Section IV, Subsection F -  Laboratory Documentation


F.  Laboratory Documentation

The calibration laboratory should maintain three important sets of
documentation: (1) the laboratory protocol; (2) the laboratory records; and
(3) the calibration records. Historical records should be maintained which
detail any changes or revisions in procedures or protocols.  The laboratory
protocol describes the laboratory operations, i.e., what the laboratory is
expected to do and how it is expected to do it.  This documentation should
also include the detailed calibration procedures for each instrument
routinely calibrated.  The laboratory records, on the other hand, is that
set of records which documents the actual activities of the laboratory.
Finally, the calibration records is that set of records which documents the
maintenance, calibration, and testing of each instrument and source used.

1.  Laboratory Protocol

Each DOE laboratory should have a written protocol for calibration of
portable survey instruments (NIST 812 (Part 5.1)).  Each page of the
protocol should indicate the date of inception or revision.  The
laboratory protocol should include the following:

 --  A statement of the laboratory's work scope, including all radiation
     types, energies, and intensities used for calibrations;

 --  a statement of requirement regarding acceptance of instrumentation
     for calibration (The requirement regarding instruments that are
     contaminated, in need of repair, or of a particular type should be
     stated.);

 --  a statement of the laboratory's procedures to assure the specified
     accuracy, in terms of deviations from a national standard, for the
     reference fields;

 --  a method of documenting the model, calibration date, and serial
     number of each critical piece of equipment that is used in any
     calibration;

 --  the procedure for calibrating each piece of laboratory support
     equipment (e.g., voltmeters, thermometers, pulsers, etc.) and a
     statement of the conditions under which recalibration is to be
     performed;

 --  a fully documented procedure for each type of instrumentation
     calibrated;

 --  an assessment of the uncertainty associated with each calibration
     procedure;

 --  an example of a completed instrument calibration report, including
     a statement of the accuracy to which the reference value of the
     radiation field is known;

 --  the procedure or method for auditing calibration data and approving
     reports; and

 --  the procedure to ensure the security of calibration records.

2.  Laboratory Records

DOE requirements for facility records are stated in RCM 761 and
additional information can be found in ANSI N13.6, "American National
Standard Radiation Protection Practice for Occupational Radiation
Exposure Records Systems" (ANSI, 1989c).  Specific information for
calibration laboratories is provided below.  A comprehensive and
readily available record system "shall" be maintained (10 CFR 835.703(d)).

The essential elements of a record system are:

 --  A full history (purchase, modification, maintenance, etc.) and
     calibration data, including certificates, for all standards and
     applicable calibration equipment (RCM 761.1 and NIST Special
     Publication 812);

 --  all procedures used for providing calibration services (RCM 761.1);

 --  records shall be maintained detailing the training of all
     calibration facility operating staff and supervisory personnel (RCM
     761.1);

--   a history of the training and educational experience of all
     calibration facility operating staff and supervisory personnel;

 --  records "shall" be maintained to document the results of internal
     audits and other reviews of program content and implementation (10
     CFR 835.704(c) and RCM 743);

 --  an inventory of all standards and calibration equipment, including
     purchase specifications and acceptance test records;

 --  the model and serial number or other unique identification for
     every item of instrumentation calibrated and the date that the
     calibration was performed;

 --  information essential to the analysis and reconstruction of the
     calibration of a specific item of instrumentation;

 --  a record of routine quality control actions and any resultant
     control charts;

 --  copies of all calibration records issued (see next section);

 --  the results of all proficiency testing; and

 --  records of all maintenance, modification, special tests, and repair
     of instruments (RCM 761.4 & 762).

All records of data should include the identity of the individual who
collected the data on which the record is based and the record's date of
inception.  All records "shall" be retained until final disposition is
authorized by DOE (10 CFR 835.701(b) and RCM 712.3 & 774.1).

If calibration data are stored in a computer, the laboratory protocol
should specify how backup is provided (e.g., data protection
procedures).  Archival tape, diskettes, microfilm, hard copy, etc., are
examples of methods of archiving data.  The method selected will
normally depend on the laboratory's record system and volume of data.

3.  Instrument Calibration Records

A record "shall" (10 CFR 835.703(d)(1) & RCM 761.1) be maintained for
results of calibration and maintenance performed for each instrument.
This includes records of functional tests (operational checks) (RCM
761.3).  Maintenance histories and repair and modification data "shall"
(10 CFR 835.703(d)(1) and RCM 761.4 & 762) be maintained for each
instrument.  Both as-found data and data on the final calibration
results for the instrument (after adjustments, if required) shall be
included in the record (RCM 761.1). The record shall be dated and shall
identify the individual performing the work on the instrument (RCM
761.1).  The record should be filed with previous records on the same
instrument in accordance with ANSI N13.6. Each instrument shall (ANSI
N323 (4.5)) be labeled with the following information, which should also
be in the calibration report:

 --  Date of most recent calibration (RCM 562.7);

 --  initials or other specific identifying mark of calibrator;

 --  energy correction factors, where required;

 --  graph or table of calibration factors, where necessary, for each
     type of radiation for which the instrument may be used (including
     the relationship of the scale reading to the measurement units,  if
     the units are not on the scale);

 --  instrument response to an identified check source (if provided by
     the calibrator);

 --  unusual or special use conditions or limitations (RCM 562.6); and

 --  date that primary calibration is again required (RCM 562.7) (not
     required on calibration report if a documented recall system is
     maintained).

All calibration reports should contain a statement of the uncertainty of
the calibration.  Alternatively, when calibrations are performed
repeatedly on the same model, a generic analysis of uncertainty may be
maintained.  This should include an analysis based on random checks of
calibrated instruments.

4.  Instrument Location

A system for tracking the location of portable survey instruments and
for recalling those instruments for recalibration shall be established
(ANSI N323).  The location of portable survey instruments should be
known by the calibration staff or by some identifi- able group assigned
with that responsibility. Because instruments may incorporate or be
accompanied by an accountable source, instrument tracking may be
required as part of the source-control program.