For the Knowledge Workers in their Journey

When I was a kid I would sometimes wake up in the morning early enough to watch my dad put on his work boots and then load up his truck. He would bring his lunch, sometimes a thermos and a couple of shirts. He worked in construction as a plumber. Growing up that way I was accustomed to loading your tools every morning. On the weekend my dad would repair, clean, sharpen and in rare instances replace his tools.

Today's employees expect everything given to them. This is not an article about shaming a different generation, it is about the lost art of being a craftsperson with the work you do.

I want to be clear here. This is about productivity. I am seriously envious of those people that can start work at a specific time and quit at another time. That is a thought technology that does not come in the Gen X model (BTW, I am using this relationally, not as an endorsement of the F your feelings moniker that has been ascribed). You should expect and advocate for these tools. What I am talking about is for those that have both the need and the want to remove obstacles out of their way and have no issues in investing in their day. This path is pathological. Be wary to those who follow. this past is fraught with pain, loss dollars and disappointment in the tools, tech and most impactful, yourself. Just like dodgeball, this reveals your character, just not in a good way.

With being a knowledge worker, there is a decision that you need to consciously make. Are you content with your productivity to remain in the pack? That is perfectly fine (or should be). I should take a second to talk about the pack. First and foremost thank you. The majority of the grind work is done by the pack. In any good system you need efficient people that work on specific tasks and get stuff done routinely. The pack deserves lots of love and attention by management. I have sat in high up meetings where they look at ways to unleash the pack. Some are great ideas, some are base and frighten me but the focus is there. There is not a lot of thinking about how do we get "Jake" to perform better on the 5 key tasks that nobody else knows how to do. It happens during a crisis for sure. But typically, no, not a lot of fretting. There are and need to be specialists. Not everyone should be one. The normal distribution wins again as it always will.

Specialists should take on responsibility on how to get thoughts out of their heads reliably and completely and learn how to process, and to optimize for productivity that is needed to achieve. Know that in practice through your career productivity changes and not always in the ways you think. There tends to be a steep curve, followed by a plateau then a slight bath tub curve. As knowledge increases the quality of the work becomes better and quicker. Productivity should be plotted against quality and if you really want to get nerdy, against knowledge. I imagine the curve in 3D space similar to when you blow up a balloon when you were a kid and let it go (I am only kind of joking).

As a specialist knowledge worker you need to have your clear head. There are days when you should not go in to face the day. Especially if the decisions you make are mission critical. Hopefully you have a person to rely on because I have been there when you should not go in but you have to anyways.

You need ritual, you need a place to put your tasks. You need a commute that is understood and accepted (notice I did not say easy).

I am going to go on a bit of a ranted list of things that you should try to have.

- If you are not okay at home, work is not the place to try to force to be okay

- Be you, be weird, enjoy your quirk. Just don't be creepy.

- Be a life long learner

- Listen to the younger associates, seek out the people who have been there years for institutional knowledge

- Talk less, listen more, find new places to eat to expose yourself to new perspectives

- Art will save you

- Toys and play at all ages are essential. They inspire.

- Make yourself comfortable without making other people less comfortable.

- Share and mentor as much as you can tolerate.

- If you must win because you must be right, then you are done. Get out. Don't talk to people.

- Quiet places, loud places, whatever works for you, do it.

The message is, ritual is part of your process. Embrace it. It is the enabler of the best version of you.

For knowledge workers our tools are different. It really does not matter what type of technology you use, it matters to what is effective and more to the point productive with your workflows. Find the behaviors and you will find your process. There are even tools that do things even better than you already do. Take that mental load off and automate what you can without losing the spirit or substance of what you add to it.

Productivity changes over time. You can have a machine that turns out many widgets, or a process that creates valuable masterpieces at a modest clip. The value of the process does to a serious degree have to include the rate of production (see how long it takes for you to get your dinner at a fine, expensive restaurant ) as we are human and have expectations driven by biology.

When I started in the industry I had a lot of throughput. Lots of validations, lots of specifications, reports, change controls, etc. My value as an individual contributor was 'good'. It was what you would expect from a new quality professional. If I held it to today's requirements meaning my requirements, the rate would be good but it would not be the finished product that my experience would say in review of my own work 20+ years down the road. There is an elegance to what to put versus what not to put. There is the textbook answer to every deliverable and then there is the craftsperson's. For productivity, you need to find the sweet spot.

At the beginning, my productivity was through brute force. It was absolutely the wrong way. I had no quality toolset. I had no ethos. I just worked hours. So you could say it was not really productivity, it was multiplication of efforts. But 80+ hours a week was not fully effective or productive. That last hour of the week was no where near as good as the first.

Out of necessity which I won't really go into here because journey's vary I had to look at how to get through a productive week with a sense of worth and feeling like there was a point to it all. The existential piece is not what I am talking about here but what I saw was how to minimize effort by standardizing on a way to do things. It meant investment to think about how to do it right the first time. But the shortcut was to mimic tools and habits that I see better and more productive performers use. Trying these tools out was a pathway. Some find the right fit, others find nothing at all. But it means that you find many disciplines and ways of thinking to approach a problem. Helping you become the solution rather than the person experiencing it for the first time. It is the way that you think about work that matters as much as being present at work to get it done. These tools both mental and physical are what you should be bringing to work every morning. Unloading your tools and laying them out being if that is on the drive in preparing yourself for the day or the ritual every morning of setting up your processes. The word journeyman comes to mind, you are on a journey and along the way you pick up tools and ways to think about the work you do. We need a better word not stepped in the patriarchy so let's call ourselves on this pathway a 'journeyist'.

My journey so far.

I have read books and listen to philosophers through podcasts. They all say some of the same things, some mention the same systems, some get into the details. My point to you is to consume as much as you can and see what fits. In the end you need to find some serious time to think about what your journey is. Where do you want to go.

To further the point the title knowledge worker says what we need to do. We need to think about how we work as much as we think and produce work. The quality of our knowledge work is only as good as our state of mind. Clearing our obstacles in our thinking is key. That does not mean shut the world away, but to have a process to make it less of a din or roar. Our lives inform us why we work, but as knowledge workers it can keep us from success of doing just that.

I love candles as they can set the mood for the day. I need a space to do my work that makes me at ease. If it can't be at home I have the escape backpack that has everything I need to work pretty much anywhere I want. Music is great but can change a mood without much leverage at all. People coming up behind me, NOPE. Respect is everything of the dojo. Having a clock or other type of widget device to tell me what is going on in the outside world is helpful for connection and valuing time. Being the right temperature or humidity can really make the day. Having a place to take breaks is clutch, maybe even meditate. Nothing can be so weird if it makes you comfortable or centers your brain. Make sure you value yourself through the day including meals and hydration (I suck at both).

Automated tools are great if you have the capacity to maintain them. They can save so much time. Know what you are doing every day and enable yourself with the right mindset. Sometimes if you are not in the right mindset, move it to another day.

Take breaks throughout the day to review what has happened and where your pace is. I start my day typically be cleaning off my workspace and setting up. When I don't I tend to know my world will soon be in disarray. Sometimes it culminates in weekend cleanings or when I was in a brick and mortar going into work to reset for the next week.

I schedule time in my calendar to do the maintenance I need to my "knowledge work areas". Sometimes that is in electronic file management, calendaring, buying the snacks I need and stocking the area, or getting paper scanned and shredded.

I review my projects to see if they are worth doing. I buy tools to try them out to see if it is better for my workflow. I have standard pieces of kit such as my mouse. I have keyboard preferences. I have keysets with macros sitting on my desk with specific functions. My area is automated so I can use voice commands where possible for lighting or other comforts. Ergonomics are somewhat shaky but I do have a good chair. My floor pad is glass but way too small for the amount I move.

I will have more on this. Right now I am saying this out to the world and don't know what is worth saying so I will say it all or as much as I can formulate. Best of luck on your journey. Always willing to have a chat for those who have questions.

Behaviors, Tools, and Training

Back when I was a baby engineer I had a lab that I had to take for fabrication of my senior design project. I got to work with this amazing machinist named “Bill”. Of all the things I took from him teaching me the stuff that mattered and that I carry to this day was about discipline. What I learned about machining was F’ all. But that was on me, not “Bill”. Every semester “Bill” would come with his truck and drop off his tools. His tools were immaculate. Those two statements encompass the first two words I mention in the title. His discipline to bring his own tools and not rely on anyone else was deliberate. He had refined his jigs, gauges, calipers, blocks, and everything else had to meet his standards. His behaviors were based on standards, meaning quality.

His expectations of himself were what he taught implicitly. You brought your tools, you knew how to use them, you valued them and took care of them. I took this teaching and extended this through out each portion of my career. Here is what I did with those basic but elegant teachings.

Behaviors (I will add more as I think of them):

  • Have an ethos about what you do and how you fit into the communities you participate.

  • Always remember you have a responsibility to your community, even when that means upsetting the norm.

  • Ensure everything you do has a process. If you need to, write it down, or better yet draw it.

  • Have the integrity to say you don’t know how to do something when asked; that does not mean anything about you. It is a learning opportunity.

  • Be graceful in your professionalism, always lift people up.

  • Always ask yourself why you are fighting for something; is it just to be right?

  • Never be afraid to fail. Be cautious to fail, don’t run into failure. But go eyes wide open. Learn from your failures when you do. Ask other people’s opinions on why you failed. Seek wisdom from those you respect to find out lessons you may not see yet.

  • Write things down, in a single place.

  • Be okay with not being okay. True leaders can be vulnerable and they can be respected.

  • Embrace that change is necessary, but do not forget who you are.

  • Be kind. Empathy is key.

  • Remember integrity is the voice that keeps you up at night and helps you like yourself.

  • Decisions need to happen, be okay with making imperfect decisions but be cognizant of imperfect information. Do the math. Listen to people worth respecting.

  • Surround yourself with people you respect.

  • Be respectable.

  • Read.

  • Take time for you both professionally and personally.

  • If you intend to build a legacy, do not make it deliberate. Just do the right things and legacy will work itself out.

  • Ask questions that matter to you. Learn to ask questions the matter to someone else, you will be surprised at how that can lead to magical places.

Tool:

  • If you do not have a library, build one

  • If you do not have a set of people (network) that you get a wide view of answers from, build one.

  • Establish a standard for communication of a process, either a narative or process flow diagram method

  • Be able to find your files by establishing a file system hierarchy.

  • Name your files per a standard

  • Have a methodology for recording your tasks and projects. It can be analog or digital. I have found digital to work best.

  • Carry the stuff you need to be effective and comfortable so that you remove stress, carry your tools.

  • Be paperless as much as practical; scan everything and OCR (optical character recognition) it.

  • Be seen and heard. We are in a technical world so being seen is profesional and being heard via a good microphone reduces the potential for not being heard.

  • Backup your files.

  • Learn programs that make your life easier; take a class if you need

  • Peripherals that help with shortcuts is key.

  • Have your office setup be the place of focus with the right monitors, comfortable with the right mouse and keyboard.

  • Subscriptions should serve your productivity.

  • Value your time; do the economics and invest in tools that preserve your time.

  • Track your time; think about a program that automates that tracking.

  • Build templates

  • Have an agenda for each meeting, the template for that agenda should also serve for the minutes.

  • Learn how to calendar; have a fantastic calendar program

  • Use a mindmapping software

  • Develop a system for personal knowledge management (akin to your library)

  • Refresh your sources for often; build links and bookmarks into a system, I suggest using a reader program

  • Checklists can really help. Use them sparingly.

Training:

  • Podcasts are critical for keeping up to date on exposure to the right behaviors and tools; choose good ones and stick with them

  • Books (audio) are clutch; find your sources and keep them. Talk to people you respect with the behaviors you think work with your ethos; ask them what they read.

  • Professional journals are good;

  • Conferences can be good; be selective

  • Talk to people in your network. Find or be a mentor

Eventually I will add more and there may be things I missed that I am going to smack my forehead and say, “oh crap I forgot”. There are some things I purposefully did not add items from a techncial side including choice of websites, software, providers. I would be happy to do so but I don’t want to advocate for anything without understanding the use case.

As you create a behavior, build the tool that helps it take hold. Teach yourself how to use the tool more effectively. Look for tools that may already be there.

I spoke at Berkley once at an ISPE conference a while back. I was asked to speak on how young professionals attain regulatory knowledge. I wish had this message more refined than I did then. For those of you who may have attended that talk, this is what I likely should have told you. And my last behavior, admit when you did not meet your own standards and try to do better.

On CAPA

Quality systems and their allowance to be used is a contract with the public. It comes out of the trust paradigm we have with our health authorities and most importantly how our overall culture developed. Even if we have strayed from that culture, the intent of regulation and these rules are to bring us back to that social contract. The trust paradigm is that, the house gives you a line of credit of trust. You lose it all, you ain't getting more. You build on that trust with your blood, sweat and tears by building credibility and integrity, and the line of credit opens. But you have to be consistent. You can't hide shit. You let your record speak for itself. I speak of that both institutionally and personally. This does not mean you are not allowed to flex and make sure the business runs, but you must be able to stand on the basis of the regulation. Don't talk yourself into shit, just always be honest with yourself and others as to why you are doing what you are doing. If that reason is for a check, seriously, get the F out of the industry. You will thank me.

Personally, whatever you want to call that, "do no harm", "your word is your bond", whatever the hell you want to call it, if you are in any type of quality role, you are operating off this single premise: "If I/we find something wrong, it will be fixed so it does not happen again. Oh and by the way if we think it could happen we aren't going to wait for it to happen for us to fix it."

F'ing simple.

I could leave it there but then, why would you be reading this (grandiose of me to think anyone is reading this I know). But then you get people in the mix and they don't believe as you do because they [insert BS reason]. Let's start with some foundational things that we, as quality professionals, need to believe:

- No matter the size of the company, you don't get to devalue a regulation or de-regulate yourself

- If you are a service provider, the contracts you get into and what your customers pay you for DO NOT absolve you of the regulation. When in doubt, suck it up buttercup, you are fulfilling the regulation or you are not releasing that product or service. There is no memorandum that absolves you. Not even a little bit.

- The owners, shareholders, etc, they knew what they were getting to (or should have), they need to put the investment in for compliance. Period.

- Management is responsible. Your integrity is tied to theirs. I leave that to you to wrestle out the question on if management does not take their responsibility what that says about you if you stay.

In my scattered way of giving background on why I think what I think I tend to keep refining how I think (AHHH CONTINUOUS IMPROVEMENT). So all that to say is that as you review regulation, stance, vision, I would beg of you to always be ready to question the foundations of what you think by looking at why you think it. You may change some seriously cool things. If you can't do that, then I would like to recommend some other things like not being in management. If you are stuck, so are all your reports.

If you believe you are constantly right, and cannot be wrong, ask yourself if you are in the right mindset to be the decider for a risk analysis, investigation or CAPA.

Let's talk about how CAPA originate.

- Deviations

- Investigations/Stand Alone CA or PA (yes stand alone investigations better have CAPA; all CAPA have to be tied to a root cause analysis)

- Audit findings

- Stock Recovery/Recall

- Management Review

- Failures to meet corporate or site goals

Some of these are my thoughts, but I have a reason for this list.

