As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.
This can be accomplished for both types of industry verticals by looking at the Critical Control Points and determining the "what-ifs" and how to make these become potential non-issues.
In the Food and Produce side of the regulations these are referred to HACCP (Hazard Analysis of Critical Control Points) and under the Food Safety and Modernization Act (FSMA), these are broadly defined as ALL Critical Control Points.
In the Pharmaceutical and Bio-Logics arena assessing risk has been a requirement for many years covered by Good Distribution Practices (GDP), Good Supply Practices (GSP) and Good Manufacturing Practices (GMP). However, in many of the global regulations that relate specifically to drug and bio-logic products and current Good Practices, coupled with regulations, the Risk Assessment and Risk Mitigation planning is now becoming an element that will become part of any on-site audits.
So what are some common elements that should be looked at as potential risk areas?
- By far it is the Human Element. Where-ever there is a human touch point there is a chance for an error to occur. The human "influenced" cause of Cold Chain logistics errors is estimated by some groups as being as high as 99% of the main cause of cold chain errors.
- Inter-modal transport. Where-ever there is a hand off point in the transportation processes there is a chance for errors to occur - especially if a new carrier or mode of transport is being used.
- Single supplier strategy - this is a big element that people tend to overlook, so never forget, as the old saying reminds us; " don't put all your eggs in one basket". A specific carton, or temperature monitoring device, or solution, sourced from one supplier can put you at risk if this supplier runs out the necessary components that make up your regular order.
- Training of key individuals on a regular and documented basis. SOP's can change as well as work instructions (WI's) and key points related to the change could be missed if staff are not regularly updated, as well as new staff going through and completing new hire training programs.
- Conduct regular self-audits to look at all potential risk areas and update your Mitigation Plans as necessary.
- Forgetting to start, or activate, the temperature monitoring device that goes with the shipment, is part of the common human errors noted in Item 1 above. We at DeltaTrak recognized this type of error as a common occurrence many years ago and all of our Single Use Data Loggers come with our patented Shadow Log™ feature that will insure that you get a temperature log for the shipment in question, even if the logger is not physically started upon shipment.
So how confident are you that your Risk Assessment and Mitigation plans are up to date, or more to the point - "How certain are you that your logistics staff activates the data logger before closing the carton?"