Audit Nonconformance - 7.2.2 - Contract Review (Review of Requirements)

#11
Hmmm - before we all run off with the idea that the "easy thing" to do is change the procedure, I'm going to ask why this requirement is in there in the first place?

Did the particular director approve this document? It sounds like they could be a process owner. Is there some level of approval for a particular $$ value on which they wish to sign off? Someone wrote this requirement into the procedure and it was approved like that, so what (apparently) went wrong? If it's now not required, who approved that change to the process without initiating a change to the document?

Before anyone simply fixes the document, you might just wish to put it in front of the relevant management and ask them! It is, after all, a MANAGEMENT system....:popcorn:
 
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J
#12
Hmmm - before we all run off with the idea that the "easy thing" to do is change the procedure, I'm going to ask why this requirement is in there in the first place?

Did the particular director approve this document? It sounds like they could be a process owner. Is there some level of approval for a particular $$ value on which they wish to sign off? Someone wrote this requirement into the procedure and it was approved like that, so what (apparently) went wrong? If it's now not required, who approved that change to the process without initiating a change to the document?

Before anyone simply fixes the document, you might just wish to put it in front of the relevant management and ask them! It is, after all, a MANAGEMENT system....:popcorn:
Some good questions - perhaps this is some of what the auditor wondered about too.

Peace
James
 
#13
Some good questions - perhaps this is some of what the auditor wondered about too.

Peace
James
James - thanks, but there's no 'perhaps' about it! At the Cove we see most commonly, just the symptom being reported to CB clients! The auditors may well have found an issue worthy of reporting, however they don't exercise their auditor skills (IF they posses them) and track the real issue down for action!
 
J
#14
James - thanks, but there's no 'perhaps' about it! At the Cove we see most commonly, just the symptom being reported to CB clients! The auditors may well have found an issue worthy of reporting, however they don't exercise their auditor skills (IF they posses them) and track the real issue down for action!

Granted, We here only get a very small snapshot and a one sided snapshot at that. We try to accept that our QA compatriots are honest and forthright but still, unless we are there, we cannot help but have only a narrow picture.

Likewise we need to accept that the auditor, also a fellow QA person, is trying to do his/her best but that they have to be careful only to report the problem and not try to prescribe the solution - at least that was what I was taught (years ago).

The better auditor will ask questions to, as you say, get at the "real issue" and make sure that the problem they suspect is actually a problem. If he deems it to be legitimate, he must report it and then he must leave it up to the company to look more closely at the troublesome area and determine the best solution.

Peace
James
 
#15
Agreed - there's a BIG difference between accurately diagnosing the issue and prescribing a fix. Just as we've seen here: people suggesting changing the procedure or the practice, without doing any further 'digging'...
 
J

Jason PCSwitches

#16
If this is part of their procedure and they are not following it, then they are not conforming to their procedures.

I would ask how did the auditor came to find out about this. Was it in a written procedure? Did they observe a missing signature field?

7.2.2 clearly states that the organization is required to review the requirements PRIOR to commitment. If the director is doing more than just signing the document this could be a critical part of the review and would need to take place prior to acceptance. If the director is responsible for final review/approval and identifies a potential conflict it's a problem if production has already begun.

On the other hand if it's merely a formality and the review has been thoroughly completed prior to this stage it can be omitted or reclassified.

You need to look at the reason this was incorporated and the age of the process as well. I don't know the size of the organization but it's possible this process was initially implemented back when the organization was small(er) and micromanagement was typical. If the organization has expanded, these elements may be outdated and need revision.

Either way it's an opportunity to possibly improve a process that may have been difficult to do without a finding due to it being associated with upper-management; which sometimes is what it takes to get things done in quality at that level.
 
J
#17
Jason's points are good and in fact could point to another issue within the system. Document review and control. If, as suggested, the procedure is old and the situation of the company has changed since it was written, it could point to potential problems with other documents.
IN other words, if this failure resulted from process changes that were not reflected in updated procedures, what other documents might have similar flaws that were not found at this audit, but might be found at future audits...
And even though this item might not particularly effect product quality or customer satisfaction, perhaps there are other items, so far overlooked, that might.

Peace
James
 
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