General files

Content of the QTG

In the 20+ years of conducting our FSTD Evaluators course which includes hands-on exercises running validation tests, the TTI team has yet to see a perfect QTG/MQTG, which is strange as it is not a complicated document and all of the requirements are listed in the rules.  Maybe it is because so many Operators do not understand the QTG is a legal requirement and their responsibility.  They think that the FSTD supplier will magically produce it and the regulatory authority will review and correct it.  They do not realize it is a requirement and the Operators responsibility to submit the QTG to the authority, complete and with acceptable results, when applying for a FSTD Qualification .  What’s more, it is the Operators responsibility to use and maintain the MQTG throughout the life of the FSTD, which is an impossible task if the Operator does not have control of access to the document, something we also find regularly.

This paper is an introduction to the contents of a QTG/MQTG and describes some of the more common misunderstandings.

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Trees & Management Structure

Although this is somewhat off-topic, this very small document is a great analogy between the structure of trees and management, at least management in some organizations 😉
We offer this as guidance material when developing your organization that will, of course, be described in your Quality Management and Compliance System manual.

This comes to you courtesy of Andy Ramsden…

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