Startup Medical Device Manufacturing Facility – Establishing the Quality System

The Challenge

A large Multi-National Medical Device company was seeking to expand manufacturing operations in Asia.  This new manufacturing site located in China, needed to develop and implement a complete quality system, and satisfactorily complete local and corporate audits in preparation for facility startup.

The Solution

Performance Validation provided consultants to assist the client team in drafting the required procedures by:

• Assisting with process mapping of the procedures.
• Conducting reviews of the drafted procedures (via email, teleconference and web conference) with client personnel to assist in understanding of the requirements and to ensure the proposed procedures met the requirements of the Quality System Regulation, ISO 13485, and industry guidance from GHTF, and AAMI were incorporated into the procedures.

The Results

The following elements of the quality system were developed over a six month period:

• Management
  • Management Responsibility
  • Quality Manual
  •  Internal Audit
  • Training/ Qualification
• Production and Process Control
  •  Product Transfer Procedures
  •  Validation system
  •  Production and In-Process Control
  • Maintenance
  • Calibration
  • Non-Conforming Control
  • Product Identification & Traceability
  • Change Control
  •  Inspection and testing
  • Statistic techniques
• Material Control
  • Purchasing Control
  • Suppliers Control
  • Contract and Order Review
  • Storage ,Handling, and Distribution
• Document and records control
  • Document Management Control
  • Quality Record Control
• CAPA
  • CAPA
  • Complaints handling
  • Risk Management
  • Correction and Removal
  • MDR
• Facility Control
  • Environmental
  • Building Maintenance
  • Security/ BMS

The Benefits

• The completed project accomplished the following for the new manufacturing facility:
• Establishment and implementation of a compliant Quality System
• Increased understanding of the Quality System Regulations, and guidance documents.
• Successfully completed local and corporate Quality System audits which resulted in the facility being qualified as an authorized suppler to all subsidiaries of the parent Multi-National.
• Facility released for operation.

For additional information, please schedule a call with one of our subject matter experts. 

Richard Van Doel
Board Chairman
Performance Validation, LLC.