Control of Documents

[lpatch83]

Hello everyone!
I just started a position as the Quality systems coordinator with a very small company who is registered as ISO 9001:2015. I previously was with a company that was both 9001 and 13485. I am working on improving the system and we cannot use a software or program as the cost doesn't make sense for the size of the company. My biggest concern is how the documentation was setup. In my very naïve opinion, as I am always learning, each document should have a unique identifier but what i am seeing is that similar documents will use the same identifier with a dash and another number. For example i will have a F035 and an F035-1. It is my belief on items such as fillable forms we want to control the template not necessarily the information inputted. Am I wrong in that?

 

[blackholequasar]

The document control system can be whatever you define it to be! Where I work, we have a system where forms are a dash # that applies to a specific SOP. So for example, SOP-001 may have two forms, they'd be FORM-001-1, FORM-001-2. The format of the form is controlled as the data entered is variable depending on the job.

But if you want to define it another way, perhaps in a way that is clearer to you, you could perhaps draw up a proposal and show management how changing the numbering system would be advantageous to those who use it because it will be more visible/clear!

 

[lpatch83]

Thank you for your response. I do understand that it is whatever we want it to be but we also have to manage it properly and that wasn't happening which led to findings because the main form would be updated however the subsequent forms would not be so for example, the companies' name changed the main document F035 was updated but F035-1 was not and so on. To me keep it simple 1 document 1 number.

 

[Miner]

Before you write off software, do you use SharePoint or Teams? Online documents are better than hardcopy. If your company is indeed small and you have a limited number of documents, don't be too hasty to include a complicated numbering system in place. It is not required, and the document names are usually sufficient. Numbers only become helpful (still not required) when the quantity of documents become large enough that you need to start organizing them.

 

[FRA 2 FDA]

I work for a small start-up (10 people) and we use Teams for our documents, FWIW. As for related forms not getting updated, in my experience, SOPs have a section that lists related documents exactly for that purpose. When the SOP gets updated, the related documents should be checked to see if any also need to be updated. This includes not only forms or lists, but also other SOPs. Then checking for this becomes a part of the DCN process.

 

[lpatch83]

Before you write off software, do you use SharePoint or Teams? Online documents are better than hardcopy. If your company is indeed small and you have a limited number of documents, don't be too hasty to include a complicated numbering system in place. It is not required, and the document names are usually sufficient. Numbers only become helpful (still not required) when the quantity of documents become large enough that you need to start organizing them.

We do not use it. Documents are stored digitally. in forms alone we have 203 unique documents. I dont understand the "dont be to hasty to include a complicated numbering system" I dont want a complicated number. I guess i wasnt as clear in my question as i should have been. We have a production data sheet with an identifier of F035, then they created a production data sheet for line 2 using F035-1. In my expierence that second document should have been F036.

 

[lpatch83]

I work for a small start-up (10 people) and we use Teams for our documents, FWIW. As for related forms not getting updated, in my experience, SOPs have a section that lists related documents exactly for that purpose. When the SOP gets updated, the related documents should be checked to see if any also need to be updated. This includes not only forms or lists, but also other SOPs. Then checking for this becomes a part of the DCN process.

The company does not have S.O.P's in that manner. We have our key procedures such as document control process. They have work instructions but they dont call out the forms.

 

[FRA 2 FDA]

Our work instructions didn't either. When I came into the picture the whole company was revamping and one of our projects was to update the work instructions- they were incomplete and not helpful. As part of that, I added a related documents section for this exact reason and it has worked to our advantage so many times!! If it's at all in the realm of possibility to rev all the WIs and add this section to them, it might be worth considering.

 

[qualprod]

Hello everyone!
I just started a position as the Quality systems coordinator with a very small company who is registered as ISO 9001:2015. I previously was with a company that was both 9001 and 13485. I am working on improving the system and we cannot use a software or program as the cost doesn't make sense for the size of the company. My biggest concern is how the documentation was setup. In my very naïve opinion, as I am always learning, each document should have a unique identifier but what i am seeing is that similar documents will use the same identifier with a dash and another number. For example i will have a F035 and an F035-1. It is my belief on items such as fillable forms we want to control the template not necessarily the information inputted. Am I wrong in that?

Hi.
What I do is the next and works fine for me.

Procedures
PRO-ENG-01/rev 01 Engineering
PRO-QUA-01 /rev 02 Quality Control
PRO= Procedure
ENG= Engineering process
QUA=Quality process

Forms

FOR-ENG-01 /rev 02 Engineering projects
FOR-QUA-01 / rev 05 Quality inspection
FOR= Forms (usually fillable forms)

General
GEN-QMS-01 Quality policy
GEN-QMS-02 Quality objectives

ENG,QUA, QMS are the processes.

This way, when browsing into the internal network or whatever access to documents
Can detect how are related to the kind of documents, and processes.

Hope this helps

 

[Jim Wynne]

in forms alone we have 203 unique documents.

The simple answer to this is to not control forms. Control the information that must be provided. In the process documentation ("documented information") specify what information must be recorded, and that it can be done in a "convenient format." Then, provide the convenient format.