August 18, 2025 • 39 mins
In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for building a successful and compliant quality management system (QMS).
Beth highlights that the key to a strong partnership is open communication and mutual respect, moving away from the "quality as a police force" mentality. She emphasizes that quality is not just a department but a company-wide mindset—a concept she calls "small Q quality." The discussion provides practical insights on how project managers and quality professionals can work together effectively, ensuring that processes are flexible yet compliant.
They also explore how language and tools can either help or hinder this collaboration. By reframing conversations to focus on shared goals like risk mitigation and efficiency, and by adopting user-friendly QMS solutions like Greenlight Guru's, teams can achieve better engagement and compliance. Beth shares a personal anecdote about turning a skeptic into a quality champion by simply explaining the "why" behind a procedure, underscoring the power of education and trust in fostering a culture of quality.
Key Timestamps
- 00:02:54 - Defining a culture of quality and the friction points in implementation.
- 00:03:21 - The problem with "big Q" and "small Q" quality and why language matters.
- 00:07:05 - The ideal relationship between a project manager and a quality professional.
- 00:10:34 - The analogy of quality as a safety guardrail for the company.
- 00:11:14 - Expanding the scope of risk management beyond patient harm.
- 00:14:53 - Strategies for overcoming resistance and low adoption of new quality tools.
- 00:17:43 - The importance of involving quality professionals early in the proof-of-concept phase.
- 00:19:30 - Tailoring communication to different departments to enhance engagement.
- 00:21:21 - Beth's story about converting a skeptic into a quality champion by explaining the "why."
- 00:24:42 - The critical role of digital solutions in streamlining change orders and design controls.
Quotes
- "Quality is doing the right thing when nobody's watching."
- "Quality can be a police force or they can be a partner. We want to make sure they're a partner." - Etienne Nichols
Takeaways
- Foster a Culture of Collaboration: Shift the mindset from quality as a policing function to a collaborative partnership. Open communication and trust between project managers and quality professionals are essential for success and compliance.
- Explain the "Why": Rather than dictating procedures, take the time to explain the purpose and regulatory justification behind quality processes. When people understand the "why," they are more likely to adopt and champion the system.
- Flexibility is Key: A rigid QMS can lead to frustration and workarounds. Build flexibility and risk-based decision-making into your processes from the start, allowing for deviations when justified without compromising safety or compliance.
- Involve Quality Early: Bringing quality professionals into the R&D and proof-of-concept phases ensures that early-stage documentation is robust and controlled. This streamlined approach prevents issues and rework later in the development cycle.
- Leverage Modern Tools: Modern Electronic Quality Management Systems (EQMS) like...
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
Welcome to the Global MedicalDevice Podcast, where today's brightest
minds in the medical deviceindustry go to get their most useful
and actionable insiderknowledge, direct from some of the
world's leading medical deviceexperts and companies.
(00:31):
Hey, everyone.
Welcome back to the.
Hey everyone.
Welcome back to the GlobalMedical Device Podcast.
My name is Etien Nichols.
I'm the host for today's episode.
And today I want to talk aboutkind of a relationship that is not
talked about very often, theproject management and quality manager
or quality professionalrelationship and the, the, the benefits
(00:52):
of those two, particularly ifyou are a quality person and you
want to build out your qms andyou want your QMS to be adopted by
company and actually to beeffective in your company.
How do you do that?
Who do you get on board tomake that happen?
And so with me today to talkabout this topic is Beth Waring.
She's a medtech quality expertwith over 10 years of experience
(01:13):
in medical devices and pharmaceuticals.
She specializes in buildingand improving quality management
systems that comply with FDA,ISO and European regulations, including
ISO1345, IEC6304 and 21 CFR 820.
As a medical device consultantat Greenlight Guru, she supports
companies through productdevelopment, design controls, kappa
audits, postmarketsurveillance and EQMS implementation,
(01:35):
and probably a lot more of,maybe even, I don't know, certain
therapeutic depressions,things, you know, as you're going
into the medical device industry.
But her background includesleadership roles at sbd, Swiss Precision
Diagnostics and mologic, ifI'm saying that right, where she
led quality efforts acrossclinical trials, manufacturing regulatory
submissions.
She has a lot of deepregulatory knowledge and I'm excited
(01:57):
to hear some of the thingsthat she has to, to share with us
today.
How are you doing today, Beth?
I'm very well, thank you.
How are you doing?
I'm doing, doing well.
I'm excited for this conversation.
Ever since we talked when you,I think one of our first conversations
ever where you talked abouthow when you kind of inherited a
quality management system thatthere was a struggle for people to,
(02:18):
to buy into and, and how youovercame some of those issues.
I'm, I, I'm excited to hearthat because that's kind of every
company struggle.
Would you agree?
I think engagement with thequality management system, whether
it's inherited or new orhowever you put it, is real, a real
struggle for a lot of people.
Engagement is key and it'sreally important to sort of build
(02:42):
a good quality culture.
And quality culture is a verybuzzwordy thing to say, but it really
is important and comes fromthe top all the way down to people
who do manufacturing.
So really important to get agood grasp of it.
Yeah, I think that's a reallygood point.
It is something of a buzzword.
It can be, but it's also a buzzword.
The FDA has used, you know, aculture of quality.
And I think that's even in thepreamble for 21, the QMSR, 21 CFR
(03:06):
predate 20 harmonization.
So that's, it's, it'simportant apparently to the regulators
as well.
So it's really interesting.
And I, I don't know if youhave any thoughts on why there is
friction so that maybe we canget, maybe let's do a quick kappa
on.
This problem, get to our root cause.
I think maybe, maybe take moretime than you and I have today, but
(03:28):
we can make a good go of it.
I actually think one of themain problems is the phrasing that
you use for it.
Just naming it quality andthen having departments called quality,
I feel like, makes it seemlike quality have some sort of ownership
of it.
And that's where we say thingslike quality is everybody's responsibility.
(03:49):
But then again, you have tohave the flip side of that.
Whereas quality is theneverybody's responsibility to implement
in the first place.
Which is why one of the thingsthat I find is there's a lot of friction
is that you'll have qualitydepartments where it's very almost
authoritative, dictatorial,where you'll say, this is how we
do it.
(04:09):
And I feel like people,generally speaking, don't like being
told what to do.
And so sort of human nature tokind of rail against that.
Whereas if you bring peoplealong for the ride and you say, look,
we together are going to builda quality management system.
We want your input.
There are things that we'regoing to have to do, but we're going
to bring you along for it.
Everybody's voice is just asimportant as everybody else's.
(04:32):
And if we can give you thequality management system that you
want as a scientist, as aproject manager, as a clinical specialist,
then we're going to get muchmore engagement because it'll be
a system that everybody wantsto use.
Yeah, I think that's a good point.
And it is a. I can also see aninherent problem.
If you just say quality iseverybody's job.
(04:53):
Well, there's going to be alittle bit of resistance in that.
Well, why did we hire someoneto do it?
You know, what do they do ifit's everybody's job.
You know, I could see a littlebit of irritation almost there.
So that's a really good point.
Our language really kind oflike that phrase, we shape our tools
than our tools shape us.
I think it's similar with thewords that we use.
Yeah.
(05:13):
And I think keeping that inmind, where quality is a very specific
function, where quality's mainrole is to make sure that the company
complies to the regulationsand that the processes that we have
in place are compliant.
So it's not that quality don'thave a role.
I think it's where you havethat you want a quality culture because
you want everybody to becompliant to quality.
(05:34):
You want everybody to befollowing the processes.
But it's also that element ofit's a function and it's a mindset.
And that's where I think thedisconnect is where you have.
I used to call it big Qquality, which would be the quality
department, and small Qquality, which is the quality mindset.
And when we say we want toimplement a quality culture, it's
that small Q quality whereeverybody does the same thing.
(05:58):
And I can't remember who thequote is for, but it was like, quality
is doing the right thing whennobody's watching.
Yeah.
Well, you can get away with itbecause especially when we work in
medical devices andpharmaceuticals, that is the difference
between potentially someone's,you know, life and death in certain
cases if you try and hide things.
And that's why quality cultureis really important.
(06:18):
But there can be a disconnectthere with some of the language of
what big Q quality is and whatsmall Q quality is.
Yeah.
And so there's differentdepartments, I guess, or different
roles that have to interactwith quality in different ways.
And the one that I'm curiousabout just because.
So project managers.
I was a project manager at onepoint, and there's.
(06:40):
They can be seen as antiquality at times because they're
trying to maintain deadlinesor maintain whatever it is, relationships
with vendors, et cetera, butthey're not anti quality.
I always felt like you neededto be friends with the quality people
in order to get those things through.
I mean, that.
That's.
They're really antiobstruction and.
But I wonder if you have anyinsight into that relationship or
(07:03):
thoughts from.
From your side?
I find the best projectmanager and quality relationships
are one with opencommunication and trust on both sides.
And that comes, I think, a lotfrom the quality side on it by being
willing to listen and beingwilling to be flexible to the amount
that you can be.
(07:24):
So for example, if you were tohave a very rigid structure for your
quality management system,which said this is a very specific
way of doing it.
