Advice You - Business

The present debate in brief is that Taiichi Ohno bought quick exchange tooling from the USA for Toyota in the 1950’s, whereas Shingo claims to have introduced them to SMED in 1969, when most Toyota presses were already being changed in less than ten minutes, so SMED is not

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

responsible for Toyota’s changeover performance. It is also a fact that Shingo taught industrial engineering at Toyota from 1955 onwards – this was an extension of the original Training Within Industry IE programme, given to Toyota, amongst other Japanese companies, by the

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

USA.

So what was Shingo’s contribution, and why is the SMED Process important?

Shingo was a great theoretician as well as a great engineer, Taiichi Ohno was a great practitioner and a hard task master. Taiichi Ohno was only interested in practice and he was a great experi

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

enter – if you read his writings you will see that some of his experiments in the 1950’s were failures, but he regarded failures as ‘mountains of treasure’ – learning to be had. The important thing was to try, not to discuss theory or say it can’t be done.

Shingo was a har

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

d task master like Ohno, but also a great theoretician – he needed to develop an overall theory of why something worked. Shingo had two major theories which defined how he approached problems. The first was his ideas about process and operation. Basically he said that impro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ving the flow through a whole process was much more important and value creating than improving individual operations. Where less skilled engineers would get involved in issues of how to improve a particular operation, Shingo thought this was meaningless unless the operatio

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

was a constraint on flow through the process. Unless the process as a whole could not meet its QCD targets, and a particular operation was the immediate constraint, improving an operation would not give returns to the bottom line. This theory was so important to Shingo tha

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

t it appears as the first chapter in many of his books, including his book on SMED.

I learnt his second major theory, which receives less attention, from one of Shingo’s students, JMA consultant Shigehiro Nakamura. This is the leveling up process, an approach to improveme

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nt. Under this theory, if you want to improve a process you first need good information on current performance and performance requirements, you then need the right people and then a good standard method. Only when you have reached the limits of these three, do you then loo

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

to improve through more traditional engineering methods – looking at measurements - the IE and QC data, machines – equipment modifications and materials, including product design.

Toyota’s approach to quick changeover was the traditional engineering methodology of ECRS –

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

Eliminate, Combine, Re-Arrange, Simplify. So Toyota were breaking down changeovers into their elements and then applying ECRS to each element. The quick release dies which Mr Ohno bought form the USA were a means of simplifying the attaching and removal of dies. Mr Ohno was

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

also wedded to idea of standard methods, and everything in Toyota changeovers was standardised, so that changeover times were consistent.

Shingo takes this further, and his theory allows the process to be applied to any changeover, not just dies. The theory developed over

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nearly twenty years by Shingo’s own account, and the 1969 invention of SMED was the culmination of this. Like all theories, SMED works by first defining categories.

In SMED the first important distinction is between Internal and External changeover. Internal Changeovers ar

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

e those elements which have to be performed while production is stopped, the rest is external. This crucial distinction focuses improvement effort on performing only internal elements while production is stopped, and then simplifying those.

The second distinction is betwee

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

n types of activities in changeover. Shingo defined these as Preparation, Exchanging Parts, Adjustment and Trial Processing. In general, exchanging parts only takes 5% of the time of the changeover, so buying quick release dies can only improve that 5%, the rest is procedur

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

l.

The first step in SMED’s three step process is to identify and separate internal and external activities. In practice this means eliminating all preparation activities from the time when production is stopped. The second step is to shift activities from internal to exte

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

rnal, thus eliminating them from the machine downtime. In practice this means focusing on externalizing adjustments and the cleaning of parts. The third step is to streamline the remaining internal elements. In practice this can mean improving fasteners and reducing any rem

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

aining internal adjustment.

SMED is a step by step process which follows the DMAIC, Define, Measure, Analyse, Improve, Control cycle. It provides categories for the analysis phase and a procedure for the improvement phase. Control is provided by the development of a standa

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

d procedure. SMED projects rarely result in less than a 50% reduction in changeover time, and often as much as 80-90%.

When I first met Shingo (I was 33, he was 80) he asked me if I had been using his SMED process. I replied that working in a machine shop we had reduced ch

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

angeovers from 90 minutes to 15 minutes. He gave me a steely look and said through his interpreter that when he was at school 15 was a two digit number; SMED meant single digit numbers – 9 minutes or less. He ended his diatribe in English with the words “You must do better”

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/20236/adviceyou-The-Power-of-SMED.html">The Power of SMED</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/20236/adviceyou-The-Power-of-SMED.html]The Power of SMED[/url]

If you're a medical billing company just starting out, you're going to need to hire programmers. What follows is a guide to what you should look for in a programmer.

Making a full time living working from home can be broken down into three simple steps. Here they are.

Tags

Links

Advice You - The Power of SMED

Related Articles: