Route Risk Assessments

Route Risk Assessments: The Neccessity of Assessing the Route

Unless you’re a global sized pharma company with a beautifully resourced quality department, route risk assessments can be a challenge.

When we say “challenge”, we mean in terms of the time it can consume, and the understanding of the supply chain required to successfully complete all stages accurately.

Before we dive into the mechanics, let’s step back a moment and ask ourselves; what exactly is a route risk assessment? (or lane assessment, or lane validation plan as referenced on page 186-187 of the Green Guide).

Definition

A route risk assessment is an exercise (documented) that uses defined risk methodology to map individual risk factors and mitigations throughout the distribution process.

To complete successfully, a solid understanding of the supply chain is required alongside real-time knowledge of the capabilities of the handling partners throughout the distribution process.

It’s a fairly common misconception that a route risk assessment covering the entirety of EMEA is acceptable to mitigate risk, as the risk profiles will differ depending on factors such as:

- Product temperature requirements
- Haulier capability
- Temperature management packaging
- Forwarder capability & facilities (GDP knowledge, quality management, WDA(H) licensed etc.)
- Chosen carrier capability (temperature, security, quality management etc.)
- GHA (Ground Handling Agent) capability (GHA’s are subcontracted to carriers and have different capabilities globally. For example, IAG is the contracted GHA for British Airways. They may have a temperature-controlled storage facility in Heathrow, but not at other global touchpoints throughout the supply chain).
- Quality management capabilities and complexity of the lane.

A shipping lane to Hong Kong could require numerous route risk assessments if different carriers are used, as the capabilities of British Airways and their contracted GHA’s will differ from Cathay Pacific’s. The complexity of the supply chain will be different, as will the storage facilities throughout.

Assessing the Risk of the Route

There are two main methodologies used to conduct route risk assessments.

Online tools are available that calculate risk scores based on global supplier capability, as well as the old reliable FMEA (Failure Modes & Effect Analysis). Both methods map each step of the distribution process and assess risk, applying mitigating actions where needed.

Of course, there are pros and cons with each. Online tools are excellent to save time, however rely heavily on the input of the carriers/suppliers themselves, essentially basing the overall risk scores on a self-assessment, which begs the question – how do we know the self-assessment has been completed accurately and without bias? If using online tools to complete route risk assessments, you should consider qualifying the information provided, which then negates the benefit of saving time.

FMEA models take longer, rely on the assessor having knowledge of the supply chain and the capabilities of the distribution partners throughout each transportation leg. The upshot, however, is the risk assessment uses hard data based on real-time experience and is unbiased. Having used and tested both methodologies (who wouldn’t want a super speedy online tool to save time?) when comparing a lane side by side, the author has noticed vast differences in risk profiles, with the online tool providing an excellent score whereas the FMEA highlights difficulties within the lane that wasn’t picked up online.

Whilst conducting route risk assessments can be time consuming and administratively heavy, when completed correctly the rewards are vast. Ensuring the highest level of patient safety is of course, the big one. It can also reduce quality and operational related costs, streamlining the process, removing waste (both procedural and destroyed product), AND give you a greater understanding of YOUR supply chain.

The most important takeaway to the route risk assessment exercise is this:

The outputs of the risk assessments must be used to drive the distribution processes. There have been countless times we have witnessed a perfectly documented lane validation plan only for it to be an exercise in administration. Don’t allow it to become a tick box exercise! Use the results to create lane SOP’s, decide packaging strategies and preferred carriers.

Assistance and Support

If you need help conducting route risk assessments, implementing lane SOP’s, or understanding the supply chain, give us a shout! We can offer a free over-the-phone initial consultation on 0330 133 0920 or you can email us on info@ukgdpassociation.co.uk.

Alternatively, use the contact form at the top right of this screen.

Together we can build a lane validation plan whilst giving you the tools and knowledge to carry it forward into the future.

Useful Links

MHRA

EU GDP Guidelines

Transportation of Medicine (UK GDP Blog)

Transporting Medicine: No Compromise (UK GDP Blog)

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