So for example, if you wanted,you have a design control and the
process specifically says youneed for this phase six procedures,
but then the product thatyou're making may not align with
(07:46):
that.
You could be requiringsomebody be writing documentation
because the procedure is so rigid.
Whereas that's why a lot ofmedical device companies will have
something like a deviation process.
And I was always very openwhen I was a quality manager to all
right, what's the risk ofdoing this?
What's the justification fordoing this?
Could there ever be a risk topatient safety down the line in which
(08:07):
this has happened and is itstill compliant?
Because a lot of people willover engineer their processes as
well through time and throughhaving audits and internal findings
where they'll just tack thingsonto procedures without necessarily
really thinking about whetheror not this is going to fix your
root cause or fix the issue.
And it's just easier to slap aline in a procedure which may have
(08:30):
detrimental effects down theline and then do you really need
it?
So having a process where youcan be as flexible and the best way
of doing that is buildingflexibility into the process itself
from the beginning.
So having some non negotiablerequirements for each design phase,
for example, and thendepending on what the product is
having built in contingencyfor, you could use this or that or
(08:53):
different things.
So I think it's inherent onquality to make sure that we're not
being dictatorial and we'rebeing collaborators rather than enforcers.
We don't want this quality asa police force mentality, which is
used to be very prevalent inthe industry.
Unfortunately, I think it's changing.
Yeah, I do too.
So I had a mentor, his namewas Eric, who told me that early
(09:13):
on he said quality can be apartner or they can be police or
they can be a partner.
We want to make sure they're a partner.
And I was leading a drugdelivery combination product at the
time and you know, we, youspoke to this about how the, the
SOPs, if there's six and maybeyou don't need all the different
things for the product thatyou're designing.
(09:34):
That was actually what got meinto reading regulations.
I looked at our SOP and I'mlike, man, why do we have to do all
this?
They said it's in the regulation.
I had somebody tell me that.
I'm like, well, I'm going toGo read the regulation.
And I read all 21 CFR part 820.
I printed off ISO 1345, haveit, have had it sitting on my desk
ever since for, so that I canalways go there.
And I thought, no, it's not inthe regulation.
(09:56):
Now that being said, theregulations are intentionally vague.
And so you as an industry,there may be reasons to make your
SOP slightly more strict andso on, but you need reasons for that
justification.
And if so, I, I love the wayyou kind of describe them as a quality,
as kind of an educator.
(10:17):
And project managers need toalso be willing to be educated.
I think that's important aswell, that receptive mindset to recognize
these people have, thesepeople that you are working with
have a very specific skill setand you need to take advantage of
that and not just push upagainst it, if that makes sense.
Yeah.
And I think if you look at acompany as a product, think of quality
(10:41):
as being a risk managementmitigation where you don't want to
have a risk managementmitigation there, which stops you
being able to function entirely.
But if you're walking on avery thin, you know, like a, walking
a plank or something, it wouldbe good to have guardrails there
to stop you from falling off.
Do you need them?
(11:02):
No.
But you'll be a lot shakier.
You're not going to feel as secure.
So if you have the guardrailsthere, and that's really what quality
is, it stops you from fallingto either side.
But you also need flexibilityto move.
If those guardrails are tootight, you're not going anywhere
either.
I've got to throw one thing inthere about risk management because
I could just hear someone inthe audience saying, well, that's
a product developmentactivity, which is not necessarily
(11:22):
fairly true, should be cross departmental.
But when you say riskdevelopment in that context, I hear
company wide risk management,it oftentimes in this industry we
hear risk management think ISO14971, where you're thinking about
the harms to the patientthrough the product.
But there are additional harmsthat could come about in that maybe
(11:43):
you're going to have a recalljust because you have a regulatory
issue, maybe you got yourlabeling wrong, you're misbranded,
et cetera.
You have to go to court and besubpoenaed because you're selling
off label or all thesedifferent things, things that may
not necessarily.
You can make an argument, Isuppose, that it could cause some
patient harm, but a lot ofthose do not.
But you're still, that's acompany risk, that product.
(12:05):
You know, in productdevelopment you may not be thinking
about because you're sofocused on the product.
I think that's really goodwhere we talk about collaborators
and I would never advocate forever having a risk project with a
single person.
So I would never want a riskproject regardless of whether it's
a company wide one, whereyou're talking about overall risk
strategy or a very specificone for even a part of a product,
(12:28):
you want cross collaboration.
And we would have a team, notnecessarily from every department,
but we would have scientists,we would have a specific risk manager
as a mediator.
We would have customerfeedback because they have really
unique insights into theprevalence of harm and complaints
that they hear and things like that.
And they have insight intowhat it is that our customers are
(12:50):
saying back to us fromprevious products.
So having them on board to beable to see.
Well, I know you're talkingabout the highest level risk, but
this is what we're actuallyseeing and being able to bring that
in and be able to influencerisk scores.
Having regulatory in there aswell, if you don't have a cross QA
and RA department because theycan catch things like what would
happen if a regulatorysubmission fails or what would happen
(13:12):
if we have a recall and whatcould preempt that.
Because as much as you wantthe device specifically to be safe,
people need to be have accessto it and people also need to be
able to get the informationthat they need.
And that's really where thissort of cross departmental function
comes in.
So yeah, I think a really goodpoint about, you know, no man is
an island and you don't wantyour project leaders and scientists
(13:36):
alone to be doing risk management.
Obviously they have a lot oftechnical knowledge and that cannot
also be shoved to one side.
But it's really important toget lots of different perspectives
on risk.
Let's talk about the tools specifically.
That's one of the things thatI can see.
Well, okay, confession time.
I guess when we tried toimplement a big quality management
(13:58):
system tool, I was one of theones who knew all the ways around
it because it took way too long.
And so I recognize thatwouldn't do that now.
There's a company issue there,you know that.
But, but I was not the onlyone either.
And it was a, it was animplementation problem and an adoption
problem.
And I'm curious what you thinkabout how to overcome that.
(14:22):
It, it, it almost doesn'tmatter what tool you're talking about
if it's different, if itchanges my workflow and it almost,
you know, you could almostextrapolate this out, out to the
product itself in a healthcare setting.
It's interesting that productdevelopment people are oftentimes
the biggest offenders in amedical device company, yet they
are also working towards thesame thing so that their product
(14:43):
is adopted in a workflow in ahealthcare system.
But anyway, that's a different topic.
How did you, or did were youable to overcome some of those resistance
to changes?
I think first of all, if youfind that somebody is getting around
the system in whatever waythat is trying to be as non judgmental
as possible, whilst alsoholding people to account is really
(15:04):
important because obviouslypeople agree to work in a certain
environment.
So when you work for aregulated company, you agree to follow
certain rules, which isfollowing the procedures.
But I would also ask thequestion of why is it that they felt
they needed to go round thecurrent procedures, Are they too
stringent, are they notmeeting their needs?
(15:25):
Because whilst quality managedthe quality management system, it
is genuinely owned by everybody.
So I would try and listen tothese people and I would also look
at the risk of what they've done.
So if they've managed to sortof like not do everything in a process
but they've gotten to the sameend goal, is there something that
we can learn from that?
Because there must be a reasonthat they didn't follow the process
(15:47):
and I doubt it's because theyjust really want to rail against
quality and they don't want todo as they're told.
It's more a case of I found amore efficient way and maybe they're
not feeling like they would beheard if they came to quality because
maybe they've in the past cometo quality and they've said, I've
got a new way of doingsomething, can we try it?
And quality have said we don'tdo that.
That's not how it's done here.
(16:08):
So again, giving people thespace to breathe, giving people the
ability to.
And it's one of greenlightguru's sort of buzz phrases of taking
risks safely.
So if it's safe, if it's notgoing to have a detrimental effect,
why not try it out?
If it's still compliant, maybewe can try and implement it and it
(16:28):
could come up with a solutionthat is beneficial for every project
manager going forward.
So if you're trying to sort ofget around a system but at the same
time, if you're doing thingsand it's not compliant, then we're
raising the nc, we're raisingthe capa.
We're doing this but it's acase of being again going back to
being collaborative.
We're not, we're not nursery.
Nursery attendants to kind ofkeep kids in line.
(16:51):
We're adult professionals whoshould be treating each other with
respect and hearing different perspectives.
So yeah, and thank you foryour non judgmental response.
That was a good one.
It's cathartic.
So.
And I also want to just do aquick caveat that nothing I did was
truly against the company, butit was rules.
But there, there was like anunderstood we're trying to move into
(17:12):
this other direction.
And I'm like, well I'm goingto stay over here moving fast as
long as I can.
But anyway, hold on the topic.
What do you think?
What do you think are some ofthe most the biggest objections or
are there certain areas that aquality management system is not
you not taken advantage of,not followed properly, Whether it's
(17:33):
through misunderstanding or Idon't want to use the word rebellion,
but you just resistance inwhatever way, even, even if there
is understanding, if thatmakes sense.
I think the biggest benefit toa company would be to get quality
more involved in a proof ofconcept phase.
Because I've always said thatgood quality design development starts
(17:58):
with really good qualityresearch and development.
