Services

Complete our Contact Form, Phone: (410)382-2586 or E-mail at info@qualityedgeconsulting.com

 Quality Management Systems

Good Manufacturing Practice (GMP) for Medical Devices

Quality Edge Management Consulting successfully takes companies through the implementation process to certification “first time” using our tested and effective approach. We do not simply provide the minimal requirements but fine-tune our services to meet the specific needs of our clients. Our knowledge, skills, openness, and customer service are unsurpassed and smooth the transition to full compliance.

Gap Analysis

Gap analyses are conducted  to identify any variances between the current state of your organization’s system, processes or performance to that required or expected by an external or internal authority.

We review your existing documentation off-site for cost savings. Upon completion of the Gap Analysis, a detailed report will be reviewed at a meeting with Client management.

– Detailed report on Current System Status
– Corrective Action Plan with Priority and Level of Effort Identified
– Recommended Documentation
– Detailed Project Plan
– Project Team Assignments

Process Mapping

Process maps illustrate in detail the activities and interactions of your business processes both inside and outside your organization. They are necessary to understand the specific activities, personnel, tools and equipment, documents and records, methods, inspections and metrics used and produced within each process.

These are a valuable instrument to evaluate required and desired improvements as well as perform audits.

Documentation Preparation

We provide a complete documentation package that meets the requirements of your organization, applicable Standard, regulation and customer in an electronic format.

The appropriate extent of documentation (not just the minimum required) is determined by working with your organization; our documentation is designed to reflect the natural flow of your processes so that all personnel can readily understand their responsibilities and includes measurement and monitoring activities.

Internal Audits

Our personnel perform your organization’s Internal Audits to determine compliance to the applicable Standard or Requirements as part of your implementation process and as a cost-efficient continual service following certification.

Our unbeatable expertise comes from auditors with years of RAB/IRCA-certified Lead Assessor registrar experience.

Training

We train you at both the executive and operational levels and develop and conduct training for other special needs:

Quality Management System Implementation
Process Validation
Design Control
Process Mapping
Internal Auditor
Root Cause Analysis
Risk Management 
Corrective Action

Business Operations Management

We offer a wide variety of services that facilitate the institution of operational controls and measurements in your organization.  We can lend a hand with these tasks and manage and monitor projects for as long as you wish.

Risk Management Project Management Productivity Measurement and Analysis Measuring Equipment and Software Calibration Systems Supplier Selection and Certification

Engineering

Our experienced personnel can assist with the short-term engineering needs for your development, production and quality assurance processes.

• Process Validation

• Quality Assurance and Control Plans/Methodologies

• Design Planning

• Sampling and Reliability

Process Improvements

Even when the need for improvement is apparent, many organizations do not know how to go about planning, organizing, implementing and tracking an Improvement Project. That’s where we can help. 

Increased Productivity Shorter Lead Times Reduced Scrap Inventory Higher Customer Satisfaction