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But they verify that the product meets the specified requirements.
I've been arguing that the list of required statements should be part of the Marketing Requirements Document, which would trickle down through the engineering response document (the Statement of Work), and eventually be on the checklist for QA.
And if the Product Line Manager (who writes the MRD) doesn't know which statements are needed, then s/he should get that info from the bod in charge of regulatory and compliance stuff.
One problem is that "compliance" is a big umbrella. We have people whose full-time jobs are to process compliance paperwork for export permits. Others deal with industry-specific evaluations (against NIST standards for example), but those do not require customer-document statements and disclaimers. The hardware guys know which labs they've sent samples for electrical and RF compliance testing, and which other labs for environmental testing (shock, vibration, temperature, etc.). Common-Criteria evaluators wander through here for a week every other year, for yet another kind of compliance. I haven't seen ISO auditors, but I'm sure it won't be long.
But off-hand, I'm not aware of a God of Regulatory Compliance that knows all.
Did you know that some folks think you must have a Lithium Battery warning on your product and in your docs if the product contains a Lithium-ion battery? But other folks think that's necessary ONLY if the Lithium battery is replaceable or at least accessible.
From: M -dot- Vina-Baltsas -at- mindray -dot- com [mailto:M -dot- Vina-Baltsas -at- mindray -dot- com]
Sent: Tuesday, June 21, 2011 1:53 PM
To: McLauchlan, Kevin
Cc: techwr-l -at- lists -dot- techwr-l -dot- com; techwr-l-bounces+m -dot- vina-baltsas=mindray -dot- com -at- lists -dot- techwr-l -dot- com
Subject: Re: WARNING! Danger, Will Robinson! Danger!
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>
Sent by: techwr-l-bounces+m -dot- vina-baltsas=mindray -dot- com -at- lists -dot- techwr-l -dot- com
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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