This is the April 2005 newsletter. In updating the newsletter archive, it
appears it was never sent out to the entire list. I am hoping that nobody
is getting it twice and if you are, I apologize.



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(+)+(+) S.M.I.L.E(sm)
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(+)+(+) Setup Minimization Improves Line Efficiency
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(+)+(+) The Quick Changeover e-letter
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(+)+(+) Published monthly by Changeover.com
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(+)+(+) Written by John R Henry, CPP
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### APRIL 2005
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SOME THOUGHTS ON...
PRODUCT SURETY

I recently did the lead-off presentation for day long conference on Product
Surety. I thought it might make an interesting topic for this month's
newsletter. As a general comment, coming up with ideas for the newsletter
is sometimes a lot harder than actually writing it. I welcome any ideas or
suggestions for future articles. I also welcome contributions. You write
it, I'll publish it.

"Product surety" seems to be a fairly new term. I first heard it last year
but immediately recognized it's usefulness to encompass a range of concerns
to the manufacturer. Product surety tends to be aimed at the more sensitive
and regulated industries like food and pharmaceuticals. As I hope to show,
it should also be a concern in other industries as well.

Let me begin with a definition:

Product surety includes all measures taken throughout the distribution
chain, from raw materials to final consumer to assure the integrity, safety
and proper identification of a product.

Product surety is important for a number of reasons:

National security - The product supply chain, especially food and drugs, is
a point through which a country could be attacked. In today's world, we
often don't know who are enemies are and may not even know we have them.

Consumer confidence - Consumers need to know that when they buy whatever
product, it is actually what it purports to be. If they lose confidence in
a particular brand, they will cease to buy it.

Product liability - If a consumer is harmed by a product, they are likely
to sue. It doesn't matter whether they have a good case or not, it will
cost the company money and reputation to defend against the suit. Tight
product surety is a means of both reducing the probability of actual harm
and reducing the risk of being found negligent in the event of harm.

Finally, there are legal and regulatory requirements that must be met.

Product surety covers four main areas of concern: Tamper resistance, Tamper
evidency, product diversion and counterfeiting. I will discuss each briefly:

The Product Surety Working Group Initiative defined tampering as:

"To change or add a substance to a product with the intent to cause harm
(health or financial)"

I think this is a good definition as far as it goes. The above definition
covers malicious tampering well. However there is also a problem with what
I call non-malicious tampering. That is the consumer in the store who opens
a package to get a better look at the product. In the case of foods, they
will occasionally even taste it. In other cases, packaging may
inadvertently become open through handling, either in the supply chain or
by the consumer. While these cases may not seem as serious as malicious
tampering, they are still a problem that needs to be addressed. They can be
addressed through a combination of tamper resistance and tamper evidency.

The first thing to know about tampering is that there is no such thing as a
tamper proof product. The best that can be done is a level of tamper
resistance. I have been told that a steel can is "tamper proof". As I show
in conferences, by introducing a can in which I have replaced the contents
with candy, this is not the case. (In the interests of safety, I'll not
tell you how I do it other than to say I use no special tools or equipment.
I will say that a roomful of packaging professionals did not notice a
problem with the can prior to opening.)

A steel can is at best tamper resistant. Other types of packaging that
provide good levels of tamper resistance include glass ampules, welded
clamshells, cartons of tear resistant board with glue seals and blister
packages. Multiple layers of tamper resistance generally work best. If
overdone though, they may make the product so difficult to use as to turn
the consumer away. A further problem with excessive tamper resistance
measure, in my opinion, is that they may create a dangerously false sense
of security to both the manufacturer and to the consumer.

Tamper evidency goes hand in hand with tamper resistance. Tamper evidency
does not seek to prevent tampering as much as it seeks to make visible the
fact that it has occurred. Some of the things that you may have noticed are
tearaway bands on bottle caps, inner foil seals, glue seals on cartons and
shrink bands or laels over bottle caps/necks. One client uses staples to
seal their corrugated shipping cases. The reason? Tape and glue can
sometimes be removed and replaced surreptitiously. Staples are much harder.
There are a number of other techniques out there and I will be happy to
discuss them privately with anyone interested. The key is that whatever
technique is used must leave visible evidence, usually by being destroyed
during opening. Too many times, it is possible to remove and replace a cap
without breaking the security band. Some cartons sealed with hotmelt glues
can be opened, undamaged, simply by freezing them. A further danger is that
the consumer may not realize that, say, a PVC shrink band is supposed to be
present. Some manufacturers glue tuck flap cartons but they can be opened
and reclosed. The consumer may not realize that they were originally glued.
A "Do not use if security band is not present" or similar instructions are
a must.

We, as consumers, have the right to expect a safe and quality product. We,
as manufacturers have a moral and legal obligation to provide that product.
It is not always easy. There are people who, maliciously or otherwise, will
interpose themselves in the process and cause bad product to get to market.
All we can do is to do all we can do to safeguard our supply chain.

Next month, in Part II, I will discuss the problems of counterfeiting as
well as product diversion including track and trace. If you would like a
copy of the PowerPoint slides that accompanied my presentation, drop me a
note and I'll be happy to provide them.

TIP OF THE MONTH...
COLOR CODING

Readers of this newsletter will know that I am a big believer in making
things as visual as possible. I am especially a fan of color coding of
tools, change parts, adjustments etc. Last month I was presenting my
"Achieving Lean Changeover" workshop at a plant and had one of those "Slap
me up the side of the head" moments. You know the kind. It's where someone
mentions something so important yet so simple and obvious (at least now)
that you feel stupid for never having thought of it.

For all my talk about color coding over the years, I had never thought of
people who might be color blind.
In a nutshell, I strongly recommend that you use color coding. But, when
you do, you must also be sure to use text or symbology to allow those
people who cannot distinguish colors to do their job.

Thanks go out to KK-H for bringing this to my attention.

Best,

John R Henry CPP



Best,

John R Henry CPP

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