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What defines a Quality Record

H

Hunter36

#1
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? :bonk:

Thanks in advance Cove buddies.
 
T

tomvehoski

#2
Re: Quality Records

Records are just a type of document, so don't worry about drawing a line between them. People usually think of a document as a procedure or blank form, and a record as a database or completed form, but they can be hybrids. A form could also include instructions which when completed becomes a record. A database could walk you through completing a process (instruction) while collecting data (records).

Say you have an audit finding form. You would control that as any other form with whatever identification and revision system you use.

When you perform an audit, you complete the form and it becomes a record, probably along with other documents.

Even procedures that don't get filled out can be records - as in keeping obsolete copies when you make revisions to maintain a history of the QMS.
 
H

Hunter36

#3
Re: Quality Records

excellent. thank you for the quick response. this makes me feel a lot better as it confirmed that there is no need for a lot of unnecessary work.

one last question then:

I obviously have a Master Document List in place. Does there need to be a master record list? I would not think that completed invoices, inspection sheets, etc would have to be logged in. That would be literally a hundred documents a day to add to a master list. Given the ridiculous amount of completed forms, I would hope that filing them away organized by PO number would be suitable enough to our form of organization, and the auditors expectations
 
T

tomvehoski

#4
Re: Quality Records

I keep a master records list separate, because they do have some different requirements.

Document List

Doc # Title
F-001 Rev 02 Internal Audit Finding Form
F-002 Rev 03 Invoice Form
F-009 Rev 01 Credit Check Form



Record List, Retention, Responsible, Location, Protection, Disposal, .....

Internal Audit Records, 10 years, Q Mgr, File, None, Trash, ....
Invoice Records, 3 years, Accounting, PDF, Standard Backup, Delete, ....
Credit Check Records, 5 years, Accounting, File, Locked Cabinet, Shred, .....


I made all that stuff up so don't take any of it as a requirement - but note there are different levels of requirements based on the sensitivity of the records. There are also records that won't originate from your documents, so you can't track them all by a document number. Things like customer POs, supplier invoices, etc.
 
#5
hunter - even simpler - records are just that, something which gives evidence that an event - review, approval, inspection, action, audit, training etc. actually took place. Don't even confuse it with obsolete documents, they aren't a record of anything, just a previous version. Be very clear you understand the difference. It's important, so check with your legal folks on retention, or maybe you have regs to comply with. These are a good source of info on what are records. If you have anything patent worthy also. These help define how long to keep records. Obsolete documents, e.g how to do things, may also be driven by what you do for clients - if you service old equipment, for example.

But don't confuse a record with a document that's obsolete...
 
T

tomvehoski

#6
Obsolete documents definitely should become records, but it does not have to be complicated. An obsolete document is a record of how a product was designed or a process was run in the past.

If they are not maintained, how would you figure out the part your customer just returned is actually to revision A of the print and was shipped two years ago vs. revision C you shipped last week? Or when your auditor (be it registration, customer, regulatory, etc.) finds other records indicating you ran a process A - C - D - B when your current procedure says A - B - C - D?

It can be as simple as saying that obsolete drawings are moved to an Obsolete folder and kept for XX years, or one hard copy of an obsolete procedure is marked accordingly and put in a file. It is doubtful you will refer to them often, but at some point you will need to.
 

Colin

Quite Involved in Discussions
#7
Just a small point, ISO 9001 used to call them Quality Records but now refers to them as just Records. When they were called Quality Records there was a tendency for people to think that the only records necessary were those related to 'quality related' subjects e.g. inspection records, audit records, etc.

Of course the control of records should extend to any records which relate to the processes of the business which are defined within the QMS. e.g. the standard doesn't state that you have to keep copies of purchase orders or delivery notes but I suspect you will want to.
 
#8
Obsolete documents definitely should become records, but it does not have to be complicated. An obsolete document is a record of how a product was designed or a process was run in the past.
I can't agree! How is an obsolete work instruction or a procedure a record of anything? Who knows if it was followed to make something. It's just an obsolete document. Design records (drawings) are totally different! Otherwise, why make a distinction in the standard?
 
T

tomvehoski

#10
I have a perfect example sitting on my desk right now. It is a work instruction to glue an insert into a bracket. The obsolete process is:

1. Clean insert
2. Apply glue to top of insert
3. Press into top bracket
4. Apply glue to bottom of insert.
5. Install bottom bracket.
6. Install spacer (for compression)
7. Clamp for 90 seconds until set


Revised process is 1, 2, 3, 6, 4, 5, 7. It was made for efficiency, but also eliminates some potential for bad adhesion.

The customer called this morning to complain about a few parts having missing inserts falling out. By knowing the date code on the box of parts, I have a pretty good idea which assembly process was followed. That helps me do my root cause analysis. If all records of the old process were destroyed, I would not know what was different in assembly between old and new and my analysis could be more complicated.

How does this example really differ from a drawing? It is a specification on how to create a product. Just because a document is created in MS Word instead of AutoCAD does not make it different.
 
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