Академический Документы
Профессиональный Документы
Культура Документы
Learnings and
Recommendations
Ellese Petty
August 2017
Restricted © Siemens Healthcare GmbH, 2016
About me – Ellese Petty
Petty| Quality
Page 2 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #1
In Process Testing - Mishawaka
Petty| Quality
Page 3 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #1
In Process Testing - Mishawaka
Actions
• Analyzed the data for DCA and Atlas in process
tests –
• Reviewed batch records
• Counted failures
• Calculated streak lengths
• Reviewed process risk in pFMEA
• Calculated AQL and RQL in Minitab
• Reviewed AQL and RQL against guidance in
DQSP-00054-G1 for process validation
Petty| Quality
Page 4 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #1
In Process Testing - Mishawaka
Status:
Petty| Quality
Page 5 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #2
Dock to Stock
Data collection for this project discovered the gaps in the incoming/re-control
Petty| Quality
process in Elkhart Page 6 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #3
Elkhart Incoming Material and Re-Control Testing
Petty| Quality
Page 7 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #3
Elkhart Incoming Material and Re-Control Testing
Actions
• Reviewed current process
• Performed gap analysis of vendor COA
requirements and current Siemens testing
requirements
• Met with cross-functional team (Materials,
Tech Ops, QA, Manufacturing) to determine
priority of materials to apply science based
testing protocols for incoming and re-control
acceptance
Petty| Quality
Page 8 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #3
Elkhart Incoming Material and Re-Control Testing
Status:
• Presented recommendations to technical
team
• Technical team in process of creating and
implementing quality plan for incoming and
re-control process
Petty| Quality
Page 9 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka
Petty| Quality
Page 10 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka
Petty| Quality
Page 11 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka
Risk Assessment
Petty| Quality
Page 12 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka
Status:
• Be willing to put in time and effort now to save more time and money later
Petty| Quality
Page 15 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty
Recommendations and Suggestions
• Pre-Arrival Suggestions:
• Introduce all OLDP candidates via email prior to arrival
• Allows for getting to know each other, network, familiar, friendly face in the
new crowd
• Allows for candidates to synergize housing/travel arrangements
Petty| Quality
Page 16 | Restricted © Siemens Healthcare GmbH, 2016
Thank you!