RE: WARNING! Danger, Will Robinson! Danger!

Subject: RE: WARNING! Danger, Will Robinson! Danger!
From: "McLauchlan, Kevin" <Kevin -dot- McLauchlan -at- safenet-inc -dot- com>
To: "techwr-l -at- lists -dot- techwr-l -dot- com" <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Tue, 21 Jun 2011 16:49:09 -0400

As it happens, our hardware engineers deal with compliance
for their part of the product. They specify what the product
should look like, including the content and placement of any
labels. QA then verifies if the product meets that specification.

But they don't usually have anything to say about content of
customer documents - that happens long after the hardware
guys (as few women as I've seen in software dev, I've never
seen a single one doing hardware....) have done their thing.

So I think it only fair that the PLM folks who specify the look-and-feel
and the functional operation of the product (its features)
should also specify which agency warnings and statements we
need, and where. They might get that from lawyers, from
hardware engineers, from a dedicated compliance manager
or engineer, or some other source, but they should be telling
me what I need to include in my docs, not issuing some vague
generalization and relying on me to guess correctly what fulfills
that general requirement. Or, the PLM folks should make
their generalization and the engineering response should flesh
out what will fulfill that requirement in detail.

Yes, I want that part handed to me. It can have important
legal implications, and I prefer not to hold that particular
bag. So I'm inquiring what normal practice is at other companies...
the companies for which many of you work.

We don't do medical or aeronautical equipment.
We do do the equipment that protects/encrypts financial
transactions between/among institutions to the tune of
hundreds of billions of dollars daily. Injuries are pretty much unheard of.


From: Tony Chung [mailto:tonyc -at- tonychung -dot- ca]
Sent: Tuesday, June 21, 2011 3:46 PM
To: McLauchlan, Kevin
Cc: techwr-l -at- lists -dot- techwr-l -dot- com
Subject: Re: WARNING! Danger, Will Robinson! Danger!


On Tue, Jun 21, 2011 at 11:33 AM, McLauchlan, Kevin <Kevin -dot- McLauchlan -at- safenet-inc -dot- com<mailto:Kevin -dot- McLauchlan -at- safenet-inc -dot- com>> wrote:
We definitely have a QA department. Hoo boy.

QA does not mean compliance. There should be a complete regulatory body who specializes in that sort of stuff. In smaller companies, the devs have taken that role, or a director of some kind. Only in the Complete Idiot companies do the leadership shirk their responsibility to comply with the standards of their industry, and the leadership allow that farce.

-Tony


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Follow-Ups:

References:
WARNING! Danger, Will Robinson! Danger!: From: McLauchlan, Kevin
Re: WARNING! Danger, Will Robinson! Danger!: From: M . Vina-Baltsas
RE: WARNING! Danger, Will Robinson! Danger!: From: McLauchlan, Kevin
Re: WARNING! Danger, Will Robinson! Danger!: From: Tony Chung

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