RE: Seeking Document Definitions Input

Subject: RE: Seeking Document Definitions Input
From: "Hemstreet, Deborah" <DHemstreet -at- kaydon -dot- com>
To: "Annetta Dunn" <annettadunn -at- gmail -dot- com>, <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Wed, 20 Aug 2008 10:12:36 -0400

Hi Annetta,

I have just finished standardizing these definitions for the company
where I am working. It is pretty easy if you have a specific standard
that you are relating to. For example, the ISO 9001:2001 standards make
it pretty clear....

An excellent resource for this type of information (invaluable to me)
have been the Elsmar Quality Forums.

With regard to your definitions, this how I've seen them used pretty
consistently when dealing with a quality system (which is my guess of
your usage, since these terms all fall into documentation
classifications for medical and manufacturing quality systems):

- procedures: These provide instructions on how to do something.
Depending on how your documentation is divided, it can be high level how
to, or the nitty gritty step-by-step. But by nature, a procedure is just
that. It does not set policy, it may or may not give the why's, and
certainly does not set out the standards. The main purpose of procedures
is HOW, and supports your standards and policies. If you have two groups
of procedures, the top level usually defines what must be done and HOW
(inflexible), and then the full details are given in a lower level work
instruction that supports the procedure. When a company is audited,
failure to follow the procedure could result in corrective actions to
make sure that everyone is following the procedure properly, for
reproducable results.

- guidelines: Guidelines (we had these at a medical device company where
I worked) support procedures - but serve as a GUIDE for how to do
things. We recommend you do it this way. You can do it differently, but
the results need to be the same. When a company is audited - if you do
not comply with a guideline, you won't get in trouble as long as your
results are in line with your standards, policies, and procedures.

- guidance: Now this is terminology usually handled by the Medical
Device and related industries... There are "Guidance" documents issued
by FDA for example, but contrary to your dictionary, you had better
follow what is written in them if you want your FDA approval

- clarifications: I've not seen this term in any of my quality or
medical writing... Per se... And would lean towards the dictionary

- standards: These are the applicable standards for a certain industry,
for example, ISO, Nadcap, etc. They set the rules for what you can and
cannot do to receive their certification. CE Marking also has a set of
standards. A company can also have separate "standards" documents which
usually define the policy for implementing required standards in an
organization. At this level, the quality documentation discusses what,
who (job title only), why - but not HOW.

- tools: We don't use this term per se, though we do talk about the
"tools" used to accomplish certain tasks, such as calibration gages,
etc. Interestingly, there are applicable standards for how gages should
be calibrated. So some standards could apply to certain tools.

I hope this is helpful.

Have fun - If find this kind of research fascinating!



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