Document Control and Identifying Distribution

C

carlosl123

#1
Hello Everyone,
I have a question, if I am stating on my document control procedure that the control is going to be electronical, i.e., all forms, SOPs and in general, any of the QMS documentation are located in the network inside a protected folder that only document control personnel's got access to, therefore there is no chance that they get altered or lost, and also it makes it available to everyone that might need any of these. However, in order to save some money we are asking a printing house to print a set of 150 sheets of an X form given that it is cheaper and faster than having to print one out everytime it is needed, thus the distribution is no longer electronic only. For that matter, I want to be backed up and have two sets of sheets, one within the document control cabinet, that as a matter of fact exist just because I think it might become handy at some point but it is not required in our document control procedure, and the other one out there in the floor where the operator actually fills it out. How shall I identify its location? just like that? something like:
Distribution:
- Production floor @ SMT
- Document control hard copy
- Document control - electronic
please let me know what you think.
 
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S

silentrunning

#2
Re: Document Control and Distribution

We state in our procedures that all controlled documents are in the mainframe. Once a document is printed out it becomes a reference document and is no long controlled. After it is filled out and put away it is a record. I haven't had anyone complain on this so far.
 

Mikishots

Trusted Information Resource
#3
Re: Document Control and Distribution

Hello Everyone,
I have a question, if I am stating on my document control procedure that the control is going to be electronical, i.e., all forms, SOPs and in general, any of the QMS documentation are located in the network inside a protected folder that only document control personnel's got access to, therefore there is no chance that they get altered or lost, and also it makes it available to everyone that might need any of these.
OK, forgive me here, but I'm confused. If only doc control has access to QMS documentation, how is that considered availability to everyone that might need any of these?

How do you ensure availability at points of use? This is a requirement.

Providing a pile of 150 copies of a document or form to the floor is causing a possible problem rather than preventing one; what if the document is revised? How do you ensure that the copies will be where you think they are when the time comes to pull them? As soon as you print a copy of a controlled document, it's typically no longer considered controlled. You're creating a lot of unecessary work, and you are incurring cost, not reducing it.

The standard says you will ensure that relevant versions of applicable documents are available at points of use. If you have a computer on the shop floor, in an office or wherever else it's used (that can print or display a copy of the document in need), the requirement is met. What the standard is trying to tell you is that at no time should an employee be prevented from doing their job because they don't have access to the current document that they require to do their job.
 
C

carlosl123

#4
Re: Document Control and Distribution

Okay, the thing is, only doc control has access to edit the QMS documentation, everyone else has read only access but access after all.
A pile of a 150 pages of a form is what we have. If it is revised, the intention is to go out and remove whatever's left from such pile. Also, being a small organization, we are able to recover it with no problems. The main question is, how is this stated under the "Distribution". Should I write all the locations that have a printed out form? it is not a reference only if it is a form (in process inspection log on this case)
 

Mikishots

Trusted Information Resource
#5
Re: Document Control and Distribution

Okay, the thing is, only doc control has access to edit the QMS documentation, everyone else has read only access but access after all.
A pile of a 150 pages of a form is what we have. If it is revised, the intention is to go out and remove whatever's left from such pile. Also, being a small organization, we are able to recover it with no problems. The main question is, how is this stated under the "Distribution". Should I write all the locations that have a printed out form? it is not a reference only if it is a form (in process inspection log on this case)
If it's a small organization (small enough to go out and find all the blank copies of a given form), have the operator request a form from Doc Control or have a .pdf available on a computer that can be printed with a watermark.

If you are adamant that you want to state your desired method under Distribution, then just state it: something like "We will print multiple copies of forms and place them on the floor. If the forms are revised we will collect all obsolete copies." Let me be clear, I'm not giving you any assurances that this will be satisfactory.

4.2.3 (g) might appear to be satisfied superficially, but the auditor will make a determination if it's effective or not. It may look simple on paper, but.....
 
Q

QC JEWEL

#6
Re: Document Control and Distribution

Okay, the thing is, only doc control has access to edit the QMS documentation, everyone else has read only access but access after all.
A pile of a 150 pages of a form is what we have. If it is revised, the intention is to go out and remove whatever's left from such pile. Also, being a small organization, we are able to recover it with no problems. The main question is, how is this stated under the "Distribution". Should I write all the locations that have a printed out form? it is not a reference only if it is a form (in process inspection log on this case)
In my last work due the work nature operators were using controlled documents the document controll assistant stamped all operators instructions, prints with the "doc control stamp" and had a controlled list of all what it was distributed, when a revision changed, she went out to replace the old documents for the new ones. This requires some kind of work and organization to controll it very well, we never had an issue with that and it was stated in our document control procedure.
 
S

silentrunning

#7
Re: Document Control and Distribution

In my last work due the work nature operators were using controlled documents the document controll assistant stamped all operators instructions, prints with the "doc control stamp" and had a controlled list of all what it was distributed, when a revision changed, she went out to replace the old documents for the new ones. This requires some kind of work and organization to controll it very well, we never had an issue with that and it was stated in our document control procedure.
You must have worked for a remarkable organization. My hat's off to those people. I wouldn't even attempt that at my company. :(
 

insect warfare

QA=Question Authority
Trusted Information Resource
#8
Re: Document Control and Distribution

Hello Everyone,
I have a question, if I am stating on my document control procedure that the control is going to be electronical, i.e., all forms, SOPs and in general, any of the QMS documentation are located in the network inside a protected folder that only document control personnel's got access to, therefore there is no chance that they get altered or lost, and also it makes it available to everyone that might need any of these. However, in order to save some money we are asking a printing house to print a set of 150 sheets of an X form given that it is cheaper and faster than having to print one out everytime it is needed, thus the distribution is no longer electronic only. For that matter, I want to be backed up and have two sets of sheets, one within the document control cabinet, that as a matter of fact exist just because I think it might become handy at some point but it is not required in our document control procedure, and the other one out there in the floor where the operator actually fills it out. How shall I identify its location? just like that? something like:
Distribution:
- Production floor @ SMT
- Document control hard copy
- Document control - electronic
please let me know what you think.
Okay, the thing is, only doc control has access to edit the QMS documentation, everyone else has read only access but access after all.
A pile of a 150 pages of a form is what we have. If it is revised, the intention is to go out and remove whatever's left from such pile. Also, being a small organization, we are able to recover it with no problems. The main question is, how is this stated under the "Distribution". Should I write all the locations that have a printed out form? it is not a reference only if it is a form (in process inspection log on this case)
Usually, to effectively control forms, several things must be in place:

1) A method of identifying what they are: A form title, control #, version # (or any combination thereof) will work.
2) A system to ensure they are available at all points of use: Printing is fine, but even a computer at a station with suitable access to online forms (which can be printed at will) can qualify as a "system" of distribution.
3) A process for ensuring that when forms are revised, the proper notification is given to those involved with using those forms, and simply making sure that no wrong forms are being used: This can mean anything from going to the floor and doing it yourself, up to granting responsibilities to each process owner for using the correct forms. If you can make the latter an auditable requirement, you will see a noticeable difference in the way people control their own use of forms.

Whatever you choose to do should be documented in your procedures as applicable. Controlling forms does not have to be complicated - only if you allow it to be...

Brian :rolleyes:
 
S

ssz102

#9
Re: Document Control and Distribution

these forms are described in related document which is belong to responsibilities dept, or in order to other people know these forms are ditribute depts, you can prepare a form ditribution log and note the effective day, so that's more clearly
 
C

carlosl123

#10
Re: Document Control and Distribution

ah! this ssz102 has hit the point, that sounds like a very interesting idea. Thanks!
 
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