Anyone else ISO-17025?

I just finished out bi-annual audit from A2LA on our (my, basically) calibration and quality system. Both days were 8+ hrs straight being interrogated about CAR's (corrective action requests, not the fun cars, even if he drove a BMW 5series), contract reviews, complaint handling procedures, internal audits, measurement uncertainty, ... Mostly one-on-one with me.

Curious if anyone else has to deal with cumulative measurement uncertainty including type A and B factors with rectangular distribution and GR&R including repeatability and drift components? (Anyone?)

WUT

I used to work in an A2LA accredited lab/R&D facility. Screw ISO-17025. Screw meticulous lab notebooks. Screw constantly signing off on each other's stuff and the audits, etc. Sorry, I did a brain dump when I moved on to another job. Oh yeah, screw calibrated rulers and pantone charts.

I live on the edge of that reality. Sounds like you are in the medical device world.

In reply to rotard:

What you said, we have to be ISO certified company wide to supply some of our end customers, and process engineers are perhaps some of the dumbest people in existence. My biggest gripe was over the last audit. Say we have a 3 step process for shipping goods to a customer, it is a streamlined version with 2 built in checks that can be accomplished in under 3 minutes per order. What the auditor proposed was a 12 step process that included 2 checks and 9 completely needless steps that are obviously there to complicate the process to cause human error and make us less productive. It took 14 minutes per order to do what the auditor suggested.

The end result was that we collectively said his process was asinine. Somehow we're still ISO certified, which makes me think we basically paid a $10k bribe to this organization for the right to sell to an end customer.

I remember working with consultants and outside agencies of that ilk in the past.

I couldn't remember how to spell the name of one of their onsite reps, and when I asked a coworker, he said it as "R-A-S-P-U-T-I-N"

In reply to NOHOME:

Coating and plating thickness measurement. Xray, beta backscatter, eddy current, magnetic, microresistance, and coulometric. 16yrs in since September, I got us accredited as the first in our field in 2000. And every berkeleying year I get a new assessor that has his ideas on how things should run and especially measurement uncertainty. Pretty much every berkeleying audit I end up changing something, sometimes lower sometimes higher. And not a god damn one of our customers could care less. They just know they have to have a number on their certificate.

Supplying calibrations to automotive, fasteners, circuit boards, etc we have to be accredited to get past their supplier requirements unfortunately.

corporate buzzwords... gotta love em..

we have something called "5S" at work, which means keep your work area clean... and they have something called "Kaizen" meetings, which means people from different areas talk to each other while eating free pizza and donuts for a couple of hours..

I'm sure that pizza helps you synergize and leverage your core competencies.

novaderrik wrote: corporate buzzwords... gotta love em.. we have something called "5S" at work, which means keep your work area clean... and they have something called "Kaizen" meetings, which means people from different areas talk to each other while eating free pizza and donuts for a couple of hours..

5S is a lot more than just keeping your work area clean, if you're following it properly. ISO-17025 is a nightmare compared to 5S.

I feel for you! I was in ISO 9001; then another company was ISO 13485 Medical and FDA. Now just FDA. Very few of those auditors have been in business, let alone run one. We've made changes just to get the certification. For 13485 it was above $50k every year. One time an auditor told me what I needed to do and I told her I could not. The standard did not allow her suggestion. She argued. I did not argue, just showed her the section of the standard. Needless to say she was pissed. But it put her on notice that I knew what I was doing.

Yeah, we utilize the 5S system at my workplace as well. It is nothing compared to the audit nightmares that ISO-anything will bring. 5S is very basic.

Audits suck, end of story. They do some good, and it's nice for the customer as a safeguard, but they always cause trouble.

Jerry wrote: I just finished out bi-annual audit from A2LA on our (my, basically) calibration and quality system. Both days were 8+ hrs straight being interrogated about CAR's (corrective action requests, not the fun cars, even if he drove a BMW 5series), contract reviews, complaint handling procedures, internal audits, measurement uncertainty, ... Mostly one-on-one with me. Curious if anyone else has to deal with cumulative measurement uncertainty including type A and B factors with rectangular distribution and GR&R including repeatability and drift components? (Anyone?)

I’m ISO 13485 for Medical Devices and ISO Horny for Funny.

I teach advanced engineering statistics so feel free to P.M. me if you have any math questions…By the way, what the hell is a rectangular distribution…is this what you kids today are calling a uniform distribution???

Good grief, one of the nicest things about math is its finality. Don’t screw with it (U-N-I-F-O-R-M) got it.

ISO 9001. Some days I want to wack our QC manager in the head.

MattGent wrote: I'm sure that pizza helps you synergize and leverage your core competencies.

i'm sure... i haven't been there long enough to take part in that stuff.. a couple of coworkers and i were talking about how fun it would be to have a time wasting meeting with management where we got to do trust falls...

I used to live this stuff- started off by implementing QS-9000 TE supplement. The last job I had in that world I dealt with TS-16949. All automotive stuff.

Now I work in a hospital, the standards are four times bigger but less prone to "interpretation" by an auditor.

Sorry, I'm too far out of it to help with any math. Unless you need power factor, voltage drop or the like

slefain wrote: