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Work Instruction Authorization

Mr Roo

Registered
#1
What is the general consensus concerning an authorization signature on work instructions?
I am of the opinion that a control number & revision level is sufficient, but a consultant has stated that their should be an authorization signature included in the footer of the document.

Please advise & thank you
 
#2
TLDR; There is a requirement to demonstrate appropriate approval within the system, but not necessarily on the document. A total absence of approval needs to be justified within the system. For work instructions, I don't think you can.

Under the previous 9001 edition there was a need to approve documents for adequacy. There was no requirement that this needed to be on the document used, though you should be able to demonstrate the controls to ensure this. Thus, you could separate approval to a system side, while control distribution of documents to only be those approved for use.
Under the new 2015 edition this must also be ensured through 7.5.2 c. If you can show that your control number (presuming that is the unique ID) and the revision level was appropriately reviewed and declared suitable and adequate.

A clarification on what appropriate means is not given in ISO 9000 or ISO 9001, so i usually presume it is equal to that of ISO 13485, which was based on the previous 9001 edition:
When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:
— product to meet requirements;
— compliance with applicable regulatory requirements;
— the organization to carry out corrective action;
— the organization to manage risks.


Thus, you could try and justify for certain classes of document the absence of assessment as suitable and adequate as it would not be needed for any of the four points. Though those justifications will be very difficult for what is typically understood to be work instructions.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
but a consultant has stated that their should be an authorization signature included in the footer of the document.
Sometimes I question how can Industry move forward, when "consultants" can be so archaic in their thinking, such as in this case. The world is going digital, real-time, cloud-based systems and the consultant thinks it is critical to have a freaking signature on the paper:horse:...if this is an indication of the consultant's capabilities, that's scary. As beautifully stated before by Jean_B, the issues at hand are: approval, correctness, availability, relevance, etc... of the work instruction. Not a meaningless signature on a piece of paper.

Good luck.
 

Mr Roo

Registered
#4
There is a requirement to demonstrate appropriate approval within the system, but not necessarily on the document.
Thank you both for the insight as it pointed me toward a solution.
All documents relevant to our QMS are cataloged in a document master list spreadsheet with hyperlinks to the specific document.
Going forward, I will record the authorization information (name, title, date) in the master list and skip the approved by line on the document itself.
 
#5
Be careful in how you ensure authenticity of approval, and how well it stands up to scrutiny. Secure that file and the linked files from unauthorized changes at the least. Then be aware whether you must commit to any further data integrity practices due to regulations or customer requirements.
 

Mike S.

An Early 'Cover'
Trusted
#6
Digital signatures such as provided for in Adobe Acrobat work well. I have also used an emailed approval kept on file to show approval.
 

John Broomfield

Staff member
Super Moderator
#7
Bunkum. Your “ISO consultant” seems not to understand the standard.

Approval signatures are not required but evidence of approval is.

So, when a document is issued for review and comment it could be under a letter revision control and as soon the document is approved for use it could be under numerical revision control.
 

Randy

Super Moderator
#8
I'm trying to find the requirement for a "Footer" to begin with, I might have missed something today while auditing document control as part of an initial certification audit. Did I miss the required signature part as well in the standard?
 
#9
I'm trying to find the requirement for a "Footer" to begin with, I might have missed something today while auditing document control as part of an initial certification audit. Did I miss the required signature part as well in the standard?
The signature as such is not required (though it is a typical method of implementation). Approval is. One could state that given a controlled set of rights to one person responsible for approval, the appearance of documents in a thus controlled location is also evidence of approval (would practically only work for the smaller companies). Though agreed, typically you would find some demonstrably authentic approval path, whether wet signature, digital signature or traceable system action.
The footer (or header) is an implementation of a recursive mark on succesive cohesive units supporting several aspects. The cohesive unit is something where a loss of integrity is self-evident. A page torn in half, even without further identifying marks, is clearly suspect for loss of information. If a document has two pages, but you lose the last this is not (always) immediately clear without aiding identifying marks.
This is meant for identification (9001:2015, 7.5.2 a), which supports suitability (9001:2015, 7.5.3.1 a) through control of changes (9001:2015, 7.5.3.2 c). This combined with the associated page of total pages it ensures loss of integrity (9001:2015, 7.5.3.1 b) could be identified.
Digitally though, you could replace this by checksums on the pagecount. In the analogue world pagecounts with 'this is the last page items' in a Table of Contents at the start. Ah the room a standard provides.
 

Randy

Super Moderator
#10
The signature as such is not required (though it is a typical method of implementation). Approval is. One could state that given a controlled set of rights to one person responsible for approval, the appearance of documents in a thus controlled location is also evidence of approval (would practically only work for the smaller companies). Though agreed, typically you would find some demonstrably authentic approval path, whether wet signature, digital signature or traceable system action.
The footer (or header) is an implementation of a recursive mark on succesive cohesive units supporting several aspects. The cohesive unit is something where a loss of integrity is self-evident. A page torn in half, even without further identifying marks, is clearly suspect for loss of information. If a document has two pages, but you lose the last this is not (always) immediately clear without aiding identifying marks.
This is meant for identification (9001:2015, 7.5.2 a), which supports suitability (9001:2015, 7.5.3.1 a) through control of changes (9001:2015, 7.5.3.2 c). This combined with the associated page of total pages it ensures loss of integrity (9001:2015, 7.5.3.1 b) could be identified.
Digitally though, you could replace this by checksums on the pagecount. In the analogue world pagecounts with 'this is the last page items' in a Table of Contents at the start. Ah the room a standard provides.

Jean, I was joking and being ugly, I've been auditing MS's about 20 years and taking a slap at that expert consultant. I see more MS garbage and krap that most here, especially "the flavor of the month", "pipe dream" requirements. It's generally those snatched out of the air requirements that jump out and say "please write the nonconformity because it ain't happened"..
 
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