Configuration Management for Medical Device

Configuration management is a system engineering process for establishing and maintaining consistency of a product’s performance, functional and physical attributes with its requirements, design, and operational information throughout its lifecycle. The configuration management process facilitates orderly management of product information and changes for purposes as to revise capability, improve performance, reliability, or maintainability, extend life, reduce cost, reduce risk and liability or correct defects.

It is imperative to develop product configurations and manage effectively. A structured configuration management program ensures accurate and consistent product documentation (e.g., requirements, design, test, and acceptance documentation) alongwith the actual physical design of the product. Configuration Management plays an important role to ensure thorough product variations to enhance customer satisfaction, competitiveness, profitability & continuous changes / requirements. Therefore, it’s critical that the product and process configuration is unified across the organization, which minimizes handoffs of specialised information.

Configuration Management must include –

1. Enterprise or Unified Supply Chain Configuration Solution
   • People from all functions will have to use the system because the configurator must configure the resources and processes required to produce the products in addition to the products themselves.
2. Error-Proofing
   • The system should not allow for invalid option selections. The system can also eliminate errors if it can automatically create bills-of-material and routings usable by purchasing, production, and your ERP System
3. Intuitive and Flexible
   • The configuration system should be flexible enough to fit many business models,
     allowing for freedom on how many parameters the user can configure at once.

IZiel’s Expertise –

IZiel has highly trained configuration managers who will be able to create, coordinate and implement the Configuration Management Plan (CMP – includes responsibilities and resources, (including personnel), training requirements, administrative meeting guidelines (including a definition of procedures and tools), baselining processes, configuration control and configuration-status accounting, naming conventions, audits and reviews, subcontractor / vendor configuration management requirements, regulatory requirements) for Product Creation Process (PCP) projects in co-operation with the Project Managers and Operations Department.

IZiel Team would assist your team to –

• Analyze the proposed changes to product design for determining effect on overall product and / or system.
• Manage change orders to prepare for change authorization and documentation by company and / or subcontractor.
• Prepare reports of change impact on overall product and product lifecycle.
• Review and analyze released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities.
• Ensure that customer requirements are implemented, and reviews change accounting activity to ensure compliance with configuration management policies.
• Maintain functional control of product Master Data, document change control, and Quality System records.
• Analyze and coordinate proposed changes of product design and quality system processes to determine effect on overall product and / or system, coordinating with change owners, providing feedback.
• Review and analyze engineering change data and coordinate changes with engineering, quality, support, manufacturing, and engineering data control activities.
• Ensure that requirements are implemented, and review change accounting activity to ensure compliance with configuration management policies.
• Analyze and maintain data in both InfinityQS and SAP for inspection criteria and other production relevant data.