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Thursday, November 30, 2023

Hour by Hour Boards in the Digital World

What does an Hour by Hour board look like in a digital world? This Lean visual management tool that is a common and useful method to drive performance in manufacturing. But what do they look like in the digital paradigm? I find that the go-to is to just digitize them, meaning replicate the whiteboard without much thought about what they can be and how we can impact outcomes, ie drive performance increase. 

If we are to really gain order of magnitude productivity increases when introducing digital technology we have to go past that "just digitize the board" mentality. Let's start by considering why its hour by hour (or some standard period). Its to provide a tangible target to aim performance at with a given frequency. Its also because the operators or person who is supposed to update the board does it at that frequency. 

However if we introduce digital tools then we also introduce means to capture the required data at higher frequencies and also varying frequencies. This can be done a simple screen to quickly quantities, to interactive capture of quantities through buttons, input devices and sensors and ultimately through advanced sensory devices such as vision.  With that in mind it becomes a bit trivial to just do it every hour! In addition we can also capture a lot of context about the data. From the obvious such as operators, stations, orders, etc. but also things like environmental data, events, materials used, stock levels, etc. 

Lets take an example of a digital solution that essentially is capturing good and bad quantities of parts produced with some context such as time stamp, operator, station, shift, product and optionally some comments. However unlike the manual boards the operators can enter data at any given frequency and much more frequent than hour by hour. The system can also prompt and even require that he enter data at a given frequency. This is of course, if we only we rely on manual entries, if we supplement with sensory devices we can get much more granular and frequent data.

Now that we have all this data we can of course display hour by hour board with total quantities. Great but let's think about what else we can derive from this data? First of all we can calculate throughput and output rates, for example:

  • Throughputs: Good parts per hour, Good parts per shift, etc.
  • Output: Total bad parts by day, total good parts by line
And then include simple predictions of performance, for example:

  • Predicted good parts by end of shift, predicted total bad parts by line, etc.

But it doesn't end there! With this data you can also visualize trends of performance for example:

  • Trend good parts by line by shift. 
  • Daily performance trend 

We can also do comparison by a multitude of dimensions for example:

  • Bad parts by vs good parts by operator, or by day 
  • Good parts by product for different shifts or operators 
We can take actions on deviations and critical scenarios, for example:
  • Send a text when Good parts per hour is below 10

With all this digital data there is just so much insight to gain from just a simple capture of quantities. We now have a continuous feed of information and the hour by hour transforms into a wealth of information and importantly insights. This information can be displayed in numerous, dare I say infinite, formats for use by the operator, supervisor, leadership and any function in the operation. 

And it doesn't end there. With enough volume of data we can start applying more advanced analytics (read AI/ML) and gain insights that we did not uncover. Then operationalize these insights by proactively doing something about the performance predictively and intelligently.

Remember we started by simply capturing good and bad quantities of parts produced in a digital form. This took us from just looking at quantities and performance against a target to the ability to look at performance trends, patterns historically, performance in the context of different dimensions. Then to insights based on human intelligence, taking proactive actions, then to predictive analytics with AI/ML ending with deep insights into our operation. This is where and how digital transformation offers order of magnitude productivity increases.  

Let me end with a favorite quote from Dr. Seuss:

"Think left and think right and think low and think high. Oh, the things you can think up if only you try!"

So do "think high", digital is much more than digitizing, re. the hour by hour board in this example. The "things that you can think" once you have digital data is where the value is.

Tuesday, November 7, 2023

The Decline of Monoliths and the JAM (Just Another MES) Trap

How many times have we heard this? "We are implements XYZ system and the project plan has a go live date in 1.5 years." We also know that immediately after hearing this statement that anybody with even minimal experience will adds 6 months to this date - just to be realistic. This is what we have been accustomed to in the area of traditional manufacturing systems -there is a sense of inevitability and even desperation. 

Good news, in the current era of digital technology this does not need to be so. As I have explained many times before transformative digital technologies time to value is measured in days and weeks and not years. They are implemented in a bottom up iterative manner that is focused on adding value by making frontline operations more productive. 

