Calibration Laboratory Quality Manual

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					             Calibration Laboratory

                       Quality Manual
                                 Revision E




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                                                                   TABLE OF CONTENTS

CALIBRATION LABORATORY QUALITY MANUAL CHANGE CONTROL.................................................................3


REVISION......................................................................................................................................................................3


1.0        PURPOSE AND SCOPE ...................................................................................................................................4


2.0        REFERENCES...................................................................................................................................................5


3.0        DEFINITIONS ....................................................................................................................................................6


4.0        ORGANIZATION AND MANAGEMENT ............................................................................................................7


5.0        QUALITY SYSTEM, AUDIT AND REVIEW .......................................................................................................9


6.0        PERSONNEL...................................................................................................................................................11


7.0        ACCOMMODATION AND ENVIRONMENT ....................................................................................................12


8.0        EQUIPMENT AND REFERENCE MATERIALS...............................................................................................13


9.0        MEASUREMENT TRACEABILITY AND CALIBRATION ................................................................................15


10.0          CALIBRATION METHODS AND METHOD VALIDATION ..........................................................................17


11.0          HANDLING OF CALIBRATION ITEMS .......................................................................................................19


12.0          RECORDS ...................................................................................................................................................20


13.0          CERTIFICATES AND REPORTS ................................................................................................................21


14.0 SUBCONTRACTING OF CALIBRATION............................................................................................................23


15.0          OUTSIDE SUPPORT SERVICES AND SUPPLIES THAT AFFECT CALIBRATION RESULTS ................24


16.0          COMPLAINTS..............................................................................................................................................25


17.0          MEASUREMENT AND TEST EQUIPMENT REQUIREMENTS ..................................................................26


18.0          REFERENCING NVLAP ACCREDITATION................................................................................................29




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                     Calibration Laboratory Quality Manual Change Control


Change Control Procedure
The Metrology and Design Engineer is responsible for making changes to the Calibration
Laboratory Quality Manual. Anybody within the organization is encouraged to suggest changes
to this document. Suggested changes shall be forwarded in writing to the Metrology and Design
Engineer for consideration. Additionally, this document shall be reviewed at periodic intervals,
approximately 12 months, to ensure its suitability for continued use. Changes to this document
from previous revision are marked by a black bar in the left margin.


Calibration Laboratory Quality Manual Change History

  Date       Revision Description of Change                 Manager of       Metrology
                                                            Engineering      and Design
                                                                             Engineer
 4/20/2001       A       Original Release                   Bill Bergquist   John Zwak
 2/18/2003       B       Minor clarifications and updates   John Zwak        Greg Zdeb
10/29/2004       C       Minor Updates                      Bill Bergquist   John Zwak
 3/31/2005       D       Update for ISO 17025 and           Bill Bergquist   John Zwak
                         NVLAP
4/13/2006        E       Updated for ISO 17025 and          Bill Bergquist   John Zwak
                         NVLAP




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                                                          1.0     PURPOSE AND SCOPE


1.1 PURPOSE
This document is intended as a system to control the calibration and support of all
measurement standards and test equipment to the extent necessary to assure conformance of
calibration services required to fulfill contractual requirements. This document incorporates the
applicable requirements of ANSI/NCSL Z540-1, ISO/IEC 17025, and NIST Handbook 150.


1.2 SCOPE
This document applies to all aspects of Burns Engineering’s calibration laboratory. It is the
responsibility of all personnel involved to familiarize themselves and adhere to the quality
procedures contained in this document.




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                                                                    2.0    REFERENCES

ANSI/NCSL Z540-1-1994, Calibration Laboratories and Measuring and Test Equipment –
General Requirements.

ANSI/NCSL Z540-2: U.S. Guide to the Expression of Uncertainty in Measurement.

ISO 8402 : 1986, Quality – Vocabulary

ISO/IEC Guide 2 : 1986 General terms and their definitions concerning standardization and
related activities.

International vocabulary of basic and general terms in metrology (VIM)

ISO/IEC Guide 30 : 1981, Terms and definitions used in connection with reference materials.

ISO/IEC 17025: 1999 General requirements for the competence of testing and calibration
laboratories.

NIST Handbook 150: 2001 Edition, Procedures and General Requirements, NVLAP

NIST Handbook 150-2H, Calibration Laboratories Technical Guide for Thermodynamic
Measurements

NIST Technical Note 1297: Guidelines for Evaluating and Expressing the Uncertainty of NIST
Measurement Results

Burns Engineering Quality Manual

Burns Engineering SOP C273 Calibration Procedure Selection and Development

Burns Engineering SOP C274 Requirements for Measuring and Test Equipment

Burns Engineering SOP C275 Procedure for Handling Customer Complaints Related to
Calibration




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                                                                         3.0    Definitions


   •   The relevant definitions from ISO/IEC Guide 2, ISO 8402, ISO Guide 30, and the
       International vocabulary of basic and general terms in metrology are applicable.
   •   NVLAP – National Voluntary Laboratory Accreditation Program.




