What is the difference between a controlled document and an uncontrolled document?

J

johnkwt

#1
can anyone make clear in my mind what is the difference between a controlled document and an uncontrolled document. when does a controlled document become uncontrolled?
 
Elsmar Forum Sponsor
#2
Re: document control basics

Hello johnkwt, and welcome to the Cove :bigwave:

can anyone make clear in my mind what is the difference between a controlled document and an uncontrolled document. when does a controlled document become uncontrolled?
Ok, a controlled document is just that: Under control. It has to be approved, reviewed and updated as necessary. Changes and current issue shall be known. The correct version shall be made available to those who need it (See ISO9001:2000, clause 4.2.3 for the full list).

If you for instance copy a controlled document without registering it acc to the rules of your system, the copy will be an uncontrolled document (You cannot expect to recieve updates, right?).

/Claes
 

Colin

Quite Involved in Discussions
#3
Re: document control basics

I usually apply the 'rule of thumb' that a document needs to be contolled under the condition that if someone could get the wrong version, and it would cause them a problem, control it. Be careful not to try and control documents unnecessarily, it can become a nightmare.

Also, be sure not to confuse documents with records, they need a different type of control.
 
J

johnkwt

#4
Re: document control basics

ok thanks. controlled doc will be issued to users at point of use 4.2.3 d). users will take copies of these docs to use. i do not uderstand why copies will be uncontrolled as long as user is usingcorrect version?
 
#5
Re: document control basics

i do not uderstand why copies will be uncontrolled as long as user is usingcorrect version?
That is the problem: The users copy will, as you say be the correct version... when the copy is made... But for how long? What if the document is updated? The copy will remain the same, because it is not controlled, and the person using the copy will not be notified about the update.

Then, all of a sudden he will be doing his job acc. to incorrect or incomplete information... and be completely unaware of the fact, unless he compares his copy with a controlled document every time he uses it. That course of action often ends in tears: It has the potential to be very expensive

/Claes
 
J

johnkwt

#6
Re: document control basics

it is clearer now. copies are treated as uncontrolled because users will be using out of date versions.

but how to stop this happening or is that impossible?
 

harry

Super Moderator
#7
Re: document control basics

it is clearer now. copies are treated as uncontrolled because users will be using out of date versions.

but how to stop this happening or is that impossible?
I think you are not as clear as you thought.

Lets take for example a drawing for fabrication purpose in your plant. You will want to control it so that your fabricators are having the latest version of drawing to work on. If changes occur, then you will need to issue them with the latest revision and at the same time collect back the previous version. This ensures that all drawing at the shop are current. Number of copies of control drawings issued and to whom it is issued need to be recorded and tallied when you collect back the documents and at the same time issue new ones.

Lets say a certain part will be outsourced to outside fabricators and you want to get 4 parties to quote. You will issue them the latest drawing but Uncontrolled. The reason being there is no point or possibility to collect these drawings back. When the successful party enters into a contract with you to undertake the work for you, then you issue them the latest controlled drawing to work on. This is to ensure that the contractor is always using the latest version of drawing/document.

Hope to have clarified this item.
 
J

johnkwt

#8
Re: document control basics

it is clear, but even if the fabricators are on site they can still copy, especially if soft copy given,which would be uncontrolled, so better to make it uncontrolled?
 

RoxaneB

Super Moderator
Super Moderator
#9
Re: document control basics

Anyone can copy a document, we aren't disagreeing with that. However, somewhere in your system there is an updated (i.e., controlled) document, right? And, as part of your document control process, are the protocols for ensuring that the document is available to the right people in the right spot at the right time.

Think of the control document as your master document. If we are using a drawing as the example, would your company allow different versions to circulate on the floor and in the system? No. There is one drawing that is updated, revisions recorded in the table and approvals received. The document is then circulated appropriately.

Some people are issued a controlled copy. This means that with the master drawing is a list of some sorts that says "The following people are to receive a copy of the revised drawing once it is approved" (or something to that effect).

