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Author Topic:   Non Conformity!!!!!!
Howard Atkins
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posted 21 December 1998 12:15 PM     Click Here to See the Profile for Howard Atkins   Click Here to Email Howard Atkins     Edit/Delete Message   Reply w/Quote
I just had a survellance audit and the auditor tried to give me a non conformance because I had added to the control plan as a result of corrective actions. I told him that I can add what I like to the control plan with out permission. In the end he accepted this.
Just shows .!!

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Dawn
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posted 22 December 1998 08:05 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
Who was your Registrar?

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Howard Atkins
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posted 22 December 1998 10:01 PM     Click Here to See the Profile for Howard Atkins   Click Here to Email Howard Atkins     Edit/Delete Message   Reply w/Quote
Standards institute of Israel who were being audited themselves by RVA from Holland

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Marc Smith
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posted 22 December 1998 10:09 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I've been thru plenty of audits - doesn't surprise me one bit. It has been one of my complaints for a number of years.

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Kevin Mader
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posted 23 December 1998 09:15 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
We are all human I guess, even Registrars. I have had a few issues myself, but so far I have been able to work through the issues. My advice to those who have or haven't been through it: be nice, explain your position well. If that does not work, differ the issue to the next level for consideration. If that doesn't work, satisfy any Corrective Actions request, don't invite that auditor back, and consider searching for a new Registrar. It's your money.

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Marc Smith
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posted 24 December 1998 01:59 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Kevin:

I disagree with interpretations being a matter of all of us 'being human'. It is an issue of experience and understanding mixed with intent. I have worked with many standards over the years. I cut my teeth on military specifications. I got my first job in quality because I told the company I understood them (MIL SPEC). I studied the appropriate ones for the product as required by contracts. I often had to explain how the company I worked for 'meets the intent' of a spec. I got into ISO as I thought it was comparatively easy - and it is.

We come down to interpretations. And with QS came rediculousness (spelling?). But then, QS is a customer requirement and ISO is an international specification, if you will.

Anyway, I approach every client from the First meeting with a diatribe which approximates the following:

"I cannot do this for you. QS9000 and ISO9000 are, as a group, requirements in so far as registration is concerned. I have to transfer my knowledge to someone. And - when that person is ready, that person will understand the requirements and the intent of the details of the requirements with respect to their business and company systems."

"Auditors are often problematic in part because there has been a rush by marginally qualified people to and thru the Lead Auditor Certification Process."

I had one auditor who was a college professor who smelled money. When it came to interpretations, he was often a wash. Yes - I know the 'time in business' aspect but even that does not ensure consistent interpretations.

I do admit the college professor would listen to reason and we often 'worked through it' to a convergent point as you say.

"You will have to be ready to fight with the auditor over points of contention. Auditors are often simply not right in their interpretation. In my very first ISO9001 audit, within 30 minutes of the start of the audit we were given our first 'minor'. The auditor said it was not easy for him to tell the differences between the current quality manual and the last version. I had written a documentation database for the company. All revisions were detailed except for that one. We had taken the old quality manual and completely revised it - like major, major revision. In the database field where we listed the changes, we simply put a statement which said "Due to the dramatic and extensive changes, the changes are not listed here. Please compare the two manuals if you need to tell differences." We did this because it didn't make much sense to list 100 pages of changes (which is what it would have taken if each specific change had been listed and addressed). I asked the auditor where in ISO9001 it said it has to be easy for him to tell the differences. He hemmed and hawed and thumbed the spec and finally said "It's implied". Well, now, bull shit. He never did buy off on it - we kept that minor. I can say, however, the rest of the audit went quite well. I think I cowed the guy. Attacked him right off the bat with a Show Me Where.... But then - we were all ready to explain how we complied. We were ready!

The point is you have to understand the spec and the intent and be ready to explain and argue your position or auditors will end up running right over you and you'll end up doing things to your systems 'because the auditor said so'. Choose your battles well, but there are times when battle is neccessary.

