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.