My Workspace

If you do not know gear, I apologize as I am going to write this with those that are somewhere down with their equipment and workspace journey. If you have questions, feel free to reach out.

My 'white whale' is my workspace. It is the greatest tool for my productivity.

It is also, when not 'primed and read' my greatest distraction. That may be more about me than my workspace but it is part of my pursuit.

In the end for me, and your mileage may vary, it is about the information incoming as well as data about my workspace.

It requires maintenance every morning to reset, meaning cleaning up from the day before of the things I don't police during the day. It also means getting things out of there that I don't need.

The struggle has been over the years of where is my workspace.

Currently I am in a loft in the second floor. You would say, as I do sometimes that it is not optimum. People can come in and bother me or more importantly when I am working on something 'confidential' that I have potential exposure to non-work personnel (i.e. family and friends). The reality is that it is actually better than at brick and mortar places. I don't have to worry about multiple people with differing agendas and "need to know" issues on initiatives.

For me the optimum issues are about interruptions which is more behavioral conditioning than not. At a work from home situation this is typically better than worrying about anyone that can come and interrupt my concentration or inadvertently be heard on a call. Again it is about conditioning and communication.

Data

For me the most important data to deal with is time. The other is regarding comfort. I wonder what the weather is like outside and what the environment is like inside.

Clocks are available in pretty much every direction with every screen there is as well as specific informational devices that add a bit of nerd cred into my space. I have a thermohygrometer that also has the particulate count via a laser particle counter. It interfaces with a HEPA filter for the space.

I keep a pomodoro timer handy when I get really distracted.

Data also includes lots of screens incoming but I can get into that separately.

Screens

The amount of screens I have is purposeful or at least that is my story and I am sticking to it. I have a 55 inch ultra wide curved monitor that is then bracketed by two 34 inch panels in portrait. Yeah. I know. The main monitor is on its own stand because it is heavy. The other two are on desk mounted arms. This is because they are mounted to a standing L shaped desk.

There is of course my phone which remains on my desk in typically 1 of 3 positions. Face down on my desk or in one of two chargers, one that is on my right in a MagSafe quick charger and then on a slow charger off to the side. The slow charger is to keep it out of site and typically out of reach to focus. The right hand charger is both functional and for when I know I will be interrupted.

I also have an iPad Pro and Mac Air on my left side. The iPad Pro is my grab and go system when I have no time to get ready. I can do most things with it and it is portable. I also have my MacBook Pro 16 inch that is in clamshell running everything.

The iPad is my main media system. It carries my audio books, a bit of my music, and movies for when I travel. It is my background noise and personal assistant.

The Air is so that I can grab and go with a bit more power and go find a place in the house to get things done. Even a coffee shop. My road bag/EDC will be a different subject as that is absolutely bonkers. My MacBook Air is mounted on an arm attached to to the desk. It usually has chats and other feeds coming in on it not related to work.

So yeah I am an Apple fanboy. Just for full disclosure I also have a desktop computer (mounted on the wall) that is windows based. Just because I use the apple ecosystem for simplicity does not mean I don't understand and know how to very proficiently use a windows system (among other OS). I just do not want my gear to get in my way. I do that enough on my own.

I have an Apple Watch that is my most personal screen and I look at it all the time. I notice when it is not on me.

Inputs

It would be an easy thing to say that I have a standard mouse and keyboard setup but I would be underselling my struggle. I have settled on Keychain keyboards. They are quality. I won't get into the battle of switches. I recently took my friend down the rabbit hole on keyboards and hours later I felt bad. He now has a keyboard he loves (until he does not) and we will get him through that as well. I have several Keychrons, the K2 and K3 are my main keyboards. Why multiples. I have one for my Pro, and then one for both my Air and iPad. I use the bluetooth switcher to go back and forth as needed. But the amount of time I need to interact with my iPad is minimal as I set it and forget it. If I am fiddling with it, I am getting distracted. Audio books and music playlists are clutch.

Audio and visual inputs are next. I am an audio snob. I have purposeful speakers for different tasks. Yeah I KNOW!!. I have a pair of edifier speakers and then 2 pair of Razer speakers on pedestals. They are all marginal. I have a surrounded myself with studio monitors as well but those are not always plugged in. They may get eliminated from my setup. I use a nano for my air as all three of these but consolidated. Still lots of customization to work on.

I also have a soundbar under my main monitor for movies and gaming (when I don't use headphones).

Mouse wise I am a Logitech MX Master 3S devotee. I also use the anywhere on the go. They all have macros and buttons customized to my workflow. This helps with my other input devices as the obligatory stream decks (yes multiple) with 3 on my main computer. One is my mail profile (an XL) and then a separate one for Omnifocus. My Plus is my app launcher and monitor manager. I also have a foot pedal version for stream deck which I am setting up for muting and cough buttons as well as other automations. I also have a ShuttlePro V 2 for video editing. Mousepad is a razor pad with RGB because I am a nerd. Also for inputs I have 2 xbox controllers for the xbox behind my monitor and the gaming computer plugged in.

I have one main mic that I use but I am setup for podcasting. I use a share sm7B with my Rodecaster Pro 2. I have it on a Yellowtec M!ka arm for a production studio. It is a fantastic solution albeit pricey, but I do not regret it. I also use a MuteMe switch for most calls. I have a physical cough button wired in as well but that can be a pain.

Cam wise I am using the Insta360 cameras, one for my air and one for my pro.

Desk wise, I am using an uplift L desk. It was an investment as was my chair which is a Steelcase chair.

Storage is a whole different thing. I will leave it at this. I have a rack mounted NAS solution in my office. It is big. It needs lots of file love, but it is absolutely wonderful.

Lighting for cameras includes two lume cube lights and an overhead light. I also have a monitor light for eyestrain. That is pretty good.

For my overall flow my chair sits on a tempered glass chair pad. I am a big guy. It does fantastic. It is a bit small but works for 95% of my movements.

My struggles have been around organization, power and wire management. It is getting better but still a constant struggle. I have lots of useable things on my desk for different projects.

Oh yea...screens. I have a very large TV in my office. It serves a purpose when chilling out. Not much more. It used to be used for gaming but that is not a thing anymore.

I am paperless, or at least I try to be. I have a Scansnap scanner (IX 1500). Totally worth it. I should upgrade eventually and will.

Lighting and Automation I use different sensors to turn my lights on and off both through Siri and through presence. I have cameras in my office for when I am away which is REALLY helpful. I can tell someone where something is by looking around with a pan/tilt camera. I don't have memory cards in them and they are not saved to anywhere. But I can always say I am always in my office.

I just put in a glass whiteboard for notes and planning. That is fantastic. Lastly, I have drink fridge and a massage chair which are very helpful to keep me on task and relax respectively.

Those are the big ticket items. I will publish some pictures of the entire office when it is clean.

Quality Backbone.

This is a small community. Let's accept that and move on. I know I have screwed up in the past. I know I will continue to screw up. I am evolving as a professional and as a human being all at the same time. I give myself some grace as long as I am actively trying to grow, be empathetic and introspective. Be honest with myself and others as much as I can be.

That being said I have always known that this 'legacy' is about the decisions and people that I care for. I have to care for them all but not all of them individually. If you are fucking up and hurting the collective, I can ask you how you are doing and try to get you help as I move you out of the area that you are impacting. It is about both the good and the individual. And furthermore, if you are not going to play our reindeer games, I am going to do my best until I have to ask you to go home.

Also, there are times when the 'system' stops me from doing what I want to do. They remove the force and power from the role. It is not always nefarious but it is often where policies are so broad that they don't leave room for a person to make things right. Let alone the pressures of the role itself. You can still have integrity there it just sucks because it does not feel right.

There are three settings to people in this industry, they love you, they are lukewarm to you, or they hate you. The percentage is like 1%/90%/10% for the roles I have been with. The 90%/10% can change depending on how you conduct yourself or likely they will flip. The goal is that regardless they respect the role. That you did everything you could for the role and for the people who execute the role.

There are those in the role I was in that in their flexibility and empathy they end up not standing for anything. The yield to pressure and 'authority' without compliance. They are the ones who say they are just doing their job but do not have any true understanding of what their job is.

It is about the integrity and the culture that matters. I have been using the phrase "it is theirs to break" for a long while now. It is theirs. It does not mean that you have to help them. Don't be an ass. Speak the truth. Don't hurt people, but help the system be better for everyone.

If you can't make a fucking decision on your own then don't do the role. If you are listening to a voice because they are all about control and you don't feel you have any control, then resign. Don't leave the chair worse. Don't just take a paycheck and yield to power. Tell them what can be done, what can't be done, and what should not be done. Don't beat your people harder for more. Don't keep asking them for more output for one more time.

Hold them to their words, their policies, their vision statements.

Bold initiatives are an admission of sins from the past. The sentences are served by the people who did not break it. That is the unfortunate thing. Be the person screaming about the need for the initiative. Value the people that are going to make it better.

Be well.

Continuous Improvement in the Age of Regulatory Reductivism

You have to appreciate the 'guts' of some people to take one statement at a training from a true subject matter expert and twist it to mean they can do whatever the F they want to. I was at a training when a very amazing presenter made the statement about how the agency cannot write up an API manufacturer sighting 21 CFR 210 and 211, that the investigator is beholden to write you up to the FD&C act. That is a true statement. Will be true all day. But you have to understand the weight of the statement. Being written up to the FD&C act I would state is worse. Further, think about this, how are investigators trained regarding cGMP? Yes to 210 and 211. Investigators are trained one way. They have discretion and they are people. They can't write you up sighting 210 or 211, but GMP is GMP. The incorrect takeaway from key people was that: 210/211 was not applicable to API (sort of true) and therefore those GMP requirements had no bearing (not true). Reductivism at its finest. I still shake my head. This was willful. And they did not listen to the quality professional telling them otherwise. Full stop. Maybe this should be a cautionary tale for subject matter experts but F that, this was willfully taken the wrong way.