It's not 'human nature' - it's a matter of interpretation, understanding of intent, and being Ready To Explain! Don't get me wrong - I have run into a lot of very qualified auditors. None the less, one must be ready.

I tell clients: I'm little more than a piano teacher. I can teach you how to play faster than you can learn yourself. I can teach you how to read music. I can teach you what the conventions are. I can teach you how to play the game. BUT - when the concert starts my fingers cannot be on the piano keys. You must play your own concert. And you have to be ready for it. I can't do it for you.

Every client I have had has been 'first audit' successful. And they know their stuff - they are READY! Much like Formal Logic and Debate in college, this is a game any company can win.

Nor do I mean to detract from the 'goodness' of ISO9001 (or many aspects of QS9000). I believe there is 'goodness' in them both. This is to say, for example, a defined, substantial, 'robust' design process is 'goodness' just as well designed and executed Nonconformance and Corrective Action systems have 'goodness'. They are beneficial and important systems to any business.

OK - now rip me up!

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Don Winton
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posted 26 December 1998 11:16 AM     Click Here to See the Profile for Don Winton   Click Here to Email Don Winton     Edit/Delete Message   Reply w/Quote
Good show, Howard.

Marc,

Rip you up - I cannot. You made all points very well. I also grew up with MIL standards. Interpretation is not a problem with GSA auditors, IT IS A WAY OF LIFE! During my experience, the GSA ( o )‚s did not even want to see the standard. They had their minds made up and did not want to hear your side. But that is another story.

I agree that with QS came ridiculousness (sp) which is part of the reason I try to shy away from QS issues. But, then again, to this point that has not been a problem for me. My company is going for ISO with the FDA‚s QSR. But interpretation is going to be an issue with the FDA inspectors anyway, so I draw on my MIL experience. I found that out during my ISO preassessment. My auditor was a former FDA inspector with EU qualifications. She kept wanting my system to comply her interpretation of the QSR (This was an ISO preassessment), which I successfully defended as not being required. I will deal with the FDA during an FDA assessment. In short: If you need it, have it. If you do not need it, do not have it, but be ready to explain WHY you do not and how you meet the intent of the standard.

Your handling of the auditor during the first assessment you mention struck a nerve. Not with what happened, but it appears from your account that this assessor‚s attitude may be typical of some (not all). They come into YOUR facility to examine YOUR system, but set themselves up as the experts. Your őShow Me Where‚ should have been enough to drop the noncompliance, but it would seem he did not want to admit an error in front of what he now perceives as a peer. Once you demonstrated your knowledge and experience, he appears to have backed off somewhat. Perhaps my interpretation is not accurate.

One last item: „The point is you have to understand the spec and the intent and be ready to explain and argue your position or auditors will end up running right over you and you'll end up doing things to your systems 'because the auditor said so'. Choose your battles well, but there are times when battle is necessary.š On this item and others when dealing with interpretation, I draw from Sun-Tzu:

„One Who Knows When He Can Fight, and When He Cannot Fight, Will Be Victorious.š
„One Who Recognizes How to Employ Large and Small Numbers Will Be Victorious.š
„One Whose Upper and Lower Ranks Have the Same Desires Will Be Victorious.š
„One Who, Fully Prepared, Awaits the Unprepared Will Be Victorious.š
„One Whose General Is Capable and Not Interfered With by the Ruler Will Be Victorious.š

Regards,
Don

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Kevin Mader
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posted 28 December 1998 09:44 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Marc,

Perhaps I did stretch the definition of a human being a bit to far. Good points on the qualifications of an auditor, I can't rip you there (or anywhere really). I agree that with the explosion of ISO9000, Registrars bent the guidelines for hiring auditors too much. You also make an excellent point that by defending your contentions you may cause the auditor to do some silent reconsideration (even if it is not at the point at hand but rather future points of consideration). I think a good auditor wouldn't be discouraged enough not to probe, but one that does not have the understanding and confidence probably would. I guess the advice I gave is based on the fact he has the power, right or wrong, to sway the outcome (honey vs. vinegar, an NFL referee).

