In Dr. Simon’s lecture, he clearly linked the quality system hierarchy back to management. Quality starts at the top, where management defines the mission statement, leading to the quality policy. This drives the quality manual, work instructions, and procedures. I think this top-down structure is essential because it makes sure that regular tasks like inspection or documentation can directly link to the mission statement of the company and regulatory requirements.
However, I found it interesting that this chain can break in large companies. When companies merge or divide, multiple quality systems can overlap and create inconsistencies. Every company has its own system, and making sure changes in the company come with compatible quality systems is essential. This makes me wonder if quality systems should be standardized globally to a greater extent, so companies can be more fluid in their movements without leading to compliance issues or inconsistencies. I think having an overarching standardization, with a little bit of room for each company, would make the pipeline cleaner and help companies in the long run when they inevitably have to make decisions in absorbing other companies or splitting themselves.
Do you think the medical-device companies should enforce one unified quality system across all regions or specific requirements for companies close together in each region? What issues might arise from a standardization of quality systems, and how can these be negated?
In terms of the hierarchy of quality, in my own way, I do think that a unified quality system sounds ideal. I naturally gravitate towards that given the experience I have with similar leadership so in a way, I do think that has more pros than cons. Seeing the shift from when leadership changes (or in the prompt, when companies merge or divide) can cause great disturbances or even the butting of heads when it comes to handling projects. To counteract this point, even though I agree, different regions around the world might have different interpretations of quality and how they enforce their own documentation, surveillance of medical devices, and history log standards. Unless the framework was able to follow similarly to how the ISO 13485 works, which could bridge the gap better between regions.
Additionally, perhaps companies could also implement policies that could reduce inconsistencies globally that can boil down to region specific procedures as well to ensure a unified philosophy. In a way (and I'm not sure if this is counter intuitive), but have a more standardized system that's more flexible rather than rigid might be beneficial.
ARA
While creating one unified quality system sound more efficient, it can actually create more problems when companies work in different regions. Depending on the countries, their rules can be different, like different reporting timelines. If a company forces all other companies to follow one global procedure, it might accidentally cause something to be removed or invalid that was protecting patients in one region. It would be better if there was one main system that covers all the main, important pieces, but allow different companies to add smaller rules to meet more local laws. That way, it makes it easier for companies to merge, as they only have to focus on the differences from the local laws. I'm curious, how much power should companies in different regions have to adjust the global quality system before is starts to feel like something else entirely?
I can understand where you're coming from when you mention that the merging of companies can create fragmented quality systems, which in turn slows company progress. However, I think your statement of having a globally standardized system already exists, but not as a system but as a framework. While every country has its own regulatory requirements, they generally follow the same “outline” of having a legislative focus, regulatory bodies (FDA in the US, the EMA in the EU, and the PMDA in Japan), and risk based classification. However, this is purely hierarchical, and what I believe you're trying to achieve is a global framework similar to ISO 13485 that defines universal expectations for documentation, risk management, and traceability, while allowing flexibility for regional bodies and their standards like FDA 21 CFR 820 vs. EU MDR. In that sense, I think an issue that might arise is maintaining consistent training and interpretation across regions. Additionally, when it comes to companies making these adjustments, they should first and foremost follow the law but also ensure that their adjustments don’t compromise the standards of another region.
