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Lot or Batch definition for IVDs

Posted 1st August 2018 at 03:35 AM by invitro_spain

US Regulation (21 CFR Part 820 (m))
Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and...
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SPC Charting frequency calculator for X hi/lo chart

Posted 16th May 2018 at 11:51 AM by bobdoering (Bob Doering)
Updated 6th July 2018 at 09:19 AM by bobdoering

One of the things that is unclear with Shewart charts is the frequency of charting. However, with the X hi/lo chart for precision machining, the frequency can actually be calculated. Attached is the Excel calculator for determining frequency. The...
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File Type: xlsx x hi-lo charting freq calc.xlsx (9.1 KB, 1153 views)
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"nds" or Number of Discriminate Samples - the Necessary Tool to Work With "ndc"!

Posted 29th March 2018 at 11:28 AM by bobdoering (Bob Doering)
Updated 10th April 2018 at 03:08 PM by bobdoering

By now, you should be aware of the concept of “ndc” or number of discriminate categories that a measurement gage is capable of discerning. It is a statistically significant discrimination, or the capability of telling the difference between items even...
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What is the difference between OOS/OOT

Posted 1st February 2018 at 06:54 AM by invitro_spain

The terms OOS and OOT always emerge in connection with the handling of deviating analysis results during Quality control processes. Both terms have the following definitions:


Out-of-Specification (OOS) Results
A result that...
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Process Measurable Objectives

Posted 27th December 2017 at 10:45 AM by sherley13
Updated 27th December 2017 at 10:56 AM by sherley13

Auditor Questions:

Organization specifies its objectives in a rather general manner. It also specifies its processes. It is not clear how the general objectives of the organization are mirrored to the processes and how the measurable...
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