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                                        4.0     ORGANIZATION AND MANAGEMENT


4.1 Organization
The Burns Engineering calibration laboratory organization is shown in Figure 1 below. An
organization chart which contains the names of the individuals can be found on the network at
..\..\..\..\Quality System\Organization Chart\Engineering & Quality Group Org Chart.doc




                                              President




                                      Engineering and Quality
                                        Assurance Manager



            Metrology and                      Metrology                         Metrology
           Design Engineer                    Technician III                    Technician I

                      Quality Assurance                      Metrology
                         Specialist                         Technician II




                          Figure 1 – Calibration Laboratory Organization


4.2 Responsibilities (as they relate to the calibration laboratory)

President – Responsible for overall operation of calibration facility including but not limited to
budget, equipment, facilities and people. The president may act as an alternate for the
Engineering and Quality Assurance Manager if necessary.

Engineering and Quality Assurance Manager – Responsible for the quality system and its
implementation. Also assigned as an alternate for the Metrology and Design Engineer when
they are unavailable.

Metrology and Design Engineer – Responsible for all technical aspects of the laboratory
including but not limited to standard selection, calibration method selection, and technical
qualifications of personnel. Also assigned as an alternate for the Engineering and Quality
Assurance Manager as related to the calibration laboratory.


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Quality Assurance Specialist – Responsible for calibration and testing of temperature
sensors, transmitters and related equipment.

Metrology Technician I, II, III – Responsible for calibration and testing of temperature sensors,
transmitters and related equipment.


A separate written job description, clearly listing responsibilities and authorities, exists for all
calibration laboratory personnel. All metrology technicians are fully supervised until they are
technically competent to perform the work independently.




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                                    5.0     QUALITY SYSTEM, AUDIT AND REVIEW




5.1 Quality-System
The Burns Engineering Inc. quality system is documented in the Burns Engineering Quality
Manual. The intent of the Calibration Laboratory Quality Manual is to supplement and refine the
overall manual as applicable to the calibration laboratory, and to insure the laboratory complies
with the requirements of NIST Handbook 150 Procedures and General Requirements, ISO/IEC
17025 General requirements for the competence of testing and calibration laboratories, and
ANSI/NCSL Z540-1 Calibration Laboratories and Measuring and Test Equipment – General
Requirements . It is the responsibility of laboratory management to ensure all laboratory
personnel are aware of, understand, and implement the elements of the quality system as
defined in the Quality Manual and the Calibration Laboratory Quality Manual. Where conflicts
between these documents exist, the requirements of this document shall take precedence.

Burns Engineering Quality Policy:
“Burns Engineering Inc. is committed to designing and manufacturing high quality temperature
measurement products with world class performance and reliability. We have a focus on and
commitment to superior products, customer responsiveness, and on time delivery. We will
accomplish this by fostering an environment of continuous improvement using a team approach
and an empowered workforce.”

To effectively support this quality policy, all calibrations conducted in the calibration laboratory
will be performed in accordance with appropriate calibration methods and procedures.
Development and/or selection of procedures is based on suitability for purpose and customer
requirements. All procedures are developed or selected and approved for use in accordance
with guidelines found in Standard Operating Procedure C273, “Calibration Procedure Selection
and Development”. All procedures are controlled documents and carry the designated approval
signatures and issue date. A listing of the most common calibration procedures used can be
found in section 10 of this document.

Burns Engineering Calibration Laboratory Description:
The calibration laboratory at Burns Engineering provides calibration of temperature measuring
instruments. The Laboratory performs NIST traceable calibrations on RTDs, thermocouples,
and temperature measuring systems by comparison over the temperature range of -196°C to
+500°C. The lab utilizes an assortment of equipment including: SPRTs, LN2 comparison bath,
stirred refrigerated and heated liquid baths, ice baths, TPW cell, dry well calibrator, resistance
bridges, and high performance digital multimeters.

Calibration of high quality (secondary standard grade) platinum resistance thermometers and
measuring systems is performed by comparison against a NIST traceable SPRT utilizing a high
accuracy resistance thermometry bridge. Industrial grade RTDs may be calibrated in a similar
manner or may utilize a high performance DMM to measure resistance. Calibration of SPRTs at
the TPW is performed using a TPW cell and a high accuracy resistance thermometry bridge.

Additional calibration and testing performed in the laboratory includes, but is not limited to:
Insulation Resistance, Dielectric Withstanding Voltage, Response Time, Thermocouple
Calibration, and Temperature Transmitter Calibration.

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5.2 Audit and Review
Audits – Internal audits shall be conducted to verify the calibration laboratory is compliant with
the system and procedures to which it is working. The audits shall be conducted by the
Engineering and Quality Assurance Manager or an appointed designee that has the knowledge
and skills necessary to understand the process being audited as well as the process of auditing.

Audit results shall be documented. All non-conformances shall require a response and
corrective action reply within 28 days. The manager will reserve the option to reduce the
allowed response time if concern of the validity of the lab results exists. It is the responsibility of
the Engineering and Quality Assurance Manager to ensure these actions are carried out within
the agreed timeframe.

The maximum interval between internal audits shall be no more than 12 months.

