Latest / Let's Talk Risk! Podcast / LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations

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LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations · Let's Talk Risk! Podcast

• 0:00
  SPEAKER_02: As we approach the deadline to get ready for QMSR,
• 0:04
  SPEAKER_02: which is going to be in February,
• 0:05
  SPEAKER_02: I'm sure many of you are wondering if you are truly ready or not.
• 0:09
  SPEAKER_02: What should you be doing now?
• 0:11
  SPEAKER_02: How should prioritize your actions in the near term?
• 0:15
  SPEAKER_02: Hi, everyone.
• 0:16
  SPEAKER_02: I'm Naveen Agarwal.
• 0:17
  And today we're going to talk about QMSR readiness and what you
• 0:21
  should be thinking
• 0:21
  SPEAKER_02: about now,
• 0:22
  SPEAKER_02: how FDA is going to see you in the future,
• 0:26
  SPEAKER_02: both in pre-market and post-market.
• 0:28
  SPEAKER_02: And for that conversation, I have a wonderful guest today.
• 0:31
  SPEAKER_02: I'm pleased to welcome Michelle Lott.
• 0:34
  SPEAKER_02: Hi, Michelle.
• 0:35
  SPEAKER_02: How are you today?
• 0:36
  SPEAKER_01: Hi.
• 0:37
  SPEAKER_01: I'm doing good.
• 0:38
  SPEAKER_01: I appreciate being on your program again.
• 0:40
  SPEAKER_01: Wonderful.
• 0:42
  Now,
• 0:42
  Michelle,
• 0:42
  you are the executive advisor for regulatory affairs at Lean RA
• 0:47
  QA.
• 0:47
  And I know you are having a lot of conversations probably with
• 0:50
  senior leaders in QA
• 0:52
  SPEAKER_02: RA to help them get ready or maybe assess their readiness for QMSR.
• 0:56
  SPEAKER_02: So I want to start by asking you,
• 0:58
  SPEAKER_02: what is your sense of where the industry is in terms of QMSR readiness?
• 1:03
  SPEAKER_01: Well,
• 1:03
  SPEAKER_01: given that we're only six weeks plus or minus away from QMSR being live,
• 1:09
  SPEAKER_01: I am really underwhelmed by industry's level of,
• 1:14
  SPEAKER_01: and I won't even say awareness,
• 1:16
  SPEAKER_01: because I think they're aware of the change,
• 1:19
  SPEAKER_01: but they're not moving towards the change.
• 1:22
  So I still think that people are holding their breath to see if
• 1:26
  the administration
• 1:27
  SPEAKER_01: is really going to go through with this.
• 1:30
  SPEAKER_01: This was already regulation.
• 1:33
  SPEAKER_01: when it wasn't like it was a draft regulation that they could pull back.
• 1:38
  SPEAKER_01: This has already been published in the Federal Register.
• 1:41
  SPEAKER_01: And in fact,
• 1:41
  SPEAKER_01: just like in the last week or so,
• 1:43
  FDA updated 179 other parts of the CFR regulation that discuss
• 1:52
  820 to align with
• 1:54
  SPEAKER_01: the new QMSR.
• 1:55
  SPEAKER_01: So this train is moving forward, you know, regardless of what
• 2:01
  SPEAKER_01: The political environment is in the FDA right now.
• 2:05
  SPEAKER_02: It's interesting for me to hear that from you.
• 2:07
  SPEAKER_02: It sounds like a lot of people are just relying on luck, plain luck.
• 2:12
  SPEAKER_02: Let's get some more time.
• 2:13
  SPEAKER_02: Let's see if it's going to go into effect or not.
• 2:17
  Maybe something like what happened to MDR might happen here
• 2:20
  that we keep postponing.
• 2:21
  SPEAKER_02: But that's not my sense, Michelle.
• 2:23
  And I think you mentioned that FDA is already preparing
• 2:25
  themselves by modifying
• 2:28
  SPEAKER_02: their regulatory framework to now refer to QMSR.
• 2:31
  Tell us a little bit more about how we can sort of influence
• 2:34
  our peers in the
• 2:35
  SPEAKER_02: industry to take this really seriously and not count on just pure luck.
• 2:39
  SPEAKER_01: Shoot.
• 2:40
  SPEAKER_01: If I knew that, I mean...
• 2:43
  SPEAKER_01: I would have sold a ton of my QMSR classes of how to prepare.
• 2:48
  SPEAKER_01: So yeah,
• 2:49
  SPEAKER_01: I just think,
• 2:50
  SPEAKER_01: you know,
• 2:51
  you can't hold your breath and wait anymore because maybe if
• 2:55
  you have an ISO 1345
• 2:58
  SPEAKER_01: certification,
• 2:59
  you're going to be more ready than somebody that is not fully
• 3:04
  1345 compliant.
• 3:06
  So I think that those are the people where if you're going to
• 3:09
  catch somebody's hair
• 3:10
  SPEAKER_01: on fire,
• 3:11
  SPEAKER_01: those are the ones that need to
• 3:13
  You don't have six weeks is not a long time to make the changes
• 3:18
  that you need.
• 3:19
  Maybe if you're 1345,
• 3:21
  there's only a handful of major things you're going to have to
• 3:25
  update.
• 3:26
  SPEAKER_01: You probably have plenty of time.
• 3:29
  So just apply a risk-based approach to your own self about
• 3:34
  where you are in making
• 3:35
  SPEAKER_01: that transition.
• 3:37
  SPEAKER_02: Yeah, we'll talk more about that.
