When enough is… enough

cho-in-azoneThis is a behavior I’ve noticed quite often in food industry, in chemical or pharmaceutical plants: cleaning and sanitation processes (mainly their duration) are extended beyond the standard procedures at the expense of costs and production capacity.

Fear of harming

In the regulatory-constraint industries like food, chemical or pharma, people on shopfloor are trained and qualified to perform cleaning and sanitation operations. They follow procedures and work instructions, based on standards.

They usually also have frequent training about the importance of sanitation or sterilization and the possible consequences if badly done. Working in food, healthcare or pharma is embracing the sacred mission to bring something good, to cure or relieve customers and/or patients and do everything to prevent hurting them in any way.

They are also reminded what consequences for the organization in case of problem beyond failing to: losing the customers’/patients trust, losing the licence to produce, being sued, being exposed to scandals…scary enough for shopfloor people to take things seriously.

Yet the people on shopfloor seldom have the scientific background to fully understand what is required for good sanitation or sterilization, when doing more is useless or even counterproductive. They also are often left on their own, without expert supervisors to reassure them, answer possible question or take decisions in case of doubt.

Furthermore, the results of sanitation/sterilization is most often only known after a sample of rinsing water or the swabbing of the tool/equipment has been analyzed by some remote lab.

Fearing to harm the organization, or worse the customers / patients or possibly to have to go over the whole lengthy sanitation process again if it is not satisfactory, the sanitation is performed longer than procedures require it. This is base on the belief the more the better.

This seemingly logical and well-intentioned assumption is never challenged, leading to waste detergents, acids, water… and time, simply because over-sanitation is not noticed by management.

Changeovers are even longer

Changeovers in such environments can be long and painstaking due to regulatory constraints and all the paperwork associated. Ignoring the over-sanitation habits can extend the changeover duration even more.

Besides adding costs for no additional value, the additional time spent on sanitation may be needed on critical equipment (bottlenecks) and the time lost will not only never be recovered but the true cost is to be counted in minutes of turnover. And this one can be skyrocketing!

Conclusion

When looking for additional productive capacity or a way to get more out of the current process, check the changeovers’ content and take a closer look on sanitation.

Give the shopfloor personnel clear indication when enough is enough, without risk to harm anybody nor to endanger quality. If necessary, have a real qualified subject matter expert attending these critical phases, ready to support the team and answer any question.

Not only will it take some concerns off the team, but may be a great payback in terms of additional yield.


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The man-machine system performance

When looking for performance improvement of a man-machine system, too often management puts emphasis onto machine or technology at large, ignoring the fact that humans associated with equipment, machines or technology form an interrelated system and consequently humans are the discriminating factor.

The fallacy of trusting the latest technology

There is a strong belief, backed up by vendor’s marketing, that the latest state-of-the-art high-tech equipment will bring a breakthrough in performance. This is welcome news for executives struggling to keep their organization up with competition and seeking a significant performance uplift.

Production managers, industrial engineers or system designers are big kids loving high-tech expensive toys, geeks of their own kind and dreaming to get the latest, biggest, fastest piece of equipment.

Once investment made, performance does not skyrocket though.

What happened?

Management blindness

Management ignored the human factor, i.e. people put in front or in charge of the new machine, the latest technology. An operator and his machine for instance are a system.

The overall performance of this system is determined by the human-machine pair, and guess what, the most variable and hardest to control is the human factor.

Unlike machines, humans have their moods, their worries, variable health and morale, private concerns and motivation issues. One day fine, the other day down.

Humans are not equal in competencies and skills. Some learn fast, some learn slow and some never really get it.

So what’s the point giving the latest top-notch technology to someone not competent or not motivated?

Yet this is most often what happens. Management assumes that the best of machines will make the difference, totally ignoring the influence of the people in charge.

The irresistible appeal of technology

Most decision makers and managers have some kind of hard-science background, got their degrees in engineering or business management. They were taught the robustness of math, the beauty of straightforward logic and to trust only facts and data.

When puzzled facing in real-life the highly variable and elusive nature of humans, they have a natural tendency to prefer hardware. This is something that can be put into equations and eventually controlled. This is what they are most familiar with or at least the most at ease with.

