Helping manufacturers and suppliers achieve a more consistent, confident, and accurate joint audit approach, the Supply Chain Quality Management Workstream was established in 2020 following a successful pilot. Its latest projects include two new pieces of work:

Supply chain quality management optimal process and RACI 15.77 MB 97 downloads

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1. An optimal process
   
   This will help users understand the supply chain quality management process at the highest optimal level and will be especially useful for those who are not deeply involved in the process or are new to the requirements for quality management. They will also learn about the impact of this important process on the movement of materials through the supply chain.
   
   The optimal process outlines the essential steps. Each process step lists the ‘who’ (i.e., which role) and the ‘how’ (i.e., what medium). This exercise drove great discussions between the suppliers and manufacturers and revealed how supply chain quality management is critical to the biomanufacturing inbound supply chain and is relevant to suppliers in all tiers. There is lots of scope here for future conversations, e.g., how do we capture the requirements and quality steps for each relevant tier and supplier?
   
   The optimal process will support and recognize that we all generally follow the same steps but may describe them differently. We are offering a standardized view of the process to create clear visibility from the highest to the more detailed levels of the process.
   
   
2. A RACI responsibility assignment matrix
   
   When creating an optimal supply chain quality management process, it is important to identify where accountability and responsibility lie.
   
   So, using the optimal process, we put an explanation against each step, including the typical roles involved. Knowing that each company may use different terminology for each role, we developed a RACI (Responsible, Accounted, Consulted, and Informed) matrix. This is a simplified view of the process and contains some definitions/explanations of the roles. It also recognizes that some individuals in smaller companies may perform multiple roles and therefore wear multiple hats.
   
   The RACI matrix will help identify the key part that each role plays in the process and should reduce confusion and create a clear understanding of key decision-makers in each part of the process. There is also a RACI Template that can be used for any process.

These projects show that sharing the optimal high-level steps can simplify a process and invite people into the discussion using a common language. And if each company is performing the same high-level steps, then we will all be working towards some standard ways of working while recognizing the breadth and size of our company members.

These conversations are where there is potential for the greatest benefit of harmonization. After all, we are all only as strong as our weakest link.