Document Control Defined? Determining what documents must be controlled

H

HillaryLynn

#1
We are currently putting together a team to "DEFINE" what criteria to use to determine what documents should be controlled and what doesn't need to be controlled. So if it meets this....controlled, if it doesn't meet this...doesn't need to be controlled. My personal opinion is that if an organization has a process that is critical to the end result customer (building something, contracts etc) it should be documented. Thoughts?
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Document Control Defined?

We are currently putting together a team to "DEFINE" what criteria to use to determine what documents should be controlled and what doesn't need to be controlled. So if it meets this....controlled, if it doesn't meet this...doesn't need to be controlled. My personal opinion is that if an organization has a process that is critical to the end result customer (building something, contracts etc) it should be documented. Thoughts?
Just because something is documented doesn't necessarily mean that the document should or must be controlled.

What you have to consider is the risk of not controlling a given document, thus the benefits of control are revealed. Some questions to consider:
  • Who can change the document?
  • How is the document to be approved?
  • What might happen if someone uses a superseded version?
  • Can everyone who might need the document access it when it's needed?
There are other considerations, but you get the idea. Try to figure out what the liabilities might be when a document isn't controlled.
 
G

Geoff Withnell

#3
Re: Document Control Defined?

Just because something is documented doesn't necessarily mean that the document should or must be controlled.

What you have to consider is the risk of not controlling a given document, thus the benefits of control are revealed. Some questions to consider:
  • Who can change the document?
  • How is the document to be approved?
  • What might happen if someone uses a superseded version?
  • Can everyone who might need the document access it when it's needed?
There are other considerations, but you get the idea. Try to figure out what the liabilities might be when a document isn't controlled.
Wow, Jim and I agree! :) A document should be controlled if it is important that those who need the information in the document can access it and that they have the correct information. if it isn't important, the question then becomes "Why do we have this document?" But that is another story.

Geoff Withnell
 

qusys

Trusted Information Resource
#4
We are currently putting together a team to "DEFINE" what criteria to use to determine what documents should be controlled and what doesn't need to be controlled. So if it meets this....controlled, if it doesn't meet this...doesn't need to be controlled. My personal opinion is that if an organization has a process that is critical to the end result customer (building something, contracts etc) it should be documented. Thoughts?
Agree with the other expert Covers.
ANother suggestion for criteria is to have a clear understanding of what documents really impacts your QMS and the other management systems ( environment, safety, security and so on).
Some example could be operative procedures, quality plans, maintenance plans, customer requirements documentation, PPAP, FMEA, control plan overall all that you assess that can have impact on your operativity.
This is up to the organization and you can state this in your document control procedure:bigwave:
 
H

Hodgy Hotsauce

#5
Hillary,

No mention is made of the specific industry to which the question applies. I must approach the question as one coming from the aerospace industry. The minimum requirements for document control will be defined by first the contracts that have been drawn up by the manufacturer and customers and the applicable ISO, MIL, ANSI, FDA, etc. standards. For any company to become a valued supplier there must be full-up traceability to the processes and materials employed and the revision level of those processes and materials. When setting up document control one must think like an auditor or ISO assessor. Document control at all levels is imperative. This includes material specs, process procedures, design, personnel training, sub-tier supplier documentation, facility/equipment modifications (i.e.; everything that goes into producing the product or providing the services requested).
 
Last edited by a moderator:

Wes Bucey

Quite Involved in Discussions
#6
Hillary,

No mention is made of the specific industry to which the question applies. I must approach the question as one coming from the aerospace industry. The minimum requirements for document control will be defined by first the contracts that have been drawn up by the manufacturer and customers and the applicable ISO, MIL, ANSI, FDA, etc. standards. For any company to become a valued supplier there must be full-up traceability to the processes and materials employed and the revision level of those processes and materials. When setting up document control one must think like an auditor or ISO assessor. Document control at all levels is imperative. This includes material specs, process procedures, design, personnel training, sub-tier supplier documentation, facility/equipment modifications (i.e.; everything that goes into producing the product or providing the services requested).
All true, but these things you mention are just subsets of the basic elements of control Jim W has laid out. Too many folks, it seems to me, are getting all involved in mission creep when it comes to document "control" and are trying to instill security factors to EVERY document in a system. Those unnecessary security factors escalate the cost of document management with no added value to the organization. Clearly, "some" organizations may require high security for "some" documents, but most of us will never have dealings with an organization where EVERY document needs high security, so it makes sense that a control process should probably include a way to identify and segregate documents which DO need high security and thus keep document management costs down. Geoff alludes to "appropriateness" of controls when he writes
if it isn't important, the question then becomes "Why do we have this document?" But that is another story.
I dealt in aerospace with sensitive documents, but the nature of our operation was such that we did not need locks on the filing cabinets which held those documents because no unauthorized persons had access to a file cabinet. Traceability is critical, but traceability is just a matter of acquiring and managing the records which provide that traceability. The point being no aerospace manufacturer would even buy, let alone use, even a simple fastener unless it had traceability documents.



:topic:
Evidence of "training" is not as important as evidence of "competence." I'm sure many folks have come across workers who had been through "training," but were still incompetent at the task to which they were assigned.
 
K

kgott

#7
A good rule of thumb is "documents which are subject to revision are controlled documents."
 

Wes Bucey

Quite Involved in Discussions
#8
A good rule of thumb is "documents which are subject to revision are controlled documents."
Records need to be controlled to protect against accidental or purposeful deletion or alteration. Records are not subject to "revision" (i.e. the "history" cannot be altered, but it can be updated [like a production log] to reflect new data.)
 
K

kgott

#9
Thats right Wes, I forgot to mention that there is a wider context of the meaning of the word controlled, good point.
 

Jim Wynne

Staff member
Admin
#10
A good rule of thumb is "documents which are subject to revision are controlled documents."
In addition to Wes's point regarding records, there can be forms that are not controlled but still might get changed from time to time. The rule should be "Documents that need to be controlled must be controlled" with need determined by the requirements of the standard(s) and rational judgment.
 
Thread starter Similar threads Forum Replies Date
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 39
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
x-files Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
I How to build a Microsoft Access MDB Database for Document Control Document Control Systems, Procedures, Forms and Templates 6
I Document Control - Document Revision History Question Document Control Systems, Procedures, Forms and Templates 16
M I Attached My first Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L ISO 13485 Document Control - Document Changes - Needing Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 1
Gman2 My Attached Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom