QM 101 - Using SAP QM to Meet the Requirements

of a Global Quality Management System

Ray Tucker
Tucker.ray@basco.com

Mike Krug
mkrug@qmsinc.com

Agenda

The Basics
Overview of QM
QM Master Data
Inspection Processes
Quality Notifications

And Beyond
Dynamic Modification
Lot Copy/Inheritance
Test Equipment Integration
SPC Charts & Reporting

About QMS

Largest Pure Play QM & Manufacturing Consulting Company in
North America

Unparalleled experience in SAP Quality Management

Focus on using SAP to meet Quality & Regulatory

Deep Industry Experience

Discrete Industry
Medical Devices
Semiconductor & High Tech Electronics
Aerospace & Defense

Process Industry
Consumer Products, Food
Pharmaceutical & Biotech
Chemical & Industrial

Why Implement Quality Management ?

Sample Drivers for Implementing SAP QM

Re-calls / Returns of failed product

Difficulty in calculating Quality metrics (KPI)

Meet regulatory and customer requirements

Standardize specifications across manufacturing sites

Improve traceability of products

Integrate Quality into the supply chain (via the ERP system)

Save on separate licensing/support costs, retire legacy systems

Eliminate paper forms, spreadsheets, local systems.

Standardize and automate QM Process across Plants & Divisions

Better Quality Metrics


If you cant measure it; you cant manage it!

Quality Management with SAP ERP

4 Main Pillars

Audit
Management

Quality
Engineering

Quality
Assurance &
Control

Quality
Improvement

Supplier audits

Specifications

Sample &
Batch Management

Product audits

Sampling plans

Corrective &
Preventive Actions
(CAPA)

Process audits

Document
management

System audits
Environmental
audits
Assessments/
Revisions

Quality Control
Statistical
Process control

Stability studies
Failure mode &
Effects Analysis

Problem handling

Complaint
management
Quality
analysis

Certificates

Control Plan

SAP ERP

SAP QM Functionality
Supporting Processes with LIMS functions and more
Ad Hoc Reporting

Interfaces (QM-IDI, QM-STI)

Audit Management

Inventory Management

Batch Management

Invoicing/Billing

Barcode / Labeling

Non-conformance Reporting

Calibration Management

Quality Data Interchange

Certificates of Analysis

Quality Disposition

Complaint / Problem / Event Management

Recurring Inspection

Corrective and Preventive Action (CAPA)

Sample Management

Digital Signature / GMP

Specification Management / Multiple Specs.

Document Management

Stability Management

Engineering Change Management

Statistical Process Control (SPC)

Goods Receipt Inspection

Test Equipment Interfacing

In-Process Control / Post-Process Control

Vendor Evaluation

Inspection Methods

Workflow

QM Flexible and Powerful

Use as much or as little as you need

Generic QM
Post to QI bucket (Can be used without using QM module)

Easy QM
Some control via posting to QI via an Inspection Lot
No results recording, stock managed via inspection lot and usage
decision

Standard QM
Post to QI via an Inspection Lot using an Inspection Plan for
specifications
Requires Characteristic Recording
COA Generation

Complex QM
Pos to QI via an Inspection Lot with an Inspection Plan using Sample
Management, Sample Calculation, SPC, Dynamic Modification, Defects
Recording, etc, etc, etc

QM Where does it fit in SAP?

Integrated throughout Logistics supply chain

Inventory Management (stock status, blocking)
Purchasing - Vendor Eval., Audits, Incoming Certs.
Receiving Inspection
Production - In Process data collection, defects
Sales & Distribution - Ship QA, outgoing Certs.
Accounting - costs due to scrap, inspection, etc.
Plant Maintenance - gauge calibration / control
Central Functions - Document Management, Batch
Management, Classification

QM Master Data

Inspection Methods
Typically are used as a reference to a procedure

Master Inspection Characteristics

An inspection characteristic is a test that has been defined for
frequent use (standardization) or reporting across inspection
plans (global reporting)

Inspection Plans
Used to describe how a quality inspection should be performed,
specifically what tests at what specification

Inspection Types
Activated in the QM view of the Material Master control where
SAP will provide Quality Assurance by stopping the process until
the QM requirements have been met

QM Process Overview

Customer
Purchasing
& QM info
records

Material
Master

Work
Centers

Inspection
Plan

Vendor
Logistics
Processes:
MM, PP, SD
orders and
material
movements

Method
PRTs
Master
Inspection
Characteristic

Code
Group
Codes
Sel.
sets

Sampling
Procedure

Dynamic
Modification

Inspection
Lot

QM Planning

Sampling
Scheme

Quality
Level

QM Processing

Results
Recording
Vendor
Evaluation

Usage
Decision

QMIS

BI

QM Evaluation

The QM Process Quality Inspection

Inspection Lot
1
Benefits
Standardized process and flows

Results
Recording

No duplicate data entry

4
Usage Decision
& Reporting

Eliminate paper files

Reduce Inspection time
Reporting and Trends
Compliance

3
Defects Recording &
Notification

Quality Notification Cycle

Structure of a Quality Notification in SAP

Q. Notif
Header

Partner
Org. Structure
User
Vendor

Tasks

Activities
From Action Box
Nonconformance
Item

Causes

Tasks

Activities

Header

Item

Tasks

Email & Workflow

Action Box: attachments

QMIS Defects

QM Evaluation Cockpit

Pareto Chart
to show
defect
frequencies

QIM A Web Based Look and Feel

QM 101 Dynamic Modification

Typically referred to as Skip lot processing

Can be at the Inspection Lot or Inspection Characteristic
level

Uses Quality Levels to maintain history on skip and
inspection statuses

Special statuses assigned when it is a Skip

Standard functionality exists to print Skipped characteristic
on the COA

Characteristic Filter on Results Recording screens can be
used to not display Skip characteristics

QM 101 Dynamic Modification

QM 101 Dynamic Modification

QM 101 Lot Copy/Inheritance

Functionality exists to inherit test results from a previous

inspection lot to the current one

BADI QC_LOT_COPY provided as of SAP release 4.7 SR2.

New configuration activity provided to allow lot copy to be
turned on for a plant/inspection type combination

Lot copy functionality can be manual or automatic at time of
lot creation or results recording

Custom code can be added to find inspection lots, or map
the characteristics from one lot to another

QM 101 Lot Copy/Inheritance

QM 101 Lot Copy/Inheritance

Transfer of Results from Test Equipment

Can be triggered manually or automatically using the

program
Data is transferred to QM results recording via a serial
interface (V24) in the form
of electronic signals (one channel)
Programming: Driver software is required
Example: Electronic scales
MII
Wedge, Web Services, etc.

Results Recording SPC Chart

QM Results History

Run Chart

Download to Excel
Histogram

QMIS Histogram & Statistics

Dashboarding

THANK YOU FOR PARTICIPATING

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SESSION CODE: 6553
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Ray Tucker
Tucker.ray@basco.com

Mike Krug
mkrug@qmsinc.com