Cal Lab Quality Manual_revE

8/14/2019 Cal Lab Quality Manual_revE

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Burns Engineering Calibration Laboratory Quality Manual, Revision E Page 1 of 30Form 0203371ANY PRINTED COPY OF THIS DOCUMENT IS CONSIDERED UNCONTROLLED

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 changesto this document. Suggested changes shall be forwarded in writing to the Metrology and DesignEngineer for consideration. Additionally, this document shall be reviewed at periodic intervals,approximately 12 months, to ensure its suitability for continued use. Changes to this documentfrom previous revision are marked by a black bar in the left margin.

Calibration Laboratory Quality Manual Change History

Date Revision Description of Change Manager ofEngineering

Metrologyand Design

Engineer4/20/2001 A Original Release Bill Bergquist John Zwak2/18/2003 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

NVLAP

Bill Bergquist John Zwak

4/13/2006 E Updated for ISO 17025 and

NVLAP

Bill Bergquist John Zwak


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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 allmeasurement standards and test equipment to the extent necessary to assure conformance ofcalibration 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 Engineerings calibration laboratory. It is theresponsibility of all personnel involved to familiarize themselves and adhere to the qualityprocedures 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 andrelated 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 calibrationlaboratories.

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

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

NIST Technical Note 1297: Guidelines for Evaluating and Expressing the Uncertainty of NISTMeasurement 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 toCalibration


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3.0 Definitions

The relevant definitions from ISO/IEC Guide 2, ISO 8402, ISO Guide 30, and theInternational vocabulary of basic and general terms in metrologyare 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. Anorganization 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

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 tobudget, equipment, facilities and people. The president may act as an alternate for theEngineering and Quality Assurance Manager if necessary.

Engineering and Quality Assurance Manager Responsible for the quality system and itsimplementation. 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 laboratoryincluding but not limited to standard selection, calibration method selection, and technicalqualifications of personnel. Also assigned as an alternate for the Engineering and QualityAssurance Manager as related to the calibration laboratory.

President

Engineering and Quality

Assurance Manager

Metrology and

Design Engineer

Quality Assurance

Specialist

Metrology

Technician II

Metrology

Technician III

Metrology

Technician I


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Quality Assurance Specialist Responsible for calibration and testing of temperaturesensors, 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 aretechnically 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 QualityManual. The intent of the Calibration Laboratory Quality Manual is to supplement and refine theoverall manual as applicable to the calibration laboratory, and to insure the laboratory complieswith the requirements of NIST Handbook 150 Procedures and General Requirements, ISO/IEC17025 General requirements for the competence of testing and calibration laboratories, andANSI/NCSL Z540-1 Calibration Laboratories and Measuring and Test Equipment GeneralRequirements . It is the responsibility of laboratory management to ensure all laboratorypersonnel are aware of, understand, and implement the elements of the quality system asdefined in the Quality Manualand the Calibration Laboratory Quality Manual. Where conflictsbetween 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 andcommitment to superior products, customer responsiveness, and on time delivery. We willaccomplish this by fostering an environment of continuous improvement using a team approachand an empowered workforce.

To effectively support this quality policy, all calibrations conducted in the calibration laboratorywill be performed in accordance with appropriate calibration methods and procedures.Development and/or selection of procedures is based on suitability for purpose and customerrequirements. All procedures are developed or selected and approved for use in accordancewith guidelines found in Standard Operating Procedure C273, Calibration Procedure Selectionand Development. All procedures are controlled documents and carry the designated approvalsignatures 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 measuringinstruments. The Laboratory performs NIST traceable calibrations on RTDs, thermocouples,and temperature measuring systems by comparison over the temperature range of -196C to+500C. 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, resistancebridges, and high performance digital multimeters.

Calibration of high quality (secondary standard grade) platinum resistance thermometers andmeasuring 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 similarmanner or may utilize a high performance DMM to measure resistance. Calibration of SPRTs atthe 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, ThermocoupleCalibration, 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 withthe system and procedures to which it is working. The audits shall be conducted by theEngineering and Quality Assurance Manager or an appointed designee that has the knowledgeand 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 andcorrective action reply within 28 days. The manager will reserve the option to reduce theallowed response time if concern of the validity of the lab results exists. It is the responsibility ofthe Engineering and Quality Assurance Manager to ensure these actions are carried out withinthe 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 forachievement of the quality objectives on a continuous basis. The maximum interval betweenmanagement reviews shall be no more than 12 months. The review should include thefollowing:

a) matters arising from the previous reviewb) reports from audits by clientsc) results of internal audits done since the last review, including corrective actions

implemented.d) results of in-house quality checkse) details of any complaints or feedback from clientsf) staff trainingg) adequacy of staff, equipment and facility resourcesh) future plans and estimates for new work, new staff, new equipment, etc.i) suitability of policies and procedures

j) reports from managerial and supervisory personnelk) the results of interlaboratory comparisons or proficiency testsl) changes in volume and type of work

The findings from the management reviews and the actions that arise from them shall berecorded. The management shall ensure that those actions are carried out within an appropriateand 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 andissued reports have been affected, customers shall be notified in writing.

Checks In addition to the periodic audits and reviews, the calibration laboratory shallimplement 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 asdescribed 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 triplepoint of water cell and one or more SPRTs on a daily basis or prior to use (when practical). Theresults 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 formaleducation and training relevant to the assigned functions. Records of the relevantqualifications, training, skills and experience shall be kept on file at Burns Engineering in thefollowing location:..\..\..\..\Quality System\Process Training Program\Calibration Lab. These

records shall be reviewed periodically by the employee and management to ensure accuracyand completeness. Additional education and training shall be made available to personnel if theneed 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 whichcould adversely effect the calibrations. The environmental conditions of the laboratory shall becontrolled to the extent necessary to assure the calibration measurements meet the requiredaccuracy. The following conditions shall be monitored, controlled and recorded, records shallbe kept for a minimum of three years.

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

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 notpermitted by the applicable calibration SOP, the Metrology and Design Engineer shall benotified. The Metrology and Design Engineer must determine the impact of the out of toleranceconditions on the calibrations and take the necessary actions to correct the situation. Additionalinformation 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 theduties assigned to them. NOTE: No employee shall remove calibration equipment from thelaboratory without first conferring with a Metrology Technician, Metrology and Design Engineer,or the Engineering and Quality Assurance Manager. All calibration equipment must becontrolled in accordance with section 17 of this manual.

7.4. Housekeeping Practices

Good housekeeping practices shall be followed to ensure conditions are conducive to goodlaboratory practices. Efforts shall be made to keep work areas neat and clean. Procedures andequipment 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, completedmaterial. Safe storage of tools and standards will be organized to promote the integrity ofcalibration 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 beavailable 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 asapplicable to the item. In the event that additional equipment must be borrowed, rented orleased, the equipment must be accompanied by objective evidence that it conforms to therequirements of ANSI/NCSL Z540-1 and NIST Handbook 150. Examples of objective evidencemay be:

a) records of audits performed by Burns Engineeringb) proof that the rental companys calibration laboratory is accredited against

ANSI/NCSL Z540 or NVLAPc) acceptance of the rental companys 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 CalibrationLab Supplies and Services.doc

8.2 Equipment and Reference Material Maintenance

All equipment and reference materials used in performing calibrations shall be properlymaintained. The maintenance procedures used shall meet the requirements listed in the BurnsEngineering 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 inthe Burns Engineering SOP for Measuring and Test Equipment, SOP C274. Referencematerials such as distilled water for the ice bath, and software used in the lab shall be verifiedand do not require calibration.