Now that I have a list let's get into the process.

Just like root cause, you wait for all of the information prior to coming up with both the CA AND the PA.

If you go in with the CA or PA known, you should recuse yourself or self identify your bias to the team. Yes, even you who have 25+ years of experience. If you see that bias take hold of others out of authority, then you are not leading.

There are several users of CAPA and each level needs to know their functional role depending how the issue comes to them.

- Identification of the failure or potential failure point

- Determine the scope quickly in a triage

- Containment actions - Execute actions that keep the failure/potential failure from happening, this includes a clear communication plan

- Collect more information, and investigate

- Expand containment actions as needed, expand and look at other batches or processes where this could have similarly happened.

- Based on new information, interviews and constraints, re-baseline your initial assumptions.

- Identify all of the why's in your investigation; determine which are containment actions, push all corrective and preventive actions to the appropriate team/system owner.

- Reset and re-home any and all biases - this assumes you know your biases

- Execute a cost analysis of the issue and its likelihood to impact again

- Develop your corrective actions and at lease 1 preventive action. Don't just rely on retraining

- Evaluate the above against known risks, established severities, and trend this against occurrence rates; question if they hold. Identify if there were new risks identified. A corrective/preventive action could be to re-execute and re-baseline the FMEA for the process.

- Communicate to all stakeholders and management. Again, remove your bias, present evidence and scenarios. Establish the level of avoidance of the issue by thoroughly evaluating corrective/preventive actions for effectiveness.

- Choose and implement your CA/PA. If you remove any CA or PA for a particular reason, document the reason why in the record. You must give management the ability to do their job and document their decisions, good or bad.

- If capital is needed, escalate the issue including any cost analysis for avoidance.

- Log all CAPA into your system and track with realistic dates.

- All CAPA should have an implementation plan.

- Execute and monitor. Resources should be monitored and managed. Ensure you are following your processes and make sure stakeholders are involved. In the end QA is responsible for oversight.

- Effectiveness of the CAPA needs to be measured objectively. Effectiveness checks should be executed after obtaining enough data and held against pre-established criteria. Otherwise they are justified as to why it is compliant to close and that the corrections have objective evidence to demonstrate effectiveness (e.g. removal of the risk).

Common issues in CAPA systems

- Not enough capital or management buy in

- A system owner with an agenda

- Resistance to change

- Lack of understanding of persistence of the issue and the potential consequences (unrealized/near misses).

- Belief that people are a sustainable prevention system

- Lack of understanding that systems degrade and changes to peripheral systems may have unintended consequences.

I can expand on each of these but at this point I think I have said enough. More later.

Change Management

Listening to people distill what change management is over the years will be no different than this post. It will be reductive and miss some major points. You have to live change management. Change management is nuanced, fraught with risk, and most importantly requires the change owner to truly 'own' the system. Not just in name but in character and responsibility, they should be the R, A, C, and I about everything to do with their system. Reductive, I told you. But the people that most corporations put into change owners are typically on of the RACI letters that some manager or supervisor says "Just give it to [so and so], they really know that system". Another level of reductivism. Owners have a keyhole view of their system. Look at how and what owners are responsible for, pieces of a program, typically around a piece of software or a piece of a quality system for an area. You may be the system or process owner (yet another issue in granularity and change) for deviations in your department. You may own a larger software system because you are an IT person. But in the end do you know what you are doing? Be honest. And if you do truly know, what did you have to do and how long did it take for you to become conversationally the proud custodian of that system. Even though, it is still a narrow view of a critical piece of the site. And even further, your site may integrate or influence other sites. If you truly think about it, this is where it gets scarier.

If you live in the world where you are always going to be a startup, guess what, you may have dodged a bullet, there is nothing for you to really be scared of. But if you plan to be acquired. If you plan to be integrated in a short time. If your mission critical goal requires that there is tight control of the 'secret sauce' that is your tech, IP or whatever, then maybe there might be nuggets to think about (I didn't say if those nuggets would be gold or shit.)

Every program needs a change manager. Every company needs a change architect. I will fight you on this. There may be multiple tracks for change but I assure you there is not enough oversight.

Unfortunately I am going to stick another sword into what the industry and quite frankly humanity has a problem with, how we communicate. More on that later. Likely lots more on that later because we are all guilty. EVERY ONE OF US.

The corporate global types of the world have such a reductive big Pharma view of the world that they don't understand that the level of churn that happened over the past several decades has resulted in our collective industry brains scrambled about change management.

In the late 90's and 2000's the industry went mad with mergers and acquisitions. Flush with cash, the growth was artificial. The integrations were shit. Only until someone said, "STAHHHHHP" in the respective company was there a step back where a corporate system pushed down a corporate standard/guidance. IT TOOK WAY TO LONG TO FIGURE THAT OUT. Millions/Billions were spent only for standards when finally applied, seeing the real value of the company acquired. We looked at financial value, and value of IP but were so reductive as to the amount of change that would be needed to assimilate to the absorbing companies values. Let alone look at the company to be absorbed and question if the acquiring company should take on the acquired companies values.

Unfortunately companies do not do the most basic thing we do when people enter into a relationship, evaluate what makes them better for being in the relationship; I digress.

When I mean every program, I do indeed mean every program. Yeah it sounds like a drag, but that is how we get to meaningful quality.

What do I mean by program? Every quality system is just that, a system. They perform one part of the overall program function. CAPA, Internal Audit, Supplier Quality Management are in general, a program when you cobble them together. They are a machine that runs one portion of the business. Quality Operations, is another program. Quality Control, yet another program.

So if you are a director or manager, you should have people assigned that are the change managers for the area. They do not need to be management themselves but to be able to manage specifics about the system and overall program at a detailed level.

Each of these programs as you put them together have interconnections. This is where you have organizational change management, a step higher than change management, which is, in my opinion a stage higher than just change control.

The interconnections are the next level to deal with, this is where the Change Architect comes in. The Architect needs the keys to the kingdom. They need the vision, the roadmaps and the reality of what is going to be able to happen. Some would say that this is the CEO or general manager, that is rubbish. HOW CAN THEY.

[sidebar] Think about every title you have ever had. Did your job description cover what you were actually doing? Did it capture 20%? MAYBE? Depending on the chaos, depending on the growth, those functional people are absolutely dysfunctional. They have no bandwidth to do the role. They need enablers. People that DO. Take people off the playing field and give them a unit focus as much as practical. For the change architect, the sell is this: dear corporate overlords, you continue to ask more and more of us faster and faster and are upset that you cannot get a weekly report on updates to what you asked in terms of implementation this Monday. How about you pay a person low six figures to just move parts and pieces into place. That you value them enough that when they tell you where it is stuck, you believe them and resource it accordingly. [Sidebar over]

Here is my pitch.

Let's take it back to training. Then let's look at systems and how robust they can be.

Scale is a problem. The FDA I would imagine understands that.

Being in the quality unit ends up being adversarial as there is this propensity to pick sides, but there should not be sides. The only way that the industry is going to grow is to lean into the trust paradigm. That being that there is no way that there are enough inspectors to look at everything in the industry. Jesus they have 1/6th of the economy. We need to be the good actors. We have to be critical of what we do and create a system that has enough data resolution with sensitivity to pick up how we are operating. My point of change management being not utilized enough is that we, as an industry, need to create the trails to diagnose what happened so we can determine what went wrong. All while trying to change the systems meaningfully to improve the environment and the system.

As I have vacillated through my career as being part of big Pharma, consulting, start up and CDMO quality person I have a perspective that I think may be helpful.

