JRKH said:
These are shoulds though, not shalls.
I agree with Claes.
I don't see where the internal audits fail.
Our registrar had some concern about how I was planning my audits for next year, (more of a 1994 style) and recommended that I consider changing the focus to a process model bcause it is more efficient and would take less time than what I was planning.
I especially have a problem with the NC being a Major.
How many other NC's were written on your system?
James
8 altogether.
One note that I am not sure everyone is aware of, I just started this job a month and a half ago. The previous QM left this system a wreck! Nothing was updated and there were no internal audits performed for over a year and a half and none to the new standard. So I walked into a mess that I am trying to clean up in a hurry. So I had 8 reports to clear up. 3 Majors and 5 minors. All are done except this one, well it WAS this one

.
I just spoke with the auditor finally and got this all squared away. This is what he told me.
Exactly what I explained above he explained again.
I think Ben Sortin's post does a good job of summing it up. The auditor actually referred to 8.4 and 8.5.1 for analysis and continuous improvement.
And basically we already doing this with our management reviews and our corrective actions but he said we need to document this in a format that SHOWS we have done a actual "process audit" . He said our corrective action report was not enough. that we need a audit format that includes questions about inputs, personnel involved, material, equipment, training, and basically any other questions we need to find the root cause and that we need to come up with ideas for a solution. And those needed to be reviewed and followed up on during management reviews. He also mentioned using
8D forms for this.
Basically I still don't think there is a clause for this, especially if you are looking at this standard like it is the OLD standard. But I guess when you start looking at this standard as if there were no old standard and just reading it as if it were new and you had have no conclusions based on your experience with the old standard THIS one starts becoming more clear, or more confusing depending on how you look at it.
But I did not fight him on this for one major reason, I think it is going to be a very useful tool in helping to identify and correct major problems, it also is a tool that keeps management even more involved, and now I can tell them "well the standard SAYS we have to do it" and that just gives me more muscle to get things done. And bottom line, it's a good thing to do.
Do I like being REQUIRED to do it though is another question.
One more thing, he is asking for no formal documentation of this as of now, he feels I have a good grasp of what he is requiring now and he will view our progress at the next audit.
He closed all our findings out and now I am waiting on word from the registrar to give us our cert.
Woo hoo for me!
G.