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.


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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