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HippoTronic Medical Devices. New Contract Manufacturing Facility Reginald Williams Andrew Harrell Polly Pitcock. Description of Project. Our company has outgrown its current facility locate a site, lease up to 15,000 square feet of space, staff it - PowerPoint PPT Presentation
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NEW CONTRACT MANUFACTURING FACILITY
R E G I N A L D W I L L I A M S A N D R E W H A R R E L L P O L LY P I T C O C K
HippoTronic Medical Devices
Description of Project
Our company has outgrown its current facility
locate a site, lease up to 15,000 square feet of space, staff it
obtain the appropriate certification and qualification to begin manufacturing a new sterile electro-surgical medical device product line under contract with a large OEM, Big Med, Inc .
Objective
HippoTronic must relocate to a larger/modern facility, relocate equipment and restructure the company’s current staff to retain highly skilled employees.
Obtain certifications and manufacturing requirements necessary to be a qualified medical device contract manufacturer.
Assumptions
The product line and volume demand is already defined & guaranteed by the OEM customer.
Upper Management gives full backing & capital is readily available.
Devices being manufactured are already 510(k) cleared (FDA approval not a concern for properties of device or processes of manufacture)
No barriers to negotiating lease requirements; site selection is based solely on property characteristics not funding.
Primary Stakeholders
Internal Stakeholders Board Executives Management Human Resources Operations Leadership Engineering Employees
Investors Big Med, Inc. Patients Surgeon
Project Milestones
Preliminary Project Milestones:1. Site Selection/New Facility/Existing Site
Shutdown
2. Employee Re-Organization
3. Facility Ramp-Up
Communication PlanAudience Vehicle of
Comm.Frequency Medium Source
Project Sponsor
Status Report
Weekly Written Report
Site Manager
Board Milestone Report
Monthly/per request
Presentation Project Team
Employees Change Plan At Outset Verbal HR ManagerProject Team
Progress Report
Task-based timeline
Electronic/ Verbal/Report/Receipt
Contractors
OEM/Customer
Progress Report
Weekly Written Report
Project Team
WBS Breakdown Highlights
Secure lease for 15,000 sq ftApproval for Construction, Installation,
Moving RFP’sStart Construction/Installation ProcessPurchase order for new EquipmentReduction in Force/Decide ongoing labor
needsPrepare Severance PackagesConduct Post Termination ActivitiesPerform Equipment/Process Validation
DELIVERABLES AT A GLANCE
Site Selection/New Facility/Existing Site
Scheduled Site Visits - Hickory Hill , Old Lamar, Directors Row Time: 2 weeks
Lease Negotiations – Negotiated discounted lease Time: 1 week Minor Improvements/Clean-up - Contract services to
build out 2,000 sq Ft “Clean Room” to install the new phone system/fiber optics Time: 2 weeks/3 days
Final Approvals - Walk thru with contractors to review clean room construction and the installation of the new phone system and fiber optics - Time: 5 days
Old facility shut down - Clean-up, secure premises, and turn keys over to the property management company - Time: 1 day
DELIVERABLES AT A GLANCE
Employee Re-organization
Change Communication Plan - Communicated all changes to through the change communication plan - Time: 1 week
Reduction in Force Plan (RIF) - Prepared a (RIF) plan to identify the 25 technicians who were no longer needed after the transition to the new facility - Time: 1 day
Ongoing Labor Needs - Determined what the new facility labor needs would be based on new requirements - Time: 6 days
Prepare Severance Packages - HR prepared severance packages for the 25 individuals identified in the RIF analysis – Time: 2 days
Post Termination Activities - Activities included recouping any company files, equipment or keys from the terminated employees
Time: 1 day
DELIVERABLES AT A GLANCE
Manufacturing Ramp-up
Equipment/Process Validation - Qualified per contract - Time: 1 week
Class 10,000 Cleanroom certification - Class 10,000 certification was required to manufacture devices - Time: 3 weeks
Total Quality Management - Performed routine maintenance and capability assessments - Time: 2 weeks
Manufacturing Workflow Structure - Created the physical map for the production environment – Time: 1 week
De-cost Manual Assembly Operations - Applied cost and price data to the workflow structure to produce a finished product - Time: 3 days
Validate Quality & Capability Maintenance - Framework for adding and changing process for post manufacturing process - Time: 1 week
Begin Production - Assessed the capability, procurement, and staffing requirements to launch production per contract - Time: 1 week
PROJECT COSTS
Site Selection - $15,391Furnishings/Equipment - $47,000Construction/Installation Services - $100,000
Moving Services - $15,000Employee Re-org (severance packages) -
$85,000Manufacturing Ramp-up - $50,300General Budget Line Items - $4,750
PROJECT RISKS
Site Selection
Ineffective site selection analysisNot adequately defining the costs of the
relocation (cost over-runs) Stalled lease negotiationsConstruction and Installation delaysDelays in the delivery of new
equipment/furnishings
PROJECT RISKS
Employee Re-Organization
Conflicts in move-over scheduleEEOC charge for wrongful termination Possible early loss of employees before date
of reduction of workforce Employee morale may cause loss in
productivity or production errors Unhappy employees may look for fraudulent
Workers comp claims
PROJECT RISKS
Manufacturing Ramp-up
Equipment qualification failures Material/process supplier changesFailure to obtain Class 100,000 Cleanroom
CertificationContamination exclusions/undiscovered issues
with facilityBig Med, Inc breaks contract/goes bankruptDe-costing reveals bad ROIRetention of skilled technical personnel in
relocation
PROJECT RISKS
OUR NEW SITE!!!
NEW SITE!!!
NEW SITE!!!
Images courtesy of Loopnet.com & Google Maps
Gantt Chart
Task Schedule
257 Days66 Tasks13,536 Work Hours
Critical Path Activities
Resource Smoothing
Staged CrossoverChange Communication PlanValidation Master Plan
Reduction of Project Duration
THE RESULTS
Outcomes
New LocationHighly Qualified StaffCutting Edge TechnologyNew Market ShareSatisfied Customer
On Time and on Budget!!!
THE END