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

A

ajtfernandes

#1
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
 
Elsmar Forum Sponsor

SteelMaiden

Super Moderator
Super Moderator
#2
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!:bigwave:
 
A

ajtfernandes

#3
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

Super Moderator
Super Moderator
#4
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.
 
A

ajtfernandes

#5
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

wikineer
Super Moderator
#6
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
 
A

ajtfernandes

#7
Re: Document Control File

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

jw2009

#8
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

Super Moderator
Super Moderator
#9
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.
 
P

pzaltz

#10
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
 
Thread starter Similar threads Forum Replies Date
M Document Control: File, Document and Verify Customer Specific Requirements Document Control Systems, Procedures, Forms and Templates 49
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 51
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Document control for tooling drawings (Document control clause 7.5.3) IATF 16949 - Automotive Quality Systems Standard 5
J Document Control Newbie - Control of Nonconforming / Returns Log AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
R External Standards List (Document Control) Document Control Systems, Procedures, Forms and Templates 3
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
M Cross Function Process Map for Document Control Process Maps, Process Mapping and Turtle Diagrams 3
0 How to deal with resistance to GDP Document Control Discipline Document Control Systems, Procedures, Forms and Templates 7
dubrizo Restructuring Document Control Numbering System Document Control Systems, Procedures, Forms and Templates 3
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
E Document Control MS Access Database Document Control Systems, Procedures, Forms and Templates 46
S Looking for Document Control Templates Document Control Systems, Procedures, Forms and Templates 1
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
tony s Performance Indicators for Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
T Document Control of FMEAs and Control Plans FMEA and Control Plans 5
T Is there a difference between form control and document control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12

Similar threads

Top Bottom