Humans are only trouble. No equation helps to understand their intrinsic drivers nor to reduce their variabilities. This is all about soft skills and psychological factors. Nothing for engineers and hard science-minded people.

Instead, they put a strong hope that the best and latest technology will trump the human factor, reduce it to a neglectable pain. But this never happens.

So again: what’s the point giving the latest top-notch technology to someone not competent or not motivated?

Leveraging performance

In order to improve a man-machine system, it is key to first have a look on the human factor, the most important one. Make sure competency is granted. If someone lacks the necessary competencies, performance is nothing than a matter of luck.

Beware of incompetent but highly motivated people though. In their desire to do well, they may have unknowingly potentially dangerous behaviours and/or take bad decisions. These motivated ones are likely to learn, do thing right but need training and guidance.

Not motivated incompetents are not likely to take any initiatives. They are the manager’s pain and burden and giving them better, faster machines won’t help. What’s worse with not motivated incompetents is passive aggressive behaviors that can lead to potentially dangerous situations as well.

Competent but not motivated people need and probably deserve management’s attention in order to get them into the winning quadrant of the competency-motivation matrix, aka skill-will matrix (top right).

There are the competent and motivated people who do their job effectively, often efficiently and without bothering anybody.

Competent Find a driver or a whip No worries
Incompetent Long way to go… Potentially dangerous good will
Not motivated Motivated

Competency-motivation matrix from a supervisor perspective

It is with these competent and motivated people that the limits of machines or technology can be found, as they will use them properly and purposely. Even when these performance limits are reached, it’s not certain that better planning and/or better organization cannot get more performance out of the system.

Think about quick changeovers and all capacity that can be regained applying SMED methodology, or rethinking maintenance in Total Productive Maintenance (TPM) style.

Wrapping up

When facing the challenge for improving performance, considering the way operations are done should be the first step. The second is to remember than investing in people is usually cheaper and more effective than investing in technology in first place, because a well utilized outdated machine will have better yield and be way cheaper than a poorly utilized state-of-the-art new one.

“Unfortunately” for tech-lovers who would prefer new “toys”, this investment in humans has to be a substantial part of their manager’s daily routine.


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Why SMED is quick win in pharma – Episode III

Improving changeovers in pharma industry is a relatively quick and easy way to… quick wins, faster and easier than usually assumed. This series tells you why.

Episode III: How to and Why it works

In the previous Episode I explained the background of the lag of many traditional pharma makers in regards to Industry Best Practices (mainly Lean) and operational performance. I highlighted faster changeovers as leverage for recovering wasted capacity and improve performances. In Episode II I gave examples of  gains that can be expected and why.
In this Episode, I explain how and why it works.

The first approach is the least “risky” one, which will not change anything, thus not jeopardizing compliance to procedures nor quality. It is based on the fact that changeovers take frequently more time than initially allocated and the assumption that the changeover procedure is sound and the time allocation is reasonable, i.e. changeover doable during the allocated time.

Reminder: pharma is regulation-constrained

As I explained in Episode II, in pharma industry all steps of a changeover are prescribed in procedures and traced. Lots of information and proofs are captured, paperwork filled because a great deal of these procedures are mandatory in order to comply with Good Manufacturing Practices (GMP) and/or local regulation.

This means there is a solid reference base available against which to compare actual way of changing over as well as a reference time allocation (standard time).

In other, lesser regulation-constrained industries, such detailed procedures and capture of data might simply not exist or will be much “lighter”.

The procedure fallacy

Industrial engineering, quality assurance and management assume that when procedures are written and approved, they are the tables of the law that personnel will follow thoroughly.

This is not always the case. People on shopfloor are pretty much on their own as management is more likely sitting behind a screen, on a desk in a remote location. So there is room for doing things slightly differently than the procedure prescribes. Often it is about swapping some tasks’ order because it is more convenient or the people’s preference.

Procedures are written for the standard (perfect world) case and won’t help if something unexpected happens, e.g. some material is not available or late. As unexpected events, big or small are likely to happen, people in charge of changeover will have to adapt or wait for instructions.

Doing things in a different order and/or in a different way will impact the changeover duration. It might speed up or delay it. The problem is that people on shopfloor may not have sufficient knowledge/insight about the possible overall impact, like negative side effects, of their even so small changes.