And you have instances whereyou'll have sort of R and D people
who are looking for proof ofconcept, seeing if things work and
then they've not documentedthings properly.
So when it comes to wanting tomove into an area like feasibility,
things aren't documented properly.
You don't have your lab logbooks put in correctly, you've not
(18:18):
had anything categorized properly.
So you don't actually havesort of the scientific validity that
you would need to move into afeasibility phase locked down.
And it's not that it'simpossible to move to that, but having
something concrete to fallback on.
And this kind of also goesback into areas of you can prove
that you were working on it first.
(18:39):
If you don't have those thingsdocumented, you don't have those
things written down properlyand properly categorized and controlled.
And I'm not saying it needs tobe to the same extent that you do
when you're in formal design developments.
But having a limited processin place for things like proof of
concept, where you can justhave a streamlined version of what
the QMS would be doing lateron in development, I think would
(19:01):
be really helpful forcompanies in order to be able to
use that initial proof ofconcept things going forward that.
Makes sense are there Arethere certain phrases or certain
terminology that you changedthat you use, and I'm not saying
that very well, but languagethat you change when you go from
department to department?
As a quality professional, arethere any phrases that you think
(19:24):
are particularly pertinent toone department over another that
really gets their attentionand helps them get on board with
what you're trying to.
Accomplish, department to department?
It really depends on thestructure of those departments.
So if you want to speak to theother side of quality, regulatory,
you want to show control.
You want to show using thingslike it's controlled, it's compliant,
(19:45):
it's, you know, safe.
They're very familiar andcomforting words to a regulatory
department.
Whereas if you wanted to speakto a scientist who's working in proof
of concept, you kind of wantto use the same buzzwords because
they want the sort of safetynet there as well.
But you want to.
You want to show things likeit's not going to impede you, it's
not going to slow you down.
(20:06):
It's just a way of it's.
And I think for talking topeople like scientists, R and D scientists,
showing that we're there toprotect them and keep them safe is
very different to.
So to allow them, because wewant them to be able to experiment,
we want them to be able to dothe things that they're going to
do.
But it's about doing thingssafely but without being able to
(20:28):
slow them down and thenshowing the effect of what happens
if they are just being able totreat it as the wild west and be
all like.
So it may slow you down alittle bit, but in the long run,
it'll get you to yourdestination faster.
So it may not be the mostdirect route, but there's pitfalls
and speed bumps and all ofthat on the direct route.
(20:49):
So we want to take you maybeon a slightly more meandering way.
But yeah, in terms ofbuzzwords for quality to different
departments, I think it really depends.
But I think quality is meantto be structure, safety.
But then showing how thatapplies to different departments
in different ways is important.
Yeah.
How do you.
Do you have any stories thatyou could share with about, I don't
(21:14):
know, using buzzwords or usingchanging their language or how you
maybe turned someone into achampion in one way or another?
I mean, my favorite story isit's not necessarily turning them
into a champion, but it's an.
It's an element of sort of aquick win.
So we had, we had a scientistwho had worked all of his life in
(21:35):
research where it wasn't asregulated, it wasn't as controlled.
And he was fairly late on inhis career and he'd started working
for us at Malogic, so tryingto teach him basic document control.
In terms of when you'reworking on procedures and when you're
working on batch records, youcan't just cross things out.
(21:56):
You can't just do all of this.
You can't just, you know,delete your entries and obliterate
them.
You know, there's certain, youknow, alcoa principles you need to
follow for all of these thingswhere you just can't do it.
And I remember one day he cameup to me and this is after I had
sent batch records back to himnumerous times, basically saying,
you've destroyed evidence, youneed to show what it was originally
(22:19):
there for, all of this.
And he came up to me in myoffice and he just put a record down
on the table in front of meand he'd crossed it out and he'd
initial and dated it and hewas like.
And I didn't even think twiceabout it.
And he was so proud of himself.
And I was like, I don't knowif he was proud of himself in terms
of he did it, but he was more like.
But he was just happy to havedone it because he wasn't doing it.
(22:41):
And obviously he wasn't doingit intentionally.
He wasn't doing it to try, buthe didn't understand the importance
of it.
So getting that understanding,getting the why behind it to say,
well, you may you cross thisout because you've put in a concentration
of a reagent, for example,you've crossed this out to put in
something new.
But what if that one that youhad put down there had been correct?
(23:03):
That could be the cause of whydispatches failed.
But we're not going to be ableto see that now because you've obliterated
that entry because you couldhave taken the wrong concentration
out of the cupboard orwhatever it was.
So it's important that we canbe able to see these things.
And once he understood thepurpose of it and that we're not
just doing it to follow someweird set of document management
rules.
(23:25):
People get on board when theyunderstand the why.
And I think that's why it'simportant to explain these things
to people when they're doing it.
It's not just telling them youshouldn't do that, it's explaining
why they shouldn't do it.
And that's sort of.
That's my favorite story interms of project management.
But it's when we wereimplementing so we, before disclosure,
(23:45):
we were implementingGreenlight Guru.
It was actually the projectmanagers who became our biggest champions
of it because of how thequality management system would really
benefit them in terms ofhaving a good quality management
system really does save themtime in terms of being able to create
the trace matrix.
Because previously we had avery long process which was very
(24:07):
manual.
And just being able to showthem a different way of doing it
is really helpful.
So it's good to have and thisis why you get them in early because
then once you get the hardestpeople in, and I think project managers
can be some of the hardestpeople in because there is an element
of seeing quality as being theresponsibility of quality.
And especially whenimplementing something like an EQMS
(24:29):
or any quality managementsystem, it's to benefit quality and
just showing that no, thiswill benefit everybody as you, the
entire company is really, Ithink showing value is important
in everything.
So yeah, when you have those,no, that's great.
I love it when you have thoseguardrails in place to make sure
that when you have a changeorder, for example, it forces you
(24:52):
to answer the question, why isthis being changed?
I mean, I just go Back to that21 CFR Part 820.42 document control.
The things that they ask for,they went, what's changing?
What was it?
What's your justification?
Who is approving this?
When is it approved?
Forcing you to go through allthose things and in addition to that
asking the question, is anyproduct being impacted?
Do you need to verify it?
Do you need to go back and validate?
(25:12):
Do you need to look at risk?
Do you need to look at this?
So it can be a little tedious.
And you know, in greenlightgrew, you can choose from a company
standpoint, you can choose touse it or not.
But I think most companieswould benefit from that because in
my experience, having gonethrough some FDA inspections and
received 43s justification onchange orders was one of the big
(25:33):
reasons.
Not any of mine personally,but although maybe had they found
some of mine, they would havethought so, I don't know.
But yeah, that's a real thing.
But if you go to what you'retalking about with the design controls
especially, I bring that upbecause I feel like the change order
process in a lot of differentcompanies is not straightforward.
It's difficult if you're paperor if you're in a system, both of
(25:56):
those can be really tedious.
I, I, man, this is like goingdown memory lane.
If I go, if I go to my papermemory days where I remember routing
paper around, wow.
I can remember losing changeorders on the VP of product development
or no, it was the VP of RDR&D's desk twice.
And I'm like, I've, I.
(26:17):
You realize if I have to dothis again, regulatory isn't going
to just accept that there areno changes that from what they, they
have to go through the wholeweek long review process again.
And so anyway, whole deal.
But with, with an eqms likewith Greenlight Group particularly,
I don't, I can't speak for alot of them, but you can go back
and see nothing's beenchanged, et cetera.
(26:38):
So if you have to backsomething up or something someone
doesn't want to approve, itmakes it much simpler to go back
and approve.
Nobody's trying to, I don'tknow, pull the wool over someone,
a previous reviewer's eyes andgetting that signature a second time.
Hopefully that some of thoseremotely make sense those, those
things that I'm saying.
But absolutely to the extentthat not in a medical device company,
(26:58):
but a pharmaceutical servicescompany that I worked for.
Because of the loss of paperwork.
When we had a paper managementsystem, they had to install a new
procedure where every time youmoved a piece of paperwork there
was a barcode and that barcodewas attached to a laptop in a tray
in a room.
So you had to scan in thatpiece of paperwork.
(27:19):
So we knew the last place thatit was because paperwork went missing
on people's desks, anywhereyou could.
People might take it into coldrooms or storage or it could just
be left around the warehouseor attached to the back of something
else.
And because it's paper based,you put a paperclip on it or whatnot
or staple it, you'veaccidentally stapled it to the back
of something else and it'sgone forever and you will never see
(27:41):
it again.
Yeah, and it's just.
So it doesn't necessarily haveto be something as sophisticated
as EQMs.
It depends on where you are inyour, your company journey.
But just having somethingelectronic, being able to write something
electronic and at least have arecord of that is, yeah, you need
to do it.
It's, it's.
I want to mention one otherthing about the design controls because
(28:02):
I don't think people realizethis or project managers probably
don't realize the benefit that using.
And I'm just going to go aheadand toot Greenlight Guru's horn because
that is actually one of thethings that sold Me on Greenlight
GRU as a platform, because asa project manager who was, who was
managing design controls andrisk management, when I saw how you
can maintain the traceabilitybetween the two and maintaining those
(28:25):
relationships from many toone, one to many relationships from
user needs, design controls,design design outputs.
