Interesting Discussion Controlled Copy Stamp - Document Control

M

maris

#21
We may resort to the use of stamp or embosser to prevent intentional violation of our company rules on document control but we think the more appropriate one would be disciplinary action to deal with the persons committing such "crime".

To prevent unintentional use of obsolete documents as required by 9001, we make use of obsolete stamp in red color. As 9001 does not require the control of prevention of unauthorized copying, NC should not be issued unless such act actually led to the use of an obsolete copy, are we correct?

Unauthorized copying could lead to the use of obsolete document but such act without an objectibve evidence of the presence of an obsolete document being use should be an observation for us to take further action, are we correct?
You may want to spell out in your doc control procedure that once you issued uncontrolled doc, the copy need not be returned to central doc controller, the recipient must be the one responsible for its disposal. Also, you need to establish a control methodology (a simple withdrawal/issuance form) that will ensure that all updated or revised documents are issued and obsolete documents are promptly removed from all points of issue or use. Then dispose all obsolete copies withdrawn from copyholders. However, I suggest you retain the original copy of obsolete controlled docs for reference purposes. These copies must be stamped "obsolete" to avoid inadvertent use.
 
Elsmar Forum Sponsor

SteelMaiden

Super Moderator
Super Moderator
#22
You may want to spell out in your doc control procedure that once you issued uncontrolled doc, the copy need not be returned to central doc controller, the recipient must be the one responsible for its disposal. Also, you need to establish a control methodology (a simple withdrawal/issuance form) that will ensure that all updated or revised documents are issued and obsolete documents are promptly removed from all points of issue or use. Then dispose all obsolete copies withdrawn from copyholders. However, I suggest you retain the original copy of obsolete controlled docs for reference purposes. These copies must be stamped "obsolete" to avoid inadvertent use.
I think that retaining obsolete documents for reference purposes depends a lot on your business, the importance of the document itself and how you record your changes. We don't keep obsolete documents with a few exceptions where we might want to reinstate the document, or parts of it at a later date. Also, can you point to where you are finding the the requirement that states that "These copies must be stamped "obsolete" to avoid inadvertent use."?

Stamping is but one method of control. We should all use what works best in our situation. Let your system work for you, don't work for it.
 
M

maris

#23
I think that retaining obsolete documents for reference purposes depends a lot on your business, the importance of the document itself and how you record your changes. We don't keep obsolete documents with a few exceptions where we might want to reinstate the document, or parts of it at a later date. Also, can you point to where you are finding the the requirement that states that "These copies must be stamped "obsolete" to avoid inadvertent use."?
I agree. It depends on how she records the revision history. The Critical is the deletion on any part of a document.
Stamping is but one method of control. We should all use what works best in our situation. Let your system work for you, don't work for it.
I knew from previous posts that she uses stamp as methodology.
 
S

savetheearth

#25
What is the the difference between a controlled and an uncontrolled document; and between a controlled and uncontrolled copy?

We thought of not to use the word "controlled" and "uncontrolled" in our life of implementing 9001. Can we not to be bother with it?

We just want to ensure control of certain documents using coding of identification, revision and effective date (quality manual, procedures, instructions, etc) without controlled stamp and embosser, but control only by means of recording its issue and updating the users of its revision.

There are many documents besides the above, for instance are internal audit plan, work order and etc. We knew from many people that these were not stamped "controlled" like the above manual and procedures. And these were mostly issued without recording its distribution. So are these documents become "uncontrolled"??

If all the documents must be stamped to be deemed as controlled, or to differentiate between controlled and uncontrolled doc or copies, I think we may go crazy!

Saying a doc is uncontrolled, or a copy is uncontrolled should be meaning to say it has not been controlled according to the company's doc control procedure right?

How about not to affix "obsolete" stamp on obsolete copy, but when you ask the users, they can tell you that is an obsolete one, and they know which is the current copy as they have been kept abreast with changes, and you found out that they are using correct one; in this scenario, do they still not conform to 4.2.3g?