You raised an interesting question (at least to me) about QS9000 and the registrar. All of us have read a lot about the qualifying of QS auditors. The question I have for you (and anyone wanting to contribute) is how have these auditors faired in comparison with the ISO auditors you have encountered? Better or worse? Knowledgeable or Not? How about their interpretations on the "should" items as there is room for interpretation and implementation? Of course these questions can be answered some better, some worse. What I wanted to see was more in line with the actual experiences and solutions. Perhaps this should have been raised as a new topic, I will leave that at your discretion.

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Marc Smith
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posted 28 December 1998 11:37 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Don:

The auditor we had at the first audit who 'it was not easy for...' was a retired GM person (this was an ISO audit, remember, not QS, and it was 6/94 as I remember). He was a nice guy but his expectations were off the wall.

Now - I think there are good auditors - I do not mean to condemn them all.

I see each auditor as a person with a specialty that they are good at. During my time with Motorola we learned several things early:

1. You have to have a single responsible auditor who attends *EVERY* audit (project manager, if you will). That person becomes the 'expert' on your company for the registrar. If the audit is a Singapore facility, s/he is there. If the next one in in Scotland, s/he is there. Before we did this the interpretations issues were really an impossibility to deal with. Again, that single individual *HAD* to be the Lead Assessor at every audit at every facility - NO Exceptions!!!!!!

2. Team composition may change but we reserved the right to (and for the most part did) 'interview' each prospective auditor with rejection power and with the input of where that auditor should be checking. (For example, one person we 'interviewed' was terrible on calibration. I mean that person was BAD. We asked that that person NOT be involved in review of any part of the calibration system(s)). We found each auditor had strengths and weaknesses and wanted to ensure we had people familiar with fabs auditing fabs, etc. A few auditors did not work out, almost all did, however.

That implementation effort taught me a lot about auditors and what happens with interpretations. Understand that many of the systems were 'master Motorola systems' and thus at each facility they were identical. One auditor would agree to compliance of a specific system while another auditor at another facility 'saw things differently' with regard to compliance of that same system. Obviously a nightmare can erupt.

We also, by the way, had an 'interpretations list' where we posed questions to LRQA (Motorola's registrar) about monthly. I must admit most of their responses, however, were so vague I was, well, I'll just say I was 'seriously disappointed'.

Kevin, you comment about the 'should' - heck - look around the site at some of my ramblings. I believe a couple of years ago I had a line which read something like "Coming Soon! QS9000 as a foreign language!" wherein I lambasted them for using the word SHOULD where SHALL was the word they should have used with regard to their expectations. This also illustrates something else I tell (and try to drill into) my clients - 'Every Word has a meaning (taken in context). Every word is important'. This is part of my 'You better understand the intent and be ready to explain' diatribe which I throw at my clients at least 5 times every time I visit. You can't understand the intent unless you have read it and pondered every word (my opinion - no kidding).

I also admit that a big part of the problem also comes from companies which do not put a person in charge of the program who has the background to do this or the company fails to recognize that there is time involved in doing all this.

As a last comment, the idea is not to stiffle an auditor. Hey - let them look and probe. I believe if you're compliant that is a non-issue.

The bottom line is we are experiencing (and are involved in) an evolution at a time when things like this (business systems) evolve at a quite rapid rate unlike anything the world has ever known. The faster the rate of evolution, the higher probability of failure (my opinion - I don't have evidence). Our defense in this 'game' is knowledge and readiness (understand and be ready to explain).

I have not noticed a big difference between QS and ISO auditors. QS just has a lot more vagaries than are apparent at first blush leading to more confusion and interpretation issues. Hell, look back at the QS "Fax in your questions and we'll (maybe) address it in an interpretations document which will eventually exceed the size of the document (qs9000) its self" stupidity. ISO has much more reason in it and vagaries (including SHOULD statements) make much more sense (remember, ISO9001 is an International Spec while QS9000 is strictly a Customer Requirement).