I'm getting all this wrong.
User needs, design inputs,design outputs, verification, validation
and the relationship betweenall of those and relationship to
revisions of documents,sources of documents.
It's just, it's huge becausewhen you try to do that in Excel,
(28:47):
that becomes your full time job.
Making sure that whoeverreviewed this last did not change
the spelling of anything sothat when we filter it then it will
filter properly and we'llactually be able to see everything.
There's lots of differentissues there that seem trivial but
take up so much time and takeaway from what you're actually trying
to accomplish.
So there's a lot there thatyou will benefit from if you actually
(29:08):
recognize.
And you know, traceability issomething everybody really wants.
If you really think about it.
You don't want to spend yourdays running after whatever revision
of document you want to.
Okay, why did we choose this?
Oh, there's an easy link hereit is.
Traceability is not, that'sone of the examples in my mind that
it's not just quality's fetish.
(29:29):
This is, this is every, whatshould be everybody's goal.
And so it's, it really doeshelp you in your, in your day to
day work.
Yeah, and I completely agreewith that.
And going back to the sort ofchange control, if you have a product
change control, being able tosay this is the change control in
which this product changed onand linking that to a design review
where you can say, okay, sowe've opened up the product again,
(29:51):
we've changed it, we've closedit, we've closed the change order
and everything is linked together.
And that will give.
Because I don't know how othercompanies do audits, but we would
always bring the projectmanager in when we were going over
a specific product becausethey need to justify the decisions
that they have made.
They need to justify thechanges that they've made and being
able to find that informationand have it linked together rather
(30:14):
than, okay, so I've got thischange order number now I need to
find this change order.
Having it there like that is,you know, it's really great.
So it's, it's a, it's a really good.
And again, I know we're justsitting here touting, well, yeah,
EQMSs are available.
But yeah, greenlight guru, theone that we're familiar with, it
just is a game changer.
And that is why going back tothe initial premise of quality management
(30:37):
system belongs to everybody.
Everybody is going to getbenefit from it.
And that's why bringing inproject managers really early in
the onboarding process,because design controls touch everything.
They require documentation,they require change orders, they're
going to require qualityprocesses if they have MCs and customer
complaints.
(30:57):
So design controls touch everything.
So it's really important thatproject managers, scientists, everybody
who's involved in that designcontrol process has a really good
understanding of every aspectof the qms, not just design controls.
And seeing how all of thosethings can work together and seeing
how, okay, if we raise an nc,how does these things all link together?
(31:18):
How can I link it to thedifferent workspaces?
How can I make sure that we'renot going to lose that traceability?
Because ultimately it's theproject manager who's going to have
to justify where these linkshave come from.
At least in my experience,when we've had an audit, we get the
project manager in and they'rethe ones who are going to have to
go through the flow and gothrough justifying why this happened
(31:38):
and what the outcome was.
And being able to link all ofthose things together is just such
a, such a time saver withouthaving to have an Excel trace matrix
and then a document tree andthen creating all of those things.
It's yet so it's a real timesaver for project management.
I would say more than anyother department, Project management
(31:59):
benefited from getting an eqmsprobably more than any other department.
They certainly enjoyed it morethan any other department, I'd say.
I know I would have, oh man,it would have made my life so much
more bearable.
And I actually enjoyed projectmanagement quite a bit.
I will say.
I didn't even mention the dhf,you know, auto generation of the
(32:20):
DHF reports and design reviewsand the way that you can actually
maintain the little bit ofthat's a whole herding of cats in
the real world as well.
So the one thing you mentionedthere, and I'm glad you did, was
in Season Kappas becauseoftentimes you think, okay, design
controls, that's early on,that's early stage, we're done with
that.
Come on, we're now we'remanufacturing and I've worked as
(32:41):
a manufacturing engineer andso rarely do I go back and look at
the risk management file.
And it was not part of myreally, I don't know, maybe I should
have broadened the aperture ofmy mind.
It wasn't necessarily in myfield of view most of the time, but
it should be for companies whoget kind of any kind of customer
complaint going back and beingable to see, why did we make this
(33:03):
red, this button red, wheneverybody says that's the go button.
Maybe it should have beengreen, but maybe there was a reason.
Maybe we had a human factorsreport and wow, I could just click
right in.
Now I see the report, now Isee the change order, how it actually
was originally green andeverybody kept getting damaged or
whatever, you know, just to.
Maybe there was a point of caution.
There's lots of differentreasons why we do things, but traceability
(33:24):
is the only way to maintain that.
Because you think, oh, youknow what?
I know this project well,guess what?
When Stryker comes calling orJ and J comes calling and you head
out the door and someone elsehas to take over your project, that
poor soul, you know, just givethem a little bit of traceability
so that they can handle that project.
So, yeah, absolutely.
And there are cases incompanies I've worked for where somebody
(33:47):
retires and a lot of that.
So we have all of theinformation written down, but it's
gone through multiple changesthrough multiple different QMSs over
years.
So you mentioned that I workedfor SPD.
They've had products on themarket for 35 years.
So pregnancy tests on themarket for 35 years, that has gone
through a lot of different regulatory.
(34:07):
So it's gone, you know, backwhen, you know, 13485 is now 2016.
I don't think even 13485existed 35 years ago.
So it's a case of it's gonethrough so many iterations and being
able to go back and obviously.
But this is why even puttingin things like old records is really
good in terms of you can thenjust search for them.
(34:28):
You don't have to look in abox and dust things off.
So scanning things in, even ifit's frustrating to do because it'll
just sit there, you don't needto worry about it anymore.
But creating an electroniccopy of something is really great
as well.
Categorizing it, putting itin, because you never know when you're
going to want to need it.
And to your point of what?
Why is this red and not green?
That decision could have beenmade 25 years ago and you don't know.
(34:52):
And then you might turn itgreen and then it could create a
whole slew of other options.
Because colorblindness orwhatever you would want to call it
or however it would be.
And so but you could lose that information.
And also if it's not documented.
So that could have come froman nc and if that NC isn't documented
and linked to a change whichis then linked to a design control
which has been updated, you'regoing to lose that.
So it's.
(35:12):
It's.
It's good to have thattraceability and then have it be
not exactly effortless, but asclose to effortless as it can be
by just piping in a search andlinking it together.
I think.
Yeah.
Yeah.
When you were you.
When you were telling yourfavorite story, I meant to come back
to this point about what Ialways call a good documentation
process or practices.
Gdp.
(35:33):
You mentioned ALCOA principles.
And maybe we just need to runthrough that because I always.
Every time we use a.
That would be an acronym.
I recently learned aboutacronyms versus initialisms.
That's a whole nother thing.
But FDA is an initialism.
Did you know this?
It's not an acronym.
An acronym makes a word or Ihave that flipped.
I think it's.
Anyway, it doesn't matter.
(35:54):
Okay.
But.
Oh, that's interesting quality people.
I just thought they were all.
Yeah, I call them acronyms allthe time.
I may have to.
We're going to have to changeevery single process now.
Which has a table of acronymsbecause most of them aren't going
to be acronyms anymore.
Table of acronyms and initialisms.
This is anything new?
This is just a pure Englishmajor, you know, thing.
(36:18):
But anyway, a friend of minecame up to me and so.
Okay, so ALCOA principles.
Just so those who are maybenot familiar with them.
I pulled them up to makemyself look smarter so that I.
Because I didn't know ifeither of us would remember.
That's too long.
Five.
It should be three, you know.
And any acronym should be onlythree letters.
But ALCOA attributable which.
Which indicates who collectsor generated the data.
(36:39):
Who made the subsequent changes.
So who do you attribute thischange to?
Legible.
And maybe I should have givenyou the opportunity to remember this.
You want me to try?
I'll try.
Let's see.
Yeah, see if you can remember all.
Okay.
It's the usual.
It's the.
I can always remember the.
Cuz it's a really silly word.
Just to make the.
Just to make the initialinitialism work or whatever.
It's attributable, legible,contemporaneous, original and accurate.
(37:05):
Oh man, Beth, that was good.
Memory.
Yes, I love it.
Contemporaneous.
I thought about that one.
I'm like, yeah, okay, I guessthe root word's contemporary, so
it's just timely.
It's just.
Yeah, it's at the time.
That's all it means.
But could have been altoa.
You don't want three A's init, I guess.
But yeah, I guess yes, couldbe timely.
But whatever.
Okay.
Anyway, contemporaneous, we'llremember because it's a weird word.
(37:27):
Beth, thank you so much forthe conversation.
This has been really fun.
If you had one takeaway thatyou would want the audience to walk
away with, what would that be?
I would say the takeaway fromthis is challenge yourselves to take
on other perspectives, which Ithink has been a bit of a theme of
what we've been saying.
Quality people, try and stepinto the shoes of your project management
(37:48):
colleagues.
Try and think about what theirwhat the problems they're trying
to overcome and then trying tostick them to their perspective.
And project managers do thesame for your quality colleagues
because we're all just tryingto get to the same point.
