Internal Audit not done for Quality Department

T

TAfu2010

Hi everyone! I have just been given the task to be in-charge of Quality Assurance as the previous person resigned.

The company just conducted it's Internal Audit against ISO 9001:2008 4 months ago for all the departments except for Finance Department. While reviewing the audit reports so I can familiarize with the quality functions and report formats, I just found out that for the internal audit 4 months ago, there was none conducted for Quality.

Finance is exempted as they have a separate audit required by management. There were internal audits done for quality department before that, they just did not do it for this particular period. An external was also conducted but this was not addressed in the external audit report.

Will this be considered as a Non Conformance?

Can anyone give their feedback please? :confused:
 

Randy

Super Moderator
Nope, as long as the audit was done accoring to whatever your procedure says (if the procedure meets 8.2.2) and the auditors were "competent" as defined by you, the audit can be done by the janitors
 

v9991

Trusted Information Resource
Nope, as long as the audit was done accoring to whatever your procedure says (if the procedure meets 8.2.2) and the auditors were "competent" as defined by you, the audit can be done by the janitors

as per OPs post, 'Qualify' function was not covered in previous schedule of internal audit.

quick clarification ...should it not be handled through suitable deviation management; because.,

Non-conformance is ....either
* procedure ...cause its not adequately emphasized to cover all functions/processes
or
* implementation...which was not-scheduled or missed it;


Further, IMHO ...just because, external audit did not pick up the instance does not make it not a compliance issue. ( its an opportunity missed to review the functioning...processes of Quality)
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I suggest you issue an internal non-conformance in the system and treat it as you would any other. It is good to see things are recognized and addressed from within the organization - that people are paying attention and addressing found issues.

I do not understand what this means: "An external was also conducted but this was not addressed in the external audit report."
 
B

BoardGuy

[FONT=&quot]You have identified in issue with the audit schedule where the quality department was missed. Simple solution would be to perform the audit and mark it off as having been completed per schedule and then assure the audit process is adjusted to prevent reoccurrence. This method meets Clause 8.2.2 without going through the more costly route of corrective action per 8.5.2.[/FONT]
 
M

mmagargee

Hello TAfu2010,
Clause 8.2.2 requires that audits are conducted at planned intervals. You implied that an audit of the QMS was planned and not conducted. But could it be that it had been done earlier in the year and the plan devised by your predecessor was designed to cover all of the clauses during audit activities spread out over the year?

Mike
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
[FONT=&quot]You have identified in issue with the audit schedule where the quality department was missed. Simple solution would be to perform the audit and mark it off as having been completed per schedule and then assure the audit process is adjusted to prevent reoccurrence. This method meets Clause 8.2.2 without going through the more costly route of corrective action per 8.5.2.[/FONT]
What is the cost of doing a corrective action for a process that did not get executed?

If the OP merely does the audit, checks the box and moves on, what prevents recurrence? We do not know why the audit was not done.

What, then is the alternative cost of recurrence or having the CB find it? (I can guess: the cost of the original corrective action plus the time to send documentation back and forth, and have to address this in their next audit.)
 
B

BoardGuy

[FONT=&quot]The issue was identified and can be corrected as required by Clause 8.2.2. There is no requirement within this clause that states a corrective action based on requirements of 8.5.2 must be performed. If a sample fix is all that is needed then it should be done and the standard allows for this. For simple issues a formal CAR per 8.5.2 does not add value to the organization.[/FONT]
 
T

TAfu2010

Hello all! Thanks for all your feedback. :)

Jen: Sorry, what I meant by external audit is the ISO 9001 re-certification audit.

Mike: Audit of Quality Department was planned and on the scheduled date it was not done, but other departments were audited. It was missed out on.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
[FONT=&quot]The issue was identified and can be corrected as required by Clause 8.2.2. There is no requirement within this clause that states a corrective action based on requirements of 8.5.2 must be performed. If a sample fix is all that is needed then it should be done and the standard allows for this. For simple issues a formal CAR per 8.5.2 does not add value to the organization.[/FONT]
Actually, 8.2.2 requires audits at planned intervals of the quality management system to determine if it's conforming to requirements and is effectively maintained. The OP described discovering a nonconformity in that not all of the planned audits were done. 8.5.2 requires corrective action to eliminate the causes of nonconformities.

While I can appreciate that this might seem like a small matter, not rising to the need of issuing a nonconformity, CB auditors can and do write nonconformities for not completing audits as planned. If the organization can show an internal corrective action on this issue it might avoid receiving one from the CB.

If a recertification audit was subsequently done and the CB auditor did not notice the missing audit or issue a nonconformity for it, then it is history - TAfu2010's next audit will only cover the previous year's activities and not what happened previously. So, issuing a corrective action now would only serve to study, resolve and address the cause(s) for not completing the audits as planned. Would that be a non-value-added activity? I suppose that depends on why the planned audits were not completed. If no one asks why, no one will know why this process was not executed as required.
 
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