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SOP11 – Data Management
96
12.0 SOP 11 - Data Management and Storage
Version 2.0
Date of Issuance: July 3, 2012
Author: Katherine Ziombra
12.1. Introduction
Detailed, systematic records must be maintained for each MERC test. Project records shall be
detailed enough to track project progress, identify decision points, and support conclusions.
Project data and records must be capable of withstanding challenges to their validity, accuracy,
and legibility. The Data Manager (DM) maintains the MERC database and ensures each testing
trial is accurate. The DM works closely with the MERC Director, senior scientists, and QA
Manager.
12.2. Data Collection
Data collected in support of MERC testing must be collected using scientifically valid methods
and retained securely. Raw (original) data collected in the field or laboratory are recorded such
that samples collected and data generated are complete and traceable throughout their history.
12.3. Data Recording
Data are recorded in standardized formats, e.g., data collection forms, bound and paginated
laboratory and field logbooks, laboratory record books, spreadsheets, computer records, and
output from instruments (both electronic and hardcopy).
The person filling in the data log during the testing series is listed as Sampler. Each sheet will
have their name and note “data entry by”. All persons involved in the test series for that
parameter will be listed as Support.
Any data collected during testing activities must be capable of withstanding challenges to its
validity, accuracy, and legibility. Data are recorded in accordance with the following minimum
requirements:
1.
Data are entered directly, promptly, and legibly;
2.
Hand-entered data are recorded legibly in ink; all original data records include, as
appropriate, a description of the data collected, the unit, the unique sample identification,
the name of the person collecting the data, and the date and time of data collection;
3.
Any changes to the original entry do not obscure the original entry, document the reason
for the change, and are initialed and dated by the person making the change;
4.
All deviations from the QAPP must be documented in writing, and approved by the testing
organization; documentation and communication include an assessment of the impact the
deviation has on data quality; and
5.
Data in electronic format shall be included in a commercially available program for word
processing, spreadsheet calculations, database processing, or commercial software
developed especially for the data collection and processing on a specific hardware
instrument or piece of equipment; backup of computer databases should be performed on a
daily basis, if possible.