Reviews – Management shall review the quality system to ensure it is adequate for
achievement of the quality objectives on a continuous basis. The maximum interval between
management reviews shall be no more than 12 months. The review should include the
following:
        a) matters arising from the previous review
        b) reports from audits by clients
        c) results of internal audits done since the last review, including corrective actions
            implemented.
        d) results of in-house quality checks
        e) details of any complaints or feedback from clients
        f) staff training
        g) adequacy of staff, equipment and facility resources
        h) future plans and estimates for new work, new staff, new equipment, etc.
        i) suitability of policies and procedures
        j) reports from managerial and supervisory personnel
        k) the results of interlaboratory comparisons or proficiency tests
        l) changes in volume and type of work

The findings from the management reviews and the actions that arise from them shall be
recorded. The management shall ensure that those actions are carried out within an appropriate
and agreed timescale.

When an audit or review finding cast doubt on the correctness or validity of calibration results,
timely corrective action shall be taken. If the investigation finds that calibration results and
issued reports have been affected, customers shall be notified in writing.


Checks – In addition to the periodic audits and reviews, the calibration laboratory shall
implement periodic checks to ensure the proper operation of the calibration equipment. These
checks shall include, but are not limited to, the TPW resistance checks of the SPRT as
described in the appropriate sections of Calibration Standard Operating Procedure (SOP) C263.
This check requires measuring the SPRT resistance at the triple point of water using a triple
point of water cell and one or more SPRTs on a daily basis or prior to use (when practical). The
results collected shall be reviewed and tracked for trends over time.



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                                                                        6.0    PERSONNEL


All personnel assigned to perform technical work in the calibration laboratory shall have formal
education and training relevant to the assigned functions. Records of the relevant
qualifications, training, skills and experience shall be kept on file at Burns Engineering in the
following location:..\..\..\..\Quality System\Process Training Program\Calibration Lab. These
records shall be reviewed periodically by the employee and management to ensure accuracy
and completeness. Additional education and training shall be made available to personnel if the
need arises.




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                                  7.0     ACCOMMODATION AND ENVIRONMENT



7.1 Designated Laboratory.
The designated calibration laboratory is located at Burns Engineering, 10201 Bren Road East,
Minnetonka, Minnesota 55343.


7.2 Environmental Conditions.
The calibration laboratory shall be located such that it is effectively separated from areas which
could adversely effect the calibrations. The environmental conditions of the laboratory shall be
controlled to the extent necessary to assure the calibration measurements meet the required
accuracy. The following conditions shall be monitored, controlled and recorded, records shall
be kept for a minimum of three years.

Temperature – The ambient temperature shall be maintained between 17°C and 25°C.

Humidity – The relative humidity shall be maintained at 80% maximum.

Deviation to these conditions may be permitted if documented in the applicable calibration SOP.
In the event that environmental conditions fall out of the allowable limits and a deviation is not
permitted by the applicable calibration SOP, the Metrology and Design Engineer shall be
notified. The Metrology and Design Engineer must determine the impact of the out of tolerance
conditions on the calibrations and take the necessary actions to correct the situation. Additional
information can be found in SOP C56 – Monitoring laboratory ambient conditions.



7.3 Laboratory Access
The calibration laboratory shall be accessible to all employees as necessary to perform the
duties assigned to them. NOTE: No employee shall remove calibration equipment from the
laboratory without first conferring with a Metrology Technician, Metrology and Design Engineer,
or the Engineering and Quality Assurance Manager. All calibration equipment must be
controlled in accordance with section 17 of this manual.


7.4. Housekeeping Practices
Good housekeeping practices shall be followed to ensure conditions are conducive to good
laboratory practices. Efforts shall be made to keep work areas neat and clean. Procedures and
equipment shall be returned to their appropriate locations when not in use.


7.5. Segregation/ Storage of Materials
The Lab will be arranged to allow the segregation of incoming, non-conforming, completed
material. Safe storage of tools and standards will be organized to promote the integrity of
calibration tools.



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                              8.0     EQUIPMENT AND REFERENCE MATERIALS



8.1 General Requirements
All equipment, software and reference materials necessary to perform calibrations shall be
available to the calibration laboratory. All equipment, software and reference materials
necessary to perform calibrations in the calibration laboratory must be calibrated or verified,
marked, and maintained in accordance with the applicable Burns Engineering procedures as
applicable to the item. In the event that additional equipment must be borrowed, rented or
leased, the equipment must be accompanied by objective evidence that it conforms to the
requirements of ANSI/NCSL Z540-1 and NIST Handbook 150. Examples of objective evidence
may be:
        a) records of audits performed by Burns Engineering
        b) proof that the rental company’s calibration laboratory is accredited against
            ANSI/NCSL Z540 or NVLAP
        c) acceptance of the rental company’s calibrations by a government agency showing
            compliance to ANSI/NCSL Z540 or NVLAP

A list of key suppliers for the calibration lab equipment and materials can be found at
..\..\..\..\Quality System\Supplier Quality\Key Suppliers for Cal Lab\Key Suppliers for Calibration
Lab Supplies and Services.doc

8.2 Equipment and Reference Material Maintenance
All equipment and reference materials used in performing calibrations shall be properly
maintained. The maintenance procedures used shall meet the requirements listed in the Burns
Engineering SOP for Measuring and Test Equipment, SOP C274.

8.3 Equipment and Reference Material Calibration and Verification
All equipment used in performing calibrations shall be calibrated or verified prior to being put
into service, and periodically thereafter, as required per paragraph 17 of this document and in
the Burns Engineering SOP for Measuring and Test Equipment, SOP C274. Reference
materials such as distilled water for the ice bath, and software used in the lab shall be verified
and do not require calibration.

8.4 Equipment and Reference Material Marking
All equipment and reference materials used in performing calibrations shall be marked, labeled
or identified to indicate their calibration status. The preferred marking method is to attach a
calibration label directly to the equipment or material. Where this is not practical the information
may be placed on the equipment or material container. The labels shall contain the following
information as a minimum:
        - specific calibration date (day, month, year)
        - specific calibration due date
        - limitations to the equipment if any

Note: Equipment and reference materials that do not contain a valid and current label
must not be used for performing calibrations in the laboratory.



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8.5 Equipment and Reference Material Records
Record shall be maintained for all equipment and reference materials used in performing
calibrations. The records shall be kept in accordance with Burns Engineering SOP for
Measuring and Test Equipment, SOP C274. As a minimum the records shall include the
following information.
         -name of the item of equipment
         -the manufacturers name, type identification, and serial number or other unique
identification
         -current location (where appropriate)
         -where applicable, dates and results of all calibrations and/or verifications and date or
criteria when the calibration and/or verification expires
         -checks that equipment complies with specification
         -details of maintenance carried out to date and planned for the future
         -history of any damage, malfunction, modification, or repair
         -measured value observed for each parameter found to be out of tolerance during
calibration/verification

8.6 Mishandled or Defective Equipment and Reference Material
Any item of equipment which has been subjected to overloading or mishandling, or which gives
suspect results, or has been shown by verification or otherwise to be defective, or has broken or
altered tamper resistant seals, shall be taken out of service. The equipment shall be clearly
identified as “OUT OF SERVICE” and, where possible, moved to an isolated storage location
until it has been repaired and shown by calibration or verification to perform satisfactorily. The
Metrology and Design Engineer and/or Engineering and Quality Assurance Manager shall be
notified to assess the effect of any equipment defect on previous calibrations which have been
performed. Measures shall be taken to ensure the results of previous calibrations are corrected
and customers notified where necessary.




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                  9.0     MEASUREMENT TRACEABILITY AND CALIBRATION


9.1 General Requirements
In order to ensure adequate calibration quality, all calibration laboratory equipment which has a
significant effect on the accuracy or validity of the calibration, including equipment for subsidiary
measurements (e.g., for environmental conditions) shall be calibrated before being put into
service and shall be included in the recall system. The equipment calibrations shall be traceable
to national or international laboratories or to intrinsic standards, where available. Calibration
certificates and/or reports shall, wherever applicable, state the traceability to national,
international, or intrinsic standards of measurements and shall provide the measurement results
and associated uncertainty of measurement. Where traceability to national, international or
intrinsic standards of measurement is not available or practical, traceability requirements shall
be satisfied by interlaboratory comparisons, proficiency testing, or mutual consent standards.

9.2 Equipment Calibration Traceability
All calibration laboratory items in the recall system shall be traceable to national or international
laboratories or to intrinsic standards through an unbroken chain of calibrations or comparisons
with stated uncertainties linking them to the relevant primary standards of the SI unit of
measurement. Measuring and test equipment requirements are contained in paragraph 17
herein and in Burns Engineering SOP C274.

9.3 Equipment Recall System
Burns Engineering SOP C274 for Measuring and Test Equipment, along with a tools database
control the recall of calibration equipment used in the calibration laboratory.

9.4 In Service Checks
To ensure continued proper operation of the SPRT and calibration equipment, the calibration
laboratory shall implement periodic checks of the calibration equipment. These checks shall
include, but are not limited to, the TPW resistance checks of the SPRT as described in the
appropriate sections of Calibration Standard Operating Procedure (SOP) C263. This check
requires measuring the resistance of the SPRT at the triple point of water using a triple point of
water cell and one or more SPRTs on a daily basis or prior to use (when practical). The results
collected shall be reviewed and tracked for trends over time.




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9.5 Control of Nonconformances
In the event it was determined that any aspect of the calibration work is not in conformance with
the policy or procedures the following steps shall be taken.
                - The Engineering and Quality Assurance Manager or designee will be notified
                   and responsible for corrective action.
                - The corrective action shall include decisions on; stopping work, stopping any
                   shipments, determining the significance, disposition of past and present
                   calibrations, recalls or customer notification and resumption of work.
                - If any doubt exists that the nonconformance could recur, a PCAR shall be
                   initiated. The PCAR shall be focused to the root cause and prevention of the
                   nonconformance.
                - The nonconformance shall be noted for future internal audits and
                   effectiveness.




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                10.0 CALIBRATION METHODS AND METHOD VALIDATION


10.1 General Requirements
All calibrations performed in the laboratory shall be performed in accordance with methods that
meet the needs of the customer and are appropriate for the calibration being undertaken. All
methods and procedures are developed and/or selected in accordance with the requirements
found in SOP C273 “Calibration Method and Procedure Selection and Development”. The
documentation shall be maintained up-to-date and be readily available to the staff.

