Changing Revision Numbers - Quality Manual and Forms

P

paula

#1
Changing revisions number

My dear friends,

I came back after a long time and I have to tell you that I missed you. I also brought a little problem with me. I managed to develop and after the implementation and initial audit, obtain the certificates for a safety management system, very similar to ISO.

.. and I have this problem now. I had the initial revision and I added a new document, in fact a new form. The forms, in this system are controlled documents.

:confused: ..and I don't know how to proceed now. To give the document the current revision of the documentation, let's say n and in this case, how can anyone tell the difference between the system with or without this later form OR should I give this form a revision n+1 and then what? .. change the whole system revision to n+1 or leave just this document like this.

It is obvious that the documentation procedure has to be modified in order to explain clearly this revision change aspect.

Please help me with an advice.
I am looking forward for your answers.

Have a nice day!!
Paula
 
Elsmar Forum Sponsor
E

energy

#2
Re: Changing revisions number

paula said:

:confused: ..and I don't know how to proceed now. To give the document the current revision of the documentation, let's say n and in this case, how can anyone tell the difference between the system with or without this later form OR should I give this form a revision n+1 and then what? .. change the whole system revision to n+1 or leave just this document like this.

Paula
Paula,

One has to ask "How did you get to Rev n without a document revision procedure?". Anyway, if you started with "m", just add a last page to the procedure with a Revision block or section showing the latest Rev letter and a brief description of what was changed. I hope this helps, but I'm still not sure if I understood the question. Are you pursuing ISO? If so, there are two mandatory written procedures that you must address. They are Sections 4.2.3 Control of documents and 4.2.4 Control of records. Post again if I didn't get the question. :ko: :smokin:
 

JodiB

Still plugging along
#3
QUOTE] paula said:
To give the document the current revision of the documentation, let's say n and in this case, how can anyone tell the difference between the system with or without this later form OR should I give this form a revision n+1 and then what? .. change the whole system revision to n+1 or leave just this document like this.

It is obvious that the documentation procedure has to be modified in order to explain clearly this revision change aspect.

[/QUOTE]

I don't understand. The word "system" is what is confusing to me.

Did you add this new form to a written procedure which was already released?

Or do you have a listing of forms listed at the back of your System's manual and your question is related to whether the manual's revision changes because you have added a form to the list?

The form should have it's own revision number. (And I recommend that it is not included within the body of a procedure, but that is only MHO). This revision number is not related to any other documentation at all.

If you changed your procedure so that it now references the use of the new form, the procedure will move to the next revision number. If it was N before, now it is N+1. Keep a history of revision on the back page that explains that it now references a new form, as energy said.

Does this help?
 
N

NITIN

#4
Ok assume that
Procedure A has an Issue number 1
Form A is added to Procedure A
Then the form will have a issue number 1+revision no.
ie-Issue 1 Rev 1.
The cover page of the manual will similarly be updated to reflect this on the footer as Issue 1 Rev 1.
You might have a documnet change form that tracks these changes on the manual if any.
 
P

paula

#5
Thanks for all the answers so far. My documentation and 'system' are made according to the ISM code, which is very similar to the ISO code, but the idea is related to the safety management. You have to have document control, management review, non-conformities, corrective actions etc. procedures and also other specific procedures. The documentation is split like this: the system manual, procedures manual, forms register (so far everything is the same as in ISO) and another 3 specific manuals. Now, for sure, I have to clarify the documentation control procedure to specify more clearly how you change or add a form or procedure. In fact, this situation, when you add a new document is not treated.

So, to resume, my problem is (and I don't enter in the long details of how we got to the revision 2 - waves of changes that modified the whole documentation, either the format, or the content)that I added a new form. It will be added in the Forms register and recorded there, in the revision list. The form is refered in one of the dedicated manuals, therefore I'll change its revision to 3. My problem is now, what revision I'll use for the form. I am a little confused here.

In fact, can anyone please help me with a model of revision control procedure or instruction?

Thank you again.

--------------------------------------
What we learn to do, we learn by doing. --Aristotle
 
M

M Greenaway

#6
Paula

I would give the new form revision 1 as there have been no previous revisions. I would reference the use of this form in my procedure, which would be up-issued to reflect this change. In my opinion that is all you need to do.
 

JodiB

Still plugging along
#7
Your form revision number is not related to any other piece of documentation. It only keeps track of how many times the form itself has been revised.

We use 0 for the initial release of a document, including forms. Then 1 for the first revision. This is briefly described in our doc control procedure.
 
B
#8
The way I handle forms is as follows. Every form has its own ID number. Every form also has its own release or revision date. Then in the various procedures, I reference the form number. only. In this way if I have to make future changes to the form, I do not have to go back and change the procedure. Hope this suggestion is of some help.
 
Q

qualitymanager

#9
paula said:

...You have to have document control, management review, non-conformities, corrective actions etc. procedures and also other specific procedures...

So, to resume, my problem is (and I don't enter in the long details of how we got to the revision 2 - waves of changes that modified the whole documentation, either the format, or the content)that I added a new form. It will be added in the Forms register and recorded there, in the revision list. The form is refered in one of the dedicated manuals, therefore I'll change its revision to 3. My problem is now, what revision I'll use for the form. I am a little confused here.

In fact, can anyone please help me with a model of revision control procedure or instruction?

Thank you again.

--------------------------------------
What we learn to do, we learn by doing. --Aristotle
My suggestion is pretty much along the lines of what went before (Have a look at ISO 9001:2000 clause 4.2.3 a, b & c for guidance):

1. Identify need for revision,

2. Get affected parties to agree on changes,

3. Change documents & make available to all affected persons (they should previously have been made aware of changes via meetings, memos, etc.).

To change the revision status of a document (any document) it means that the content has changed significantly. For instance, if I changed only the font on a form from Arial 10pt to Times New Roman 12pt I wouldn't change the revision status (but I'd probably let users know that the content remained the same - change can throw people off sometimes.)

Given that a change is necessary (i.e. to an existing document), all I do is update the revision status on the particular document AND the relevant master list - those are the only 2 places where the revision number is recorded (if you record the revision number in the procedure you have to change the procedure every time you change a form - too much work for me :vfunny: ). If it's a new form, and you are required to have a documented procedure which addresses the form, then you change the content of the procedure (and it's revision number) as well.

I strongly advise that, if you have recorded revision numbers of documents (e.g. forms) in other documents (e.g. procedures), you change that practice (slowly or quickly - up to how much time you have on your hands :p ).

To reiterate, the revision number changes from "n" to "n+1" on the changed document & the relevant master list. I come from the same school of thought as Lucinda (if I remember her post correctly) - I start at REV 0. It doesn't matter in practice which you start with (0, 1 or 10) - just that current and obsolete versions can be identified.

paula said:

Now, for sure, I have to clarify the documentation control procedure to specify more clearly how you change or add a form or procedure. In fact, this situation, when you add a new document is not treated.
My reading of the 9001 standard doesn't require that you document the method you use to change revision numbers, just that the current revision status of documents is identified - please post the requirement in the standard you are following.


If this post is too confusing, send me the requirements & the current procedure & I'll take a stab at it.


qualitymanager
 
E

energy

#10
qualitymanager said:

My reading of the 9001 standard doesn't require that you document the method you use to change revision numbers, just that the current revision status of documents is identified -
qualitymanager
Qual Mgr,

4.2.3

You document the method used to change revisions. Obviously it can be letters, numbers, symbols, etc.. Whatever you decide to use. "A documented procedure shall be established to define the controls needed b) to review and update as necessary and re-approve documents" that goes hand in hand with c) "to ensure that changes and the current revision status of documents are identified". Also, Paula isn't doing this for ISO 9001:2000.

Paula,

I will send you a Model for Revision Control of Documents, via regular e-mail. Too long to post here. Right after the long weekend. We have (2) procedures. The other is for Administration and Control of Documents. I'm sure you'll find something you can use. Enjoy the holiday.
:ko: :smokin:
 
Thread starter Similar threads Forum Replies Date
G Revision number when changing over to ISO 9001 edition 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Z Quality Manual Revision - Update - Changing our company name Quality Management System (QMS) Manuals 4
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2
K Changing the Auditor within a Notified Body ISO 13485:2016 - Medical Device Quality Management Systems 4
B Process Capability - Changing Limits to Improve Cpk or find Root Causes? Capability, Accuracy and Stability - Processes, Machines, etc. 6
M Changing Notified Body - Anyone have stories to share CE Marking (Conformité Européene) / CB Scheme 3
R Changing ISO 9001 Certification Scope Quality Manager and Management Related Issues 4
W Depth Gage Spindle moved when changing Contact Point Calibration and Metrology Software and Hardware 6
M Changing a Chinese Legal Agent China Medical Device Regulations 5
B Changing dimensional tolerances to approve rejected product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Change Control Requirements when changing Suppliers IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom