How Communication Affects the Outcomes of Quality Activities

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.

Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individuals and teams to fine-tune their quality conversations, initiatives, and internal communications with the goal of creating more and better understanding of the role and concepts of quality assurance in organizations.

Listen to the episode to hear Lesley’s take on how communication affects the outcome of audits, impacts the lives of quality professionals, and the common communication pitfalls Lesley sees in organizations.

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Some of the highlights of this episode include:

• Why writing to be understood is difficult for quality professionals

• Whether it’s possible to get completely away from jargon

• Common pitfalls that Lesley has seen

• The length of attention spans and how reading and writing have changed

• The importance of reading, including fiction

• What audits mean for communication and writing

• Fear of writing differently from the way it’s always been done

• Lesley’s LinkedIn game and how she keeps up with all the writing

• Other important points that Lesley covers when teaching

• Embracing the haters

• Making sure that everyone has the same vision

• Letting down your guard

Links:

Lesley Worthington's LinkedIn

Lesley Worthington Consulting

Etienne Nichols LinkedIn

MedTech Excellence Community

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Lesley Worthington:

“It’s not just about sounding different; it’s about the science of how we sound and how we read.”

“The clearer your writing is, the more likely the reader will be to think that you know what you’re doing.”

“Sometimes when things get really technical and really complex and really high-level, people lose the thread.”

“The purpose of regulations are completely different from the purpose of procedures in your organization.”

Transcript:

Etienne Nichols: Hey everyone. Welcome back. It's good to be back with you today. Today I get to talk with Leslie Worthington.

Leslie, how are you doing?

Lesley Worthington: I'm good, I'm good, thanks. Leslie Worthington.

Etienne Nichols: We were talking about that just before we got on, like, okay, are we going to be coherent? There are lots of things going on in this world. But today, you know, oddly enough, we're going to be talking about communication or specifically writing for the quality professional.

And I don't know, maybe we could just jump in. Before we jump in, let's talk a little bit about what you're doing and what that even does, what that even means to you, Leslie.

Lesley Worthington: Okay, so what I'm doing right now, I feel like I sort of started a business by accident.

I used to work in quality for about 20 years. I worked in, as a quality assurance regulatory affairs person in a medical device company in Canada.

And then as my kids were leaving the nest, I thought, oh, this is a good transition time. I was kind of bored with that kind of role.

And I wasn't sure what I wanted to do next, though.

But back in the, in the back of my mind, there was this, oh, I want to be a teacher in my head from when I was a little kid.

And so, I started teaching kids online English. And then I thought, okay, I want to do more than this. I'm like, what do I know about. Oh, I don't know anything.

Wait, I do. I know about quality.

So, I started, I. Then I started a LinkedIn account I started just exploring this world and how I can figure out, like, how can I help people with their communication skills in this space?

Because I noticed when I was in the space that writing communication generally is a bit weak.

And so, I thought, this is my passion.

It's time for me to figure out what I want to do when I grow up. And I think this is it. So that's how I got here.

Etienne Nichols: Oh, that's fantastic.

Lesley Worthington: I help non-native English speakers, you know, just feel more confident about their communication skills in English. But I'm also helping companies like the quality teams learn how to talk about quality in a way that everybody else gets it a little better so that they can start moving towards a quality culture.

So that's sort of the direction things are going now.

Etienne Nichols: Very cool. And if you as A listener do not or have not seen Leslie's LinkedIn. It's. You should go follow her because it's really fantastic the way she just lays out, you know, seemingly complicated or, or issues that cause complications. So maybe, let me put it that way. And she shows a very easy way to overcome those things. It's one of the few people that I actually, and I'm not lying here, Leslie, one of the few people that I really enjoy reading your posts.

I don't always react, but I always love seeing your posts pop up.

So maybe that's a testament to your ability to write. So maybe we can get into that.

1. Why do you think it is that that's an issue with quality assurance professionals? Maybe particularly that there's a difficulty with writing in such a way that it's easily understood.

Lesley Worthington: I think most quality professionals come from a science engineering sort of background, like hard science. And they're great writers for the academic world.

Etienne Nichols: Yeah, right.

Lesley Worthington: They know their stuff, they know how to talk about their stuff, but nobody's, you know, taught them how to make the shift into the real world.

So, they've got these great ideas, they know what they're doing, but they just can't communicate in a way that is real worldy. Right?

Etienne Nichols: Yeah.

Lesley Worthington: Especially in the writing.

Etienne Nichols: When I came out of college, I worked for a guy named Paul Wanamaker, who is a fantastic friend, first boss and mentor. And he had me write a report. It was for the FAA because we were doing destructive testing on custom aircraft interiors.

And I was writing a report that we were going to be submitting to the FAA.

He read the report, and he turned around his desk. We had back to basket desks. And he turned around and said, Etienne, I don't really want any fluff in our reports.

And I was from college, I'm like, well, you got to have a thousand words, five thousand words, whatever it is.

So, besides the irritation maybe I caused him or anyone who reads it, what do you think are the downstream effects of this science type writing that doesn't quite always communicate the.

What are your thoughts on the negative side of doing that?

Lesley Worthington: I think that the message isn't clear.

Like we're not thinking of.

Like we have to think of two main things when we write. Who are we, who are we writing to and what are we trying to achieve?

Etienne Nichols: Right.

Lesley Worthington: So, it's like before you even write, you gotta be thinking, think.

Like, because if your thoughts aren't clear, there is no way your writing's gonna be clear.

So, you have to think what's my message. What do I want to happen here? I'm not trying to get an A here. I'm trying to get Billy Bob to give me money for something or I'm trying to get so and so to, you know, whatever.

Etienne Nichols: Right.

Etienne Nichols: Put together a device, whatever it is. Right.

