Complaint Handling With Quality Notifications Cohesion

Complaint Managementwith Quality Management within SAP ERP

Application Solution Management

Manufacturing – QM, SAP AG

Update - Cohesion, Inc.

© SAP 2008 / Complaint Management with SAP ERP Quality Notifications / Page 2

Executive Summary and Value Proposition:

Complaint Management with SAP

SAP offers a generic complaint management solution for all

industries. It can be adapted to industry-specific needs, e.g. to meet

regulatory compliance.

Quality Notifications in SAP ERP are one key element to handle quality-related complaints of all kinds (internal, supplier,

customer).

Complaint management is a very complex process, handled

individually by every customer. Resolving complaints usually requires access to data from multiple sources and application areas.

Therefore, quality notifications…

� are seamlessly integrated into SAP ERP

� are flexible and adaptive

� are service-enabled

� can be triggered in many ways

� can be evaluated with SAP NetWeaver Business Intelligence


1. Business Processes

1.1. General Process Overview

1.2. Complaint Management in the Process Industry

1.3. Complaint Management in the Discrete Industry

2. SAP Solution

2.1. Quality Notification with SAP ERP

2.2. Web-based Notifications

2.3. Reporting

3. Summary

3.1. Key Take-Aways

3.2 . Reference Activities

3.3. Outlook

Agenda


ServiceSalesProductionProcurement

Complaint Management along the Supply Chain

Complaint against

vendor

Customer

Complaint

Notification:

Defect/Damage

Internal Problem

Message


Role # 1 -

Local Call

Center Rep

Role # 2 –

Safety OfficerRole # 3 –

Investigator(s)

Role # 4 -

Management Level

pull

LOCAL OFFICE CENTRAL OFFICE

Customerloop

Qualityloop

Complaint Management –

Business Process Overview

1a

Complaint

Capture

2

Case Mgmt

a Processing

b Monitoring

3

Investigation

4c

Closure

4a

Case Resolution

4b

Fulfillment

5

CAPA

Processing

6

Reporting & Trend Analysis






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


What is Complaint Management –

Process Industries

Complaint

Submission

Complaint

CaptureComplaint

Management

Complaint

Resolution

& Closure

CAPA Investigation

Complaint Management Team

Trending, Analytics, and Reporting

In all regulatory environments, customer complaints are an

important indicator for product quality and potential compliance

issues. In life sciences, manufacturers are required to:

� Adequately investigate all customer complaints

� Maintain records about the complaint and the investigation

� Make data are accessible during inspections and audits


� Management review & approval

� Evaluate risk-impact analysis

� Assignment and routing

� Complaint tracking

� Global visibility

� Proactive monitoring and trending

� Analysis reporting and tracking

� Early warning and alerts, due date tracking

� Contact Management

� Capture complaint / Inquiry

� Complaint Triage (Classification)

� Attribute analysis

� Search related complaints

� Detailed Evaluation

� Task routing

� Touch-Points to

CAPA and LIMS as

required

� Approvals & audit log compliance to 21 CFR Part 11

� Use of Standard

libraries

� Review completed task for correction / approval

� Resolution

� Letter generation and Complaint Closure

� Fulfillment

� Audit log & records

maintenance

Complaint Management Process in DetailComplaint Management Process in DetailComplaint Management Process in DetailComplaint Management Process in Detail

Trending,

Analysis &

Closure

� The process can be applied to internal problems (deviations during the production process)

as well as external problems (customer complaints, complaints against vendors)

� Access to multiple data from the ERP system, e.g. batches, production orders, inspection

lots, are required during the investigation

� All steps of the process must be documented

Complaint

Resolution &

ClosureEvaluation

Complaint /

Management

Complaint /

Inquiry

Capture






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Quality Loop for Continuous Improvement

Corrective Action (8D)8D Report

Solution DB

Planning Realization

Preventive

Actions

Quality Circle

Production Product

� Closed Loop for Defects

Prevention and Continuous

Product- and Process

Improvement

APQP – Advanced Product Quality Planning

FMEA – Failure Mode and Effects Analysis

Analysis / Know-How / Methods


8D (8 disciplines) methodology

according to German VDA and

QS9000 is a…

� Process to solve a Problem

� Perform specific steps in a give

sequence

� Different business partners can be

involved

� Standard Method

� Based on facts / real data

� To remove the root cause

� 8D-Report

� Used as activity plan

� To document the performed steps

� Exchanged between the different

parties

8D-Methodology

Supplier Customer

Specification

Defect

detected

Ask for 8D

report

Correction

actions

Delivery

Create 8D

report

Approve 8D

report

� The 8D process is a methodology that is used for internal problem handling

as well as for customer complaints.


Customer Brand Owner Business Partners

Manufacturer

Forwarder

Claims

DepartmentMarket

Units

Customer

Complaint

Complaint

against Vendor

Clarify

Reliability

Return

Products

Rework

Internal

Problems

All types of complaints can be covered by the 8D-Methodology

� Customer Complaint

� Internal Problems

� Complaint against vendor

Advantages of the 8D-Methodology

� Systematical problem description

� Cause Analysis

� Limitation via Immediate Action

� Elimination via Corrective Action

� Exclusion via Preventive Action

Complaint Management

Using the 8D-Methodology for Discrete Industries


Usage of

SAP Solution DB

Find similar notifications

8D Analyses

Notification

Customer Complaint

Production Failure

Internal Problems

Notification

Complaint against vendor

Improvement Process in Detail

Analysis

of Problem

Analysis

Failure & Causes

Find Solution

Define Action

Execute Action

& Control

Update of

FMEA &

Control

Plan

if required






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


� Status Management

� Use of Catalogs

© SAP 2007 / Page 15

Using Quality Notifications with SAP ERP for

Complaint Management

� Workflow

� Classification

� Quality-related costs

� Follow-up actions

� Solution Database

Problem &

Complaint

Management

Corrective &

Preventive Action

� Predefined queries and key figures in SAP BI

� Evaluation cockpit for Ad hoc reporting

� Supplier evaluationQuality

Analytics


Structure of a Quality Notification

Quality Notification

Header

Tasks

Activities

Defect

Item

Partner

CausesTasksActivities


Process Flow of problem processing with

Quality Notifications

Quality

Notification

Create

Notification

Perform

immediate tasks

Process

Notification

Perform

tasks

Complete

Notification

Problem or

defect analysis

Record

activities

SAP WorkflowSAP Workflow



Elements of the Quality Notification

Status Management

Evaluations

Controlling

Nonconformity Costs

QM Costs

Workflow

Document Management

Service (DMS)

Change Records

Action Log

Classification System

Archive Link

Quality

Notification


Problem Processing with Quality Notifications

� SAP provides standard examples for activities for distinct notification types.

� The activities can be enhanced by the customer via customizing


Follow Up ActionsFollow Up Actions


Corrective and Preventive Action (CAPA) –

Processing

� Follow-Up actions can be defined for a notification

� Progress of these actions can be tracked


Creating a General Notification

� If the type of problem is not clear right from the beginning, a general

notification can be created

� The notification type can be changed afterwards

� Different views are available on the notification or task


Customizing Settings for Quality Notifications

Notification types

& parameters

Partners

Priorities &

priority types

Action box/follow-up

functions

Catalogs/catalog profiles

Response time

monitoring

Follow-up actions

for tasks

Print control

List definition

Status Profile

Field selection

Defects recording/

classification

Settings for Digital

Signature


Digital Signature for Quality Notifications(New with SAP ERP 6.0, EhP3)

Business Goal

When processing a notification within SAP ERP, digital signatures are required

for distinct steps. It is possible to provide them with status change and when

performing distinct activities at header or task level. Also signature strategies

are allowed.

Solution

� New customizing

functions for

notifications

� New functions

during notification

processing


Characteristics

Characteristics

Characteristics

Characteristics

Characteristics

Defects

Defects

Defects

Defects

Defects

Closed Loop Inspection Planning –

An Integrated Continuous Improvement Process within

SAP ERP

FMEA (Product/Process)

Control Plan

Inspection Plan

SPC

Complaints (8D-Method)

Zero Defect Production

Specification

CAD

Stamping

Characteristics

Characteristics

Available with

SAP ERP 6.0 EhP3

Available with

SAP ERP 6.0 EhP3

Quality Notification






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Web-based Quality Notifications

Notification

Processor

Creator of

Notification

Dispatcher

ITS = Internet Transaction ServerxMII = xApp for Manufacturing Integration & Intelligence

Analysis

Quality

Notification

Complete

Task

Notification

Processing

� SAP offers multiple ways to trigger a quality notification through Enterprise Services, SAP

Portal, SAP xMII and Web-Services (ITS)

� Creation of a notification using web-based templates by different sources

� Dispatcher is informed by worklist or workflow and processes notification

� Processor is informed by workflow and completes tasks and/or notification

Task


xMII

ITS


Creating a Web-Interface for Notifications

using Enterprise Services

� Enterprise Services for Quality Notifications are available with the ES

bundle “Integration of Quality Management Systems (IQM)”