Chances are that procedures will be followed globally but variations will be found in the details of execution. That’s one of the reasons for the differences between allocated time and actual changeover duration.

And chances are that actual duration exceeds the usually generous allocated time, reducing the productive capacity, overall effectiveness and efficiency.

The easy way to reduce changeover duration

Let’s be clear: the easiest way to reduce changeover duration in pharma industry will probably not be the most rewarding one in terms of production capacity recovery, but… it’s the easiest one.

It is easy because it is only about sticking to already agreed procedure and standard time, thus no risk assessment nor quality assurance validation required.

This approach is based on following assumptions:

  • Changeover procedure is sound
  • Allocated changeover time(Standard Time)  is reasonable, i.e. changeover can be done within allocated time
  • Excessive duration changeovers outnumber the shorter ones, hence there is a net capacity loss when summed up

Step 1: Gather data about changeover duration. If there was no data capture or what was in place does not serve your purpose, create a form and capture what data is necessary

Step 2: Start analyzing. Look for trends, correlations and if possible causation

Step 3: Display a graph with changeover durations compared to standard time. Update it real time. The simple display of the graph and the information to shopfloor teams that changeovers durations will be monitored is enough to improve the situation, because now there is some management’s attention on it.

Step 4: Go see, ask why and show respect (this is a Lean management mantra). In other words, go and spend some time observing reality on the shopfloor (gemba). Do not hesitate to ask why this or that to people, they are the Subject Matter Experts. While asking, do not lecture but listen truly, without judgement and without disturbing operations. Try to find the root causes of good AND poor performance.

Step 5: suggest or make the necessary changes (without compromising GMP/safety/quality rules) in order to reduce the duration. Chances are the improvement will require someone with the necessary authority and know-how to coordinate the whole changeover, from new material delivery to leftovers sending back to storage place, including paperwork and human resources allocation to roles. Stress the necessity not to exceed allocated time.

Step 6: when necessary, run problem solving kaizen events. Always have at least one operational personnel involved.

Step 7: Keep capturing data, analysing it and understand the causes of longer AND shorter changeovers. Changeovers that will take exactly the allocated time are highly suspect, but will be dealt later. Watch for trend: after a short while, changeovers should seldom exceed the Standard Time, although some accidents may happen.

Step 8: iterate to step 4.

Results

The last time I used this soft approach (2015), we could recover the equivalent of one week of productive capacity within a period of 3 months, roughly 8% and about 170,000 additional units made available for sales. This was done at zero additional costs as all we needed was better organization, committed and refocused people and more management’s attention.

Of course this improvement was sustainable.

The changeovers done way under Standard Time were the proof of the excessive allocation and/or potential better way to proceed. With the relevant data, it was easy to convince management to have the procedure and Standard Time updated, giving the opportunity to improve further using SMED methodology.


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Why SMED is quick win in pharma – Episode I

Improving changeovers in pharma industry is a relatively quick and easy way to quick wins, faster and easier than usually assumed. This series tells you why.

Episode I: The Background

There are roughly two cases to consider when addressing operational performance in pharma industry :

  1. the traditional (big) ones
  2. the tollers and generic makers.

Traditional pharma makers used* to be protected by their patents, granting them several years (about 20) of monopoly in order to payoff the huge initial investments in R&D.

*Many blockbusters drugs have lost patent protection, allowing generic makers to produce and sell them much cheaper. The dramatic drop in revenue for the original makers brought up the term “patent cliff”, a metaphor for the sudden fall of incomes. For manufacturers without other blockbusters to compensate, it is a sudden exposure to leaner and meaner competitors.

Tollers (or subcontractors) and generic makers are not investing in hazardous R&D and will not have patent protection in return. They manufacture for others or “copy” drugs after they fell into public domain and sell at much lower price.

On the operational side, during the blockbusters years – when huge incomes were secured – the (big) pharmas did not care much about capacity exploitation and efficiency. When more capacity was required, new equipment, lines or even whole factories were bought/built.

The payoff was such that it was faster to setup a new facility and run it at relatively low productivity level than to try to improve already installed capacities.

