Can two exact forms be placed in one centralized location with two different QA-P-#'s

M

mhans

#1
Controlled Forms

Hello anybody and everybody...

Here's a good documentation question... Can two exact forms be placed in one centralized location with two different QA-P-#'s on them....

An example.... Credit request QA-P-1000-01-F1
Credit request QA-P-1000-01-LF1

If someone could please give me some info regarding this, I would greatly appreciate it.

Thank you,
Marcy-
 
Elsmar Forum Sponsor

CarolX

Super Moderator
Super Moderator
#2
Hi Marcy,

What is the difference between the 2 forms? Since they have different numbers, I assume there is a slight difference between the 2.

An example.... Credit request QA-P-1000-01-F1
Credit request QA-P-1000-01-LF1
I am just guessing here....the first one is the standard form, and the second is the long form? If so, I would answer your question as "Why not?".

If you could provide more info, I might be better able to answer your question.

Regards,
CarolX
 
B

Bob_M

#3
mhans said:
Can two exact forms be placed in one centralized location with two different QA-P-#'s on them....
Simple answer: Sure why not?
Simple Question: If they are EXACT copies, why would you want two copies with two different form numbers?

If CarolX assumed right and their is a long and short version of the form then the are NOT EXACT and should have two different numbers.

More details please.
 
M

mhans

#4
Cotrolled Forms

Hello CarolX and Bob...

These are two exact same forms.... The info within them are different....

I suggested that they need to be slightly different to show validation for the two different QA-P-#'s or share the same QA-P-#'s....

What would your response be to that?? Do you still think that the two "exact" forms should be placed in the same location but with two different QA-P-#'s??

M-
 
M

mhans

#5
One of the forms is within a larger spreadsheet that contains that form plus other forms.....

The other exact form is used outside of the larger spreadsheet.
 
B

Bob_M

#6
So if it get this right:
The 2 forms are identical, but are used for two different tasks, and the 2nd version of the form is used with additional forms...

If the short version is used and printed all by it self, and the larger one is use in conjunction with the other forms i would recommend:

A) Only use the larger spreadsheet and use the "exact" form and "other" forms AS NEEDED.
B) Keep the seperate forms and form numbers. Not a problem just harder to update 2 at the same time.
Either or will work "within" ISO as long as the user knows which one to use when.
 
M

mhans

#7
Hello Marc....

The problem is.. That these two forms are in the same location, and our "end" user would use what ever is "easier" for them.. Even if it's not the correct one to use....

What I mean is... If asked by a BSI auditor to look at a customer file, and within that customer file, all the forms within this larger shreadsheet is used except this one.. The one he used is the "other" exact form.. BUT.. The other forms have the same and correct controlled # on it, except this one....

Being an auditor.. I would question why the person didn't use the correct form....

I just need a good justification as to "Why" two of the "exact" form should NOT have two different controlled #'s on it. Can you help me out??? I've looked through the elements.... and I've found things that would somewhat agree with me, but nothing on the spot.... Would a BSI auditor "hit" us with a NC??

Thanks,
Marcy-
 

CarolX

Super Moderator
Super Moderator
#8
Marcy,

I agree with Bob. Keep them numbered seperately. Just as long as everyone know how to use them, you should be ok.

Carol
 
B

Bob_M

#9
mhans said:
The problem is.. That these two forms are in the same location, and our "end" user would use what ever is "easier" for them.. Even if it's not the correct one to use....
With this statement I'd be more worried with the person using the wrong form or form "package".

I go back to my earlier suggestion. Use one spreadsheet (with the form in question) and educate/document HOW/WHEN people should be using which form(S).

If you WANT 2 copies of the SAME form with 2 different numbers, go right ahead, but good luck teaching people when to use each one. If you update the standalone one, do you need to update the bundled one? If yes why bother with two seperate forms?

Note: I'm assuming you're using something like Excel with multiple tabs and each form is on one of the tabs...
 
R

Randy Stewart

#10
I have to agree with Bob on this one.
If the "bundled" form is updated how does it effect the "stand alone" form?

That these two forms are in the same location, and our "end" user would use what ever is "easier" for them.. Even if it's not the correct one to use....
If this is your only justification for multiple forms then, as an auditor, it would raise a few questions for me. The first being where is the discipline to operate inside your system?

There is nothing that states you can't operate the way you currently are. What does your procedure state? As long as you spell it out somewhere and can prove it is followed then there is no NC. It has been my experience that when this type of form sharing is allowed that 1 doc will be updated and the other is forgotten. Or, the process for filling out the form is changed but it is not used that way on the other, therefore violating the procedure. These are very minor issues, but can leave questions in an external auditors mind as to the validity of your system.

