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Calibration Proc
Calibration Proc
PURPOSE
1.1. Establishes working policy and procedure for the control, calibration, and
maintenance of inspection, measuring, and test equipment; and defines control of
the process for calibrating product.
2. SCOPE
2.2. Facilities other than Corporate Irvine may also have local versions of this
procedure, or supplements to this procedure. Local versions are the primary
document for the respective facility.
2.3. In the event of a conflict between this procedure and a local version, or if a local
procedure does not address a requirement, this procedure has preference for the
applicable paragraph(s).
2.4. Calibration performed under the scope of ISO/IEC Guide 25 or ISO 17025 are
addressed by the Accredited Calibration procedure, NPP-99171.
3. DEFINITIONS
CALIBRATION
The set of operations which establish, under specified conditions, the relationship
between values indicated by a measuring instrument or measuring system, and the
corresponding standard or known values derived from the standard.
MEASUREMENT STANDARD
A measuring instrument, reference material or system intended to define, realize,
conserve or reproduce a unit or one or more known values of a quantity to serve as a
reference.
QUALITY
Correctness of calibration result and meets the customer’s need.
TRACEABILITY
The property of a result of a measurement whereby it can be related to appropriate
standards, generally national or international standards, through an unbroken chain of
comparisons, with uncertainty stated at each link in the chain.
4. POLICY
4.3.1. The Corporation Quality Policy is the corporate position on quality. The
calibration program at Corporation, and specifically for product
calibration, supports the corporate Quality Policy with specified
commitments and objectives.
4.3.4. This measure will be presented to the Quality Council a minimum of once
per year per.
4.4. For the purposes of this procedure, Quality Assurance and Corporate Calibration
Manager refer to personnel within the Corporation Corporate Division responsible
for the duties and/or functions described.
5. PROCEDURE
5.2. The production area manager or an assigned representative will work with Quality
Assurance to determine the calibration process (subcontracted or in-house) for the
M&TE and/or measurement standards.
5.3. Records
5.3.2. The record will reflect each item requiring calibration including
measurement standards and will provide a description or identification of
the item, calibration interval, date calibrated, identification of calibration
source, calibration procedure used, calibration results and calibration
actions taken.
5.3.6. Local facilities may also maintain, or have copies of, the calibration
database and calibration management program as appropriate for the
maintenance of the calibration program at that facility.
5.4.1. Quality Assurance is ultimately responsible for the calibration sources and
vendors.
5.4.4. Purchasing
5.4.4.2. In the event that conformance to ANSI Z-540 and/or ISO Guide
25 is either cost and/or time prohibitive, or is not available from a
vendor, the requirement may be left off the purchase order,
provided the MAPICS system indicates the item must be
calibrated before being placed into service. Calibration shall be
performed by an approved vendor.
and year), the serial or identification number, the specific calibration due
date, and who performed the calibration.
5.5.2. Items not calibrated to their full capability, or have limitations of use,
shall be labeled or otherwise identified as to the limitation. For impractical
applications of calibration label, the label will be affixed to instrument
container or some other suitable measures will be used to reflect
calibration status.
5.5.4. If the seal is removed, Quality Assurance shall be informed and a Quality
Assurance representative shall determine if removal of the seal affects the
performance of the M&TE.
5.5.5. Quality Assurance and production area managers are responsible for
maintaining all M&TE and measuring standards to a calibration status.
This includes new equipment.
5.6.1. All measurement standards used for calibration of M&TE and other
measurement standards shall have the accuracy, stability, range and
resolution required for the intended use, and be traceable to the National
Institute of Standards and Technology or other national standards body.
5.6.2. The collective uncertainty of the measurement standards shall not exceed
25% of the acceptable tolerance for each characteristic being calibrated.
5.8.1. All M&TE and measurement standards shall be calibrated and utilized in
an environment controlled to the extent necessary to assure continued
measurements of required accuracy, giving due consideration to
temperature, humidity, vibration, cleanliness, and other controllable
factors.
5.9.2. Quality Assurance and production area manager will be responsible for
determining the intervals of calibration.
5.10.3. The manager of the area where M&TE is located, or designee, shall be
responsible for compiling the equipment requiring calibration, with
assistance from QA.
5.11.1. The affected production area manager, with the assistance of Quality
Assurance will be responsible for the generation of calibration procedures
for all M&TE and measurement standards.
5.11.2. Procedures shall be utilized for the calibration of all M&TE, measurement
standards, and product. The calibration procedure shall specify the
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5.11.3. The quality engineer with the assistance of others, if necessary, shall
determine if any corrective action is necessary, and the results shall be
recorded on the certificate of calibration form.
5.12.1. When using test hardware (e.g., jigs, fixtures, templates, and patterns) or
test software as suitable forms of inspection, they shall be checked to
prove that they are capable of verifying the acceptability of product prior
to use.
5.12.4. The safeguarding of inspection, measuring, and test facilities for both
hardware and software from adjustments which would invalidate the
calibration setting shall be incorporated.
5.12.5. Measurement design data shall be made available, for verification that it is
functionally adequate.
5.14.1. All products inspected, measured, and tested with a measuring and test
equipment that is malfunctioning shall be held until appropriate corrective
action has been taken.
5.14.4. The department shall document the results of the investigation per NPP-
99037. Records shall be maintained per the Quality Manual.
5.16.1.2.If the due area of the calibration sticker is left blank, a note shall
accompany the calibrated product stating that at time of
production, the item was calibrated to the applicable standard,
and that our Quality System and storage methodologies safeguard
the integrity of the calibration until shipment to the customer. The
note will also inform the customer that for tracking purposes the
customer should fill in the due date as one year from delivery of
the product.
5.18. Once the product is inspected and the technician has accepted the product, it shall
be returned to the customer. A Certificate of Calibration and a Calibration Sticker
shall accompany the product. The Calibration Sticker shall have all areas
completed, including Due.
5.19.2. Calibration Due area of the calibration certificate may be left blank, at
management discretion, to compensate for differences in order and
delivery methodologies between different products.
5.19.4. Any Out Of Tolerance condition noted during a product recalibration must
be documented, including test type, nominal (desired) reading, actual
reading, and tolerances or uncertainty. The information may be provided
as an attachment to the calibration certificate.
5.20.2. If, in the Board’s opinion, there is legitimate doubt about the integrity of
the calibrations, or adherence to procedures, or other reasons as defined by
the Board, an audit shall be performed by personnel as assigned by the
Board. The audit shall be documented per.
5.21. Quality Assurance and the production area manager or appropriate representative,
will ensure that the measurement equipment and M&TE are calibrated within the
interval of calibration.
5.23. Quality Assurance will maintain calibration records (reports, certificates, or data
sheets) of M&TE and/or measurement standards in an appropriate location.
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5.24. Quality Assurance will generate a list of equipment due for calibration.
5.25. Quality Assurance will file the calibration record as a hardcopy file or in a data
base system. A typical example is shown in Exhibit A. Exact format may differ.
5.27.1. Quality Assurance, the production area manager, and/or assigned qualified
personnel:
Ensure that the measurement equipment and M&TE are calibrated within
the interval of calibration.
Perform the calibration procedure.
Label the M&TE or measurement standard.
Document the calibration actions of appropriate calibration records.
Formally notify any departments affected of the completion of calibration
action(s). This notification may be by e-mail or other formal method.
5.28. Impound
5.29.2. Equipment turned in for calibration, and signed for, must have positive
control. The methods may vary, but should be appropriate to the type of
equipment turned in.
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5.29.4. Equipment that appears to be useable, but is not identified as being owned
by any department, will be maintained in the impound area.
6. EXHIBITS
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CALIBRATION
SN___________
By_____Day___
DUE__________
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Date: