Risk Management in Pharmaceutical Supply Chains the experience of the insurer

Transcription

1 22. October 2015 Risk Management in Pharmaceutical Supply Chains the experience of the insurer Cluster for Logistics Luxembourg Chambre de Commerce Dr. Verena Brenner

2 HDI Risk Consulting (HRC) Short Introduction Provision of risk engineering services across lines of business More than 100 years of experience in damage prevention International Risk Engineering Network present in 21 countries Approx. 180 own Risk Engineers and Specialists worldwide

3 Why cares HRC about pharmaceutical supply chains? Huge loss potential if damaged during transport Claim in marine insurance line of business Risk of major Business Interruptions, if pharmaceuticals are destroyed during production or transport (especially APIs) Claim in property or marine insurance line of business If something happens to the product in the supply chain, we have claims

4 HRC s approach to improve pahramceutical supply chains Proceeding Data collection: Claims history SOPs and SLAs Frequent routes and transport types Protection & monitoring measures Data analysis: Patterns in damage causes Completeness & correctness of process documentation External risk factors Capabilities & deficiencies of measures Reports & recommendations: Highlighting weaknesses & strengths Explanation of potential results Summary of practical countermeasures Results Increasing transparency on the supply chain Identification of frequent causes of damage Implementation of countermeasures Reduction of claims caused by foreseeable obstacles Increasing customer satisfaction Ongoing dialogue with client as a preventive measure

5 Practical insights Risk assessment of delivery routes Based on WHO Climatic Zones won t work for pharmaceutical transportation (average vs. actual temperature) Harmonization of risk assessments and countermeasures between supply chain partners Documentation Temperature documentation is required for every pallet, as partshipments cannot always be avoided Clear documentation of when and where the shipment changes owner, also during transport Clearly state on the AWBs the storage conditions no if possible, no at destination Transportation There is no controlled environment in cold chains protection is key Interfaces still pose major risks, direct shipments whenever possible

6 Observations of HRC Logistical plans of pharmaceutical companies do not always match reality: No safety buffers, e.g. of dry ice No consideration of delays, communication failures, weather conditions, etc. no plan B in case of deviations SOPs and SLAs are not a magic cure: Amount and complexity of documents increase human error Need for feasibility and realistic assumptions Application to all segments of the supply chain The design of supply chains requires several departments to work closely together e.g. QA, Logistics, Sales, and also Insurance Purchasing The new GDP requirements increase temperature claims because now the temperature has to be monitored! Improving pharmaceutical supply chains reduces: claims for the Insurer, deductibles for pharmaceutical companies, and recourses, paperwork and trouble for LSP

7 Contact for further questions Dr. Verena Brenner Tel.: +49 (0)