View Full Version : How to approach "Documents shall remain legible and readily identifiable" - 4.2.3 e)?
womble 31st May 2006, 08:06 PM I think I am probably missing something that is right in front of my eyes (& have searched the forum), but I am struggling to address the Control of Documents "to ensure documents remain legible and readily identifiable" [ISO 9001:2000 4.2.3 e)] clause. We are a small job shop chasing certification (full electonic control is not plausible).
How have others addressed this clause? i.e. what controls have been successfully implemented
Thanx
Wes Bucey 31st May 2006, 09:01 PM I think I am probably missing something that is right in front of my eyes (& have searched the forum), but I am struggling to address the Control of Documents "to ensure documents remain legible and readily identifiable" [ISO 9001:2000 4.2.3 e)] clause. We are a small job shop chasing certification (full electonic control is not plausible).
How have others addressed this clause? i.e. what controls have been successfully implemented
ThanxIn my opinion, this clause merely means taking PHYSICAL care of documents to assure they don't get dirty, faded, torn, lost, modified without authorization, etc.
As I looked at the situation in my own shop, I decided different types of documents (paper documents) needed different kind of care than others. Thus, drawings and other documents which would be out in the shop environment were laminated in plastic which prevented damage from dirty hands, spilled beverage, and unauthorized notations modifying the document.
Documents which never left the office were left in normal file folders.
Periodically, we reviewed all active documents to assure they were the most recent version to lessen the probability of using an obsolete document to make or inspect a product.
There are lots of reasonably priced commercial systems for efficient handling and storage of documents to reduce the possibility of damage from handling or ambient conditions or loss from misfiling.
This whole topic comes under the topic heading of "document management" and it should be remembered most folks think "document control" is merely a subtopic under document management.
For the purpose of clarity, I think of document management as primarily concerned with safe storage and efficient retrieval of documents, while document control is concerned with who should or should not have access to documents and whether they may author, modify, read, copy, or print them. "Configuration Management" is a special subset of document management which is concerned with both
maintaining files up to date
AND
assuring document users and authors consider the ramifications of any modifications in relation to other documents and processes.
samer 1st June 2006, 03:42 AM freind
i agree with Wes regarding the physical care of the document but i will add
that you should also build your documentation system to deal with any damage of yr documents to keep it always legable , this will lead to pack up yr electrnic documents as example ,and having more one document in the organization for the hard copies, ie quality assurance copies
samer
Caster 1st June 2006, 11:16 PM I think I am probably missing something that is right in front of my eyes (& have searched the forum), but I am struggling to address the Control of Documents "to ensure documents remain legible and readily identifiable" [ISO 9001:2000 4.2.3 e)] clause. We are a small job shop chasing certification (full electonic control is not plausible). How have others addressed this clause? i.e. what controls have been successfully implemented Thanx
Don't forget electronic data and the systems to read it. We actually have an old 286 PC with a precursor to AutoCAD on it in case we need to be able to read some really, really old CAD drawings. We think it has an amber monitor (now that was cool) but are afraid to turn it on.
Electronic records go obsolete fast. I did my MBA on a Commodore 64 - and I've since seen one in a Technology museum! I still have the 5 1/4 floppies but they can not be read by anything I now own!
If you are in automotive GM now wants stuff kept 50 years, by which time we will be storing data on individual atoms..or hyper space.....so some thought is needed.
Could be a business opportunity....a perpetual data format upgrading service...
Wes Bucey 2nd June 2006, 02:37 AM [/size]
Don't forget electronic data and the systems to read it. We actually have an old 286 PC with a precursor to AutoCAD on it in case we need to be able to read some really, really old CAD drawings. We think it has an amber monitor (now that was cool) but are afraid to turn it on.
Electronic records go obsolete fast. I did my MBA on a Commodore 64 - and I've since seen one in a Technology museum! I still have the 5 1/4 floppies but they can not be read by anything I now own!
If you are in automotive GM now wants stuff kept 50 years, by which time we will be storing data on individual atoms..or hyper space.....so some thought is needed.
Could be a business opportunity....a perpetual data format upgrading service...I agree with you that the rapid obsolescence of technology creates a perpetual upgrade problem for many organizations ranging from libraries to manufacturing corporations.