The organism that is management in its evolutions and distractions does not have enough self awareness to manage itself in the current minimalistic paradigm which is cGMP. This isn't taking on a total quality management schema. What I am proposing is that change management is a proper tool that needs wider usage that is empowered. We empower our operators, but we don't empower the people because quite frankly we don't communicate the vision.

For example, when looking at a simple piece of equipment, I gather that the simplicity of an equipment use and cleaning log at scale tend to get convoluted from their simple purpose. The purpose being that at any point in time, what happened to the equipment? Let's take that even a step further back. How often in an environment is the following paradigm executed; "each time I touch a piece of equipment, I need to have a permission piece of paper to interact with the quality system that is the equipment use and cleaning log so I can use the equipment? However, the level of detail needed to interact is NEVER built into the system. The process of signing on, because of people, takes the lazy route. Checkboxes make it quicker, but it has no substance. We have used change management to dumb down our systems. As an industry, we need to elevate our operators through training. Training an experience in the cGMPs should, in my opinion, be amended to the following. "Have the training and experience to understand the intent of their role and how it impacts the quality of the products they directly/indirectly produce." See what I did there? This both helped to define the deliverables while helping to screen out the bad ones. If the training does not relate back to the intent of what they are doing and how it supports the quality of the product, then it sucks as a training. See you have a reductive horizon. You. Are. Welcome.

I hate saying that but it's true.

Operations wants to do one thing, make product. Right. Yeah. Makes sense. But because of the overhead of a quality system we have yet to see the collective value of execution in a quality mindset. I mean, some people absolutely get it, but ask yourself as a quality professional, how many people in your peer and colleague group get the religion of cGMP. The real meaning of it. Be honest.

The paper gets in the way. Being honest again, it is supposed to be in the way. But how many people get that? They need to know WHY it is in the way.

We have valued the operator's time and therefore paper burden and training to minimize errors, but we do not consider that part of the errors that we are introducing through being reductive in our systems is devaluing compliance itself. We need to value operators and that they can fully understand the intent of what they do. How it impacts their families and friends.

We in pharmaceutical management are using different value statements. Quality has one mission, Operations, has another. And in the end Quality gets marginalized. What I am proposing here is that we take some of the medical device mindset from ISO and take it into Pharma. Give it teeth. Both the program managers will have the intimacy of the programs, with the architect setting the vision, and the operators seeing the point of it all.

Pushing Through

Your week is done. You have been in meetings all week. No deliverables are done. You have not gone through any of your emails. You look at weekend days and you try to ‘catch up’. There is no catching up.

The reality is that if you continue to believe that you can catch up you will de-motivate yourself. The reality is that you need to believe in your system. You will see more results by committing to your system than to continue to try to answer emails. Instead of catching up, the point is pushing through. The realizaiton that there are no people that can go back to catch those things. You have to realize a couple of things:

  • If you are scheduling your own meetings, take accountability for the way you schedule or learn a new meeting discipline

  • If you are not scheduling your own meetings and feel you have agency, realize that you are applying your time correctly; give yourself that grace.

  • If you took time off, you deserved the time off

  • If you had to travel for business that was the priority

  • If you had some super huge project, that there is only so much you can do at one point in spacetime

  • Information has evolved. There are some things that were super hot that fixed themselves, there are items that were low level that festered. You have to reassess what the situation is.

think of a mantra when you get to this point. I go with “nothing I can do about my week, moving on.” It is not perfect but it go with it because it sounds like me. And if I am heard by my people they get what I am saying. They hear grace that I cam giving to myself. A bit of verbal leadership.

Pushing through is the only option.

My quick fixes have caveats as all quick fixes should. If you are coming to this without a system, then I have hope for you but this post aint it. You need to have a system to prioritize you tasks.

You need this mindset; not every email, task, phone call, or other needs you to respond. They just don’t. That is the hardest part. The anxiety is already building, I know. But if you don’t get this down, then you can push through but you will still wake up after you push through in the middle of the night sweating. Sorry; its on you.

If your boss is an asshole, not much I can do about this with advice. My assumption is that you are in a ‘healthy’ job or at least you understand that there should be a worlk life balance. I have no real standing to talk about work life balance but that is my journey.

My pushing through process:

  • Again, your mindset needs to be on valueing your time. Every minute of every day should be focused on getting to a point where you feel that you have a command of the here and now so you can be present for your team members.

  • Check your calendar for new meetings for things that you were not aware of. Look for emails or talk with the responsible people. A stand up meeting with your reports or peer meeting with collegues is clutch here. Don’t just go by rumor.

    • This is when you cancel and delegate meetings or find a person that can brief you afterwards.

  • Check your voice mail; people in a panic call, don’t ask me why. But most cluster Fs end up with the statement “ I called you, I texted, I emailed!” So there is some type of perceived hierarchy. Call them back. Text them back, then email. I dunno why this works but it does.

  • Your first day back, or if you so choose, the weekend, don’t plan to get any real stuff done. You need to re-charge and doing a task will just pro-long the week in your brain. You allow yourself a few hours to “Push Through”.

  • The first part is knowing how big the iceberg is. Go through your emails in the following way in triage:

    • Get rid of the stuff that you know for certain are just informational. If you need to take notes on a task or follow up enter that into your system

    • Note the big players, by seeing how many emails you got from your leaders and stakeholders. This is where I want you to put a pin in it. Hold off on responding. You can read but first, talk with people before you respond. More on that shortly.

    • Look at how the evolvement of projects and problems happened. A few takeaways are to note who you should have verbal conversations with to console, congratulate, or problem solve with people. This is where you find coaching opportunities if you could help your people navagate through a problem sooner. If you prioritize your people as soon as you come back, it will mean so very much to them.

    • Let the small stuff go. But if you must, instead of asking yourself for an update to the meeting via email. Check the meeting minutes. If that made you laugh because there are no minutes, ask someone who went that you trust for a download. The email should be “How did _________ go?”. If it was a cluster they will come and tell you. If it was nothing, they will tell you it was fine and that X came out of Y.

    • Get context or as I like to say, READ THE ROOM. What happened on the site/office? Where are people’s attitudes and what needs attention. Your prioritization may not be what the team needs. Sometimes that is okay but that is why you are in the seat that you are in.

    • Prioritize: Look at the big player communications; respond back with what you know so they don’t waste time trying to persuade you (if you are in a leadership role), make sure your chain of command, peers, and your reports are aware and escalate accordingly so your management knows you are aware/engaged when you were back. Show that you are attacking the right things the right way with discipline and facts.

      • It is perfectly acceptable to call them to assuage fears and that you are working on it but give them a date/time on the response

      • Have a communication plan with key points so the message is consistent (write these points down")

      • Evolve the data as needed. If you look at the issue and it is a non-issue, get it out as soon as practical so no more bandwidth is wasted on your part or their part.

      • If the data shows it is a bigger issue, get ready to SCRUM the issue. SCHEDULE THE WEEK ACCORDINGLY.

  • The emails that need a response get a quick “Understood, I can get X to you on this date”

  • The emails that need a clarificaiton need a response with the key information you need to get the deliverable completed. You can give them a preliminary date otherwise if they cannot get that information to you that you would have to figure out on your own.

  • The emails that need a “heard” response go out but time them to go outside of work hours so that you do not create a tsunami of “Oh [you] are back and answering emails, let’s bring them in on this.” Don’t shoot yourself in the foot.

  • There are just some emails that need to go to the electronic version of the Marianas' trench to be eaten by whatever lives in that digital hellscape. LET THEM FLOAT

Now put your deliverables into your work system, task manager, or even your physical binder. Then start working a now scoped problem.

Good luck.

Leadership

The first time I was put in charge of something, I had no idea I was in charge. You can talk about how I was unaware but in the end I was not set up for what I needed. I was given a task. People were supposed to help. Or I was supposed to work with people. Great. Cool. The stuff got done but it was a broken process. I don’t think anyone thought that there should be a process.

[Wow…is this post going to deveolve to a systems post, maybe?]

I have come from many different companies that have tasks. Some have processes…. but nobody thought that there needed to be a fully architected solution in the true sense of the word. For the most part I don’t think that American companies are pre-disposed to that thinking unless they due modeling, or they have brought in multiple consultants.

My opinion is that those businesses that talk about architected solutions have no idea what the F they are talking about. They have a narrow lane of a software and maybe some integrations but they don’t think about the life cycle of what processes need to work together, what processes need information from another process… etc. Think about it as a RACI for processes. Design accordingly. I digress.

So here I was like 23 years old and working on a project. I did some work for professors in a futile attempt to get a masters (long story). I looked at everything like an assignment. But this time there was no sylabus it was just a task, or so I thought. A really hard complicated task by the way. As an engineer you are expected to be able to do hard things, so I did what any engineer would do… I went to the library. What I started was a literature search. This is what we do now every day with Google. So why go down this path. Education taught me how to start. Nobody told me what to do when I was part of a team. Sure there were group projects, but there were no leaders. Group projects identify the people who are not leaders. [This statement may likely be another post]

So pushing through, I was given a team but nobody called them that. I saw them just like all my other peers; students. I did not know what my role was. People were looking to me to establish what was next.

I had no F’ing idea. So back to my fundamentals.

Rather than bore you with an example, if I haven’t bored you already, my fundamentals worked. The task was completed and I was rewarded with another project.

So the next task was slightly easier. Still figuring it out day by day. By the 10th task (likely a lot sooner) I decided to stop repeating myself to my team members. It was the proto-ooze version of a system. Still no leaders in sight. Then came schedules. Then came predictability. Then came problems. When you have a team with a problem, the chaos and firefighting takes over the frontal lobe for most of the team. When you get to predictability, then there is a space for people to either innovate or to derail to get back to chaos. I don’t know why…it just tends to happen. I think it tends to be about control, but I am not a psychologist.

As the predicatability increases, the decrease of each team members span of control or as I was told once “the value” they provide through their experience tends to influence things in good but often ways that are not person agnostic. These are the systems that only work when a certain person is on shift or available. The indespensibility of a person is often passively put into a system through multiple touch points of control along the process.

They are not aware of the impact they provide, both good an bad. Truly unintended consequences because how the process evolved. It could be due to lack of foresight or investment. Likely it could be based on constraints of time or having the right experts in designing the system. How you get there is irrelvent. It is just true.

So in trying to fix the past systems I would do what I was trained to do as a mechanical engineer. Build a system with a purpose. Design the system to accommodate all common uses with the end in mind. Build the machine. As with any good machine you drive simplicity. But with typical company ways of thinking here come the constraints. You get to train, you may get to de-risk, and sometimes you get to continuously improve. I built many systems like this. And then you would have to hand them over.

That is where leadership started to bud. It was out of handover that I had to teach ownership, by detailing how to protect the outcome. My designs and my training were there to show how to get the collective results. How you treat the system is how you get the results. Stewardship. Thoughtful care.

Over the years then the reality and competency of people who run these things became my focus. The reality and competency is not about the negatives, it is purely on the perspective of who they are, their experience and training, their frame of mind, and lastly the information they have. This profile combined with their nature and their process to make decisions tells you a level of leadership success. This was regardless of if they are in management or not. Leaders are leaders. The systems ran better with people who cared. They are part of the system. What they value, people and the impacts of their decisions to the stakeholders along the way, made them a better leader and the system a better system. It was a self re-enforcing mindset. However, their care needed to be engineered as well so it was not just person dependent.

So fast forward 10 years, 15 years, and my journey of building systems and building people. Thinking with the end in mind I thought about sustainability and the one thing that until our alien or AI overlords take care of us all there will always be human brains in the mix. Some indirectly. So in the maintenance of the system you have to think about the maintenance and more directly the repeatability of those brains.

I invested in myself over those years. Productivity books, leadership books, podcasts, meditation, whatever. But you can sum it up in looking at a belief system that promotes balance. In yourself, and in your people. Balance stats from empathy. For yourself and then for other people.

I need to work for leaders that allow me to do be the complete person that I am. What we do every day is hard given our set of constraints. We lose sight of that. Even the best leaders do, but the best leaders know how to reset. They know when they can’t reset to step away to preserve the best resource they can, the people.

So if you want to lead, or start the journey, start with these simple things of note:

  • What am I doing?

  • Why am I doing it?

There are TONS of things that come from these questions. If you don’t know what you are doing, go back to your tools, experience, and problem solving process.

If you don’t know why, think about yourself and the people.

Best of luck. You got this.

Continuous Improvement

There is a duality of continuous improvement in a regulated industry; it has been festering in my head for a bit so here we go. For the uninitiated the concept of continuous improvement is unlike your mantras each year to lose a few pounds, or to eat healthier, call your parents more often, etc., but only if you were a systems perspective. You can take anything and see how you can do it better, more efficient, or most importantly make it make sense to where you get the best outcome for what you are trying to do.

For example, you want to lose a few pounds, you can do 100 different things, right? But in the end you are trying to comply with take in less calories than you are burning each day. Continuous improvement would tell you to for starters, to stop eating cookies before bed, then maybe next month after your time on a scale further motivates you, to limiting the number of cookies, to buying the ‘thin’ cookies, to eating cookies earlier in the day, to how about we stop buying cookies.

Extreme right?

So let me get back to the duality. Let’s assume you know how to execute continuous improvement, in that you do a true root cause analysis as part of an investigation (BECAUSE YOU SHOULD EACH TIME) so that you can get to the real reason that you are eating the aforementioned cookies before bed because you may be seeking to connect with a comforting memory each night, and instead call your grandma more often. Maybe, just maybe you may lose those pounds inadvertently. Okay so that was a tangent, but here is the point on duality.

In a regulated industry as in the example previously you first have to self identify the problem. What that means is that you have to fight the inertia to do the analysis. And when that analysis can keep you from 1) doing what you want, 2) keeps you from dealing with something unpleasant, or 3) you are limited from doing then you continue the status quo. So the duality from self identifying your problems keeps you locked in. You are afraid of what the analysis may tell you to do.

Take that to a company which wants to keep doing what it wants to do. You identifying a problem to make something better is the opposite to what any business wants, the continued pursuit of putting out units. Further, then by self identifying you open yourself up to regulators that are telling you that “great its perfect you want to lose the weight, but how come you did not do it sooner, or you need to get down 30lbs so you can look great at your cousin’s wedding”.

The fear. The inertia. The resistance to change. The identification of problems that nobody wants to put the work into because it means you may have to recognize other things as well. If I start talking about that, we could be here a while.

Okay so what? The difference between those people, companies, and systems that get better is the ability to be introspective. Those things that do not evolve die out. They are replaced. And often they are replaced with a simple but likely inadequate form. The brute force of analysis. Companies react to problems like splinters, they pick at it, they are irritated by it and when they can’t do something about it they don’t go to the people that know how to fix it because they don’t like the answer or investment. They look for ‘experts’. In regulated industries, let’s call them consultants who do the same analysis that you have done but then they don’t give an F and put in a system that is oversimplified, on the most base ideas and implement. They do this because people recognize the problem but they don’t want to do the work. Consultants are necessary. They are the third party that tells you “hey, you better lose the weight because…”. And then they scare not only you but they scare the right boss with the right funds, or their job is on the line because they have been neglecting the issue for too long and there are receipts.

