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Information/Instruction Signs that refer to controlled documents - FDA Environment

S

suziwann

#1
We have signs up here that refer to controlled documents but they are not copies of the documents, they are instruction signs with graphics.

On the bottom of the sign it states that it is from the 'latest revision of WI 332'

Do the signs need any reference to documents at all?
My thought is that they don't and they certainly shouldn't refer to 'latest revision.'

Thankyou in anticipation.
 

RoxaneB

Super Moderator
Super Moderator
#2
I'm curious why they are not controlled as part of the document. Instruction with graphics...sounds like a work instruction and if vital to the process/product, shouldn't they be controlled?

We have something referred to as job aids around our location. Settings of equipment, some pictures, etc. These are controlled but in a manner different than that taken with our work instructions.
 
S

suziwann

#3
Hello RCBeyette,
Thankyou for taking the time to reply.

I have just been told that BSI had told us in a previous audit that the signs should refer to the controlled document.

They were all updated to include the document number and issue.

Then in a further audit we were told that to refer to the document was enough, without the issue number. They were updated without the issue number.

Last week however an auditor told me that the phrase 'latest issue' is a non conformance. I do agree as every issue at some point was the 'latest issue.'

I am still trying to find out before our ISO audit tomorrow and the Quality Manager isn't here at present.

Sign examples with doc ref - 20 kg max.
Four bins max.- taken from WI's.

We have other signs around the place such as 'put all waste in skips provided' - these are taken from our Environmental Policies, they have no document reference though.

I have read the posts on 'controlled documentation,' yet I can't seem to find the answer to my question.
 

RoxaneB

Super Moderator
Super Moderator
#4
My concern lies not with the reference to the work instruction, but whether the work instruction references this apparent job aid. What if this job aid refers to WI-123 but then WI-123 is rendered obsolete? Where is the trigger to update/remove this job aid? Our own documentation provides links/references to all related documentation, even that which is outside of the document control software.

With an audit tomorrow, I highly doubt that you will reach a resolution to this issue in time...what I would suggest is that you formulate a plan with the Quality Manager when s/he arrives. That plan might alleviate any concerns an external auditor might have.

Signs like "put all waste...", don't need to be controlled (in my opinion). A line has to be drawn somewhere.

Rule of thumb...ask yourself "If this sign/instruction is not followed, is there the possibility of an adverse situation to the product/process/environment/safety?" If your answer is yes, then it should probably be controlled.
 

Scott Catron

True Artisan
Super Moderator
#5
RCBeyette said:
What if this job aid refers to WI-123 but then WI-123 is rendered obsolete? Where is the trigger to update/remove this job aid?
Just to back up Roxane here - all forms or job aids should be referenced in the supporting procedure and, at the same time, the forms or job aids should reference back to the procedure. You should also list the distributed location of aids, so you can change/remove them as the situation requires.

RCBeyette said:
Rule of thumb...ask yourself "If this sign/instruction is not followed, is there the possibility of an adverse situation to the product/process/environment/safety?" If your answer is yes, then it should probably be controlled.
I'll add an amen to this.
 
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