8.4 Equipment and Reference Material Marking

All equipment and reference materials used in performing calibrations shall be marked, labeledor identified to indicate their calibration status. The preferred marking method is to attach acalibration label directly to the equipment or material. Where this is not practical the informationmay be placed on the equipment or material container. The labels shall contain the followinginformation 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 labelmust 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 performingcalibrations. The records shall be kept in accordance with Burns Engineering SOP forMeasuring and Test Equipment, SOP C274. As a minimum the records shall include thefollowing information.

-name of the item of equipment

-the manufacturers name, type identification, and serial number or other uniqueidentification-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 givessuspect results, or has been shown by verification or otherwise to be defective, or has broken oraltered tamper resistant seals, shall be taken out of service. The equipment shall be clearlyidentified as OUT OF SERVICE and, where possible, moved to an isolated storage locationuntil it has been repaired and shown by calibration or verification to perform satisfactorily. TheMetrology and Design Engineer and/or Engineering and Quality Assurance Manager shall benotified to assess the effect of any equipment defect on previous calibrations which have beenperformed. Measures shall be taken to ensure the results of previous calibrations are correctedand customers notified where necessary.


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9.0 MEASUREMENT TRACEABILITY AND CALIBRATION


In order to ensure adequate calibration quality, all calibration laboratory equipment which has asignificant effect on the accuracy or validity of the calibration, including equipment for subsidiarymeasurements (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 traceableto national or international laboratories or to intrinsic standards, where available. Calibrationcertificates and/or reports shall, wherever applicable, state the traceability to national,international, or intrinsic standards of measurements and shall provide the measurement resultsand associated uncertainty of measurement. Where traceability to national, international orintrinsic standards of measurement is not available or practical, traceability requirements shallbe 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 internationallaboratories or to intrinsic standards through an unbroken chain of calibrations or comparisonswith stated uncertainties linking them to the relevant primary standards of the SI unit ofmeasurement. Measuring and test equipment requirements are contained in paragraph 17herein and in Burns Engineering SOP C274.

9.3 Equipment Recall System

Burns Engineering SOP C274 for Measuring and Test Equipment, along with a tools databasecontrol 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 calibrationlaboratory shall implement periodic checks of the calibration equipment. These checks shallinclude, 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 checkrequires measuring the resistance of the SPRT at the triple point of water using a triple point ofwater cell and one or more SPRTs on a daily basis or prior to use (when practical). The resultscollected 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 withthe policy or procedures the following steps shall be taken.

- The Engineering and Quality Assurance Manager or designee will be notifiedand responsible for corrective action.

- The corrective action shall include decisions on; stopping work, stopping any

shipments, determining the significance, disposition of past and presentcalibrations, 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 thenonconformance.

- The nonconformance shall be noted for future internal audits andeffectiveness.


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10.0 CALIBRATION METHODS AND METHOD VALIDATION


All calibrations performed in the laboratory shall be performed in accordance with methods thatmeet 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 requirementsfound in SOP C273 Calibration Method and Procedure Selection and Development. Thedocumentation 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 appropriatefor the calibration undertaken. When the customer does not specify the method to be used, thelaboratory shall select appropriate methods from existing procedures whenever possible. Whenthe customer specifies a method which is considered to be inappropriate or out of date for thecalibration being undertaken, the customer shall be notified.

10.2.1 Routine CalibrationsWritten Calibration Standard Operating Procedures (SOPs) shall be followed when performingroutine calibrations in the laboratory. The most current revision of each Calibration SOP shall bereadily available to the staff. A partial list of SOPs used in the calibration laboratory is givenbelow. The current Master List of all calibration SOPs, as well as the Master Copy of eachcalibration SOP, is located in the engineering area. The Master List contains the documentnumber, title, current approved revision, and date of all calibration SOPs.