� https://wiki.sdn.sap.com/wiki/x/kww


Triggering Quality Notifications from

SAP Portal (Role “Quality Inspector”)

� A quality inspector can create a quality notification from SAP NetWeaver

Portal using a service included in the role “Quality Inspector”


Triggering Quality Notifications from SAP xMII

� Example is available as part of the QM productivity pack for SAP xMII

� Download via https://www.sdn.sap.com/irj/sdn/downloads -> Templates for

Manufacturing

1111

2222

3333






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Reporting on Quality Notifications in SAP ERP

Reporting capabilities in SAP ERP

� List reports (transactions QM10 to QM19)

� Quality Management Info System (QMIS)

� QM Evaluation Cockpit (transaction QGA4)

� Extended search (TREX) available with SAP ERP 6.0 EhP 3


QM Cockpit for Evaluations

New Features

� Ad hoc evaluations of quality notifications

� New graphics types:

� Pareto Chart

� Scatter Plot


Evaluations on Quality Notifications

with SAP NetWeaver Business Intelligence

ERP Data Modell

Notification

� Partner

� Activity

� Task

� Item

� Location� Cause

� Activity

� Task

Data Extraction

Q-Notification

� PM-Notification

� CS-Notification

Info Cube

Notification

Notifications

Number of notifications

Notifications in time

Notifications outstanding

Number of tasks

Tasks outstanding

Tasks successful

Processing time

Downtime

Downtime counter

Defective Quality external

Defective Quality internal

Return Quality

Sales/Distribution

Location/EquipmentAssembly

Purchasing Org

Customer

Vendor

Notification Plant / Material

Info Cubes

� Notifications

� Notification Items

� Causes

� Tasks

� Actions


Evaluations on Quality Notifications –

wit SAP NetWeaver BI - Example


SAP Analytics –

Quality of Purchased Parts

� Visual Composer

Model for Quality

Notifications

� Based on SAP BI

content

� Released with

SAP Analytics 1.0






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Key Take-Aways:

Using Quality Notifications enables you to…

Handle all types of problems and across all industries

Define individual follow-up actions, user-defined tab strips, and

field control

Benefit from direct integration into the supply chain, e.g. to

handle return deliveries, quality-related costs or inspection lot

data for batches/serialized parts

Set up flexible reports within SAP ERP and/or SAP NetWeaver

Business Intelligence

Make use of enterprise services to create a flexible and easy user

interface






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Customer using Quality Notifications

for Complaints Handling

AUTOMOTIVE

CHEMICALS

� BASF AG, Germany

� Clariant, Germany

� Roehm GmbH, Germany

� SGL Carbon GmbH, Germany

� Sika Deutschland GmbH, Germany

� Merckle ratiopharm GmbH, Germany

� B. Braun Melsungen AG, Germany

� Solvay Pharmaceuticals B.V., USA

� Brenntag Schweizerhall AG, Switzerland

LIFE SCIENES

� BMW Manufacturing Corp., USA

� Brose Fahrzeugteile, Germany

� Continental Teves, Germany

� Grammer AG, Germany

� Modine Europe GmbH, Germany

INDUSTRIAL COMPONENTS &

MACHINERY

� Andreas Stihl AG & Co., Germany

� Briggs & Stratton Corp., USA

� HDW Howaldtswerke, Germany


Success Stories & Reference Slides

KSM Castings

Available IDES Scripts (internal use only)

Scenario ID: 010000002990

Pharmaceuticals Incidence Reporting

Life Sciences

Scenario ID: 010000000535

Internal Quality Notification

Life Sciences

Clariant VerwaltungsgesellschaftRoche Diagnostics






2. SAP Solution



2.3. Reporting

3. Summary

3.1. Key Take-Aways


3.3. Outlook

Agenda


Planned Developments for Quality

Notifications with EhP4 for SAP ERP 6.0

� Allow assignment of multiple objects, such as batches, serial

numbers, inspection lots or production orders in one

notification

� Enhance usability in sending mails from within a notification

and attaching documents.

� Including usage of mail distribution lists based on task responsible

people.

� Improve selection screens and result lists for notification-

related worklists (QM10-QM19).

� Allow multiple selections of partner roles.

� Allow display of additional information in the lists.

DISCLAIMER: These slides reflect current planning. Contents may be changed without prior notice, and are in no way binding upon SAP.


Thank you!


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Complaint Handling With Quality Notifications Cohesion