I clarified this with the instructor. I had them clarify with the group. The reductivism was still rampant.

Read for yourself. https://www.fda.gov/media/75201/download

This is not a new era. But please be prepared that the folks that are going to oversimplify what regulation does and does not do are going to be bold and rampant. Combined with there being a tolerance for 'alternative views' these days and Quality Professionals need to be vigilant. During the pandemic, everyone became a virologist or immunologist. In the coming years I expect that every operations person will continue to become a armchair quality and regulatory professional as regulations are scrutinized in an even more openly hostile environment.

I find it amusing that a keyhole reading of a single statement in a guidance or a training is taken as commandment. All when the regulation is clear and more importantly they don't read the full guidance for total context.

Regulation is the bare minimum. It is the lowest bidder that meets the government contract. Regulation is because we have people that walk and breathe and run companies that advocate for the bare minimum. Regulation is there because our industry is fraught with these lowest common denominator people.

Here is the rub, I understand why some people push the boundaries for regulatory. They have a therapy or device that would not be profitable otherwise to make. Healthcare is a right as far as I am concerned. But so is taking a therapy or using a device is as safe as practical with known risk/benefits. That is not a political statement. It is a human one.

There should not be a business or manufacturing choice that introduces new risks batch to batch. The patients need to be fully informed (or capable of being informed) that the product purports to have all the quality characteristics it was approved for use.

However the majority of those who push the boundaries of regulatory requirements are doing it for pushing product out the door with the leanest checks and burdening the people responsible for release with undue pressure under ridiculous timelines.

The quality people care. I have seen the tears in their eyes. The burnout on their bones. I have existed in these companies to push to normalcy. To push back on schedules and make a system. To resource appropriately. To prioritize upstream and reduce defects.

I have been and always will be a continuous improvement evangelist.

So then when we extend it to correction and continuous improvement here is what I have to say:

- If you are not good at corporate politics and are the quality leader, I implore you to get in the game. You have a professional responsibility to push improvement. Fix it or get out of the seat. Get a spine and strengthen it.

- Start talking about quality culture and responsibilities. Especially talk about Management Responsibility per ICH Q10.

- Use risk management to cut both ways. For the longest time it was to take liberties (inappropriately). Make management sign off on residual risk. Make the consequences of the risks apparent and make sure they are in the context of patient safety/defects. Be clear in what they are signing in the approval statements.

- Document EVERYTHING

- Continuous improvement is the system level, not the person level. Retraining/instruction/communication is a containment action not a corrective action.

- Elimination of the risk/hazard is the gold standard. We all know how hard that is to come by. Fiercely advocate. If you can't get it the first time, trend and collect data.

- Communicate everything up the chain of command. Talk about defects, risk, trends, and tell them why. Put a cost to the defects/deviations including lost time and schedule impacts. Talk about missed opportunities and what we have known and for how long. Make sure those breadcrumbs are easy to find and documented in communications to management. Make the impacts easily accessible.

- Talk about liability and expectations from regulators. Use warning letters and 483 as your friends.

Your typical new year post.

It has been a minute. Apologies for those of you who read this on the reg (why?). My endeavor this year is to keep writing for me. Not a resolution, but a goal that I have had for some time. I have had this site for years now and did nothing with it. My intent was to have open source materials for people. It still is. Things that you can use as a model to start up a medical device or a product development program.

I have other endeavors as well. You should too. Quality is about the community and it is about you as well. You are a key part of the community that looks after a corner of the world with a different set of eyes.

You should be well rounded and healthy or you can't put the mask on for anyone else. Take care of you first so you can take care of others. Do that and you figured out some really good life stuff and a way to be happy.

If you are reading this, here is the audience that I am writing for:

- You believe that quality is both a regulatory requirement and a mindset

- Empathy is critical

- You know that power and ladder climbing is the quickest way to abandon the above

- You have a story as to why you stay late, do what it takes, and have the integrity to keep going

- You are likely tired and feel isolated and alone in your quality journey (spoiler, you are not).

- You likely have a MAD rampant case of imposter syndrome

- You know you don't know it all (bigger spoiler, you can't)

I am getting this post off my chest because I seem to have folks reading this for some reason and I always get royally pissed off when I find that the people I am reading in trying to be edgy, say something that I hope that it isn't them, but they end up closing the door for me. I am not saying I am looking for an echo chamber. I am looking to build a community, or a corner of a room conversation that is like jazz. Something that flows, is natural and makes the corner a better, cooler place to be. Cool daddy-o? If so, welcome to the corner.

My first instinct was to talk about my family. They are my horizon. That is all I should say about them. And frankly that is all you should need to know about where my universe is defined. My family consists of blood, marriage, and friends. They are my tribe. My tribe grows through serendipity and friendship and shrinks through choice and life's path.

I am a nerd. A tech nerd. As I have said before, an engineer. I find systems and mechanisms fascinating regardless if they are intimate or biological based.

Computers are my jam. Fiction. Lego (particularly Star Wars). Books of the audio persuasion. Audio engineering and music. 3D printing. Teaching people. Photography/videography.

I am a Mac nerd, but I build windows based computers for my friends. I am a data hoarder. I am paperless as much as practical.

My imposter syndrome is based on being in the right place and the right time. I have been in rooms talking with people I have ABSOLUTELY no business talking too and that they listen just floors me. I have met basketball legends, actors, senators, congress people, heads of big federal agencies, tech influencers, and some other interesting humans all while David Byrne is singing "How did I get here?". In the end, I am just me and that is all I know how to be.

Seeing things I do exist in the world and do things, absolutely makes my heart cry a little with some self pride.

Okay so why write this. Samuel Florman wrote the "The Introspective Engineer". If all you take from it is the title, great. This is my message to you on introspection. Take time to be honest with yourself about the good and the bad. Recognize the good and the bad. Accept you and work on those things you want to be. Be those things. Bad does not mean accept diabolical shit. It means that you give yourself grace for the normal human shit that you aren't especially proud of.

I have lost some friends over the years and it is on me. In this pursuit of 'me' which was not always well guided, I did things and didn't do things that I should not have been proud of at the time and I am surely not proud of now. I didn't waive a wand and 'forgive' myself, I didn't just move on. I learned from them more than they will ever know. I agonized and still do. I am so very sorry. But life will move on and I can accept being the bad guy in someone's life because I was. I will and have tried to do better.

I want us to be better, to share this stuff in our corner of the room so we can realize that we can change ourselves and that means we can change the world by being okay. Not happy, but just okay. I want the jazz to flow out of us. I want the band to be envied and I want as many players as possible to join in the jam session. Total nerd...

Find out who you are, be introspective and find your path. Here for you if you need it.

Why we do this…

For some of you, you are getting ready as I write this, or you may already be sitting on a chair watching the little ones open gifts with wide eyed anticipation of what did they get from Santa. Maybe some of you are alone thinking of loved ones far away that you wish you could be near, missing them dearly.

Take stock today and every day of why you do what you do. I know some of you may be working because people don't stop getting sick. There may be a release or an issue that is stopping production. There may be a critical validation that needs execution and this is the only time they will let you on the line.

You may be heartbroken for what you have missed and what you will miss. The looks on their faces when they only want you around.

Not many people know. I do. And I want to thank each and every one of you for what you do. You have saved people's lives to where they can enjoy this day, or even make it to their last. You are the nameless, faceless, and thankless heroes in this saga.

For those mothers who got to see their daughter's wedding. For this husbands that got to have one last fishing trip. For those people who got to hang on longer to say goodbye. For those who have had years, months or days, that otherwise they would not have. I say my humblest of appreciations to you.

This last weekend, I met someone who through out conversation we discussed what I did. They literally thanked me for saving their life.

Yeah that sits with you.

Much love. Look around to see the hearts and faces of those who you do it for. Realize there are hundreds of thousands, if not millions more for with what you do touches their lives. Touches their heart beat, their well being and quality of life.

You are a hero. At least you are to me.

How Operations Need for simplicity in SOPs are then Used as a Weapon against cGMP.

Apologies for not writing for a while. Holidays, traveling, and such kept me from focusing on writing.

There is an appropriate push for simplification of standard operating procedures (SOPs). As well there should be. Simplification is quality. Operations love it as they should since it reduces a training burden and time to 'effectiveness'. They love it until they don't. While this post is about simplification it is also about opportunism, hypocrisy, and when it get's down to it, cooking the metrics.

I want a simplified procedure. Every effective CAPA should have an element of review of the procedure but it does not mean the expansion of the procedure. That way we do not bulk up and rely on words that frankly are not going to be read or executed each time.

I am fine with adding items to training but that is not an effective CAPA. Operations hates this as they want to move on from their mistake. Why? They hate what they consider 'wasted effort'. If they are not making product they see it as a waste of time, burden and overhead.

These are talented people with a focused mindset as we are in Quality. But their intent for product and efficiency does not take into account that compliance is part of their product.

I have preached to my people about how working on the right things is key. However, where operations tends to loose the plot is that they feel they are the final word on what is compliance. That is where the hypocrisy comes in.

They want a simple procedure, yet when something that is clearly non-compliant and in the spirit of the procedures intent, logic, or just plain regulatory requirement they hide behind "well it's not in the procedure."

