Records are a special type of document - Can anyone clarify this statement? 4.2.3

V

vinaynin

please refer 4.2.3 - Records are a special type of document and shall be controlled according to the requirements given in 4.2.4

can any one clarify regarding above- which type of Records should considered as documents and how it will controlled as per 4.2.4 (Control of Records)

Vinay
 

Randy

Super Moderator
Technically all records are documents, but they have a specific difference. You can review and revise documents, but you don't revise records. Documents (procedures, instructions, etc.) are essentially living things subject to change but records provide information of historical nature or past occurances, conditions, events, etc.

You need to controls records in a manner that they can be accessed and protected from damage or loss. Refer to ISO 9004 to help give you more guidance.
 
T

tarheels4 - 2007

Randy said:
Technically all records are documents, but they have a specific difference. You can review and revise documents, but you don't revise records. Documents (procedures, instructions, etc.) are essentially living things subject to change but records provide information of historical nature or past occurances, conditions, events, etc.
I am not trying to be nit picky here Randy but what you said is a bit confusing. It sounds like what you are saying above is. Records are documents and you review and revise documents but you cannot revise records even though they are documents which are to be reviewed and revised.

Why not just keep it simple. Forms are a form of document, which when filled in become a record of an activity.
 
D

ddunn

"Why not just keep it simple. Forms are a form of document, which when filled in become a record of an activity."

I believe the primary point that Randy was making is that records cannot be revised. Once a form is filled in and becomes a record it cannot change.

Forms (blank), procedures, instructions, checklists (again blank) can be revised.
 
T

tarheels4 - 2007

ddunn said:
I believe the primary point that Randy was making is that records cannot be revised. Once a form is filled in and becomes a record it cannot change.
If this is the point that Randy is making I disagree with the point. I hope you will agree that typically environmental aspects and impacts are recorded on a form (document). The form then becomes a record. In order to maintain this record of aspects it needs to be reviewed form time to time and revised if there is changes in processes of the organization which would require modifications or revision to the aspects list/record.

So I guess a record can be changed.
 

Cari Spears

Super Moderator
Leader
Super Moderator
tarheels4 said:
If this is the point that Randy is making I disagree with the point. I hope you will agree that typically environmental aspects and impacts are recorded on a form (document). The form then becomes a record. In order to maintain this record of aspects it needs to be reviewed form time to time and revised if there is changes in processes of the organization which would require modifications or revision to the aspects list/record.

So I guess a record can be changed.
But you are not altering previously recorded environmental readings, you are simply adding the next reading. Records are documented evidence of actual occurances and should not be changed. Just because you add to a form as the environment changes - or more parts are inspected - or whatever the case - Randy's statement is correct.
 
T

tarheels4 - 2007

Cari Spears said:
But you are not altering previously recorded environmental readings, you are simply adding the next reading. Records are documented evidence of actual occurances and should not be changed. Just because you add to a form as the environment changes - or more parts are inspected - or whatever the case - Randy's statement is correct.
Yes Ma'am
 

Wes Bucey

Prophet of Profit
Randy briefly touched on the main point - a record is a HISTORY of an activity. As such, it should NOT be changed. It may be added to (a running tally of production for instance), but the previously entered data may not be altered.

I normally explain the distinction between "modifiable" documents and "unmodifiable" documents by saying:
  1. Modifiable documents are plans or instructions, which may change as circumstances change
  2. Unmodifiable documents (records) are history of events. Thus, correspondence between customer and supplier is normally considered a "record" since you can't erase what has been said or written. You can ADD to a record (to explain a previous error?), but it is taboo to change it as if it never happened. (A history of "changes" to a modifiable document is also a record.)
A special case needs to be made for RETENTION of records. Each organization should have a policy and procedure in place to set an original retention period for each type of record and then to review the record at the end of the initial retention period to determine
  • if the retention should be extended
  • or if the record should be relocated to an archive
  • or if the record may be destroyed.
I hope this helps clarify the matter. If not, come back.
 

Jim Wynne

Leader
Admin
Wes Bucey said:
Randy briefly touched on the main point - a record is a HISTORY of an activity. As such, it should NOT be changed. It may be added to (a running tally of production for instance), but the previously entered data may not be altered.

I normally explain the distinction between "modifiable" documents and "unmodifiable" documents by saying:
  1. Modifiable documents are plans or instructions, which may change as circumstances change
  2. Unmodifiable documents (records) are history of events. Thus, correspondence between customer and supplier is normally considered a "record" since you can't erase what has been said or written. You can ADD to a record (to explain a previous error?), but it is taboo to change it as if it never happened. (A history of "changes" to a modifiable document is also a record.)
A special case needs to be made for RETENTION of records. Each organization should have a policy and procedure in place to set an original retention period for each type of record and then to review the record at the end of the initial retention period to determine
  • if the retention should be extended
  • or if the record should be relocated to an archive
  • or if the record may be destroyed.
I hope this helps clarify the matter. If not, come back.
Records may be changed in order to correct errors, but there must be an explicit addendum to the record stating, A) the fact than an amendment was made, B) the reason(s) for the amendment and C) the name person who made the change. Authority for changing records should be documented.
 

Wes Bucey

Prophet of Profit
JSW05 said:
Records may be changed in order to correct errors, but there must be an explicit addendum to the record stating, A) the fact than an amendment was made, B) the reason(s) for the amendment and C) the name person who made the change. Authority for changing records should be documented.
Medical, among others, are a special case where the record may be "amended" to note an error and supply the correct data, but it may not be erased and correct data supplied.

Some electronic document management software absolutely maintains an audit trail of the original document or record and all changes for exactly that reason.

In general, it is not a good practice on a "record" to delete data, even erroneous data. It is better to note the error, add a correction, and perhaps investigate "WHY" the erroneous data was entered in the first place. If a person entering data is dyslexic, it may be better to replace the person with one who does not have such a problem.
 
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