• 3:38
  SPEAKER_02: So Michelle,
• 3:39
  SPEAKER_02: you see this across the board,
• 3:41
  SPEAKER_02: whether they are ISO 1345 certified or not,
• 3:44
  SPEAKER_02: you see maybe not as much urgency as you would expect them to have.
• 3:49
  SPEAKER_02: Is that kind of a fair statement?
• 3:50
  SPEAKER_01: Definitely the people that are in the US market only without that 1345,
• 3:54
  I think are the ones that are really hurting and are really
• 3:58
  going to be hurting.
• 4:00
  SPEAKER_01: And I think that
• 4:01
  The ones that already have a 1345 and a certificate and are
• 4:05
  already used to that
• 4:06
  SPEAKER_01: mindset,
• 4:08
  SPEAKER_01: then,
• 4:08
  SPEAKER_01: yeah,
• 4:08
  maybe it's only a few administrative changes to their
• 4:11
  procedures to be compliant.
• 4:14
  So that they're not nearly as at much risk of the potential
• 4:20
  inspection being a really big deal.
• 4:21
  SPEAKER_02: And maybe a lot of people are counting on the fact that,
• 4:24
  SPEAKER_02: you know,
• 4:24
  SPEAKER_02: perhaps FDA is not going to show up right on,
• 4:27
  SPEAKER_02: you know,
• 4:28
  SPEAKER_02: 3rd of February on their door and start inspecting them to QMSR.
• 4:31
  Maybe they'll have a little bit more time,
• 4:32
  maybe some kind of a grace period.
• 4:34
  I don't think they have announced that at all,
• 4:36
  officially,
• 4:37
  that there'll be any grace period.
• 4:38
  SPEAKER_01: Well,
• 4:39
  SPEAKER_01: they officially announced when they launched QMSR,
• 4:43
  SPEAKER_01: you know,
• 4:44
  SPEAKER_01: in 2024,
• 4:44
  SPEAKER_01: that February 2nd,
• 4:47
  SPEAKER_01: 2026 would be a drop dead date,
• 4:50
  SPEAKER_01: effectively.
• 4:51
  SPEAKER_01: and that they will be conducting audits effective February 3rd in QMSR.
• 4:57
  So they've already said this two years we're giving you,
• 5:01
  that is your grace period.
• 5:03
  SPEAKER_01: So get ready.
• 5:05
  SPEAKER_02: Get ready.
• 5:05
  SPEAKER_02: So let's talk about that in just a moment.
• 5:07
  But I have a feeling that those who go to FDA after QMSR comes
• 5:12
  into effect for
• 5:13
  pre-market submissions might be impacted a lot more than where
• 5:17
  FDA shows up for an
• 5:18
  SPEAKER_02: inspection.
• 5:18
  SPEAKER_02: And I say that because,
• 5:19
  SPEAKER_02: as we know,
• 5:20
  recently FDA came out with their draft guidance where they have
• 5:24
  specified the
• 5:25
  SPEAKER_02: expectations.
• 5:26
  SPEAKER_02: for QMSR-related information to be included in a PMA submission, right?
• 5:30
  SPEAKER_02: So they're already giving us a signal that,
• 5:32
  SPEAKER_02: hey,
• 5:32
  SPEAKER_02: if you're coming to us with a new submission,
• 5:34
  SPEAKER_02: we do expect this type of information.
• 5:36
  SPEAKER_02: So let's talk a little bit more about that.
• 5:38
  SPEAKER_02: First of all,
• 5:39
  were you surprised to see that draft guidance come out from the
• 5:41
  FDA for pre-market
• 5:43
  SPEAKER_02: submissions?
• 5:43
  SPEAKER_01: I was really surprised to see that for a number of reasons,
• 5:47
  SPEAKER_01: and not the least of which,
• 5:49
  SPEAKER_01: that the FDA
• 5:51
  SPEAKER_01: has not launched what its inspection model is going to be yet.
• 5:55
  SPEAKER_01: So I was like,
• 5:56
  between the inspection model that's going to impact every
• 6:00
  single medical device
• 6:02
  company that is marketing in the US and versus pre-market
• 6:08
  approvals are only like
• 6:10
  SPEAKER_01: five,
• 6:11
  SPEAKER_01: maybe 10% of the types of submissions that go into the FDA.
• 6:15
  SPEAKER_01: I felt like it wasn't the best use of FDA resources to start there,
• 6:23
  SPEAKER_01: which is ironic because,
• 6:25
  SPEAKER_01: you know,
• 6:25
  you're going to be harping on that concept of risk-based
• 6:29
  approach for probably not
• 6:31
  SPEAKER_01: only until February and beyond.
• 6:35
  SPEAKER_01: So to me, the FDA didn't use a risk-based approach in choosing the
• 6:40
  SPEAKER_01: where to start explaining its expectations.
• 6:43
  SPEAKER_02: You know,
• 6:43
  SPEAKER_02: now that you say that,
• 6:44
  it makes a lot of sense to me because aren't they under this 10
• 6:47
  to 1 rule that for
• 6:48
  SPEAKER_02: every new guidance or regulation they come out,
• 6:51
  SPEAKER_02: they have to throw away 10?
• 6:52
  So the fact they will prioritize a PMA submission draft
• 6:57
  guidance over QCIT,
• 6:58
  you are right.
• 6:59
  SPEAKER_02: It's kind of crazy to think about that.
• 7:01
  SPEAKER_02: Yeah.