I think these people are hacks. They are spineless to their superiors, but have no problem telling quality what to do because they feel ambivalent with their mission. Whatever that mission is. I am calling into question their integrity.

To my quality colleagues, you are the final word on compliance. If you are not supported by your managers, then don't work for them. Yes we are in business to make product, but not to fall over.

A couple of motivating factors for this behavior:

- Reduction of deviations or cooking the metrics

- Do not want to put time into something they feel is not value added

- Do not take ownership for their actions - 'they got caught'

- Resistance to change in the power dynamic

- They do not want limitations beyond how the procedure is written

Oh and yes, every once in a while there is a logic trap or contradiction in the procedure. During those issues, fix them. But and it's a big but (giggle), you have to read the most logical intent into the procedure. If they come at you from a literalistic sense then they can rightly F' off.

When using a procedure you need to use the frontal cortex of your brain. You cannot willfully read something that you know better about.

People that cook the numbers on metrics are falsifying data. Pure and simple.

I rather open the instance and then close it based on the rationale so it is documented. They need to own the instance. If QA F'd up, then write it down. If operations messed up then investigate it.

Simple.

This then gets us to management speaking out of both sides of their mouth. We want to reduce deviations but we don't want to stop production or invest the time.

There is then no hierarchy of control capable capable in this example system. There is willful ignorance or a straight push to not give a shit about compliance.

Your resources, training and feedback based on risk need to be practical and feedback. Otherwise you are not using risk management, you are taking all of the benefit and none of the management responsibility.

If you are using risk to NOT open deviations, you are wrong. Every issue is entered into the system and opened and then appropriately adjudicated in the QMS.

Oh yeah. To the executives that get mad at deviations that impact the bottom line. They are your fault, maybe not directly but yeah.... You own that. You have set the organization and the culture to not address things properly. Your quality culture is in question as is your leadership.

No deviation investigator should have more than 5 investigations at a time. The people investigating need to be in the department that owns the process. Metrics should be around prevention not totals of deviations (event though it shows the effectiveness). Each CAPA should be graded on a scale of the hierarchy of control. Technical writers can be used to deal with a bolus. If your system is too burdened with deviations, STOP production to catch up. Have the conversation.

Quality must own the deviation system and investigations. Investigators, as I stated previously should reside in the departments and then Quality Engineering or similar disciplines have oversight along with Quality Systems personnel.

For those who disagree the one thing I challenge is for you to explain to me the purpose of deviations and investigations and how it fits in with the regulations and guidance you are supposed to uphold.

Don't talk about wasted time, talk about your failures to develop the right culture, procedures, training and level of resources. Talk about how you value production over compliance. Then, we can have an honest conversation.

Why Diversity, Equity and Inclusion Matters to Highly Functioning Teams

I have worked for the wrong people in my career. That does not mean companies. I mean I worked for people that I fundamentally do not agree with how they conduct business or treat people including their customers. I have also worked with some of the absolute finest people in the industry. I smile as I write this and if you know me and are reading this, then likely you are why I smile.

The wrong people sometimes had great outcomes and fantastic deliverables. Nobody loved the journey. You worked with them in spite of who they were. The majority of the time the work product was trash. It, just like their attitude, was just good enough not to get fired.

I started to hear about DEI and how companies are reviewing their policies or straight out rolling them back. I share with you what I share with other people I chat with in the industry. It is theirs to break.

Maybe I am completely wrong. That phrase has kept me on my toes for a very long time, but until my training, experience and objectivity are provided evidence to the contrary I will stick on this path. So if just the thought of DEI pisses you off, there are other things you may want to read. My voice is only one. Your spent energy and my indifference to those who would chat me about this particular topic and where my guess your intentions would come from, let's just not. K?

This is not an overtly political post. It is however a position that I hold firmly. It comes from personality traits, even though for full disclosure I am a person of color, minority, or whichever phrase to say that I would not be described as "white".

I was told that I am an introvert but I consider myself a forced extrovert. There is a distinction if only in my mind. I never want people on my team or in my life sitting in a corner not being heard.

Why? They have things to say and they have value as humans. It is that simple.

The wrong people I worked for had one telltale sign, they only saw things their way. I will leave it at that. When I saw that, I left. Maybe not immediately but I ended up leaving and not having an issue with it.

The mechanism that is humanity processes for the masses but not for all. We build processes for the simplified understanding and to meet most requirements of the largest population. Up until the past 20 years, nobody saw an issue with it. I thought it was strange. I saw men making products for women without any input from a woman. Doesn't that seem fundamentally odd no matter what era you would be from?

In being responsible to humans as a whole, not just the median of the curve, we all collectively have to do some work. This is not just to those in power, but to all of us. Because we all have our "us vs. them" mentalities. I am not saying that they are wrong, in fact what I am saying is that there are differences, we just need to value and consider them. Not out of political correctness, but out of more than a few good and appropriate reasons. Consideration means market potential. Consideration means a better product. Consideration means recognition of the quality and thoughtfulness in the design.

As an engineer there is not one perfect product that caters to all. But why wouldn't we try? For those of you who are saying "cost", "speed to market", "political climate", you may be making my point. The triangle of Cost, Schedule, Quality and you get to pick 2 legs holds true here. And I keep saying out loud and proud my intentions in writing these posts are about Quality.

Quality teams and Quality Mindsets are my purpose. But in being honest we have to process through our "us vs. them" to see if we are doing ourselves a disservice, or are we positively recognizing differences objectively and in most cases as positively as the context allows. Let's hold on to the healthy and let's recognize the ones that create fear in us or others. Just a thought on how to treat people. Everything else I write about centers on empathy, so not a huge shock for anyone who knows me or has read my stuff.

By doing the healthy recognition we drive these perceptions to recognize value and YES limitations that we need to accommodate for in the population so that we can make everyone feel hear and considered. If consideration pisses you off, I assure you that products for left handed people are not a cabal to make anyone a socialist. I said "overtly political".

So in short, I do believe in a just, equitable society. Because, why not? If I don't believe it for everyone, then what audacity and hubris must I have to believe in justice and equity for myself. Rights are rights, not just for those who are able to fight for them. Otherwise we are talking about the weak versus the powerful. Guess what? I guarantee you the majority of you probably feel pretty powerless. We will gain that justice and equity by, as a society pushing for this across the board.

Remember at any point you can stop reading if you has "madz".

We need to drive the "wrong" perceptions out if we want to achieve what we say we as quality professionals want: a good quality product, process or system.

If it sounds like a lot of work then guess what, you do hard things every day. Life is hard work. Life is about bringing people up and not tearing them down.

If you are in the pharmaceutical and/or medical device industry DEI teams help us meet the intent of what we are supposed to do. We are supposed to make products that help the masses. We work on orphan drugs and custom devices with the same intensity and integrity that we work on novel drugs.

How do you do that without the perspective of a diverse team? How do you do that without making equity between those who have not had the same advantages, even if that only dis-advantage is not being in majority of the heard.

There is an expectation that the heard protects the entire heard. Those who fall outside of the margins are brought into the heard. If they are pushed out, there are reasons.

DEI is not about power, changing power structure from one group to another. What I am saying here is that we agree that voices are heard equally and your reaction to not being heard equally would be similar if you saw someone you care not get their cake at the party because someone made a choice that they did not deserve cake. Now I want cake.

My point IS NOT that the minority are powerless. In fact the backlash against DEI is about the loss of overall agency (of fear of that loss). That is fear of power. Army ants.

Power is a relative structure in the grand scheme of the human process.

I digress

Perspective, training and experience can lead to a better process especially based on experiences that other team members would not have or could not have without that perspective and experience. We as leaders and members of society need to actively listen and hear just like we do with our reports. Value them. As leaders we do not have to ask permission. We all have that level of agency if you think about it.

Valuing all voices is the recognition that other communities in their experiences must be taken into account for the processes, products, or systems that they participate, use or are required to be part of. Not listening to these communicates is disenfranchisement. It always makes me wonder how capitalism and freedom do not already have a coalesced philosophy on this. Maybe there is a scale like I discussed earlier of "proto" capitalism where the cheapest and fastest to market was the first thought technology that capitalism built. Call it greed if you wish; I don't because the whole point of production is return. Capitalism is a good thing. It is how the world economy flows.

But here we are as quality professionals and if you put those "proto" words on one end of the scale and big "Q" quality on the other end of the scale that has all the words you would expect then you may have a continuity of a) cheap, b) value, c) quality, d) luxury. I don't love the word luxury on this system just for the same reason that I did not put greed as part of denoting cheap, because quite frankly the luxury items and the cheap items are likely motivated by greed, but just in different scaled of margin versus market product. Sips versus gulps. "Luxury" can be an illusion regarding quality as many luxury items are about prestige and not true quality, I use it here as a placeholder. If we are going to be honest, the difference between all the words not that continuum is each one of those is a judgement of quality of cheap having little quality (maybe utility), value having adequate quality for the expected lifespan, quality as having set expectations

That is the point of DEI, we all get a voice to objectively work on the products, processes, and systems in various points of the lifecycle. All humans that can participate in the economy or system have the ability to judge the spectrum. Every person, family, friend group, and yes, culture, have a perspective on what is on that spectrum of cheap through luxury. There are cultural brands. You can think of them.

DEI allows us to ENSURE that these voices are brought in earlier in the development of these products, processes, and systems. It is democracy, agency and freedom enabling.

DEI is important to cross functional team. If you think about scientific advisory committees, there is a push for patient advocacy to give the people being affected a voice. That makes all the sense in the world when you think about it from healthcare.

