Program Requirements

Transcription

1 METCAP Program Requirements METrology and Calibration Accreditation Program ANSI/NCSL Z subclause 5.3 Accreditation Bureau (L-A-B) - All Rights Reserved. August 31, No part of this document may be reproduced or utilized, in any form, or by any means electronic or mechanical, including photocopy or recording, or by any information storage and retrieval system, without written permission from the publisher, the Accreditation Bureau (L-A-B). LABPR Accreditation Bureau Coldwater Rd. Suite 101 Fort Wayne, IN Phone: (260) Fax: (260) LABPR Rev 3 5/27/11 Page 1 of 27

2 1. Introduction 1.1. The purpose of this document is to establish specific program requirements as defined by the Accreditation Bureau, hereafter known as L-A-B. This document is written to help laboratories develop and implement a laboratory management system that is in compliance with ANSI/NCSLI Z , Subclause 5.3 that is suitable for their size and workload, and that will meet their clients needs Laboratories that are contractually bound to control their measuring and test equipment or that of their customers, the requirements of this standard is applicable. All requirements of the standard can be superseded by the requests of the customer ANSI/NCSLI Z Subclause 5.3 Requirements for the calibration of measuring and test equipment Checklist sets out the criteria for laboratories wishing to demonstrate that they are technically competent, and are able to generate technically valid calibration and test results. The standard will form the basis for the accreditation of competence of laboratories by accreditation bodies. 2. L-A-B Specific Requirements 2.1. Applications Laboratories applying for the accreditation of ANSI/NCSL Z540.3 subclause 5.3 will be required to apply the requirements of subclause 5.3 to their own Measuring and Test Equipment (M&TE) and calculate the Probability of False Acceptance (PFA) for their own M&TE Laboratories that calibrate equipment internally and are not accredited to calibrate those particular items, the laboratories will be required to calculate PFA for those supporting calibrations Documents to be submitted At the time of the notification of the assessment, documentation will be sent to the laboratory describing what is needed for the review prior to the assessment including: Annex A and B of this document Procedures for the determination of Measuring and Test Equipment calibration requirements Procedure for Measurement Assurance L-A-B Form 001 Traceability Tracking Procedure for the estimation and expression of the uncertainty of measurement Uncertainty analysis Proposed scope of accreditation. Scope of Accreditation examples can be found Annex B of L-A-B AG s procedure(s) for calculating PFA Examples of the PFA calculations Procedure for establishing and adjusting calibration intervals Example of a calibration certificate that is issued to the customer complying with the requirements of ISO/IEC 17025, L-A-B Policy s and PR requirements Name(s) of personnel who are responsible for maintaining compliance to these requirements. LABPR Rev 3 5/27/11 Page 2 of 27

3 3. References 3.1. ANSI/NCSL Z Requirements for the calibration of measuring and test equipment 3.2. Handbook for the Application of ANSI/NCSL Z Requirements for the calibration of measuring and test equipment 3.3. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories 3.4. International Vocabulary of Basic and General Terms in Metrology (VIM) 4. Definitions 4.1. Calibration - The set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards Calibration system, calibration program - The set of interrelated or interacting elements necessary to maintain the measurement performance of measuring and test equipment to defined requirements Guard band - The offset of a measurement decision value from a stated specification or tolerance Measurement assurance - The result of a process to provide adequate confidence that a measurement will satisfy stated requirements Measurement decision risk - The probability that an incorrect decision will result from a measurement Measurement process - The set of operations to determine the value of a measurement quantity Measurement quantity - An attribute of a phenomenon, artifact, or substance that may be distinguished qualitatively and determined quantitatively Measurement reliability - The probability that all the applicable measurement quantities of measuring and test equipment are within tolerance Measuring and test equipment - The measuring instrument, measurement standard, reference material or auxiliary apparatus, or a combination thereof, necessary to realize a measurement process M&TE- Abbreviation for Measuring and Test Equipment Organization - A group of people and facilities with an arrangement of responsibilities, authorities, and relationships PFA Abbreviation for Probability of False Acceptance Test uncertainty ratio - The ratio of the span of the tolerance of a measurement quantity subject to calibration, to twice the 95% expanded uncertainty of the measurement process used for calibration Tolerance - Extreme values of an error permitted by specifications, regulations, etc., for a given measuring instrument, test, or measurement application Validation - Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. General Requirements above and beyond ISO/IEC LABPR Rev 3 5/27/11 Page 3 of 27

