Industry needs a common language and consistent understanding to reduce risk and ensure that both parties fully understand the requirements of a transaction. This paper contains industry-agreed definitions for terms such as total lead time, inventory days, and economic order quantity.
Supply Chain Quality Management
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This template allows suppliers and customers to exchange the right information at the right time and helpa standardize this function and ensure that the ‘minimal required information’ is created and shared.
This paper provides an introduction and a high-level view of on time in full (OTIF) so that when we use the acronym, we know how it is calculated and are all using it in the same way. It examines detail on the components of ‘Actual orders delivered’ and ‘Expected orders to be delivered’ and talks about the information included, actions to take and gives tips on how to best use each component.
These tools support sharing the optimal high-level steps to simplify a process and invite people into the discussion using a common language. The optimal process outlines the essential process steps and for each one lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). The RACI supports people to understand where accountabilities and responsibilities lie.
The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.
Over the course of 14 months, eight site audits were carried out on BioPhorum’s Supply Partner supplier member company sites and these were made available for industry to license via the Rx-360 website. The audits were conducted through the Rx-360 Joint Audit Program and its audit partner BSI. This report details the methodology of the approach, the feedback and the findings of all the stakeholder groups involved and the reviewer panel involved in the pilot program.