We thought 4.2.3g does not mean obsolete copy shall be stamped "obsolete" while retained even though it has been a practice in the industries. We thought this is a good practice. As long as the revised and the obsolete have identification (i.e. revision number) instead of obsolete stamp, and the user can differentiate which is obsolete due to the revision, then there should be no uncontrolled copy and they have prevented the unintended use of obsolete doc. Are we correct?

In summary, we think of just to stipulate what docs are subject to coding, revision no.....etc in a doc control procedure, and control these according to this proc. But the proc also stipulate that "other doc" not required to be controlled according to the coding.....etc there in are also required to be controlled to meet 4.2.3g. And we will raise NC for all types of docs if their obsolete or incorrect revision doc have been found used.

We were quite confused all along, please help clarify, thank you!
 

Stijloor

Staff member
Super Moderator
#26
What is the the difference between a controlled and an uncontrolled document; and between a controlled and uncontrolled copy?

We thought of not to use the word "controlled" and "uncontrolled" in our life of implementing 9001. Can we not to be bother with it?

We just want to ensure control of certain documents using coding of identification, revision and effective date (quality manual, procedures, instructions, etc) without controlled stamp and embosser, but control only by means of recording its issue and updating the users of its revision.

There are many documents besides the above, for instance are internal audit plan, work order and etc. We knew from many people that these were not stamped "controlled" like the above manual and procedures. And these were mostly issued without recording its distribution. So are these documents become "uncontrolled"??

If all the documents must be stamped to be deemed as controlled, or to differentiate between controlled and uncontrolled doc or copies, I think we may go crazy!

Saying a doc is uncontrolled, or a copy is uncontrolled should be meaning to say it has not been controlled according to the company's doc control procedure right?

How about not to affix "obsolete" stamp on obsolete copy, but when you ask the users, they can tell you that is an obsolete one, and they know which is the current copy as they have been kept abreast with changes, and you found out that they are using correct one; in this scenario, do they still not conform to 4.2.3g?

We thought 4.2.3g does not mean obsolete copy shall be stamped "obsolete" while retained even though it has been a practice in the industries. We thought this is a good practice. As long as the revised and the obsolete have identification (i.e. revision number) instead of obsolete stamp, and the user can differentiate which is obsolete due to the revision, then there should be no uncontrolled copy and they have prevented the unintended use of obsolete doc. Are we correct?

In summary, we think of just to stipulate what docs are subject to coding, revision no.....etc in a doc control procedure, and control these according to this proc. But the proc also stipulate that "other doc" not required to be controlled according to the coding.....etc there in are also required to be controlled to meet 4.2.3g. And we will raise NC for all types of docs if their obsolete or incorrect revision doc have been found used.

We were quite confused all along, please help clarify, thank you!
You make this way to complex!! :mg: This is what you do. Keep all documents on the computer/server. These documents are your "controlled" versions. If someone needs a hard copy, they can print it, and there is a date stamp in the footer stating that: "This document expires on xx-xx-xxxx"). See?

Good luck.

Stijloor.
 
M

maris

#27
What is the the difference between a controlled and an uncontrolled document; and between a controlled and uncontrolled copy?

We thought of not to use the word "controlled" and "uncontrolled" in our life of implementing 9001. Can we not to be bother with it?

We just want to ensure control of certain documents using coding of identification, revision and effective date (quality manual, procedures, instructions, etc) without controlled stamp and embosser, but control only by means of recording its issue and updating the users of its revision.

There are many documents besides the above, for instance are internal audit plan, work order and etc. We knew from many people that these were not stamped "controlled" like the above manual and procedures. And these were mostly issued without recording its distribution. So are these documents become "uncontrolled"??

If all the documents must be stamped to be deemed as controlled, or to differentiate between controlled and uncontrolled doc or copies, I think we may go crazy!

Saying a doc is uncontrolled, or a copy is uncontrolled should be meaning to say it has not been controlled according to the company's doc control procedure right?

How about not to affix "obsolete" stamp on obsolete copy, but when you ask the users, they can tell you that is an obsolete one, and they know which is the current copy as they have been kept abreast with changes, and you found out that they are using correct one; in this scenario, do they still not conform to 4.2.3g?

