Printed Controlled Document

Hi all, 

Normally we printed out Form from Master Copy to use and there is no any chop on it, however   an auditor commented that the FORM that use in production area all should be chopped or printed with "Controlled Document" on the bottom of the form.

Hi guys, wondering Is it necessary or compliant? 

The purpose of document control is to ensure that all relevant information is available, accessible, and properly controlled throughout the organization. This helps to ensure the consistency and accuracy of the information used to support the quality management system. Document control is a key element of the quality management system and includes the following components:

1. Identification: Documents must be clearly identified and labeled to ensure they are easily recognizable and retrievable.
2. Approval: Documents must be reviewed and approved by the appropriate individuals before they are used.
3. Distribution: Documents must be distributed in a controlled manner to ensure they are available to all relevant individuals.
4. Storage: Documents must be stored in a secure manner to ensure they are protected from unauthorized access, alteration, or damage.
5. Revision: Documents must be reviewed and revised as necessary to ensure they remain current and relevant.

Header:

• Unique document identification:  
• Title
• Logo
• Start date: 
• Revision date: 
• Review date: 

Footer or in a change log: 

There should be the following columns: 

1. Who changed or reviewed what?
2. When?
3. Why?
4. Who approved it? 
5. in some companies they also include who it was distributed to. 

Having a Control Number/Document Number on the document itself is more effective than a silly stamp.  I've always tried to use a numbering format that includes a version number in it in addition to a revised date.  DOC-101-1.1 where DOC-101 identifies what department and the form number, 1.1 being used to show version (1.0/2.0/3.0 for major revisions, 1.1/1.2/1.3 to show minor updates).  Your Document Control Program will need to explain that any form that needs to be controlled will follow the proper formats and include a Control Number on the form.

I kept the most recent version of the form in a binder to be used as a master for making photocopies from, replacing the master form when needed due to wear or update.  Never had an auditor push back on this practice.

Possibly controversial, but I don't like putting a full revision history on my forms.  Makes production/QA/receiving forms used daily far too long, but I keep a log of all document changes with explanations on it.  I can always go backwards using the Replaces or Supersedes date and version number on the form to show when the change occurred and way, and auditors have accepted it.

Hi all, 

 

Normally we printed out Form from Master Copy to use and there is no any chop on it, however   an auditor commented that the FORM that use in production area all should be chopped or printed with "Controlled Document" on the bottom of the form.

 

Hi guys, wondering Is it necessary or compliant? 

Hi Carine,

Not too sure what "chopped" means ?

With respect to "Controlled Documents" I  daresay you can find 2 "extreme" interpretations/responses to your query -

(1) - Some Companies make all their issued documents "Controlled" by Stamping or "footering" as such. This avoids your received criticism.

(2) - Some Companies have a footer on all their issued documents stating something like - Documents when printed are Uncontrolled.

(3) - Some Companies go in-between (1,2) and make some Documents controlled.

All the above options are supportable via appropriate, customised, Documentation Control Systems however you should familiarise yourself with the additional, consequential requirements before choosing. Personally, IMEX (1) is convenient but may involve significant effort if a lot of documents exist.

Hi Charles, 

Chopped here means stamping. 

I will choose option 1 printed 'footering' controlled copy Form for our production workers to use to avoid confusing.