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TRANSCRIPT
3/11/2015
Products Solutions Services
Calibration Management
Slide 1
3/11/2015
Calibration Management cornerstones
Calibration Management
Calibration
Management
Defined Criticality
Classification
and Tolerance
1
Technically Valid
Calibration Procedures
2
Competent
Calibration
Personnel
4Traceable
Reference Standards
3
Slide 2
3/11/2015
Calibration Management Process
Calibration Management
Slide 3
Calibration Management
Process trigger
Clear and consistent management
of calibrations
Ensure quality & sustainability
on instrumentation
Input:
Calibration Workorder
Maintenance responsible
/ QA
Output:
Calibration Certificate
Receiver:
Maintenance
Strategy
Target
Scope
Maintenance responsible /
QA
Sender:
Superior Process
Planning &
schedulingExecutionAssigning
Validation
/ verifyReporting
3/11/2015
Calibration Management
SAP-PM
Maximo
Infor
CompuCalInstrument specific
centralized information
Work-order System
Calibration Management
MANAGEMENT
QUALITY DEPT.MAINT. DEPT.OPERAT. DEPT.
Slide 4
Departments using different Systems
Documentation Management
W@M
3/11/2015
Calibration Management
CompuCal
Calibration Management
Slide 5
Calibration Management
3/11/2015
CompuCal operation
Set Up of CompuCal
DDe / SSO PAMSlide 6
3/11/2015
Calibration Management System - CompuCal
CMS Workflow
KPI - Dashboard
3/11/2015
Calibration Management
Key features of CMS CompuCal• Management/Execution
• Plan and schedule PM Routines and (not only Calibrations)• SOP and Safety statement management• Enterprise version or Web based solution (Proven 128 bit security)• Automatic tracking of deviations & corrective actions – email alerts• Reference instruments – planning and scheduling
• Documenting/Traceability• Full time and date stamped audit trail• Issues certificates as defined by ISO17025 and deviation reports • Extensive reporting • KPI dashboard available to keep track on results and improve• Issues work orders and reports as defined by maintenance personnel• Compliant with the requirements of 21 CFR Part 11 for electronic signatures and electronic records
• Integration – GO PAPERLESS!• Prepared to integrate mobile calibrators – e.g. Fluke• Open for integrating with other systems – e.g. SAP/Maximo/MP2• Documentation Management W@M integration
Slide 8
3/11/2015
Calibration Management
Instrument specific
centralized information
Slide 9
Documentation Management
Documentation Management
W@M
3/11/2015
¹Studies in maintenance consistently show a 30 to 40 percent efficiency gap due to poor
information management…
“Information is Key but documentation is Pain”
Calibration Management
Slide 10
• User manuals• Specification sheets• Technical information• Safety statements• Product Status• Parameter Settings• Supplier specific events• Calibration data• Certificates• …• Software versions• Spare part information• Drawings• …
¹Excerpted from: ARC Strategies, Sid Snitkin, January 2010
3/11/2015
Asset Information integrated in one central place
W@M Life Cycle Management
PC= Product CenterSC= Service & Sales Center
CER
Serial#Flow
Pressure
Level
Temperature
Analysis
Slide 11
Endress+HauserSales center• Maintenance reports• Calibration reports• Service reports• Repair reports• Inspection reports
within maintenance orcalibration contracts
Endress+Hauser Product center• Tag number• Serial number• Order code• Manuals• Certificates• Purchase infoEvents:• Production info• Calibration info• Repair info
Endress+HauseriDatabase
3/11/2015
Calibration Management
Instrument info and Product Status
Calibration Certificate
Spare Parts, info and Pictures
INFORMATION AUTOMATICALLY PRESENT! A few examples:
Commissioning Service Report
Slide 12
3/11/2015
Calibration Management
SAP-PM
CompuCalInstrument specific
centralized information
Work-order System
Calibration Management
MANAGEMENT
QUALITY DEPT.MAINT. DEPT.OPERAT. DEPT.
Slide 13
How do we make this work?
Documentation Management
W@M
3/11/2015
Calibration Management
Service results from:
- Customer (CMMS)
- E+H (CompuCal)
Manual Field Calibration
Calibrator
XYZ
Automated
Field Calibration
Any
System
Middleware
- SAP-PM
CompuCalAsset update
for audit trail
KPI update
In dashboard
Update Work
order data
Calibration
Work order
Import WO
into Calibrator
Export results
to CompuCal
Calibration Integration ExampleImprove efficiency/Reduce errors
Calibration
executed
& Managed
Work-order System
Calibration Management
CompuCal
Handheld Device
Slide 14
Instrument specific
centralized information
Documentation Management
W@M
3/11/2015
Check Device Information in SAP with W@M integration
CMS Workflow
Check device information with W@M Integration within the work order
Documentation system W@M Integration in SAP!
Slide 16
3/11/2015
Calibration Management
Calibration management integration value
Slide 17
• Ensured quality & sustainability on all assets by…
• Providing clear and consistent management of calibrations
• Paperless solution to get more efficient calibration management with less errors
• Integrating into the current Maintenance business process (SAP)
• Using a 21 CFR Part 11 compliant solution which ensures quality
• Having a full date and time stamped audit trail
• Having all information stored in the Asset Information Management system
• Proving the consulting to get a perfect tuned solution for operator’s business process• Process Workshop + Functional Design Specification workshop
• Providing the services to implement it as a turn-key working solution• Installed Base Data Collection + SOP writing• Installation/Configuration• Data Migration• ERP and Calibrator integration
3/11/2015
Calibration Management
Project – with timelines
Slide 18
3/11/2015
Calibration Management
Thank You!
Slide 19
3/11/2015
Process Workshop – 18+19 December 2014
Asset Information workflow improved.
Before: After:
Removed
Slide 20 M. van Veen
3/11/2015
Process Workshop – 18+19 December 2014
Agenda – 18 December 2014
Slide 21 M. van Veen
3/11/2015
Process Workshop – 18+19 December 2014
Agenda – 19 December 2014
Slide 22 M. van Veen