:topic: I, too, have some old 5-1/4 floppies (unlabeled, of course) from the 80's. I used to have some 8 inch floppies - I can't even remember what computer ran them. As we cleaned out my father-in-law's home after his death, we came across punch cards! Anybody know who has a reader? I also ended up throwing out some magnetic stripe cards from an old statistical magnetic tape reading typewriter ($10,000 new!) which used interchangeable IBM typeface balls. I also have some old 8mm films, but I came across a bell & howell projector to show them and a small supply of bulbs to last for a few years anyway..
I suppose there must be commercial services to retrieve data on old-fashioned media. Certainly, if push came to shove, the plans must still exist somewhere to replicate the original equipment used to create and read such media.
It's been awhile since I saw a computer which had 3.5 inch floppy readers. My newest notebook computer doesn't have one, but a ten year old Compac laptop has both CD and 3.5 floppy readers (it also weighs about a thousand pounds!)
Nemain 2nd June 2006, 03:31 AM There are even companies specialized in retrieving data from severely damaged hardrives (e.g. after a fire) - so I am quite sure that there are also companies that transfer data from old fashioned media to modern types...
Unfortunately I can not find the webaddress anymore - but I had one of a company that actually specialized in recovering data from extremely damaged harddrives with a funny section where they showed example photos of totally crushed harddrives together with the percentage of data they successfully recovered from it & a brief description of the incident that happened...
:lol:
Wes Bucey 2nd June 2006, 03:47 AM There are even companies specialized in retrieving data from severely damaged hardrives (e.g. after a fire) - so I am quite sure that there are also companies that transfer data from old fashioned media to modern types...
Unfortunately I can not find the webaddress anymore - but I had one of a company that actually specialized in recovering data from extremely damaged harddrives with a funny section where they showed example photos of totally crushed harddrives together with the percentage of data they successfully recovered from it & a brief description of the incident that happened...
:lol:Curiosity drove me to Google with this result:
Results 1 - 100 of about 314,000 for "media (http://www.google.com/url?sa=X&oi=dict&q=http://www.answers.com/media%26r%3D67) conversion (http://www.google.com/url?sa=X&oi=dict&q=http://www.answers.com/conversion%26r%3D67)".
which certainly seems to produce the kind of operations performing conversion from old media to new media that we are discussing.
RosieA 2nd June 2006, 05:52 PM Womble, something else to consider: if you use thermal paper for anything (older fax paper technology or strip recorders, or cash register receipts) this paper fades pretty quickly. Sometimes the image disappears when you highlight the type or cover it with scotch tape. So a requirement to photo copy certain types of records on thermal paper might apply to some businesses...
2.5bostons 2nd June 2006, 08:48 PM When I reviewed this thread my first question regarding 'legible and readily identifiable' was if this referred to employees entering information into a form or log.
During a recent internal audit we were hit for illegible entries in the equipment log books. These forms list hourly trigger points entered manually.
At my previous job the procedure was no white out, no crossing or scribbling out of written entries -only one simple line drawn through, initial and date, no red pen except for out of spec entries.
At my current employer- we have white out, scribbles are ok, first shift enters information in red pen, second in green pen and third in blue pen. no initials or date for corrections.
I think this is why we get hit for illegible entries.
Is this one of the aspects that we are discussing?
Jim Wynne 3rd June 2006, 11:23 AM When I reviewed this thread my first question regarding 'legible and readily identifiable' was if this referred to employees entering information into a form or log.
During a recent internal audit we were hit for illegible entries in the equipment log books. These forms list hourly trigger points entered manually.
At my previous job the procedure was no white out, no crossing or scribbling out of written entries -only one simple line drawn through, initial and date, no red pen except for out of spec entries.
At my current employer- we have white out, scribbles are ok, first shift enters information in red pen, second in green pen and third in blue pen. no initials or date for corrections.
I think this is why we get hit for illegible entries.
Is this one of the aspects that we are discussing?
I think so; the idea of the clause is that records do no one any good if they can't be read or used, regardless of the reason. I know of a company that had a lot of old drawings on microfiche, but nothing to read them with. It became an issue during a registration audit, and rightfully so, because most of the records were classified as "current" by default, because they hadn't been declared obsolete. It doesn't matter if you have a warehouse full of "good" information if no one can read it.
RosieA 5th June 2006, 10:36 AM In Doc Control the no wite-out and single line and dates and initials thing is pretty standard. Although I 've seen that written up as an unauthorized change, not a illegible document.
I think you can see from the responses you got that there are a lot of legibility and identification issues out there to be dealt with.
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