We thought 4.2.3g does not mean obsolete copy shall be stamped "obsolete" while retained even though it has been a practice in the industries. We thought this is a good practice. As long as the revised and the obsolete have identification (i.e. revision number) instead of obsolete stamp, and the user can differentiate which is obsolete due to the revision, then there should be no uncontrolled copy and they have prevented the unintended use of obsolete doc. Are we correct?

In summary, we think of just to stipulate what docs are subject to coding, revision no.....etc in a doc control procedure, and control these according to this proc. But the proc also stipulate that "other doc" not required to be controlled according to the coding.....etc there in are also required to be controlled to meet 4.2.3g. And we will raise NC for all types of docs if their obsolete or incorrect revision doc have been found used.

We were quite confused all along, please help clarify, thank you!

Keep in mind the following:

- All documents related to your quality management system should be reviewed and approved prior issuance and implementation.
- All changes or revision on existing documents should be reviewed and approved.
- Only Process Owner can initiate change and have the complete authority to review, identify errors and place comments for correction on the entirety of document content.
- All obsolete documents should be withdrawn from all points of issue or use.
- A back-up soft copy of all controlled documents should be kept by the document controller.
- Uncontrolled copy can only be issued for i.e. revision/updating, audit, training, etc.
- Unauthorized reproduction and/or possession of controlled documents is strictly prohibited.
- Relevant versions of applicable documents should be made available at points of use.
- Change/s on document should be traceable e.g. in a revision history

Hope this helps.
 

Stijloor

Staff member
Super Moderator
#28

Keep in mind the following:

- All documents related to your quality management system should be reviewed and approved prior issuance and implementation.
- All changes or revision on existing documents should be reviewed and approved.
- Only Process Owner can initiate change and have the complete authority to review, identify errors and place comments for correction on the entirety of document content.
- All obsolete documents should be withdrawn from all points of issue or use.
- A back-up soft copy of all controlled documents should be kept by the document controller.
- Uncontrolled copy can only be issued for i.e. revision/updating, audit, training, etc.
- Unauthorized reproduction and/or possession of controlled documents is strictly prohibited.
- Relevant versions of applicable documents should be made available at points of use.
- Change/s on document should be traceable e.g. in a revision history

Hope this helps.
Well... Let's be cautious here. What's required is stated in the appropriate Standard. For example, 4.2.3 in ISO 9001:2009. How an organization fulfills the requirements is entirely up to them. What works for one organization, may be overkill for another. My motto? Keep it simple and user-friendly. Too many document control systems have deteriorated in a mindless bureaucracy. :mg:

Stijloor.
 
S

samsung

#29

Keep in mind the following:

- All documents related to your quality management system should be reviewed and approved prior issuance and implementation.
- All changes or revision on existing documents should be reviewed and approved.
- Only Process Owner can initiate change and have the complete authority to review, identify errors and place comments for correction on the entirety of document content.
- All obsolete documents should be withdrawn from all points of issue or use.
- A back-up soft copy of all controlled documents should be kept by the document controller.
- Uncontrolled copy can only be issued for i.e. revision/updating, audit, training, etc.
- Unauthorized reproduction and/or possession of controlled documents is strictly prohibited.
- Relevant versions of applicable documents should be made available at points of use.
- Change/s on document should be traceable e.g. in a revision history

Hope this helps.
You have made extensive use of the phrase 'should be' that nearly makes your statements a 'requirement' and most of what you mentioned above are not mandated by the standard. What 'should be' (or shouldn't be) done, should depend on the 'documented procedure' formulated by the individual organization.

One example I may cite:
- Only Process Owner can initiate change and have the complete authority to review, identify errors and place comments for correction on the entirety of document content.
In my organization, I'm not the 'process owner' (someone else is) yet if I need to amend a document, I myself review it, identify the errors, advise what needs to be amended and finally forward it to the 'Process Owner' for 'approval' and I am sure I don't violate any of the requirements of the relevant standards. BTW, my 'process owner' as well as the (documented) procedure has authorized me to do it.
 
