages:
New XML-based technology
(Web services)
Greater flexibility (a subset of ser-
vices can be deployed)
Enhanced functionality (quality notifi-
cations and unplanned inspection
points, for example)
The IQM enterprise services bundle
bridges data from the quality planning
level to the inspection data level and
right down to the instrument recording
SERVICE-ORIENTED ARCHITECTURE
FOR SERVICES-BASED BUSINESS
SOLUTIONS
a tightly integrated business application
suite that adds value to every facet of an
organization and the external value chain.
SAP Business Suite applications are
based on the SAP NetWeaver technol-
ogy platform, an integration and applica-
tion platform that supports the evolution
of SAP Business Suite applications to a
services-based architecture.
SAP ERP
The SAP ERP application is integrated
business management software that
includes the functionality and methods
that are needed to effectively plan and
manage a business. QM functions are
seamlessly integrated.
SAP NetWeaver
SAP NetWeaver is a Web-based tech-
nology platform that serves as a founda-
tion for SOA and enables the integration
and alignment of people, information,
and business processes across busi-
ness and technology boundaries. By
using open standards, it can integrate
with information and applications from
virtually any source or technology.
SAP NetWeaver Portal
The SAP NetWeaver Portal component
unifies the applications, information,
and services existing in an enterprise
into one platform and includes a portal,
content management, and business
intelligence.
service-oriented architecture (SOA)
SOA is a software architecture that
uses policies, practices, and frame-
works that enable application function-
ality to be provided and consumed as
services. These services are published
at a level of granularity relevant to ser-
vice consumers.
Key Terms
CAPA
Corrective and preventive action
(CAPA) is an instrument for compliance
management in terms of systematic
processing of quality deficiencies,
errors, and malfunctions. Its aim is to
document the entire process of solving
the issue and providing appropriate
corrective actions and further preven-
tive actions to avoid a recurrence of
an issue in the future.
CAQ
Computer-aided quality assurance
(CAQ) is the application of computers
and computer-controlled machines
for the definition and inspection of the
quality of products.
collaborative business
Collaborative business occurs between
companies using a regulated exchange
of information and data on the Internet.
LIMS
A laboratory information management
system (LIMS) is computer software
that is used in the laboratory for the
management of samples, laboratory
users, instruments, standards, and
other laboratory functions such as
invoicing, plate management, and work
flow automation.
SAP Business Suite
SAP Business Suite is a comprehensive
family of adaptive business applications
that provide industry-specific functional-
ity. The software is built for complete
application integration, scalability, and
collaboration over the Internet. SAP
Business Suite applications help to man-
age critical business processes and form
For More Information
To find out more, refer to the following:
For general information about the
SAP ERP application, visit the
SAP Service Marketplace extranet at
www.service.sap.com/erp (login is
required).
For general information about the
quality management (QM) functional-
ity with SAP ERP and QM as an
enterprise laboratory information
management system, visit
www.service.sap.com/qm (login is
required).
For online documentation (SAP
Library) for SAP applications, visit SAP
Help Portal at http://help.sap.com.
The following link is an example of the
online documentation available for
quality management:
http://help.sap.com/erp2005
_ehp_05/helpdata/en/a6
/df293581dc1f79e10000009b38f889
/frameset.htm.
For information about electronic
records (SAP audit trail functions,
table logging, and change docu-
ments), refer to online documentation
(SAP Library) at http://help.sap.com
/saphelp_erp2005/helpdata/EN/02
/05cce0e4b0c34cb485de7246093ce8
/frameset.htm.
For information about enterprise
services, see wiki documentation at
http://wiki.sdn.sap.com/wiki/x/kww
and go to the Enterprise Services
Workplace site at www.sdn.sap.com
/irj/sdn/esworkplace.
To coordinate visits or phone calls
with companies using SAP ERP, con-
tact your SAP sales representative.
APPENDIX
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 Benets
Increased customer satisfaction and loyalty Provide better product quality and
enhanced complaint management and tracking (corrective and preventive action)
Accelerated employee performance Increase efficiency with automated tasks that
guide employees through key steps
Greater transparency Make quality decisions based on reliable, integrated, traceable,
and accurate data
Enhanced collaboration Integrate employees and business partners in your entire
product lifecycle and the supply chain
For More Information
For detailed information about SAP ERP, visit our Web site at www.sap.com/erp or contact
your SAP representative.
50 058 498 (11/11)
2011 SAP AG. All rights reserved.
SAP, R/3, SAP NetWeaver, Duet, PartnerEdge, ByDesign,
SAP BusinessObjects Explorer, StreamWork, SAP HANA, and other
SAP products and services mentioned herein as well as their respec-
tive logos are trademarks or registered trademarks of SAP AG in
Germany and other countries.
Business Objects and the Business Objects logo, BusinessObjects,
Crystal Reports, Crystal Decisions, Web Intelligence, Xcelsius, and
other Business Objects products and services mentioned herein
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 specications may vary.
These materials are subject to change without notice. These materials
are provided by SAP AG and its aliated 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.

Sap QM

Încărcat de

Informații document

Titlu original

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Sap QM

Încărcat de

Drepturi de autor:

Formate disponibile

A comprehensive approach

S-ar putea să vă placă și