4 5. Requirements of ANSI/NCSL Z540.3 subclause Calibration of measuring and test equipment - Calibration of measuring and test equipment shall be in accordance with the requirements of this National Standard. Calibration may be performed within or outside a designated calibration facility, e.g., in situ, on-site, or at a customer s facility, provided compliance with the requirements of this National Standard is maintained. The scope of the calibration capability shall be consistent with the calibration requirements and provide levels of measurement decision risk acceptable to both the customer and supplier. 5.3 a) Where calibrations provide for reporting measured values, the measurement uncertainty shall be acceptable to the customer and shall be documented. 5.3 b) Where calibrations provide for verification that measurement quantities are within specified tolerances, the probability that incorrect acceptance decisions (false accept) will result from calibration tests shall not exceed 2% and shall be documented. Where it is not practicable to estimate this probability, the test uncertainty ratio shall be equal to or greater than 4:1. Calibration-servicing components may be considered competent to provide calibration services when they have been accredited to meet ANS/ISO/IEC 17025, including the requirements of this sub-clause, or otherwise found to be in conformance by an authority acceptable to the customer. Competence shall be confirmed for the required calibration services and reflected in a scope of accreditation or in a similar listing of calibration capability and conformity in the non-accredited laboratory. All measuring and test equipment included in the calibration system, including measuring systems, calibration equipment, reference standards and material, and other inspection and monitoring equipment, shall be calibrated prior to use and recalibrated at predetermined intervals to ensure acceptable measurement uncertainty, traceability, and reliability. Intervals may be based on usage or time since last calibration. When there is doubt as to the suitability of an item for calibration, when an item does not conform to the description provided, or the calibration required is not specified in sufficient detail, the calibration-servicing component shall consult with the customer for further instructions before proceeding and shall record the discussion Calibration procedures - Calibrations shall be performed using calibration procedures that: address the measuring and test equipment performance requirements; are acceptable to the customer; are current and appropriate for the calibrations; and provide reasonable assurance that the calibration results are as described. All calibration procedures shall: a) contain sufficient information on requirements for the associated measurements and instructions to perform the calibrations. In addition, the number of different measurement quantities and values in a calibration procedure shall be sufficient to ensure conformity of the measuring and test equipment to determined requirements; b) provide for determining and recording the as-found performance of the measuring and test equipment being calibrated; and c) be suitable for use by the calibration staff to perform and reproduce a calibration to the established performance criteria. Deviation from calibration procedures shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer. LABPR Rev 3 5/27/11 Page 4 of 27