SOP Number Title

C1 Calibration of RTD at Ice Point (0C)C3 Comparison Calibration for RTDs

C246 High Pot TestingC263 SPRT Calibration

C265 Secondary Standard PRT Inspection, Annealing and CalibrationC266 Calibration of TA/TB TransmittersC267 Indirect Comparison Calibration of IPRTs, Secondary Standard PRTs and

SPRTsC268 Direct Comparison Calibration of IPRTs, Secondary Standard PRTs and

SPRTs

C269 Calibration of TL Transmitters

10.2.2 Custom CalibrationsWhen custom calibration is required the calibration method used must meet the needs of thecustomer and must be appropriate for the calibration undertaken. Written calibration proceduresare 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 isrequired, 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, andstandard methods used outside their intended scope to confirm the methods are fit for theintended use. The validation shall be as extensive as necessary to meet the needs of the givenapplication. 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 thetheoretical principles of the method and practical experience

10.5 Sampling Procedures

The calibration laboratory does not perform sample calibration but may perform sample testingfor other tests which are performed in the laboratory. When using a sampling method withtesting 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 onengineering input and/or customer specific requirements. All samples shall be randomlyselected from the entire lot.

10.6 Estimation of UncertaintyCalibration uncertainty estimates shall be made using recognized methods and shall take intoconsideration the equipment and procedures used for each calibration. All uncertaintycomponents which are of importance in the given situation shall be taken into account usingappropriate methods of analysis. ANSI/NCSL Z540-2-1997 U.S. Guide to the Expression ofUncertainty in Measurement contains information on methods for estimating uncertaintyhowever other methods may be used if deemed appropriate by the Metrology and DesignEngineer. When a calibration certification or report is required by the customer, the expandeduncertainty shall be stated with a coverage factor k=2 (95%). Unique circumstances may requirean alternate method for calculating and/or reporting the uncertainty, in these cases the methodshall be chosen by the Metrology and Design Engineer and shall take into consideration therequirements 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 thecalibration laboratory computer software. Software used by the laboratory for NVLAP accreditedcalibrations must be validated before being put into use, after any modifications are made, andperiodically as required by the recall system. Records of the validation must be kept on file. Offthe 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 passwordprotected access.

10.8 Consumable Materials

All consumable materials used in the calibration laboratory shall be purchased, inspected andstored in accordance with Burns standard procedures. These materials include but are notlimited 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


All calibration items shall be handled and stored in a suitable manner to prevent degradationand 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 intheir original case when not being worked on. Secondary Standard and Industrial Grade RTDsand thermocouples shall be handled carefully and may be stored in boxes, totes, or directly onbench tops or carts at the discretion of the Metrology Technician. All calibration items shall beexamined, processed and labeled as described below.

11.2 Examination

All calibration items shall be examined prior to calibration for any abnormalities or physicaldamage. If any unusual conditions are found which could effect the intended purpose of theitem, the findings shall be documented and the customer shall be notified of the findings. Thecustomer may be requested to make a decision as to the disposition of the item prior tocompletion 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 becalibrated along with a description of the work to be performed. The description shall list alltesting which is to be performed, and any additional requirements that are considered unique. Ifthe instructions do not fully specify the information needed to perform the calibration, or askmore of the calibration than the item is capable of meeting, the customer shall be consultedprior to proceeding.

11.4 Calibration Seals

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


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12.0 RECORDS


Both quality and technical records shall be maintained.

12.2 Quality RequirementsQuality records include reports from internal audits and management reviews as well as recordsof corrective and preventive action. The official records shall be kept in accordance with thequality 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 inaccordance with the record retention policy of the Burns Engineering Quality Manual. As aminimum the records must contain the results of the test and identification of the individual whoperformed the work. The results may include actual values, or only pass/fail results as requiredby the job paperwork. Records may be changed for the purpose of correction or some otherappropriate reason, but a traceable history of these changes should be preserved. Anacceptable method to accomplish this is to draw a single line through the material to bechanged and to date and initial the alterations. Data acquired electronically may be deleted ifthe data was taken as part of the set up, stabilization check, or was erroneous due to equipmentproblems or some other appropriate reason. Data taken which may indicate a problem with theUUT may not be deleted but may be tagged as initial and retaken to determine if the UUT isfunctioning 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 ofcalibration. 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


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 requiredmethod. 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 requirementsapply to both paper and electronic format.

13.2 Minimum Requirements

Unless otherwise specified the following minimum information shall be included on thecalibration report.

a) Title: e.g. Calibration Reportb) 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 atthe 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 discrepanciesfound 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 thefederal 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 correcterroneous calculations or insert omitted data. Amendments to calibration reports after issue mayonly be made in the form of a further document or data transfer including the statementsupplement to calibration report or other equivalent wording, and including the report numberand serial number of the affected item. Amendments shall meet the relevant requirements ofparagraph 13.2. When it is necessary to issue a complete new calibration report, it shall beuniquely identified and shall contain a reference to the original that it replaces.

13.5 Subcontractor CalibrationsIf all or part of the calibration is performed by a subcontractor, this fact must also appear on thereport 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 otherelectronic or electromagnetic means, the requirements of this manual shall be met.


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14.0 SUBCONTRACTING OF CALIBRATION


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 therequirements of ANSI/NCSL Z540-1, ISO/IEC 17025, NIST Handbook 150, and/or has beenaudited by Burns Engineering and found to be competent. The specific requirements willdepend upon the customer requirements for the calibration performed. Burns EngineeringQuality Manager or his designee is responsible to assure the compliance by the sub-contractedlaboratory, and maintain objective evidence of that assurance. The Quality Manager (ordesignee) shall record and retain details of its investigation into the competence andcompliance of its sub-contractors, and maintain a log of approved laboratories that may be usedas sub-contractors. The customer shall be advised if any portion of the calibration is to besubcontracted to another party.


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15.0 OUTSIDE SUPPORT SERVICES AND SUPPLIES THAT AFFECTCALIBRATION RESULTS


Outside services and supplies used in support of calibrations in the laboratory shall be ofadequate 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 includecalibration). All servicing and supplies shall be verified as adequate prior to being put intoservice. Records shall be maintained for all suppliers of support services and supplies thataffect calibration results.


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16.0 COMPLAINTS


Complaints from customers or other parties regarding the laboratorys activities shall be handledin accordance with SOP C275 Procedure for Handling Customer Complaints Related toCalibration. 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


The calibration/verification system covering measurement and test equipment (M&TE)and measurement standards used by the calibration laboratory is described in thisparagraph with additional details contained in SOP C274 Requirements for Measuringand Test Equipment.

17.2 Measurement and Test Equipment

All measurement and test equipment (M&TE) used by the calibration laboratory todetermine compliance with technical specifications shall be calibrated or verified inaccordance with the requirements of this document. When calibrations give rise to a setof correction factors or coefficients, these correction factors shall be implemented perthe appropriate SOP requirements. M&TE including software shall be safeguarded fromunauthorized adjustments and changes which would invalidate the calibration orverification results.

17.3 Measurement Standards

Measurement standards used for calibrating M&TE and other measurement standardsshall comply with the applicable requirements of paragraph 8, 9 and 10 of this documentregarding the use of adequate equipment that has been calibrated using appropriateprocedures.

17.4 Recall System

All M&TE shall be included in the calibration recall system described in SOP C274Requirements for Measuring and Test Equipment which requires periodic calibrationand/or verification of the M&TE.

17.5 Removal from Service

M&TE which has exceeded its calibration interval, has broken calibration seals, or issuspected to be malfunctioning because of mishandling, misuse, or unusualmeasurement results shall be removed from service and handled in accordance with therequirements 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 validresults. In general the requirements of paragraph 7.2 of this document shall be met, withdue consideration given to other factors which could affect the results such as lighting,

vibration, electromagnetic interference, etc. When appropriate and necessary acorrecting compensation shall be applied to measurement results to account forextreme environmental conditions.


