Control of Documents or Control of Records?

kensonic_qmr

Starting to get Involved
Hello guys! We just conducted an Internal Audit last week and submitted our Internal Audit Report Findings to our Quality Management Representative last saturday. We have a little (and good) argument about one of our findings. :argue:

He noticed that one of our findings is that some of our records like time cards are not signed by employees and we call it under 4.2.3 a of Control of Documents. He is just curious because records should be controlled under 4.2.4 Control of records. I already said to him that we call it under 4.2.3 because 4.2.4 doesn't state that records should be approved prior to issue but 4.2.3 a clearly says it. I considered also the fact that records are a special type of documents which means that it can be treated or controlled under 4.2.3.His argument is that it can't be called under 4.2.3 because a portion of 4.2.3 Control of documents state that "Records are a special type of documents and shall be controlled according to the requirements given in 4.2.4".

I need your help guys! What clause in ISO9001:2008 standard can we call the said findings. Arigato!! :thanx:
 

somashekar

Leader
Admin
Hello guys! We just conducted an Internal Audit last week and submitted our Internal Audit Report Findings to our Quality Management Representative last saturday. We have a little (and good) argument about one of our findings. :argue:

He noticed that one of our findings is that some of our records like time cards are not signed by employees and we call it under 4.2.3 a of Control of Documents. He is just curious because records should be controlled under 4.2.4 Control of records. I already said to him that we call it under 4.2.3 because 4.2.4 doesn't state that records should be approved prior to issue but 4.2.3 a clearly says it. I considered also the fact that records are a special type of documents which means that it can be treated or controlled under 4.2.3.His argument is that it can't be called under 4.2.3 because a portion of 4.2.3 Control of documents state that "Records are a special type of documents and shall be controlled according to the requirements given in 4.2.4".

I need your help guys! What clause in ISO9001:2008 standard can we call the said findings. Arigato!! :thanx:
Instead of an :argue: over the reference clause of the ISO9001 standard, we can spend quality time on the finding to see if the context stated in the NC can be corrected / further a CA taken to see that it is not occurring again. Such a record may or may not be your QMS requirement, however it is certainly an organization requirement (that is why you have designed it and have it in place)
Just spend that much time as appropriate to address it.
You understand the requirements as said in the standard without trying to put each activity and the audit finding into the clauses. That is the business and requirements of the CB. Take the learning from CB audits without emulating how they address the NC to ISO9001 clauses.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I am thinking along Sidney's lines. :agree1:

There are a number of records required by ISO 9001:2008, and then there are records in addition to that required by the organization as defined by the quality manual, procedures and work instructions. What do they say?

When doing an internal audit we are supposed to assess conformance with systems and procedures, which in turn conform with standards and regulations. If employee signatures are called out as necessary on time cards which are called out as records in the QMS, then the absence of signatures could constitute a nonconformance. But we can't imagine QMS controls that do not exist. So I suggest you check to see if these time cards are called out as records as per 4.2.4 and why; I am wondering what the auditor is referring ti as a requirement.
:2cents:
 

qusys

Trusted Information Resource
Hello guys! We just conducted an Internal Audit last week and submitted our Internal Audit Report Findings to our Quality Management Representative last saturday. We have a little (and good) argument about one of our findings. :argue:

He noticed that one of our findings is that some of our records like time cards are not signed by employees and we call it under 4.2.3 a of Control of Documents. He is just curious because records should be controlled under 4.2.4 Control of records. I already said to him that we call it under 4.2.3 because 4.2.4 doesn't state that records should be approved prior to issue but 4.2.3 a clearly says it. I considered also the fact that records are a special type of documents which means that it can be treated or controlled under 4.2.3.His argument is that it can't be called under 4.2.3 because a portion of 4.2.3 Control of documents state that "Records are a special type of documents and shall be controlled according to the requirements given in 4.2.4".

I need your help guys! What clause in ISO9001:2008 standard can we call the said findings. Arigato!! :thanx:

I agree with other exper Covers' response.
Have those records some kind of "legal aspect"? What was the scope of your internal audit? If it was violeted a point of your internal procedure, we can write finding vs it. Was it an isolated episode or had you multiple evidences??
 

Wes Bucey

Prophet of Profit
Over 50 years ago, when I was in college, fellow students (including me) got into a heated argument over some now long-forgotten point of minutia during class when the professor set us all back on our heels with the following which remains firmly fixed in mind even 50 years later:
"This argument is like separating fly specks (poop) from pepper. Even if successful, is anyone still going to want to use the pepper on his food?"
My point today is:
"What possible difference is it going to make which clause it is called? The point is to find a mistake proof way to eliminate the shortfall."
The waste of time and energy [and money] in such bureaucratic oneupmanship described by OP would make many CEOs tear someone a new excretory orifice regardless if it were ultimately decided in either camp's favor. (He sure wouldn't be happy if the "rescued" pepper were spread on HIS food.)
 

Jim Wynne

Leader
Admin
Hello guys! We just conducted an Internal Audit last week and submitted our Internal Audit Report Findings to our Quality Management Representative last saturday. We have a little (and good) argument about one of our findings. :argue:

He noticed that one of our findings is that some of our records like time cards are not signed by employees and we call it under 4.2.3 a of Control of Documents. He is just curious because records should be controlled under 4.2.4 Control of records. I already said to him that we call it under 4.2.3 because 4.2.4 doesn't state that records should be approved prior to issue but 4.2.3 a clearly says it. I considered also the fact that records are a special type of documents which means that it can be treated or controlled under 4.2.3.His argument is that it can't be called under 4.2.3 because a portion of 4.2.3 Control of documents state that "Records are a special type of documents and shall be controlled according to the requirements given in 4.2.4".

I need your help guys! What clause in ISO9001:2008 standard can we call the said findings. Arigato!! :thanx:

Is there a documented requirement in your own QMS for timecards (or other records) to be signed? If so, use that as your NC citation. If not, how are people supposed to know about the requirement? ISO 9001-2008 has no requirements regarding signatures on records or forms.
 

Wes Bucey

Prophet of Profit
Is there a documented requirement in your own QMS for timecards (or other records) to be signed? If so, use that as your NC citation. If not, how are people supposed to know about the requirement? ISO 9001-2008 has no requirements regarding signatures on records or forms.
Excellent point!:applause:
 
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