ISO 9001 and ISO 13485 GDP (Good Documentation Practices) Findings

mdurivage

Quite Involved in Discussions
#1
I occasionally run across companies with poor documentation practices i.e. using correction fluid, pencil, scribbles, date changes, etc. I know there is not a specific site (ISO/CFR). What is the best way to write these practices up as a finding in an audit report and what do you use as a citation?
p.s. I did run a search here on the Cove and the internet and did not really find a solid answer!
 
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somashekar

Staff member
Super Moderator
#2
I occasionally run across companies with poor documentation practices i.e. using correction fluid, pencil, scribbles, date changes, etc. I know there is not a specific site (ISO/CFR). What is the best way to write these practices up as a finding in an audit report and what do you use as a citation?
p.s. I did run a search here on the Cove and the internet and did not really find a solid answer!
If it is leading to anything not legible in documents / records, then it is a sure NC.
" There is evidence to state that documents / records are not legible as seen in the following examples " .... (cite examples)
To err is human, but to hide the error is more a sin.
The procedures for documents and records can address this effectively.
Errors when noticed can be deleted with a strike through and re-written legible at the place and signed off at the nearest place.
 

Doug Tropf

Quite Involved in Discussions
#3
I occasionally run across companies with poor documentation practices i.e. using correction fluid, pencil, scribbles, date changes, etc. I know there is not a specific site (ISO/CFR). What is the best way to write these practices up as a finding in an audit report and what do you use as a citation?
p.s. I did run a search here on the Cove and the internet and did not really find a solid answer!
With regards to ISO 13485, the guidance document (ISO 14969), offers some specifics in sections 4.2.4.4 and 4.2.4.5.
 
T

treesei

#4
I occasionally run across companies with poor documentation practices i.e. using correction fluid, pencil, scribbles, date changes, etc. I know there is not a specific site (ISO/CFR). What is the best way to write these practices up as a finding in an audit report and what do you use as a citation?
Besides whatever specified in the standards, you may cite them against the company's GDP procedure. If there is one, most likely the poor practices have violated the procedure.
 
#6
Besides whatever specified in the standards, you may cite them against the company's GDP procedure. If there is one, most likely the poor practices have violated the procedure.
... and if there's not a discussion of GDP as part of the Control of Records (or standalone) SOP, and any handwritten records are being maintained as part of the QMS, is that a large enough failure versus ISO13485 4.2.4 to warrant a major NC? I bet you :2cents: that some of our medical OEM Customers would say so! :whip:
 
#7
:bigwave:
Rolling out Good Documentation Practices at our site and lots of good questions.
One that has come up is regarding the comment section on a form.
If there are no comments, is it acceptable to leave it blank?

Our GDP SOP says that blank fields should be marked "N/A" with initial/date...
but does this count?
 

somashekar

Staff member
Super Moderator
#8
:bigwave:
Rolling out Good Documentation Practices at our site and lots of good questions.
One that has come up is regarding the comment section on a form.
If there are no comments, is it acceptable to leave it blank?

Our GDP SOP says that blank fields should be marked "N/A" with initial/date...
but does this count?
A lot has got to do with the design of the form itself.
A comment section on a form must have 'comments' or '-- NIL --'
The N/A (Not Applicable) as I understand is always a grey area.
I would even suggest you look into your GDP SOP with more insight.
Never let a field go blank.
 

GStough

Staff member
Super Moderator
#9
:bigwave:
Rolling out Good Documentation Practices at our site and lots of good questions.
One that has come up is regarding the comment section on a form.
If there are no comments, is it acceptable to leave it blank?

Our GDP SOP says that blank fields should be marked "N/A" with initial/date...
but does this count?
If your GDP SOP instructs you to mark blank fields with "N/A" with initial/date, why would you not want to follow it? IMO, to blatantly not follow the SOP, well, that is just low-hanging fruit for a zealous auditor, who will likely write an NC.

However, there are ways to modify a form so that blank fields are acceptable. For example, a question such as, "Additional information and/or comments? Y/N" and a checkbox with the correct option checked would be reasonable.
 
Q

qualityphil

#10
I have a similar question - Can you intentionally leave a comments section blank? I was always told that a comment section should be left blank and not marked N/A in the event of an NC or Recall, the form could be updated? is this accurate?
 
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