• 7:02
  SPEAKER_02: But it tells me that FDA is not one thing.
• 7:05
  SPEAKER_02: Many people work in different teams.
• 7:06
  SPEAKER_02: They have different priorities, different goals.
• 7:08
  And maybe this team came out first and they published their
• 7:11
  draft guidance.
• 7:12
  SPEAKER_02: That's what it seems to me.
• 7:13
  SPEAKER_02: And having said that, let's talk about that.
• 7:15
  When I glanced at this PMA draft guidance,
• 7:19
  I basically see them repeating what 1345 requires.
• 7:24
  SPEAKER_02: Essentially, I think they are laying the groundwork for
• 7:27
  SPEAKER_02: for saying this is what we will expect in the documentation.
• 7:30
  SPEAKER_02: And oh,
• 7:30
  SPEAKER_02: by the way,
• 7:31
  if you cannot convince us that your QMS is ready and capable of
• 7:37
  making risk-based
• 7:38
  SPEAKER_02: decisions,
• 7:38
  SPEAKER_02: we can deny your PMA.
• 7:40
  I think that's what they are doing by setting this in writing
• 7:43
  because on surface,
• 7:44
  SPEAKER_02: FDA has claimed that even in quality system regulation,
• 7:47
  SPEAKER_02: their expectations were no different than what 13485 says today,
• 7:51
  SPEAKER_02: right?
• 7:52
  SPEAKER_02: So what's the need for putting this in writing?
• 7:54
  SPEAKER_02: I'm kind of trying to
• 7:55
  SPEAKER_02: pick at that and would love to hear your perspective on what you think.
• 7:58
  SPEAKER_01: Yeah.
• 7:59
  SPEAKER_01: Yeah, you're not wrong.
• 8:00
  And this guidance pretty much just goes through and it flat out
• 8:06
  says ISO 1345 clause.
• 8:08
  SPEAKER_01: That's what,
• 8:09
  SPEAKER_01: you know,
• 8:09
  SPEAKER_01: and it goes like through all of the major subsystems,
• 8:14
  SPEAKER_01: specifically calling out not only 1345,
• 8:18
  SPEAKER_01: but exactly what it expects to see,
• 8:21
  SPEAKER_01: not only what procedures are expected,
• 8:25
  SPEAKER_01: but what those procedures should contain at minimum.
• 8:29
  SPEAKER_01: And not only have the term risk in concept of,
• 8:33
  SPEAKER_01: you know,
• 8:34
  SPEAKER_01: the product 14971,
• 8:36
  they've used the 1345 concept of risk based approach within a
• 8:43
  element of a quality
• 8:44
  SPEAKER_01: management system.
• 8:45
  So we're not just talking about,
• 8:48
  you know,
• 8:48
  everybody's hazard analysis or,
• 8:51
  you know,
• 8:53
  SPEAKER_01: Yeah.
• 8:55
  SPEAKER_02: So it's not like they are telling us,
• 8:57
  SPEAKER_02: if you are coming to FDA with a PMA submission,
• 9:00
  SPEAKER_02: give us everything you have,
• 9:02
  SPEAKER_02: all these worksheets and hazard analysis and whatnot.
• 9:05
  I think they are telling us to go to them to gain that level of
• 9:08
  confidence from the
• 9:09
  SPEAKER_02: agency and communicate that level of assurance to
• 9:12
  that we now have in our quality management system so that when
• 9:15
  our device goes to
• 9:16
  SPEAKER_02: the market,
• 9:17
  SPEAKER_02: we can sustain its safety and effectiveness.
• 9:20
  SPEAKER_02: I think that's what they're looking for, assurance, not for compliance.
• 9:23
  SPEAKER_02: Did I get that right?
• 9:24
  SPEAKER_01: Yeah, I believe so.
• 9:25
  SPEAKER_01: I think that they are saying,
• 9:27
  SPEAKER_01: okay,
• 9:28
  if you have a quality management system and it meets all these
• 9:31
  requirements,
• 9:32
  then you have all the controls in place that you need to
• 9:37
  monitor your product's
• 9:39
  SPEAKER_01: safety and efficacy.
• 9:41
  on your own without us having to have,
• 9:44
  you know,
• 9:45
  so much direct oversight of you.
• 9:48
  SPEAKER_01: We can trust that you have got your processes,
• 9:51
  SPEAKER_01: you're following your processes,
• 9:53
  and your processes in and of themselves are going to be
• 9:57
  adequate for validate your
• 9:59
  SPEAKER_01: product safety and efficacy.
• 10:01
  So it seems to me that they're trying to push the button where
• 10:04
  they think industry
• 10:05
  SPEAKER_02: is going to respond more urgently.
• 10:07
  SPEAKER_02: And they're trying to push the button in the pre-market phase.
• 10:09
  And they're saying,
• 10:09
  hey,
• 10:10
  if you're coming to us with a PMA,
• 10:11
  make sure you are ready.
• 10:12
  SPEAKER_02: Because when we are going to come in for our pre-approval inspection,
• 10:15
  SPEAKER_02: we're going to expect a risk-based QMS,
• 10:18
  SPEAKER_02: which is effective.
• 10:19
  And we won't just trust anything that you have given to us on
• 10:22
  paper,
• 10:22
  but be ready.
• 10:23
  SPEAKER_02: So I have a feeling that they are trying to push that button first,
• 10:26
  SPEAKER_02: because normally people prioritize going to market
• 10:29
  SPEAKER_02: over being in compliance all the time.
• 10:31
  I mean,
• 10:32
  compliance is important,
• 10:33
  but business is driven by new product launches,
• 10:35
  right?
• 10:36
  So having said that,
• 10:37
  I think it does signal to us how FDA views this whole notion of
• 10:42
  risk.
• 10:42
  SPEAKER_02: They have left no doubt anymore.
• 10:44
  SPEAKER_02: I think they are telling us more and more.
• 10:46
  So let's talk about what it might signal to the rest of the
• 10:49
  industry in the post-market phase.
• 10:51
  SPEAKER_02: And we talk a lot about risk-based control.
• 10:54
  SPEAKER_02: What does that really mean from an FDA perspective?
• 10:56
  SPEAKER_01: I think...
• 10:57
  We have to interpret it to the best of our experience from 1345
• 11:02
  and certification
• 11:03
  audits that they're going to interpret things similarly because
• 11:08
  the risk-based
• 11:09
  SPEAKER_01: approach is like,
• 11:09
  SPEAKER_01: say you have a nonconformity.
• 11:12
  SPEAKER_01: Not all nonconformities are created equal.
• 11:16
  SPEAKER_01: And also say you have suppliers.
• 11:18
  SPEAKER_01: Well, not all suppliers are created equal.
• 11:20
  So the level of controls that you have need to be appropriate
• 11:25
  towards however that
• 11:27
  incident or that company or whatever has an impact on product
• 11:32
  safety or quality.
• 11:33
  SPEAKER_01: For instance,
• 11:34
  like a risk-based approach would be in a supplier setting that
• 11:38
  your critical
• 11:39
  SPEAKER_01: suppliers that are supplying products
• 11:41
  finished device,
• 11:43
  sterilization,
• 11:44
  sensitive components that if they fail,
• 11:47
  the whole thing fails.
• 11:48
  So those critical suppliers have a higher level of control
• 11:54
  that's required for them.
• 11:55
  SPEAKER_01: Whereas like
• 11:57
  The Grangers or the Home Depots where they just go for a basic
• 12:02
  off-the-shelf screw,
• 12:03
  SPEAKER_01: those might be on your supplier list,
• 12:05
  but there's no controls because Home Depot is not going to give
• 12:09
  you anything,
• 12:10
  SPEAKER_01: you know,
• 12:11
  SPEAKER_01: in regards to the product.
• 12:14
  So that's just an example of not just applying one tool or one
• 12:20
  thought process,
• 12:21
  SPEAKER_01: just blanketed across everybody or everything.
• 12:25
  but having like these tiers of severity that you respond to
• 12:30
  accordingly,
• 12:31
  if that makes sense.
• 12:32
  SPEAKER_02: Yeah, it does make sense.
• 12:33
  And I think this situation might become even more complex and
• 12:36
  challenging for software.
• 12:38
  If it's a SAMD or AI ML device,
• 12:40
  you know,
• 12:41
  it can become a little bit crazy.
• 12:42
  We're also going to be turning the camera on to not just
• 12:47
  software in and of the
• 12:49
  SPEAKER_01: product,
• 12:49
  SPEAKER_01: but in and of the quality management system.
• 12:53
  SPEAKER_02: Yes, that's correct.
• 12:54
  SPEAKER_02: And they did come out with a guidance about that,
• 12:56
  SPEAKER_02: which I think people should pay close attention to.
• 12:59
  And I think that is where I started kind of understanding a
• 13:01
  little bit more about
• 13:02
  SPEAKER_02: where FDA is coming from,
• 13:04
  is they really want us to have an assurance mindset and not a
• 13:07
  compliance mindset.
• 13:09
  I keep repeating that often because it is important for us to
• 13:13
  think like that,
• 13:14
  SPEAKER_02: especially if you're in a leadership position,
• 13:15
  SPEAKER_02: right?
• 13:16
  SPEAKER_02: Being leaders,
• 13:17
  SPEAKER_02: of course,
• 13:17
  SPEAKER_02: we can prepare our organizations for audits and inspections,
• 13:20
  SPEAKER_02: have this procedure ready,
• 13:21
  SPEAKER_02: that form and template ready,
• 13:23
  SPEAKER_02: people get trained,
• 13:24
  SPEAKER_02: all the records in place,
• 13:25
  SPEAKER_02: our place looks clean,
• 13:26
  SPEAKER_02: nothing is in the hallways.
• 13:28
  But we have to lead our organization towards this goal of
• 13:32
  assurance,
• 13:33
  right?
• 13:33
  and making sure that we convince our agency or even our
• 13:36
  customers and stakeholders
• 13:37
  SPEAKER_02: that,
• 13:38
  SPEAKER_02: hey,
• 13:38
  SPEAKER_02: we have assurance in mind,
• 13:39
  SPEAKER_02: not compliance in mind.
• 13:40
  SPEAKER_02: I think this is the essence of it.
• 13:42
  SPEAKER_02: And we have to start talking about that a little bit more.
• 13:45
  SPEAKER_02: So great, Michelle.
• 13:46
  SPEAKER_02: Let's continue this conversation.
• 13:48
  SPEAKER_02: As we mentioned,
• 13:48
  a lot of people in the industry are maybe not as serious about
• 13:53
  this or not treating
• 13:54
  SPEAKER_02: this with a sense of urgency they should.
• 13:56
  Having said that,
• 13:57
  what would you recommend them to prioritize at this stage,
• 14:00
  SPEAKER_01: Well, first you have to do the stopgap.