So let's all row in the same direction.
Absolutely.
Be willing to listen, projectmanagers, because a lot of quality
people are trying to make yourlife easier.
(38:10):
So yeah, same back to qualitypeople, though.
So willing to listen.
Thank you so much, Beth, andthank you, those of you who've been
listening.
Reach out to us if you haveany questions.
I'm sure Beth would be willingfor you to blow up her LinkedIn or
however else we could put oremail on here.
Feel free to reach out to meif you have any positive or constructive
feedback.
We're always trying to get better.
Until next time.
(38:31):
Take care.
Thanks for tuning in to theGlobal Medical Device Podcast.
If you found value in today'sconversation, please take a moment
to rate, review and subscribeon your favorite podcast platform.
If you've got thoughts orquestions, we'd love to hear from
you.
Email us at podcastreenlight Guru.
Stay connected.
For more insights into thefuture of medtech innovation.
(38:51):
And if you're ready to takeyour product development to the next
level, Visit us at www.greenlight.guru.
until next time, keepinnovating and improving the quality
of life.
Welcome to the Global MedicalDevice Podcast, where today's brightest
minds in the medical deviceindustry go to get their most useful
and actionable insiderknowledge, direct from some of the
world's leading medical deviceexperts and companies.
(00:31):
Hey, everyone.
Welcome back to the.
Hey everyone.
Welcome back to the GlobalMedical Device Podcast.
My name is Etien Nichols.
I'm the host for today's episode.
And today I want to talk aboutkind of a relationship that is not
talked about very often, theproject management and quality manager
or quality professionalrelationship and the, the, the benefits
(00:52):
of those two, particularly ifyou are a quality person and you
want to build out your qms andyou want your QMS to be adopted by
company and actually to beeffective in your company.
How do you do that?
Who do you get on board tomake that happen?
And so with me today to talkabout this topic is Beth Waring.
She's a medtech quality expertwith over 10 years of experience
(01:13):
in medical devices and pharmaceuticals.
She specializes in buildingand improving quality management
systems that comply with FDA,ISO and European regulations, including
ISO1345, IEC6304 and 21 CFR 820.
As a medical device consultantat Greenlight Guru, she supports
companies through productdevelopment, design controls, kappa
audits, postmarketsurveillance and EQMS implementation,
(01:35):
and probably a lot more of,maybe even, I don't know, certain
therapeutic depressions,things, you know, as you're going
into the medical device industry.
But her background includesleadership roles at sbd, Swiss Precision
Diagnostics and mologic, ifI'm saying that right, where she
led quality efforts acrossclinical trials, manufacturing regulatory
submissions.
She has a lot of deepregulatory knowledge and I'm excited
(01:57):
to hear some of the thingsthat she has to, to share with us
today.
How are you doing today, Beth?
I'm very well, thank you.
How are you doing?
I'm doing, doing well.
I'm excited for this conversation.
Ever since we talked when you,I think one of our first conversations
ever where you talked abouthow when you kind of inherited a
quality management system thatthere was a struggle for people to,
(02:18):
to buy into and, and how youovercame some of those issues.
I'm, I, I'm excited to hearthat because that's kind of every
company struggle.
Would you agree?
I think engagement with thequality management system, whether
it's inherited or new orhowever you put it, is real, a real
struggle for a lot of people.
Engagement is key and it'sreally important to sort of build
(02:42):
a good quality culture.
And quality culture is a verybuzzwordy thing to say, but it really
is important and comes fromthe top all the way down to people
who do manufacturing.
So really important to get agood grasp of it.
Yeah, I think that's a reallygood point.
It is something of a buzzword.
It can be, but it's also a buzzword.
The FDA has used, you know, aculture of quality.
And I think that's even in thepreamble for 21, the QMSR, 21 CFR
(03:06):
predate 20 harmonization.
So that's, it's, it'simportant apparently to the regulators
as well.
So it's really interesting.
And I, I don't know if youhave any thoughts on why there is
friction so that maybe we canget, maybe let's do a quick kappa
on.
This problem, get to our root cause.
I think maybe, maybe take moretime than you and I have today, but
(03:28):
we can make a good go of it.
I actually think one of themain problems is the phrasing that
you use for it.
Just naming it quality andthen having departments called quality,
I feel like, makes it seemlike quality have some sort of ownership
of it.
And that's where we say thingslike quality is everybody's responsibility.
(03:49):
But then again, you have tohave the flip side of that.
Whereas quality is theneverybody's responsibility to implement
in the first place.
Which is why one of the thingsthat I find is there's a lot of friction
is that you'll have qualitydepartments where it's very almost
authoritative, dictatorial,where you'll say, this is how we
do it.
(04:09):
And I feel like people,generally speaking, don't like being
told what to do.
And so sort of human nature tokind of rail against that.
Whereas if you bring peoplealong for the ride and you say, look,
we together are going to builda quality management system.
We want your input.
There are things that we'regoing to have to do, but we're going
to bring you along for it.
Everybody's voice is just asimportant as everybody else's.
(04:32):
And if we can give you thequality management system that you
want as a scientist, as aproject manager, as a clinical specialist,
then we're going to get muchmore engagement because it'll be
a system that everybody wantsto use.
Yeah, I think that's a good point.
And it is a. I can also see aninherent problem.
If you just say quality iseverybody's job.
(04:53):
Well, there's going to be alittle bit of resistance in that.
Well, why did we hire someoneto do it?
You know, what do they do ifit's everybody's job.
You know, I could see a littlebit of irritation almost there.
So that's a really good point.
Our language really kind oflike that phrase, we shape our tools
than our tools shape us.
I think it's similar with thewords that we use.
Yeah.
(05:13):
And I think keeping that inmind, where quality is a very specific
function, where quality's mainrole is to make sure that the company
complies to the regulationsand that the processes that we have
in place are compliant.
So it's not that quality don'thave a role.
I think it's where you havethat you want a quality culture because
you want everybody to becompliant to quality.
(05:34):
You want everybody to befollowing the processes.
But it's also that element ofit's a function and it's a mindset.
And that's where I think thedisconnect is where you have.
I used to call it big Qquality, which would be the quality
department, and small Qquality, which is the quality mindset.
And when we say we want toimplement a quality culture, it's
that small Q quality whereeverybody does the same thing.
(05:58):
And I can't remember who thequote is for, but it was like, quality
is doing the right thing whennobody's watching.
Yeah.
Well, you can get away with itbecause especially when we work in
medical devices andpharmaceuticals, that is the difference
between potentially someone's,you know, life and death in certain
cases if you try and hide things.
And that's why quality cultureis really important.
(06:18):
But there can be a disconnectthere with some of the language of
what big Q quality is and whatsmall Q quality is.
Yeah.
And so there's differentdepartments, I guess, or different
roles that have to interactwith quality in different ways.
And the one that I'm curiousabout just because.
So project managers.
I was a project manager at onepoint, and there's.
(06:40):
They can be seen as antiquality at times because they're
trying to maintain deadlinesor maintain whatever it is, relationships
with vendors, et cetera, butthey're not anti quality.
I always felt like you neededto be friends with the quality people
in order to get those things through.
I mean, that.
That's.
They're really antiobstruction and.
But I wonder if you have anyinsight into that relationship or
(07:03):
thoughts from.
From your side?
I find the best projectmanager and quality relationships
are one with opencommunication and trust on both sides.
And that comes, I think, a lotfrom the quality side on it by being
willing to listen and beingwilling to be flexible to the amount
that you can be.
(07:24):
So for example, if you were tohave a very rigid structure for your
quality management system,which said this is a very specific
way of doing it.
So for example, if you wanted,you have a design control and the
process specifically says youneed for this phase six procedures,
but then the product thatyou're making may not align with
(07:46):
that.
You could be requiringsomebody be writing documentation
because the procedure is so rigid.
Whereas that's why a lot ofmedical device companies will have
something like a deviation process.
And I was always very openwhen I was a quality manager to all
right, what's the risk ofdoing this?
What's the justification fordoing this?
Could there ever be a risk topatient safety down the line in which
(08:07):
this has happened and is itstill compliant?
Because a lot of people willover engineer their processes as
well through time and throughhaving audits and internal findings
where they'll just tack thingsonto procedures without necessarily
really thinking about whetheror not this is going to fix your
root cause or fix the issue.
And it's just easier to slap aline in a procedure which may have
(08:30):
detrimental effects down theline and then do you really need
it?
So having a process where youcan be as flexible and the best way
of doing that is buildingflexibility into the process itself
from the beginning.
So having some non negotiablerequirements for each design phase,
for example, and thendepending on what the product is
having built in contingencyfor, you could use this or that or
(08:53):
different things.
So I think it's inherent onquality to make sure that we're not
being dictatorial and we'rebeing collaborators rather than enforcers.
We don't want this quality asa police force mentality, which is
used to be very prevalent inthe industry.
Unfortunately, I think it's changing.
Yeah, I do too.
So I had a mentor, his namewas Eric, who told me that early
(09:13):
on he said quality can be apartner or they can be police or
they can be a partner.
We want to make sure they're a partner.