5 When a calibration procedure proposed by the customer is considered to be inappropriate, the customer shall be notified Contents - calibration procedures shall include the following information: a) identification and document control information; b) scope and/or description of item to be calibrated; c) measurement quantities and ranges to be determined for the item to be calibrated and any associated tolerances; d) minimum performance requirements of the equipment to be used for calibration, including measurement and reference standards, and reference materials; e) environmental conditions required and any stabilization period needed; f) description of steps associated with the calibrations to be performed; g) criteria and/or requirements for calibration decisions, such as approval or rejection; and h) data to be recorded and method of analysis and presentation Validation - Calibration procedures and their modifications, shall be validated. The validation shall be as extensive as is necessary to meet the needs of the procedure s application Measurement assurance procedures - Measuring processes incorporating measurement assurance methods, such as statistical process control, shall use a measurement assurance procedure. This procedure shall be systematically applied and include stated measurement uncertainty or reliability goals, control criteria, and methodology to verify that the goals and criteria are being attained. The controls shall be adjusted when the results of the previous measurements indicate that such action is appropriate to maintain acceptable measurement uncertainty or reliability. Measurement assurance controls may be based on the use of calibrated check standards, usage, and/or time since the last performance. The measurement assurance procedure shall include mandatory instructions to preclude the use of the measuring process that exceeds its controls. The measurement assurance procedure and any associated measuring and test equipment shall be documented as a calibration procedure in accordance with the provisions of this National Standard Measurement uncertainty and traceability - The uncertainty and traceability of all measurement results associated with processes included in the calibration system shall meet the requirements of their applications. Measurement uncertainty components which have an influence on such measurement results shall be included in the estimates of measurement uncertainty Expression of measurement uncertainty - A documented procedure shall be used to estimate and express the uncertainty of measurement for all calibrations. As a minimum, the procedure shall address: a) sources of measurement uncertainty; b) estimation and combining of uncertainties; c) conditions and assumptions; d) documentation and reporting criteria; and e) bibliography. LABPR Rev 3 5/27/11 Page 5 of 27

6 Measurement traceability- The results of a calibration or measurement shall be traceable through a controlled, unbroken chain of competent calibrations to and through the National Institute of Standards and Technology to the SI units of measurement. This traceability to a national measurement institute other than the National Institute of Standards and Technology is acceptable when: a) a mutual recognition agreement, such as the Comité International des Poids et Mesures (CIPM) Mutual Recognition Arrangement (MRA), is in effect with the National Institute of Standards and Technology and sufficient equivalence of applicable calibration services exists; or b) when the calibration service of the National Institute of Standards and Technology is not available or does not meet the measurement performance requirements. Where traceability to SI units through national metrology institutes is not available, or SI units are not established, a consensus standard including a reference standard and related calibration procedures, which are clearly specified and mutually agreed upon by all parties concerned, shall be applied Calibration equipment - All measuring and test equipment required for the correct performance of calibrations and related measurements, including calibration and reference standards and reference material, shall be available to the calibrationservicing component. In those cases where the calibration-servicing component needs to use equipment outside its permanent control, it shall ensure that the requirements of this National Standard are met. Measuring and test equipment used for calibration and associated measurements shall be capable of achieving the performance required and shall comply with specifications relevant to the calibrations performed. Measuring and test equipment that may affect the results of the calibrations shall be calibrated and included in a calibration system meeting the requirements of this National Standard Documentation- Instructions on the use and operation of all relevant equipment shall be available to the calibration-servicing component where the absence of such instructions could jeopardize the results of calibrations Calibration personnel - Personnel who operate specific equipment, perform calibrations or measurements, evaluate results, give opinions and interpretations, prepare calibration records, and/or sign calibration reports shall be competent. When using personnel who are undergoing training, appropriate supervision shall be provided Authorization - Specific personnel shall be authorized: to perform particular types of calibrations; to issue calibration procedures and reports; to give opinions and interpretations; to prepare calibration records; and to operate particular types of equipment. Records of such authorization shall be maintained, readily available, and include the date of authorization Influence factors and conditions - All factors and conditions of the calibration area that adversely influence the calibration results shall be defined, monitored, recorded, and mitigated to meet calibration process requirements Calibration quality - Calibration quality shall be monitored to assure the validity of the calibration services. The monitoring process shall be documented and the resulting data recorded and evaluated. This monitoring process may include, but not be limited to, the following: LABPR Rev 3 5/27/11 Page 6 of 27

7 a) sampling of calibrated measuring and test equipment; b) calibrations using different procedures or methods; c) regular use of measurement assurance methods; and/or d) participation in measurement inter-comparison programs. When the results of any of the procedures indicate suspect calibrations, appropriate actions shall be taken to identify the root cause and take any corrective and preventive actions Reporting the results - The results of each calibration or series of calibrations shall be reported accurately, clearly, unambiguously, and objectively. The results reported shall include all information requested by the customer and necessary for the interpretation of the calibration results, and all information required by the calibration procedure used Calibration reporting - Where a calibration report is issued, the report shall include at least the following information: a) title; b) identification of the calibration-servicing component, and the location where the calibrations were carried out, if different; c) unique identification of the calibration report; d) identification of the customer; e) identification of the calibration procedure used; f) description of, the condition of, and unambiguous identification of the item calibrated; g) date of performance of the calibration; h) calibration results with, where appropriate, the units of measurement; i) calibration results before and after adjustment or repair, if available; j) person authorizing the calibration report; k) statement of measurement traceability; l) factors and conditions under which the calibrations were made that have an influence on the measurement results; and m) uncertainty of measurement, where appropriate, and/or a statement of conformance. Where a statement of conformance with specified calibration performance requirements and/or calibration procedure is provided, the extent of conformance shall be provided and included in the calibration records Opinions and interpretations - When opinions and interpretations are included, the basis upon which the opinions and interpretations have been made shall be documented. Opinions and interpretations shall be clearly marked as such in a calibration report Control and source - When it is necessary to amend or issue a complete new calibration report, it shall be uniquely identified and shall contain a reference to the original that it amends or replaces Calibration records - Records of the calibration process shall be completed to attest to the correctness of the results, as appropriate. These records shall be maintained and made available. Records of the calibration process shall demonstrate whether LABPR Rev 3 5/27/11 Page 7 of 27

8 measuring and test equipment have satisfied the performance requirements specified. The records should be sufficient to demonstrate the traceability of the measurements and reproduce the calibration results under conditions close to the original conditions. Records shall be maintained of each item of equipment and software where its use contributes to the results of the calibrations performed. The records shall include the following: a) description and unique identification of the measuring and test equipment (manufacturer, model, nomenclature, serial number, etc.); b) identification of the calibration-servicing component; c) identification of the calibration procedure used; d) date on which the calibration was completed; e) as-found measurement performance condition of the equipment; f) calibration actions taken (adjusted, repaired, new value assigned, limited, derated, modified, etc.); g) calibration results and the as-returned measurement performance condition of the equipment; h) limitations of use; i) assigned calibration interval; and j) identification of calibration reports. Generation, amendment, issuance, and deletion of records shall be authorized. In addition, the reason for an amendment or deletion of a record shall be documented. REVISION HISTORY Revision Revision Level Date Revised By Brief Description of Revision Original 08/31/09 Randy Long Rev 1 11/30/10 Ryan Fischer Original Issue, requirements section numbering matching that of Z540.3 Further identified the documents needed prior to the assessment in Approved: Date: 12/13/2010 LABPR Rev 3 5/27/11 Page 8 of 27

9 Annex A Documentation Checklist Name: Number of Lab Techs: Instructions: This documentation checklist and the documentation stated below are required to be sent to L-A-B at least 30 days prior to the scheduled Full Assessment. L-A-B does not maintain any laboratory quality documentation on file. Any delays in receiving the necessary documentation may result in a rescheduling of the assessment per L-A-B Policy 004. Electronic documentation must be sent to laboratorydocuments@l-a-b.com. All remaining hard copy documents must be sent to L-A-B operations office. Documentation Requirements for an Assessment Date Sent to L-A-B Electronic Hard Copy Proof of Purchase of ANSI/NCSL Z540.3 (Initial Assessment Only) Procedures for the determination of Measuring and Test Equipment calibration requirements. Procedure for Measurement Assurance L-A-B Form 001 Traceability Tracking Please provide this form which details the traceability of the calibrated items in the lab. Procedure for the estimation and expression of the uncertainty of measurement Proposed scope of accreditation. Scope of Accreditation example can be found Annex B of L-A-B AG s procedure(s) for calculating PFA Examples of the PFA calculations Procedure for establishing and adjusting calibration intervals Calibration Certificate or Test Report Example of a calibration certificate that is issued to the customer complying with the requirements of ISO/IEC 17025, L-A-B Policy s and PR requirements LABPR Rev 3 5/27/11 Page 9 of 27

