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PURPOSE This procedure defines the requirements and responsibilities
for the control and calibration of measuring and test
equipment (M&TE) at Oak Ridge National Laboratory (ORNL).
APPLIES TO This procedure applies to control and calibration of M&TE
at ORNL. Specifically, it is applicable to M&TE users and
support organizations engaged in the control and calibration
of M&TE. Calibration and control measures are not required for
rulers, tape measures, levels, and other such devices if
normal commercial equipment provides adequate accuracy.
Requirements to be met are:
o M&TE and test systems shall be calibrated at either
prescribed intervals or before use.
o M&TE users are required (1) to exercise the basic
responsibility for control of M&TE used in their
operations, (2) to coordinate with the calibration
and verification organizations to maintain current
all calibrated M&TE in use, and (3) to determine the
impact of, and perform corrective action for, data
collected and items evaluated or tested with M&TE
found to be out of tolerance.
o Calibration organizations are required to maintain
(1) a calibration recall system for all M&TE under
their cognizance and (2) standards in current
calibration or verification.
OTHER o ORNL Procedure X-AD-7, ORNL Records Management
DOCUMENTS
NEEDED
WHAT TO DO A. Responsible User/Task Leader Calibrator
NOTE 1: The following definitions are essential to
proper application of this procedure:
o calibration--the comparison of a measurement system
or device of unverified accuracy to a measurement
system or device of known and greater accuracy to
detect or to correct any variation from required
performance specifications of the unverified
measurement system or device
o M&TE--items used for measuring, gauging, testing, or
evaluating performance or conformance to measurement
requirements
o verification--the act of reviewing, inspecting,
testing, checking, auditing, or otherwise
determining and documenting whether items,
processes, services, or documents conform to
specified requirements
Note 2: Calibrations/verifications performed by the
user are subject to the same general requirements as
those done by a support organization providing
calibration services. Documentation of calibration
activities may be recorded in a technical notebook or a
calibration log.
User/Task 1. Reviews the application of M&TE for each task and
Leader consults with appropriate technical staff to
ensure that M&TE is of the proper type, range,
accuracy, and tolerance for its intended use.
2. Establishes the status of M&TE (i.e., to be
calibrated or verified by the user or the support
organizations or not to be calibrated).
3. Identifies M&TE requiring a calibration
verification as opposed to a calibration.
4. Initiates a user program or requests the services
of a calibration support organization to place
identified M&TE on a calibration recall program as
appropriate.
5. Determines, in consultation with the support
organizations, the interval, procedures,
certification range, and accuracy to be achieved
for calibrating or verifying M&TE.
These determinations shall be documented between
the user and the calibrating organizations.
Extensions to the interval (i.e., grace period) up
to 30 days may be given by the user. If the 30-day
grace period is prohibited by a U.S. Department of
Energy (DOE) order, law, safety requirement, or
regulation, then the exception should be
documented, and the new requirements should be
defined. The maximum period between calibrations
is 5 years.
6. Ensures that calibration procedures, internally
developed or provided by a manufacturer or
calibrating organization, are adequate and
accessible.
Calibration data should include the as-found and
the as-left status of the M&TE being calibrated.
7. If calibration support is requested, then
delegates record keeping to the appropriate
calibrating organization.
8. Labels M&TE indicating calibration status (see
Appendix A). The label provides for identification
of the M&TE, calibrating organization, calibration
date and next due date, and identification of the
person performing the calibration.
9. When M&TE is found to exceed the calibration limits,
then determines the effect on data, the impact on
items evaluated or tested, and performance of M&TE
since the date of most recent calibration.
10. When M&TE is found to be consistently out of
calibration, then determines whether the M&TE
should be repaired or replaced or whether the
calibration frequency should be shortened. If the
M&TE being calibrated is found to be consistently
within the limits of calibration, then may extend
the frequency of calibration.
11. Ensures that personnel using M&TE are cognizant of
the calibration status of M&TE.
