Supply Chain Risk Management for the Pharmaceutical and Medical Device Industries

[bio_subbu]

The Chartered Quality institute (CQI) & Pharmaceutical Quality Group (PQG) has been published the document on A guide to supply chain risk management for the Pharmaceutical and Medical Device Industries and their Suppliers to help organizations and their suppliers to adopt a common approach to risk management. The basic structure of this Risk Management guide comprises a general introduction followed by four parts.

Part 1 considers specifically the challenges with supply chains and provides an overview of some of the types of controls that can be applied to increase assurance of quality, safety and security of supply.

Part 2 provides an overview of the Risk Management process and emphasizes that this is a living and reiterative process. The stages follow a consistent format:

Part 3 gives an overview of a number of readily available Risk Management tools and techniques that have been used in many industries, with guidance on their use and some worked examples and / or templates. The format for each tool provides an overview, some advantages and disadvantages, and advisory notes on its use.

Part 4 provides 19 real-life examples relating to supply chain events. It gives an overview of the scenario and some learning points.

For more details refer on guideline to access a page on the CQI website from which the document can be downloaded free of charge.

Regards
S. Subramaniam

 

[arios]

Thank you Amigo!

 

[Marcelo]

Good info, but i think it´s really more related to the pharma field as it ises ICH Q9 as a framework, and this differs from ISo 14971 for medical. But it´s a good source of ideias anyway as the general risk management philosophy is the same.