Document Control Procedure - Review and Feedback Needed

J

JaimeB

#1
Hello!

I am new to Quality and AS9100/ISO 9001, but am in the position of helping a small company develop a QMS. I'm working on procedures. Attached is the document control procedure I'm working on (with input from many folks within the company, and tips I've read at this forum).

If anyone has time, I would really appreciate any feedback. Please, let me have it! Is anything unclear? Have I unknowingly created any bureaucratic nightmares? Will anything come back to haunt me in an audit? As long as we follow this procedure, we should be compliant, right?

Document control seems relatively straightforward to me, but the more I learn, the more I realize I don't know, so I'm a bit gunshy to roll this out without a few expert opinions.

Thanks in advance.:)
 

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S

samsung

#2
I find it perfectly OK except for the last column of the table where you mentioned 'freq. of document review' 'as applicable'. I didn't find any reference to 'as applicable' in your procedure. What does it mean?

Secondly, what will happen if a document isn't reviewed for it's suitability and effectiveness within a certain time frame, e.g. one year or so. What can trigger a document review? May be this information is available in some other documents.
 

somashekar

Staff member
Super Moderator
#3
Hello!

I am new to Quality and AS9100/ISO 9001, but am in the position of helping a small company develop a QMS. I'm working on procedures. Attached is the document control procedure I'm working on (with input from many folks within the company, and tips I've read at this forum).

If anyone has time, I would really appreciate any feedback. Please, let me have it! Is anything unclear? Have I unknowingly created any bureaucratic nightmares? Will anything come back to haunt me in an audit? As long as we follow this procedure, we should be compliant, right?

Document control seems relatively straightforward to me, but the more I learn, the more I realize I don't know, so I'm a bit gunshy to roll this out without a few expert opinions.

Thanks in advance.:)
Within your procedure, what is the procedure you have in place to ensure that relevant versions of applicable documents are available at points of use ?
I ask this because one of your controlled document is the Work Instructions ...
 
J

JaimeB

#4
I find it perfectly OK except for the last column of the table where you mentioned 'freq. of document review' 'as applicable'. I didn't find any reference to 'as applicable' in your procedure. What does it mean?

Secondly, what will happen if a document isn't reviewed for it's suitability and effectiveness within a certain time frame, e.g. one year or so. What can trigger a document review? May be this information is available in some other documents.
Thank you!

If I stated within the procedure "New and revised documents are reviewed and approved prior to use. Documents are reviewed and reapproved any time changes are made", would that work?

I guess what I'm trying to avoid is giving a firm "we will review every document X times a year," and then get cited for missing a document review.

Maybe I'm thinking about this wrong...for instance, we have a plethera of design documents that are used throughout the product realization phase, but then because they are so specific, we may never use the drawings again. Do we need to define a frequency of review for documents such as this? Or is simply reviewing them in the event we need to use them again sufficient?

I was thinking of including in the Internal Audit procedure that documents such as the QM, procedures, and work instructions would be reviewed, say 1 time a year, is that sufficient or do I need to state it here as well?

I'm sorry, my questions seem so banal and basic, I know I'm probably just overcomplicating this in my mind.
 
J

JaimeB

#5
Within your procedure, what is the procedure you have in place to ensure that relevant versions of applicable documents are available at points of use ?
I ask this because one of your controlled document is the Work Instructions ...
Thank you!

Basically, all of our documents are accessible from anyone's desk or office, and if someone needs to print a work instruction to take it into the production area, they would be responsible for ensuring that the printed copy is the most recent version.

A lot of this is implied in the procedure, are you saying I need to explicitly state this?
 

somashekar

Staff member
Super Moderator
#6
Thank you!

Basically, all of our documents are accessible from anyone's desk or office, and if someone needs to print a work instruction to take it into the production area, they would be responsible for ensuring that the printed copy is the most recent version.

