Consulting Services & Rates
The following topics are areas of expertise for our firm. We can serve our customers by simple advisement and training, or establishing a complete system including design, execution and effectiveness measurement:
Quality Systems (FDA QSR, ISO 9000/13485):
Quality Policy/Objectives/Goal setting
Quality Metrics - General Scorecards, Manufacturing, Quality, Service, Trending, Statistical analysis
QA System Design & Troubleshooting
Proceduralization and structure
Organizational structure and effectiveness
Designing and writing procedures
International Quality Stds (ISO/CE/AUS/Japan/Canada)
Quality Improvement:
Philosophy of Improvement
Classical styles/History
Transitioning from Reactive to Proactive
Problem Solving
Failure Investigation/Root Cause Analysis
Voice of the Company internal feedback
Voice of the Customer external feedback
Selling Quality to Management
Servicing of product and service feedback analysis
Cost Of (Poor) Quality (COPQ):
Measurement and tracking systems
Defects, Appraisal, Prevention cost optimization
“Hitting the bottom line” – Managing COPQ
Manufacturing Quality Assurance/Control:
Quality Plans/Planning
Preventive Maintenance
Facilities & Environmental Control
Device History Records (DHR)
Calibration Systems, instrument tracking and corrective action
Inspection Plan Methodologies
SW Quality Management..eSystems advisement
Kaizan rapid improvement events
New product design transfer requirements
Product acceptance and release requirements
International manufacturing requirements
Document Control:
Quality Records
Engineering Design/Dwg control schemes (Draft/Aprvl/Final)
Supplier Management:
Focused Supplier programs
Supplier Agreements/Standards setting & compliance monitoring
Quality Improvement Education programs
Supplier evaluation audits and selection
Supplier relationship building
Dock to stock programs
Corrective and Preventive Action (CAPA):
Zeroing in on the real problems
Root Cause Analysis
Prioritization schemes
Rapid resolution programs
Verifying effectiveness
Regulatory Affairs:
510(k)s
IDEs
Technical Files
Sales and Marketing materials compliance
Regulatory Compliance:
Your responsibility with FDA and ISO
Complaints/MDR - Adverse Event reporting
Vigilance Reporting
Preparing for an audit/inspection
FDA/ISO audit management
483/Warning Letter responses
Auditing:
Internal/External audits to FDA/ISO/Material stds
SW Validation Master Plan (VMP)
Software Quality Data Management Systems (local & global)
New product Development:
General Design Controls
Design Reviews
Key Documentation (design dossiers/design history files)
Device Master Record (DMR)
Material/Process/Product Specifications Development
Marketing plans translation to Design Specifications
Identifying critical specifications
Design History Files
Standards libraries
Using standards effectively
Lifecycle Risk Management (FDA/ISO 14971):
Design/Process FMEA/Fault tree analysis
Design of Experiments
Statistical Tolerance Analysis
Management Review:
Who do you need?
What do you talk about?
How do you get it together?
Telling the Story
Decision making
Follow up
Testing:
Test Specifications
Design Verification
Design Validation
In-process checks
Test Methodologies \
Reliability functions
Test Report writing
Training:
Training systems
Job Descriptions
Employment Qualifications
Training materials
Education on any topic listed above….”Train the Trainer”
Consulting Rates:
Lead Consultant $300/hour:$3,000/day:$15,000/wk
Staff Consultant $200/hour:$2,000/day:$10,000/wk
Support/Offsite Work $150/hour:$1,500/day
For budgeting purposes, time estimates are provided by DBE, Inc. with each project proposal. Travel time is billed at half rate. All related travel expenses, materials, and supplies are billed as actually incurred. Rates may be adjusted when the scope of work is substantial or if project tasks or scope change occurs.