12. Ensures that M&TE found to be out of calibration
is tagged and/or segregated and not used until
recalibrated.
13. When recall is no longer required, then
provides written notification to calibrating
organizations to remove M&TE from a recall system.
B. Organizations Responsible for Calibration
Note 1: The Office of Radiation Protection, the Office
of Safety and Health Protection, the Office of Quality
Programs and Inspection, the Instrumentation and
Controls Division, and the Plant and Equipment Division
typically perform calibrations.
Note 2: Calibration services shall include but are not
limited to (1) a recall system for the periodic
calibration of M&TE, (2) the ability to uniquely
identify M&TE under their control, and (3) maintenance
of a system for inventory, maintenance history,
calibration history, calibration status, standards
identification, and notification of M&TE overdue for
calibration.
Calibration 1. Must be cognizant of the applicable codes, standards,
Organizations DOE orders, and ORNL and ORNL policies and procedures.
2. Consult with the M&TE user and agree on calibration
procedures to be used, certification range, calibration
interval, and accuracy to be achieved.
3. Perform calibrations on M&TE in accordance with the
provisions of this procedure.
4. Determine the qualifications needed by personnel
engaged in performing calibration activities. Identify
training requirements, provide for training, and
maintain training records as evidence of personnel
qualification.
5. Provide for management of calibration standards used in
performing calibration activities.
Standards used for calibration activities shall be
traceable to nationally recognized standards. Standards
management shall be carried out in accordance with
each organization's specific operating procedure. If
no nationally recognized standards exist, then the
basis of calibration shall be documented.
6. Maintain calibration standards in good repair, ensuring
that standards are recalled at regular intervals for
recalibration.
7. Provide for the recording and storage of calibration
data.
The calibration process shall include the recording of
the as-found and the as-left condition of the M&TE.
8. When M&TE being calibrated is found to exceed the
calibration limits, then notify the user in writing
of the as-found and as-left condition.
9. Provide notification to the user of calibration
records exceeding retention periods of 5 years or
greater and a request for disposition.
10. Verify the status of M&TE used for calibration prior
to performing calibration activities.
11. Perform calibrations in accordance with documented,
reviewed, and approved procedures.
Calibration procedures may be specific to ORNL
activities or provided by the M&TE manufacturer.
Procedures recommended by a manufacturer shall be
reviewed for adequacy prior to use.
12. If M&TE is found to be consistently out of calibration,
then notify the user.
13. Secure approval of the responsible user or facility
manager prior to removing M&TE from a recall system.
14. Upon completion of the calibration process, affix to
the M&TE, container, or other retrievable documents a
calibration label or tag (see Appendix A for sample of
label or tag) indicating the calibration status.
15. If calibrations are performed under controlled
environmental conditions, then record the existing
environmental conditions.
If not, then document the conditions affecting the
calibration process and the impact on the results.
16. Evaluate the calibration program for effectiveness and
take actions based on the results to improve
effectiveness.
17. When standards are found to exceed calibration limits,
then provide to the user a list of M&TE calibrated
with the standard since the last acceptable
calibration.
RECORDS NOTE: Calibration records are quality assurance records and
shall be kept in accordance with an approved Records
Inventory and Disposition schedule and ORNL X-AD-7.
User/Task 1. Determines the retention time and disposition of
Leader calibration records associated with the task
requirements.
Calibration 2. Maintain records of calibrations performed for a
Organizations minimum of 5 years. This applies to organizations
(internal and external to ORNL) that provide
calibration services.
User/Task 3. If calibration records are to be retained for more
Leader than 5 years, then determines the disposition of
the calibration records.
Approved by: [J. H. Swanks]
Associate Director
Operations, Environment, Safety, and Health
Oak Ridge National Laboratory
PIC - D. G. Prater
FPM - P. B. Hoke
Directives Coordinator
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Updated:Wednesday, 12-Feb-97 12:49:32 EST(npn)