A team that is diverse, equitable, and inclusive have the ability to develop a better process because it is not just patient population but other perspectives that can help us better understand the human condition. It values the individual selves, all of the contributors, and allows us in our capacity to lead, to be better at what we do.

Different voices that are passionate about their advocacy and understand their mandate helps make the status quo process better.

Inclusiveness in teams is being honest about what your team does not have. Set up a framework for evaluating the overall team perspective and values; make sure they align with the company and yours (which yours should match the company, just saying).

The framework should further take stock as to what you have in terms of training and experience. When you have a gap, then you look for other potential team members. You can also be looking at external available subject matter expertise with a particular profile. There is not a team in the world that cannot become more well-rounded. We should be questioning the structure and DEI attributes of our current teams. Otherwise our messaging is that our current teams are "good enough. From a quality perspective that should not be the message from management. This is the human resource side of continuous improvement.

Leaders should be looking to hear the message of what resources are needed and not forget DEI.

Currently there is not a widespread push to think about teams in terms of needing to consider DEI as a criteria in resource recruitment. It scares some people because they think these new criteria will be the only criteria and that they will be excluded. We need communicate and to see as a society that it is an appropriate ancillary criteria to solving a difficult problem or by helping to find sensibilities that otherwise have not been available to the team before.

As leaders we need to have a serious level of reflection until we can normalize what should, in my opinion, be normal. It should seen as fundamentally taking care of your team needs. They don't always know what they need and you are unapologetic about getting them those resources; how is this different?

We are at a tipping point. Our problems are getting more complex. It is our job to recognize that the typical mindset, tool set, and thinking are no longer enough. So how do you change this in your role? I think we need to bring these issues up in terms of expectations of ourselves and our management. Be the differentiator in who you economically support in your life or in how you execute your team. It could start simply with actively seeking input from team members that otherwise may not have time to be on the team, but you are doing a check-in.

Recognize all success with management and highlight DEI traits that made a difference to the goal and the bottom line. Get management to understand through active communication that the collective teams values were the differentiator and brought the best possible solution given the resources and constraints. The structure of the team needs to be a common theme till DEI considerations becomes holistically and organically recognized as the mainstay of better results.

As a quality professional that is what we're trying to get to. Anything less than that should worry you as a professional or as a consumer.

I appreciate you getting this far. I wish you well.

Mindset

Of all the obstacles that I have had to get through, mindset has been the consistent one. Not formidable but like the tide, it is there and can be came one day, non-existent the next, and then raging when I least expect it.

Tools for mindset are hard to talk about since the variability of how you got into the mindset. My process about getting into the mindset starts with my morning ritual. There are days that I just know before getting out of bed that I am not going to be at the top. I have a ritual that helps me try to turn it for the better. It works a lot of the time. There are times that I am in a spectacular mood but something grabs me and takes me in the wrong direction. There are some things that I do about getting it back from there.

For most days it is about the first few minutes of the morning. It is a time of opposites. If I am cold that morning, I warm up. If I am sad in the morning for whatever reason, I task myself on what I am intending to do that day. I look at all my control surfaces and levers.

For the times I commuted I chose an audible book to listen to that would help me set the tone for the day. Have multiple on tap, fiction, non-fiction, biography, productivity. Each of them have a trigger for me. Podcasts are excellent as well. Going to deep into any one thing can mess with you so, choose what is going to help influence you to be better, not to compliment your negativities. The book, podcast or radio show I picked would set the tone. There is also always music and particularly the well curated playlists.

Before I left the door, I had did the norms for self care. I would also prior to getting into the shower, would take a look at my calendar and either move, delegate or write a quick email instead of going to a meeting that could be an email. You need to take all the agency you can to make those meetings emails. Explain why you should not attend and make sure you are not doing it to the same person over and over again, or if you have to, make sure you make time to talk with them so as they do not take it personally.

I would look at my task system and see what I had so I could mentally prepare for that task. Somedays the mindset is not there with the other workload to get a certain task done. Value your head AND the task. If your head is not in it, don't do it. Also, there were days that emails from other continents with bigger problems surfaced.

Doing all this before a shower allowed me to gauge the headspace needed for the day. Knowing the docket, clearing things out and going in feeling in control of your day helped my mindset immensely. Know who you should deal with, who you should avoid, and who you critically need to talk to.

The negative things I stopped doing was checking my email after a certain hour when I got home. I gave my folks a time as to when I would not look at my email. I would tell them to text, or to "message" me via whatever platform the company used. If they needed me, they could call me. My phone is always with me unless it cannot be with me.

I also stopped a few things that contributed into negative mindsets. I have a text rule, if you text me more than 5 times, unless I know where the conversation is going, I am going to call you. None of this passive aggressive stuff. That way there is true back and forth communication. Again you have to be in a non-negative confrontational mindset, but help them help you. They likely need your undivided attention and may not value what they are saying or they have fear of what is going on after hours. Help deal with their fears. If they are up at night thinking about stuff, then you should be as well.

Key to all this was learning about what I actually needed to value and care about my role and my people. Yes, you do need boundaries. You should value self care, always. There are times you need to focus on the problems that extend beyond hours for people that are pouring their souls into an issue. Here is how that helps mindset. Walking away from your team when they need to see leadership will sabotage your relationships with your team. Empowering your team to make decisions will strengthen them. Your team should send you home when they don't need you. If it means that you are sweeping, picking up food, removing obstacles or getting resources, then stay. Your mindset will be so much better for it. Your team will be valued and you will know it.

For the times I work from home.

I have a ritual in the morning. All the typical stuff as before. But I have candles, humidifiers, lights, music, breakfast and all the other things as well with calendar and email.

I also take time to reach out to people and to see how they are. Self care for myself by checking on them.

For the times I travel.

I makes sure I am effective. I have my tools with me. My mindset is enabled by my road ritual. Stuff, timing, planning, and execution. When I travel, I plan for the scenario and task that I am there for. I anticipate issues. I have the tools (stuff) I need to execute on the plan and anything for the first tier issues. I make sure I have a schedule on the ground with in itinerary and as always I plan for things to go sideways. In the end, while I am not in control, I feel it. Confidence to handle what is thrown at me.

I check in with my people and value that I am not there both at home and work. I value them because I care. If you don't, do not be authentic. But when you are with them be present.

Here is how I broke down mindset for myself.

• Grounded - Ground yourself so you have your faculties about yourself. Take stock of what you have and don't have.

• Intentionality/Direction - Have an agenda for the day, ensure that agenda has purpose.

• Presence - Be present to affect your world and the world you operate in.

• Engagement - When communicating be authentic

• Aware - Use all of your senses and accept the cues your are give to receive the world and people.

• Enablement - have the tools you need to be effective so you can solve problems and help people

• Actively Listen - actively listen with empathy, and allow your authenticity to also be critical and communicate/reflect why.

• Appreciation - appreciate my surroundings, people's values, and read the room

• Empathetic - Focus your energy on understanding

• Integrity - lead with integrity to be a kind person

• Refinement - With all of the above sharpen yourself, your skills, your kit, your values to be a better person

• Impact - As the person above I will have impact for the better, or at least be my authentic self.

Mindset is up to you. Don't blame anyone but yourself for how you engage with the world.

Find grace for others and you will find grace for yourself. Be in the moment so you can make the best decisions for the patients and ultimately for your own family, friends and loved ones.

Don't let your worst mindset and the resulting decisions be taken out on someone who does not deserve it.

Being Consultative

- to Robin B. - I hope I am wrong about a lot of things. Especially if it means I get to ask you some more questions.

From the time you are helping your mom in the kitchen to the time you are trying to stay out of your father's light in the garage when he is working on the car or some other project, there is always a lust to be helpful. The joy that you feel from providing basic utility to those we care about is pretty wondrous. If you stop and think about a time I bet you can recall that rush of dopamine from praise. That singsong voice from a person when you were little is the gateway drug. The same voice you use with your pets when they did something good. It seems silly and totally devaluing if you think about the condescension but please tell me how wrong I am. I loved it and I think that is a driver that we want to have.

And here I am going to F that all up by talking about roles. I am feeling quite happy with how I am feeling right now but nevertheless I am going to assault my memories about roles and agency to drive the differences in how we should be actors in the workplace.

Full disclosure I was a consultant for almost 8 years. I was a Senior Director and had multiple consultants and projects under me at any one time, I was in charge of a vertical for biologics and in charge of running the CMO for production of medical devices over my tenure. I was also in charge of training people. More to the point I was told to 'geek' the incoming engineers to see where there utility was. Were they going to be ready for client facing work in months, weeks or never. Geek was the term my boss used. He had me create a test to weed out the non-critical thinkers (read client ready). My test was deemed impossible to pass for outgoing engineering students from some of the best engineering schools. Trick was thatI didn't want them to solve the problems, I wanted them to show me how they think in a limited time with stress. I thought it was pretty slick. In fact, if you passed the test you were likely to be doomed to be my right hand just because you had tons of potential and likely needed some close monitoring to give you people skills. Only one person passed the test and they did not stay. They were bored with working with people. The ones that were close to passing felt that they did receive the compensation they thought they deserved.

The ones that were slightly right of the median on the curve...that is who I thrived on. Good relationships and most of them I still know.

To this day my interviews for roles are around how a person thinks and how they treat people. I want people to be authentic. No game show hosts on my watch. I want to be able to know if I can trust the person I am in the trenches with. Are they going to preserve themselves or are they going to tell me that they messed up?

I want people who are free thinkers with empathy and compassion. I want them to know that based on trust, they can tell me when they mess up. Do they have integrity?

You can't test that. But you can see how people explain their work. The test I gave these kids was not about the test. It was about the discussion I had after the test and more importantly the assessment I made of them after I told them what I was or may need to get out of them. There were 60+ items that I told them they were going to need to understand over the next year in order to have a productive conversation with me and to be useful.

I remember one instance where after showing this one incredibly bright person the slide, the arrogance on him was still intact. It was thick on him.

Mind you this was 20 years ago. I was an engineer in my 30's. They saw me as a peer who had been in practice a bit longer but they could see themselves as me in months.

I sent him on projects on hours notice across the country. He called a lot. He needed lots of guidance. And eventually a year later when we had our review of the past 12 months, he stated he realize he was so very wrong. That he realized he had to learn so much to be useful. He looked back on school as "what the hell did I learn?".

The reality was that he learned how to learn in some cases. He learned how to solve problems. He also learned some stressors and the indifference of judgement in an academic setting. In short, he learned to be an individual contributor. To fear group projects. To hone his skills as a technical samurai. Then he entered the real world and got dispatched quickly.

I can hire consultants by the dozen. But are you truly consultative? Do you want to truly help? Or are you stuck on the role that you are the consultant and are there to be respected and listened to.

Let me be clear. Consultants have their place and their utility. The ones that are ready to get in the trenches and deliver on work product. Those that are truly consultative are the ones that shape the market place.

Being Consultative:

- Having a deep set of tool sets and basis of knowledge (those 60 items I mentioned)

- Actively listening to the problem statement. Being bold enough to question the statement and the assumptions

- Know how to view a process and characterize it (sitting and watching the line and making themselves invisible)

- Taking their observations and the procedure and making a process flow diagram

- Checking their biases and searching the literature. Find case studies and see patterns.

- Not being afraid to fire your client.

- Speaking truth to power, telling them the things they need to hear.

- Protecting the people that you are advocating for at the site by taking their voice and amplifying while giving the team the credit

- Being a positive experience for everyone you work with.

- Being authentic at all times knowing that every interaction could be the key to solving the problem

- Checking biases, recognizing the ones you still carry and working the problem by doing all the steps of the process.

- Asking for help and saying you don't know when you don't know.

- Identifying team members that are and are not helping the process.

- Being fair to all involved including finding those who have not been recognized.

- Asking for a second set of eyes and doing a check with the right people.

- Re-level the problem statement with the client. Check assumptions again.

- Execute work product and make a useable deliverable.

- Do not meet just to meet. Provide value every minute you are on site.

- Do not distract from their mission.

- Do not measure your productivity against the client team as they have day jobs.

- Be mindful of the fears that consultants are being used.

- Own the potential gaps in your work product. Train people to use it so that the deliverable/tool is useable after you leave.

- Let your work do the selling of more hours. Mind your wake when looking at what service offerings that you mention the firm can do. People may take offense.

- If you are done for the day, get offsite. Don't look like you are charging when sitting there.

- Stay in your lane by keeping to the scope of work.

- Teach as you deliver. Know when people do not want to be taught and they just want the work done.

Hiring consultant should solve a problem. It should not be nebulous. The deliverables should not be proprietary. Their name should not be on everything. If you are buying hours then they should deliver hours by the end of the prescribed time frame. They don't need to be managed, they are self sufficient. They check in and advise.

And if they keep saying "in my experience" I would ask what does the resulting deliverable look like and measure it against it being a functional and useable deliverable as soon as it is handed over. If it needs to be re-worked....run or make sure you watch your budget.

Be well.

Beyond Root Causes

Full disclosure, I have been writing this since 2021.

I have had some time to think lately. Trying to figure out what went wrong with what I was working. I made the mistake of going down a rabbit hole on decisions and how they are made. More importantly on how we think and reason. That really ended up messing me up. It made me think about how our brains works and how our bias coupled with first impressions of a problem can color what we are working on and our perceptions. Man did that really do a number on me.

So check this. The bias that we have in analyzing an incident is not contained to our investigation. Our biases as humans probably started the whole thing. They sway the investigation. They shape the responses we get. When we look at the system and analyze it to determine what is wrong, the more we handle the situation, the likely we are introducing a Heisenberg Uncertainty like principle to what we are trying to understand. For those that forgot or never cared, the Heisenberg Uncertainty principle is where when you study a particle you end up influencing or reducing the certainty of what you are observing inadvertently. It seems easy to apply that same principle to what we are trying to solve or understand when investigating a deviation or malfunction of a system. This is absolutely nothing new but it is new to me in my application of thinking to a systemic process.

What I am going to attempt to do in this is to break out each stage of what is happening. I will attempt to identify where bias comes in and where I think our bias based Heisenberg principle comes into play and how. It may not be complete but it should hopefully give you a flavor of what to be aware of.

**Incident**

Like I said previously. The bias already happened before you were made aware of the incident. It will continue throughout the incident unless personnel are removed from the investigation process and only data is used. The fear of removing people from incident review (or investigation process) is that it may not give you the complete picture. I think it starts with establishing a culture at the site that removing potential errors is more important than blame. This is not to say that accountability would not be an issue here. But based on the severity and the history of the person involved I could only see a few extreme circumstances where HR would allow a person to transition out to another position or out of the company given due time to find other employment. Removal of them from work product as a liability and trust of the person in question would have to be resolved but that is not out of the realm of impossibility. Especially if you put forth that the credibility of the company is much more expensive to the public trust.

_Common Perception_

Immediately when the incident is observed/discovered, we are dealing with competing perceptions. In my thinking I'm using the term _common perception_ as what the average/median observer would portray as fact. This does not necessarily mean that bias has been minimized or that the incident is completely characterized but more to the point that the main facts that describe the incident can be agreed upon. In the capturing of the incident you have to think about who has the potential (higher likelihood) to have the common perception. The outside world would be a bystandard witnessing a crime or historical event. Depending on the person's frame of mind and attention as well as duration of the event what you will receive in description of the event are broad strokes and general outcomes. So how do we deal with this? What is the parallel in a regulated industry doing cGMP work? Everyone is supposed to be trained. Everybody has the experience in the field. Is it the supervisor? Is it a person on the line doing other work? Is it security cameras on the line?

There is a need to look at your data and grade it for its resolution and reliability. What is the foundation of the data? Is it memory which is flawed? Is it an electronic system that cannot be tampered with? Integrity and humans are fallible, just because it is a person with 20+ years of experience and service cannot keep you from evaluating their perceptions or their influence on the issue.

Bias throughout RCA

Each one of the questions above regarding the framework of this concept shows that bias needs to be taken into account in each aspect of not just the root cause analysis but to determine the substantive ways it can impact understanding the incident. To take a step backwards it may not be directly bias but a compendium of both biases, stressors, and frame of mind to provide a general context from each perspective of everyone involved including the investigators, approvers, management and department heads which are affected.

What I mean by that is there are those incidents that are true mistakes and they are waiting to be discovered. And there are those systemic issues that are due to culture of operations. This does not mean that our issues as humans did not come into play. But imagine an employee that is made several of those mistakes in a short period of time. The incident itself will certainly be a stressor in the identification of the incident in the information to be evaluated in its appropriate context. We are looking for trends too late in the investigation.

We need to be honest about the culture from a quality and operations perspective. Many firms will accept mistakes and further systemic issues as "known" for the sake of timeline. This is of course antithetical to quality and cGMP but it is of course present in the industry. Further there are those "acceptable" issues that are unspoken.

But this is already known by those who have investigated a "sensitive" issue which is currently on managements radar or which can impact timeline to a critical project. So how do we set that culture? It has to be from the top down. It has to start from the inception of the project. The inherent risk needs to be understood not just from the technical perspective but the execution by a trained operator during the establishment of the process. We should apply known stressors or common themes of the culture as a failure mode.

The culture needs to state that the status quo is unacceptable and that our measure for ourselves is continuous improvement. But the improvement needs to be systemic and meaningful to where the simple mistakes are the norms and the systemic issues are the exception. When in early stages that is an issue, but it does not need to be. We should set an example of ascendancy of conformance as the process is being developed.

From an incident capture perspective we need to have a plan as well as technique to gather this information.

So regarding the incident I think as investigators we need to establish a baseline for our investigative process understanding that just because you are informed of a bias it does not remove the bias. So what can we do?

We need other eyes on critical or major investigations of repeat issues or where we failed to determine root cause.

Post mortem/case studies of the investigations by a board or committee that understand the biases above and have received training in human error as well as investigation. These people have to have executed investigations and have a high level of integrity to drive both continuous improvement and be fair to those involved. If not, maybe we need to anonymize items for review.

Establish procedural requirements for hierarchy of control. Where there are escalations of approvals and budget to ensure that critical items and their failure modes are removed or detection systems increased. Do not allow by procedure, to do nothing for a repeat deviation or similarly to only train and update a record. Consider Kaizen events, scrums, tiger teams, etc.

Have cost metrics reported to operations based on the total cost of quality to drive the business case of quality. Don't just look at downtime but also against the cost avoidance of compliance remediations.

Have outward facing metrics that lay bare the success or lack thereof any corrections. Have a report card on your effectiveness checks. These should be managed objectively by a group of people that live with the system and rated on a neutral scale.

Use those bright big words on the vision, mission and guiding principles on the wall against management. Be ruthless about it. It is not insubordinate if it is based in data. Have them put their names on the line as to why we can't fix what is obvious.

Report repeat issues that require capital as compliance issues by establishing both the compliance risk AND the impact to operations. Would you rather spend $25K on a piece of equipment or not test and release a batch worth $1M to the bottom line.

Hold management accountable for resources through town halls, employee surveys and use of the ombudsman.

