SBS - the best value in QMS software

Can a document (form) approval record be separate?

ISO_Man

Involved In Discussions
#1
I have a form to approve. The first 2 pages is the business content - what the form is really for -- the 3rd page is just the approval, revision history, approval signature, etc. The creator of the form wants to be able to print pages 1 and 2 of the approved form for daily use but not waste the 3rd page by printing it every time.

I know that ISO doesn't specify EXACTLY how to do this, but can I have a form that's approved and the approval record is not part of that document? If an auditor picks up the form and it's page 1 of 3 and 2 of 3, the first question is going to be "where's page 3?"

Can I have a separate approval record for each form?
 
Elsmar Forum Sponsor

blackholequasar

Involved In Discussions
#2
I have worked with companies that have something called a DCN/DCR - a document change notification/document change record. A separate document captures the revision history of the document and a log (record) keeps track of changes. In the company I work at currently, I hyperlink this DCN document in the footer of the document for anyone who may want to see the full revision history with signatures. (This is also maintained in a document master binder)

Some older documents have revision changes well into the double digits and it would take up pages of the document. It just seemed to be very cluttered. The DCN serves as record.
 

RoxaneB

Super Moderator
Super Moderator
#3
Since ISO doesn't tell you how to do something, it's up to your organization to create a management system that works for (i.e., adds value to) the organization.

Does having that 3rd page add any value? If Page 3 goes missing, what is the impact to the process?

My own take is that the approval for forms (re: template for what will eventually become a record) doesn't belong on the form itself. Your doc control system should be robust enough to handle this approach.
 

John C. Abnet

Teacher, sensei, kennari
#4
Can I have a separate approval record for each form?
Good day @ISO_Man
I'll answer your question with another question. Why change anything? As long as you can show evidence that the current level document (i assume you keep the " master" as a digital document), is the same level as the document in use, then there is no problem.

Specific to your question of "can I have a separate approval record"? The answer is yes, of course.

One method I have used is as follows...
- A log (data base in some cases) assigns a sequential "serial number" for identifying all change point control (e.g. CP-0001, CP-0002, CP-0003, etc..etc..)
- The log (data base in some cases) simply identifies the following by the assigned serial number.. ..
a) The document number impacted by a given change point control serial number (e.g. CP-0022)
b) WHY the change is desired
c) WHAT changed
d) WHO approved the change
e) WHEN (date of change implementation)

The change point control serial number (e.g. CP-0022) is listed on the document (generally a field on the front/first page).

Now when a document is used, it is clear to see the most recent CPC serial number (instead of rev level) listed on the document. To understand if that is the most recent version and the WHY-WHAT-WHO-WHEN associated with the change (i.e. change history) simply look up CP-0022 in the log (data base in some cases).


Regardless of your approach, don't overthink it. As long as you can show evidence that the relevant information on the document in use is consistent with the intent (current "revision" level), then you have ensured the correct document is being used (and, by the way, satisfy the requirements of the standard).

Hope this helps.
Be well.
 

outdoorsNW

Quite Involved in Discussions
#7
Many places have the document approvals on a separate form, and the actual document or form only has a revision number or date to be used to connect to the approvals. As long as you have good doc control practices so only the current version is accessible and in use, you will not have audit problems.

With printed forms the biggest problem is people printing out a large amount and using outdated revisions.
 
Thread starter Similar threads Forum Replies Date
L ISO 9001 Document Review and Approval Form Requirements Document Control Systems, Procedures, Forms and Templates 6
K Can a document approval be in the form of password? Document Control Systems, Procedures, Forms and Templates 22
S Document Control (Need an Approval Form) - ISO 9001 clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 35
T Document Review and Approval Form - Examples Attached Document Control Systems, Procedures, Forms and Templates 11
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Nonconformity for missing form number on the job description document Nonconformance and Corrective Action 1
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
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
L Procedure Change Request Form - "ISO Procedures" Document Changes Document Control Systems, Procedures, Forms and Templates 5
T Is there a difference between form control and document control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Definition of a controlled document --> is a form a controlled document Document Control Systems, Procedures, Forms and Templates 14
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
x-files Signature(s) on ?Document control form? and/or on ?Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Document Revisions - How do I track the Form Revision History/Approvals? Document Control Systems, Procedures, Forms and Templates 5
G Requirement for Form Numbering (Document Identification) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Document Creation and Amendment Form example Document Control Systems, Procedures, Forms and Templates 2
K Form 42-2 for Document Initiation and Change Record - Template wanted Document Control Systems, Procedures, Forms and Templates 3
H SOP (Standard Operating Procedure) for Form and Document Approvals ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Document Format vs Content Revision - Form changed from MS Word to MS Excel Document Control Systems, Procedures, Forms and Templates 7
H Example of DCR (document change request) form needed Document Control Systems, Procedures, Forms and Templates 14
A Is revision level required in the document / form? Document Control Systems, Procedures, Forms and Templates 7
C Control of Document and Form Master Lists Document Control Systems, Procedures, Forms and Templates 9
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Do Document Master Lists need a Form Number Document Control Systems, Procedures, Forms and Templates 4
M Blank Form vs. Completed Form - A document or record? Records and Data - Quality, Legal and Other Evidence 11
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Nitpicking on document released dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Refusal to Document Complaints Customer Complaints 39
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

Similar threads

Top Bottom