There is an increased focus on safe and secure supply chains – reinforced by the statement by the FDA in their Strategic Priorities for 2011 – 2015 – Section 2.2 Strengthen the Safety and Integrity of the Global Supply Chain (Draft 9/29/2010)
“FDA must require more – and better – information about product supply chains and monitor this information throughout the product lifecycle, and regulatory standards must foster corporate responsibility to identify, protect and control risks.”
This is just one of the issues that Life Science companies are facing these days – coupled with additional pending mandates for shipment tracking, monitoring and e-pedigree compliance. In this blog I would like to invite readers to share some of their own experiences, and concerns, related to the movement of raw materials, work in process and finished goods across an increasingly global supply chain environment. To get the ball rolling I thought I would share some of the following misconceptions.
1. If you do a supplier due diligence when evaluating new suppliers you should not have to do onsite inspections as part of a supplier quality program.
WRONG – Just because you make a site visit and everything appears to be as it should does not provide any assurance that this will be the ongoing status quo. Constant vigilance and ongoing communication is important to ensure that service level agreements are adhered to – prevention is better than cure.
2. Once a shipment has been passed to a certified carrier it is in safe hands and there should be no concerns.
WRONG – Global logistics includes many players – in many cases there are second and third party providers that have a key role to play – and could drop the ball. Understand each of the elements across the links in the supply chain environment – trans-shipments, flight delays and other unplanned interruptions not only cause delays but compromise security.
3. It is the responsibility of the ‘authorities’ to ensure the safety and security of shipments entering the USA.
WRONG – Customs and Border protection authorities cannot inspect every shipment. The onus is on key supply chain participants to consider the risk factors and put mitigation strategies in place.
4. Once a product has been manufactured and packaged – and shipped to a customer – there is nor further liability for the ‘Brand Owner’.
WRONG – Patients trust the Brand and depend on the ‘Brand Owner’ to ensure that they receive a safe product – no matter how many participants there are in the chain of custody the onus is on the ‘Brand Owner’ to stand by this promise.
5. Counterfeit and dangerous drugs are only being distributed through illegal channels and on the Internet.
WRONG – The proliferation of diverted, adulterated and counterfeit drugs is a growing problem – and even traditional distribution channels have been compromised in the past. (there are many documented examples of this – for example go to www.safemedicines.org for some facts and figures!)
For those of you that disagree with me I welcome your comments – and for those of you who are experiencing challenges related to supply chain security please participate in this virtual forum. This is an opportunity to learn from others – and share your own experiences to help facilitate a safer supply chain environment for products that are designed to save lives – not to put them in jeopardy!
I look forward to a lively exchange – as the expression goes – It is a small world after all!
Carla Reed has more than 20 years’ experience working in global supply chain and logistics environments. An authority on ‘discovery to distribution’ supply chain best practices in the life sciences industry Carla leads the Supply Chain Management team at Tunnell Consulting. Tunnell Consulting integrates strategic, technical, process and organizational skills to boost its clients’ business performance. Carla Reed is speaking at the INTERPHEX 2011 Conference (www.interphex.com) next month in New York City.
Contact Carla directly at firstname.lastname@example.org