Document Control File - Identifying all documents which need to be controlled

[ajtfernandes]

Hello to you all,

I have been looking in the web for different type of info regarding 9001 implementation, and I found this forum. I already read some discussions, and I found it wonderful for experts and also for people just starting in the ISO world (just like me).

I am working in a small biotech company and I proposed the ISO 9001 certification, which top management said yes. So I am trying to do as much as I can.

After drafting some documents, I am now trying to make all the procedures, SOP, Records maintenance and document control.

I am writing to you to ask you if by chance you have a excel template where I can identify all the documents to be controlled. I have been trying to imagina a way to do it in excel, but than I found that, if I identify all the documents in one excel file and then when I start reviewing them this excel file will be a mess, since I will have identificaion and track record of the documents. Should I do two escel files, one for identification and other for "monitoring"? Do you have any templates/suggestions to help me on this.

Thank you all in advance.
Best
Andre

 

[SteelMaiden]

Re: Document Control File

I think that as you learn more and more, you will discover that each organization ends up with their own set of requirements for document control. As a general rule of thumb, your quality manual, quality policy, work instructions, procedures, and records of your production conformity/nonconformity (a special set of documents) need to be controlled. Any document that controls what you do and might cause a nonconformity if not followed, in other words.

At the bottom of this page you will find some related threads, there is also a search function in the navigation bar above. And of course, if you have any more specifics you would like to check on people will always be happy to help. Welcome and enjoy your stay at the Cove!

 

[ajtfernandes]

Re: Document Control File

Thank you for you reply.
Yes, as I will, hopefully, evolve I will learn more and more. The needs of documents will also evolve along time. However what I am looking for is a way to control the documents, code, name, revision, date, responsible, etc...
I have tried to find ideas and/or template to do it in the forum, but unfortunately I was not lucky. I will keep searching, but if meanwhile if you have any suggestion/idea/template please let me know.
Best
Andre

 

[SteelMaiden]

Re: Document Control File

Thank you for you reply.
Yes, as I will, hopefully, evolve I will learn more and more. The needs of documents will also evolve along time. However what I am looking for is a way to control the documents, code, name, revision, date, responsible, etc...
I have tried to find ideas and/or template to do it in the forum, but unfortunately I was not lucky. I will keep searching, but if meanwhile if you have any suggestion/idea/template please let me know.
Best
Andre

So much depends on whether you will have a paper system or electronic. Electronic systems can be designed to pretty much guarantee control through passwords, file protection administrative rights. Perhaps you could give us some examples of what you are thinking about and we can give you some dos and don'ts from there? There are lots and lots of threads on how to control documents to help you get some ideas.

 

[ajtfernandes]

Re: Document Control File

The system will be electronic.
The documents I am talking are all the procedures mandatory in the ISO9001:2008, corrective and preventive actions, internal audits, etc. Also, all of our production protocols, suppliers identification conception and development...
The idea is to have a principal excel file (or similar) where we could identify the document either by the name or code. This main file is also fundamental to add new documents that we may think that are necessary. Another file, or another need, is a control of the revisions of the different documents.
For example, if I have 100 listed documents (in the mais file) and I want the review one of such a document, I think that we would benefit (in terms of self organization) to have this control in another file, leaving the first fil (main file) as the "storage" of the final reviewed docuemtns...
I dont know if I was clear enough...

If you have any other suggestion, please feel free to tell me.
best
Andre

 

[Pancho]

Re: Document Control File

If you have any other suggestion, please feel free to tell me.

Hi Andre,

Have you thought about using a wiki?

Wikis are websites that anyone in your group can edit. Every change is recorded. Documents in a wiki can link with each other to build indexes, hierarchies, and other logical organizational structures. And when something is changed, every related document gets updated. Automatically.

There is no better time to use the right tool than when you are starting out. Take a look at wikis.

Good luck,
Pancho

 

[ajtfernandes]

Re: Document Control File

Thank you for your suggestion. I will study this alternative, it seems promising.
Best
Andre

 

[jw2009]

Re: Document Control File

The system will be electronic.
The documents I am talking are all the procedures mandatory in the ISO9001:2008, corrective and preventive actions, internal audits, etc. Also, all of our production protocols, suppliers identification conception and development...
The idea is to have a principal excel file (or similar) where we could identify the document either by the name or code. This main file is also fundamental to add new documents that we may think that are necessary. Another file, or another need, is a control of the revisions of the different documents.
For example, if I have 100 listed documents (in the mais file) and I want the review one of such a document, I think that we would benefit (in terms of self organization) to have this control in another file, leaving the first fil (main file) as the "storage" of the final reviewed docuemtns...
I dont know if I was clear enough...

If you have any other suggestion, please feel free to tell me.
best
Andre

I work for a small eco-friendly company and we are also going the paperless (or electronic) route for documentation updates. My R&D department has recently purchase a electronic documentation control program that allows us to create, update and manage files. There are editor and viewer rights to allow proper access. All updates are stored as a "new" file and previous versions are archived for reference purposes. For example, we use this program for product formulations, packaging specs, SOP's, chemical database, etc. But of course there is a set-up price as well as yearly maintenance fees and viewer and license fees. Not sure if this is something you could budget for; but could be worth looking in to.

 

[SteelMaiden]

Wikis, canned document control programs, SharePoint (MicroSoft application), plain word processing documents stored in electronic files or saved as pdf files for read only purposes, create your own website using any web design application. The choices are myriad.

 

[pzaltz]

Re: Document Control File

Dear Andre,

Be carefull not confusing documented procedures and records. You called "documents" to the non conformities and audit reports, but they are specifically records. May I suggest to read carefully the standard in order to understand clearly the diferentiated requierements for controling records and documents.

On the other topic, I use a current document version list to show to the users the number of current version of each controlled doc. Additionally, I upload a PDF version of the document to a networked folder with read only access for the staff; reserving for myself the ability to change this files. All this electronic version of the documents shows a header stating clearly that any printout of the documents constitutes a non-controlled copy.

Regards,


Pablo