10 Information Company Name Annex B Assessment Checklist Address (Include addresses of all sites covered by this assessment) Quality Manager Phone FAX Contact Form Completed By Date Form Completed Assessor Name Date of Assessment LABPR Rev 3 5/27/11 Page 10 of 27

11 Instructions Accreditation Bureau (L-A-B) and its applicants for laboratory accreditation will use this document to conduct an ANSI / NCSL Z , subclause 5.3 Quality System Review, and as an assessment checklist during the assessment process. The clauses of ISO/IEC are paraphrased in this document, and do not necessarily reflect the complete requirements. The laboratory is required to prove compliance with the full requirements as stated in ANSI / NCSL Z , subclause 5.3 in their entirety. Applicant The applicant shall complete the column Your Document by referencing its document that shows they are compliant with the specific requirement. This is the only column that is to be filled out by the applicant. This reference should indicate the document name, page and paragraph(s) in which the compliance can be confirmed. This checklist and all documentation referenced on the checklist will then be forwarded to L-A-B Operations office. Lead Assessor Document Review The lead assessor must confirm the documentation s compliance with the requirements of ANSI / NCSL Z , subclause 5.3, and indicate the laboratories compliance in the document compliance C and N columns of this form. The assessor should inform the client of any observations or requirements the laboratory may need to address prior to the assessment. Lead Assessor Pre-assessment Visit (Optional) The lead assessor will use this document to review each section and highlight areas which may be necessary for further review during the pre-assessment visit. Lead Assessor Assessment Visit: The lead assessor is responsible for completing this checklist by indicating the laboratory s compliance to its own policies and procedures, and the requirements of ANSI / NCSL Z , subclause 5.3. The laboratories compliance shall be indicated in the Assessment C and N columns, and comments on compliance, nonconformances, and observations shall be documented in the Assessment Notes column. Assessment Results Assessor shall complete Form 14 for Assessment results, and recommendations. LABPR Rev 3 5/27/11 Page 11 of 27

12 Assessment Summary LABPR Rev 3 5/27/11 Page 12 of 27

13 Comments on Calibration of Measuring and Test Equipment 5.3 Calibration or measuring and test equipment shall be IAW with ANSI/NCSL Z Calibration may be performed within or outside a designated calibration facility. The scope of the calibration activities shall be consistent with the calibration requirements and provide levels of measurement risk acceptable to customer and supplier. a) b) Where calibrations report measured values, the measurement uncertainty shall be documented and acceptable to the customer. Calibrations that provide for verification that measurement quantities are within specified tolerances, making statements of compliance: The probability that incorrect acceptance decisions will result from calibration tests shall not exceed 2% and shall be documented. If not practicable to estimate probability the test uncertainty ratio (TUR) shall be equal to or greater than 4:1 Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 13 of 27

14 Comments on Independent laboratories shall apply a 95 % Calibration Process Uncertainty Guard Band or TUR based Guard Band where reliability data of the UUT is not available Services provided to the organization supporting calibration services shall be considered competent when they have been at least: Accredited to Met the requirements of ANSI Z540.3 Found in conformance by an authority acceptable to the customer Competence for the calibration services shall be confirmed and reflected in a scope of accreditation or similar listing of calibration capability and conformity in the non-accredited laboratory. All measuring and test equipment included in the calibration system shall be calibrated prior to use and recalibrated at predetermined intervals. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 14 of 27

15 Comments on Where doubt to the suitability of an item for calibration or it does not conform to the description provided, or there is insufficient detail of the required services. The customer must be consulted and the discussion recorded. Calibration Procedures Calibration procedures shall assure: The measuring and test equipment performance requirements are addressed Are acceptable to the customer. Are current and appropriate for the calibrations. Provide reasonable assurance that the calibration results are as described. All calibration procedures shall: Contain sufficient information on requirements and instructions to perform the calibrations. a) Different measurement quantities and values in a calibration procedure shall ensure conformity of the measuring and test equipment to determined requirements. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 15 of 27

16 Comments on b) c) Include determining and recording the as-found performance of the M&TE being calibrated. Be suitable for use by the calibration staff to perform and reproduce a calibration to the established performance criteria. Deviation shall occur only if it has been documented, technically justified, authorized, and accepted by the customer. The customer shall be notified when a calibration procedure proposed by the customer is considered to be inappropriate Contents Calibration procedures shall include the following information: a) Identification and document control information. b) Scope and/or description of item to be calibrated. c) Measurement quantities and ranges to be determined for the item to be calibrated and any associated tolerances Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 16 of 27

17 Comments on d) e) f) Minimum performance requirements of the equipment to be used for calibration, including measurement and reference standards, and reference materials. Environmental conditions required and any stabilization period needed. Description of steps associated with the calibrations to be performed. Measurement Assurance Procedures A procedure shall be established for measuring processes incorporating measurement assurance methods Measurement uncertainty or reliability goals, control criteria, and methodology to verify that the goals and criteria are being attained shall be stated and systematically applied. Measurement assurance controls may be based on the use of calibrated check standards, usage, and/or time since the last performance. The controls shall be adjusted when the results of the previous measurements are needed to maintain acceptable measurement uncertainty or reliability. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 17 of 27

18 Comments on The measurement assurance procedure shall include mandatory instructions to preclude the use of the measuring process that exceeds its controls. The measurement assurance procedure and any associated measuring and test equipment shall be documented as a calibration procedure in accordance with the provisions of this National Standard Measurement Uncertainty and Traceability a) b) The uncertainty and traceability of all measurement results associated with processes included in the calibration system shall meet the requirements of their applications. Measurement uncertainty components which have an influence on such measurement results shall be included in the estimates of measurement uncertainty Expression of Measurement Uncertainty A documented procedure shall be used to estimate and express the uncertainty of measurement for all calibrations. The procedure shall address at a minimum: Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 18 of 27

19 Comments on a) Sources of measurement uncertainty b) Estimation and combining of uncertainties c) Conditions and assumptions d) Documentation and reporting criteria e) Bibliography Measurement Traceability The results of a calibration or measurement shall be traceable through a controlled, unbroken chain of competent calibrations to and through NIST to the SI units of measurement. This traceability to a national measurement institute other than the National Institute of Standards and Technology is acceptable when: a) A mutual recognition agreement is in effect with the NIST and sufficient equivalence of applicable calibration services exists. b) When the calibration service of the NIST is not available or does not meet the measurement performance requirements. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 19 of 27

20 Comments on Where traceability to SI units through national metrology institutes is not available, or SI units are not established, a consensus standard including a reference standard and related calibration procedures, which are clearly specified and mutually agreed upon by all parties concerned, shall be applied Calibration Equipment All M&TE required for the correct performance of calibrations and related measurements, including calibration and reference standards and reference material, shall be available to the calibration-servicing component. In those cases where the calibration-servicing component needs to use equipment outside its permanent control, it shall ensure that the requirements of this National Standard are met. Measuring and test equipment used for calibration and associated measurements shall be capable of achieving the performance required and shall comply with specifications relevant to the calibrations performed. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 20 of 27

