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Action on Quality Records - Approve, Update and Carry Out Revision Control

A

alvisan

#1
“For implementing ISO9001:2000, we must approve, update and carry out revision control on all quality records. It is because record is a type of documents”. Right? Wrong?
 

Colin

Quite Involved in Discussions
#2
Re: Action on Quality records

Firstly, the term 'quality record' is old terminology. It was used in previous versions of ISO 9001 but is now referred to simply as 'records'. Is that important? well, I think it is as people tended to think only of records of inspection and the like whereas it should be any records generated by the QMS.

Next, there is often confusion between records and documents. I talk about records being 'dead', they are 'past tense' whereas documents are 'live' and often need keeping 'alive' by applying document control to them.

Records can be very important to the organisation and therefore have to be looked after by filing, protecting and defining retention periods for them. However, they do not require document control in the same way as documents do.
 

RoxaneB

Super Moderator
Super Moderator
#3
Re: Action on Quality records

To add on to Colpart's response, if you're are talking about records - that is forms which have information on them - then what he said is great. If, by record, you are talking about the blank form, you should:
  • Understand the difference between a form and a record
  • Control forms like work instructions, procedures, etc., to ensure that everyone is working on the same revision.
 
#4
Re: Action on Quality records

To add on to Colpart's response, if you're are talking about records - that is forms which have information on them - then what he said is great. If, by record, you are talking about the blank form, you should:
  • Understand the difference between a form and a record
  • Control forms like work instructions, procedures, etc., to ensure that everyone is working on the same revision.
Actually there may be a simpler way to keep terminology accurate:
Documents can be be divided into two main categories:
  1. Active documents which usually describe an action to be taken in the future (one second or one century in the future)
  2. Static documents (records) which describe an action already taken in the past (one second or one century in the past)
Since the action documents describe something in the future, they can be changed or revised according to an organization's own procedures. A part of "control" for active documents is keeping the revisions straight and not mixing them up.

Since the static documents describe something in the past (history), they should not be changed. Sometimes, though, the history may be amended by adding new information from time to time (a production log?)

Forms versus documents versus records
Most organizations follow this usage:
"document" is the generic term for active documents, static records, and blank forms used as a template to complete either an active or a static document.
"Form" is a blank template, waiting for data to be filled in either for activity to take place in the future or as a history record of activity that has already taken place.

To add to the mix, "document" does not mean ONLY PAPER documents. Documents may exist only in electronic form, but they are still "documents" - this post is document, even though it exists only in electronic form [unless you print out a copy!]
 

Colin

Quite Involved in Discussions
#5
And of course (just to confuse things further) a document (e.g. a form) becomes a record when is is filled in with data!:confused:
 

RoxaneB

Super Moderator
Super Moderator
#6
:) Wes, I was attempting to keep my answer short and to-the-point as my gut says that our Original Poster's first language is not english. And I didn't wish to repeat what Colpart had already said (aligned with your response)...merely add on to it. :)
 
C

curryassassin

#7
:) Wes, I was attempting to keep my answer short and to-the-point as my gut says that our Original Poster's first language is not english. And I didn't wish to repeat what Colpart had already said (aligned with your response)...merely add on to it. :)
I thought the same thing when I read Wes's contribution.

I teach that a record is created when we have to write down or capture electronically, information or data. This includes completed forms, reports, spreadsheets, databases.

Usually a document (policy/process/SOP/work instruction) tells us to record the info/data.
 

Jim Wynne

Staff member
Admin
#9
Re: Action on Quality records

Since the static documents describe something in the past (history), they should not be changed.
But sometimes they should be changed in order to correct errors. This is why some level of control of records is important. That control can be accomplished in the form of explicitly defining when such changes are permissible, how they are to be carried out (so as to leave a trail), and by whom. How customers are to be notified when changes are made should also be explicitly defined.
 
#10
And of course (just to confuse things further) a document (e.g. a form) becomes a record when is is filled in with data!:confused:
It may sound like Abbott and Costello doing "Who's on First?" but this is absolutely right if it is data of an activity that has been performed. It may be only a document if it is data filed in on a form for an activity yet to take place (like filling in an Engineering Change Order Request.):lmao: Isn't this nit picking about terminology frustrating?:frust:
 
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