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SEVER HALL CONSULTING GROUP
Instrumentation LaboratoriesMedical Device Manufacturing
Process
December 9, 2010
Presented by:Sever Hall Consulting Group
Rita DistelDustin EspositoKathryn Holmes
Winston KuoMichael Snitkovsky
Davide Zocco
SEVER HALL CONSULTING GROUP
Instrumentation Laboratory (part of Werfen Group)• Headquartered in Bedford, Massachusetts.• Founded in 1959 has operations worldwide.• Market leader in diagnostic instruments for real-time blood
testing - 40% market share.• Primary stakeholders are hospitals.• Innovative technology - GEM Premier 4000 cartridges.• 285,000 GEM 4000 cartridges projected to be sold in 2010.
Background
SEVER HALL CONSULTING GROUP
Background:GEM 4000 cartridges are used during surgery to measure
patients physiological parameters and provides real-time information to a surgeon.
Scope:Identify the root cause of the source(s) of fiber
contamination of cartridge.Propose solution(s) to mitigate fiber contamination.
Project Scope
SEVER HALL CONSULTING GROUP
Impact of defective cartridge
Actual incident:10/16/2010: Infant at local hospital was
intubated due to a cartridge malfunction – improper/inaccurate Oxygen reading.
Cartridge evaluation:Fiber contamination on Oxygen sensor.
SEVER HALL CONSULTING GROUP
Impact of Fiber Contamination
Cartridges returned by costumer (35%)
Cartridges manufactured/yr: 285,000Defective cartridges/yr: 99,750Defective cartridges due to fiber contamination/yr: 24,938 Loss: $ 2M/year
$80.20/cartridge
SEVER HALL CONSULTING GROUP
Stakeholders
SEVER HALL CONSULTING GROUP
Name Interest Influence
Project Support(Verbally)
Project Support(Actions)
Project Support(Desired) Expectations
Ways to Manage Expectations
MichaelProject Manager High High Strong Strong Strong
Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.
MarkDirector of Operations
High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
DougVP of Operations
High High Strong Weak StrongProvide financial backing and influence from company owners
Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study.
Werfen GroupParent Company, Sponsor
High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.
Name Interest Influence
Project Support(Verbally)
Project Support(Actions)
Project Support(Desired) Expectations
Ways to Manage Expectations
MichaelProject Manager High High Strong Strong Strong
Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.
MarkDirector of Operations
High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
DougVP of Operations
High High Strong Weak StrongProvide financial backing and influence from company owners
Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study.
Werfen GroupParent Company, Sponsor
High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.
Name Interest Influence
Project Support(Verbally)
Project Support(Actions)
Project Support(Desired) Expectations
Ways to Manage Expectations
MichaelProject Manager High High Strong Strong Strong
Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.
MarkDirector of Operations
High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
DougVP of Operations
High High Strong Weak StrongProvide financial backing and influence from company owners
Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study.
Werfen GroupParent Company, Sponsor
High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.
Name Interest Influence
Project Support(Verbally)
Project Support(Actions)
Project Support(Desired) Expectations
Ways to Manage Expectations
MichaelProject Manager High High Strong Strong Strong
Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.
MarkDirector of Operations
High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
DougVP of Operations
High High Strong Weak StrongProvide financial backing and influence from company owners
Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study.
Werfen GroupParent Company, Sponsor
High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.
Name Interest Influence
Project Support(Verbally)
Project Support(Actions)
Project Support(Desired) Expectations
Ways to Manage Expectations
MichaelProject Manager High High Strong Strong Strong
Plan, schedule and coordinate detailed phases of the engineering work in a multi-departmental initiative to reduce manufacturing variability and increase quality.
MarkDirector of Operations
High High Strong Strong StrongNeeds to gain influence with engineers to validate proposed changes and provide support to obtain financial backing.
DougVP of Operations
High High Strong Weak StrongProvide financial backing and influence from company owners
Need to find a more effective method to show a need to spend money to improve the process. Doug expressed strong concerns about the quality but feels that R&D is responsible to propose changes. R&D is currently running an 18-month study.
Werfen GroupParent Company, Sponsor
High Medium Strong Weak Strong Provide financial backingThe company is financially stable and profitable.
Impact of Key Stakeholders
SEVER HALL CONSULTING GROUP
Project Timeline and Tasks
SEVER HALL CONSULTING GROUP
High Risk• Identify root cause but not able to determine satisfactory solution.• Resource constraints to identify and complete testing.
Medium Risk• Failure to identify root cause of fiber contamination.• Not able to complete the project within the required timeline.
Low Risk• Identify root cause but not able to obtain financial support to implement the changes.• Training required to implement changes maybe too time consuming or IL may be required
to modify employees' skill set.• Automation equipment does not exist in market place and would need to be custom
designed.• Required changes may render product no longer financially feasible.
Project failure may lead to loss of Market Share
Risk Analysis
SEVER HALL CONSULTING GROUP
Process Mapping
SEVER HALL CONSULTING GROUP
Performance Metrics
What do we measure?
Fibers
Colorful•Clothes•Cardboard boxes• Workers (hair, make-up etc..)
Transparent• Manufacturing process• Dust• Ventilation system
SEVER HALL CONSULTING GROUP
Phase I - Hygiene & Work Environment Hypothesis: Colorful fibers from clothing and paper fibers from
cardboard boxes are transferred to the product • Wear jump suits instead of lab coats• Gloves must be worn at all times• No make up/lotions policy• Beard nets• Cardboard boxes cannot be stored near the cleanroom • Sweaters and jackets cannot be stored near the cleanroom
Phase II - Work Environment Hypothesis: Frequently opened door allows dust particles to enter
the cleanroom and contaminate product• Process glass disks in the hood• Relocate operation further away from the door
Phase III - Process Change Hypothesis: Operators are rushed which may negatively impact
quality • Decrease batch size by 10%
Eliminated rejects due to colorful fibers during in-process
inspection
Significantly reduced rejects due to dust particles during in-process
inspection, from 5.5% to 1.2%
The reject rate during in-process inspection increased by 11%
Implemented Pilot Testing
SEVER HALL CONSULTING GROUP
Impact of short-term “pilot study”
Cartridges returned by costumer (35%)
$ 2M/year (loss) $ 1.66M/year (loss)
Overall fiber contamination rate decreased by 17% upon testing by the
simulation lab, translating into potential ~$340,000 annual savings.
Defective cartridges due to fiber contamination/yr: 24,938 (8.8%)/ (20,699)(7.3%)
SEVER HALL CONSULTING GROUP
• Retraining of personnel
• Review current inspection criteria (quality control) and modify SOP/workstation based on more data in conjunction with quality control department
• Modify new employee application guidelines
• Conduct brainstorming exercise to identify further process improvement opportunities
Follow-up
SEVER HALL CONSULTING GROUP
Questions?