Supply change notifications across the biomanufacturing industry have increased significantly since the start of the pandemic due to the increased requirements for raw materials used in the vaccine manufacturing process. One BioPhorum member has reported an increase from two notifications a week to 200 a month.
Unfortunately, this surge has highlighted inefficiencies in the change management process for single-use systems (SUS) and its ability to handle the increased volume of information. It is a frustration across many BioPhorum members.
Yet, the vast increase in notifications is only part of the problem – incomplete data in a non-standard format, together with the low adoption of BioPhorum’s SUS change management guidelines (see below), makes it difficult for the notification receiver to effectively process the change. There is also no consistent way of bundling change notifications together.
Now is a perfect time to review how this process is managed across the industry and add more rigor to the practice by proposing that communication of the required content and information is made mandatory.
In response to this proposal, BioPhorum has produced a Supply Change Notification Template, which will allow suppliers and customers to exchange the right information at the right time.
It will help standardize this important industry function and ensure that the minimum required information is created and shared. This may require some additional effort for the creator but will result in an agile process and reduce re-work, time, and delays further along the process.
Implementing this template will have quality, safety, and cost benefits ranging from better right-first-time information and a standard way of working to reduced delays in qualifying a change and strengthened end-to-end supply chain relationships.
The template has been designed to allow attachments and links to be added and reduce duplication of effort if information exists elsewhere. It is based on BioPhorum’s Single-use, change notification: A guide to the classification of changes to SU manufacturing systems and Change Notification: A guide to change notification packages for single-use manufacturing systems.
If this situation is not resolved, existing problems will continue to create waste that impacts people, resources, time, and cost – it may even have a greater impact on the supply chain and delivery of the end product to patients. The effect of not having a standard process includes:
- The receiver cannot process changes efficiently, often due to a lack of clarity or enough information being provided – this leads to a poor understanding of the change impact and so presents a risk to delivery
- The sender may often have to re-work or provide extra information to confirm or check missing data – the receiver may then have to ask repeated questions to clarify information as it is drip-fed.
This template is an example of BioPhorum working toward best practices and standards for SUS supply change notifications and improving the flow of process data up and down the supply chain. It is a real template for success.