21 Comments on Measuring and test equipment that may affect the results of the calibrations shall be calibrated and included in a calibration system meeting the requirements of this National Standard Documentation Instructions on the use and operation of all relevant equipment shall be available. Calibration Personnel Personnel who operate specific equipment, perform calibrations or measurements, evaluate results, give opinions and interpretations, prepare calibration records, and/or sign calibration reports shall be competent. Authorization Specific personnel shall be authorized: to perform particular types of calibrations, issue calibration procedures and reports, give opinions and interpretations, prepare calibration records and to operate particular types of equipment. Records of authorization shall be maintained, readily available, and include the date of authorization. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 21 of 27

22 Comments on Influence Factors and Conditions All factors and conditions of the calibration area that adversely influence the calibration results shall be defined, monitored, recorded, and mitigated to meet calibration process requirements. Calibration shall be stopped when the adverse effects of the influence factors and conditions jeopardize the results of the calibration. Calibration Quality a) b) c) Calibration quality shall be monitored to assure the validity of the calibration services. The monitoring shall be documented and the resulting data recorded and evaluated. This monitoring process may include, but not be limited to, the following: Sampling of calibrated measuring and test equipment. Calibrations using different procedures or methods. Regular use of measurement assurance methods. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 22 of 27

23 Comments on Participation in measurement inter-comparison programs. d) When the results of any of the procedures indicate suspect calibrations, appropriate actions shall be taken to identify the root cause and take any corrective and preventative actions. Reporting the results The results of each calibration or series of calibrations shall be reported accurately, clearly, unambiguously, and objectively. The results reported shall include all information requested by the customer and necessary for the interpretation of the calibration results, and all information required by the calibration procedure used. Calibration reporting Where a calibration report is issued, the report shall include at least the following information: a) Title Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 23 of 27

24 Comments on b) Identification of the calibration-servicing component, and the location where the calibrations were carried out, if different c) Unique identification of the calibration report d) Identification of the customer e) Identification of the calibration procedure used f) Description of, the condition of, and unambiguous identification of the item calibrated g) Date of performance of the calibration h) i) Calibration results with, where appropriate, the units of measurement Calibration results before and after adjustment or repair, if available j) Person authorizing the calibration report k) Statement of measurement traceability l) m) Factors and conditions under which the calibrations were made that have an influence on the measurement results. Uncertainty of measurement, where Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 24 of 27

25 Comments on appropriate, and/or a statement of conformance. Where a statement of conformance with specified calibration performance requirements and/or calibration procedure is provided, the extent of conformance shall be provided and included in the calibration records. Opinions and Interpretations When opinions and interpretations are included, the basis upon which the opinions and interpretations have been made shall be documented. Opinions and interpretations shall be clearly marked as such in a calibration report. Control and Source When it is necessary to amend or issue a complete new calibration report, it shall be uniquely identified and shall contain a reference to the original that it amends or replaces. Calibration Records Records of the calibration process shall be completed to attest to the correctness of the results. Shall be maintained and made available. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 25 of 27

26 Comments on Records of the calibration process shall demonstrate whether measuring and test equipment have satisfied the performance requirements specified. Records shall be maintained of each item of equipment and software where its use contributes to the results of the calibrations performed. The records shall include the following: a) Description and unique identification of the measuring and test equipment. b) Identification of the calibration-servicing component. c) Identification of the calibration procedure used. d) Date on which the calibration was completed. e) f) As-found measurement performance condition of the equipment. Calibration actions taken (adjusted, repaired, new value assigned, limited, derated, modified, etc.) Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 26 of 27

27 Comments on g) Calibration results and the as-returned measurement performance condition of the equipment. h) Limitations of use. i) Assigned calibration interval. Identification of calibration reports. j) Generation, amendment, issuance, and deletion of records shall be authorized. An amendment or deletion of a record shall be documented. Legend: C=Compliant, NC=Noncompliant, NA=Not Applicable, Document=laboratory s document where compliance to the LABPR Rev 1 11/30/10 Page 27 of 27