Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote?

[r0nyn]

Hello All!

Just a quick QMS question to start. Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? My understanding is that only Forms and Logs require these footnotes, as they are documents that are able to be used multiple times, whereas an SOP would only need to be contained within the QSM and does not constitute a physical "Point of Use" within a company.

Thanks very much in advance for any responses.

 

[Mikishots]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

Hello All!

Just a quick QMS question to start. Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? My understanding is that only Forms and Logs require these footnotes, as they are documents that are able to be used multiple times, whereas an SOP would only need to be contained within the QSM and does not constitute a physical "Point of Use" within a company.

Thanks very much in advance for any responses.

Not familiar with the QSM acronym.

These footnotes you've mentioned are not a requirement - what standard are you using as reference?

 

[GoKats78]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

I would guess QSM stands for Quality System Manual?

As the the "Point of Use" and/or "File In" requirement...what requirement?
Unless, of course, their "QSM" places such a requirement on their system...

We get ourselves in so much trouble by adding requirements to our systems that exist only in the mind of the author of that requirement.

We have gone through many of our high level documents in an attempt to pare them down to what is required (and what we really need) to avoid over-burdensome requirements

 

[AndyN]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

Hello All!

Just a quick QMS question to start. Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footnote? My understanding is that only Forms and Logs require these footnotes, as they are documents that are able to be used multiple times, whereas an SOP would only need to be contained within the QSM and does not constitute a physical "Point of Use" within a company.

Thanks very much in advance for any responses.

Welcome to the Cove. Great questions. Short answer is - no. No document, forms or other, are required by any ISO standard to have such notes. Maybe the person who authored your document control procedure thinks it is required or useful, but that's an internal battle...

 

[Mikishots]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

I would guess QSM stands for Quality System Manual?

As the the "Point of Use" and/or "File In" requirement...what requirement?
Unless, of course, their "QSM" places such a requirement on their system...

We get ourselves in so much trouble by adding requirements to our systems that exist only in the mind of the author of that requirement.

We have gone through many of our high level documents in an attempt to pare them down to what is required (and what we really need) to avoid over-burdensome requirements

I was thinking that too, but...never heard it presented like this.

 

[J0anne]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

We get ourselves in so much trouble by adding requirements to our systems that exist only in the mind of the author of that requirement.

^^^^ This ... I love!!!

 

[r0nyn]

Re: Do SOPs contained within the QSM require a "Point of Use" and/or "File In" footno

I would guess QSM stands for Quality System Manual?

As the the "Point of Use" and/or "File In" requirement...what requirement?
Unless, of course, their "QSM" places such a requirement on their system...

We get ourselves in so much trouble by adding requirements to our systems that exist only in the mind of the author of that requirement.

We have gone through many of our high level documents in an attempt to pare them down to what is required (and what we really need) to avoid over-burdensome requirements

My thoughts exactly! The more streamlined, the better... no need to get bogged down with extraneous requirements that auditors won't even pay attention to.

Welcome to the Cove. Great questions. Short answer is - no. No document, forms or other, are required by any ISO standard to have such notes. Maybe the person who authored your document control procedure thinks it is required or useful, but that's an internal battle...

SOPs are part of the Quality Systems Manual within a company, correct? They wouldn't be contained anywhere else, so Point of Use is pretty moot, as is File In.

My personal feelings are that PoU and FI are better suited for forms, which can be used in different instances/functions and may have to be filed in a specific location for record-keeping.