Ginger Glaser always has great insights. I'll add that for the ISO 13485 context (which now seems to be the prevailing QMS requirement globally), there is a built-in provision to assure that "regulatory requirements" doesn't become overblown with unintended regulations. Specifically, "regulatory requirements" are limited to requirements for the QMS and for device safety or performance.
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Original Message:
Sent: 13-Feb-2024 10:14
From: Ginger Glaser
Subject: eQMS implementation
"Regarding the involvement of regulatory affairs when documenting (establishing, implementing, maintaining) a QMS implementation: Ultimately, a QMS is a regulatory requirement in multiple jurisdictions. Thus, excluding the regulatory affairs team from a QMS design and/or implementation effort is in stark conflict with this reality.
For example, an ISO (or EN ISO) 13485 QMS must include many attributes that are tethered to regulatory requirements, not the least of which is its general requirement that the QMS is to be documented (established, implemented, maintained) in accordance with applicable regulatory requirements. Indeed, 13485's title is Medical devices - Quality management systems - Requirements for regulatory purposes."
Quoting from part of the previous response here (with which I generally agree with - more communication is better)... But I think the above is part of what ends up causing confusion, because it depends on what specifically the companies "Regulatory" and "Quality" teams are responsible for and expected to be the experts in. For instance, in many of the companies I worked for, and for some of my current clients, the "Regulatory" team mainly does pre-market submissions and device change submissions, while the "Quality" team is expected to be the experts on regulations such as global QMS requirements, post market reporting etc. Thus, despite the fact that "regulations require" something, in those companies "regulatory" would not be deemed required to weigh in because of the above, because the "quality" team is the assigned responsibility for it.
In other companies, "regulatory" would be responsible for these items and would need to be highly involved.
The challenge is many aspects of a business involve "regulations" but are not the domain of "regulatory" - think OSHA regulations, SEC regulations, EPA regulations etc. Now I did work at one (small) company in my life where "regulatory" included all that and more, but it is rare.
I think the challenge is that the QMS requirements are in various geographies "medical device regulations" and, in the case of the EU MDR, there seems to be an assumption that the "regulatory" function is responsible for it - even if not the case in many, many companies.
All that said, as intertwined as the Regulatory and Quality functions are these days, more communication is better, and as others have said - in order to successfully implement a QMS solution, all stakeholders should be involved. In fact, I would argue the system should be based on stakeholders REQUIREMENTS including those of regulatory, R&D, manufacturing etc etc....as well as quality.
Ginger
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 12-Feb-2024 10:51
From: Kevin Randall
Subject: eQMS implementation
In general, a key rule of designing and implementing any aspect of a QMS is to engage the input of affected stakeholders. If we instead design and implement the QMS in a vacuum without getting input from affected stakeholders, then it can alienate them and cause them not to support or cooperate with the QMS. This is not because of their stubbornness (sometimes it is, but oftentimes not). Instead, it is because the QMS impacts stakeholders' day-to-day operations. Thus, whenever we endeavor to insert a new paradigm into a stakeholder's world, we would be remiss if we didn't involve that stakeholder. I think this is one of the reasons behind ISO 13485 clause 5.5.3 (internal communication).
Regarding the involvement of regulatory affairs when documenting (establishing, implementing, maintaining) a QMS implementation: Ultimately, a QMS is a regulatory requirement in multiple jurisdictions. Thus, excluding the regulatory affairs team from a QMS design and/or implementation effort is in stark conflict with this reality.
For example, an ISO (or EN ISO) 13485 QMS must include many attributes that are tethered to regulatory requirements, not the least of which is its general requirement that the QMS is to be documented (established, implemented, maintained) in accordance with applicable regulatory requirements. Indeed, 13485's title is Medical devices - Quality management systems - Requirements for regulatory purposes.
In addition to these fundamental elements, there are also many specific aspects of the QMS that directly impact regulatory stakeholders. Some examples include design and development, risk management, post-market surveillance (e.g., complaint handling and adverse event reporting), change management, recalls, outsourced process control, and others.
The same dynamics exist with respect to the organization's other stakeholders too (e.g., manufacturing, engineering, etc.).
When a quality department fails to properly engage a QMS's affected stakeholders, it is a classic textbook failure that undermines the overall effectiveness of a QMS and gives quality a bad name.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 12-Feb-2024 09:16
From: Robert Blanks
Subject: eQMS implementation
Anon,
Agree with Anne, there is no regulation that requires input from regulatory. However, as regulatory and quality changes are often intertwined (e.g. quality change may require regulatory input as to impact on filing, and regulatory must inform QA if HA approve the change so can be implemented.), I would highly recommend you work together in the implementation as needed.
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Robert Blanks RAC
VP, Regulatory Affairs and Quality Assurance
[Ardelyx]
Auburndale MA
United States
Original Message:
Sent: 08-Feb-2024 17:27
From: Anonymous Member
Subject: eQMS implementation
This message was posted by a user wishing to remain anonymous
Currently, the Quality Department is leading a project to migrate from a paper-based system to an eQMS system, but they have done this without any input from users, such as regulatory, manufacturing, supply chain, engineering, etc. How important is regulatory oversight and input on implementing the eQMS system? I believe input from regulatory is required but wondering I am offbase.