To finish up - folks, I set this site up specificaly because of the this issue of interpretations. I even called it (and still do) an information forum. From the main page:

-----snippo----
The Cove is Your Beacon for Direction Thru
The ISO900 - QS9000 Fog and 'Intent' Blurrr-r-r...
Do You... Understand the Intent?
Are You... Ready to (Can You) Explain?
Site Mission Statement:
To serve as an ISO9000 / ISO14000 and QS9000
Information Exchange and Co-Operative
-----snippo-----

I used the words "Fog and 'Intent' Blurrr-r-r..." for a very specific reason - Interpretation Confusion.

So - we're off to fight some more good fights!

[Whew...]

Who's next??

[This message has been edited by Marc Smith (edited 12-28-98).]

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Kevin Mader
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posted 29 December 1998 08:42 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Marc,

I shall not use "should" again * 100. I vaguely remember a back-and-forth discussion you posted at your old site to that point (also remember other postings between you and the award winning Plexus, another bad word).

Thanks for the feedback on ISO vs. QS auditors. I suspected as much but had heard that they are generally "very" literal and often opinionated (QS auditors that is) in their interpretations. I see this as a potential problem as an organization may find itself in the position of trying to meet a registrar's opinion rather than satisfying the intent of the standard (and requirements) as it suits an organization. To your point, being compliant should eliviate any debate. Still, we will fight the good fight when we must.

Regards,

Kevin

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Marc Smith
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posted 02 January 1999 08:49 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Well, as an 'implementation consultant, my job is to prepare companies for battle.... Folks may not agree with the word 'Battle' but that's what it can be. Some auditors are liberal. Some auditors are ignorant a__holes. Some auditors listen. Some auditors just want to get out of town.

I tell clients:

If you're not prepared, it's your own d__n fault. Like in college. If you're not ready for the test - tough s__t...

[This message has been edited by Marc Smith (edited 01-02-99).]

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Marc Smith
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posted 03 January 1999 09:23 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Ah, yes - Plexus. Alex Chong. Her got his in, alright. But - I better not re-live that.

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barb butrym
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posted 21 January 1999 08:53 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
I am preparing for battle as we speak. the registrar has just completed the DQS and hit me with 36 nonconformances...bullshit every one of them/...well 2 were fairly valid as observations...the rest were silly. Could argue each one easily....typos, all wording he preferred to the wording used...even that a procedure (3 n/c raised for this)was signed twice by the same person (QA manager was both originator and Management rep...also had a reviewer and mfg signatures. Even one for not having an org chart or responsibility matrix. Actually have both, but not submitted as part of the DQS as they were in update/sign off mode. QA manual clearly defined responsibilities anyway. He even said one of the level 3 documents needed to be renumbered as a level 2. As if I even need to number them as level anything !!!

I called the registrar..bitched got little satisfaction, so will take it up with the auditor on site. Sounds to me like he is consulting. I have requested the auditor's resume. I have responded as nicely as I could to the report actions..gave in on some counts (choose my battles so to speak) and am gearing up for a "hell week" audit. All I can think of is the poor smuck that tries to go it alone. I remember when I was in the industry as the "management Rep" at a company...I wanted NO part of a consultant,didn't need one. I was lucky, it was a good company and I had support we did well...BUT had i known then what i know now...there were several issues that could have been raised,,,,and things I would have done differently..very differently. i would never have argued the standard as i would today....AND WILL NEXT WEEK....LOL

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Kevin Mader
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posted 21 January 1999 09:08 AM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
Barb,

Sounds like you have your hands full! Did you have the opportunity to interview with the Lead Auditor prior to selecting this Registrar? If you did, was the window dressing too convincing? I guess that I am fairly fortunate to have gotten a registrar open to interpretation and without preconceived notions. Our partnership is great. Wish I could send him out there to do your audit for you next week. A real pleasure to work with. Do you have any specific issues you might want some feedback on? I would like to help if I could.