And I was leading a drugdelivery combination product at the
time and you know, we, youspoke to this about how the, the
SOPs, if there's six and maybeyou don't need all the different
things for the product thatyou're designing.
(09:34):
That was actually what got meinto reading regulations.
I looked at our SOP and I'mlike, man, why do we have to do all
this?
They said it's in the regulation.
I had somebody tell me that.
I'm like, well, I'm going toGo read the regulation.
And I read all 21 CFR part 820.
I printed off ISO 1345, haveit, have had it sitting on my desk
ever since for, so that I canalways go there.
And I thought, no, it's not inthe regulation.
(09:56):
Now that being said, theregulations are intentionally vague.
And so you as an industry,there may be reasons to make your
SOP slightly more strict andso on, but you need reasons for that
justification.
And if so, I, I love the wayyou kind of describe them as a quality,
as kind of an educator.
(10:17):
And project managers need toalso be willing to be educated.
I think that's important aswell, that receptive mindset to recognize
these people have, thesepeople that you are working with
have a very specific skill setand you need to take advantage of
that and not just push upagainst it, if that makes sense.
Yeah.
And I think if you look at acompany as a product, think of quality
(10:41):
as being a risk managementmitigation where you don't want to
have a risk managementmitigation there, which stops you
being able to function entirely.
But if you're walking on avery thin, you know, like a, walking
a plank or something, it wouldbe good to have guardrails there
to stop you from falling off.
Do you need them?
(11:02):
No.
But you'll be a lot shakier.
You're not going to feel as secure.
So if you have the guardrailsthere, and that's really what quality
is, it stops you from fallingto either side.
But you also need flexibilityto move.
If those guardrails are tootight, you're not going anywhere
either.
I've got to throw one thing inthere about risk management because
I could just hear someone inthe audience saying, well, that's
a product developmentactivity, which is not necessarily
(11:22):
fairly true, should be cross departmental.
But when you say riskdevelopment in that context, I hear
company wide risk management,it oftentimes in this industry we
hear risk management think ISO14971, where you're thinking about
the harms to the patientthrough the product.
But there are additional harmsthat could come about in that maybe
(11:43):
you're going to have a recalljust because you have a regulatory
issue, maybe you got yourlabeling wrong, you're misbranded,
et cetera.
You have to go to court and besubpoenaed because you're selling
off label or all thesedifferent things, things that may
not necessarily.
You can make an argument, Isuppose, that it could cause some
patient harm, but a lot ofthose do not.
But you're still, that's acompany risk, that product.
(12:05):
You know, in productdevelopment you may not be thinking
about because you're sofocused on the product.
I think that's really goodwhere we talk about collaborators
and I would never advocate forever having a risk project with a
single person.
So I would never want a riskproject regardless of whether it's
a company wide one, whereyou're talking about overall risk
strategy or a very specificone for even a part of a product,
(12:28):
you want cross collaboration.
And we would have a team, notnecessarily from every department,
but we would have scientists,we would have a specific risk manager
as a mediator.
We would have customerfeedback because they have really
unique insights into theprevalence of harm and complaints
that they hear and things like that.
And they have insight intowhat it is that our customers are
(12:50):
saying back to us fromprevious products.
So having them on board to beable to see.
Well, I know you're talkingabout the highest level risk, but
this is what we're actuallyseeing and being able to bring that
in and be able to influencerisk scores.
Having regulatory in there aswell, if you don't have a cross QA
and RA department because theycan catch things like what would
happen if a regulatorysubmission fails or what would happen
(13:12):
if we have a recall and whatcould preempt that.
Because as much as you wantthe device specifically to be safe,
people need to be have accessto it and people also need to be
able to get the informationthat they need.
And that's really where thissort of cross departmental function
comes in.
So yeah, I think a really goodpoint about, you know, no man is
an island and you don't wantyour project leaders and scientists
(13:36):
alone to be doing risk management.
Obviously they have a lot oftechnical knowledge and that cannot
also be shoved to one side.
But it's really important toget lots of different perspectives
on risk.
Let's talk about the tools specifically.
That's one of the things thatI can see.
Well, okay, confession time.
I guess when we tried toimplement a big quality management
(13:58):
system tool, I was one of theones who knew all the ways around
it because it took way too long.
And so I recognize thatwouldn't do that now.
There's a company issue there,you know that.
But, but I was not the onlyone either.
And it was a, it was animplementation problem and an adoption
problem.
And I'm curious what you thinkabout how to overcome that.
(14:22):
It, it, it almost doesn'tmatter what tool you're talking about
if it's different, if itchanges my workflow and it almost,
you know, you could almostextrapolate this out, out to the
product itself in a healthcare setting.
It's interesting that productdevelopment people are oftentimes
the biggest offenders in amedical device company, yet they
are also working towards thesame thing so that their product
(14:43):
is adopted in a workflow in ahealthcare system.
But anyway, that's a different topic.
How did you, or did were youable to overcome some of those resistance
to changes?
I think first of all, if youfind that somebody is getting around
the system in whatever waythat is trying to be as non judgmental
as possible, whilst alsoholding people to account is really
(15:04):
important because obviouslypeople agree to work in a certain
environment.
So when you work for aregulated company, you agree to follow
certain rules, which isfollowing the procedures.
But I would also ask thequestion of why is it that they felt
they needed to go round thecurrent procedures, Are they too
stringent, are they notmeeting their needs?
(15:25):
Because whilst quality managedthe quality management system, it
is genuinely owned by everybody.
So I would try and listen tothese people and I would also look
at the risk of what they've done.
So if they've managed to sortof like not do everything in a process
but they've gotten to the sameend goal, is there something that
we can learn from that?
Because there must be a reasonthat they didn't follow the process
(15:47):
and I doubt it's because theyjust really want to rail against
quality and they don't want todo as they're told.
It's more a case of I found amore efficient way and maybe they're
not feeling like they would beheard if they came to quality because
maybe they've in the past cometo quality and they've said, I've
got a new way of doingsomething, can we try it?
And quality have said we don'tdo that.
That's not how it's done here.
(16:08):
So again, giving people thespace to breathe, giving people the
ability to.
And it's one of greenlightguru's sort of buzz phrases of taking
risks safely.
So if it's safe, if it's notgoing to have a detrimental effect,
why not try it out?
If it's still compliant, maybewe can try and implement it and it
(16:28):
could come up with a solutionthat is beneficial for every project
manager going forward.
So if you're trying to sort ofget around a system but at the same
time, if you're doing thingsand it's not compliant, then we're
raising the nc, we're raisingthe capa.
We're doing this but it's acase of being again going back to
being collaborative.
We're not, we're not nursery.
Nursery attendants to kind ofkeep kids in line.
(16:51):
We're adult professionals whoshould be treating each other with
respect and hearing different perspectives.
So yeah, and thank you foryour non judgmental response.
That was a good one.
It's cathartic.
So.
And I also want to just do aquick caveat that nothing I did was
truly against the company, butit was rules.
But there, there was like anunderstood we're trying to move into
(17:12):
this other direction.
And I'm like, well I'm goingto stay over here moving fast as
long as I can.
But anyway, hold on the topic.
What do you think?
What do you think are some ofthe most the biggest objections or
are there certain areas that aquality management system is not
you not taken advantage of,not followed properly, Whether it's
(17:33):
through misunderstanding or Idon't want to use the word rebellion,
but you just resistance inwhatever way, even, even if there
is understanding, if thatmakes sense.
I think the biggest benefit toa company would be to get quality
more involved in a proof ofconcept phase.
Because I've always said thatgood quality design development starts
(17:58):
with really good qualityresearch and development.
And you have instances whereyou'll have sort of R and D people
who are looking for proof ofconcept, seeing if things work and
then they've not documentedthings properly.
So when it comes to wanting tomove into an area like feasibility,
things aren't documented properly.
You don't have your lab logbooks put in correctly, you've not
(18:18):
had anything categorized properly.
So you don't actually havesort of the scientific validity that
you would need to move into afeasibility phase locked down.
And it's not that it'simpossible to move to that, but having
something concrete to fallback on.
And this kind of also goesback into areas of you can prove
that you were working on it first.
(18:39):
If you don't have those thingsdocumented, you don't have those
things written down properlyand properly categorized and controlled.
And I'm not saying it needs tobe to the same extent that you do
when you're in formal design developments.
But having a limited processin place for things like proof of
concept, where you can justhave a streamlined version of what
the QMS would be doing lateron in development, I think would
(19:01):
be really helpful forcompanies in order to be able to
use that initial proof ofconcept things going forward that.
Makes sense are there Arethere certain phrases or certain
terminology that you changedthat you use, and I'm not saying
that very well, but languagethat you change when you go from
department to department?
As a quality professional, arethere any phrases that you think
(19:24):
are particularly pertinent toone department over another that
really gets their attentionand helps them get on board with
what you're trying to.
Accomplish, department to department?
It really depends on thestructure of those departments.
So if you want to speak to theother side of quality, regulatory,
you want to show control.
You want to show using thingslike it's controlled, it's compliant,
(19:45):
it's, you know, safe.
They're very familiar andcomforting words to a regulatory
department.
Whereas if you wanted to speakto a scientist who's working in proof
of concept, you kind of wantto use the same buzzwords because
they want the sort of safetynet there as well.
But you want to.
You want to show things likeit's not going to impede you, it's
not going to slow you down.
(20:06):
It's just a way of it's.
And I think for talking topeople like scientists, R and D scientists,
showing that we're there toprotect them and keep them safe is
very different to.
So to allow them, because wewant them to be able to experiment,
we want them to be able to dothe things that they're going to
do.
But it's about doing thingssafely but without being able to
(20:28):
slow them down and thenshowing the effect of what happens
if they are just being able totreat it as the wild west and be
all like.
So it may slow you down alittle bit, but in the long run,
it'll get you to yourdestination faster.
So it may not be the mostdirect route, but there's pitfalls
and speed bumps and all ofthat on the direct route.
(20:49):
So we want to take you maybeon a slightly more meandering way.
But yeah, in terms ofbuzzwords for quality to different
departments, I think it really depends.
But I think quality is meantto be structure, safety.
But then showing how thatapplies to different departments
in different ways is important.
Yeah.
How do you.
Do you have any stories thatyou could share with about, I don't
(21:14):
know, using buzzwords or usingchanging their language or how you
maybe turned someone into achampion in one way or another?
I mean, my favorite story isit's not necessarily turning them
into a champion, but it's an.
It's an element of sort of aquick win.
So we had, we had a scientistwho had worked all of his life in
(21:35):
research where it wasn't asregulated, it wasn't as controlled.
And he was fairly late on inhis career and he'd started working
for us at Malogic, so tryingto teach him basic document control.
In terms of when you'reworking on procedures and when you're
working on batch records, youcan't just cross things out.
(21:56):
You can't just do all of this.
You can't just, you know,delete your entries and obliterate
them.
You know, there's certain, youknow, alcoa principles you need to
follow for all of these thingswhere you just can't do it.
And I remember one day he cameup to me and this is after I had
sent batch records back to himnumerous times, basically saying,
you've destroyed evidence, youneed to show what it was originally
(22:19):
there for, all of this.
And he came up to me in myoffice and he just put a record down
on the table in front of meand he'd crossed it out and he'd
initial and dated it and hewas like.
And I didn't even think twiceabout it.
And he was so proud of himself.
And I was like, I don't knowif he was proud of himself in terms
of he did it, but he was more like.
But he was just happy to havedone it because he wasn't doing it.
(22:41):
And obviously he wasn't doingit intentionally.
He wasn't doing it to try, buthe didn't understand the importance
of it.
So getting that understanding,getting the why behind it to say,
well, you may you cross thisout because you've put in a concentration
of a reagent, for example,you've crossed this out to put in
something new.
But what if that one that youhad put down there had been correct?
(23:03):
That could be the cause of whydispatches failed.
But we're not going to be ableto see that now because you've obliterated
that entry because you couldhave taken the wrong concentration
out of the cupboard orwhatever it was.
So it's important that we canbe able to see these things.
And once he understood thepurpose of it and that we're not
just doing it to follow someweird set of document management
rules.
(23:25):
People get on board when theyunderstand the why.
And I think that's why it'simportant to explain these things
to people when they're doing it.
It's not just telling them youshouldn't do that, it's explaining
why they shouldn't do it.
And that's sort of.
That's my favorite story interms of project management.
But it's when we wereimplementing so we, before disclosure,
(23:45):
we were implementingGreenlight Guru.
It was actually the projectmanagers who became our biggest champions
of it because of how thequality management system would really
benefit them in terms ofhaving a good quality management
system really does save themtime in terms of being able to create
the trace matrix.
Because previously we had avery long process which was very
(24:07):
manual.
And just being able to showthem a different way of doing it
is really helpful.
So it's good to have and thisis why you get them in early because
then once you get the hardestpeople in, and I think project managers
can be some of the hardestpeople in because there is an element
of seeing quality as being theresponsibility of quality.
And especially whenimplementing something like an EQMS
(24:29):
or any quality managementsystem, it's to benefit quality and
just showing that no, thiswill benefit everybody as you, the
entire company is really, Ithink showing value is important
in everything.
So yeah, when you have those,no, that's great.
I love it when you have thoseguardrails in place to make sure
that when you have a changeorder, for example, it forces you
(24:52):
to answer the question, why isthis being changed?
I mean, I just go Back to that21 CFR Part 820.42 document control.
The things that they ask for,they went, what's changing?
What was it?
What's your justification?
Who is approving this?
When is it approved?
Forcing you to go through allthose things and in addition to that
asking the question, is anyproduct being impacted?
Do you need to verify it?
Do you need to go back and validate?
(25:12):
Do you need to look at risk?
Do you need to look at this?
So it can be a little tedious.
And you know, in greenlightgrew, you can choose from a company
standpoint, you can choose touse it or not.
But I think most companieswould benefit from that because in
my experience, having gonethrough some FDA inspections and
received 43s justification onchange orders was one of the big
(25:33):
reasons.
Not any of mine personally,but although maybe had they found
some of mine, they would havethought so, I don't know.
But yeah, that's a real thing.
But if you go to what you'retalking about with the design controls
especially, I bring that upbecause I feel like the change order
process in a lot of differentcompanies is not straightforward.
It's difficult if you're paperor if you're in a system, both of
(25:56):
those can be really tedious.
I, I, man, this is like goingdown memory lane.
If I go, if I go to my papermemory days where I remember routing
paper around, wow.
I can remember losing changeorders on the VP of product development
or no, it was the VP of RDR&D's desk twice.
And I'm like, I've, I.
(26:17):
You realize if I have to dothis again, regulatory isn't going
to just accept that there areno changes that from what they, they
have to go through the wholeweek long review process again.
And so anyway, whole deal.
But with, with an eqms likewith Greenlight Group particularly,
I don't, I can't speak for alot of them, but you can go back
and see nothing's beenchanged, et cetera.
(26:38):
So if you have to backsomething up or something someone
doesn't want to approve, itmakes it much simpler to go back
and approve.
Nobody's trying to, I don'tknow, pull the wool over someone,
a previous reviewer's eyes andgetting that signature a second time.
Hopefully that some of thoseremotely make sense those, those
things that I'm saying.
But absolutely to the extentthat not in a medical device company,
(26:58):
but a pharmaceutical servicescompany that I worked for.
Because of the loss of paperwork.
When we had a paper managementsystem, they had to install a new
procedure where every time youmoved a piece of paperwork there
was a barcode and that barcodewas attached to a laptop in a tray
in a room.
So you had to scan in thatpiece of paperwork.
(27:19):
So we knew the last place thatit was because paperwork went missing
on people's desks, anywhereyou could.
People might take it into coldrooms or storage or it could just
be left around the warehouseor attached to the back of something
else.
And because it's paper based,you put a paperclip on it or whatnot
or staple it, you'veaccidentally stapled it to the back
of something else and it'sgone forever and you will never see
(27:41):
it again.
Yeah, and it's just.
So it doesn't necessarily haveto be something as sophisticated
as EQMs.
It depends on where you are inyour, your company journey.
But just having somethingelectronic, being able to write something
electronic and at least have arecord of that is, yeah, you need
to do it.
It's, it's.
I want to mention one otherthing about the design controls because
(28:02):
I don't think people realizethis or project managers probably
don't realize the benefit that using.
And I'm just going to go aheadand toot Greenlight Guru's horn because
that is actually one of thethings that sold Me on Greenlight
GRU as a platform, because asa project manager who was, who was
managing design controls andrisk management, when I saw how you
can maintain the traceabilitybetween the two and maintaining those
(28:25):
relationships from many toone, one to many relationships from
user needs, design controls,design design outputs.
I'm getting all this wrong.
User needs, design inputs,design outputs, verification, validation
and the relationship betweenall of those and relationship to
revisions of documents,sources of documents.
It's just, it's huge becausewhen you try to do that in Excel,
(28:47):
that becomes your full time job.
Making sure that whoeverreviewed this last did not change
the spelling of anything sothat when we filter it then it will
filter properly and we'llactually be able to see everything.
There's lots of differentissues there that seem trivial but
take up so much time and takeaway from what you're actually trying
to accomplish.
So there's a lot there thatyou will benefit from if you actually
(29:08):
recognize.
And you know, traceability issomething everybody really wants.
If you really think about it.
You don't want to spend yourdays running after whatever revision
of document you want to.
Okay, why did we choose this?
Oh, there's an easy link hereit is.
Traceability is not, that'sone of the examples in my mind that
it's not just quality's fetish.
(29:29):
This is, this is every, whatshould be everybody's goal.
And so it's, it really doeshelp you in your, in your day to
day work.
Yeah, and I completely agreewith that.
And going back to the sort ofchange control, if you have a product
change control, being able tosay this is the change control in
which this product changed onand linking that to a design review
where you can say, okay, sowe've opened up the product again,
(29:51):
we've changed it, we've closedit, we've closed the change order
and everything is linked together.
And that will give.
Because I don't know how othercompanies do audits, but we would
always bring the projectmanager in when we were going over
a specific product becausethey need to justify the decisions
that they have made.
