What if I told you how one biotechnology manufacturer, who was knocked out of the vaccine race, could have avoided that catastrophe completely? Is the answer as simple as a shower and a change of clothes? Well, not quite.
These days, supply chain assurance is typically disjointed and industry-specific. We only know about the site contamination, which was attributed to lack of adherence to shower and clothing procedures, because, after issues became apparent, inspectors were engaged to identify how the product was contaminated. However, challenges such as this are not limited to one incident or industry. Visit a store today and you will note that supply chain issues are rampant.
The System and Organization Controls (SOC) for Supply Chain assurance report, which I’ve written about before, was created to aid in solving these challenges. Organizations need to trust that their supply chains can meet their contractual obligations. Can your supply chain deliver the right amount of product, to the right people, at the right place and at the right time? I hope so. Because from the enablement of scientific development to raw material procurement, manufacturing, quality assurance and distribution, you are betting your business on your supply chain.
Getting this wrong is costly. Consider the loss of shareholder value, the increased regulatory oversight, the loss of product, the expense of retesting and recertifying and the erosion of customer trust—it all adds up very quickly.
A purpose-built SOC for Supply Chain assurance report will drive the trust that management, third parties and customers have in your offerings. Trust is even more important for the extended enterprise as it has become the glue that binds a modern supply chain network. This is because a modern supply chain network cannot function without data sharing among the parties. From manufacturing to delivery, data sharing is foundational to meeting—if not exceeding—expectations. That’s something to write home about—or turn into great advertising!
Beyond the production integrity of your supply chain, there are two other trust considerations that SOC for Supply Chain addresses well: confidentiality and privacy. They may sound like the same thing, but they’re actually quite distinct.
Consider confidentiality in the case of vaccines. One question that often looms among the various partners in a vaccine manufacturing network is whether the proprietary formula will be kept safe. Other considerations could be contract terms (such as who is prioritized for delivery), or fees (such as who pays what and under what terms). The bottom line is that you are counting on confidentiality in your supply chain.
Privacy invites an even more complex supply chain narrative. In situations where elements within a supply chain have access to personal information, a SOC for Supply Chain report can help to ensure appropriate controls are in place. Consider the scenario of a vaccine in its early days. Perhaps there is limited supply and high demand, the product is emerging, it has challenging storage and delivery requirements, and there are late-stage trials that require the collection of substantial personal information from the trial participants. Likely, this type of supply chain would leverage personal information in several ways, including:
- Helping to limit waste and maximize both efficiency and impact with the creation of a patient-aware distribution network. Think of a vaccine with a cold chain. The temperatures required for transportation, storage and handling in combination with expiry dates would necessitate the distribution of the vaccine based on patient personal information (including their locations).
- Helping to create a robust feedback loop. This is especially important in early clinical or pre-clinical activities. Consider the volume, velocity, and sensitivity of the information required to adjust vaccine development based on participant feedback, and the complexity of the feedback loop needed to create a vaccine that sufficiently protects a diverse population.
When I consider the last couple of years, I cannot think of an industry that supply chain breakdowns have not disrupted. What is the greatest risk to your supply chain? Have you established sufficient trust? If you want to find out, look into a SOC for Supply Chain report. And if you’re not entirely sure how to go about doing that, give me a call.
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