Why SMED is quick win in pharma – Episode II

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 II: What Gain? Why?

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 this Episode, I explain what gain can be expected and why.

A changeover – as the name tells – is changing over from one finishing series or production batch to the next one. This can mean completely resetting a production line, changing formats or “simply” change the batch and product-related information and paperwork.

Changeover in pharma is more thorough than in lesser regulated activities as most often the lines must be totally cleared from anything related to the finished batch, sometimes cleansed, inspected, approved, reset and restarted.

All steps are traced, lots of information and proofs are captured, paperwork filled. A great deal of these procedures are mandatory in order to comply with Good Manufacturing Practices (GMP) and/or local regulation.

Many (additional or redundant) steps and procedures are the maker’s choice, often as a countermeasure of former problems or deviations. They can also be a consequence of regulation misinterpretation or fear not to be compliant. I will not discuss challenging these self-imposed constraints in this post, but please note these self-inflicted constraints are improvement potentials per se.

The changeover procedure is therefore a relatively lengthy one, closely monitored (mostly afterwards and through paperwork though) by Quality Assurance (QA).

As the big fear is to leave something from previous batch contaminating the new one (it can be a physical part, an information leaflet, etc. in case of packaging) the changeover durations are generously allocated, based on the assumption the more time to perform the changeover, the fewer the risks.

I emphasize; allocated time is much more than strictly necessary to changeover and remaining compliant to procedures and requirements.

On top of that, nobody in management would dare stressing the operators to speed up a changeover in fear of making them forget something or ending up with a quality deviation.

The later leads shop floor operators to extend the changeover duration beyond already generous time allocation, wasting even more productive capacity.

The reasons for the drift may vary:

  • On the positive side, the constant fear to do something wrong or forget something.
  • On the negative side I noticed frequent lack of discipline: operators do not stick to procedures and management is not following-up and monitoring closely enough.

Over time the extended duration tends to be accepted as the new standard, planners including the actual changeover time in their schedule. Nobody questions, nobody challenges.

This is Parkinson’s law: a task will always take all allocated time. Extend the allocation and the task will never again finish before the new allocated time.

Wrapping-up

During changeover production is stopped, which means changeover is non-productive and reduces the production capacity. Changeovers tend to be more frequent as batch sizes shrink, so the challenge is to change over quick in order to minimize the production stop.

Changeover duration often exceed what is really necessary to perform a changeover in good conditions, without taking chances with safety nor quality nor GMP/regulatory compliance.

The main reasons for this are:

  • Generous time allocation
  • Lack of rigor / discipline
  • Immaturity regarding industrial best practices (Lean, SMED…)

Reducing changeovers durations is a way to recover recover wasted capacity and improve productivity by earning more output with the same resources.

Changeovers waste capacity

How Much?

I just explained why a significant part of wasted capacity can be recovered, but how much is this?

Detailed data are not always available to estimate the recovery potential, therefore a rule-of-thumb can come in handy.

Experience told me the “Lean rule-of-thirds”, which means about 30% (at least) of wastes can be turned into savings. This is relatively scale-invariant but of course much easier to achieve at the beginning of a continuous improvement journey than later, in a more mature state.

Thus, a changeover duration of 2 hours or 120mn could be reduced fairly easily to 80mn or 1hr20, especially if the drift from initial standard time happened.

Example in primary or secondary pharma packaging

Based on the same example as above, with a production rate of 60 units a minute (not very high-speed), forty minute capacity recovered means 40mn x 60 units = 2,400 additional units.

Changeovers may occur several times in a shift or at least in a 24 hour timeframe, multiplying the gain.

Now with highly automated, high-speed equipment, these additional gains may be far higher. Think about how fast tablets are packed into blisters or vials filled with liquid.

Big money

Even after patents have fallen into public domain, some original molecules still sell well, especially when customers are somewhat reluctant to use generics. Therefore if each additional unit yields a net profit of one monetary unit ($, €, £, etc.), which is not uncommon for ex-blockbusters, the additional profit is worth the improvement effort and the Return On Investment fairly quick.


Next Episode: How to and Why it works?

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