Must I mention "records kept" in the Quality Manual itself

H

HeyBooBoo

#1
Must I mention when records are kept in the Quality Manual itself, or in fact that they are even kept?
Example 5.6.1 Management review of QMS

Must I state that:
the Management review of QMS...... and records are kept.

or

the Management review of QMS...... and records kept in "some location".

or

or is it not necessary to even state in the QM that the records are kept?
This question is specific to the writing of the Quality Manual.

If this must be in there then I need to make sure everywhere that a record is required (I have that list) has a statement about the records being kept?
 
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Jim Wynne

Leader
Admin
#2
Re: Must I mention "records kept" in QM?

Must I mention when records are kept in the Quality Manual itself, or in fact that they are even kept?
Example 5.6.1 Management review of QMS

Must I state that:
the Management review of QMS...... and records are kept.

or

the Management review of QMS...... and records kept in "some location".

or

or is it not necessary to even state in the QM that the records are kept?
This question is specific to the writing of the Quality Manual.

If this must be in there then I need to make sure everywhere that a record is required (I have that list) has a statement about the records being kept?
You must have records as required by the standard, but they need not be mentioned in the QM, per se, nor does their location have to be given. Your qm doesn't have to repeat, mimic or follow the clauses of the standard. It just has to meet the requirements stated in 4.2.2.
 
Q

Quality_Steve

#3
We keep a records matrix which is just an excel spreadsheet with the list of required records and where they are kept and for how long. In the QM we simply state "records are kept in accordance to the records matrix".

It seems easier to maintain this way rather than updating the QM when records are added or moved to a new location.

Cheers,
Steve
 
H

HeyBooBoo

#5
No, no one is asking for this to be done.

I have address the required procedures by stating "see process number XXX" and was at a quandary as to if this actually NEEDED to be documented that the records were being kept in the QM
 
H

HeyBooBoo

#6
We keep a records matrix which is just an excel spreadsheet with the list of required records and where they are kept and for how long. In the QM we simply state "records are kept in accordance to the records matrix".

It seems easier to maintain this way rather than updating the QM when records are added or moved to a new location.

Cheers,
Steve
That brings another point. If these are kept on a network, how do you balance availability vs security? Such as: You say something is stored here, but Jim in accounting decided to move it. Then if you lock it down, now you are the new data entry guy!

I would like to do what you are stating but this is my major concern.
 

Jim Wynne

Leader
Admin
#7
That brings another point. If these are kept on a network, how do you balance availability vs security? Such as: You say something is stored here, but Jim in accounting decided to move it. Then if you lock it down, now you are the new data entry guy!

I would like to do what you are stating but this is my major concern.
If you have documents on a network drive, you (or your IT people) should be able to control read/write/access permissions.
 
Q

Quality_Steve

#8
That brings another point. If these are kept on a network, how do you balance availability vs security? Such as: You say something is stored here, but Jim in accounting decided to move it. Then if you lock it down, now you are the new data entry guy!

I would like to do what you are stating but this is my major concern.
Only the people making the record such as the data entry guy should need to have read/write access, everyone else gets read only or no access at all depending on the security group they are assigned to. I don't deal with the I.T. side of it. I know we occasionally have to retrieve something from a backup because somebody accidentally deleted a folder.:mg:
 
#9
No, no one is asking for this to be done.

I have address the required procedures by stating "see process number XXX" and was at a quandary as to if this actually NEEDED to be documented that the records were being kept in the QM
Not in the QM. The records procedure is a good place to develop the basics of what constitutes a records and why it's kept etc. - in plain language, not "ISO-speak"...
 

John Broomfield

Leader
Super Moderator
#10
Must I mention when records are kept in the Quality Manual itself, or in fact that they are even kept?
Example 5.6.1 Management review of QMS

Must I state that:
the Management review of QMS...... and records are kept.

or

the Management review of QMS...... and records kept in "some location".

or

or is it not necessary to even state in the QM that the records are kept?
This question is specific to the writing of the Quality Manual.

If this must be in there then I need to make sure everywhere that a record is required (I have that list) has a statement about the records being kept?
HeyBooBoo,

Your quality manual should not be a rewrite of the standard for auditors. It should describe your management system and how it works.

Try writing it for grade 8 readability.

Your manual will also refer to or include your filing and archiving procedure.

Try to avoid repetition of what is specified elsewhere in your management system. This reduces the complexity and cost of upkeep.

John
 
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