ML070670105

Comment (13) of Ed Stamas Re Renewal of Vermont Yankee Facility

ML070670105
Person / Time
Site:	Vermont Yankee File:NorthStar Vermont Yankee icon.png
Issue date:	02/02/2007
From:	Stamas E S - No Known Affiliation
To:	NRC/ADM/DAS/RDB
References
71FR76706 00013
Download: ML070670105 (3)

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Ed & Emma Stamas <estamas@mtdata.com>

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Creation Date From: Created By: Comments Fri, Feb 2, 2007 3:58 PM Ed & Emma Stamas <estamas@mtdata.com>

estamas @mtdata.com Recipients nrc.gov TWGWPO03.HQGWDOO1 VermontYankeeEIS Post Office TWGWPO03.HQGWDOOI Route nrc.gov Files MESSAGE TEXT.htm VermontYankee .doc TEXT.htm Mime.822 Options Expiration Date: Priority: ReplyRequested:

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Security: Size 93 799 31744 752 47909 Date & Time Friday, February 2, 2007 3:58 PM None Standard No None No Standard Junk Mail Handling Evaluation Results Message is eligible for Junk Mail handling This message was not classified as Junk Mail Junk Mail settings when this message was delivered Junk Mail handling disabled by User Junk Mail handling disabled by Administrator Junk List is not enabled Junk Mail using personal address books is not enabled Block List is not enabled I am recently retired as Director of Quality Assurance for a major Pharmaceutical firm. My department was responsible for inspecting all of our plants worldwide for compliance to FDA regulations.

While this industry is not the same as the nuclear industry, I feel there are similar issues that could be related.During my many years in Quality Assurance, I realized that quality cannot be inspected into a facility.

If there were systematic problems they would still be there after the inspection team left.No inspection team, however proficient, can inspect 100% of every system. At best you are inspecting a small percentage of random components that hopefully gives a true representation of the entire system. I have seen plants pass internal inspections with glowing reports, only to be shut down by FDA inspectors within six months of the initial inspection.

I have also seen our internal plant inspectors provide me with a list of major deficiencies, each capable of causing a plant shutdown due to possible contamination.

But before we had a chance to correct them, the FDA would send in their team, only to give us a clean bill of health and permission to continue to manufacture pharmaceuticals for human' consumption.

At that point, it would be the responsibility of the plant to openly admit to FDA inspectors that it had overlooked several critical system deficiencies.

However, too often, the temptation fs to keep silent and let money and greed make our decisions.

My responsibility was to assure that our plants were meeting FDA regulations so when the FDA came in to inspect, there would be no problems.

In my experience, this was futile. A team of inspectors with fresh, unbiased eyes always had the advantage over the internal inspection team and in some cases, I admit not all, they found major issues that were overlooked by the plant inspection team.Based on the above comments, I have the following questions for the NRC as related to the renewal of the Vermont Yankee Facility: 1. How do you plan to assure that any upgrades, retrofits or system componentry changes to the exiting system will not have a detrimental effect on another system which may then become a major problem that was overlooked by inspectors?

2. How will you ensure that inspections are carried out not only by well trained, experienced individuals, but by teams that are unbiased and looking at things without prior observations creating a mindset that everything is OK?3. How can you be sure that your quality inspections are looking at 100% of every plant system. If you admit that they are not, how can you justify using a random inspection as being representative of the entire facility?4. And finally, how will you guarantee to the public, that if the Vermont Yankee is given a 20 year renewal, that we will be assured of honest decisions related to these inspections and not let greed, money and jobs interfere with the truth?Edward S Stamas Colrain, MA