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Subject:Re: WARNING! Danger, Will Robinson! Danger! From:M -dot- Vina-Baltsas -at- mindray -dot- com To:"McLauchlan, Kevin" <Kevin -dot- McLauchlan -at- safenet-inc -dot- com> Date:Tue, 21 Jun 2011 13:52:37 -0400
It doesn't sound like you have a Regulatory or QA department where you
are; am I right?
I write for a hardware/software company also and all our warning/cautions,
indications for use, disclaimers, misc. risk management statements are
given to me by our Regulatory and/or QA departments. We also have industry
standards (EC11, EC13, etc.) that we must comply with and those also need
to be included in the manual. Those are generally given to me by
Engineering but sometimes by RA/QA.
I need to ensure that they are all included in the manual but am not
responsible to fully understand what each standard is all about. I have a
clue, but could not comfortably tell which standard would be required for
a new document unless I cheated and used a previously released manual as a
template.
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"McLauchlan, Kevin" <Kevin -dot- McLauchlan -at- safenet-inc -dot- com>
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Subject
WARNING! Danger, Will Robinson! Danger!
How many of you are your own regulatory-compliance authority?
How do you KNOW that you have enough of the right kinds of statements,
warnings, and disclaimers in your documents for hardware products?
Somebody just asked me for a sheet of all the warnings and disclaimers
that I provide for a particular product of ours, that is being proposed
for a big sale or partnership arrangement in some country somewhere. The
person requesting the info very obligingly provided a Cisco document as an
example of what was wanted. The Cisco document (for whatever product of
theirs) had page after page of NUMBERED statements (each translated into
about a dozen languages). The numbers went into the high hundreds, but the
majority were skipped. That is, somebody knew that they needed just twenty
three statements (starting at 17B and ending at 1079) for that product.
I don't have that.
I have an FCC statement, an equivalent CSA statement (also in French...),
the CE logo and some little blurb, and that was about it.
No problems ever from anyone making noises about "We will punish you for
not having this-or-that statement" nor about "We'd love to buy from you
but we can't if you don't have this-or-that statement".
I only accidentally learned that it's a good idea to have a dual power
supply warning on a product that has redundant power. I saw another
company's doc for some product of theirs and thought "Jeez! That makes all
kinds of sense!" So, I included a dual power supply warning (unplugging
one power supply does not necessarily remove risk of shock; this puppy
could still be hot) in the document refresh, about six months after our
product was released. Nobody complained that it was missing from our
original release. Not our QA or secret shopper. Not any customer
(including government departments).
I can certainly sniff around the Weeb and find all sorts of statements
that _could_ be included.
But it would not be long before we were killing six trees for every unit
we shipped, just to print the warnings.
A previous, related thread had some people implying that every techwriter
should be on top of all this stuff and be ready to go to jail or reimburse
the company for any lawsuits if they miss something, while others thought
that such responsibility should rightfully lie with the company's legal
department, or at least a compliance manager/engineer who would merely
provide a list to the techwriter.
Our own legal beagles have not gotten back to me yet.
If your employer sells hardware, how warm and fuzzy do you feel about the
amount of litigation teflon you have applied in your docs? Why? What
justifies that feeling, for you?
- kevin
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