First, I apologise to everyone for posting this list and not paying attention. My central AC went out and it's a 30 year old unit so it's replacement time. And, as some of you know, I'm doing a couple of months of Yard Duty and the recoil starter on my chipper broke. And I wanted to try to stabilize this new forum software. Etc, etc, etc... So - I'll try to address the issues.
Don - You are 100% correct and said it in a lot fewer words than I would have used.
As barb said:
--> ...the confusion is a result of non creative-people
--> deciding they need to see a job description in order to have evidence of the requirements.
Something I try to tell my clients is:
What is the intent and how do you comply! Please explain to me how you meet the intent. And this is evident through out. Look at the current MSA 'controversy'. For the last year MSA has become a registrar
Hot Button. It's damn simple if you understand that MSA is simply a high level system that *
someone* in a company has to understand. And, if you're a big company your design engineers and process engineers *should* also understand. It's a niche specialty which should be part of an engineering education - and it doesn't appear to be (my degree is in biology if that telly you any thing). I learned MSA in college in the context of chemistry, physics and biology. Measurement is very important in those focuses. So it makes sense to me. Understanding the dynamics and variables is important.
And - don't forget. Just like
Debate in college - Folks - This is a
War of Words.
The registrars are looking for someone to explain how a company meets the intent of every section and each element within each if only to say "We don't do that and this is why..." with a valid explaination - like the machinist in your example. Which requires thought and understanding. I tell my clients up front - I'm a consultant but I am like a piano teacher. I can teach you how to play it faster than you can learn yourself and I can help you avoid the common pitfalls. But when it comes time for the concert I can only give (thanks, Dad)
Moral Support.
Pat - If you take a look at each of the items in the list there is a good thought with each. What I mean is challenge yourself with each number. Cay you think of a contradiction for each? You have to look at every word in the line item and think about it and contrast it to the words of the requirement. Can you describe the intent of the element or section?
Take this one:
--> ...14) Records of corrective actions have to be retained for a defined period...
Can you think of a place where the standard
specifically requires this? Can you think of an instance where one might be kept longer than whatever your defined minimum is? Or do you have a minimum defined period?
Look at 4.16 and see what it says. Don't confuse with QS9000 requirements. The closest it comes is to say "Retention times of quality records shall be established and recorded." Is your CA report specifically defined within your system as a quality record?
The point of all this is there are times when you meet the intent but it might not be in the paradigm of the auditor in which case you have to 'educate' the auditor.
An example of this is 4.20 Statistical Techniques. It says you have to "...identify the need for..." - which is the key to the sentence. It
doesn't say you
have to use any. Period. I went through this with an auditor who had a very hard time with us explaining that we investigated where statistical techniques would help and found none.
Scenario: Small 14 soul company. No turnover of any employees in almost 10 years. Mix bulk chemicals for cleaning metal parts. Noting precise at all. Empry bags or barrels into hopper. Mix. Package in drums. Both powder and liquid product 4 mixers each for 8 total mixers. No customer complaints in years but then the guy who owned the companies visited every customer regularly. Only QA test was specific gravity (big deal). Tolerances wide. Limits established. long established, stable process. No desire to expand customer base. No desire to get into automotive business. It was like a happy little family
So - where would a statistical technique help? The guy doing the QA checks had been there for years. He didn't need a graph to tell him what the process is doing. Again, their product was so basic with such wide tolerances that we're FAR from rocket science. I will admit I did not find the place particularly aggressive. They're just nice people who are in some ways a throwback to the 60's. In a way I'm jealous, as a matter of fact. The old 'simplier time' thing. At work at 7, leave at 4. Every day. Rarely any overtime or anything. As I said - I was/am impressed. anyway, I digress...
The auditor finally bought it (no ST needed - intent met with proof 'opportunities' for ST were investigated and the need is re-evaluated yearly in their management review meeting). And the company is happily(?) registered...
Has this confused the issue or has it made sense? I can take criticism! I just can't spell worth a damn.