Document coding system

kkamp

Involved In Discussions
I have created 3 coding systems for the different documents required in the QMS.

For procedures, I use:
TYPE-PROCEDURE-VERSION
Since no further information is required in the code to differentiate them from each other.

However, for forms and other documents such as Work Instructions, Templates, etc., I need to identify more than one document that can be associated with a single procedure. That is, the same procedure may consider two or more forms, different from each other, to be completed. Therefore, I use:

TYPE-PROCEDURE-NAME-VERSION
Name is the name of the form but only using two letters for identification.

Continuing with the case of forms, once they are completed, they are transformed into records. The register code considers:

TYPE-PROCEDURE-NAME-NUMBER-VERSION
Where Number is a two-digit incremental number that allows you to identify the same form filled out on several occasions. For example, a training form:
Number: 01 (Employee #1)
Number: 02 (Employee #2)
Number: 03 (Employee #1. Yes, #1)

Is it possible to use 3 different systems? I receive recommendations and suggestions
:thanx:
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I have created 3 coding systems for the different documents required in the QMS.

For procedures, I use:
TYPE-PROCEDURE-VERSION
Since no further information is required in the code to differentiate them from each other.

However, for forms and other documents such as Work Instructions, Templates, etc., I need to identify more than one document that can be associated with a single procedure. That is, the same procedure may consider two or more forms, different from each other, to be completed. Therefore, I use:

TYPE-PROCEDURE-NAME-VERSION
Name is the name of the form but only using two letters for identification.

Continuing with the case of forms, once they are completed, they are transformed into records. The register code considers:

TYPE-PROCEDURE-NAME-NUMBER-VERSION
Where Number is a two-digit incremental number that allows you to identify the same form filled out on several occasions. For example, a training form:
Number: 01 (Employee #1)
Number: 02 (Employee #2)
Number: 03 (Employee #1. Yes, #1)

Is it possible to use 3 different systems? I receive recommendations and suggestions
:thanx:
Hello kkamp,

Based on what I see, I can think of no reason why you should not identify whatever coding systems you choose.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
If you are as clear here as you would be during an inspection the regs just say you have to control documents. How is kind if up to you. If you show control, its demonstrated. Auditors may opine but its your system.
 

AndreaPBeagle

Starting to get Involved
Hello,

As long as your procedure is clear to how you name items, you can be complaint. However, I see the risk of inadvertently not following the correct option-especially as new associates come on unless this is somehow autogenerated by an electronic database.

I would state that while complaint, it is integral to get stakeholder buy-in. What do they think of this naming convention? Will they easily be able to locate SOPs, forms, etc? Can this naming convention be implemented effectively and be repeatable?
 

kkamp

Involved In Discussions
Can I ask why you feel the need to do this? How many documents are you attempting to code and for what practical purpose?
I can give you an example of why I feel I need this. If you have an easier way to encode documents, I would appreciate your help.

For example, in the case of a procedure associated with training (Training Procedure), I have two different forms to complete:
1) Training Form (TF)
2) Trainee Feedback Form (FF)
According to my coding, both are encoded as:
1) FRTRTF01
2) FRTRFF01
Where FR corresponds to an abbreviation of Form, TR to an abbreviation of Training, TF and FF to the names of the forms, and 01 to the version of the document.

As we both know, these forms can be completed many times and thus obtain several records from the same form.
But here my complication arises, because the code system of the records is very long for me. I don't know how to make it simpler.

The code for the logs, according to what I mentioned, turns out:
1) For training form (TF):
Record #1: QRTRTF0101
Record #2: QRTRTF0102
Record #3: QRTRTF0103
...
A similar case occurs with the trainee feedback form, where TF is changed to FF.

If you know of any way to make the coding simpler for both documents and records, I would appreciate your help, since this is the first time I am faced with ISO 13485.
Thanks.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
kkamp, I can appreciate your concerns because those numbering strings do look very long to me. How will users understand them? That is what matters, as I checked my copy of 13485 and did not see any specifics about how you must enumerate your documents. What if you just identified them with F01, F02 etc. and provided a readily available reference index for users?
 

SeanN

Involved In Discussions
What if you just identified them with F01, F02 etc. and provided a readily available reference index for users?
Agreed with Jen. Systemic, consistent, and expandable, right the first time you name SOPs, WIs, Forms... Take it simple. A form can be named, for example, F004/WI007/SOP002 - 015 meaning Form#4 to roll out the WI#7 under the SOP#2, ver. 15
 
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