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17.7 Calibration and Verification Intervals

M&TE requiring calibration shall be calibrated or verified at periodic intervals establishedand maintained to assure that the M&TE will remain in tolerance throughout theinterval. 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 onusage or time since last calibration. All exemptions from periodic calibration orverification must be documented. The recall system may provide for the temporaryextension 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 thisdocument as applicable to the particular item being calibrated or verified. All M&TEcalibrations 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 theMetrology and Design Engineer and/or the Engineering and Quality Assurance Managerfor evaluation. It is the responsibility of the Metrology and Design Engineer and/orEngineering and Quality Assurance Manager to determine the significance of the out oftolerance condition. It is the responsibility of the Engineering and Quality AssuranceManager to promptly determine the appropriate action which needs to be taken as aresult of the out of tolerance condition. As a minimum, the action shall take intoconsideration the effect on previous calibrations and customer notification wherenecessary

17.10 Adequacy of Calibration and Verification System

The adequacy of the calibration system shall be verified through audit and review inaccordance with paragraph 5.2 of this document.

17.11 Calibration Sources

M&TE requiring calibration shall be calibrated or verified by laboratories meeting therequirements of Part I of ANSI/NCSL Z540. Control of subcontractor calibration shall beper paragraph 17.14 of this document.

17.12 Records

Records shall be kept for all M&TE requiring calibration and verification. The recordsshall 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 ofuse, etc.;


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f) actions taken as a result of the calibration; e.g., any adjustments or correctionsmade, any repairs performed or parts replaced; and

g) any pertinent occurrences not directly related to periodic calibration, such asoperational 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 notpractical the information may be placed on the item container. The label shall identifythe 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 mustnot 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. BurnsEngineering Quality Assurance Manager or his designee is responsible to assure thecompliance by the sub-contracted laboratory, and maintain objective evidence of thatassurance. The Quality Manager (or designee) shall record and retain details of its investigationinto the competence and compliance of its sub-contractors, and maintain a log of approvedlaboratories 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 notadversely 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 inthe calibration or verification procedure.


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18.0 REFERENCING NVLAP ACCREDITATION


The following conditions, which pertain to the use of the term NVLAPand the NVLAP logo, shallbe followed.

a) The term and logo shall not be used in a manner that brings NVLAP into disrepute ormisrepresents the scope of accreditation or accredited status.

b) When the term NVLAPis used to reference the accredited status, it shall beaccompanied by the NVLAP Lab Code.

c) When the NVLAP logo is used to reference accredited status, it must be accompaniedby the NVLAP Lab Code in an approved caption. The caption shall appear below and inclose 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 scopeof accreditation. A calibration report that contains both data covered by accreditation anddata not covered by accreditation shall clearly identify the data that are not covered byaccreditation. The report must prominently display the following statement at the

beginning of the report: This report contains data that are not covered by the NVLAPaccreditation.

g) When the term and logo are used on a calibration report that also includes work done bya subcontracted laboratory, such use shall be limited to reports in which some or all ofthe data are taken from calibrations performed by the laboratory under the scope ofaccreditation. A calibration report that contains data covered by the accreditation anddata provided by a subcontractor shall clearly identify the data that were provided by thesubcontracted laboratory. The report must prominently display the following statement atthe beginning of the report: This report contains data that were produced undersubcontract 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 bya body other than NVLAP, then the name of the accreditation body and the laboratorys

number or other unique identifier should also be stated. If the subcontracted laboratoryis not accredited, then this must be stated.

h) Each calibration report that bears the term or logo shall include a statement that thereport must not be used to claim product certification, approval, or endorsement byNVLAP, NIST, or any agency of the federal government.

i) When used in a contract or proposal, the term and logo shall be accompanied by adescription of the laboratories scope of accreditation and current accreditation status.


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Burns Engineering Calibration Laboratory Quality Manual, Revision E Page 30 of 30F 0203371

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

Figure 1 NVLAP Logo

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