Regulatory Open Forum

 View Only
  • 1.  QMS Organization Structure

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jan-2022 10:47
    This message was posted by a user wishing to remain anonymous


    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?

  • 2.  RE: QMS Organization Structure

    Posted 20-Jan-2022 04:53
    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.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 3.  RE: QMS Organization Structure

    Posted 20-Jan-2022 08:17

    Dear Anon,
    I agree with Richard. I have seen large global multi-site manufacturers organizing and re-organizing their Quality units over time driven by changes in regulatory environment and business needs. 

    1. Re. Document management : The Global Quality unit sets Global policies and procedures which are then adopted by individual sites. There are only few exceptions due to site specific operations and regional regulations. During site GMP audits, the inspectors can compare compliance to global procedures across sites. For example, the change control process or Sterility Assurance should be governed by  global Policy/ SOP ( Global Quality Document). And applied across each site with only product specific or regulatory reporting differences.
    Also, each site should have in place a Quality Manual with overall site Quality policies and commitments.
    2. Re. Quality organization: The quality units should remain independent of rest of the organization and report to global Quality…
    In my experience, site specific quality can include sub- groups such as Quality Systems ( Self audits and inspections, complaints, change controls, RMS, supplier management, Quality tools and databases, etc); Deviation and investigation management , Quality Control ( QC), Product Quality / Assurance( Batch release, BPRs, Records and Systems), etc… Supply chain is another independent organization. RA and supply chain are independent of Quality ( just because of the nature of their function). All three Quality , Supply and RA can report into a site head. Research and development remains a separate entity independent of GMP functions.
    Hope this helps you…

    [Meena] [Garg] [Dr.]
    [InxSys BioSolutions Consulting]