What constitutes an acceptable naming convention for traceability?

[BParker]

I am inquiring about what is acceptable, not necessarily "best practice". Any input valued and appreciated.
Consider case below:

• 2 documents, both work instructions for similar, but different tasks

Only footer available on both documents are originators initial and the date of origin

• Date and initials are the same on both documents

Title of the two documents are different from one another, in name of document, and on headers
There are no revisions, these are original documents

In my opinion, technically you could get away with this, not having a non-conformance, based on the fact that the titles could serve to differentiate.
Would you guys flag this as a Non-Conformance, all considerations for above, or an OFI?

This is not at all how I have laid out documents in the past, and am moving forward with suggestions to move to more proper forms of documentation i.e.; "WI-xxxx_".

Again, any input is appreciated.

 

[Miner]

It depends on the size of the company and how many procedures/instructions exist. If there are relatively few, there is no reason they can't use titles. Once you get to a certain number though, it becomes easier and less confusing to make logical groupings and number them.

 

[anneliesehuss]

at my company doc mgmt. no goes

Department-Process-Part number or machine (if applicable)-Document Type-serialized number

So ...
QA-GA-PRO-01-Gauge Calibration Procedure
QA-GA-PRO-02-Gauge Study Procedure
QA-GA-WI-01- Work Instructions for Calipers
QA-GA-WI-02- Work Instructions for Micrometers

and so on.
This makes it so if I want to look up All QA owned Documents, I can just search "QA-"
or if I want all Gauge Work Instructions I can search "GA-WI"

 

[BParker]

at my company doc mgmt. no goes

Department-Process-Part number or machine (if applicable)-Document Type-serialized number

So ...
QA-GA-PRO-01-Gauge Calibration Procedure
QA-GA-PRO-02-Gauge Study Procedure
QA-GA-WI-01- Work Instructions for Calipers
QA-GA-WI-02- Work Instructions for Micrometers

and so on.
This makes it so if I want to look up All QA owned Documents, I can just search "QA-"
or if I want all Gauge Work Instructions I can search "GA-WI"

This is similar to my historical experience as well.
As a secondary; Does anyone see an issue with a controlled document being in an editable format such as a word doc? I have always locked down by saving as PDF, and keeping editable versions accessible to only those who may need to edit a document.

 

[Miner]

Definitely! If it's editable, you do not have control. Someone can change it at will without it being obvious. Sure, you can check the version history of a Microsoft document to see what changed after the fact but some damage may have already occurred before you detected it.

 

[Ed Panek]

Most quality standards ISO 9001 ISO 13485 MDR Annex IX etc. care about document identification and control, not cosmetic uniqueness.

A defense could be "The documents are uniquely identifiable by title and purpose. At the time of issue no revisions existed and no ambiguity or misuse risk was identified. The organization is implementing a more structured identifier scheme going forward as part of QMS maturity improvement" I t might be an OFI if no harm occurred IMO

 

[Bev D]

You can’t issue a NC just because something is different from what you’re ’used to’. YOU have to think about actual compliance. If the Titles provide unique identification they comply. In fact in larger orgs where documents are searched by index number the search can be quite difficult making documents difficult to access. That is my experience. Accurate titles are far better for the users even if it’s harder for the doc control person who doesn’t understand the documents. That’s what I’m used to.

 

[BParker]

Most quality standards ISO 9001 ISO 13485 MDR Annex IX etc. care about document identification and control, not cosmetic uniqueness.

A defense could be "The documents are uniquely identifiable by title and purpose. At the time of issue no revisions existed and no ambiguity or misuse risk was identified. The organization is implementing a more structured identifier scheme going forward as part of QMS maturity improvement" I t might be an OFI if no harm occurred IMO

Yes, I was definitely leaning toward an OFI, not NC. I do believe that doc control by title alone is not optimal. AS QMS coordinators and auditors, I believe it's our goal to guide processes toward accuracy, consistency and functionality, not just compliance to standards. Meaning that just because something is "technically passable", it does not mean that it is optimal condition.
Appreciate everyone's input, good conversations...

 

[BParker]

You can’t issue a NC just because something is different from what you’re ’used to’. YOU have to think about actual compliance. If the Titles provide unique identification they comply. In fact in larger orgs where documents are searched by index number the search can be quite difficult making documents difficult to access. That is my experience. Accurate titles are far better for the users even if it’s harder for the doc control person who doesn’t understand the documents. That’s what I’m used to.

I am all for accurate titles, totally agree with that. The typical layout I would use is "QA-WI 001 Gage#5 Work Instruction" or similar,,, so that it is searchable by title, but starts with the document control number, which is in the footer, along with document location path.

 

[Bev D]

Yeah I always use the ISBN to search for books in Amazon…

alpha-numerics are useful for the ‘inventory control people; they are not useful for the users. Be sure that we are focused on the users and not the administrative wonks.

An auditor audits to the requirements. OFIs are too often useless results of the auditors biases and not actual expertise.

A ‘QMS coordinator’ is a type of internal traffic controller/consultant but still should be focused on the ultimate goal: product/service quality not esoteric administrative details that do not make things easier for the user…

And yes as a data analyst I love alpha numerics for slicing and dicing data. My job at Honda would have been harder without the VIN. But the bulk of the job was understanding and using actual words to identify field problems and then solve them. Same at every other job…the ‘number’ was only one thing in a quest to improve quality.