Falling off the cliff

The consequences years after, once most of the blockbusters fell off the patent cliff into public domain and related revenues plummeted, are:

  • huge overcapacities, often whole plants,
  • low productivity* compared to other industries,
  • lower maturity regarding industrial best practices (e.g. Lean Manufacturing, Lean Management),
  • no real sense of urgency** to improve in operations,
  • lack of agility,
  • a “sudden” and unprepared facing of leaner and meaner competitors, meaning ordinary competition,

*OEE (Overall Equipment Effectiveness), is often in the range 15-35% when in other industries it is rather in the 50-65% range.

**this lax posture of well paid pharma workers, even when “the platform is finally burning”, make them the “spoiled children” from the perspective of others, struggling in harsher competition with lesser compensation.

Tollers and generic makers must be lean and efficient at once because of their business model. They don’t have secured incomes nor a patent shielded-off competition. They compete with makers in low wage countries, with lower sales prices, hence lower profit per unit.

They nevertheless have to invest and carry costs related to regulatory compliance.

Given the circumstances these makers understood much sooner the importance to close the gap with Best Practices in more mature industries. This does not mean that generic makers are all best in class, but they had powerful and early drivers to push them up the performance ladder.

Now that the scene is set, what is the link to quick changeovers?

For traditional pharma experiencing normal competition, investments are no more that easy they once were. Given the many remaining overcapacities, when delivery is poor, the solution is no more installing additional capacity but make better use of the one installed.

When looking closer how the installed capacity is wasted, changeover duration most often pops up as a major cause. And as changeovers tend to multiply with the shortening of runs and smaller, more frequent batches, they become good candidates for capacity / performance improvement.


In the next Episode, we’ll see how much can be gained and why.


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SMED explained while doing laundry – Part one

SMED is a systematic approach to quick changeovers in order to minimize machine downtime.

>Lisez-moi en français

To explain what SMED is good for to non-specialists discovering it, I use the laundry example.

Let’s imagine the mundane washing machine is a very precious resource and it should wash (add value) as much as possible in 24 hours a day.

The machine stops at the end of a washing cycle and there’s no choice but swapping washed laundry with a new batch to-be-washed laundry. This exchange is equivalent to production changeover. In order to minimize the washing machine stoppage, the laundry swap has to be as swift as possible.

But before designing a laundry cannon to shoot the clothes high velocity into machine’s drum, let us observe how a laundry swap is done (go see).

The usual changeover cycle

When the machine stops at the end of a cycle, the “operator” has to notice it and be ready for action. If the machine does not signal itself and/or the operator is not waiting for this moment, the reaction time until noticing and acting is wasted.

The first thing to do is to remove the washed laundry from the drum. This clean laundry should be protected against stains and put in a clean empty basket for example.

Ah! Empty basket? Where is the empty basket? The time searching for the empty basket with arms full of clean laundry is lost for washing as the machine sits idle waiting to be fed another batch.

When the clean laundry is eventually dropped into a clean empty basket, and assuming the “operator” does not waste additional washing machine time to further take care of clean laundry, he’ll has to come back to the machine to load it with the next batch of laundry to be washed.

At this point boys have to understand to their amazement that delicate, white, dark and light laundry have to be sorted and washed separately, except for those who like their white shirt turn light pink thanks their daughter/sister/wife’s blouse. Girls usually know this.

If the to-be-washed laundry was not sorted beforehand, the time to sort it lets the machine idle and wasting more time.

Finally, one part of the sorted laundry is thrown into the drum, a gesture that could have be done in a softer manner, as the violent acceleration of clothes does not compensate much of the time lost until that point.

The changeover is not finished as long as the machine is not restarted. And before restarting, it should be refilled with detergent.

Detergent? Where’s the detergent?

While searching for detergent, the machine… sits idle.

When detergent is filled and machine started, the changeover is done.


———–
This imaginary scenario is not that uncommon in households nor is the equivalent not uncommon in factories.

Instead of washing machine we’ll find machine tools or any production or test equipment. Instead of laundry it’s raw material or parts and instead of detergent, operators may look for tools, templates, jigs, plans or whatever should be handy and is not.

In the next post of this series, we’ll see how the washing machine downtime can be drastically reduced!


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