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Ing. Alejandro Arcelus De:

Philippe Morneau [Morneau@agatlabs.com]

Enviado el: Jueves, 05 de Abril de 2012 05:43 p.m. Para:

arcelus@caru.org.uy

Asunto:

CARU - your letter

Hello Alejandro, In response to your letter dated February 8, 2012, please accept this email as my formal response to your concerns. After completing a review of all CARU files as well as all of the raw data and the client services communications, I have found that your concerns were indeed well founded. We have completed several non conformance reports and implemented corrective actions that will eliminate the chances of the same problems occurring in the future. Wendy will be transmitting all of your certificates of analysis again. To summarize the cause of the problems encountered with the original transmission of our results to you; they were caused by the combination of programming problems with our translation tool which was used to provide you with results in English plus some confusion when units were changed at your request from the original data. Ultimately additional document review would have picked up these errors so there was a lack of supplemental report screening. With respect to your specific concerns, please accept the following comments: A) Hardness results – problems occurred converting the results to units that were requested (change units, multiply or divide results by appropriate factor, then re translate the document so that the units appear correctly in both versions). B) Ca, Mg, Na, K results – similar conversion problems as in a). C) Ca, k, Na, Mg results – similar conversion problems as in a). D) Total Sulphur – incorrectly translated, should have read Sulphide or Total Sulphide in all reports. E) RDL – Reported Detection Limit. This limit is determined arbitrarily based on observations made for a wide variety of sample matrices in order to allow for efficient processing of the many different samples that are analyzed without sacrificing time or damaging analytical instrumentation. It is either equal to the validated method detection limit or greater within reason so as not to pass any regulations once a dilution factor is applied. We sincerely apologize for the confusion that these problems caused you. It is clear that you made significant effort to understand the numbers that we sent you despite the fact that it was impossible to decipher them without the original versions of the certificates and the data. Please replace the old reports with the new ones being sent by Wendy. I wish that we could have communicated a little more regularly and before these problems were included in the series of reports that were sent to you so that we could have ironed out some of the kinks in the tools that we were using to generate the reports and make changes based on your requests. I am confident that both the procedural changes as well as software programming changes that I have implemented following your letter have improved our procedures and will help ensure that these problems do not happen in the future for any results that require similar measures. If you require any additional information or explanation please do not hesitate to contact me anytime. Sincerely,

09/04/2012

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