60 LONG RIDGE ROAD > SUITE 403 > STAMFORD, …...Integration of SAP PM and QM QM Inspection Lot functionality used extensively for material testing and analysis – both raw materials

Real. World. Experience. www.vestapartners.com

VESTA QMCSAP Calibration

Real. World. Experience.

AGENDA

IntroductionsOverview of calibration in standard SAPOverview of Vesta QMCDemoQ&A


INTRODUCTIONS

VESTA

Vesta Partners provides its customers with industry best practices in business process, brought to life through proven Enterprise Asset Management (EAM) technology applications. Vesta’s mission is to deliver the highest quality, most efficient maintenance process and technology consulting solutions to our clients. Our real world experiences and practical solutions deliver results that directly translate into efficiency improvements and real cost savings.

Vesta ContactsPeter Möbert Director, Software Products

[email protected]

Silvio Somers Director Sales, Europe Middle [email protected]


SAP CALIBRATION FUNCTIONALITY

Integration of SAP PM and QMQM Inspection Lot functionality used extensively for material testing and analysis – both raw materials and final product.In PM, inspection lots from QM are used for calibration data of test equipment.Inspection characteristics define individual parameters to be tested.Inspection lots are groups of inspection characteristics, that are assigned to work orders (and task lists), results are recorded, and compared to specifications.Results recording enters raw data for inspection lots.Usage decision evaluates results and ranks the calibration result based on predefined criteria.Follow up actions (notification creation for equipment replacement or repair, time confirmation, equipment status or work flow for email) can be defined based on usage decision ranking.


One system for corrective, preventive and calibration ordersAbility to enter more data points than measuring pointsUse SAP maintenance plan engineUse and schedule SAP resources

• Work Centers• Materials• Documents

Standard SAP transactions for work control available to managementSAP records cost and calibration history for analysis and reportsInspection lot with required readings printed with work order shop papers

Use of calibration test instruments tracked using serialization or equipment numbers providing linkage from test instrument to field instrument to production resource to production lotCalibration data entered directly into SAP.SAP evaluates allowable data rangesSAP generates usage decision based on data entryFollow up actions can be defined for usage decisionsResults and validity dates can be entered in equipment classes and characteristicsWork flow (with email) can be triggered by usage decisionsStandard SAP statistical analysis on entered data

BENEFITS OF USING CALIBRATION TYPE WORK ORDERS


VESTA QMC

Quality Management CalibrationSAP Certified Add-OnSupplements QM and PM functionalitySupport FDA compliant industriesRobust and user friendly

• Plan, capture and report calibrations across enterprise

• Ensures calibration data is traceable and auditable for compliance

Record STANDARDS usedQMC Data Sheet – New master data object


QMC DATA SHEETS

New Master Data objectActs as a templateOne or more assigned technical objects (Equipment or Functional Location)Represents one more operations (Functions) related to calibration process

• Example – Scale Calibrationo Weight

Low Weight High Weight

o Temperature Low Temperature High Temperature

Upper and Lower tolerance values for each stepInstrument and Calibration rangesPlausibility Limits and Calculation typesAdjustment Limits and Calculation TypesProcess Limits and Calculation TypesOne or more reading types, Input values and expected output values


VESTA QMC BENEFITS

Recording of Lab StandardsReading Type

• As Found• As Left

Equipment Characteristics updates• Calibration Due Date• Last Calibration Date

“Spot Check”• STANDARD’s reading vs Actual Reading

Linear CalculationsMass creation

• Data Sheets• Equipment Assignment

Calibration CertificateDigital Signature


STANDARD SAP CALIBRATION

Step 1• Create equipment master record

Step 2• Master Inspection Characteristics (MIC)

Step 3•Assemble master inspection characteristics into a task list for an instrument with a specific span

Step 4•Create maintenance plan for instrument (equipment record).

Step 5•Schedule maintenance plan, call work order

Step 6•Enter results from calibration into inspection lot

Step 7•Enter usage decision for inspection lot


STANDARD SAP CALIBRATION

Step 1 • Create equipment master record

Step 2• Master Inspection Characteristics (MIC)

Step 3• Assemble master inspection characteristics into a task list for an instrument with a specific span

Step 4• Create maintenance plan for instrument (equipment record).

Step 5• Schedule maintenance plan, call work order

Step 6• Enter results from calibration into inspection lot

Step 7• Enter usage decision for inspection lot

Steps 2-4 Results in:• Many Task Lists for each instrument type and range for that equipment (0-10

grams, 5-150 grams etc)• Gets very confusing• Cumbersome


VESTA QMC CALIBRATION

Step 1• Create equipment master record

Step 2• Assign QMC class with specific Data Sheet characteristics

Step 3• Create Data Sheet and assign all related equipment

Step 4• Create maintenance plan for instrument (equipment record), referencing generic

QMC task list

Step 5• Schedule maintenance plan, call work order***

Step 6• Enter results from calibration into inspection lot

Step 7• Enter usage decision for inspection lot

Step 8• *Record Standards used

*** Master inspection characteristics are assembled into an inspection lot ‘ad hoc’ controlled by the data sheet rather than through the task list


USING VESTA QMC – QMCCHARACTERISTICS

Use of characteristics linked to equipment master record to track calibration

Calculated by Vesta QMC:• Calibration Due Date• Last Calibration Date


USING VESTA QMC

Use of data sheets to simplify assembling inspection characteristics for a test

Assign data sheet to multiple equipmentRecords, or functional locations


VESTA QMC ENHANCEMENT

Documenting standards used for calibration


QMC REPORTS

Calibration Certificate - /N/VESTA/QMC_CERT• customizable SmartForm

Traceability Report –/N/VESTA/QMC_TRACE• Determine which Standard used for which calibration

Equipment in Data Sheet- /N/VESTA/DS_EQUIP_DS• Which equipment used by which Data Sheet

Data Sheet Upload - /N/VESTA/DS_UPLOAD• Mass upload Data Sheets and equipment information • Initial setup• Mass modification

Audit log - /N/VESTA/QMC_AUDIT• Changes by timestamp


ADDITIONAL QMC FEATURES

Reading Point Specific sequences• New Calculation Type• Custom per reading

Linear Calculation• Output calculated based on input and output ranges

Guard Banding• Adjusting test limits lower than Specification limits • Limit False-accept and False-Reject


READING POINT SPECIFIC

Allows for granular control down to the individual readingsStandard: Plus/Minus Input’s reading

Reading Point specific


READING POINT SPECIFIC –INSPECTION LOT

Standard

Reading Point Specific


LINEAR CALCULATION


LINEAR CALCULATION – RESULT RECORDING


GUARD BANDING

Amount that minimum product specifications are increased to ensure that even with measurement uncertainty the product meets the minimum specifications with a specified level of confidence.Setting test limits lower than Specification limitsAdjustments factoring in measurement errors

FailIndeterminate -

FailIndeterminate -Pass

Pass

FailIndeterminate -

Fail

Indeterminate -Pass

Pass

Nominal Value

Upper Guard Band

Upper Tolerance

Lower Guard Band

Lower Tolerance

Fail

Fail


GUARD BANDING –CHARACTERISTIC ON EQUIPMENT


GUARD BANDING

Calculation• Tolerance = ( Upper - Lower ) / 2.• Mid Point = Lower + Tolerance.• New Lower = Mid Point – (Tolerance * Guard band ).• New Upper = Mid Point + (Tolerance * Guard band).

For example:• Guard Band % = 50%• Lower Limit = 95• Upper Limit = 105• Tolerance = (105 – 95) /2 = 5• Mid Point = 95 + 5 = 100• New Lower = 100 – (5 * 0.5) = 100 – 2.5 = ~98• New Upper = 100 + (5 *0.5) = 100 +2.5 = ~103


LINEAR CALCULATION –INSPECTION LOT


DEMO


Q&A