They need to justify thechanges that they've made and being
able to find that informationand have it linked together rather
(30:14):
than, okay, so I've got thischange order number now I need to
find this change order.
Having it there like that is,you know, it's really great.
So it's, it's a, it's a really good.
And again, I know we're justsitting here touting, well, yeah,
EQMSs are available.
But yeah, greenlight guru, theone that we're familiar with, it
just is a game changer.
And that is why going back tothe initial premise of quality management
(30:37):
system belongs to everybody.
Everybody is going to getbenefit from it.
And that's why bringing inproject managers really early in
the onboarding process,because design controls touch everything.
They require documentation,they require change orders, they're
going to require qualityprocesses if they have MCs and customer
complaints.
(30:57):
So design controls touch everything.
So it's really important thatproject managers, scientists, everybody
who's involved in that designcontrol process has a really good
understanding of every aspectof the qms, not just design controls.
And seeing how all of thosethings can work together and seeing
how, okay, if we raise an nc,how does these things all link together?
(31:18):
How can I link it to thedifferent workspaces?
How can I make sure that we'renot going to lose that traceability?
Because ultimately it's theproject manager who's going to have
to justify where these linkshave come from.
At least in my experience,when we've had an audit, we get the
project manager in and they'rethe ones who are going to have to
go through the flow and gothrough justifying why this happened
(31:38):
and what the outcome was.
And being able to link all ofthose things together is just such
a, such a time saver withouthaving to have an Excel trace matrix
and then a document tree andthen creating all of those things.
It's yet so it's a real timesaver for project management.
I would say more than anyother department, Project management
(31:59):
benefited from getting an eqmsprobably more than any other department.
They certainly enjoyed it morethan any other department, I'd say.
I know I would have, oh man,it would have made my life so much
more bearable.
And I actually enjoyed projectmanagement quite a bit.
I will say.
I didn't even mention the dhf,you know, auto generation of the
(32:20):
DHF reports and design reviewsand the way that you can actually
maintain the little bit ofthat's a whole herding of cats in
the real world as well.
So the one thing you mentionedthere, and I'm glad you did, was
in Season Kappas becauseoftentimes you think, okay, design
controls, that's early on,that's early stage, we're done with
that.
Come on, we're now we'remanufacturing and I've worked as
(32:41):
a manufacturing engineer andso rarely do I go back and look at
the risk management file.
And it was not part of myreally, I don't know, maybe I should
have broadened the aperture ofmy mind.
It wasn't necessarily in myfield of view most of the time, but
it should be for companies whoget kind of any kind of customer
complaint going back and beingable to see, why did we make this
(33:03):
red, this button red, wheneverybody says that's the go button.
Maybe it should have beengreen, but maybe there was a reason.
Maybe we had a human factorsreport and wow, I could just click
right in.
Now I see the report, now Isee the change order, how it actually
was originally green andeverybody kept getting damaged or
whatever, you know, just to.
Maybe there was a point of caution.
There's lots of differentreasons why we do things, but traceability
(33:24):
is the only way to maintain that.
Because you think, oh, youknow what?
I know this project well,guess what?
When Stryker comes calling orJ and J comes calling and you head
out the door and someone elsehas to take over your project, that
poor soul, you know, just givethem a little bit of traceability
so that they can handle that project.
So, yeah, absolutely.
And there are cases incompanies I've worked for where somebody
(33:47):
retires and a lot of that.
So we have all of theinformation written down, but it's
gone through multiple changesthrough multiple different QMSs over
years.
So you mentioned that I workedfor SPD.
They've had products on themarket for 35 years.
So pregnancy tests on themarket for 35 years, that has gone
through a lot of different regulatory.
(34:07):
So it's gone, you know, backwhen, you know, 13485 is now 2016.
I don't think even 13485existed 35 years ago.
So it's a case of it's gonethrough so many iterations and being
able to go back and obviously.
But this is why even puttingin things like old records is really
good in terms of you can thenjust search for them.
(34:28):
You don't have to look in abox and dust things off.
So scanning things in, even ifit's frustrating to do because it'll
just sit there, you don't needto worry about it anymore.
But creating an electroniccopy of something is really great
as well.
Categorizing it, putting itin, because you never know when you're
going to want to need it.
And to your point of what?
Why is this red and not green?
That decision could have beenmade 25 years ago and you don't know.
(34:52):
And then you might turn itgreen and then it could create a
whole slew of other options.
Because colorblindness orwhatever you would want to call it
or however it would be.
And so but you could lose that information.
And also if it's not documented.
So that could have come froman nc and if that NC isn't documented
and linked to a change whichis then linked to a design control
which has been updated, you'regoing to lose that.
So it's.
(35:12):
It's.
It's good to have thattraceability and then have it be
not exactly effortless, but asclose to effortless as it can be
by just piping in a search andlinking it together.
I think.
Yeah.
Yeah.
When you were you.
When you were telling yourfavorite story, I meant to come back
to this point about what Ialways call a good documentation
process or practices.
Gdp.
(35:33):
You mentioned ALCOA principles.
And maybe we just need to runthrough that because I always.
Every time we use a.
That would be an acronym.
I recently learned aboutacronyms versus initialisms.
That's a whole nother thing.
But FDA is an initialism.
Did you know this?
It's not an acronym.
An acronym makes a word or Ihave that flipped.
I think it's.
Anyway, it doesn't matter.
(35:54):
Okay.
But.
Oh, that's interesting quality people.
I just thought they were all.
Yeah, I call them acronyms allthe time.
I may have to.
We're going to have to changeevery single process now.
Which has a table of acronymsbecause most of them aren't going
to be acronyms anymore.
Table of acronyms and initialisms.
This is anything new?
This is just a pure Englishmajor, you know, thing.
(36:18):
But anyway, a friend of minecame up to me and so.
Okay, so ALCOA principles.
Just so those who are maybenot familiar with them.
I pulled them up to makemyself look smarter so that I.
Because I didn't know ifeither of us would remember.
That's too long.
Five.
It should be three, you know.
And any acronym should be onlythree letters.
But ALCOA attributable which.
Which indicates who collectsor generated the data.
(36:39):
Who made the subsequent changes.
So who do you attribute thischange to?
Legible.
And maybe I should have givenyou the opportunity to remember this.
You want me to try?
I'll try.
Let's see.
Yeah, see if you can remember all.
Okay.
It's the usual.
It's the.
I can always remember the.
Cuz it's a really silly word.
Just to make the.
Just to make the initialinitialism work or whatever.
It's attributable, legible,contemporaneous, original and accurate.
(37:05):
Oh man, Beth, that was good.
Memory.
Yes, I love it.
Contemporaneous.
I thought about that one.
I'm like, yeah, okay, I guessthe root word's contemporary, so
it's just timely.
It's just.
Yeah, it's at the time.
That's all it means.
But could have been altoa.
You don't want three A's init, I guess.
But yeah, I guess yes, couldbe timely.
But whatever.
Okay.
Anyway, contemporaneous, we'llremember because it's a weird word.
(37:27):
Beth, thank you so much forthe conversation.
This has been really fun.
If you had one takeaway thatyou would want the audience to walk
away with, what would that be?
I would say the takeaway fromthis is challenge yourselves to take
on other perspectives, which Ithink has been a bit of a theme of
what we've been saying.
Quality people, try and stepinto the shoes of your project management
(37:48):
colleagues.
Try and think about what theirwhat the problems they're trying
to overcome and then trying tostick them to their perspective.
And project managers do thesame for your quality colleagues
because we're all just tryingto get to the same point.
So let's all row in the same direction.
Absolutely.
Be willing to listen, projectmanagers, because a lot of quality
people are trying to make yourlife easier.
(38:10):
So yeah, same back to qualitypeople, though.
So willing to listen.
Thank you so much, Beth, andthank you, those of you who've been
listening.
Reach out to us if you haveany questions.
I'm sure Beth would be willingfor you to blow up her LinkedIn or
however else we could put oremail on here.
Feel free to reach out to meif you have any positive or constructive
feedback.
We're always trying to get better.
Until next time.
(38:31):
Take care.
Thanks for tuning in to theGlobal Medical Device Podcast.
If you found value in today'sconversation, please take a moment
to rate, review and subscribeon your favorite podcast platform.
If you've got thoughts orquestions, we'd love to hear from
you.
Email us at podcastreenlight Guru.
Stay connected.
For more insights into thefuture of medtech innovation.
(38:51):
And if you're ready to takeyour product development to the next
level, Visit us at www.greenlight.guru.
until next time, keepinnovating and improving the quality
of life.
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If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
CrimeLess: Hillbilly Heist
It’s 1996 in rural North Carolina, and an oddball crew makes history when they pull off America’s third largest cash heist. But it’s all downhill from there. Join host Johnny Knoxville as he unspools a wild and woolly tale about a group of regular ‘ol folks who risked it all for a chance at a better life. CrimeLess: Hillbilly Heist answers the question: what would you do with 17.3 million dollars? The answer includes diamond rings, mansions, velvet Elvis paintings, plus a run for the border, murder-for-hire-plots, and FBI busts.