A lot of this is implied in the procedure, are you saying I need to explicitly state this?
When it comes to work instructions in particular, I feel a bit uncomfortable.
A lot is said about how a printed copy is NOT a controlled copy. However can I touch my heart and say that I have addressed this question ...
What are my controls to ensure that relevant versions of applicable documents are available at points of use ?
Give a thought ...
 

somashekar

Staff member
Super Moderator
#7
Thank you!

If I stated within the procedure "New and revised documents are reviewed and approved prior to use. Documents are reviewed and reapproved any time changes are made", would that work?

I guess what I'm trying to avoid is giving a firm "we will review every document X times a year," and then get cited for missing a document review.

Maybe I'm thinking about this wrong...for instance, we have a plethera of design documents that are used throughout the product realization phase, but then because they are so specific, we may never use the drawings again. Do we need to define a frequency of review for documents such as this? Or is simply reviewing them in the event we need to use them again sufficient?

I was thinking of including in the Internal Audit procedure that documents such as the QM, procedures, and work instructions would be reviewed, say 1 time a year, is that sufficient or do I need to state it here as well?

I'm sorry, my questions seem so banal and basic, I know I'm probably just overcomplicating this in my mind.
to review and update as necessary and re-approve documents,
This is the requirement about review and reapprove in ISO9001 and here there is no specific frequency that you are to state. However in other management systems there may be such needs.
 
J

JaimeB

#8
When it comes to work instructions in particular, I feel a bit uncomfortable.
A lot is said about how a printed copy is NOT a controlled copy. However can I touch my heart and say that I have addressed this question ...
What are my controls to ensure that relevant versions of applicable documents are available at points of use ?
Give a thought ...
Sorry, I'm sure I seem dense. :eek:

Once the document is printed, the only control we have established is that the employee is responsible for verifying that it matches to the most recent release of the document on our network. I'm not sure what other controls we could implement, we are trusting that the employees are following the procedure. What am I missing?
 
S

samsung

#9
Thank you!

If I stated within the procedure "New and revised documents are reviewed and approved prior to use. Documents are reviewed and reapproved any time changes are made", would that work?

Maybe I'm thinking about this wrong...for instance, we have a plethera of design documents that are used throughout the product realization phase, but then because they are so specific, we may never use the drawings again. Do we need to define a frequency of review for documents such as this? Or is simply reviewing them in the event we need to use them again sufficient?
This is fine. What I wanted to convey is if there are no changes in the process, say for last 2 years, do you still feel a document should be anyway recalled for review. Further, most documents never require a review, e.g. blank forms, standard work instructions, regulated procedures etc. You may decide upon which documents (e.g. procedures) need to be reviewed once every xxx years or so. Since all other related documents/ forms are referred within the procedures, all get reviewed alongwith the procedures. This is just an opinion.


I was thinking of including in the Internal Audit procedure that documents such as the QM, procedures, and work instructions would be reviewed, say 1 time a year, is that sufficient or do I need to state it here as well?
IMO, instead the procedure for document control is more relevant for this purpose.
 

somashekar

Staff member
Super Moderator
#10
Sorry, I'm sure I seem dense. :eek:

Once the document is printed, the only control we have established is that the employee is responsible for verifying that it matches to the most recent release of the document on our network. I'm not sure what other controls we could implement, we are trusting that the employees are following the procedure. What am I missing?
Are the work instructions viewed and used by the user's at the place of use from the network ?
YES, I am happy.
NO, then I mean that a controlled document like a work instruction is in a print form (now not controlled since printed) and the same is varified by the user, say daily with the work instruction on the network., day after day after day >>> .
Am I here attempting to make a system that works by trust or a system that just works.
I believe that you are required to define the controls needed to ensure that relevant versions of applicable documents ARE available at points of use, and trust on employees behaviour is not a quality management system control.
Something more robust and visible control that can be demonstrated, audited and made to work within your system >>> Think over.
 
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