Hello Anon,
It may be difficult to answer these questions succinctly because there can be quite a few ways this is done. I have seen a number of global quality systems over the years and have seen 10+ different variations. When working in industry with a global organisation, I did set up the "corporate" quality structure as high level operating procedures or policies for common processes, i.e. corrective action, management review, training. Then each site was responsible for transposing the corporate procedure/policy into their local requirements based on what the company does. This worked well when each site is more independent. Another example was the corporate procedures were followed by each individual site - no ifs, ands, or buts. This was a smaller global company with only 4 sites. So basically every site was following the same processes. Then sites would have specific procedures or work instructions which were specific to the work activities they were doing or products they manufactured. There are different ways this can be done.
In most multi-national or global companies I have seen, the lines of reporting were always consistent within the functional area. Product Development reported up through Product Development, Operations reported up through Operations, Procurement reported through Procurement, Quality reported through Quality, and so forth. Certainly some functions as they reported up through a corporate structure became consolidated, like quality, regulatory, or clinical, all reporting up to the corporate VP or something similar, but at each site there was a Quality Manager and a Regulatory Manager and a Clinical Affairs Manager, etc. Again this is really dependent on the company and how it is structured; most global companies already have a well established reporting structure.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Jan-2022 16:54
From: Anonymous Member
Subject: QMS Organization Structure
This message was posted by a user wishing to remain anonymous
Hello,
My company is continuing to grow globally but we want to be a true global company and set up our QMS organization correctly. I have two main questions for people in a large global company that has a great QMS:
- How are your SOPs set up between your headquarters and subsidies throughout the world? Are there certain SOPs that are "high-level" or applicable to the whole company and then each subsidy sets up SOPs specific to them? Could you provide examples of such?
- Which departments report up into the RAQA umbrella? For example, does product development (project managers), product and process compliance, which could include product quality, design control, document control report to RAQA?