But what makes this possible and why can't traditional systems do the same? That is because traditional systems are monolithic, they are built on the premise of providing a business function that works the same for all. The same solution that can serve all industries, in all modalities, in all scenarios, with any equipment, and for all operators. They have to be implemented top-down with a lengthy implementation process that maps out all the requirements, scenarios and contingencies upfront. They require the adaptation of existing operational processes to what the system can support and in the way that it supports it. They provide standardized rigid hierarchical structures for representing manufacturing operations with a standard data model in a one-size fits all approach.  Monolithic systems are also designed for maintainability, meaning that they try to optimize to ease the maintenance and management of the solution by a team with specialized skillsets. 

Bottom Line! Monolithic Solutions rob your organization of rapid time to value and exponential productivity increases that is at the core of the digital transformation (Industry 4.0, Smart Factories, etc).  This may not be news to some but the reason I felt it was necessary to discuss this topic is because I see many companies adopting new digital technologies but then go happily down the path of recreating monoliths. A path that will inevitably result in what I call "Just Another X": JAM, JAL, JAW, JAC - Just Another MES, LIMS, WMS, CMMS, etc. These solutions that will at best be “just as good” as the other MES, LIMS, WMS, CMMS, etc., and will inherently have all the associated shortcomings.

A Composable solution is built from the bottom up in an iterative manner. It is inherently agile and adaptable and provides the most efficient way to digitize manufacturing operations. It provides a solution in which the manufacturing execution is organically integrated with the operations and business processes. It provides the most robust and effective way to increase productivity with a modern digital tools specifically a Frontline Operations Platform.

This is in stark contrast to a Monolithic approach where top down hierarchical process is used to provide a solution that fits within specific constraints that is hard to change. The goal is to fit the solution to the process in contrast to fitting the process to the solution. Composability removes the difficulties associated with adhering to complicated standards and systems. It frees the engineers to focus on rapidly building targeted apps that solve a specific problem, fit the process, and increases the rate of solution development by an order of magnitude.
  • Tailored specifically to each process, activity, operation - no compromises.
  • Instrumentation of each discrete process - capturing granular data about each activity
  • Complexity is distributed across the solution's Apps and easier to maintain
  • Highly adaptable and agile - easy to change, minimal impact to overall system behavior

This brings us back to Holonics and holarchies which explain the fundamental principle enabling agility and why monolithic system will never be able to support agility. We talk all day long about digital transformation but until we understand that the technologies we use have to enable these fundamental principles we will not get the promised order of magnitude productivity increases. Let me close with a quote from what was once the Agility Forum, one of the research initiatives that is the foundation for Industry 4.0: 
“Instead of building something that anticipates a defined range of requirements based on ten or twelve contingencies, build it so it can be deconstructed and reconstructed as needed.” 

                                                                                                   -Rick Dove, Agility Forum 

Sunday, September 10, 2023

Stating the obvious, a post with many quotes and cliches!

This is an exciting week, I am preparing for the different panels for an event this week at Operations Calling. I found myself searching for ways to drive home the main point about adoption of digital platforms.  I have tried in so many ways to explain this in this blog, at events, with industry influencers and of course with all my customers. I have used technical explanations, analogies, theories, examples and more.  At the end I find myself repeating cliches and quotes that I believe provide a concise and memorable phrasing and drive a point home - and I love them. They are also very effective in the face of all the debate and skepticism around digital transformation, a topic a write a lot about.

So this post is going to be a bit full of what seems like cliches and obviosity but at the same time points out how ridiculous it is that we are still dealing with skepticism and denial about what digital technologies can do for our industry. 

Digital Transformation requires a commitment to a fundamental change that results in an order of magnitude productivity increase. 

And it does and can happen! I have seen it with my own eyes - two recent examples of manufacturing sites that have successfully transformed show how true this is (you can watch one here, the other is still not public). Once you see and experience it, the reality of it seems so easy, so obvious. At the end of the day what make this a reality is the collective human organization's quest to achieve a goal and the focused effort that it takes. If you will it, it will come true! And let's be clear it is a collective team's and organization's effort to achieve a common goal. "Unless someone like you cares a whole awful lot, nothing is going to get better. It's not.", from The Lorax, 1971, Dr Seuss.

Its not a secret that change requires a focused strategy, just listen to Walker Reynolds. Strategy is nothing without a clear goal. So many companies and people talk about strategy but they have no well defined objective or goal Drucker wrote that “Objectives are the fundamental strategy of a business. Objectives must be derived from what our business is, what it will be, and what it should be.” 

So defining goals and objectives are key. Arnold Schwarzenegger says that you should "visualize the person you want to become". In other words visualize your goals, draw a picture of what your manufacturing operations will look like when you are fully transformed and has achieved three digit precent improvements, for example increasing throughput by 100%. I can just hear the critics, its not easy, its complicated, you don't understand. Well here is quote from Clint Eastwood: "If you want a guarantee, buy a toaster". Nelson Mandela said: "It always seems impossible until its done. Nelson Mandela".

But remember that "culture eats strategy for breakfast", another of Drucker's famous quotes (borders on being a cliche). In the examples mentioned above it was clear that culture was a critical factor in the transformation. It works hand in hand, driving change with a clear goal ignites people and that helps create a culture of change. Also aligning a culture of continuous improvement with digital tools is an explosive catalyst for change. That is exactly what happened in this case - its just incredible to watch. 

Change is infectious because the results and accomplishments are real and rewarding. Organization and their people that change are eager and proud to share their feedback and observations. This is something that you can use to gauge the impact of a digital technology as well as the other way around if it affects change. 

Monday, August 28, 2023

Why Pharma is primed to capitalize on Digital

Digital and GxP compliance - a topic that is in high demand and interest these days. The general skepticism and misunderstanding of people in the quality functions of life sciences manufacturing companies is simply put; the biggest barrier currently in digital adoption. I spend so much time explaining and trying to convey the potential in digital technologies and why they are much more compliant than any paper based documentation method. The paper mindset is a shackle that all pharma and biotech companies have to cut off, now and fast otherwise the implications are dire! And, this is not news; regulators know it, executives know it, operations know it, even the quality leadership in most companies know it. That is why such concepts and guidances as Pharma 4.0, Control StrategyCSA, Continuous Validation, etc. are being introduced and advocated.  

The industries dependency on paper as a mean of documented evidence for compliance is so engrained that it more than a solution it has become weaved into the culture. The selected attempts to introduce electronic solution for compliance such as eBR, LIMS, QMS, etc have been so painful, expensive and unwieldy that they have left us grasping and finding comfort in the paper based solutions. This has left the industry is in a constant dilemma where we know we need to step into the digital era (the unknown) but feel most comfortable staying in warmth of the paper world (known). While some opt for the compromise of traditional systems as an alternative (another known). 

Pharma and Biotech operations and processes are inherently dependent on data. Unlike other industries where the products are physical and you can see problems and defects, the processes can in most cases only be seen or observed through data. Yet we choose to observe by capturing this data mostly on paper and resist the adoption of digital means - why? Because of preconceived notions of compliance and painful experiences with other systems? This is mind boggling - its like someone with poor vision refusing to get a pair of glasses or contacts with obscure excuses that its "not allowed" (reference to regulatory guidance).

In other manufacturing industries operational excellence is the only way to stay profitable. In the life sciences industries the profit margins allow some leeway in productivity levels but of course have the additional burden of compliance. It means that the opportunity to gain significant productivity improvements are very high, e.g. in the CPG industry productivity increase of less than 1% are welcome. In life science not many will make an effort for such a again. With that in mind think about "the waste of documentation" in most processes - I would venture to say that there is more than 10% productivity increase potential by digitizing all paper records across most operations. 

With this I am making a plea to all my peers in the life sciences manufacturing industries. Adopt a "digital anything" mindset and start the transformation. If you see a piece of paper being used that is your opportunity to start digitizing. It does not have to be an intricate complicated "system" that needs IT and top down approvals. Start small and digitize a paper a day, one paper at a time and you will become digital faster than you have ever imagined. Yes there are regulatory implication but do no use that as an excuse, start the digitization process where the skepticism (or maybe fear) is greatest, e.g. the QA or documentation departments.

If one thing you should take aways from the changing paradigm is that transforming paper to digital is not only a must but also significantly easier than it was in the past. I have said this many times, there are no excuses not to start adopting digital technology, and that means the improvements can be incredibly rewarding.  Eliminate paper there are easier way to capture evidence in the digital world!