Lesley Worthington: It's like. And so, if you hide everything, like, if you hide your. Well, you know, the call to action. I hate jargon. That's my big pet peeve. But if you hide the call to action, right, People will read this big, long thing. They're not exactly sure what they're supposed to do with it. How is it relevant to me? Why did you give this to me?

So, I think just the messaging gets lost.

If you're not thinking about your audience.

You can't know how to write to them because you don't know what.

What they know. You don't know how they feel about you and about the subject. Are you going to get resistance?

Maybe I should be approaching this, you know, knowing that in mind already.

Etienne Nichols: Right.

Lesley Worthington: Do they speak English as their first language? Good to know, like, all these things. And so, we're writing as though we're trying to show all our knowledge.

That's not the point of writing in the business world.

Etienne Nichols: Yeah, yeah. So, you mentioned you don't like jargon, so feel free to call me out because I too, am a recovering engineer. So.

Lesley Worthington: So.

Etienne Nichols: But what are some of the. Can we get completely away from jargon in the scientific world? Or what are your. What are your thoughts there?

Lesley Worthington: No, And. And some people have, like, corrected me and said, oh, jar jargon's fine. I'm like, yeah, it is jargon. Jargon is fine. I mean, because jargon, Jargon is words that are used and understood by a particular discipline that aren't used outside of that discipline.

So, if you're sitting with your engineers all together and you're working on something, go for it. That's your language.

Etienne Nichols: Right.

Lesley Worthington: So that's okay.

Etienne Nichols: Right.

Lesley Worthington: But then if you're going to go to HR and tell them something, no, get rid of that jargon. Know who you're talking to.

You know? Know who you're talking. Even something like CAPA.

Etienne Nichols: Right?

Lesley Worthington: Even, like the term CAPA. Even if you say to someone, oh, that's corrective and preventive action, that still doesn't even clarify, like, what. Okay, but what's that?

Etienne Nichols: Right.

Lesley Worthington: And so, it's possible, like, the problem with jargon is that no one wants to admit they don't know it.

Etienne Nichols: Right.

Lesley Worthington: No one's going to say, sorry, excuse me?

Etienne Nichols: What.

Lesley Worthington: What's CAPA?

Etienne Nichols: Right.

Lesley Worthington: But it's possible your CEO, someone on the C suite, doesn't really know. They've just for years been going, yeah, we should do a CAPA on that, right?

So that's why, you know, that's why jargon is so dangerous, because people aren't going to say, I don't get it.

Like, no, no one wants to say that. So. So we have to be very, very aware of who we're talking to.

Etienne Nichols: You just made me think of something when I. So, we had a new plant manager when I was a manufacturing engineer. Came in, sat in a group with all of us engineers, and I said something, and it wasn't even technical jargon. So, I'm originally from Oklahoma. And I said something like, you're gonna wanna do this.

And he looked at me and said, gonna wanna.

And I was so embarrassed, but I was like, I never forgotten that. And I think, you know, just speaking the language of the people you're speaking with.

So how do we. How do we do that? What? Well, how do you. Maybe the question I'm trying to ask is, how do you coach people to be able to do that?

What are the tips you give people?

Lesley Worthington: I think you've got to build relationships. Like, this goes.

Go. Goes back to the foundation. It's not about, like, what's happening now. It's about, like, how. How do I know this person? If this person knew you were from Oklahoma, he'd go, oh, yeah, gonna wanna, like, no big deal.

I know this is how this guy talks. I know he can probably string a sentence together properly, but this is how he talks. No big deal, right?

It. This is even more complicated because we are totally in an international world now. All our business, we are dealing with intercultural issues. But also, we've got, like, how power dynamics work in different cultures.

How do gender dynamics work in different cultures? There's so to think about.

So, I. I think you gotta really do your research, know who you're talking to, show respect where you need to show respect. Don't make eye contact in a culture where you're not supposed to make eye contact to show, you know, like, know that stuff, right? And when it comes to our writing, we want to have the skills to be flexible enough to adjust our writing.

Oh, I'm writing to a regulatory authority. Okay. I'm gonna up the game, right?

Oh, I'm writing to, you know, someone working on the line. Okay. I'm going to change how I. How I speak. So, you need those skills to know how can I change my tone, how can I change my formality?

How can I change my words? How can I change my sentence structure?

Etienne Nichols: Yeah, that makes a lot of sense. So, when, and I'm curious, what are some of the specific problems maybe that you've seen? What are the common pitfalls that you see people getting into?

Lesley Worthington: It's kind of like what we were talking about earlier. I think we're too academic sounding and too formal sounding.

And this is often a problem when people are writing not in their native tongue as well, because when you learn the language, you learn it based on the rules. And so, it's very structured.

And a lot of times, like in the academic world, we are taught to write passive sentences. We're not supposed to put I and we and all these things in there. So, we're just used to that, and we think that's how we should be writing.

But the brain has a hard time with passive sentences.

Etienne Nichols: Right.

Lesley Worthington: So, it's not just about like sounding different. It's about the science of how we read and how we understand.

Etienne Nichols: Right.

Lesley Worthington: The brain says, oh, oh, I want to know who's doing what and I want to know it early, please.

Etienne Nichols: Right.

Lesley Worthington: They don't want to be hanging on because you have to, the brain has to store the rest of the sentence in short term memory while it's waiting to find out what's actually happening.

And so, you're putting a drain on the reader.

If you got someone reading a document that is telling them how to do something that might involve safety or something like that, you don't want a tired reader, you don't want a reader scratching their head going, not sure what should mean here, you know.

Etienne Nichols: Yeah, that's really interesting that you bring that up because I can even hear some engineers in my head thinking, okay, I'm going to write this work instruction. Maybe I make the argument that you're making.

Let's write it in a, in a way that the person on the line is going to want to read it, who will enjoy reading it, whatever the case may be, that they'll fully understand it and they might. I, I can hear the argument already where they would say, no, it needs to be this way because it's, this is a, this is an important action or whatever the case may be, and they need to take it seriously, they need to focus, and they need to get in here. But that's not really accurate. We're, we're taking the human element out of it.

Lesley Worthington: When we're doing it, we're just sort of being stubborn like well, they should be able to do it, right? So, it's like, okay, but what's your goal?

To be high and mighty and force people to be smart or to get them to do what you need them to do.

Like, that's going back to thinking about, why am I writing this? I'm not writing to learn them a lesson, you know, I'm writing to, you know, make sure that what we're trying to do in our organization is done well and is done right. And it's done, hopefully the first time.

So, you know, you got to think, too. The clearer your writing, which means going for the passive sentences and the simple words and the short sentences, the, the clearer your writing is, the more likely the reader will be to think that, you know, that you. What you're doing, what you're talking about.

Etienne Nichols: Right.

Lesley Worthington: Sometimes we think, I'm going to put the fancy stuff in there. I'm going to make it very clear that I know my stuff.

And all that happens is that it becomes fuzzy and the reader thinks, does this person know their stuff? Because I'm a little confused.

Etienne Nichols: Right.

Lesley Worthington: So, it kind of backfires.

Etienne Nichols: It's interesting how that works.

So, when I was. When I was young, I wanted to be a writer, and I broke my mom's heart when I became a mechanical engineer. I was supposed to be a writer.

But that's okay. I bounced back, I guess. But I had an English composition professor, Matt Gifhorn, if I remember his name correctly. He told me, make your sentences lean and tough.

Take everything out that doesn't. That doesn't actually do something.

And it sounds like that's what you're saying, too.

Lesley Worthington: Yeah, exactly, exactly. So, say everything you need to say and nothing you don't need. And so, you gotta have a lot of discipline. Like, you really gotta have a lot of discipline.

And it. It's really hard to, like, throw out our words after we've written them. So, this is why, like, spend a lot of time thinking and planning, then write. And then when you're editing, be ruthless.

Like, be like, okay, and read it out loud when you're editing. I do that as one of my first passes when I'm editing my stuff. Because if. Because when someone's reading it, they're saying it out loud in their.

In their head or out loud in their head.

Etienne Nichols: Right?

Etienne Nichols: Yeah.

Lesley Worthington: And so, when you're reading it to yourself, when you're editing, if you stumble across anything or have to backtrack, there's something wrong, go fix it.

Etienne Nichols: Right.

Lesley Worthington: And so that's because that's really how we read.

Etienne Nichols: You made me think of something I was reading last night at 2am I don't know. This is dangerous. I wasn't expecting to do this, but the book is on my desk.

I'm gonna see if I can find it real quick. Oh, I did find it. Page 26 of this book called Range why Generalists Triumph in a Specialized World by David Epstein.

For those who aren't here.

He talked about how the brain chunks things differently so just the words are not enough. And he has two sentences. I'm gonna just hold it up so you can see them and then I'll read them.

Sorry, you won't be able to read them. Yeah, here's the two sentences. Number one, because groups 20 patterns meaningful are words easier into chunk remember really sentence familiar can to you much na so it's, it's potentially understood. But this is the second way of writing it.

20 words are really much easier to remember in a meaningful sentence because you can chunk familiar patterns into groups.

Lesley Worthington: Absolutely, absolutely.

And our, our brain is expecting stuff, right? And this is how AI has, this is how chat CGT thing has developed, right?

Because our brain expects to stuff and, and we, and we're waiting for it and we're, every time a little bit of information comes in, we're putting it into the pile and, and processing it and figuring out where it fits in.

And so, we definitely chunk. And so, I, I think one of the reasons why I give advice to keep those sentences, everybody gives advice to keep the sentences short is so that you can do a short chunk digest, think, move on to the next chunk. If you have a big, long sentence with a gazillion things in it, you are keeping something so much information in the front of your mind in your short term memory that by the end, you know, by the time you get to the end of the sentence you're like, I have no idea what's going on in here.

Etienne Nichols: Right.

Etienne Nichols: Yeah.

Lesley Worthington: And that is often in procedures. That's what happens sometimes. And you're like, I don't know what I'm supposed to do because I don't remember the beginning of the sentence.

Etienne Nichols: And the fact that attention spans are so much shorter than they used to be too that I mean, you can't take that into consideration without some detrimental impact.

Lesley Worthington: So. Oh my gosh, yes.

The like reading has changed.

Therefore, writing must change.

We cannot, we can't be stubborn about it. Like, great, we want to write like, you know, like we used to. No, we can't.

I think I'm so scared that reading is going out of style. Like, I'm so scared that reading is going. Because reading is so important for writing.

And I don't mean just reading to get knowledge. I'm not talking technical stuff. I'm talking like reading fiction.

Because, because a reading fiction helps you get more familiar with words, what you like, what sounds good, what's easy to read, you know, and then you can start doing that. But also, it's critical for focus.

And we don't know how to focus anymore. Like, have you ever, like, with that book there, I bet you 10 years ago you could sit down and read that book quickly.

Right now, it's like, you know, we just very hard to focus the way we used to.

And then also it's critical. Fiction reading in particular is critical for developing empathy.

And empathy is what we need if we're going to think about the reader of our stuff, right? And so, if we don't develop empathy, we can't think. Ah, I wonder what this reader is going to think about this.

I wonder what this reader's priorities and motivations are. I wonder how I should attack this kind of, you know, this email or this whatever it is I'm writing.

Etienne Nichols: I want to get to the. The QA side and, and talk a little bit about how your law degree played in. But before I do, you've sparked my interest a little bit with the fiction.

And I have to ask, what are. Do you have any recommended fiction reading? What's your favorite anything come to mind?

Lesley Worthington: I. I am one of those people that will read anything.

Okay, no, sorry, I won't read science fiction. I won't read. I hate science fiction and fantasy. I've never read Harry Potter. Like, I just.

Etienne Nichols: Ender's Game.

I'm just, just. Okay, okay, fine.

What. What is one? Well, I'm gonna throw one out that I really liked. I'll give you a time to think.

So, Brothers Karamazov by Dostoevsky.

Sounds crazy.

Lesley Worthington: Major reading.

Etienne Nichols: It's. I mean, you talk about the social science and learning people. I think it's fantastic. I never understood that until I read his book. But I want.

It's just one I want to throw out there.

Lesley Worthington: Well, you can't put me on the.

Etienne Nichols: Spot like, oh, no, we'll come back to it.

Lesley Worthington: I can't even think. I. Like, I have read hundreds upon hundreds upon hundreds of books. Like, I read usually about 100 books a year. I just read so much.

And I actually love short stories too, too. But maybe that's a function of Me having less focus than I used to have, I don't know. But.

Etienne Nichols: Well, we're going to come back to this. Maybe not in this episode, but I'll hit you up later on for my own sake.

Lesley Worthington: Okay, we'll do a post.

Etienne Nichols: But, but I have a question about. So, when we were talking about the more readable sentences and writing things that on a more human level have you as your quality assurance background, since you have the quality assurance background,

I can see some people wondering, well, the FDA is going to come in and read it. Maybe internally we can figure this out and make sure, you know, that it, it does what it does.

Are there any arguments that you've heard where people are going to say, well, what about when we get audited? Are people or agencies going to think we're not professional? Is there any balance there for that?

Professional versus human centered communication.

Lesley Worthington: Yeah. I would say, first of all, remember this, that even a technical document is nothing more than a conversation between the writer and the reader or the user. If it's a doc, if it's a procedure or something like that.

The, the regulatory people really don't care about the words in your document.

They don't like. It's a mistake. I think it's a mistake to take to quote out of a regulation and stick it in your document. Are regulations easy to read?

Etienne Nichols: Legalese? No.

Lesley Worthington: No, they're not. So why would you put that in your document? Figure out what it means, figure out the intent, like when you're being audited. I don't care what your documents say. Obviously certain things must be documented. So, you must make sure you've met the requirements in terms of, like if something says it has to be in a document, make sure it's somewhere in your system, fine. But all they care about is, you know, this is what has to be documented, this is what has to be done.

This is what you say you're gonna do.

Do you do it? Show us.

Etienne Nichols: Right?

Lesley Worthington: And that's what you gotta be thinking about when you're thinking about your documents. How are we going to write our stuff that A, we've got everything in it that we have to have in it because the regulations or the standard tells us we need it?

B, how do we make sure everybody knows about it? How do we make sure everybody does it, does the task properly, and how do we prove to the auditor that we did it?

That's it.

Etienne Nichols: Right.

Lesley Worthington: So, it's like, it's, it's like simplifying your thinking about it. Like just settle down about the Wording of the standard and the regulations.

Etienne Nichols: Right.

Lesley Worthington: Just go, okay, what, what's the principles behind this? What's the intent of this?

Etienne Nichols: And I'm going to go back to something you already said because it just popped in my mind again.

A lot of times when we write these things, we are, we're trying to impress our boss, the director, whatever. Yeah. And that we just got to get away from that and do the job.

I talked to somebody recently who we were talking about fulfilling regulations, pursuing compliance versus quality, and, you know, the ramifications.

And we came up with three kinds of impacts. You have a business impact, you have a regulatory impact, and you have an ethical impact. All three of those need to be considered.

And that's just kind of, I don't know. One of the things I think about are you just focused on regulatory impressing the regulatory bodies and you're going to fall down?

Etienne Nichols: Exactly.

Lesley Worthington: I do this sort of. I don't know if it's a masterclass or a workshop because I've done two versions of it, but it's on writing procedures and it's like taking people through the thinking part of this.

Etienne Nichols: Right.

Lesley Worthington: And so, one of the first parts is like, who's going to read this thing, who's going to use this thing? And it's not going to be one person.

Etienne Nichols: Right?

Lesley Worthington: It's not, it's going to be hopefully the person who's doing the task. But often that's the last person we think of. The first person we think of, like you say the first person is the, the regulator, the auditor coming by, or the inspector.

And we think, oh, we gotta, you gotta have all the boxes ticked. It's got to be good. This guy's gotta approve us. It's like, well, he's not going to give you the tick box if the task isn't being done.

Doesn't matter. It does not matter how brilliant your procedure is in terms of being compliant.

If someone's not able to read it, it doesn't do you any good.

Etienne Nichols: Right.

Lesley Worthington: But in terms of like making sure that you're addressing like the business side of things, ethical side of things, regulatory side of things and the practical side of things.

I think when you're writing anything at work, you, you kind of need a team approach.

Etienne Nichols: Right.

Lesley Worthington: Nobody knows all of all, like, nobody knows all the bits and pieces of everything. And you need to know, like if you've got a subject matter expert, that's great. Is that person good at like taking their specialized knowledge and making it clear.

Maybe you need a writer to work with that person, or maybe you need that person just, you know, put their, put their thoughts on the page and the writer comes along and helps make it, like, readable, you know.

Etienne Nichols: I have a question buried in this. I'm going to tell a quick story. I remember when I went out to the clean room at one of my jobs. Went out to the clean room.

We had a co-op named Mace. I think her name was Mace Johnson. I hope she doesn't mind me calling her out, but she was fantastic to work with. She was really fun.

She wrote a lot of work instructions that nobody read except the workers themselves. And she seemed to be a master at this. She was, she had not finished college yet.

She was just a baby engineer, and she would write these things. And I went out there and I was reading a work instruction at one point, and I looked up like, hey, this says you wrote this, Mace?

She's like, yeah, I'm kind of a big deal. And it was, I just, it was so easy to read. It was, it almost seemed, you know, in my mind I'm thinking, okay, this doesn't seem very scientific, but I know it got the message across.

Lesley Worthington: Exactly.

Etienne Nichols: Do you find that other people, from. Whether it's, you know, an adjacent field or the beginner's mindset.

Lesley Worthington: I don't know.

Etienne Nichols: How do you, how do you get into that mindset? Or do you have any thoughts on that?

Lesley Worthington: I think, I think there's a lot of fear of like, of standing out, like, of being different and of taking that chance of going like, no, we're going to write our things differently now. Let's, let's try this.

Etienne Nichols: Right?

Lesley Worthington: It's so hard to get other people to buy into this because, because we're. Things have been done a certain way. Documents, procedures, look a certain way, and we're, we're stuck on that. We think we have to do it the way the guy before us did it, but that person has probably copied from the person before that.

And you're probably doing things that were done 50 years ago that maybe sort of, kind of might have made sense back then.

So, I remember when I, when I first got into quality, I knew zero about medical devices or about quality or about regulatory nothing.

I'm like, somebody just took a chance on me and I'm like, okay.

I guess they figured I could figure stuff out.

So, I'm like, quality management system, what exactly is this?

And I, and I, it was a startup, so I was like creating this quality management system.

And the auditor came by and said, wow, I'VE never seen documents like this. And I was like, oh no, oh no. He's like, why can't everybody write like this?

This is so clear. And they looked like; I call them like my baby procedures because they look like the beginner ones where it's like. But they were so clear. And the most important thing is that all the staff, who, all the staff understood why the procedures were there, what they had to do, why they mattered.

Etienne Nichols: Right.

Lesley Worthington: And sometimes when things get really technical and really complex and really high level, people lose the thread, like, what, what are these for again? Why are we doing this?

Etienne Nichols: That makes sense.

I can. I remember myself when people would put that stack of SOPs and I try to read them. We do the read and understand. I feel like it's tradition to break the spirit of a new hire by forcing them to do that.

Had they been easy to read, maybe they would have retained more.

So, I have to ask though, I know you have the law degree. I'm curious how that fit into your career and maybe how that's shaped your thinking with communication, if at all.

Lesley Worthington: No, I often forget that I have a law degree.

It was just this thing I did.

So, my first degree was science, but with a psychology focus.

And then, I don't know, I just went into law school, finished article, did all that. And then this opportunity at this startup came up and I'm like, oh, that's. That sounds interesting.

So, I just did it. Yeah, I never really looked back.

But the, the, the law degree obviously helps with the thinking, with the writing, with the, with the confidence too. And, and I don't know, like, honestly, obviously we're dealing with regulations and standards and so I'm not intimidated by reading that sort of thing.

Etienne Nichols: Right.

Lesley Worthington: So that maybe that's the leg up that the law degree gives me. And certainly, the auditor, like, you know, auditor. Oh, law degree. Oh, you must know what you're doing. It's like, not really, but.

Etienne Nichols: Because no one does.

Lesley Worthington: But.

Etienne Nichols: That’s really cool.

I think what drove me to start reading the regulations was desperation.

My project was going to be behind, and I didn't know why we were doing this. They said, well, the SOP says we have to.

So, I went upstream And I said, ISO 1345 does not say that.

Incidentally, it's funny, one of the.

You mentioned just translating that law speak or not lifting the regulation into your SOPs. You mentioned that one of my top performing posts, just because we talked about LinkedIn last year was where I just took the Patch act, which was a software as a medical device thing, you know, as an act that was being proposed and I just read it and rephrased it and it was just.

Lesley Worthington: People like, just amazing go off, right? It's like, oh my God, so clear.

Yeah. And I have to, you know, I, I tell people, well, the regulations, that's the law, right? Like, it's like sometimes people are like, you realize that's the law, right? That's what it is. And so, it's written for a different purpose than our procedures.

It's written for like, you know, litigation purposes.

And so, it has to be. It kind of has to be. I mean, I don't believe everything has to be so quite so legal, easy.

But I mean the purpose of regulations are completely different from the purpose of your procedures in your organization.

And so just knowing that, it's like, why would you lift that and stick it in your procedure? It's not logical to do that unless you think you're going to get brownie points from the.

Etienne Nichols: Right.

Yeah, probably is the motivation, I'm guessing. So, what are some tips?

What's some additional tips? I mean the content makes total sense.

And I'm curious if you have any thought about formatting. I know that seems kind of, eh. You know.

But it seems to make a difference.

Lesley Worthington: In some stuff formatting matters, like whether we're talking an email or procedures or whatever. Because how do you feel when you open an email and it's just black, like you're like, I think I'll save this one till later.

Right.

And you know, if, if someone's got a procedure in front of them and it's dense, right. It's going to be like, oh. Or if things aren't laid out easily, if there's steps that are hidden in a paragraph and they have to do something, come back to it, do the next thing.

So much time wasted trying to figure out where they were in the process.

We like white space, like we just. Our brains. It feels like we can breathe a little bit, right. And also, visuals, right. Not everybody, like a lot of people think in pictures. So, stick, stick a diagram in, right?

Etienne Nichols: Yeah.

Lesley Worthington: If you, especially if you've got a procedure that's got a few different decisions, right. Instead of saying, so if this happens, then do this. But if that happens, then do this.

Have a picture too showing.

This goes here, this goes there and just like just be really. And again, we're thinking of the thinking of the user or think like, okay, where's this document going to be used?

Is it going to be used out in the field in the back of a warehouse where it's dark.

Is someone going to have goggles on when they're looking at this? Are they going to have gloves on?

Etienne Nichols: Right.

Lesley Worthington: Or is this going to be a binder on a lab? In a binder on a lab desk? Is this going to be on a phone?

Like, all of these things you have to think about, like, how are people going to look at this thing? There are certain, like, there are certain standard ways of doing things, like the front matter and the middle and the end matter generally is the same in most procedures. But, you know, really, I personally think you should look at each procedure on its own merit based on what the purpose is and who's looking at it. You know, if you've got somebody who doesn't speak English outside of work and they've got this, they've got to follow this procedure, think very carefully about how you want to do this procedure.

Etienne Nichols: Yeah.

And that seems, I guess it seems like it could potentially be a foreign thing. It was like, well, no, everybody's internal. But that might not always be the case. When I was a manufacturing engineer, we ran up against a hard deadline where we were not going to make certain products because a lot of documentation changes had to happen. So, we outsourced a lot of that to a team of engineers in India.

And that was a game change as far as the speed. But we really, I mean, that. I think that was my crash course through communication or probably miscommunication.

Lesley Worthington: Yeah. But, yeah, yeah, that, that's difficult because when you're outsourcing, they don't really understand your organization.

Etienne Nichols: Right.

Lesley Worthington: So, like, you know, even, even our documents represent, like sort of the mindset of our organization.

So, if whoever's working on them doesn't really get what you're all about, you know, they might not do a very good job. The other thing to think about with your documents in terms of who might see them and what you have to think about is that your suppliers and customers sometimes have to see these things.

Etienne Nichols: Right.

Lesley Worthington: So, you have to keep those potential readers in mind as well.

Etienne Nichols: Right.

Lesley Worthington: If you're, you know, if you've got a supplier and you've got to make sure they are doing something according to your, your system, can they read it? Like, you know, can you explain it to them if they can't read it? So, then it comes up, your, your verbal communication skills matter at that point as well.

Etienne Nichols: So, yeah, time, you know, the time of day, everything else, just understanding them.

Like you said, just understand the environment, the user, and I am.

I'm gonna go somewhere that I'm probably gonna regret. So, it's. It's an analogy that is probably in the realm of the esoteric, like you're saying and the. The jargony.

It makes me think of design controls. It's a product development engineer. I can't help it. You'd stop me. But when I think of design controls, I think.

And I'll just run through the process so that people. And then we can just get back on track.

When you're developing a medical device, the regulations require that you go through user needs, establishing what the user actually needs.

Then you turn those into design inputs, which. Okay, what do you. The actual message. And then design outputs, which would be the actual document. And then you validate or verify and validate.

Those are the five steps that you have to go through. And it almost. My brain immediately goes there when you start. Started talking about the user and understanding the environment.

Indications for use. I.

Medical device jargon is coming to head. So, I'm making a mistake.

Lesley Worthington: But yeah, medical device podcast. It's okay.

Etienne Nichols: Okay, thank you. Thank you for your patience.

I kind of want to go a little bit different just.

And I'm sure there's a lot more we could talk about this. I'm really curious about how you write for LinkedIn and how you. How you manage to do all that.

This is almost me personally curious about your LinkedIn game and your ability to do all of that communication.

Lesley Worthington: I don't know. I love writing. I love writing, right?

And a lot of my posts are written. The idea comes to me in the shower, lying in bed. I'm like, oh, here's a good one.

And it. And it's easy for me. I love writing.

Now. I. I worry sometimes that people judge my writing ability based on the way I write on YouTube. No, no. Purpose. Remember the purpose.

So, yeah, no, I'm just. What I like this goes back to me sort of starting creating this business by accident. It's kind of like I'm just like seeing what are people responding to?

Like, what are people excited about? Or what are people going, oh, my God, I never thought of that before. Right?

Etienne Nichols: Yeah.

Lesley Worthington: And it's this whole thing about like, like clarity.

Like everything I think gets.

We're such a technical group, you know, for the most part, people in quality and regulatory are kind of technical and they don't. Haven't really thought about the people piece all that much.

Etienne Nichols: Right.

Lesley Worthington: And I'm like, okay, I'm the people peace person.

Etienne Nichols: Right?

Lesley Worthington: It's like. And People piece means thinking about how we write, thinking about how we speak, thinking about our relationships. Because building our relationships is going to mean if you have really good relationships, it actually takes the pressure off writing. I'm not talking about procedures and stuff, but I'm talking about emails and something like that.

There will be.

Even if you're not clear, you'll always get the benefit of the doubt.

If you've got a relationship with the person, they're not going to think, oh, what an idiot. Why did she say that?

Etienne Nichols: Right.

Lesley Worthington: Yeah, I think we just wandered off. I don't know if I answered your question.

Etienne Nichols: No, no, I think you did. So.

And I'll just use a personal. So, I was actually.

I'm always excited for a podcast episode. I really am. I get excited, but sometimes I'm nervous. But just I feel like I know. Knew you better than most people just because of your posts and I have a tremendous amount of respect for you and the top shelf respect, but also was at ease thinking, okay, she's a. She's a human being. This is gonna be good, you know, so I'm excited.

Etienne Nichols: Yeah.

Etienne Nichols: So, when we talk about that, I'm curious if there are any other things that you tell or the good, the bad, the ugly, whichever one it is. When you do those master classes, are there any other things that you consistently teach people that.

That really help that you've gotten good feedback on?

Lesley Worthington: Well, I think, I think a lot of what I like this is kind of embarrassing to say, but I basically based a whole business on common sense. That's how I feel.

That's how I feel. Because everything I say, people are like, oh, yeah, I kind of knew that. I kind of knew that. I just kind of forgot. Yeah, that makes sense. That makes sense.

Etienne Nichols: Right?

Lesley Worthington: So, you know, like when it comes to the writing and communicating of any kind, it's like know who you're talking to and know what you're trying to achieve and that, that comes down to the relationships and all that kind of stuff.

But also, you want to have credibility.

Etienne Nichols: Right.

Lesley Worthington: So, you got to know what you're talking about.

You got to be correct.

You got to be. Especially when it's, you know, you. So.

So, you know, it's not enough just to have good relationships and just, you know, you actually gotta know what you're talking about. So, make sure you know what you're talking about.

Make sure you understand the regulations. If you don't understand them, go talk to someone who can help you.

Etienne Nichols: Right.

Lesley Worthington: Like, just make sure you understand what you're supposed to understand, know your purpose. I would say for writing and for speaking. Have a plan, right? Don't just start and hope for the best, right?

Have a plan. And again, the plan goes back to what's my purpose? What do I want to happen here? What's my call to action? Whether I want to call it a call to action or not, what do I need from this person?

Or what do I want this person to know or do, right?

And then that edit ruthlessly thing.

And, and I would say this goes for communication and like, like verbal communication and writing.

Just, just stop with the unfamiliar words, the big fancy words.

It's not a competition, right? If it's that important for you that people know you're smart, wear a hat that says you have a PhD, like, whenever, right?

It's about connecting with people.

Etienne Nichols: Right.

Lesley Worthington: It's not about showing off.

And the world is so competitive now. That's why it kind of is about showing off. But people have to go, wait a second. I'm going to get way more respect and I'm going to get further in my career if I act like a person, if I treat other people like they're people, if I'm clear, if I'm credible.

And the best path to being credible is, is being clear. Like I said earlier, like when you're clear, people go, yeah, he knows what he's talking about.

Etienne Nichols: That's really good.

Lesley Worthington: Yeah.

Etienne Nichols: When I came to this job that I'm in now, I worked with a lot of customers doing a little bit of consulting and things like that just to help them understand software, understand the regulations.

I was nervous. And my coach, because we had an internal coach, she, she helped me come up with my own little personal mantra. And I came up with three Cs.

I am confident, competent and charismatic.

And maybe I need to put clear on there, you know, just to help myself. Four Cs. Yeah, that's really good. I'm curious because QA and RA are a little bit skeptical sometimes and we are a scientific, technical group.

Do you have any haters? Are there, is there anybody who pushes back or says or is the industry kind of embracing this a little bit?

Lesley Worthington: I.

If there's a hater, I embrace the hater. Because what I get to do is then explain a little bit more to the hater and make the hater my friend.

I did this one post, I've done it three times, I think, over the last two years.

And it says one and the caption is like; you don't need a quality department or something. Like that on the slide. And it's just an empty office room.

And some people, and I know this is going internationally, and some people are not English native speakers, so they don't, they don't hear the tongue in cheek part of this post, but they are like, yes, you do.

You do need a quality department, you know? And I'm like, I know, I know. I'm not saying that. I'm just saying we need to change the way we think. But it is allowed.

Like, most people. Most people are nice. That's the way I have to. That's the way I approach the world. Most people are nice and it's okay if they disagree because then it gives you a chance to.

Because maybe they have some valid points.

Etienne Nichols: Right.

Lesley Worthington: So, I think for all of us in that LinkedIn world just to be open to the haters and not just suddenly get defensive because it's hard. Like the first time. And only once or twice has someone said something where I felt like they were basically calling me an idiot and I'm like, oh, God.

So. But it's like, how am I going to deal with this? How am I going to turn this around? A, so that this person has, like, more understanding of where I'm coming from, and B, so that other people can see how I'm engaging with this person and go, oh, I could do that the next time someone does something that's difficult, you know, with me.

Etienne Nichols: Right.

Lesley Worthington: Sort of like a symbolic way of teaching. Yeah.

Etienne Nichols: But gives you that feedback so that you kind of know where those extremes are and how to tailor your message so that you're communicating with them.

Lesley Worthington: Yeah, but, but for the most part, people are realizing that the communication is the bit that's missing in this space.

Because, I mean, think about it. Every single job on earth, number one.

Well, we need good communication skills. That's the number one requirement. But it's on. It's on the job application, it's on the resume, even.

But in real life, it's often not there once the job starts.

Etienne Nichols: Right.

Lesley Worthington: It's kind of. And it's hard to.

It's hard to put a value on it, to try and convince the people that count the beans that, hey, this could make a difference. If you get your people communicating better, it could make a difference to the bottom line. But it's so hard to put a value on it that it's hard to sell it.

Yeah, but, but a lot of people are like, I feel like I get a lot of support on LinkedIn, like, so much support.

And I started a group on LinkedIn called Building a Quality Culture, and there's not too much discussion in it. Groups on LinkedIn are weird. I haven't figured out exactly how they work, but there's not as much discussion as I had hoped.

But there's lots of eager joiners. So, I know that's like, okay, they're interested, they want to know about this. And building a culture of anything comes down to communication.

So, again, communication, you know, ranks higher than we.

Than we're ranking it, really.

Etienne Nichols: Yeah. And we'll put a link in the show notes to that. To that community, too. So, you can check that out as well.

It's. You're kind of, maybe I need to hear this message over and over again throughout this conversation, because it's even sinking in a little bit deeper for me too. When you say communication, that word immediately conjures up the image of just a couple people talking at the water cooler or the coffee machine or whatever.

But. But even when you're communicating through a graph, like you said, the bean counters or whatever, to the CEO, that's communication through a visual, you know, artifact.

That's really good point. You know, a lot of just what we do is communication. The tools we use.

Lesley Worthington: Yeah, yeah. Like, you know, when you think of your organization, you've got these different levels of, you know, the hierarchy of who's who and who's in charge of whom and who has the power.

How does communication work in your organization?

Like, what happens if someone down below has a problem with someone up above?

Is there a mechanism in place for dealing with it? What if someone down below realizes this procedure's not right?

Is there a mechanism in place for that?

What sort of digital sort of communication do you have going on there?

And do you have posters on the walls with your mission and values? How does.

How do the people that do the work know how things are going in the business?

Etienne Nichols: Right.

Lesley Worthington: And how do the people at the top, like, if you stop them on the street, could they tell you what your quality policy is or your quality objectives?

Etienne Nichols: Right.

Lesley Worthington: And if you stopped a middle manager on the street, could they tell you what the business objectives are? They should be able to.

Etienne Nichols: Right.

Lesley Worthington: But that's not likely the case in most companies.

And you want to get to the point where the communication is just so robust that everybody knows what's going on and everybody's got the same vision. Like, we're all on the same team.

We all have our little things that we do, but we're all aiming for the same thing.

Etienne Nichols: Yeah, that hits Home so hard. When you talk about what used to be on the wall, like at the medical device companies I worked for, I couldn't have told you what the core values were, even. Honestly, they were probably generated by AI from the 90s, so. So, but, like, Greenlight Guru. I could rattle those off right now. I know our mission is to improve the quality of life. I know our core values are to be. Be innovative, fanatical support, and true quality.

So, it just, you know.

Lesley Worthington: Yeah. And that's culture. You guys have this great culture where everybody gets it. Right. So, every single thing that you do, you've got that foundation behind you going, okay, am I, am I meeting these?

Am I in line with the vision? Like, everything you do is in line with the vision. And that's what we want to aim for. And that only comes through good communication, trust, relationships.

Like, does anyone know about the CEO and the fact that his wife's got cancer?

Etienne Nichols: Yeah. Right.

Lesley Worthington: Because maybe that would really help and take the edge off some of the conversations. When someone thinks the CEO is being all serious. No, no. He's distracted because he's got a crisis going on in his life.

Etienne Nichols: Right.

Lesley Worthington: So, you know, I think we. We forget to show up as humans a lot of the time, and I think that's critical if you want to have, like, the kind of company that you're at.

You know, your people all know that you were up last night changing diapers, right?

Etienne Nichols: Yeah, we, we talked about it this morning in the standup.

Lesley Worthington: Because you're a person.

Right. And so, we have to. We can't. We should, we should stop pretending that we're not people. Right, right. We have to let down our guard a little bit to do that, and that is hard for people to do, especially because the world has changed.

The loyalty of, of employees to organizations isn't there, and the loyalty of organizations to employees isn't there. So, the world has changed. And that, you know, that makes us have a little bit of a guard around us.

So, I think we just have to trust people and just go, okay, right now, I'm here, I'm at this organization, and I know what we're trying to do with this organization.

Etienne Nichols: Yeah. And I'm going to add one more. You add. You talked a lot about the communication between the manager or to the lower, the mechanism, to the upper, and so forth.

And one other little piece that I know you've mentioned earlier is not only is that communication internal, but your quality management system is communication to the FDA, for example, about how your approach to quality and what you're doing. So that is. I mean, like you said, it's just. It boils down to communication there as well.

Lesley Worthington: Absolutely, absolutely.

Yeah. Like, because if. If the. If the FDA arrives on your doorstep and they sense like everybody gets it here, everybody gets it, it's just going to be easier. Right? It's just gonna be easier.

And it's like you will be given the benefit of the doubt because.

Because it's clear that everyone's on board, everyone's in tune. Everyone knows what. What the FDA is and why they would be here today.

Etienne Nichols: Right.

Etienne Nichols: Which. Which is difficult to quantify, but it's probably possible to quantify that lack of churn or that reduced amount of audit time, all those different things. It does. Eventually.

Lesley Worthington: I mean, there's so many things, you know, I say it's hard to quantify. There's so many ways you could say. But look, look how much time. Like, for example, I worked with someone who works at Big Pharma, and she was.

She was doing a Sig Six Sigma project that it involved, like, cleaning up the procedures.

So, she developed this app to, like, search for vague words, to search for long sentences, to search for redundancies, to make sure that all the. All the other documents that interacted with this document were tracked. And the right version numbers were.

Wow, amazing.

And then she was testing this thing.

So, she took one document, and I think it was design and development, and it had been like 40 pages of, like, what.

What is this?

She got it down to maybe 30 pages or something like that. And then when she was testing it, she, like, she was trying to promote this app to her leadership.

So, when she was testing it, she said, okay, guys, you. Not only do we want to see if you can actually do the process, but we want to see if you can read this right, and we want to see how long it takes.

Let's just look at that one little metric. How long does it take?

Okay. And it took whatever, 30% less time.

That's money times 10,000. Like, this company had so many procedures times thousands of procedures. So, time alone, and most likely, if it's clearer, there'll be fewer mistakes. So, we're not even talking about mistakes. We're talking about time alone. So, there are all kinds of ways that you can go to the bean counters and say, look, we're saving money here or we're not spending money by doing this.

Etienne Nichols: Right?

Etienne Nichols: Yeah. And for those of you bean counters who may be listening, we love you.

Lesley Worthington: Absolutely. They're the favorite people.

Etienne Nichols: So. Okay, I know we're out of time. So, any last pieces of advice or where can people find you? What, any, anything that you want. One last thing you want to say.

Lesley Worthington: Well, thank you very much for having me. I have a very tricky website name. It's Leslie Worthington.com and that's where I am on LinkedIn. And those two places are really the only place that I am right now.

I don't really want to go to other social media just because.

No, I'm, I'm passionate about writing. I'm passionate about helping people figure out how to communicate better and, and, and help their careers and help their organizations. And that's pretty much it. That's, that's why I'm here.

Etienne Nichols: Absolutely. Well, thank you so much for being on the podcast. I've really enjoyed it, and I know I've learned a lot, so I'm excited to take that away and I'll let you get back to the rest of your day.

Thank you so much for being on the Global Medical Device Podcast.

Lesley Worthington: Thanks very much.

Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.

Email us at podcast@greenlight.guru.

Stay connected for more insights into the future of MedTech innovation. And if you're ready to take your product development to the next level. Visit us at www.greenlight.guru. Until next time, keep innovating and improving the quality of life.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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