So back to introspection. F the duality. Be honest with yourself and your peers, and your management. Be consistently honest. Don’t be the person who has an agenda to increase their span of control. Be thoughtful. See where you are part of the problem. The regulator is going to bust you anyways, but if it is staring you in the face, and you don’t recognize and have the plan, you are not doing your job. Use the quality system. Effect the change in your area.

If you want to own your part of the world to make your life and the systems better here is a simple thing to think about. It may be a value differentiator between you and your other colleagues.

  • What problems do you deal with every day?

  • How does it impact what you do? Time, money, frustration, potential for introducing downstream errors, non-compliant with a rule or procedure? Cause rework?

  • Do other people deal with the same problem? Talk it out with your colleagues to find out (whoa…communication).

  • Why does it happen? No really, get into the problem without trying to take anyone down. Accountability, not blame.

  • Are there solutions to it? Can you phase solutions in so that it’s not a huge change or investment all at once?

  • Who do you need to talk to so you can make it happen? Can you take some agency and do it on your own?

Identification of your problems with artful packaging, marketing and communication of thoughtful and constructive analysis is the chef’s kiss of being a conscientious contributor. Be bold, be brave. You may fail, but failure is where we purposefully evolve. That is continuous improvement.

So, get over the fear, it is better to self identify and get it into the quality system with a clear action plan than to just sit there taking the regulatory hit when you knew dam well that you would not be where you are if you just listened to yourself. Oh and yes, if you can, call your grandma.

Letting Go

it does not matter what kind of professional you are, when you find a team, a tribe, a set of people that make your work life not just liveable but enjoyable, it is one of the most painful things to let go of. But if they are the team that you think they are and you are the leader you have always wished to be, then you will do the right things to keep in touch. Not stalkery, not like besties, but out of mutual respect. Find the things that bring you to the job, not the tasks but the drive to build each person. Check on how they are doing with themselves, their balance, their needs as a person. Be kind. Be understanding. Sometimes you have to leave for all the right reasons but they may not see it that way whatever the circumstance. Find the grace in you so you can be understanding. You may be more or less to them than you think.

If you have been your authentic self, good for you. If you have not and have had the gameshow host face on at all times, then before you leave, try to pry that mask off a little bit. Let them be humans. You do your best to show them that there is absolutely a time and place to engage as a person, not as a role. Be you.

Man I am not good at this.

Stress is a part of any job. It is a perspective that is compounded by your economics, your responsibilities, making your way through the times and common experiences, and then you get your day. Each one of those components has an interesting dynamic and interplay with each. Staying present is the key, focusing on the good portion of your responsibilities (where possible), loving the time you get on your own.

I know this. I have thought this many times. And I continually have to check myself. Find your ritual, find your cues, find the things that bring you presence. You deserve to be the whole you in this experience. I wish you all nothing but peace.

Listen and Mean it

I have been wanting to write more about the finer points of what I try to be in my career. When you are interfacing with anyone while you are in the middle of something, value them by putting down what you are doing. This does not mean give them agency over everything in your day. Read the room before you ask for time or “later”. The relationships you are trying or have built can be dealt a serious blow for a reason you will likely not remember later. People first. Kindness always.

30 Days or so later...

Its been a little over a month since I have been done with the last gig. Or it was done with me. I am getting better at the day to day. Friends of mine are losing their jobs though and that pains me more. It is not necessarily the economy as it is the push for corporations to better their numbers so they can be lean and turn a profit. It is not personal. It feels personal. Just breathing through it takes some stuff out of you.

But onward. I am safe and healthy and so is my family. Perspective they say is critical to mental health. I think perspective is also critical to calibrate your sense of humanity with all that is going on with the world.

In taking stock of what I have I know I will work again. So will you. We are built to task and labor. We are built to solve problems and be more than the sum of our parts.

I wish I could be angry. No sense to it. I wish that I can be useful. But with everything that is going on, just breathing and knowing that I am better off than many. That is all that I need. I will be okay. So will you.

Reducing the Costs of Operations: Processes and Decisions

Meetings, when done appropriately, are a good thing. They are a necessary thing. In looking at the majority of meetings that I have been to could have been handled in an email. The reactions to well run meetings are enlightening and bring some type of resolve, good or bad. I have been to some of those meetings. I long for those meetings. I want more of those. I think that we can get there if we think about it.

My selling point for this is not just my sanity, it is economic. In the end it is simple math. X number or people at Y mean dollars per hour. It is not just lost productivity it is the creation and propagation of the next meeting. They snowball. They take on lives of their own. Then nobody remembers the reason why the original meeting was called.

In trying not to generalize the business world today I rather talk about the good meetings:

  1. They start on time

  2. They have a written agenda (and minutes)

  3. The topics are discussed and kept on track.

    • Anything off topic is tabled unless it is elevated to a central topic because some oversight in preparation.

    • People are called in as needed in the expanse of the topic

  4. Everyone that attends the meeting needs to be there for a purpose.

    1. to hear the content,

    2. to deliberate,

    3. provide background, or history

    4. are subject matter experts

    5. the appropriate decision makers are there

    6. Stakeholders are either their or copied on the minutes.

In the end meetings should result in a decision. If it is about status and accountability, I get it. There are uses for those types of meetings to provide pressure for action. But once the culture of compliance and doing then the creation of a report is likely. But then that creates a deliverable. Which brings me to a purpose here. If you as the person calling the meeting, if it is supposed to be a standing meeting, and you would not be willing to create a report as a deliverable in the frequency of the meeting you are creating, then is the meeting truly worth it?

Resume tip I learned today

Always look at the founders of the company of a startup. You may know someone. It would reveal the character, work ethic, and expectations of any position.

Sometimes it just does not work in your favor.

Woke up one morning and saw that someone I know by name but never worked with called an all hands meeting 2 hours from the time I saw it. That is never good. In the end a quick Google search told me everything that I needed to know about my meeting. The company was done. Que sera, sera.

If you been through this you may be reliving what I am living through now. A tightening of the chest. Feeling uncertain. A bit disconnected. Yeah. All those feels. I am writing this here well before I tell extended family because I am thinking about my brothers and sisters that have gone through this before. Going through it now. Or will go through this in the future.

I keep telling myself that I am not my work. I am more than an individual contributor behind a keyboard. I don’t always know this. I bet sometimes you do too. It has been normalized but it is not okay. It should not be okay by anyone. Not today.

When parents want better for their children its typically goal related. To get that job or degree. That has evolved for some to want their kids to be healthy and happy. It really just occurred to me today other than a few errant high level phrases, I don’t think I ever really had a talk with my parents of elders who were not in my career about what it is to be a successful worker.

Work ethic, yes. My father worked his fingers, shoulders, ankles and knees to the bone. Our parents were conditioned to not rock the boat. Do what you are told. Shut up and take it for the paycheck.

About 24 years ago I worked for a man who told me that there were things that he was still trying to figure out about being a boss, an employee and a human. He was no forward thinker as I reflect on it, he just had no idea what to do like most of us do through out our work arc.

He used puppets in staff meetings. Would take us out to strange restaurants for team building. We went for drives. We even went to the movies in the middle of the day. I was young and dumb. I did what was asked, I went where I was told, and I thought there was going to be some grand realization about what all that random stuff meant.

So here I am with these two strange examples, the certainty of ethic and doggedness of loyalty versus random stray creative energy assigned to complex problems. Where was I going to land? And why am I talking about it here and now? I just got fired along with the rest of my company. Chemistry can be a cruel mistress in the pharma world.

I think I am reminding myself. Precision application of my skillset is key. Panic does me nothing. Trusting in my abilities and my expertise just like everyone else does who will never know the decisions I make but affects their life.