10.2 Calibration Procedures
All calibration procedures used shall meet the needs of the customer and must be appropriate
for the calibration undertaken. When the customer does not specify the method to be used, the
laboratory shall select appropriate methods from existing procedures whenever possible. When
the customer specifies a method which is considered to be inappropriate or out of date for the
calibration being undertaken, the customer shall be notified.
10.2.1 Routine Calibrations
Written Calibration Standard Operating Procedures (SOPs) shall be followed when performing
routine calibrations in the laboratory. The most current revision of each Calibration SOP shall be
readily available to the staff. A partial list of SOPs used in the calibration laboratory is given
below. The current “Master List” of all calibration SOPs, as well as the “Master Copy” of each
calibration SOP, is located in the engineering area. The Master List contains the document
number, title, current approved revision, and date of all calibration SOPs.

  SOP Number         Title
      C1             Calibration of RTD at Ice Point (0°C)
      C3             Comparison Calibration for RTDs
    C246             High Pot Testing
    C263             SPRT Calibration
    C265             Secondary Standard PRT Inspection, Annealing and Calibration
    C266             Calibration of TA/TB Transmitters
    C267             Indirect Comparison Calibration of IPRTs, Secondary Standard PRTs and
                     SPRTs
       C268          Direct Comparison Calibration of IPRTs, Secondary Standard PRTs and
                     SPRTs
       C269          Calibration of TL Transmitters

10.2.2 Custom Calibrations
When custom calibration is required the calibration method used must meet the needs of the
customer and must be appropriate for the calibration undertaken. Written calibration procedures
are not required, however the methods should follow good metrological practice. In addition, the
calibration report shall provide a brief description of the method used and, where traceability is
required, an estimation of the uncertainty must be stated on the report.

10.3 Deviations From Calibration Methods
Deviation from calibration methods shall occur only if the deviation has been documented,
technically justified, authorized, and accepted by the customer.


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10.4 Method Validation
The laboratory shall validate all non-standard methods, laboratory developed methods, and
standard methods used outside their intended scope to confirm the methods are fit for the
intended use. The validation shall be as extensive as necessary to meet the needs of the given
application. Techniques used to validate a method may include:
        - calibration using reference standards
        - comparison of results achieved with other methods
        - interlaboratory comparison
        -systematic assessment of the factors influencing the result
        - assessment of the uncertainty of the results based on scientific understanding of the
theoretical principles of the method and practical experience

10.5 Sampling Procedures
The calibration laboratory does not perform sample calibration but may perform sample testing
for other tests which are performed in the laboratory. When using a sampling method with
testing the number of samples selected shall be as defined in the manufacturing paperwork.
The number of samples is typically 8 parts per lot but can be adjusted up or down based on
engineering input and/or customer specific requirements. All samples shall be randomly
selected from the entire lot.

10.6 Estimation of Uncertainty
Calibration uncertainty estimates shall be made using recognized methods and shall take into
consideration the equipment and procedures used for each calibration. All uncertainty
components which are of importance in the given situation shall be taken into account using
appropriate methods of analysis. ANSI/NCSL Z540-2-1997 “U.S. Guide to the Expression of
Uncertainty in Measurement” contains information on methods for estimating uncertainty
however other methods may be used if deemed appropriate by the Metrology and Design
Engineer. When a calibration certification or report is required by the customer, the expanded
uncertainty shall be stated with a coverage factor k=2 (95%). Unique circumstances may require
an alternate method for calculating and/or reporting the uncertainty, in these cases the method
shall be chosen by the Metrology and Design Engineer and shall take into consideration the
requirements of the test method, the requirements of the customer, and the limits on which the
decisions on conformance to a specification are based.

10.7 Data Acquisition and Analysis
Calibration data may be acquired and analyzed manually or automatically through the use of the
calibration laboratory computer software. Software used by the laboratory for NVLAP accredited
calibrations must be validated before being put into use, after any modifications are made, and
periodically as required by the recall system. Records of the validation must be kept on file. Off
the shelf software such as Microsoft Excel is considered to be validated without further testing.
Software shall be controlled and have limited access. Control shall be through password
protected access.

10.8 Consumable Materials
All consumable materials used in the calibration laboratory shall be purchased, inspected and
stored in accordance with Burns standard procedures. These materials include but are not
limited to: oil for the baths, salt for the baths, distilled water for the ice baths and ice maker
(when purchased), and liquid nitrogen.




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                                       11.0 HANDLING OF CALIBRATION ITEMS



11.1   General Requirements
All calibration items shall be handled and stored in a suitable manner to prevent degradation
and damage from occurring. SPRTs’ are delicate instruments and must be handled very
carefully so that no mechanical stress is experienced by the SPRT. All SPRTs’ shall be stored in
their original case when not being worked on. Secondary Standard and Industrial Grade RTDs’
and thermocouples shall be handled carefully and may be stored in boxes, totes, or directly on
bench tops or carts at the discretion of the Metrology Technician. All calibration items shall be
examined, processed and labeled as described below.

11.2   Examination
All calibration items shall be examined prior to calibration for any abnormalities or physical
damage. If any unusual conditions are found which could effect the intended purpose of the
item, the findings shall be documented and the customer shall be notified of the findings. The
customer may be requested to make a decision as to the disposition of the item prior to
completion of the calibration.

11.3   Calibration Instructions
All items submitted to the calibration laboratory shall be accompanied by written instructions.
The instructions shall identify the model or part number, and serial number of the item to be
calibrated along with a description of the work to be performed. The description shall list all
testing which is to be performed, and any additional requirements that are considered unique. If
the instructions do not fully specify the information needed to perform the calibration, or ask
more of the calibration than the item is capable of meeting, the customer shall be consulted
prior to proceeding.

11.4 Calibration Seals
Tamper resistant seals shall be affixed to operator accessible adjustments on measuring and
test equipment when the equipment lends itself to this method. Any measuring and test
equipment which has been equipped with tamper resistant seals shall not be used if the seals
have been altered or broken. If the seals have been altered or broken the equipment must be
considered defective and handled in accordance with paragraph 8.6 of this document.




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                                                                           12.0 RECORDS


12.1   General Requirements
Both quality and technical records shall be maintained.

12.2   Quality Requirements
Quality records include reports from internal audits and management reviews as well as records
of corrective and preventive action. The official records shall be kept in accordance with the
quality audit policy of the Burns Engineering Quality Manual.

12.3   Technical Requirements
Records shall be maintained for all calibrations performed. The official records shall be kept in
accordance with the record retention policy of the Burns Engineering Quality Manual. As a
minimum the records must contain the results of the test and identification of the individual who
performed the work. The results may include actual values, or only pass/fail results as required
by the job paperwork. Records may be changed for the purpose of correction or some other
appropriate reason, but a traceable history of these changes should be preserved. An
acceptable method to accomplish this is to draw a single line through the material to be
changed and to date and initial the alterations. Data acquired electronically may be deleted if
the data was taken as part of the set up, stabilization check, or was erroneous due to equipment
problems or some other appropriate reason. Data taken which may indicate a problem with the
UUT may not be deleted but may be tagged as “initial” and retaken to determine if the UUT is
functioning properly.

12.4   Customer Calibrations
All customer calibration certificates and reports shall be held secure and in confidence.
Certificates and reports shall be readily accessible for a minimum of 12 months from the date of
calibration. After this period the records may be moved to an archive location where they will be
available for a total of seven years minimum.




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                                                 13.0 CERTIFICATES AND REPORTS


13.1   General Requirements
When a certificate or a report is required, the results of the calibration shall be accurate, clear,
unambiguous and objective, and carried out in accordance with the instructions of the required
method. The certificate or report shall include all the information necessary to interpret the
calibration results and all the information required by the method used. These requirements
apply to both paper and electronic format.

13.2   Minimum Requirements
Unless otherwise specified the following minimum information shall be included on the
calibration report.

a) Title: e.g. “Calibration Report”
b) Address of the laboratory performing the work, e.g. “10201 Bren Road East, Minnetonka,
   MN 55343”. In most cases it will include the name Burns Engineering but will be omitted at
   the request of certain customers.
c) Sensor serial number, report number, page number and total number of pages in the report.
d) Name and address of the customer, where applicable.
e) Description and unambiguous identification of the item calibrated.
f) Condition of the calibration item as received when items are not new. This may include an
   “As Found” resistance at the triple point of water and any apparent damage or discrepancies
   found such as altered, dropped or otherwise damaged items.
g) Date of the calibration.
h) Identification or description of the calibration method used.
i) Any additions, exclusions or deviations from the calibration method.
j) Measurements and derived results as appropriate with any failures identified.
k) A statement of the estimated uncertainty of the calibration result.
l) The name, title, and signature of the person performing the calibration, and date of issue.
   When the NVLAP logo is included on the report, this signature must be of an Approved
   Signatory.
m) A statement that the report shall not be reproduced except in full, without the written
   approval of Burns Engineering.
n) Any special limitations on use.
o) Statement of traceability.
p) Statement that the results relate only to the item calibrated.
q) Environmental conditions in the lab.
r) When the NVLAP logo is included on the report, a statement that the report must not be
   used to claim certification, approval, or endorsement by NVLAP, NIST, or any agency of the
   federal government.




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13.3   Out of Tolerance Conditions
Affected customers shall be notified in writing of:
a) defective calibration equipment or errors in procedure which are found to cast doubt on the
    validity of the results given in any calibration report, or amendment to a calibration report.
    Such notifications shall quantify the magnitude of the error created in the calibration results.
b) any customer equipment found out of tolerance during calibration. Measurement data shall
    be reported so that appropriate action can be taken.


13.4   Amendments to Certificates and Reports
Amendments to calibration reports may be required for various reasons such as to correct
erroneous calculations or insert omitted data. Amendments to calibration reports after issue may
only be made in the form of a further document or data transfer including the statement
“supplement to calibration report” or other equivalent wording, and including the report number
and serial number of the affected item. Amendments shall meet the relevant requirements of
paragraph 13.2. When it is necessary to issue a complete new calibration report, it shall be
uniquely identified and shall contain a reference to the original that it replaces.

13.5   Subcontractor Calibrations
If all or part of the calibration is performed by a subcontractor, this fact must also appear on the
report as well as other related information per 13.2 for the sub-contractor.


13.6   Electronic Transmission of Results
In the case of transmission of test or calibration results by telephone, facsimile or other
electronic or electromagnetic means, the requirements of this manual shall be met.




