Documents and Records - To sign or not to sign

V

Vikings1

#1
I've read many threads involving the signing of documents. Most of them, in fact all of them, involve approvals. I agree that there is nothing stipulated that a document must be signed. However, we all know the adage, if it's not documented then it didn't happen. With that in mind, I have a question about RECORDS/FORMS.

If I require an employee to enter information onto a document from a task they've performed, shouldn't I also require that employee to sign/initial that they were the one who made the entry or completed the record/form? I have always required them to sign-off that they completed a task, but if I didn't, would this look unfavorable to an auditor?

The ultimate question is, are records/forms required to be signed to provide objective evidence that a worker performed a task?
 
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Wes Bucey

Quite Involved in Discussions
#2
Re: To sign or not to sign

First, forget the BS about "Does the auditor need ...?"

The most important thing is what YOUR organization needs (or finds useful.)


  1. Is there any question whether the data is "fudged" by an operator (or one of several operators?) THEN, by all means, have each operator sign when entering data for analysis and forensic evidence should it be necessary later.
  2. Are multiple operators entering the same data (multiple machines? multiple shifts?) THEN, have them sign for possible internal auditing of efficiency, effectiveness.
  3. Are these data entries measurements? THEN, more reason for internal analysis.

I'm pretty sure no international Standard calls for signatures, so 3rd party auditors don't need this information.

Some government regulations for different industries may require signature data to assure qualified, certified personnel perform operations.

Some customers (I can't think of any today) may require this data for their own reasons and so second party auditors may require such signatures, WHEN AND IF the contract specifies.

Which leaves internal auditors and they only need to verify sign off if the organization determines there is a benefit and makes it a process requirement.
 
#3
I have had many external auditors look at me, raise the old eyebrow, and say something like: -I think this could benefit from a wet signature...? My answer remains the same: -No, our system does not require that. Most let it go at that, a few persist, and the next time someone persuades me that our documents (be it records or written procedures) benefits from a wet signature will be the first.

Welcome to the 21st century... :cool:

/Claes
 
T

TRD00001

#4
I agree with Wes...

Don't mind what the auditor needs... Also you can always contest an auditor if he/she raises a nonconformity or a finding for a record which has no signature... because its not required by the standard... It was always an arguement between what the auditor wants and what the standard requires....

In our case... we are going into paperless monitoring and recording of data... and this does not require any type of signature... whenever an auditor ask us who did the recording... we could always show the auditor manpower schedule and from there we can always trace the operator who did the monitoring...
 

TWA - not the airline

Trusted Information Resource
#5
I always argue that documented evidence is when you have all the necessary data put down in writing (or in a validated database btw). So the question is what is necessary to document? Typically the "What?", often the "When" and sometimes the "Who?", but that really depends and it is up to you to decide. You may e.g. need to document readings or measured values, check boxes for PASS/FAIL, short paragraphs of prose etc. Signatures sometimes are a regulatory requirement or when it comes to approvals and your system restricts the respective authority. Also initials are often good to document that an employee performed a certain action. But to document that an inspection has been performed I would argue that you only need the results to document that it happened, not necessarily who performed it. Dates are important when you need to show that you met timeline requirements like for medical device reporting or time until closure of a CAPA (if you have a requirement in your system) or if this impacts the expiry data etc. If I need the date, then typically I'd also require intials, but that is just my personal requirement...
 
T

t.PoN

#6
I totally agree with Wes. He is 100% right. I could not have said it better myself.

The ultimate question is not "Should the record be signed?". The question is "How are you going to protect that record?" by protection we mean, that the data is not cahnged or altered or "Fudged" as Wes said
and the next question is "How can you ensure the tracability; "if needed", of the records?"

Some standard like the ISO 17025 state it clearly in clause 4.13.1.2: "Records may be in any media, such as hard copy or electronic media"

This was a huge relief for us, whenever an auditor says "sign it", i say read it.

ISO 9000, clause 3.7.6 state it even better:
Records: document (3.7.2) stating results achieved or providing evidence of activities performed.
NOTE 1: Records can be used, for example, to document traceability and to provide evidence of verification, preventive action and corrective action.

and a document (3.7.2) is information and its supporting medium.
and The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof

So, ISO 9000 doesn't leave a doubt or an area to arguments

Its a general practice to sign the record, but its not requirement.

Records can be paper or can be electronic.
Paper records are not required to be signed. but you still need to have a procedure for protection and tractability "when needed"
 

drgnrider

Quite Involved in Discussions
#7
One of my issues with procedures requiring signatures... if not signed it is a NC; just another thing to get dinged-on. Our purchasing department, in our previous PO system, was notorious for forgetting at least one of the four signatures on PO's before filing them away. Took us almost a year :mg: to get them all signed before being filed.

I try to avoid requiring them. :2cents:
 
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