My dad did not always know. My first boss/mentor certainly did not. What I got from them is to ask the question of myself. What kind of employee do I want to be?

  1. I want to have the best work ethic I can have for the day that I am having.

  2. I want to realize that every day cannot be my best, even if I want it to be.

  3. I probably mess up more than I ever realize; don’t harp on the ones that I self notice and then end up owning myself.

  4. I want my work to have purpose for everyone I work with, work for, or who my work product affects. Even if they don’t always now it.

  5. The recognition of a paycheck is enough for them, it should be enough for me. That should cut both ways. They pay me for a job. When that job is done I need to know that I am done.

  6. I need to value the people I work with, even if its hard truths, tough expectations, or to tell them how to give the level of service that I expect.

  7. I need to value the people I work with through verbalizing my appreciation for their meeting my expectations and celebrating when they surpass it. How you ask does that jibe with number 5, it is a one way valve.

  8. I want to lead.

  9. I want to make leaders.

  10. I want to make a living to live, not just work.

  11. Hard work is a good thing. Excessive hard work does happen. But I need to give myself a break. Even with all that, failures happen. Decisions are made. And I need to remember its not personal.

  12. I will never work past the limitation that I am human.

All of this evolves. Some of this wording and rationale will be lost with the tempering of age. I hope not. I want what I do in the back end of my career punctuated not just by project successes but by being the best person I could be. Not just an employee. Thank you for listening. By the way, that is a really marketable and human soft skill.

Quality Edicts

1.    Get a pet or hobby that makes you feel better about yourself.

2.    The regulation is the regulation; your job is to enforce what we have interpreted.

a.     Anyone asking for leeway or “just this time” is not your friend, see rule 7.

3.    Do not assume that anything you have been told is correct, verify with objective evidence

4.    Oversimplification of your tasks or anyone else’s tasks will screw up everything.

a.     If someone is oversimplifying something critical, you must correct them.

b.    Leaving a false impression is as bad as the oversimplification itself.

c.     Sometimes you may make people mad for making them feel stupid; refer them to rule 1.

5.    Any decision you have been compelled to make will come back to haunt you; that haunting can go from 15 to life in an orange jumpsuit.

6.    Plan

a.     Make everyone else plan.

b.    If they don’t know how to plan, teach them.

c.     Planning is not taking what the customer wants and then figure it out how to get there.

d.    Saying “Yes” is not project management.

7.    Precedents: If you give an inch, be prepared to hand out miles with a smile. Setting precedents is a luxury you cannot afford.

8.    Clarify. If you hear something stupid, clarify. If you hear something shady, clarify again.

a.     When you clarify something shady: Always get it in writing. “It won’t protect you, but it will help with sentencing.”

b.    If they are not willing to put it in writing, then DON’T DO IT.

9.    Say it with me: Hardly anyone remembers being late on a date. Everyone remembers when someone dies because something was rushed.

10. None of this is personal.

11. Even when it feels personal, its not personal.

12. Even when it is personal, you can’t take it as personal.

13. Everyone wants things, give them what they need.

14. It’s hard to say “no”. Do it anyways. If you clarify maybe you can say “yes” to a different question.

Quality Assurance: Root Cause Analysis

Root cause analysis (RCA) is a true multidisciplinary process. Good RCA requires that technical and human aspects of process failures are evaluated conscientiously. 

The application of RCA should be consistently applied in almost every interaction you have in the quality realm. In meetings, you should apply these methods in determining if you are hearing a perspective or hearing fact. In conversations about investigations you need to communicate what your intent is; to solve the problem so it does not happen again. You are trying to make the system better for them. Its the process, not the people*.

With consistency every interaction will become more focused and personnel will become more compliant. Everyone who has gone through RCA with you, or knows of your reputation will know that you will not be satisfied with the established narrative. You ask questions. And you will keep asking if it does not make sense. You are going to ask for documentation. You are going to ask for objective evidence. You are going to talk to everyone you can. You may ask for testing of the product. You will pull electronic files and evaluate machinery. You check timelines.

This does not mean that each person involved is going to lie or not be forthcoming, it is human nature to paint the issue in the best possible light, or to state that they do not know what happened even if they do because of the perception that blame will be assigned. No one wants to get anyone into trouble including themselves. 

*Get this through your head now: You are not looking to fire someone or to have them fired. If you are please recuse yourself. Otherwise there may be an investigation of another type into you and your motivations with people who are motivated to find blames and reduce personnel risk.. I caveat this statement here as you should to those under investigation: If there is a trend of making the same mistake (not learning from past mistakes through good RCA), if there is a coverup, if there is someone who has been hurt because you knowingly did not do something you knew you had to do (trained on a procedure), if you don't care about what happened, if you do not evaluate potential for accountability, there may be no way that you can end up turned loose on the process you were trained to do again. That does not mean fired, it means scrutiny as to what processes can be completed with that mindset. There may be very few of those seats on the bus.

In short: If you were a bad actor we will find out. If you were conscientiously executing the process and something went wrong, they should have NOTHING to worry about. 

I use this as a philosophy about the investigation of human based processes. If the person involved can articulate the circumstances, the headspace, the objective evidence, the status of equipment, the information they were provided, and any other information borne out by the investigation and I can understand the result of the process including how they could have made those decisions knowing what they knew and when, then it is a process issue. This does not include excusing poor judgment. This does not excuse doing what they were told. But it does take into account human limitations: 

  • Was this at the beginning or end of the shift?
  • Have they been moved from day to nights or swings?
  • How many hours have they been working this week?
  • How long have they been doing this process?
  • When was the last time this equipment was serviced?
  • Were they set up for success?
  • What work constraints are they under?

This post is not about excuses. This is about objectively looking at how the process failed and human factors impact human operated processes. This isn't about finding a smoking gun. 

So with all of this narrative, I now can discuss what I think root cause analysis is

Root Cause Analysis (RCA) is a structured investigation that aims to identify the true cause of a problem and the actions necessary to eliminate it.  RCA helps understand which aspects of a problem need to be resolved and describes the real nature of the problem and its consequences.

The following workflow can be used as a tool to help with this process. It is especially useful when applied to the procedures used to resolve deviations and to design corrective and preventative actions. The user may employ any other techniques, alone or in conjunction with this procedure, to resolve nonconformances and should always be aware that there may be more than one cause/condition that leads to an unexpected event. The attached spreadsheet can be used to document the RCA process.

The RCA process is described in three parts:

1)     A detailed description of the symptoms of the nonconforming event, its source and its criticality.

2)     A determination of the probable causal factors/conditions and selection of the likely root cause(s).

3)     A determination and implementation of corrective action(s) needed to eliminate the cause and an assessment of the efficacy of those actions.

My general workflow:

0).   Investigation and Collection of Evidence

       As discussed above, you need to come up with an investigation technique. Your technique should be adaptable to the situation. If you have a batch that a simple question needs to be answered for release would require a different tact (maybe?) than a serious adverse event. I can blather about investigation technique all day (...no really, you don't say). 

1)    Event Symptoms

a)     Description

i)      Concisely state the objective evidence that supports the existence of an undesirable event. A thorough understanding of the process is required to effectively complete this description.

ii)     Describe what actually happened (What, When, Where, Who, Why). Flow charts and other visual aids should be used as needed and included in the RCA summary package.

iii)   Include a description of what was expected to occur. This information may exist in various forms:

(1)   Written (e.g. internal/external specifications, PO, regulatory standards).

(2)   Verbal (e.g. something agreed upon but is not in writing).

