What do you do when an auditee says "No thank you"

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#71
An update: the matter went up two management levels with the incredible notion of exempting this group from full audits actually being considered as an edit for the Quality Manual. :mg:

But today the message arrived:
I have had my scope expectations for this audit properly reset. I am truly sorry for the delay caused. I will provide you whatever information you need to complete your work.

To that end, what would you like to see? I am out of the office next week, but will try to get you what you want before I leave.
And so it is. I am relieved to get some support in this.
 
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Wes Bucey

Quite Involved in Discussions
#72
An update: the matter went up two management levels with the incredible notion of exempting this group from full audits actually being considered as an edit for the Quality Manual. :mg:

But today the message arrived: And so it is. I am relieved to get some support in this.
Savor the victories - they are hard to come by!
 
T

treesei

#73
An update: the matter went up two management levels with the incredible notion of exempting this group from full audits actually being considered as an edit for the Quality Manual. :mg:

But today the message arrived: And so it is. I am relieved to get some support in this.
:applause:

Here is another true story: During an internal audit the auditors repeatedly requested information from a quality manager whose group was being audited. No response. The auditors wrote in the report something like "information was requested from the quality manager but the request was not answered". The sentence was deleted by another quality manager (equal level on org chart as the first one) responsible for the review and approval of internal audit reports. Case closed. No explanation to the auditors.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#74
:applause:

Here is another true story: During an internal audit the auditors repeatedly requested information from a quality manager whose group was being audited. No response. The auditors wrote in the report something like "information was requested from the quality manager but the request was not answered". The sentence was deleted by another quality manager (equal level on org chart as the first one) responsible for the review and approval of internal audit reports. Case closed. No explanation to the auditors.
This is disturbing on the surface, but not knowing what information was being requested it's difficult to comment further.

Sometimes there's concern about confidentiality. In some cases I am not permitted to see the data in records, such as employee health records that are protected by The Health Insurance Portability and Accountability Act (HIPAA) of 1996. And that's fine. In other cases there may be worry about the discovery process in the event of investigation, and resulting efforts are made to control availability of access to sensitive data. Within the extent of legality that's fine too. I'm so low on the organizational charts that my extent of responsibility and authority is to verify and record that a required process exists, is in control and is effective. I think perceptions of my powers are often exaggerated.
:2cents:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#75
Savor the victories - they are hard to come by!
Yes - but this is overall too embarassing to think of as a victory. I was treated courteously throughout, but the very exersize of pushback and needing two levels of escalation points to a rather serious case of dysfunction in my view. When auditing I go to considerable effort to put my people at ease, and I'm rarely questioned about scope. It's interesting to note that the other persons who questioned me about scope have themselves been, shall we say less than completely on board with what the audit process is trying to accomplish.

Overall it's been an extremely valuable exersize in my self control; for that reason plus the entertainment value I don't regret it though I feel it's a pretty sorry representation of management. But who am I to judge that? :rolleyes: I'm just a little fish in a very big pond here.
 
T

treesei

#76
This is disturbing on the surface, but not knowing what information was being requested it's difficult to comment further.
The audit was on complaint handling. The complaint tech told the auditors that she prepared complaint summary reports periodically and submitted them to the quality manager and that she did not do any data/trend analysis on the complaints. The auditors then asked the manager whether data analsysis on the complaints were done in his organization. No reply (he is located in a different facility so the auditors could not knock his office door). The auditors put down "lacking of management support was noticed" as an observation. It was taken off.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#77
I think the lack of analysis of customer complaints bothers me less than tampering with audit records.:whip: In any case I would be pointedly back to audit that the next time.
 

Mikishots

Trusted Information Resource
#78
I'd ask once more, with an explanation as to why it's needed. Another refusal results in a non-conformity, stating that evidence of Control of Documents was not seen. You're also required to report this directly to management.
 
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Wes Bucey

Quite Involved in Discussions
#79
I'd ask once more, with an explanation as to why it's needed. Another refusal results in a non-conformity, stating that evidence of Control of Documents was not seen. You're also required to report this directly to management.
where's the "shall" on reporting directly to management? I'm not familiar with any such clause in the normal ISO Standards. Citation, please?
 

Jim Wynne

Staff member
Admin
#80
I'd ask once more, with an explanation as to why it's needed. Another refusal results in a non-conformity, stating that evidence of Control of Documents was not seen. You're also required to report this directly to management.
where's the "shall" on reporting directly to management? I'm not familiar with any such clause in the normal ISO Standards. Citation, please?
5.6.2 of ISO 9001:2008 says, in part, "The input to management review shall include information on...results of audits...."

There's certainly some wiggle room in interpretation vis a vis the present situation, but I'm sure that 5.6.2 is what Mikishots is referring to.
 
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