What defines a Quality Record

[John Broomfield]

Ok, at this current point we have implemented our ISO system and are now moving to upgrade it to AS9120 within the next 2 weeks as I am awaiting the standard in the mail. Our registration is set for late October so now it's just fine tuning...

so here is my first question of the day:
Quality Records vs Documents.
I understand the concept of the documents and the procedures for keeping such controlled. But what defines a quality RECORD? As we do not do any manufacturing or assembly here and are solely a distributor, we do not do any type of testing or calibration. So in my mind, quality records is limited to RFQs, POs, inspection sheets, and manufacturers certifications. Would I include Management reviews and Audits in this record collection, or are they quality documents? Where do I draw the line of record vs document?

Thanks in advance Cove buddies.

Hunter,

Rule of thumb: "records (4.2.4) are not subject to revision control whereas documents (4.2.3) are".

Arthur Anderson tried revising (deleting) their records and look what happened to them!

John

 

[Eloy Gomez]

Quality Records vs Documents.
I understand the concept of the documents and the procedures for keeping such controlled. But what defines a quality RECORD? As we do not do any manufacturing or assembly here and are solely a distributor, we do not do any type of testing or calibration. So in my mind, quality records is limited to RFQs, POs, inspection sheets, and manufacturers certifications. Would I include Management reviews and Audits in this record collection, or are they quality documents? Where do I draw the line of record vs document?

Thanks in advance Cove buddies.

Simplified: A record is just proof that an action took place.

 

[Jim Wynne]

Simplified: A record is just proof that an action took place.

Not proof. Evidence.

 

[Stijloor]

Not proof. Evidence.

Where can I find the evidence that proofs this?

Stijloor.

 

[Eloy Gomez]

Not proof. Evidence.

Hello Jim:

I thought it meant the same thing, but I like the word evidence better, thanks

proof

   /pruf/

Show Spelled[proof]

Show IPA
–noun 1. evidence sufficient to establish a thing as true, or to produce belief in its truth.

2. anything serving as such evidence: What proof do you have?

3. the act of testing or making trial of anything; test; trial: to put a thing to the proof.

4. the establishment of the truth of anything; demonstration.

5. Law . (in judicial proceedings) evidence having probative weight.

 

[JaneB]

So in my mind, quality records is limited to RFQs, POs, inspection sheets, and manufacturers certifications.

If all you're focussing on at that particular point is product-related records, yes. (You don't do any purchasing including outsourcing at all? Because I'd expect some records there)

Would I include Management reviews and Audits in this record collection

Sure would - otherwise, how can you show that these have occurred?
Don't forget also records of employee competency eg, CVs, training records etc.
I suggest highlight each bit where the Standard says records shall exist/be kept/whatever blah blah... and make sure you've got them.

And yes, I suggest forget the term 'quality' record, which is potentially very misleading.

 

[bdames]

It can be helpful to think of documents and records as two different things. The requirements for documents are found in 4.2.3 and the requirements for records are in 4.2.4. Notice that these two sets of requirements are VERY different. That is because a record cannot be changed – rather it must be protected from change. Documents can be changed – as long as those changes are controlled. It may be helpful to think of a record as “dead” and a document as “alive”. You really can’t have both at the same time (there are some technical exceptions to this).

Sometimes we make a mistake with a record; for example during the month of January I will often write the wrong year on the checks I write. In this case I will not change the record, rather, I will correct my mistake – remember, you cannot change a record. I know this is semantics, but it really can help if you make this distinction.

A record is then anything you want to keep (not subject to change) to provide proof or evidence of something. Training records, management review records, corrective action records. All of these and many others provide the evidence needed to demonstrate you have done something. Refer to the standard you are using and look for the word record – from this you can develop a list of the records you need.

 

[Jim Wynne]

It can be helpful to think of documents and records as two different things. The requirements for documents are found in 4.2.3 and the requirements for records are in 4.2.4. Notice that these two sets of requirements are VERY different. That is because a record cannot be changed – rather it must be protected from change. Documents can be changed – as long as those changes are controlled. It may be helpful to think of a record as “dead” and a document as “alive”. You really can’t have both at the same time (there are some technical exceptions to this).

Sometimes we make a mistake with a record; for example during the month of January I will often write the wrong year on the checks I write. In this case I will not change the record, rather, I will correct my mistake – remember, you cannot change a record. I know this is semantics, but it really can help if you make this distinction.

So long as there are no legal or regulatory concerns to the contrary, records can be changed and should be changed if they don't accurately reflect what needs to be recorded. We need to disabuse ourselves of this idea of changing records being verboten. The methods and circumstances for changes need to be controlled, but records that don't reflect the true state of affairs are useless and potentially dangerous.

A record is then anything you want to keep (not subject to change) to provide proof or evidence of something.

I fixed that for you, but otherwise that's a nice, concise definition of "record."