Tell your C-suite. When they ask for reasons or what is needed, tell them. You may be fighting against middle management but I guarantee you more often than not, the C-suite are trying to mine ideas from all levels. If they don't want to do something about it, then it is their responsibility. Make the issue easy to understand and the solution even easier. Think elevator pitch.

Advocate for all solutions even if they are not yours and they only address part of the problem. Find allies in all places at all times. It may open up you to solutions you have not thought of.

You are not stuck unless you want to be. We jail our minds in the prisons of our own creation. There is always a door if you look hard enough. Even if that means leaving and letting them know why. Tell them that unfunded mandates and lack of support as expected by management responsibility requirements are not being fulfilled and you are not expecting the culture to change. Be prepared to show them receipts.

We are here for the patients, we are here for the operators. Be their advocates. It is your job.

Knowledge Management

Humans process really well, especially when patterns are found easily. However, our brains got scooped together like a biological ice cream sundae; our brains can identify the things making noises in the brush to let us know, "I should probably start running and grab a sharp stick".

Patterns are not knowledge, at least not directly knowledge. Patterns are fraught with bias and misapplication. It is the frontal cortex saying, “Close enough for government work". Sometimes it is not close enough, and that scares the hell out of me if I am being honest.

I have had the privilege of working with some really fine and smart people. Like super smart. Not just at engineering topics, but that taught me how the relationships and limitations of patterns leading to knowledge and then knowledge leading to systems.

You start building a bunch of systems and implement them, run them, see their limitations, fail miserably, and retool; then you get what I think is most coveted, wisdom.

I was once told that wisdom is found in the warnings of those people who have F'd up big time and have had the human decency to tell you about the paths you really don't want to travel.

I don't have wisdom for you. I am sure there is a sign over some mythical cave that says, "For those of you coming here to find wisdom, give up all hope". I can help you with a couple of steps before then.

If you try to store knowledge in your head, you are doomed to a life of fear of loss of that knowledge. You will hold on to things harder and be biased on what you remember. Not good. Professor friends of mine and general smarty-pants I have had the pleasure of knowing, they all used to have these MASSIVE libraries. I would ask them how they kept them organized. Each one of them said in one way or another, they tried at the beginning, but eventually, THEY GAVE UP. Their libraries, like their offices, were cluttered with papers in boxes, books piled.

What did I do? I tried to emulate them, which has been a general hazard in my occupational and life journey in being the best me I can be.

The number of backpacks that I went through in carrying around books. The parts of my mind and treasure that I have shed in losing or lending my copies of "Roark's Formula for Stress and Strain" would make you concerned for my well-being. I am STILL looking for this amazing book on integrals that I lent to this guy named Jaime. I WILL FIND YOU (the book…and if I am being honest, Jaime).

Side note, I did run into Jaime at an Office Depot in California once when I was visiting. Talk about knowledge and memory quirks. FIVE MINUTES after saying goodbye to him, I remembered the F'ing book. This was like 15 years after we graduated from university.

Digressing….

Back to the backpacks. I carried books on trips, I had journals with notes in them on key information. They would all rip at the straps on the top outside right hand strap. And as I have heard many time "It's me... not you", my poor heartbroken backpack. My endeavor to keep these key books with me was horrific for me and those around me. I lugged HUNDREDS of books with me when we moved over 20 years ago. I kept this mental and physical load with me. I had to keep this monolith of information straight in my head. I would tell people where to find what they may be looking for, and ultimately they would tell me they don't have it. Hence the lost books.

My quest led me to be paperless, which I won't bore you with, but I am still in love with my Fujitsu scanner. I have had many in my life. I have a travel scanner that has been retired. My current Fujitsu (IX1500) is like 2 feet from me on my desk. I have been as "paperless as practical" for over 15 years. It took me about 10 years to get there.

Hundreds of books have been de-spined, scanned, and OCR'd. I have bought books from garage sales, sell-offs from libraries, I have had the honor of receiving the library of a fallen engineer (rest in peace, Richard).

All of this information is with me. Right at my fingertips. Hundreds turned into THOUSANDS of books in my library (a bit over 6,000 books that are all searchable). Not to mention articles from magazines that were in my possession. I have my own little Google of my life.

The hardware to do this is not insignificant. But that investment has done for me what I don't think can be done any other way (and if there is an easier way, I will go there after kicking myself for not thinking about it on my own). The investment has taken so much load that I was carrying from state to state and from job to job. I could allow myself not to remember things that I don't need to use every day. I no longer have to think about where that knowledge could be. I just know how to search for it.

I have a container outside my brain. It is stuffed with things that likely don't have to be there. I can be neurotic and obsessive over other things now. And this blog is one of the fruits of that admittedly odd tree.

I did not want to go out like my professors and colleagues that just gave up. Long story short, I am still on my journey on knowledge management, but I can tell you where I am. I am very, very capable in both Windows, Mac, and I am on my Linux journey. My daily driver is Mac. For those of you who have a visceral reaction to that, seriously? For those of you Mac nerds (I am one, remember) that look down your noses in judgement, REALLY?

- I have my content and a process for gathering new content. Google Dorks are your friend. Also, there is a tool called DevonThink Pro Agent (which is a different program from DevonThink) that I use for finding content. That little program is like having an odd little curator that looks at the Internet my way. Reeder, GoodLinks, TabToLInks help me gather information. I use Yoinks, Default Folder X, and Dropzone for quickly triaging of information to go to my file structure.

- My method for categorizing is still evolving. In short, I have a file structure on my computer that I have kept in parts for a long time. In fact, I have it laid out for every company that I worked on and ‘deadfile’ that way. If I ever worked for you I can tell you where I would have kept it. The folder structure could be 99% empty, but I know where to find what I worked on. It consists of folders lettered and numbered using the hierarchy of symbols that computers recognize so they can be grouped accordingly (letters for administrative and running the business, numbers for deliverables). As numbers climb, they become more spaced out. Still a work in progress. The folders are structured and named for deliverables, projects, and most importantly the requirements in hierarchy of importance and use.

- I have tools to find deliverables/files. Real talk, Windows files management F'ing sucks. I am a Mac person. Do with what you are comfortable. No judgement. It is your workflow. I use HoudahSpot on my Mac with saved searches (or at least I am building my saved searches).

- File management - I use Hazel. I would write about it if David Sparks (Macsparky.com) has not already done the most usable course to make your life better. Knowledge pro tip: when someone has put up the definitive work, don't F with it. Give it the props it deserves.

- Hardware - thanks to TSA, yes that TSA, I have been through more laptops in 15 years of international/domestic travel and when I think about it makes me unhappy and very sad. There is a stack of laptops in my basement that have been dropped or otherwise sacrificed to the technical overlords (hail Skynet). All that to say. Don't mess around with spinning drives in laptops or carry around a spinning drive for backup. Solid state. If you have a lot of information like me I carry 2TB of data in a 1.25" by 1.25" square by about a 0.5 inch solid state hard drive (enclosure by DuoCase and drive by Sabrent). Those are my core files. Keep it encrypted. I have this backed up on my NAS Drive(s). I keep a 60TB array and a 16TB array. I can get to the information on the road if need be. There is a hefty cloud backup in the world encrypted. Gone are the days of my lugging spools of DVD-Rs.

- Knowledge Management - I use DevonThink - David has also done a course on DevonThink. I use the Pro Office and have for a very long time now. I am no expert and I don't know if one truly breathes except for Mr. Sparks and the developers. I owe those people a meal and an adult beverage if they so imbibe. The magic of DT is fantastic. I have databases upon databases. It was practical AI for years before the current models. And it is mine. I put in what it needs to evaluate and organize. I just dump tons of data at it and then send in my query. I can type a statement and it's finishing my thoughts before I am finished. It is the only time I like that. The secret sauce is how I have things titled in my file structure. Each deliverable that has subsequent value as a behavior, tool, or training, is named as such and is the first word in my file structure. I can type my query and I will have Books return, procedures (SOP), process flow diagram (PFD), articles, templates, forms, all show up. I can then look at the folder structure to see the context further. Was this back in the days when I was working on stem cells or med device? DT then highlights the phrases and keywords that I was looking for. If you are not getting excited, I don't know what to do for you.

So now, here is the best part of all of this. I can collect information and classify it in my system. I can pick up books for pleasure. I can gather knowledge without worrying about the burden of keeping it. I keep audio books and a small number of hardcover and paper back books (with the exception of many D&D books but that is something else for another time).

I have other workflows for notes and incidental information that ages like potato salad at a summer's picnic. Contextual information goes into a repository. I am currently using Drafts to capture that information. It has an extension to send to DevonThink and lots of other places. I finally moved my blog writing to Drafts. Eventually, I will get an extension to my blog platform.

Well, dear readers. That's what I got.

Appreciate you. Be well. Every day you make this place a better place to live and breathe in. For those of you on your journey, feel free to shoot me a question.

Books and Quality

Here are the books that I am reading currently or read recently, that have something worthwhile to offer (at least to me):

The Organized Mind, Daniel J. Levitin

- For those starting their organization journey or those far into it, you get something out of it. It explains what you are looking for or why you have your idiosyncrasies.

The Subtle Art of Not Giving a F*ck, Mark Manson

- Really tells you what you should give an F about. For those beginning their journey on productivity and being centered for a work life balance.

Read Chris Bailey

* Productivity Project

* Hyperfocus

* How to Calm Your Mind

Read Sydney Decker - These are fundamental for Quality professionals

* The Field Guide to Understanding Human Error

* Drift Into Failure

Thinking Fast and Slow, Daniel Kahneman

- Seriously this is GOOD stuff for Quality professionals

Misbehaving, Richard H. Thaler

- After Thinking Fast and Slow, go to this.