Last edited by a moderator:
M

maris

#30
Well... Let's be cautious here. What's required is stated in the appropriate Standard. For example, 4.2.3 in ISO 9001:2009. How an organization fulfills the requirements is entirely up to them. What works for one organization, may be overkill for another. My motto? Keep it simple and user-friendly. Too many document control systems have deteriorated in a mindless bureaucracy. :mg:

Stijloor.
I gave the OP a picture that can serve as guide in maintaining documents throughout their lifecycle. I thought that the OP is the document controller so I included the protection, back-up, archive, etc. Of course, it can be modified by the OP on what’s best suits them.
 
Thread starter Similar threads Forum Replies Date
S Controlled Copy Stamp on "Paper Originals" Document Control Systems, Procedures, Forms and Templates 10
B Stamping Documents as "Controlled Copy" - Clause 4.2.3 Document Control Stamp Document Control Systems, Procedures, Forms and Templates 17
W Controlled Document vs. Uncontrolled Copy - Stamp requirements Document Control Systems, Procedures, Forms and Templates 11
G Document Control-AS9100 - Marking of Documents as Master Copy of Controlled Copy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
eternal_atlas Is not having a controlled copy of ISO 9001 standard a NonConformance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 114
K Document Control Terms: Obsolete, Master Copy, Controlled and Uncontrolled Copy Document Control Systems, Procedures, Forms and Templates 2
A Distribution of Controlled Copy vs. Uncontrolled Copies Document Control Systems, Procedures, Forms and Templates 4
A What is an uncontrolled copy of a controlled document? Document Control Systems, Procedures, Forms and Templates 11
M External prints - Should copies should be marked ?Controlled Copy?? Document Control Systems, Procedures, Forms and Templates 2
N Definition Controlled Copy vs. Uncontrolled Copy - What are the definitions and differences? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
J Supplier Controlled Shipping (GM CS1) Condition Manufacturing and Related Processes 3
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D Controlled Environment requirements Miscellaneous Environmental Standards and EMS Related Discussions 1
C Work Instructions; Controlled/Uncontrolled? Document Control Systems, Procedures, Forms and Templates 5
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
qualprod Controlled sticker for product identification? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
S Controlled Document Location Document Control Systems, Procedures, Forms and Templates 3
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
G Defect codes and process codes need to be controlled AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
M Training template - controlled document? Document Control Systems, Procedures, Forms and Templates 21
D Controlled Documents & Note Making ISO 13485:2016 - Medical Device Quality Management Systems 4
P Controlled Setup Sheets for a production line Document Control Systems, Procedures, Forms and Templates 2
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
M ISO 14644 - Cleanrooms and associated controlled environments -Recovery Test Other ISO and International Standards and European Regulations 0
E Do all Controlled Document copies require a Stamp? Document Control Systems, Procedures, Forms and Templates 3
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
C Leveraging previous results in IQOQs - Environmentally Controlled Room 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R FAI (First Article Inspection) on source-controlled parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Definition of a controlled document --> is a form a controlled document Document Control Systems, Procedures, Forms and Templates 14
P Employment Application Form - Controlled or Not? Document Control Systems, Procedures, Forms and Templates 3
L Specific Question about Printing Controlled Documents. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Controlled Forms - Centralized or Decentralized? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S CS2 (Controlled Shipping Level) by GM - CB notified. What about other customers? IATF 16949 - Automotive Quality Systems Standard 1
R Digital Storage of ITAR Controlled Documentation Other ISO and International Standards and European Regulations 7
N Do Material MSDS's Need To Be Controlled? Document Control Systems, Procedures, Forms and Templates 3
C Need examples for Controlled Shipping I and II (CSL) IATF 16949 - Automotive Quality Systems Standard 3
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
D Should Customer Drawings be controlled per AS9100 QMS ? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Types of Controlled Documentation - Call Lists of Emergency Contacts Quality Manager and Management Related Issues 5

Similar threads

Top Bottom