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                                      14.0 SUBCONTRACTING OF CALIBRATION



14.1   General Requirements
In the event that a sub-contractor is used for calibration, the sub-contracted laboratory shall be
competent for the work required. A competent subcontractor is one that complies with the
requirements of ANSI/NCSL Z540-1, ISO/IEC 17025, NIST Handbook 150, and/or has been
audited by Burns Engineering and found to be competent. The specific requirements will
depend upon the customer requirements for the calibration performed. Burns Engineering
Quality Manager or his designee is responsible to assure the compliance by the sub-contracted
laboratory, and maintain objective evidence of that assurance. The Quality Manager (or
designee) shall record and retain details of its investigation into the competence and
compliance of its sub-contractors, and maintain a log of approved laboratories that may be used
as sub-contractors. The customer shall be advised if any portion of the calibration is to be
subcontracted to another party.




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    15.0 OUTSIDE SUPPORT SERVICES AND SUPPLIES THAT AFFECT
                                      CALIBRATION RESULTS

15.1 General Requirements
Outside services and supplies used in support of calibrations in the laboratory shall be of
adequate quality to sustain confidence in the laboratories calibration capabilities. Examples
include items such as fluids for the calibration baths and servicing of equipment (not to include
calibration). All servicing and supplies shall be verified as adequate prior to being put into
service. Records shall be maintained for all suppliers of support services and supplies that
affect calibration results.




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                                                                      16.0 COMPLAINTS


16.1   General Requirements
Complaints from customers or other parties regarding the laboratory’s activities shall be handled
in accordance with SOP C275 “Procedure for Handling Customer Complaints Related to
Calibration”. This SOP requires that a record be maintained of all complaints and of the actions
taken by the laboratory and that all complaints be resolved in a prompt manner.




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        17.0 MEASUREMENT AND TEST EQUIPMENT REQUIREMENTS


17.1 General Requirements
The calibration/verification system covering measurement and test equipment (M&TE)
and measurement standards used by the calibration laboratory is described in this
paragraph with additional details contained in SOP C274 “Requirements for Measuring
and Test Equipment”.

17.2 Measurement and Test Equipment
All measurement and test equipment (M&TE) used by the calibration laboratory to
determine compliance with technical specifications shall be calibrated or verified in
accordance with the requirements of this document. When calibrations give rise to a set
of correction factors or coefficients, these correction factors shall be implemented per
the appropriate SOP requirements. M&TE including software shall be safeguarded from
unauthorized adjustments and changes which would invalidate the calibration or
verification results.

17.3 Measurement Standards
Measurement standards used for calibrating M&TE and other measurement standards
shall comply with the applicable requirements of paragraph 8, 9 and 10 of this document
regarding the use of adequate equipment that has been calibrated using appropriate
procedures.

17.4 Recall System
All M&TE shall be included in the calibration recall system described in SOP C274
“Requirements for Measuring and Test Equipment” which requires periodic calibration
and/or verification of the M&TE.

17.5 Removal from Service
M&TE which has exceeded its calibration interval, has broken calibration seals, or is
suspected to be malfunctioning because of mishandling, misuse, or unusual
measurement results shall be removed from service and handled in accordance with the
requirements of paragraph 8.6 of this document.

17.6 Environmental Conditions
M&TE shall be used in an environment controlled to the extent necessary to insure valid
results. In general the requirements of paragraph 7.2 of this document shall be met, with
due consideration given to other factors which could affect the results such as lighting,
vibration, electromagnetic interference, etc. When appropriate and necessary a
correcting compensation shall be applied to measurement results to account for
extreme environmental conditions.




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17.7 Calibration and Verification Intervals
M&TE requiring calibration shall be calibrated or verified at periodic intervals established
and maintained to assure that the M&TE will remain in – tolerance throughout the
interval. The interval setting system shall be systematically applied with a goal of 100%
of M&TE remaining in-tolerance throughout the interval. Intervals may be based on
usage or time since last calibration. All exemptions from periodic calibration or
verification must be documented. The recall system may provide for the temporary
extension of the calibration due date for limited periods of time under specified
conditions that do not reasonably impair the satisfaction of the customers requirements.

17.8 Calibration Procedures
Procedures used to calibrate and verify M&TE shall comply with paragraph 10 of this
document as applicable to the particular item being calibrated or verified. All M&TE
calibrations and verifications must be performed to documented procedures.

17.9 Out-of-Tolerance Conditions
If any M&TE is found to be out of tolerance during the calibration/verification process,
the out of tolerance condition along with the measurement data shall be reported to the
Metrology and Design Engineer and/or the Engineering and Quality Assurance Manager
for evaluation. It is the responsibility of the Metrology and Design Engineer and/or
Engineering and Quality Assurance Manager to determine the significance of the out of
tolerance condition. It is the responsibility of the Engineering and Quality Assurance
Manager to promptly determine the appropriate action which needs to be taken as a
result of the out of tolerance condition. As a minimum, the action shall take into
consideration the effect on previous calibrations and customer notification where
necessary

17.10 Adequacy of Calibration and Verification System
The adequacy of the calibration system shall be verified through audit and review in
accordance with paragraph 5.2 of this document.

17.11 Calibration Sources
M&TE requiring calibration shall be calibrated or verified by laboratories meeting the
requirements of Part I of ANSI/NCSL Z540. Control of subcontractor calibration shall be
per paragraph 17.14 of this document.