There are other books that I am reading on human error by James Reason (Human Error and The Human Contribution) but I am still absorbing.

If you are not reading, part of you is dying.

Be Well.

Workflows

I wanted to talk about the basics that I wish I knew when I was starting. Every person that is great at anything has the fundamentals down. These basics are practiced over and over again till they are inate. When they start getting off of their game they go back to the fundamentals to center themselves.

Fundamentals are not necessarily taught. As I said, I was not taught. Starting off in engineering I was put in a position that I thought was rare when I started. I found out later that I was not alone in the complexity of my predicament. I had a job 2500 miles away from my boss, the VP of Engineering.

I was a pup.

I was given an upstairs attic as an office at a facility. It was huge and it was filled with junk. This was in the mid-90’s. I went back there to see a friend in the 2010’s and they still call that attic, my office. That felt very nice.

So I took that 1000 square feet of office space and I cleaned it up myself. Sold off material that they did not need with the help of accounting. Dumpstered a lot. And then had folks take whatever they would like. Several days later (or likely several weeks as memory is flawed) the area was clear and I had a desk, chair, mobile white board, file cabinets, and a chair mat. Computer was in hand and I was off to the races.

The head of the facility where I was stationed as a corporate employee was impressed with that simple initiative. Little did I know he had taken pictures of the place they put me in and shared with my boss. Subsequent pictures were taken and sent via snail mail. I found out later that they wanted to see what I would do with that problem. Live with it or do something about it. I passed with flying colors. I did not ask for permission, I just did it. They saw that as a strength. I look back on that as a potential failure.

As an engineer I was trained to solve problems. But if you asked me how to solve a problem back then I would have asked you about the problem statement. I would look at who it was coming in terms of the class like I would back at university. I would try to figure out how to classify the problem.

But problems are not cut and dry. Problems do not come on a worksheet with a title. Those worksheets help you with unit operations and processing of pieces of problems. Those worksheets help you define pieces, not how to put them together.

I had a successful time at that job and look back at it fondly. I got to be a real engineer for a time, testing things, destroying things, writing papers, engineering cost out of product while making it better.

What I took away from that job was building my fundamental tool set because my first assignment was similar to my last assignment. It was “Figure it out”. So I had to come up with a workflow to figure things out.

I don’t think anything I am going to write next is unique to engineering disciplines except maybe system engineering.

My problems would come from either a phone call that I learned later to record (with permission) or from a fax machine with scrawls of horribly written diagrams that looked like they were written on a dash of a car (I confirmed that later by observing this happen). Alternatively I would get phone calls from board rooms with multiple people shouting into a horrible speaker phone.

The first discipline of my workflow: CONFIRM THE TASK

I would both verbally reflect the task back to my boss who was fantastic or if it was a group of folks or people who were harder to communicate with for various reasons I would draw it up on engineering paper and include my knowns, unknowns, problem statement that I assumed and then I would start giving them options for what I could do and the costs associated with it.

From there I would often have to design my own testing equipment which I thought was super cool.

Which lead to my second discipline: GATHER YOUR TOOLS, IF YOU DON’T HAVE THEM PURCHASE THEM, IF YOU CAN’T PURCHASE THEM, MAKE THEM.

Taking stock in tools tells you what problem you can solve easily so you can focus on what really needs focusing. I came up with a third discipline that I still use today but not always.

Third Discipline: CHECK IN WITH SMART PEOPLE OR GIVE A PROGRESS REPORT TO THE ASSIGNER FOR FEEDBACK

The third discipline was not always done third depending on the result of the second discipline. The reason being is that sometimes you are given problems because the people above don’t F’ing know the answer (or if they do they oversimplified it). So I give you the fourth discipline.

Fourth Discipline: DO A LITERATURE SEARCH (OR WATCH VIDEOS)

So this has become fraught with risk over the years because not everything published is gold. They are perspectives. Sometimes with an agenda. I have refined my sources over the years and do something that a lot of people don’t like to do, I find those people and network with them. It has made me better at what I do.

Now that I have all of this information then I look back at the problem statement and see what I have covered. See what I don’t have covered. With engineering problems I designed my experiment. I would set up my data sheets before hand. I would run models through my calculations (verify/validate). I would write any code for my automation. I would check those. I would establish a checklist for running the setup.

I would plan for success by pre-writing the final report with everything as it should have gone. Leaving the conclusion blank. I would space out the report and mark it up during execution if possible. By the way, record everything with your experiments. Video, audio, telemetry, have someone recording analog gauges. All this to say is that in the execution my fifth discipline.

Fith Discipline: BE PREPARED TO FALL FLAT ON YOUR ASS AND PREPARE TO RECOVER

Let the data take you where you need to be taken. Learn from your mistakes. Do a post mortem. Listen to people and do everything in reverse to see where you failed. Root cause principles are key. And if you did everything correct then great, write up your report. Here is my last discipline.

Sixth Discipline: WHEN EVERYTHING WORKED OUT THE WAY YOU WANTED TO, TURN ALL YOUR DELIVERABLES INTO TEMPLATES (BUILD YOUR TOOLBOX)

This is to say, reflect on what is worth keeping. Refine what was not. Celebrate your accomplishments. And file the stuff away.

Workflows are disciplines in order (or out) that you use your brain to navigate. I use my workflows to coach. Lay out not just the actions but the potential failure points. By preparring to fail you avoid failure many times.

The discipline that I did not talk about you may understand already if you have read anything posted here. It is consistent through out every problem. It is about people. Take into account the human aspect. Even your own. Check your work. Make sure people understand what the goal is. Get their buy in. See if they want to be on your team or not. Understand their bias and yours.

Don’t forget to celebrate the wins. Even with the people who don’t like to.

Be well.

Staying Strong when the Job Sucks

First off, I am not an HR professional. By the way, real talk, hug your HR professionals (if that is allowed in the handbook and by them). They are human beings and they have a job to do. Also real talk, some of them just like some of the quality professionals you know aren’t handling their gigs well. I get it. But the same people that give us a bad rap and don’t understand the job we have to do, are the same people that give HR a bad rap. Empathy people!

This isn’t employment advice. These are just tools and musings that I have had when going through the job life cycle.

There is an ebb and flow of the normal gig. If you are going through your work life without a set of basic tools there is not much I can do for you. I am considering writing something on basic tools and what I use currently for what that is worth. For those needing an answer now, contact me.

But let’s talk about when it really sucks. I am talking ethics issues, I am talking where budgest suck, everything is a problem, there are 400 initiatives and you are on every team (or conversely nobody is listening to you and it’s your process).

Now full disclosure, I have never googled, “what to do when the job sucks”. I just haven’t. I work the problem but that is my nature. But as with everyone else that tends to be human (I am part robot somewhere on my father’s side) you get to a point where working the problem just F’ing does not work. I leave you with this little nugget:

“I am not my work.”

Your brain is giving away rent free space to people you would not let in your front door.

I mean, you can be your work if you really want to, free country and all. BTW, I am in the US and that previous statement is up for debate in the coming months and years. Too soon?

So if you are amenable to the thought technology (props to Merlin Mann) that you are not your work and that you are a human being that has the choice in your brain to find a perspective other than FAAACK THIS PLACE, then here are is an alternative. BTW I was going to write more but I only have like 20 minutes to write this.

We are creatures that tend not to see good things until they have lit our face on fire (not literally). BUT OHHHH….how we can detect negativity and turn it into our central focus 1000 miles away and at the bottom of the F’ing Mariana’s Trench. Use that to your advantage. When you ID the neg, fast forward your brain.

Being in my 50’s (ow that hurt to write) I lived through movies that I had to pay once to see, pay even more money when they came out on video tape, and then a bit more when laser disc came out then the rationale world came with DVD. Then we now have YouTube. All that to say is that during the first part of my life when sitting through bad movies I wanted, F, I NEEDED the ability to fast forward through some pretty horrific movies. (By the way the movie analogy still holds with work because you can always leave the movie unless you brought someone with you then you are kinda F’d or a tragic asshole). As I got older and the technology got better, so did my thought technology. I learned that you can fast forward your good parts. And by the way, props to the new generation that just bail out of a video or fast forward when it sucks. You little F’rs are going to go far with this whole empowerment and agency thing.

YOU. HAVE. SEEN. THIS. MOVIE. BEFORE.

Or at least you have heard how it ends from other old timers. This will pass. You will get through it. But in the end. You are not your work just like you are not the movie. Yes both of those can change you in ways deeply and for a time. But I say to you, how sane are you if you let it own you? If you let it own you it means someone was selling it.

Now, there are people who don’t know that work is not a mental contact sport. Those people just suck. Don’t work for them. I mean work for them as long as you are healthy and can fast forward through their crap. In those cases, document everything. You are a person who deserves respect. I don’t give a F who is dishing it out.

Not saying report everything, but have your journal. I want you when you are feeling rather put down upon to read through what you have to realize, you are not crazy, and that this is not normal. Leave yourself mental breadcrumbs as to why you feel what you feel and who was a party to it. Journaling is a key discipline that evovled into this blog here. You should see some of the stuff I journal.

Be well. Stay Strong. They can’t eat you.

https://www.youtube.com/watch?v=Lk0hSeQ5s_k&pp=ygUQbWVybGluIG1hbm4gZmVhcg%3D%3D

Empathy and Kindness

I keep thinking this blog is truly focused on quality (it sure ain’t focused on grammar and spelling).

Quality is so nebulous when you try to talk to people about what you do. Day to day as a site quality head or a director I am not on the line seeing what is going on (1).

I explain quality as all of the attributes that give you the certainty/belief that the product is going to work without any negative effects. High quality means that you don’t even think about it not working the way it is intended to. That it is safe and reliable.

These attributes are built into systems by smart, well intentioned people. They attend to their jobs seriously. Even when life has them by the neck, they do what is right.

So if the regulated community is reliant on people, as it will be for a very very long time, I keep coming back to what centers us as humans. And from there what quality should be so as to make it easier to administer and to see as managers and site quality heads.

Quality culture is the measure, but what is then the criteria that we should measure the quality culture. I posit that it is Empathy and Kindness. Not just in day to day, but in the development of these systems. We need to be honest about how we use the system and the data out of the system.

The honesty that we have with ourselves helps us engineer quality in our systems. When we design a system, are we looking at it with the endpoint and mind AND by who it will be implemented and then used by?

Do we take the empathy and kindness in the type of training needed to use the system; cutting down the BS out of it and simplifying as much as practical?

Do we as managers write in or even know when we should be checking in on the users and administrators of the system? Do we advocate for personnel prior to implementation?

So yes, everything I am talking about is derivative of managing/implementing complex change (google away). But I am trying to go a bit deeper on the human aspect. Engineering simple is incredibly hard. It takes lots of trial and error and understanding about people. The most amazing user interfaces evolved from the dashboard of dials, indicators and sliders that took a doctorate to manage. But that is not quality, even if it gets us the result we are looking for. We want scale, we want person independent from a results perspective, we want person focused in its usage and consistency. The best systems are easy to use and you get what your expectations are out, every single time. You believe the outputs and understand the maintenance of the system (in fact you do it responsibly and lovingly).

How we get there is by leaning into the human aspect. Human factors are not just for devices or user interfaces. It comes from talking to people across the usage life cycle of the process. To think with them and where needed to help think for them through thoughtful questions. We get there through recognizing the empathy and kindness needed in their daily jobs. What complexities they have already? What complexities will this process introduce? What are the obstacles to success and implementation? (2)

Do you know what the end of the process actually is?

I am not saying a disertation for each process, but I am asking that you talk with users, implementers, etc.

• Do a literature search.

• Read the existing procedures, be honest about their function and quality

• Look at the quality and resolution of the data in place

• Look at the constraints that they have in time, training, data integrity (reliability of data)

• How quick does upstream data change?

• How long does it take to process all variables to the appropriate degree?

• Are all the right people being asked and involved?

• Are you listening to the wrong people? Or how do you know the team is large enough?

• Is it the right time for this process?

In short, I suggest you question your certainties and your understanding. Be willing to change your perspective based on data and input from people. Have empathy and kindness for the users and consumers of this system.

I have heard people use the phrase “do it with them, not for them” albeit without much power behind it, but the sentiment is sound. Your northstar needs to be that in building the tool, process, report, how do you intend it to be used and any unintended consequences. What is the load the process will create, and is the “juice worth the squeeze” for all involved?

Footnotes:

(1) I certainly make it out weekly but not on a daily basis. Also, as a note, going out at a managerial level gives great familiarity but you have to understand their may be a bit of a heisenberg effect of watching. Trust any of your quality associates (especially quality on the floor) to give you the intelligence that you need. Do not over react or cause them to lose credibility with their peers/colleagues.

(2) Look at the people involved and see if there is an agenda to implementation as sometimes loss of control is terrifying.

By the way…

I am all for the conversation. If you take issue or have a question about what I am talking about, please feel free to contact me through the ‘contact us’. I am trying to invest more time in this for many reasons. Let me know your thoughts.

Leadership and Fear

My first job out of out of college, a real engineering job I had the pleasure of working with my first real leader. He was my direct supervisor and the vice president of engineering. He and I stayed in touch LONG after I left that company. He is the one that suggested that I would do well in quality/pharma. I also had the displeasure of working with the biggest failure of a leader. I will afford that person empathy and grace and not discuss what role he had. In fact, I can combine several people of that company that he had taught over the years into an amalgum of what a leader should not be. Rather than point out the obvious, I have a list (I know you are shocked) of what disciplines and traits you should try to do.

If you feel you need to lead through fear you are not leading or inspiring. You are not being real. You are giving people an ultimatum. They may follow you a few times, but the fear you put in them is what has the power. You do not.

If that is okay for you and that relationships especially in work are fleeting, sure, okay. But you are the source for things being miserable and people leaving. The phrase about leaving bosses, is true. There are times you leave for reasons not related to the place but in those instances if it does not sting a little, then the leadership or peer relationships were not there.

• Be kind

• Be organized or recognize your organization issues

• Be human while being a boss

• Explain and teach, those are 2 different things

• Check on people and mean it. Care about their well beings. If there is something they tell you that is important check in again.

• Be careful on who you respect in messagiong when their leadership styles do not meet yours. Explain who they are to your reports and their issues. Be credible without punching down.

• Make all the people as happy as you can; if you can’t make everyone happy, make the people that you can happy ecstatic

• Give out candy. I am right on this.

• Remember when you were in their role. If you were never in their role, learn about the toughest part of their days.

• Remove obstacles

• Invest your time into your group

• Get them external training

• Be the buffer between you and the corporate beurocracy as much as practical

• Trust people to accept the message as is. There are going to be people who do not get the message but you need to make sure they have every opportuity to understand

• Get rid of the low performers. I have not been amazing at this because of empathy and the above. I have refined this to get rid of the bad actors. Most of the time low performance is because of issues that you don’t know about. If you care and inquire about your reports and colleagues, you can be the difference from low performance and finding their groove.

This is a short one for me. So in short in the words of my grandfather who taught me more about leadership without knowing, Don’t be a D#$# or as I put it, do everything with love.

Your New Responsibilities

This is my message to those who are fearful of changes to the regulatory state with the FDA. Please keep your head about you. The way rules promulgate take time and are codified in law. From there it is your job to bring attention through the public hearings and comment periods what it would do to public health and safety. Your comments are on the record and are the breadcrumbs for the lawyers will feast on it. They may siphon off money but they and then pressure from insurance companies will put pressure on requirements.

If for some reason those are thrown out the window, and that would be a big if (like huge), then run your quality management system to the letter. You are responsible for it. That is enshrined in the CFRs.

The regulatory state may change but lawfare will not change. The only way this breaks is if lawyers stop suing companies for bad actions. That means every decision is on the record. If legal accountability is thrown out the window, then we have bigger problems.

Stack up your objective evidence. Show the value of guidance and that it keeps the wheels turning.

If the regulatory landscape changes overall be assured that the rest of the world has not. For drugs and devices, the rest of world would likely preclude import without the the critical objective evidence.

Stay in the game. Remember the good actors that surround you. If you work for a company that has no boundaries then that is a different category of problem all together and that problem exists right now. Integrity is key.

You are the person standing responsible for public health. Do. Your. Fing. Job.

There may be stupidity afoot. There may be things that you agree with. But remember the patients and the public. You will have to look your family in the eye and yourself in the mirror.

Good luck.

PS: if there is a law that codifies preemption for FDA clearances then I reserve my right to add some new responsibilities.

On Regulation (or de-regulation)

The things that stand out to me today are the disatisfactions with the government or authorities on results. “There ought to be a law against [blanl]”. I won’t try to get into the motivations but I will talk about where regulation is needed and why. This is not overtly a political opinion but more on the mechanics of regulation. The majorit of people are dissatisfied with what government is doing about our problems, yet we have made a move towards people and policies that wish to diminish the regulatory state to ensure the freedom of markets. Cool story. But it isn’t what we think it is. Unless those same people pull away the protections for companies in terms or recourse, award caps, etc. I do not take you seriously. You are putting companies above people. It is a corprotocracy in the guise of freedom.

The regualtions that I deal with as a quality professional are out of outrage and necessity because left to their own devices, the company will only do what it must to market their products. It is not even about outrage by the public. Sometimes there is outrage but in today’s media cycle, people forget or never know because of the overall flow of information.

I consistently use this example for people on what they think the value of regulation is: How often do you think about putting that pill in your mouth every morning wondering if it is safe or not. If you don’t think or worry, then thank regulation.

Companies, while they may be legally people, are not obliged to have any more ethics that the regulations they are under. There are absolutely many companies that do the right thing because there are people in charge, but then there is always the bottom line. This is not a screed against capitalism. It is a comment that removal of regulations or worse, railing against the peopel that enforce or instill them in a company is acting against your own self interest. Maybe not to your pocket book but I assure you against the health and welfare of someone you love.

Regulation is here to keep our markets from devolving to the lowest common denominator. Regulations and regulators are there to only keep companies measured against what the bare minimum is. There are only specific regulatiosn because bad actors got away with common sense actions that were not required.

I leave you with this. Regulation keeps you safe. It is the reason why we are safer than we ever have been. De-regulation means you will have to be worried about more things in a world where you have less time. Be ready to be engaged or be a victim of namesless and faceless actors with very little recourse through a court system that is overloaded.

Good luck.

Balance

This is for all my quality professionals.

If you are not the calmest person in the room with your head about you and your feelings in check, you are not going to do yourself, your reports, your peers, or the public any good. Remember that there are people who use anger and reductavism as a lever to manipulate the situation. Never be afraid to collect information or feeling compeled to settle questions on the terms of anyone else but you. You need to defend it. You need to own it. If you don’t believe it why would you say you did. Resolution is the fruit of productive confrontation. Find your empathy. Collect your data. Read your procedures and guidance. Do what is right. But most importantly when you make the decision you need to be in balance. Peace.

Be. Better. Than. Them.