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    SAP QM 101 WebcastIntro to SAPs Quality Module

    Carl Dunlap Mike [email protected] [email protected]

    January 17, 2008

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    Speakers

    Speaker Biographies:

    Carl Dunlap is the President ofCohesion, Inc. - an SAP Services company focused on

    software & services for the Life Sciences Industry. Carl has 14 years of experience with

    Enterprise Applications, including 13 years of SAP Quality Management (QM)experience. Carl has also worked as a Senior Business Development Manager for

    Plumtree Software. Prior to Plumtree, Carl held the position of Business Development

    Manager for BrightStar's SAP ERP practice. Carl came to BrightStar through the

    acquisition of TBQ Associates, Inc. where he was the co-founder.

    Michael Krug is the President ofQuality Management Solutions (QMS). QMS is a

    niche consulting company focusing entirely on SAP's Quality Management module. He

    is a recognized expert of SAP QM and has over 11 years of consulting experience

    focusing on delivering QM solutions to customers in a wide variety of industries. He

    has developed a special focus on calibration and was instrumental in implementing thefirst pharmaceutical calibration implementation.

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    QM 101 Webcast

    QM 101 Agenda

    What is QM? Why QM?

    Project Drivers

    QM Integration Points (Where does it fit?) Inspection Types

    A Working Example (DEMO)

    QM Master Data (How we made that work)

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    QM 101 Webcast What is SAP QM?

    A complete quality management solution that provides

    Quality Assurance and Quality Control throughintegration (an end to end solution)

    A Hidden Gem you already own with Core SAP ERP

    Enterprise LIMS System

    Ask yourself why not SAP QM before you buy somethingelse

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    Why?

    Improve Quality of your Products Integrate Quality functions within your business

    Better Quality Metrics

    If you cant measure it, you cant manage it

    Support Six Sigma and Black Belt Initiatives

    Increase visibility across Supply Chain

    Everybody cant be on the shop floor

    Why QM?

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    Sample Drivers for Implementing SAP QM

    Re-calls / Returns of failed product Difficulty in calculating Quality metrics (KPI)

    Meet regulatory requirements (i.e. FDA)

    Officers/Directors can be liable

    Improve traceability of products

    Integrate Quality into ERP system

    Save on separate licensing/support costs

    Eliminate paper forms, spreadsheets, local syst.

    Standardize and automate QM Process acrossPlants & Divisions

    Project Drivers

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    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, BatchManagement, Classification, Engineering Change

    QM Where does it fit in SAP?

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    QM Flexible and Powerful Using QM at varying levels of complexity

    Generic QM

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

    Easy QM

    Some control with 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

    Extended QM Post to QI via an Inspection Lot with an Inspection Plan using

    Sample Management, Sample Calculation, SPC, DynamicModification, Defects Recording, etc, etc, etc

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    QM Integration Points

    QM Integration

    Points

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    QM Integration Points

    QM Inspection Types MM

    01 Goods receipt insp. for purchase order 0101 - Model inspection at GR for purch. Order

    0130 - GR inspection from external processing

    07 - Audit inspection for a vendor

    08 - Stock transfer inspection

    0800 - Insp. lot with insp. stockat QM actvtn

    09 - Recurring inspection of batches

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    QM Integration Points

    QM Inspection Types PP

    02 - Goods issue inspection 03 - In-process insp. for manufacturing order

    04 - Goods receipt inspection from production

    05 - Inspection for other goods receipt

    13 - In-process insp. for repetitive mfg

    89 - Other inspection

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    QM Integration Points

    QM Inspection Types PM

    14 - Inspection in Plant Maintenance 16 - Inspection for Storage Condition (Stabi)

    1601 - Initial Test (Stability Studies)

    1602 - Manual Insp. Lot for Storage Cond (Stab)

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    QM Integration Points

    QM Inspection Types SD

    06 Customer Returns 10 - Insp. for delivery to cust. (w/ order)

    11 - Insp. for delivery to cust. (w/o order)

    12 - Inspection for delivery in general

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    QM Cycle (How does it work?)

    Planning

    Processing

    Evaluation QM

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    Goods Receipt for P.O.

    Defects

    Recording &

    Notification

    Usage Decision

    & Reporting

    Results

    Recording

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    22

    33

    44

    QM Demonstration

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    11

    Goods Receipt for P.O.

    Automatic creation of Inspection LotQuality Inspection StockAuto Select Inspection PlanCalculate Sample Size

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    11

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    Results

    Recording

    Goods Receipt for P.O.

    Qualitative Results

    Quantitative Results

    SPCElectronic Signature

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    11

    22

    33

    Defects

    Recording &

    Notification

    Goods Receipt for P.O.

    Results

    Recording

    Defects RecordingQuality Notification

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    11

    22

    33

    44

    Usage Decision

    & Reporting

    Goods Receipt for P.O.

    Results

    Recording

    Defects

    Recording &

    Notification

    Final signoff by QualityIntegrated Stock PostingQMIS

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    Goods Receipt for P.O.

    Defects

    Recording &

    Notification

    Usage Decision

    & Reporting

    Results

    Recording

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    22

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    Benefits

    Standardized process and flows

    No duplicate data entry

    Eliminate paper files

    Reduce Inspection time

    Reporting and Trends

    Compliance

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning: inspection plan

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    Inspection

    Characteristic

    Dynamic

    Modification

    Purchasing

    & QM inforecords

    Method

    InspectionPlan

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning -Processing: Logistics

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    Inspection

    Characteristic

    Dynamic

    Modification

    Inspection

    Plan

    Logistics

    Processes:

    MM, PP, SD

    orders and

    material

    movements

    QM Processing

    Purchasing

    & QM inforecords

    Method

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning - Processing: Inspection lot

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    InspectionCharacteristic

    Dynamic

    Modification

    Inspection

    Plan

    Logistics

    Processes:

    MM, PP, SD

    orders and

    material

    movements

    QM ProcessingInspectionLot

    Purchasing

    & QM inforecords

    Method

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning - Processing: Results

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    InspectionCharacteristic

    Dynamic

    Modification

    Inspection

    Plan

    Logistics

    Processes:

    MM, PP, SD

    orders and

    material

    movements

    QM ProcessingInspection

    Lot

    Results

    Recording

    Purchasing

    & QM inforecords

    Method

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning - Processing: Usage decision

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    InspectionCharacteristic

    Dynamic

    Modification

    Inspection

    Plan

    Logistics

    Processes:

    MM, PP, SD

    orders and

    material

    movements

    QM ProcessingInspection

    Lot

    Results

    Recording

    Usage

    Decision

    Purchasing

    & QM inforecords

    Method

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    Work

    CentersPRTs

    Material

    Master

    Vendor

    QM Planning

    QM Planning--Processing--Evaluation

    Customer

    Code

    Group

    Codes

    Sel.

    setsMaster

    InspectionCharacteristic

    Dynamic

    Modification

    Inspection

    Plan

    Logistics

    Processes:

    MM, PP, SD

    orders and

    material

    movements

    QM ProcessingInspectionLot

    Results

    Recording

    Usage

    DecisionQMIS QM EvaluationVendor

    Evaluation

    Purchasing

    & QM inforecords

    Method

    BI

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    Next Steps:Contact us to help you get started on SAP QM

    Demonstrations of additional functionality in QM that maybenefit your company (WebEx or in-person)

    Quality Notifications Gauge Calibrations Digital Signatures Certificates of Analysis

    SPC Custom tailor a QM prototype for your company(in your SAP Environment, with your data)

    Help you get business buy-in

    Email: [email protected]

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    Questions?