1. 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
2.1. This document applies to all Corporation facilities.
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.
MEASURING AND TEST EQUIPMENT (M&TE) All of the measuring instruments, measurement standards, reference materials, and auxiliary apparatus that are necessary to perform a measurement. This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration.
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. Calibration Page 2
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.
SIGNIFICANT OUT OF TOLERANCE (OOT) CONDITION At least twice the identified tolerance of any measurement.
4. POLICY
4.1. Industry Standards
4.1.1. Calibration shall comply with requirements of: Calibration Laboratories and Measuring and Test Equipment - General Requirements (ANSI/NCSL Z540-1-1994)
Quality Systems - Model for Quality Assurance in Production, Installation, and Servicing (ISO 9002:1994) section 4.11, Control of inspection, measuring and test equipment.
Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment (ISO 10012- 1:1992).
General Requirements for the Accreditation of Calibration and Testing Laboratories (CAN-P-4C:1991 a.k.a. ISO/IEC Guide 25)
4.2. Conformance to the requirements of the calibration system
4.2.1. Quality Assurance is responsible for establishing and maintaining documented procedures to evaluate the adequacy of the calibration system and to ensure compliance with the requirements of this document.
4.3. Commitment and Objectives
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.
4.3.2. The calibration program is committed to providing outstanding service to our Customers by maintaining customer satisfaction and by providing high quality in calibration services to our customers, internal or external.
4.3.3. Both parts of the commitment will be measured by tracking a combination of calibration related customer complaints and by tracking internal errors in calibration and/or documentation. The organization(s) actually performing the calibration will track errors. The Corporation Customer Complaint Review Board will track customer complaints per NPP-99066.
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 Calibration Page 3
Manager refer to personnel within the Corporation Corporate Division responsible for the duties and/or functions described.
5. PROCEDURE
5.1. Identification of inspection equipment and M&TE to be calibrated. This includes measuring equipment belongings to employees.
5.1.1. The production area manager or designee that possess inspection equipment and M&TE, with the assistance of Quality Assurance, will be responsible for determining: Which equipment requires calibration
Identifying the measurements to be made
Accuracy (trueness and precision) required
Selection of the appropriate inspection, measuring, and test equipment
Selection of the appropriate calibration cycle
Ensure delivery of the equipment to be calibrated on schedule
Provide space and power for the calibration provider
Verify function of equipment received from calibration
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
5.3.1. Quality Assurance is responsible for the records documenting that established schedules and procedures are followed to maintain the accuracy of all M&TE and measurement standards.
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.
5.3.3. If accuracy is reported via a calibration certificate or report, it shall be stated on the report.
5.3.4. If needed, Quality Assurance will assign an ID # sufficient to link the calibration record (see Exhibit A) with the unit calibrated to maintain traceability.
5.3.5. All documentation (reports, certificates, or data sheets) that is related to calibration will be appropriately located in Quality Assurance.
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. Calibration Page 4
5.3.7. Customer confidentiality, proprietary rights and trade secrets ( or customer), and related types of information shall be protected by all company personnel.
5.4. Calibration sources and vendors
5.4.1. Quality Assurance is ultimately responsible for the calibration sources and vendors.
5.4.1.1. The Corporate Calibration Manager (by whatever name) is responsible to evaluate calibration providers and provide recommendations regarding usage of their services.
5.4.1.2. The Corporate Calibration Manager is responsible to manage calibration contracts, including billing, scope of service, delivery of service, and other related functions and issues.
5.4.2. All M&TE and measurement standards shall be calibrated utilizing measurement standards whose calibration is traceable.
5.4.2.1. For occasions when traceability is not possible, there must be at least one sufficiently comprehensive test using traceable calibrated equipment to check the validity of tests performed with non- traceable equipment.
5.4.2.2. Traceable equipment may also be used to monitor appropriate parameters tested by non-traceable equipment.
5.4.3. All measurement standards used in the calibration system shall be supported by certificates, reports, or data sheets attesting to the description or identification of the item, the calibration source, date of calibration, calibration assigned value, statement of uncertainty and environmental or other conditions under which calibration results were obtained.
5.4.4. Purchasing
5.4.4.1. Purchase orders issued for new equipment requiring calibration and/or items sent for calibration shall request a certification that the items have been calibrated under a Quality System that conforms to the requirements of ANSI/NCSL Z540-1-1994 and/or ISO Guide 25.
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.
5.4.4.3. Purchase Orders to a National Standards body (e.g. NIST, NRC) do not require the ANSI Z-540 or ISO Guide 25 statement.
5.4.5. Quality Assurance
5.4.5.1. Outside agencies used for calibration purposes will be approved by Quality Assurance, and will be surveyed by qualified personnel to verify the calibration system conforms to the requirements of Calibration Page 5
ANSI/NCSL Z540-1-1994 and/or ISO Guide 25.
5.5. Calibration status
5.5.1. All M&TE and measurement standards shall be labeled to indicate calibration status. The label shall include the date calibrated (day, month, 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.
5.5.3. Tamper-resistant seals shall be affixed to control adjustment or panels/screws leading to control adjustment on M&TE and measurement standards.
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.
5.5.5.1. Area managers, or their designee, are responsible for delivering equipment due for calibration to Quality Assurance in the time and manner prescribed by Quality Assurance.
5.6. Adequacy of measurement standards
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.
5.7. Acceptable tolerance
5.7.1. Equipment that is in a significant OOT condition will be impounded until it can be recalibrated, repaired, replaced, destroyed, or identified as "For Indication Only".
5.7.2. Equipment in an OOT condition that is not significant may receive a limited calibration, specifying calibration parameters, providing the equipment is not used for product certification or other critical measurements.
5.8. Environmental controls
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 Calibration Page 6
temperature, humidity, vibration, cleanliness, and other controllable factors.
5.8.2. M&TE in Receiving Inspection and manufacturing areas shall be kept in a temperature environment between 15° C and 30° C (60 deg F to 85 deg F) and relative humidity (RH) of 20% to 70%.
5.8.3. Special working areas where temperature or RH is critical shall be identified.
5.8.4. Where the environment departs from acceptable conditions, compensating corrections shall be applied to the calibration results obtained or the calibration activity shall be stopped until the environmental condition can be corrected. Compensating conditions may be physical or software enabled.
5.9. Intervals of calibration
5.9.1. The intervals of calibration shall not exceed 3 years.
5.9.2. Quality Assurance and production area manager will be responsible for determining the intervals of calibration.
5.9.3. M&TE and measurement standards shall be calibrated at periodic intervals established and maintained to assure acceptable accuracy and reliability. The Intervals are based on accuracy, reliability, purpose and degree of usage.
5.9.4. Intervals shall be shortened or may be lengthened, when the results of previous calibrations indicate that such action is appropriate to maintain acceptable reliability. Newly purchased equipment shall be placed on the next calibration interval unless certification is provided with the equipment. An established recall system for the mandatory recall of the M&TE and measurement standards to assure timely recalibrations shall be incorporated.
5.10. Recall of M&TE
5.10.1. The computer database software GAGEtrak will be used by Quality Assurance to coordinate the recall of equipment requiring recalibration.
5.10.2. Equipment requiring recalibration shall be calibrated within 4-weeks from the calibration due date. Equipment that exceeds calibration due date for more than 4-weeks shall be impounded until it is calibrated.
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.
5.10.4. When equipment is turned in for calibration, the calibration manager or designee shall employ adequate safeguards to ensure equipment is controlled until the equipment is returned to the owning department, and to ensure the equipment is correctly returned.
5.11. Calibration procedures
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. Calibration Page 7
5.11.2. Procedures shall be utilized for the calibration of all M&TE, measurement standards, and product. The calibration procedure shall specify the measurement standards and details of equipment type, identification number, frequency of checks, check method, the required parameter, range, and accuracy of the measurement standards and the acceptable tolerance of each instrument characteristic being calibrated.
5.11.2.1. Procedures used may be those available from DOD or other U.S. Government agencies, available in manufacturer's manuals, or published standard practices, provided they meet the requirements of this document.
5.11.2.2. Test equipment measured or tested out of tolerance shall be reviewed by a quality engineer to decide to what extent the condition will affect the product performance.
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. Test fixtures
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.
5.12.2. Hardware/software shall be rechecked at periodic intervals. The extent and frequency of such checks shall be established through usage and records shall be maintained as evidence of control.
5.12.3. Process Assurance Engineers (PAEs) are responsible to identify the periodic interval (cycle) at which fixtures shall be checked. The cycle shall not exceed 2 years. PAEs will provide QA with appropriate information once the scheduled checks are completed. QA will maintain the records per NPP- 99012.
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.
5.13. Handling and storage
5.13.1.1.All M&TE and measurement standards shall be handled, stored and transported in a manner which will not adversely affect the calibration or condition of the equipment.
5.14. Positive recall action
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.
5.14.2. If an item of M&TE is found to be out of calibration by more than 30 days, Calibration Page 8
or during calibration was found to be out of tolerance, then the department which owns the M&TE shall investigate the validity of certifications and / or calibrations performed using that item of M&TE.
5.14.3. If the certifications and / or calibrations are found to be invalid, the department, in cooperation with QA and any other departments that are directly affected, shall determine whether to recall product, and the extent of such a recall.
5.14.4. The department shall document the results of the investigation per NPP- 99037. Records shall be maintained per the Quality Manual.
5.15. Thread gauges
5.15.1.1.Thread gauges used to inspect products shall be tracked by usage and/or time. Records of usage shall be maintained as evidence of control, where appropriate.
5.15.1.2.Thread gauges with estimated usage over 100/year will be identified and calibrated every 12 months. Thread gauges with estimated usage under 100/year will be identified and calibrated every 36 months.
5.15.1.3.Thread gauges shall be permanently identified with a unique identification such that gauges can be recorded separately. The identification is never duplicated, even for identical replacements.
5.15.1.4.The threaded portion of thread plugs may be replaced with new items without requiring a new identification number. The new threads must be purchased with a calibration certificate compliant to Z540-1, and retained on file with other calibration certificates.
5.16. Product calibration
5.16.1.1.Calibration of product for sale to customers shall include a Certificate of Calibration and a Calibration Sticker. The Calibration Sticker shall have the S/N, By, and Date areas completed. The Due area may be left blank. This will be determined by appropriate management personnel for the product being produced. A typical example of a calibration sticker is provided in Exhibit B. Exact format may differ.
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.
5.16.1.3.Actual calibration of product is detailed in lower level calibration procedures per.
5.17. Product recalibration Calibration Page 9
5.17.1.1.When a customer sends product for recalibration, after receipt the product will be routed to the appropriate technician who will determine whether the product can be calibrated in-house, or must be sent to the manufacturer or calibration vendor. The product will be routed and calibrated in accordance with the technician’s determination. An appropriate record must be made of the determination and routing.
5.17.1.2.Upon completion of the calibration, the technician shall perform an appropriate inspection of the calibrated product. An appropriate record must be made of the inspection, including criteria used to perform the inspection, any deficiencies noted, and whether the product is accepted or rejected.
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. Calibration certificates
5.19.1. Calibration Certificates provided to the customer shall meet the requirements of ISO Guide 25.
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.
5.19.3. Recalibrations require Condition on Arrival and Condition on Departure be documented, regardless of product.
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. Customer Complaints
5.20.1. Customer complaints shall be addressed via the Corporation Customer Complaint Review Board per.
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.
5.22. Quality Assurance will control the out-of-tolerance conditions of equipment. If needed, Quality Assurance will be responsible for taking the appropriate action for notification of the out-of-tolerance condition to the respective user.
5.23. Quality Assurance will maintain calibration records (reports, certificates, or data Calibration Page 10
sheets) of M&TE and/or measurement standards in an appropriate location.
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.
5.26. Subcontracted calibration
5.26.1. Sub-contracted calibration refers to calibration provided by an organization external to Corporation, and providing calibration certificates representing Corporation.
5.26.2. Sub-contracted calibration providers must be evaluated by Quality Assurance, approved, and provide calibration compliant with ANSI/NCSL Z540-1.
5.26.3. The organization responsible for the product receiving sub-contracted calibration is also responsible to provide a cover calibration certificate informing the customer that the calibration was provided by an approved calibration provider.
5.27. In-house calibration
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
5.28.1. Quality Assurance and the production area manager Recall and transport M&TE or measurement standards that are out of calibration status to the calibration impound.
Tag with a sign indicating no usage is allowed until corrective actions have been taken the M&TE that are out of calibration status and difficult to remove from the working area.
5.29. Asset Control
5.29.1. Departments turning in equipment for calibration may have QA or the calibration company sign for the equipment. A sample format for a signature form is provided in Exhibit C, exact format may differ.
5.29.2. Equipment turned in for calibration, and signed for, must have positive Calibration Page 11
control. The methods may vary, but should be appropriate to the type of equipment turned in.
5.29.3. Equipment maintained in the Impound Area will be reviewed at least annually. This review will attempt to determine if items impounded may be used within the company, or must be written off per NPP-99049. Items that are written off may be donated to local non-competitive organizations such as High Schools or Colleges, or disposed of.
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 Calibration Page 12
7.1. Exhibit A - Calibration Record DESCRIPTION______I.D.______CALIB. INTERVAL______ACTIVE______INACTIVE______CALIB. SOURCE______CALIB. PROC.______
CAL. DATE BY DUE RESULTS ACTION REMARK
7.2. Exhibit B - Calibration Sticker Note: Phone number is not required on Calibration Sticker.
CALIBRATION SN______By_____Day___ DUE______
Calibration Page 13
6.3 Exhibit C – Calibration signature log sample
Date:
Item No. Part Number S/N or Asset No. Print/Sign Organization