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OLDP – Project

Learnings and
Recommendations
Ellese Petty
August 2017
Restricted © Siemens Healthcare GmbH, 2016
About me – Ellese Petty

• Senior Biomedical Engineer at Rose-Hulman Institute of Technology


• Past internships with Ambu, and Hope Haven Horse Farm
• Verification/Validation activities
• Designed and Tested devices to aid disabled children ride horses
• Hobbies: Volleyball, Roller blading, and Knitting

Petty| Quality
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OLDP/Petty Project #1
In Process Testing - Mishawaka

Current State: In-process testing lacks statistical


based sampling plans

Show example from PMP where testing is once


per hour (DCA cartridge appearance)

Petty| Quality
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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:

• IMTM team will use data to formulate


statistically based sampling plans based on
AQL/RQL data provided

Petty| Quality
Page 5 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #2
Dock to Stock

We Lead by Being LEAN

Dock to Stock Opportunities:


• Reviewed re-control history of several materials –
• How many times it has been re-controlled
• How many times it passed re-control
• If the data met requirements in SOP 90-20-0051 for dock to stock approval,
completed recommendation form for approval

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

Current process has no scientific rationale


regarding requirements for raw material
acceptance or re-control acceptance

Petty| Quality
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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

If recommendations are taken, the process will


be lean and technically based for acceptance of
raw materials

Petty| Quality
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OLDP/Petty Project #4
Calibration - Mishawaka

A MASSIVE amount of calibrated


equipment

• Created list of all active assets in


Mishawaka– included owner, location
on CERDAAC, and calibration and pm
interval
• ?? pieces of calibrated equipment

Petty| Quality
Page 10 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka

How to Streamline Based on Risk Assessment?

• Determined quality relevance per DQSP-00021-


A2
• Recorded amount out of tolerance cases and
adjustments over ~2 year period

Petty| Quality
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OLDP/Petty Project #4
Calibration - Mishawaka

Risk Assessment

• Met with asset and process owner to


determine process usage
• Discussed how OOT would impact
product or process

Petty| Quality
Page 12 | Restricted © Siemens Healthcare GmbH, 2016
OLDP/Petty Project #4
Calibration - Mishawaka

Status:

• Calibrations reviewed and assessed

• Recommendations have been made to


calibration status (i.e. calibration or
maintenance) and service interval

• X number of change requests have been


written
Petty| Quality
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OLDP/Petty Project #5
X-Samples for Microalbumin/Creatinine

• Joined x-sample team prior to test method characterization (TMC)


• Assisted in development of the TMC plan
• Responsible for calculating pump adjustments needed for each of the 9
experimental runs
• Observed manufacturing process during TMC; assisted with weighing of
reagents during the TMC runs
• Reviewed TMC data with team
• Recommended new process limits for MAC reagent weight dispense

Status – Test method validation approved by CRB


Petty| Quality
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OLDP/Petty
Lessons Learned

• Question why something is done

• Be willing to put in time and effort now to save more time and money later

• Don’t be afraid of change

Petty| Quality
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OLDP/Petty
Recommendations and Suggestions

• Benefits of career coaching

• 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!

Restricted © Siemens Healthcare GmbH, 2016

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