(3)   Assumptions (e.g. common sense, public opinion generally accepted practices).

iv)    Describe the discrepancy between the expectations and what actually happened.

b)     Information Source

i)      List the source of the information about the event (e.g. complaints, information from personnel, literature, business journals, adverse events records, audits).

c)     Criticality

i)      Assess the criticality of the events. Identify what really are the most troublesome symptoms of the event.

ii)     Assign a criticality level (e.g. High/Med; Low; 1, 3, 5; etc.). Use this assignment to determine the appropriate resources/time to commit to the resolution of the problem.

iii)   Include a justification for the criticality assignment.

2)    Possible Causal Factors/Conditions

a)     Description

i)      Generate a list of factors that may have caused the undesirable event. Consider any associated conditions that are required in order to make the causal factor assignment.

ii)     Answer the question “What Caused the Change And What Condition Existed That Allowed This Change To Have an Impact On The Process?”

iii)   Analyze any changes observed in the process (random, non-random). Consider the impact of the following groups/causes on the event:

(1)   People – Poor Work Practices, Inadequate Training/Education, Ineffectively Defined Job Descriptions, Poorly Designed Schedules, Ineffective Management.

(2)   Materials – Incorrect Materials, Materials Out-of-Specification/Expired, Unqualified Vendor.

(3)   Machine/Instruments –Ineffective Maintenance, Calibration Expired, Poor/Expired Warranties, Complex or Dangerous Man/Machine Interface.

(4)   Methods – Inadequate SOP Quality, Ineffective Training Quality, Incorrect Method Used, Method Used Incorrectly, Method Not Validated, Inferior Reagents Purchased/Used.

(5)   Environment – Temperature Excursions, Exposed Hazards, Noise Levels too high to Concentrate, Crowded Work Area.

(6)   Process Controls – Ineffectively Designed, Process Changed, Analytical Methods Changed, Lack of Validation, Incorrect Critical Control Points Identified.

iv)    Determine cause and effect relationships. Include the “5-Whys” approach.

v)     Chart data as needed to improve understanding.

vi)    Create a hypothesis on the root cause and justify.

b)     Likelihood

i)      Assign a probability that the identified causal factor and condition represent a possible root cause (High/Med/Low; 1, 3, 5; etc.).

c)     Information

i)      Detail all information that supports the assignment of a potential root cause and any tests or further information that are needed to verify the description.

d)     Obtain consensus on the probable root cause.

 3)    Possible Corrective Actions

a)     Description

i)      Describe possible actions that could be used to correct the root cause.

ii)     Ensure that these actions can generate measureable outcomes.

b)     Risks

i)      Describe risks associated with implementing the corrective actions.

ii)     Assign a probability that the risk would occur (High/Med/Low; 1, 3, 5; etc.).

iii)   Detail actions that could be used to mitigate the risk and assess the degree of mitigation (i.e. High reduced to medium, or 5 reduced to 1).

iv)    Determine if the mitigated risk level is acceptable.

c)     Measure Effectiveness

i)      Identify test methods and acceptance criteria that would provide objective evidence for effectiveness of the corrective actions. Address any required timelines for completion of the corrective actions.

ii)     Documents results as they become available and present them for discussion.

iii)   Document conclusions derived from the presented results.

iv)    Obtain consensus on the efficacy of the corrective actions and determine changes required to any processes required as a result of these conclusions.

 

4)    Closure

a)     Obtain required signature approvals for completion of the RCA process.

b)     Include this information in any associated process documents (CAPA, Deviations and Investigations, Audit Responses, etc.)

   Okay, so you made it through this post. You can make it through an RCA. Good luck.  Hit me up if you ever need to talk about something unique or challenging. I would like that. Yes I am that weird.         

 

Good Background:

https://en.wikipedia.org/wiki/Root_cause_analysis

 

Manufacturing Quality: Risk Management

Risk Managment is not permission to take risks. Risk management and the tools of risk analysis are there to justify doing what you should be doing, not what you want to do. There is a fundamental misunderstanding of the burden of risk management and how wide spread it is supposed to be within the organization. 

The executives that do not get risk management paradigms see it as a vehicle for justifying their organizational goals. I wish that mode of thinking was rare. 

Risk management is all encompassing. Get that first and foremost. Risk analysis is part of every step. It starts from development and design. It transitions from product to manufacturing process. It is in every part of the life cycle including retirement. For instance, you are ready to retire a product or a feature. You need to determine the risk to your customers on the elimination or retirement. Think about removing a headphone jack from a phone or taking a product that is fundamental to a small populations quality of life or survival. If you say your company has a risk management system think about how far it is implemented. Has it penetrated all aspects of every process? Are there feedback loops? Are there metrics about those feedback loops. 

Is your product so good that it does not need improvement in some way? Not just in its intrinsic quality but also customer experience, supply chain, servicing, design and manufacturing processes?  

Points to note:

  • ISO 14971 impacts each device process and quality system
  • ISO 62304 impacts medical device software in the same framework of risk as 14971
  • Risk Management programs describe the program; tools and frameworks should be defined in sub-procedures such as risk analysis methods (i.e. FTA or FMEA)
  • Continuous improvement and correction systems require feedback loops into all processes including design and manufacture. 
  • Servicing and kitting processes require all the same evaluations and risk controls as all other risk based processes.
  • Outsourced services are to be included in risk evaluations and controls
  • Quality Agreements to third parties need to account for responsibilities to risk management programs and feedback loops.

What are the next steps?:

  • Obtain and read the associated regulations and guidance. Read all of the annexes as well. 
  • Ensure your technical file and 510K/PMAs 
  • Products require risk analysis; these need to be kept up to date
  • A general risk narrative should be developed for the business processes
  • A general risk analysis should be developed for the quality management system
  • A risk analysis is required for all aspects of product realization and manufacturing (development, design, manufacturing and servicing)

Ensure that responsible people accept the residual risk and that the risk is as low as reasonably practical. Further for products put into commerce in the EU risk needs to be as low as possible. 

 

Quality Assurance: Being right is only part of compliance

Every quality professional has been through it. If you have not then either you can skip and whistle across water or you may be delusional. The dilemma is: Being right and no one listening. Let's face the truth that what we do while we know is essential, is pretty boring to most. Why boring? There is a rant that I will be going on for a while.  

What happens is there is a tendency for us to be tuned out. The complexity of what we do, coupled with the word "no" or the phrase "Yes, however.." infuriates those that want to produce product. They see our mandate against progress or operation. When you have well intentioned people on both sides, this tends to work out. When you have people who may be good people but are driven only by mandate, you have a problem.

Then comes of the complexity of those that do not want to listen as their goal do not align with your own. That tends to be the big bullshit lie. That they are your goals. Its compliance. Its the law.  It should be their goals as well. Right?

How many of you are shaking your heads in my over simplistic view of regulation. Yeah I get it. But that is kind of the point. 

Most folks have a saturation point on how much they want to hear and the steps that they want to follow. The steps need to be spoon fed. Then in their willful ignorance they are flabbergasted to the details when the steps in their head are complete but a system is not full. implemented. 

Of course you are having musings of why hasn't their been communication? Why wasn't their a project plan? Why...why...why?

What I have found in most start ups is there are few executives that understand the complexities of their wants with little true understanding of their needs. Couple that with a resistance of executives to only want to lead through milestone and mix in poor project management skills among the technical side and you have a complete mischaracterization of scope through passive/behavioral rooted dissonance. 

So its not about being right. Its not just about the organization structure.. Its not about understanding the mission. It is about ensuring the stakeholders and decision makers understand the effort, complexity, gating and steps. The commitment of resources and treasure needed to make everything go from red on the project schedule to green. That they understand the what they do impacts lives and failure to do so trivializes their company and your role.

More to come...stay tuned.