• 14:02
  SPEAKER_01: So any of those areas where under the QSR,
• 14:07
  SPEAKER_01: like a procedure wasn't required or wasn't specified,
• 14:12
  SPEAKER_01: you need to start there.
• 14:13
  SPEAKER_01: And so like quality manual, number one.
• 14:16
  SPEAKER_01: Now,
• 14:16
  SPEAKER_01: most companies still had a quality manual,
• 14:19
  but that's an example of one difference where technically it
• 14:23
  was not specified in
• 14:25
  SPEAKER_01: QSR.
• 14:26
  SPEAKER_01: But now it's clearly the foundational document in QMSR.
• 14:32
  SPEAKER_01: So that's the first thing is like close those big gaps.
• 14:37
  The second thing is that when we get the 43 data at the end of
• 14:44
  the fiscal year for
• 14:46
  SPEAKER_01: the previous year and FDA breaks it down,
• 14:50
  by oh and a 483 by the way the audience is it's basically just
• 14:56
  the form number that
• 14:57
  fda writes down your observations on so it's fda observations
• 15:02
  so they break down
• 15:03
  their observations or their number of 43s by subsystem and
• 15:08
  these are all always not
• 15:10
  SPEAKER_01: in this order but always these five kappa
• 15:15
  complaints,
• 15:16
  sign controls,
• 15:17
  supplier controls,
• 15:18
  and non-conforming products.
• 15:20
  SPEAKER_01: So if under the QSR,
• 15:23
  companies are already not meeting expectations consistently
• 15:28
  year over year in those
• 15:30
  SPEAKER_01: five,
• 15:31
  SPEAKER_01: and those five have significantly increased the number of requirements,
• 15:38
  SPEAKER_01: increased the number of ways to think about it.
• 15:43
  then we are going to be even further behind in those five big
• 15:47
  areas because we
• 15:48
  SPEAKER_01: already weren't doing those right.
• 15:50
  SPEAKER_01: So that's where,
• 15:51
  SPEAKER_01: you know,
• 15:51
  SPEAKER_01: we've got to not just raise the bar in those areas,
• 15:55
  SPEAKER_01: but we've got to exceed what the bar was in those areas.
• 16:00
  Oh,
• 16:00
  that's a very nice way of breaking it down and helping people
• 16:02
  prioritize.
• 16:03
  It'll be important for folks to understand that they are not
• 16:06
  isolated processes.
• 16:08
  SPEAKER_02: They are not standalone processes.
• 16:09
  SPEAKER_02: They are connected.
• 16:11
  SPEAKER_02: They are interrelated.
• 16:12
  And this is where ISO 13485 becomes a little bit challenging to
• 16:16
  apply in practice
• 16:17
  SPEAKER_02: because it is a process-based QMS.
• 16:19
  SPEAKER_02: It talks about inputs and outputs and interrelationships.
• 16:23
  SPEAKER_02: And that is where you have to think about risk,
• 16:25
  SPEAKER_02: is it not,
• 16:25
  SPEAKER_02: in terms of its relationships with each other?
• 16:27
  SPEAKER_00: Mm-hmm.
• 16:29
  SPEAKER_02: So that's what I'm thinking,
• 16:30
  that people will have to kind of mature to a point where they
• 16:33
  begin to understand
• 16:35
  SPEAKER_02: the relationships between these processes.
• 16:37
  SPEAKER_01: And,
• 16:37
  SPEAKER_01: you know,
• 16:38
  it's ironic to go back to that pre-market approval guidance
• 16:41
  document and hear how
• 16:43
  SPEAKER_01: FDA is talking about them.
• 16:45
  SPEAKER_01: You know, another kind of gap, if you will, is management review.
• 16:50
  SPEAKER_00: Yeah.
• 16:51
  SPEAKER_01: Review, FDA has never had purview to, but now underneath the QMSR,
• 16:58
  SPEAKER_01: they can look at your management review.
• 17:01
  And that was one area that they specifically added to this PMA
• 17:05
  document is,
• 17:07
  SPEAKER_01: hey,
• 17:08
  SPEAKER_01: you do have to turn in your management review,
• 17:11
  SPEAKER_01: not only your procedure,
• 17:13
  but we want a clear idea of your inputs and where they're
• 17:18
  coming from and how
• 17:19
  SPEAKER_01: they're related to your outputs.
• 17:21
  SPEAKER_01: And we need all of that described, not only in your procedure,
• 17:26
  SPEAKER_01: but in like a detailed, you know, like executive summary within the PMA.
• 17:32
  SPEAKER_01: So,
• 17:33
  SPEAKER_01: yeah,
• 17:33
  they are going to be specifically looking within each subsystem
• 17:39
  for what the input
• 17:40
  SPEAKER_01: to that subsystem is.
• 17:42
  And then you've got that kicker of the analysis of data that
• 17:46
  goes with pretty much
• 17:47
  every other subsystem that FDA is going to expect to see those
• 17:52
  things kind of go
• 17:53
  SPEAKER_01: hand in hand,
• 17:54
  SPEAKER_01: if that makes sense.
• 17:55
  SPEAKER_02: Yeah.
• 17:56
  SPEAKER_02: So let's talk about management review a little bit.
• 17:58
  SPEAKER_02: This is a big change.
• 17:59
  Is it not that FDA can now really review exactly what happened
• 18:04
  in the management review?
• 18:05
  What are you hearing about that in terms of response or just
• 18:09
  perceptions in the industry?
• 18:11
  SPEAKER_01: I think the feedback's a little bit mixed.
