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Understanding ?to ensure the changes are identified?? Revision Status of documents

D

darkafar

#21
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

I’d like to introduce my document system further to make the case more specific.
We have four level documents.
Level 1 is Quality Manual. I keep the whole change history because I think Quality Manual being the top level document deserves this.
Level 2 are the procedures, mainly describing the interaction between different departments. They tell what are the inputs and outputs of a process, and who is responsible, and how and where the process happens. I don’t think they are very important to the product, so I don’t want to keep the complete history of changes.
Level 3 are the work instructions. They are specific to a particular process, and explain how to transfer the inputs into outputs. I think they are important to product quality, so I keep the whole change history.
Level 4 are the control forms. Their forms are loosely controlled, and there is no change description when the revision is updated. I only tell the relevant people that a new revision control form is released, and they should use it.
In my specific case, I don’t think keep the complete change history of level 2 document is value-added. I also think the ISO9001:2000 clause 4.2.3 c) need elucidation to judge whether my documents violate it or not.
 
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S

sardonyx

#22
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

We use coversheet of all our documents which includes the brief description of the changes, ECR#, ECR date and the author's name. The coversheet has the ECR# information that we could reference if we need the detail of the changes. This is very helpful to keep track of the history of the device/documents.:rolleyes:
 

Crusader

Trusted Information Resource
#23
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

Our procedures (level 2 documents in the QMS) only show the latest changes. For example, if the current revision of a procedure is R03, the R03 procedure only shows what was changed when the R02 procedure was updated to R03, doesn’t show what was changed when the R01 procedure was updated to R02.

An auditor said our procedure violated ISO9001:2000 clause 4.2.3 c) “to ensure the changes and the current revision status of documents are identified.”

Was he right? What are the advantages and disadvantages of keeping the past revisions?

How did you do it?

Sorry to dig up an old discussion but I was searching for "Master List" to see what others are doing and if they are still used under ISO 9001:2000. As far as your audit finding goes....I do exactly what you do: Only show the current changes in the current revision. But, all past changes are with the past revision in archived electronic files. I've never had a problem with this method and it is not violating 4.2.3 c. JMO and experience for the last 8 years. ;)

The reason for only showing the current revisions in the document is it can become quite lengthy and confusing. People(including the registrar) seem to look at the change record and think they are looking at the actual procedure even though it is clearly marked "Change Record". This can lead one to not follow the documented process and cause an actual finding. Past information, unless specifically requested, is unnecessary in current revisions. JMHO. ;)
 
S

silly girl

#24
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

<snip>

The reason for only showing the current revisions in the document is it can become quite lengthy and confusing. People(including the registrar) seem to look at the change record and think they are looking at the actual procedure even though it is clearly marked "Change Record". This can lead one to not follow the documented process and cause an actual finding. Past information, unless specifically requested, is unnecessary in current revisions. JMHO. ;)
We keep information about all changes to all documents in our document database...this lets us know what happened when without having to load down the documents themselves with tons of historical information. Databases are ideal for this kind of thing!

Silly Girl
 

Crusader

Trusted Information Resource
#25
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

I just pull up the archived document to see past changes. Similar to looking up in a database. Curious what "database" you chose to use?
 
S

silly girl

#26
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

Curious what "database" you chose to use?
It's a homebrew Access database. It records the document information including doc number, title, owner, review due date, current revision and revision date, affected departments. Retention information is recorded for quality records. The database also records the change history of each document. It also gives us a cross reference that shows which documents refer to which other documents. It emails out notifications weekly to inform people about documents that have changed, and also lets the owner know that it is time to review their documents... works pretty well for us.

Silly Girl
 

Crusader

Trusted Information Resource
#27
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

It's a homebrew Access database. It records the document information including doc number, title, owner, review due date, current revision and revision date, affected departments. Retention information is recorded for quality records. The database also records the change history of each document. It also gives us a cross reference that shows which documents refer to which other documents. It emails out notifications weekly to inform people about documents that have changed, and also lets the owner know that it is time to review their documents... works pretty well for us.

Silly Girl
Nice. Sounds like a winner! Homebrews always seem to work best. :applause:
Let me know if you ever plan to share the structure for others. :) Can't say it would work for us due to limitations in the company but someone might benefit.
 
S

silly girl

#28
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

Let me know if you ever plan to share the structure for others. :) Can't say it would work for us due to limitations in the company but someone might benefit.
If people are interested I might consider it. The biggest problem is that it is so tied into data automations within our company, I would have to do some surgery to make it usable outside our network. I must admit, I have often wondered if I could make a living just making homebrews for different organizations!

Silly Girl
 
C

C Emmons

#29
Re: Understanding “to ensure the changes are identified”? Revision Status of documents

Our Documents are all on the company intranet - I had the IT department "build" in a revision history tool that allows me to note changes as well as view the archived file when the new document replaces the old.
Screen sample attached.
 

Attachments

N

Nehal

#30
Re: Understanding “to ensure the changes are identified”? Revision Status of document

Maybe, but not for that citation. How do you know the revision status of your documents? If you have a master list of your documents with the revision status, he was wrong. BTW, what you have described is not what I would do. I like to keep the complete history of the documents. It's not that difficult especially if you keep it electronically.
i am completely agree with you
 
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