Wednesday, September 9, 2009

Medical Device Supply Chain - Managing the long chain as per FDA regulations

with the recession looming large on all businesses Medical device Manufacturers are focussing more on outsourcing the manufacturing and services function to low cost destinations. But with the benefit of low cost also comes lots of problems related to regulations and management. As the supply chain becomes longer and more diverse it becomes more difficult to control. But the company is reponsible for any kind of problem happening with the devices and ultimately will be held responsible for its failure. Hence it is very important to have a concrete process for the supplier selection, evaluation and management. The FDA has formulated many regulations for medical devices that define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. In February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers. This guidance document has become the global de facto standard for supplier management.

As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers. As the supply chain becomes longer and more diverse, the methods of control become more difficult and the expectations of regulators become more stringent.

The best approach implements specific actions:
· Create clear requirements for supplier
· Evaluate potential suppliers against the criteria
· Create cross-functional multi-discipline teams that remain active beyond the selection process
The team approach, often called a commodity team or supplier team, is one of the most effective methods for supplier selection and management. The team needs to understand the requirements, implement the best practices in the GHTF document, and work with suppliers.

There is a webinar on this conducted by Complianceonline in Oct 30. Click on the link below to view the complete agenda.

Download the GHTF Document -
Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

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