An ISO/TS16949 Registration Maintenance Diary

[Icy Mountain]

External Audits, Football, Coffee and Blood Pressure

We just finished Periodic Audit #3 by DNV. Before I post the results I have some humor:
The first day of the audit (Tuesday), I had to leave my auditor with my boss while I went through a "Health and Wellness" screening, one of our insurance company's way of finding issues early in order to hold down costs.

Part of the screening included a blood pressure check and mine was 138/80. The current guidelines put anything between 130 and 140 as "pre-hypertensive" so you get urged to see your doctor for preventive action. I pulled out my Red Cross card and pointed out that over the last 12 months, I have 6 blood pressure data points from screenings before a blood donation with an average of 120/78, 114/74 min and 130/80 max (ever the quality engineer).
Nurse: Icy, what would you say is causing today's reading?
Icy: Let's see, I stayed up until 2AM last night eating chips, drinking beer and watching my beloved Buckeyes get creamed in the Championship. I got up at 6AM and I have had 3 cups of coffee instead of the usual one so I could be alert since I am in the middle of an ISO/TS external audit. AND, right now the auditor is talking to my boss and I am not there to make sure that doesn't go into the weeds.
Nurse: Well, considering all of that, I'd say you handle stress in your life pretty well.

 

[Icy Mountain]

External Auditor's Response to Blood Pressure

My registrar's auditor (a.k.a. He Who Makes Coffee Nervous) responded with this Draft Report:

Scientific evidence now proves that audits raise blood pressure significantly. Be advised for your own safety when involved in this potentially dangerous activity. The US Center for Disease Control offers the following precautions if and when you are involved:

1) Avoid conflict and any excess stimulation with the auditor.

2) Emergency equipment such as portable cardiac defibrillators and oxygen are advised before, during, and after audits.

3) Remain calm and utilize the Socratic method of answering a question with a question to always seek the truth.

4) Do not schedule health fairs during audits as this causes high blood pressure and emotional stress for employees.

5) Drink plenty of fluids, avoid bright lights, and stay out of the heat during all interrogations.

6) If you do not know the answer to a question, remain silent.

7) Calmly mention the fact that you are sick with a highly contagious virus as you are introduced to the auditor.

8) Seek first aid immediately if needed.

9) Wear suitable personal protective equipment and attire.

10) Remind the auditor of their obligation to the health, safety, and well being of humanity.

 

[Jim Wynne]

Re: External Auditor's Response to Blood Pressure

My registrar's auditor (a.k.a. He Who Makes Coffee Nervous) responded with this Draft Report:

I'd like to know what constitutes "stimulation with the auditor" and then how to tell when it has become excessive.

 

[Icy Mountain]

Management Review in December 2006 went smoothly and there where only extremely positive indicators for the QMS.

Two day Periodic Audit on January 9 & 10, 2007 results:
Over a dozen positive indicators
Three Opportunities for Improvement all related to adding detail to objective evidence/records of the QMS
One Finding:

A documented procedure shall be established to define the controls needed
f) to ensure that documents of external origin are identified and their distribution controlled

Evidence: Found TS customer's shipping and packaging specification at different revisions in Order Review vs. Shipping. Could not locate process notice called out on the purchase order.

Rebuttal:
This is a minor finding. There have been no complaints about and/or violations of the current revisions of either of these documents. Our system has been adequate from our registration until now and we have checked externally controlled documents, and specifically the shipping document, at every internal and external audit.

On the gripping hand:
This is a clear cut Document Control finding. The biggest problem here is that sub-paragraph f) is covered in the manual and our system has executed properly until now. As the findings get fewer and ever more detailed, it gets more difficult and detailed for me to implement system corrective measures. I thought that these doggone findings would get easier to response to, not harder.

 

[Icy Mountain]

Re: External Auditor's Response to Blood Pressure

I'd like to know what constitutes "stimulation with the auditor" and then how to tell when it has become excessive.

Stimulation: The auditor, who is from "that state up north", begins to sing "Hail to the Victors" with the single Michigan fan on your production floor.
Excessive: We can hear them in the Operations Director's office

 

[Icy Mountain]

One Finding:
Evidence: Found TS customer's shipping and packaging specification at different revisions in Order Review vs. Shipping. Could not locate process notice called out on the purchase order.

Here's another funny story. It turns out that the second piece of evidence, the "process notice", is the generic form number for the customer's Purchase Order itself. We were actually holding it in our hand! Well of course we meet that specification, we'd get killed if we didn't review and execute purchase orders properly. No wonder we didn't know the number, our customer has told us a million times, "You must meet the requirements of our Purchase Order", but not once have they said "You must meet the requirements of Form123". I don't know how I'm gonna answer this one...

 

[Icy Mountain]

Answering the process notice portion turned out to be really easy. I contacted my auditor and explained the situation and the notice in question was removed from the evidence list.

As for the finding:
We regularly check our customer's "what's new" page and update our files. We do a compare against the previous revision to see what has changed (if anything), and adjust our system accordingly. Of course, the customer gives no notice or clue what requirements may have changed. In the case of some of the larger tomes (100 pages +), we were not updating the paper copy in shipping after this review when only the phone number of the receiving clerk in Sri Lanka had changed.

Solution:
Paper copies at point of use eliminated. Computer shortcut to the documents on the customer's website installed at point of use.

 

[Icy Mountain]

Based on the above response, Periodic Audit #3 is closed.

And now for something completely different...
I got an email today that starts off: "Congratulations on achieving supplier status at Big Three Automotive Customer."

Now the fun really begins!:mg: :truce:

 

[Icy Mountain]

I suppose an update to the diary is in order given the 3 month gap.

I have spent a lot of time working through the Customer Specific Requirements for one of the Big 3. We are planning on shipping a catalog product that has been in production for about 6 years. Therefore, there are a lot of requirements that are not appropriate like just about all of the product development stuff (take it or leave it). Post PPAP (again very limited, doing full dimensional layout on a product that is basically two aluminum extrusions around a circuit board is both pointless and expensive, of course they don't want to pay), there are also a number of non-applicable clauses, or at least extremely expensive per piece, as the volume is extremely low (ie. < 1,000 per year). It is really amazing that these guys have a one size fits all approach to purchasing: Give me a better price than you give anyone else, however, spend 10x more labor on paperwork, an oh, yeah, I want to buy a smaller quantity than your other 2 customers.

Anyway, we had the standard Management Review at the end of March. All of our metrics like Customer Scorecards and On Time Delivery are trending up (or perfect) and all of our metrics like scrap, rework and warranty costs are trending down, continuously. Yours truly looks like a quality genius: "Hey, Icy, this formal QMS thing really works!" Duh

Spent about 2 hours today making sure all my quality records are up to date. Just a last minute check of the Improvement database, calibration database, etc. to make sure that no "gotchas" have slipped in there since January. Ho-hum, a couple of updates here and there but, really, this system basically runs itself and all I do is make sure that our sales force doesn't get us in a huge jam with potential customers that are TS subscribers.

Internal Audit for the next 3 days. Our DNV surveillance is scheduled for June 19 & 20.

 

[Helmut Jilling]

I suppose an update to the diary is in order given the 3 month gap.

I have spent a lot of time working through the Customer Specific Requirements for one of the Big 3. We are planning on shipping a catalog product that has been in production for about 6 years. Therefore, there are a lot of requirements that are not appropriate like just about all of the product development stuff (take it or leave it). Post PPAP (again very limited, doing full dimensional layout on a product that is basically two aluminum extrusions around a circuit board is both pointless and expensive, of course they don't want to pay), there are also a number of non-applicable clauses, or at least extremely expensive per piece, as the volume is extremely low (ie. < 1,000 per year). It is really amazing that these guys have a one size fits all approach to purchasing: Give me a better price than you give anyone else, however, spend 10x more labor on paperwork, an oh, yeah, I want to buy a smaller quantity than your other 2 customers.

Anyway, we had the standard Management Review at the end of March. All of our metrics like Customer Scorecards and On Time Delivery are trending up (or perfect) and all of our metrics like scrap, rework and warranty costs are trending down, continuously. Yours truly looks like a quality genius: "Hey, Icy, this formal QMS thing really works!" Duh

Spent about 2 hours today making sure all my quality records are up to date. Just a last minute check of the Improvement database, calibration database, etc. to make sure that no "gotchas" have slipped in there since January. Ho-hum, a couple of updates here and there but, really, this system basically runs itself and all I do is make sure that our sales force doesn't get us in a huge jam with potential customers that are TS subscribers.

Internal Audit for the next 3 days. Our DNV surveillance is scheduled for June 19 & 20.

Excellent, Icy. That's how it should work. Sorry about the CSR's. You can always ask/require the customer to waive the meaningless or non-value added ones.