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SOP11 – Data Management
98
Internal working document versions are named with the file name and the date updated. Review
versions are re-named by adding the initials of each reviewer to the document. Internal revisions
in response to comments are named logically using the format above to again track changes
through the revision process.
If the data log is inaccurate or incomplete, the DM will return it to the appropriate person to
amend corrections. Once the data log is corrected, the DM will re-sign the sheet.
12.6. Data Storage
The data logs and records are maintained on an intranet server. Hard copies of the data logs are
stored in a binder labeled with vendor name and testing date and kept offsite.
The DM establishes and implements the appropriate chain of custody and confidentiality
procedures for evidentiary records. When samples are transported from the field, regardless of
transportation method, a sample transmittal or chain-of-custody (COC) form must accompany
the samples. The form should list each sample present in the shipping container. Samples are
considered to be in a person's custody if:
•
The samples are in a person's actual possession.
•
The samples are in a person's view after being in that person's possession.
•
The samples were in a person's possession and then were locked or sealed up to prevent
tampering.
•
The samples are in a secure area.
Electronic records are archived on write-protected, secure electronic media following accepted
data management practices. Metadata should accompany data archives. Metadata should include
the data format, data fields with associated units, and other information intended to inform the
data user about the nature of the data, their quality, or their use. A duplicate copy of the data
archive must be stored in a secure, off-site location. Program files and QA records will be
maintained for 5 years. The final step in the life cycles is disposition. Disposal procedures for
documents and records that are no longer required after 5 years include electronic deletion of
documents and records from the MERC website and the personal computers of MERC personnel
and manual shredding of hard copies.
12.7. Compliance with Records and Documents
Testing performed by MERC must conform to the QMP, generic QAPP, Test/QA Plan and
applicable SOPs. A deviation occurs when testing does not comply with the requirements of
these documents. Once a deviation has been identified during testing, it must be communicated
to the MERC Director and Quality Manager within 24 hours and documented in a formal
deviation. Deviations must be fully documented including, date and description of deviation,
and impact on the test.
12.8. QA/QC
After each trial, the data generator signs their respective datasheet and has an individual familiar
with the parameter review and sign the same sheet. The datasheets accrued are copied and
scanned onto a USB thumb drive after it is reviewed (Data sheet 12.1).