Traditionally, there is a means by which a controlled copy is identified (for hard copy documents). My own company has taken the approach of a "non black ink stamp stating 'controlled copy'".

Ideally, only the electronic document is the controlled copy and all hard copies are uncontrolled. But this approach only works if the organization's culture recognizes that every time they wish to use the document, they need to go online to find it instead of rifling through the stack of paper on their desk to the copy they printed off last week.
 

harry

Super Moderator
#10
Re: document control basics

it is clear, but even if the fabricators are on site they can still copy, especially if soft copy given,which would be uncontrolled, so better to make it uncontrolled?
The control drawings will be your 'contract drawings' issued to the contractor. If he or his workers chooses to use outdated drawings, they will have to pay for any mistakes if there are deviations from the original/contract drawings. That's why ISO mandate that there must be some way to control documents (drawings included). It is a good management practice.

p/s Your contractor will need to have his own system to control the drawings issued by you or you can insist on it if you for see problems.
 
Last edited:
Thread starter Similar threads Forum Replies Date
H Difference between Controlled & Uncontrolled Documents Document Control Systems, Procedures, Forms and Templates 13
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
H Difference between Stainless Steel 316 ASTM F899 and ASTM A276 Other Medical Device Related Standards 3
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
M Difference between MSA and MSE? General Measurement Device and Calibration Topics 1
gramps What is the difference between discrete and continuous variables? Problem Solving, Root Cause Fault and Failure Analysis 3
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
C IEC 60601-1-8, difference between table 4 and annex D IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Aluminum - What is the difference between 6061-T6 and 6061-T651 (both per ASTM B211)? Manufacturing and Related Processes 4
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
S Difference between Surface Finish (Ra) and Flatness (GD&T) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
O Air Flow - Which is the operational difference between LAF (vertical and horizontal) and RLAF? Manufacturing and Related Processes 2
S What the difference is between Stub Acme & Acme thread? Oil and Gas Industry Standards and Regulations 1
S DO 178B - What is the difference between review and verification? Federal Aviation Administration (FAA) Standards and Requirements 1
T The difference between SOP and Kaizen Standardization Lean in Manufacturing and Service Industries 2
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
J What is the difference between Process Variation and Tolerance? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
O Difference Between PFMEA & Control Plan FMEA and Control Plans 3
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
qualprod What is the difference between 7.4.1 (2008) and 8.4.1 (2015)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Difference between uncertainty and expanded uncertainty of measurement General Measurement Device and Calibration Topics 1
S EASA Part 145 - The difference between non-certifying staff and Certifying staff Federal Aviation Administration (FAA) Standards and Requirements 2
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
S What is the difference between a service request and a complaint? ISO 13485:2016 - Medical Device Quality Management Systems 2
I What is the difference between OOS/OOT Imported Legacy Blogs 3
A Definition Difference between Quality System Procedure and Standard Operating Procedure (SOP) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Q Difference between Monitor & Measurement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T QA vs. RA - The difference between QA and RA Coffee Break and Water Cooler Discussions 6
A Difference between Discrimination and Least Count IATF 16949 - Automotive Quality Systems Standard 2
K Difference between Medical Electrical Equipment and Medical Equipment System IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Usability Standard - The difference between IEC 60601-1-6 to IEC 62336 Human Factors and Ergonomics in Engineering 1
S What is the difference between Verification and Validation of Test Reports? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF 16949 Cl. 8.4.2.2 vs 8.6.5 - Is there any difference between these clauses? IATF 16949 - Automotive Quality Systems Standard 7
C What is the difference between "Overall Risk" and "Risk"? (ISO 14971) ISO 14971 - Medical Device Risk Management 10
C The difference between a Critical Dimension vs. Critical Characteristic Misc. Quality Assurance and Business Systems Related Topics 2

Similar threads

Top Bottom