I believe, whole heartedly, in a flexible system. It can't be so rigid that it makes more work for people. But, the system should govern the employees, the employees should not govern the system.
 
Thread starter Similar threads Forum Replies Date
A Exact terms for a plating failure and difference between rejection rate and failure rate Manufacturing and Related Processes 9
P What is the exact difference between Risk and Opportunity in context of ISO 27001? IEC 27001 - Information Security Management Systems (ISMS) 7
D What is the exact Temperature Coefficient Value to be set on a Conductivity Meter? General Measurement Device and Calibration Topics 2
shrutisancheti Exact Classification for Trans Radial Compression Device per EU directive 93/42/EEC EU Medical Device Regulations 2
C Do titles that are called out in processes and procedures have to be exact? Document Control Systems, Procedures, Forms and Templates 3
C Calibration Dates - Exact day or end of month? General Measurement Device and Calibration Topics 24
G What is the exact meaning of Single Fault condition? EU Medical Device Regulations 4
R Using Exact Words from ISO 9001:2008 in Level 1 Document (Quality Assurance Manual) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S Use of Exact Text with the Graphical Symbols in User Guides EU Medical Device Regulations 7
S Definition OEM (Original Equipment Manufacturer) - Exact definition of OEM Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
ScottK Definition Copy Exact - Committment to abide by a Process Control Plan without deviation Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 34
J What is the exact meaning of "calendar year"? TS2-Rules2 clause 4.13 IATF 16949 - Automotive Quality Systems Standard 20
apestate Exact Format of Clause 2 References ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
M Forms review Manufacturing and Related Processes 5
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Serialization and Reconciliation of Forms Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 7
I When do FORMs and Log Files become Records? Document Control Systems, Procedures, Forms and Templates 9
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Forms Master List versus Record Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M What to do about Non Conformance forms that are deleted or missing? Nonconformance and Corrective Action 4
R Purchase order forms - who keeps them? ISO 13485:2016 - Medical Device Quality Management Systems 3
GreatNate Various Audit Templates - Canned forms and templates Document Control Systems, Procedures, Forms and Templates 9
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
I Document levels and approval requirements for lower level documents like work instructions, forms etc. Document Control Systems, Procedures, Forms and Templates 18
S Supplier Audit Assessment / Evaluation Forms IATF 16949 - Automotive Quality Systems Standard 1
K Do Forms and Templates ALWAYS become Records? Records and Data - Quality, Legal and Other Evidence 4
M ISO13485 Documentation packs (manual, procedures, forms etc) ISO 13485:2016 - Medical Device Quality Management Systems 3
S Medical Device Servicing - Forms and Signature ISO 13485:2016 - Medical Device Quality Management Systems 1
S Control of Forms Document Control Systems, Procedures, Forms and Templates 4
M AS9100D Process Map Requirements - PEAR Forms AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
O AS9102 FAI report Forms 1-3 Document Control Systems, Procedures, Forms and Templates 6
QSM_Rick Controlling Multi-Tab Microsoft Excel Forms Excel .xls Spreadsheet Templates and Tools 5
R Standards Data Forms (form 3654) - American Academy of Sleep Medicine (AASM) US Food and Drug Administration (FDA) 0
H Manufacturer vs. Supplier - Which is which on PPAP Forms APQP and PPAP 3
pammesue ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
P FDA has just released the forms for "Small Business Qualification and Certification" Other US Medical Device Regulations 6
W Form Approval - Blank forms Document Control Systems, Procedures, Forms and Templates 9
W Unattached (stand-alone) Forms acceptable for AS9100C? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
J Training SOP and Forms Training - Internal, External, Online and Distance Learning 3
M Some ISO 9001:2015 Forms and Templates Document Control Systems, Procedures, Forms and Templates 5
P Customer Forms as external documents Document Control Systems, Procedures, Forms and Templates 4
H Incomplete forms and records missing date or a name Records and Data - Quality, Legal and Other Evidence 6
T Controlled Forms - Centralized or Decentralized? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Document Numbers (Identification) on Forms (AS9100) Document Control Systems, Procedures, Forms and Templates 15
S Clinical Trial Informed Consent Forms ("retro-signing") US Food and Drug Administration (FDA) 2
A How to Verify Supplier I-9 Forms for ITAR Requirements Other ISO and International Standards and European Regulations 2
Gman2 Control of Documents and (FORMS) on a Computer Network ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
MichaelDRoach Where in ISO 9001 is White Out on Forms and Records Prohibited? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12

Similar threads

Top Bottom