• 18:13
  SPEAKER_01: I think there is definitely,
• 18:15
  SPEAKER_01: you know,
• 18:15
  how are they going to answer that issue of why they originally
• 18:19
  protected those
• 18:20
  SPEAKER_01: records,
• 18:20
  SPEAKER_01: being management review,
• 18:21
  SPEAKER_01: internal audit,
• 18:22
  SPEAKER_01: supplier audits,
• 18:23
  SPEAKER_01: because they wanted those records
• 18:26
  SPEAKER_01: procedures or processes to be as effective as possible internally.
• 18:32
  SPEAKER_01: And they felt like,
• 18:33
  SPEAKER_01: well,
• 18:34
  SPEAKER_01: by us not looking at it,
• 18:36
  SPEAKER_01: the company will be a little bit more honest about themselves,
• 18:41
  SPEAKER_01: about the problems they have,
• 18:43
  SPEAKER_01: about discussing the problems.
• 18:45
  If they're not worried that we're going to be like looking over
• 18:48
  their shoulder at
• 18:49
  SPEAKER_01: exactly what's wrong.
• 18:51
  SPEAKER_01: So I think that's still out there.
• 18:54
  SPEAKER_01: But then at the same time,
• 18:56
  SPEAKER_01: they're like,
• 18:57
  SPEAKER_01: well,
• 18:57
  every other government agency basically in the world doesn't
• 19:00
  have those protected.
• 19:02
  SPEAKER_01: So why should we be any different?
• 19:04
  SPEAKER_01: So again,
• 19:05
  SPEAKER_01: back to the people that I think are going to be most impacted,
• 19:08
  SPEAKER_01: just like the ones that have only been marketed in the U.S.
• 19:12
  are going to be mostly highest,
• 19:14
  most unprepared and most impacted by QMSR.
• 19:17
  SPEAKER_01: The same goes for management review.
• 19:19
  SPEAKER_01: Those companies who've been marketing only in the U.S.
• 19:22
  and they've never had their management review or internal audit
• 19:25
  or supplier audit
• 19:26
  SPEAKER_01: inspected by a registrar or a notified body,
• 19:30
  SPEAKER_01: they're not going to know what to expect.
• 19:32
  SPEAKER_01: And they might not even be doing them properly already.
• 19:36
  SPEAKER_01: So I think that that's going to be a learning curve for everybody.
• 19:40
  SPEAKER_02: So is it fair to say that FDA insisted on this requirement because...
• 19:45
  SPEAKER_02: You know, we have like over 25 years of experience with QSR.
• 19:49
  SPEAKER_02: And yeah,
• 19:50
  they gave industry this freedom to do the reviews they wanted
• 19:53
  to do and show them
• 19:54
  SPEAKER_02: meeting minutes or anything like that.
• 19:56
  SPEAKER_02: But they didn't really believe that management reviews were effective.
• 20:00
  SPEAKER_02: And now they really want to see, or am I reading too much into this?
• 20:04
  SPEAKER_01: No, I think that they're going to use the management review.
• 20:08
  And if they look across your other subsystems and they feel
• 20:13
  that either they're not feeding them
• 20:15
  or you're not identifying problems out of them,
• 20:18
  then that's where the breakdown is going to be.
• 20:20
  SPEAKER_01: They're going to go to top management,
• 20:24
  SPEAKER_01: that management with executive responsibility,
• 20:26
  and you're going to get probably an observation against that
• 20:29
  subsystem and an
• 20:31
  observation against the subsystem where they felt like that
• 20:35
  breakdown should have
• 20:36
  SPEAKER_01: been discussed.
• 20:38
  SPEAKER_02: Both.
• 20:38
  SPEAKER_02: And they'll have explicit regulatory language under,
• 20:41
  SPEAKER_02: I believe,
• 20:41
  Clause 5 or 485 to hold top management accountable if there is
• 20:46
  a deficiency.
• 20:47
  SPEAKER_02: But I still have a feeling that FDA is a mature agency.
• 20:51
  They're not going to use that lightly or in a manner which is
• 20:55
  not focused.
• 20:56
  I think they're going to go after that only if they are
• 20:58
  convinced that there is a
• 20:59
  SPEAKER_02: fundamental systemic issue,
• 21:01
  SPEAKER_02: that it is not being addressed for many,
• 21:04
  SPEAKER_02: many years.
• 21:04
  SPEAKER_02: In fact, one case study I recently wrote about
• 21:07
  was a company that had been shipping product in a
• 21:11
  non-conforming package for more
• 21:13
  SPEAKER_02: than 20 years,
• 21:14
  SPEAKER_02: more than 10 years.
• 21:15
  And these products were failing in the field and they were
• 21:17
  revision surgeries and
• 21:18
  SPEAKER_02: the packaging was missing a very key oxygen barrier layer.
• 21:22
  SPEAKER_02: And they were clueless about that.
• 21:24
  SPEAKER_02: So obviously it's not just a breakdown of purchasing controls,
• 21:27
  SPEAKER_02: even though my case study was about that.
• 21:29
  SPEAKER_02: It's a breakdown of the entire management structure.
• 21:32
  So I have a feeling that,
• 21:34
  and I'd like to give people the benefit of the doubt.
• 21:36
  SPEAKER_02: So it's not like they want to go after people just for the sake of it.
• 21:40
  I think they want to make sure that they have regulatory
• 21:44
  enforcement authority when
• 21:45
  they are convinced that there is a deeper systemic issue and
• 21:48
  that needs to be taken
• 21:49
  SPEAKER_02: seriously.
• 21:50
  SPEAKER_02: That's my read.
• 21:51
  SPEAKER_02: What are your thoughts around that?
• 21:53
  SPEAKER_01: No, I agree with that assessment.
• 21:58
  Because the point of the quality management system and the
• 22:01
  subsystems is that they
• 22:03
  SPEAKER_01: feed each other.
• 22:04
  SPEAKER_01: And so if you have a significant breakdown in one area,
• 22:09
  SPEAKER_01: like what you were just describing,
• 22:10
  SPEAKER_01: there should have been other subsystems functioning around it.
• 22:15
  that should have caught that somewhere and have been elevated
• 22:21
  to a management level
• 22:23
  SPEAKER_01: to be addressed.
• 22:24
  SPEAKER_02: Yeah, yeah.
• 22:25
  And essentially what they're saying is that we are not going to
• 22:28
  hear about excuses or reasons.
• 22:30
  SPEAKER_02: We're just going to go after,
• 22:31
  if we are convinced that this is a management issue and an
• 22:35
  issue of focus and
• 22:36
  SPEAKER_02: strategy and resources,
• 22:37
  we're just going to go after the executive management
• 22:41
  responsibility that is now
• 22:43
  SPEAKER_02: available to us from a regulatory, explicit regulatory.
• 22:47
  SPEAKER_02: Yeah,
• 22:47
  SPEAKER_02: before they did have some language in the QSR,
• 22:50
  SPEAKER_02: but it was not as explicit as it is in clause five.
• 22:53
  SPEAKER_02: So I know we are talking in great detail,
• 22:55
  SPEAKER_02: but I want our viewers to understand that on paper,
• 22:58
  SPEAKER_02: it appears like a simple change going from QSR to QMSR with 13485.
• 23:04
  SPEAKER_02: as a foundational piece.
• 23:05
  SPEAKER_02: But if you go just one layer below the surface,
• 23:10
  you immediately see the enormous regulatory power now FDA has
• 23:15
  in being more
• 23:16
  SPEAKER_02: explicit.
• 23:17
  SPEAKER_02: And where does it play in my mind, Michelle?
• 23:19
  SPEAKER_02: Let me know what you think is
• 23:21
  SPEAKER_02: their ability to write warning letters,
• 23:23
  which are the next pathway to the next action from a regulatory
• 23:28
  perspective,
• 23:29
  warning letters in a more clear way that can be defended in a
• 23:32
  court of law.
• 23:33
  SPEAKER_02: So I'm beginning to see the dots,
• 23:36
  but this is what I do since I'm not involved in day-to-day
• 23:40
  affairs of companies.
• 23:41
  SPEAKER_02: This is what I do.
• 23:42
  SPEAKER_02: And I want our viewers to have that foresight.
• 23:45
  Would you add something to that perspective or you have a
• 23:48
  different opinion about it?
• 23:50
  SPEAKER_01: Well,
• 23:50
  SPEAKER_01: for anybody else that missed our previous discussion on your podcast,
• 23:56
  SPEAKER_01: one of the example,
• 23:57
  SPEAKER_01: the case study we looked at there,
• 23:59
  SPEAKER_01: that warning letter specifically called out 13485 and 14971.
• 24:03
  And it was very clear that the inspector understood both of
• 24:08
  those in great detail.
• 24:09
  SPEAKER_01: And so I think that the 1345 is just
• 24:20
  one piece of the expectation puzzle and that if you really want
• 24:24
  to know like what
• 24:26
  what that warning letter what those expectations are going to
• 24:30
  look like of things
• 24:31
  that get escalated it's i think we're going to see more things
• 24:35
  that are specific
• 24:36
  SPEAKER_01: iso clause this 14 971 concept that and we really need to align wording
• 24:43
  SPEAKER_01: expectations and whatnot to the whole
• 24:46
  ecosystem of standards around 1345,
• 24:50
  even though they're not,
• 24:51
  quote,
• 24:51
  codified.
• 24:52
  SPEAKER_02: Yeah, yeah.
• 24:53
  SPEAKER_02: And we will give a link to that conversation, Michelle.
• 24:55
  SPEAKER_02: I distinctly remember it was fascinating.
• 24:57
  SPEAKER_02: We'll give a link to that in the show notes here.
• 25:00
  SPEAKER_02: The key difference to note and emphasize here is that
• 25:03
  Yes,
• 25:03
  they could write that before in the warning letter,
• 25:06
  but that was not the finding.
• 25:08
  SPEAKER_02: That was the evidence that they used to support the finding.
• 25:11
  SPEAKER_02: The finding was your procedure is inadequate.
• 25:14
  SPEAKER_02: That's the language they could use because that's the language of QSR.
• 25:17
  But now they're going to use the language that your XYZ process
• 25:21
  is not following a
• 25:22
  SPEAKER_02: risk-based control because of this clause.
• 25:24
  SPEAKER_01: That's a very different finding.
• 25:26
  Every warning letter I read starts with both your response was
• 25:32
  inadequate,
• 25:33
  SPEAKER_00: Yes.
• 25:34
  SPEAKER_01: Number one.
• 25:34
  And then number two,
• 25:37
  your procedure is still inadequate because your response was
• 25:42
  inadequate.
• 25:43
  SPEAKER_02: Correct.
• 25:44
  SPEAKER_01: So I think we're just going to have more,
• 25:47
  SPEAKER_01: like you said,
• 25:48
  clear articulation about what was inadequate rather than kind
• 25:53
  of a broad statement.
• 25:56
  SPEAKER_02: Wonderful.
• 25:57
  SPEAKER_02: So, Michelle, I know we have raised a lot of concerns here.
• 26:00
  SPEAKER_02: Let's end on a little bit of a positive and promising note.
• 26:04
  SPEAKER_02: And personally,
• 26:05
  I think that this is where our colleagues in the QARA
• 26:08
  profession can play a huge
• 26:09
  SPEAKER_02: role in the future.
• 26:11
  What are your thoughts about that and how we can motivate them
• 26:15
  to see their role as
• 26:16
  SPEAKER_02: bigger than what they might be doing right now?
• 26:19
  SPEAKER_01: Well, you know, I think it gets back to top management.
• 26:22
  SPEAKER_01: Now top management are going to be held not only more accountable,
• 26:26
  SPEAKER_01: but it will be more visible if they miss something.
• 26:29
  So you really have to position yourself and articulate that you
• 26:35
  are a part of the solution here.
• 26:38
  SPEAKER_01: In fact, you're part of the prevention program.
• 26:41
  SPEAKER_00: Mm-hmm.
• 26:43
  SPEAKER_01: where you have to just say,
• 26:44
  SPEAKER_01: Hey,
• 26:45
  SPEAKER_01: not only am I just doing my job here,
• 26:47
  but I'm helping you do your job in a way where you're not going
• 26:50
  to end up in a
• 26:51
  SPEAKER_01: morning letter,
• 26:52
  SPEAKER_01: you know?
• 26:55
  SPEAKER_01: So I think that,
• 26:56
  SPEAKER_01: that,
• 26:56
  SPEAKER_01: that becoming a partner instead of a necessary evil,
• 27:01
  SPEAKER_01: just the,
• 27:03
  SPEAKER_01: and the culture around all of that,
• 27:06
  SPEAKER_01: the culture is going to be critical.
• 27:08
  SPEAKER_01: And
• 27:08
  SPEAKER_01: This is a little bit of a side note,
• 27:10
  SPEAKER_01: but it goes back to some comments that you had made a few minutes ago.
• 27:14
  SPEAKER_01: Oh, where the FDA is looking now for assurance more than compliance.
• 27:21
  SPEAKER_01: They even have a, it's a VIP program.
• 27:27
  SPEAKER_01: The whole thing is about the company culture itself.
• 27:30
  SPEAKER_01: around quality.
• 27:31
  SPEAKER_01: How is the company talking about quality?
• 27:34
  SPEAKER_01: How is the company embedded quality?
• 27:36
  SPEAKER_01: And they have a whole maturity model for that described.
• 27:40
  So I think that we can see the FDA is probably going to start
• 27:45
  pushing more on that
• 27:47
  culture program as well when the 1345 and all these additional
• 27:53
  requirements,
• 27:54
  SPEAKER_01: they expect
• 27:56
  SPEAKER_01: Yeah, like you said, more than compliance.
• 28:01
  SPEAKER_01: They think that is minimum.
• 28:03
  SPEAKER_01: Minimum is your compliance,
• 28:05
  but minimum is not going to sustain in this regulatory
• 28:09
  environment a system that
• 28:12
  SPEAKER_01: ensures the safety,
• 28:13
  SPEAKER_01: the ongoing safety and efficacy of your products.
• 28:15
  SPEAKER_02: Yeah, I'm so glad you mentioned that, Michelle.
• 28:18
  SPEAKER_02: And we'll give a link to the VIP program.
• 28:20
  SPEAKER_02: It was part of the case for quality initiative from the FDA.
• 28:23
  SPEAKER_02: A lot of good work was done.
• 28:25
  SPEAKER_02: We'll give a link to that in the show notes.
• 28:27
  SPEAKER_02: Michelle, thank you so much for your insights today.
• 28:30
  SPEAKER_02: As we close, do you have any final parting thoughts?
• 28:33
  SPEAKER_01: Yep.
• 28:33
  SPEAKER_01: So I saw these things come in when the FDA first announced QCIT.
• 28:40
  SPEAKER_01: So I've created like classes around QCIT itself.
• 28:44
  but then classes around all five of those biggest hitters for
• 28:48
  the existing 43.
• 28:50
  SPEAKER_01: So if you guys are lost or wondering where to start and need help,
• 28:56
  SPEAKER_01: check those out and those will get you caught up to the game at least.
• 29:00
  SPEAKER_02: Great, Michelle.
• 29:00
  SPEAKER_02: Thank you for being such a great resource for our industry.
• 29:05
  SPEAKER_02: I encourage everybody to go check out LeanRAQA website.
• 29:09
  SPEAKER_02: Follow Michelle on LinkedIn.
• 29:11
  One of the most wonderful things that I admire about you is
• 29:13
  that you don't
• 29:14
  SPEAKER_02: sugarcoat your message,
• 29:16
  SPEAKER_02: but you deliver it with great empathy and your signature humor.
• 29:20
  And that allows us to relate with you and see you as the
• 29:24
  thought leader you are in this space.
• 29:25
  SPEAKER_02: So I really encourage everybody to go check it out.
• 29:29
  We'll give links in the show notes,
• 29:31
  and I hope you will benefit from that.
• 29:32
  SPEAKER_02: Michelle, what a wonderful, delightful conversation once again with you.
• 29:36
  SPEAKER_02: I learn a lot from you every time we speak.
• 29:40
  SPEAKER_02: I wish you all the best in the coming year, and thank you once again.