17.12 Records
Records shall be kept for all M&TE requiring calibration and verification. The records
shall contain:
   a) the identification of each piece of M&TE;
   b) the current calibration interval and date of the last calibration;
   c) identification of the calibration source (laboratory);
   d) calibration procedure used;
   e) results of the previous calibrations; e.g., condition found, (in tolerance or out of
       tolerance), measured value if a fixed measurement standard, any limitations of
       use, etc.;


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   f) actions taken as a result of the calibration; e.g., any adjustments or corrections
      made, any repairs performed or parts replaced; and
   g) any pertinent occurrences not directly related to periodic calibration, such as
      operational failures, erratic behavior, etc.
      As a minimum these records shall be maintained as long as the M&TE is in use.

17.13 Calibration Status
All M&TE shall be labeled to indicate calibration or verification status. The preferred
marking method is to attach a calibration label directly to the item. Where this is not
practical the information may be placed on the item container. The label shall identify
the following information as a minimum:
        -      specific date calibrated (day, month, year)
        -      specific calibration due date
        -      limitations to the equipment if any

Note: Equipment and materials that do not contain a valid and current label must
not be used for performing calibrations.

17.14 Control of Subcontractor Calibration
In the event that a sub-contractor is used for calibration or verification of M&TE, the sub-
contracted laboratory shall comply with the requirements of ANSI/NCSL Z540-1. Burns
Engineering Quality Assurance Manager or his designee is responsible to assure the
compliance by the sub-contracted laboratory, and maintain objective evidence of that
assurance. The Quality Manager (or designee) shall record and retain details of its investigation
into the competence and compliance of its sub-contractors, and maintain a log of approved
laboratories that may be used as sub-contractors.

17.15 Storage and Handling
All M&TE shall be handled, stored, and transported in a manner which shall not
adversely affect the calibration or condition of the equipment. When necessary, specific
details on the proper handling, storing and transporting of M&TE shall be specified in
the calibration or verification procedure.




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                                 18.0 REFERENCING NVLAP ACCREDITATION


18.1   General Requirements
The following conditions, which pertain to the use of the term NVLAP and the NVLAP logo, shall
be followed.

   a) The term and logo shall not be used in a manner that brings NVLAP into disrepute or
      misrepresents the scope of accreditation or accredited status.
   b) When the term NVLAP is used to reference the accredited status, it shall be
      accompanied by the NVLAP Lab Code.
   c) When the NVLAP logo is used to reference accredited status, it must be accompanied
      by the NVLAP Lab Code in an approved caption. The caption shall appear below and in
      close proximity to the logo. The following captions are approved:
              - “For the scope of accreditation under NVLAP Lab Code 200706-0”
              - “NVLAP Lab Code 200706-0”
   d) The form of the logo must conform to the following guidelines.
              - The logo shall stand by itself and not be combined with any other logo,
                  symbol, or graphic.
              - The aspect ratio (height to width) shall be 1 to 2.25.
              - The logo and caption shall be of a size that allows the caption to be easily
                  read. The size of the caption shall not exceed the size of the logo itself.
              - The logo shall appear in black or blue and may be filled or unfilled. In the
                  case of a filled logo, the same color shall be used for the outline and fill.
   e) The name of at least one Approved Signatory must appear on all calibration reports that
      display the NVLAP logo or references NVLAP accreditation.
   f) When the term and logo are used on a calibration report, such use shall be limited to
      reports in which some or all of the data are from calibrations performed under the scope
      of accreditation. A calibration report that contains both data covered by accreditation and
      data not covered by accreditation shall clearly identify the data that are not covered by
      accreditation. The report must prominently display the following statement at the
      beginning of the report: “This report contains data that are not covered by the NVLAP
      accreditation.”
   g) When the term and logo are used on a calibration report that also includes work done by
      a subcontracted laboratory, such use shall be limited to reports in which some or all of
      the data are taken from calibrations performed by the laboratory under the scope of
      accreditation. A calibration report that contains data covered by the accreditation and
      data provided by a subcontractor shall clearly identify the data that were provided by the
      subcontracted laboratory. The report must prominently display the following statement at
      the beginning of the report: “This report contains data that were produced under
      subcontract by Laboratory X.” If the subcontracted laboratory is accredited by NVLAP,
      then its Lab Code should also be stated. If the subcontracted laboratory is accredited by
      a body other than NVLAP, then the name of the accreditation body and the laboratory’s
      number or other unique identifier should also be stated. If the subcontracted laboratory
      is not accredited, then this must be stated.
   h) Each calibration report that bears the term or logo shall include a statement that the
      report must not be used to claim product certification, approval, or endorsement by
      NVLAP, NIST, or any agency of the federal government.
   i) When used in a contract or proposal, the term and logo shall be accompanied by a
      description of the laboratories scope of accreditation and current accreditation status.

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   j)   Figure 1 below shows the typical appearance of the NVLAP logo and caption on the
        calibration reports where an accredited calibration has been performed. Any variation to
        this logo must comply with the requirements specified in this manual and Annex A of
        NIST Handbook 150.

                                    Figure 1 – NVLAP Logo




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Form 0203371
ANY PRINTED COPY OF THIS DOCUMENT IS CONSIDERED UNCONTROLLED