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Marc Smith
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posted 23 January 1999 07:46 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Ok, ok, barb. Tell us. Which registrar if you be so bold... You know none of us will tell.... At least e-mail me in confidence.

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Don Winton
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posted 23 January 1999 08:21 AM     Click Here to See the Profile for Don Winton   Click Here to Email Don Winton     Edit/Delete Message   Reply w/Quote
Yes, barb, do share. Seriously, it sounds like you have your hands full. Good luck. Just one thing.

quote:
He even said one of the level 3 documents needed to be renumbered as a level 2.

I would have went through the roof. I sure hope you handled it better than I would have. I can assure that if he had implied something like that at my assessment, it would have set my registration back months while the registrar was searching for the body. Again, good luck and DO let us know what happens.

Regards,
Don

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barb butrym
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posted 23 January 1999 12:36 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
yes...my hands are full and my guns loaded...been a while since I had to deal with such foolishness....

The lead auditor we interviewed when contracting the registrar has left the company, so thats where that came from !!!

I have used this registrar before and been very pleased, I actually did some guide 25 audits for them in the past. They have always had the philosophy...."show me, and if it works..ok" very flexible and easy to work with...but as everything else...its auditor dependant, and they have just lost 2 (of 4) lead auditors. One to promotion to President (so per QS cannot audit) and one left the company. All they have left are contract auditors they plan to bring on full time, and this new aquisition's auditors.

This LA is an auditor I have not met yet, probably new as they just acquired the business of another registrar, I suspect he came with the package. (I came to this conclusion after I cooled down)

I was real disappointed in the response I got from the main office as I have known them a number of years and they got real snooty with me. The 2nd auditor on the team, I do know pretty well. I suspect that they are evaluating the LA to see if he will fit their philosophy. And depending on his position in the acquisitiion, they will act on it. I just don't like being the guinea pig, and I resent the lack of respect I got...but then...they have to stand behind their people, and I did come on strong...LOL
BUT I will have the last laugh, the company is ready, they have a good system, and it's working well....AND I am ready, laminated battle worn copy of the standard in hand and all. I also won't do business with them again. I have one more after this scheduled with them, and if I get mad enough I will pull them out, and reinburse thier application fee myself.

I do audits for URS as a contractor, and keep all my consulting away from there to eliminate all possible hints of a conflict, but I am beginning to think I should change my thoughts on that. Any comments?

Thanks for the support guys, tune in next weekend for the results, I leave for Syracuse Monday....

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Marc Smith
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posted 23 January 1999 05:08 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
We just missed. Left Syracuse after a week there yesterday - got into Cincinnati late last night.

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barb butrym
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posted 25 January 1999 09:20 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
we'll meet up somewhere I am sure...one of these days...LOL

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barb butrym
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posted 30 January 1999 05:13 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
Well...I'm back.

The company has been recommended for registration. Audit ended with 9 minor nonconformances......AND i mean minor...as a matter of fact, they were all corrected and signed off as accepted/closed before the auditors left. I didn't have to say much, and more than half of the N/C's were simple additions to a procedure as in...said " reviews", should say " reviews and signs" (signatures were there, and a signature block). others were real, and no big surprise. I could see where he was coming from when I didn't agree, so I didn't push where it was easy... wanted to choose my battles wisely, but never got to do battle !!!
Took issue with a thing about job descriptions....but that came from the HR person pointing him there....her fault.
Still don't agree with his interpretation of design validation, but again it was a 'wording' thing. Not the best auditor, but fair, I feel a lot better.....about the registrar now and would use them again, abet carefully.

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Don Winton
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posted 01 February 1999 10:35 AM     Click Here to See the Profile for Don Winton   Click Here to Email Don Winton     Edit/Delete Message   Reply w/Quote
Good show, barb. Congrats.

Regards,
Don

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