RECMGMT-L Archives

Records Management

RECMGMT-L@LISTSERV.IGGURU.US

Options: Use Forum View

Use Monospaced Font
Show Text Part by Default
Condense Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Content-Type:
text/plain; charset=utf-8
Sender:
Records Management Program <[log in to unmask]>
Subject:
From:
"David T. Macknet" <[log in to unmask]>
Date:
Tue, 4 Dec 2012 09:54:45 -0800
Content-Transfer-Encoding:
quoted-printable
MIME-Version:
1.0
Reply-To:
Parts/Attachments:
text/plain (94 lines)
 In response to Julie,

 "But what if the organization itself isn't the master, and is only
establishing bureaucracy to respond to an external master? I'm interested
to hear more thoughts on this."

 I'm certain that we've all run across cases wherein bureaucracy has gone
insane, but I'd like to throw out an example which is particularly
dismaying.  I studied a biotech company a few years back which had seen
its administrative costs skyrocket over the years.  These administrative
costs increased mostly within the Quality Assurance departments (yes -
there were more than one), in response to FDA regulators becoming
increasingly demanding with regards to documentation production.  This
demand for documentation was fueled by certain members of the organization
who refused to provide electronic databases of information, preferring to
meet the "letter of the law" by providing paper documentation.  Each
exercise resulted in masses of paper document production, followed by an
increased frustration on the part of the FDA and subsequent additional
demands for documentation.  This feedback loop, wherein an external
regulatory body had valid requirements and was met by resistance, resulted
in a huge bloat within the bureaucracy.  It also resulted in a paranoia
within that bureaucracy, to the point that NO electronic information was
allowed into our out of that bureaucracy with regards to certain process
areas.

 This type of relationship could have been avoided, had the true goal of
regulation been recognized, and all parties worked to establish that
manufacturing was taking place in accordance with appropriate controls
within the manufacturing environment.  There would have been very little
need for bureaucracy, and certainly no need for the veritable army of
"quality assurance" personnel.

 I contrast this bureaucratic nightmare with another biotech, which
maintains a good relationship with the FDA regulatory body: they have a
handful of people in the quality assurance department, all of whom work
towards the goal of the organization, which is to manufacture within
adequate controls.  There are records, surely, and there are controls
(bureaucracy) ... however, it is this non-adversarial relationship which
leads to a decrease in paranoia and a more reasonable approach to the
production of records.  The focus isn't so much upon "what the FDA wants"
as it is upon whether the product manufactured can be made safely and can
be traced back to original ingredients (in case some of those ingredients
prove to have been defective).  The processes (bureaucratic, certainly)
are integrated into the culture and generate records which are viewed more
as a by-product than as a goal in and of themselves.

 The first bureaucracy (adversarial, paranoid, and pernicious) and the
second (present, but unobtrusive) are both direct results of having an
"external master."  The results, however, demonstrate that the mere
presence of that external master is insufficient to lead to a particular
type of bureaucracy: it is necessary that the culture subjected to the
regulation respond by the establishment of a bureaucratic process, and that
process is a result of the perception with regards to the enforcement of
control upon the culture.

 "Do our information-based economy and technological realities present an
opportunity to effect external regulation?"

 Certainly, with additional information systems, there are more
opportunities to make use of the information produced and gathered and,
thus, more opportunities for regulation.  This isn't what you were asking,
though, I don't think.  In what sense did you intend the question?

 Best,

 -David

-------------------------

 Dr. David T. Macknet 
 MCP, MCSD, BA, MSc, MLitt, PhD

 email: [log in to unmask] [1] 
 Skype: david.t.macknet [2] 
 Flickr: http://www.flickr.com/photos/wishiwerebaking/ [3] 
 Blog: http://davimack.members.sonic.net/blog/ [4] 
 LinkedIn: http://www.linkedin.com/in/davidmacknet [5] 
 Stack Overflow: http://stackoverflow.com/users/6850/david-t-macknet [6]
 

Links:
------
[1] mailto:[log in to unmask]
[2] http://webmail.sonic.net/callto://david.t.macknet
[3] http://www.flickr.com/photos/wishiwerebaking/
[4] http://davimack.members.sonic.net/blog/
[5] http://www.linkedin.com/in/davidmacknet
[6] http://stackoverflow.com/users/6850/david-t-macknet

List archives at http://lists.ufl.edu/archives/recmgmt-l.html
Contact [log in to unmask] for assistance
To unsubscribe from this list, click the below link. If not already present, place UNSUBSCRIBE RECMGMT-L or UNSUB RECMGMT-L in the body of the message.
mailto:[log in to unmask]

ATOM RSS1 RSS2