Query on major NC for Manual

Hi Pancho!

You make some really good points here. Setting aside "the finding" issue, there should be some element of taking what the auditor saw and using it for improvement. There is an issue of whether the manual is even required or not; certainly. But if the manual exists, make it a good one.

I do feel the issuance of the NC is pretty relevant. I appreciate auditors value in the outside view of things. There is a huge difference between the enhancement/observation "hey... here are some things you should consider..." and " I have found evidence of non-conformity". In the grand scheme of things, there doesn't seem to be a lot of risk/process impact with the condition of the quality manual. Why a major? To me, a compelling reason should be noted and made clear.

What if someone has a document control system and hyperlinks don't function or can't link to other documents? I can address this in a response to their suggestion. If it's a NC, now... I have to jump over hurdles for it.

Too... many times individuals are forced to deal with management's response to audit findings. They see a non-conformity and they want to know what is happening, why did it occur, blah, blah. Getting upper management (as a general rule) to understand and embrace quality systems is challenging enough for some. Having to deal with potentially bogus findings and poorly written audit results, don't help things.

 

I don't agree Brad that there's even a hint of "improvement" here. What needs improving? Do we know? Maybe, as with other auditors we read about, they have their own biases and expectations - often not based in any practical reality - and giving such comments credence as "improvement" is a step too far. I see nothing reported here than an auditor's agenda!

 

Marni - my concern for you and other clients who may read this is that once people take poorly worded reports and act on them, auditors take that as a signal it's OK. There's no requirement stated and no evidence either, two key elements of an nc statement. My colleagues seem to be basing their recent comments that it's the "spirit" of the nc which counts. You don't even have an nc to work with.
Do what you will, but don't let the CB or auditor get away with shoddy work - any more than you would other suppliers.

 

I understand what you're saying, Andy. I'm not defending the auditor's write-up or their finding. What I am saying is there is a litmus test of personal understanding. A person coming in from the outside that picks up the quality manual, should be able to gain understanding of what is being presented and how to find what they need. If the document is not clear enough for an outsider, then maybe it can be improved upon.

You wrote a book. Yes? Editors and reviewers will review it and make comments about parts that are not clear/ambiguous/ etc. They're not saying its wrong; merely they're saying they don't follow what you're trying to say.

So having a fresh pair of eyes can be of some value, in my opinion.

Either it's a finding or it isn't. Unless we review the previous findings (and their content), the current finding and its content, what their quality system says they will do/ not do, and what standard they are working on, it's merely conjecture and opinion what it is and what it isn't. If the investigation is that it is a finding, then fix it. If it's bogus, fight it.

I think anchoring the organization on extremes needs to be avoided. Reacting and making changes on every single bullet point an auditor noted is not constructive and will end up with a bunch of non-valued added (and many times silly) requirements and steps. On the other end, "if the auditor didn't write it up as a 'must-fix or you won't pass', we can put all this audit junk behind us until the next audit". So all I'm suggesting is if the organization is going to have and use a quality manual, make it a useful, readable document, and not just a "checkbox complete" item.

 

Since the Quality Forum is fairly new, I might mention...

I have known Andy for many years, and have learned much from him. If I ever needed a quality team to be in my corner, I would ask him (and some other contributors to this thread) to be there. They're the best.

So since we know each other well... we may engage each other a bit more (like good friends do) than we would newer members.

So don't think we're arguing or anything. We're just sharpening each other's swords.

 

You keep your hands off my sword!

 

You are right, Marni! Parliament is much, much worse!

 

Thanks, Marni! Always good to know outcomes.