Internal Auditing a previous Nonconformance?

J

JoShmo

#11
We're doing the entire audit in advance of our upcoming surveillance audit. We can't stop what we're doing or stop production to do it all at once so we've done it a piece at a time. This is the last piece.
Did you do any other audits in the past year?
 
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K

Kchnwtch

#14
We don't really have criteria except ISO's once per year. I've been trying to do a full audit once per quarter to keep in practice and remind employees of our ISO responsibilities as we go into our first surveillance audit. After that we'll probably go to once or maybe twice per year.
 
J

JoShmo

#15
We don't really have criteria except ISO's once per year. I've been trying to do a full audit once per quarter to keep in practice and remind employees of our ISO responsibilities as we go into our first surveillance audit. After that we'll probably go to once or maybe twice per year.
That's your problem, right there! "ISO's once a year" isn't applicable since it's not even anything to do with "ISO" (unless you are a register and follow ISO 17021)

"Full audit" - do you mean the whole QMS? If so, why? Copying the register isn't helping you even of the regster's auditor thinks it's OK. (shows how much they know)
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#16
When I followed up on the CA, I asked the CEO the questions we ask in audit, such as " how are verbal customer requirements confirmed with the customer before being accepted?" and "How are subsequent changes to customer requirements handled...." and I got the answer "It kinda comes piecemeal, rather than get too elaborate I think the answer to your question is verbally."
This is not a process, it is not an effective method (as evidenced by the repeat complaint) or an effective corrective action if there was one.
Not a great answer, so I thought this example would be a good one to use to audit 7.1, 7.2 and 7.3 (2008), so that I could figure out what is actually happening with this customer, since I thought all the customer data was being handled the same way.
If this was a part of a previous audit, it's probably no good to bring it up again except as evidence a nonconformity was not effectively addressed.

It is better for you to find this and address it than to wait until just before the CB audit and have your registrar bring it up, because issues that can result in nonconforming product to the customer can be issued as majors.

Therefore, I suggest you make a schedule that conforms to 8.2.2, that is, based on status and importance of processes, and result of previous audits. In order to "stop the bleeding" I suggest an unscheduled audit of the customer order process, now. And I suggest not going along with the CEO's description of the process "It kinda comes piecemeal, rather than get too elaborate I think the answer to your question is verbally." ISO 9000:2015 says "A QMS comprises activities by which the organization identifies its objectives and determines the processes and resources required to achieve desired results" and that "Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system." That clearly has not happened here. The verbal customer request did not get transferred from the CEO's ear to the group that fulfills the order.
 
K

Kchnwtch

#17
Once a year internal audit is in our audit procedure. It's not hurting us especially...according to what I have so far, everyone but the CEO is remembering everything they need to do, and doing it.
 
K

Kchnwtch

#18
This NC was not found on the previous audit, and I'm in the middle of an internal audit now. Not planning to wait for the CB auditor to catch it; I'll write it up as part of this audit. Thanks for the great advice, everyone! :thanx:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#19
Once a year internal audit is in our audit procedure. It's not hurting us especially...according to what I have so far, everyone but the CEO is remembering everything they need to do, and doing it.
8.2.2 states we are to audit based on process importance and status, and results of previous audits. A yearly blanket QMS audit with popup issues like you have described here hint the audit program nay not be serving your QMS fully. A CB auditor can, and should ask "How did the customer complaints affect your audit plan?" and might issue a nonconformity if you say "They don't; we audit everything yearly."

I absolutely support your including this discovery in your current audit plan. Doing so would provide you with the chance to point to even that single audit trigger as evidence of fulfilling 8.2.2's requirements.
 
J

JoShmo

#20
Once a year internal audit is in our audit procedure. It's not hurting us especially...according to what I have so far, everyone but the CEO is remembering everything they need to do, and doing it.
And your audit procedure doesn't comply with the 8.2.2 requirements, as a result. I'm always amazed that the requirement for an audit programme to be established based on status and importance is universally overlooked and the default is always what's the least I can do to pass a register's audit... If it was once a year, 8.2.2 would say that. Amazes me how two simple words in the English language can be written and totally ignored or just glossed over.
 
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