Interesting Discussion Controlled Copy Stamp - Document Control

M

maris

#31
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.
A "process owner" could be a department head, organization head, supervisor or designated alternates, whoever within the organization. It’s up to how you define "process owner". I think the important thing he is authorized to modify and add/remove process.
 
Elsmar Forum Sponsor
M

maris

#32
savetheearth,

I hope you could establish a method for preparation, approval, revision, release, tracking and maintenance of controlled documentation. Listen to them. Once you are done with the draft of your doc control procedure, you can post here for constructive criticisms.

It’s time for me to go to bed. Good luck. :bigwave:
 
M

miross

#33
Regarding your "controlled copy" stamp, you might want to take a look at StampIt for Word. Not only can that add-in stamp existing Word documents, but is fully capable to stamping existing paper using your printer. It's well worth a look. Just Google StampIt for Word.
 
S

savetheearth

#34
Our appreciation to everyone! But we hope anyone can provide us the answer to each of our questions.

We look forward to the answers....though it depends on the company's preference.

Please help...:(
 

Helmut Jilling

Auditor / Consultant
#37
hello..

may i know, if we want to give the drawing to customer, what should i stamp?
ISO does not require you to stamp it at all, unless your procedure requires it. The document you give away would be accurate at the time you print it, but would be classed as an uncontrolled document going forward.
 
B

buterfly

#38
ISO does not require you to stamp it at all, unless your procedure requires it. The document you give away would be accurate at the time you print it, but would be classed as an uncontrolled document going forward.
thanks for your reply..

im new in this field..so, i need to learn from basic.
thank you once again. :thanks:
 
S

savetheearth

#40
Any further questions unanswered ?
What is the the difference between a controlled and an uncontrolled document; and between a controlled and uncontrolled copy?


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"?? Like buterfly's drawing? "Uncontrolled" doc/copy lead to NC?


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?


Dear Ajit Basrur, could you help me with these questions? Thank you....
 
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