NYC 9/11 Public Portal Document
It would be very unusual for the contractor's QA Officer to perform data
validation, as stated in C4.1. That is usually performed by the laboratory or a
third party. Section 5.1 appears to say that the Lab's QA Officer would do data
validation, although the validation described there is not complete. It is a "non-
conformance" review as stated in 5.1, covering many important areas, but
seeming to ignore important areas like problems that the analyst encounters, or,
more likely, detection, identification, and quantitation issues. These need to be
included, along with how all of this will be covered by data qualification
designations, probably via qualification codes. Then, this section also needs to
include a sub-section describing the process that will be followed for determining
the usability of any data that are flagged during data validation. Finally, a section
is needed describing in detail the process that will be followed for notification
when any exceedances are found.
QA Officer will review laboratory validation reports. New Sections 7.0
ASSESSMENT AND OVERSIGHT, 8.0 DATA VALIDATION AND USABILITY and 9.0
EXCEEDANCE NOTIFICATION have been added.
C5.3 The frequency of such audits should be identified.
C6.0 This section also needs to include the process that will be followed when
the potential need arises to modify a specified procedure, indicating who needs to
be notified, who is authorized to make and approve a corrective action, and how
that will be distributed to all who need to know it, and to those who had approved
the previous procedure.
New Sections 7.0 ASSESSMENT AND OVERSIGHT, 8.0 DATA VALIDATION AND
USABILITY and 9.0 EXCEEDANCE NOTIFICATION have been added.
NYC-WTC 000134349
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