NIST Handbook 143
State Weights and Measures Laboratories Program Handbook
Appendix C. Part 2, Laboratory Assessment Checklist (from NVLAP Technical Guide)
GENERAL OPERATIONS CHECKLIST
Instructions to the Assessor:
This checklist addresses general accreditation criteria prescribed in applicable sections of NIST Handbook 150, NVLAP Procedures and General Requirements and this Handbook 143, Program Handbook. As an aid to those laboratories wishing to comply with both OWM recognition and NVLAP accreditation criteria, cross-referenced items in this section reference NVLAP Handbook 150. Sections 5 and 6 of Handbook 143 are nearly identical with Subpart D, section 285.33 Criteria for Accreditation. Items marked with other NVLAP cross references may not apply to OWM recognition - in that case, indicate "NA" for not applicable. A checklist for specific technical criteria is not included in this handbook at this time.
Place an "X" beside each checklist item which represents a deficiency. Place a "C" beside each item on which you are commenting for other reasons. Record the item number and your written deficiency explanations and/or comments in this list or on the attached comment sheets. Place a check beside all other items you observed or verified at the laboratory.
SEC. 285.33 CRITERIA FOR ACCREDITATION (and OWM Recognition)
(b)Organization and management
(1) The laboratory shall be:
_____ (i) legally identifiable; Legal name of laboratory ownership:
_____ (ii) organized and shall operate in such a way that its permanent, temporary and mobile facilities meet the NVLAP requirements [see also (b)(2)(i), (c)(2)(ii)];
_____ (iii) properly identified on the NVLAP Application.
(2) The laboratory shall:
_____ (i) have managerial staff with the authority and resources needed to discharge their duties [see also (b)(1)(ii), (c)(2)(ii)]; _____ (ii) have policies to ensure that its personnel are free from any commercial, financial, and other pressures which might adversely affect the quality of their work;
_____ (iii) be organized in such a way that confidence
_____ (iv) specify and document the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of calibrations and tests;
_____ (v) provide supervision by persons familiar with the calibration or test methods and procedures, the objective of the calibration or test, and the assessment of the results. The ratio of supervisory to non?supervisory personnel shall be such as to ensure adequate supervision;
_____ (vi) have a technical manager (however named) who has overall responsibility for the technical operations;
Name of person:
_____ (vii) have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources, and to the technical manager. In some laboratories, the quality manager may also be the technical manager or deputy technical manager;
Name of person:
_____ (viii) nominate deputy(ies) in case of absence of the technical or quality manager;
Name(s):
_____ (ix) have documented policy and procedures to ensure the protection of clients' confidential information and proprietary rights [see also (c)(2)(xviii)];
_____ (x) where appropriate, participate in interlaboratory comparisons and proficiency testing programs [see also (c)(2)(xiv), (c)(6)(ii), (g)(3)];
_____ (xi) have documented policy and procedures to ensure that its clients are served with impartiality and integrity.
(c) Quality system, audit and review
(1) The laboratory shall:
_____ (i) have an established and maintained quality system appropriate to the type, range, and volume of calibration and testing activities it undertakes; _____ (ii) have the elements of the quality system documented;
_____ (iii) ensure that the quality documentation is available for use by the laboratory personnel;
_____ (iv) define and document its policies and objectives for, and its commitment to, good laboratory practice and quality of calibration or testing services;
_____ (v) have the laboratory management which ensures that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned;
_____ (vi) ensure that the quality manual is maintained current under the responsibility of the quality manager [see also (c)(2)(iv)].
Date of quality manual: Date of latest update:
(2) The quality manual, and related quality documentation, shall state the laboratory's policies and operational procedures established in order to meet the NVLAP requirements. The quality manual and related quality documentation shall contain:
_____ (i) a quality policy statement, including objectives and commitments, by top management; _____ (ii) the organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts;
_____ (iii) the relations between management, technical operations, support services, and the quality system;
_____ (iv) procedures for control and maintenance of documentation [see also (c)(1)(vi), (j)(1)];
_____ (v) job descriptions of key staff and reference to the job descriptions of other staff;
_____ (vi) identification of the laboratory's approved signatories (list here or in the comments section):
_____ (vii) the laboratory's procedures for achieving traceability of measurements;
_____ (viii) the laboratory's scope of calibrations and/or tests;
_____ (ix) written procedures for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;
_____ (x) reference to the calibration, verification, and/or test procedures used;
_____ (xi) procedures for handling calibration and test items;
_____ (xii) reference to the major equipment and reference measurement standards used;
_____ (xiii) reference to procedures for calibration, verification, and maintenance of equipment;
_____ (xiv) reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes [see also (b)(2)(x), (c)(6)(ii), (g)(3)];
_____ (xv) procedures to be followed for feedback and corrective action whenever:
_____ a) testing discrepancies are detected, or _____ b) departures from documented policies and procedures occur;
_____ (xvi) the laboratory management policies for departures from documented policies and procedures or from standard specifications;
_____ (xvii) procedures for dealing with complaints [see also (n)];
_____ (xviii)procedures for protecting confidentiality and proprietary rights [see also (b)(2)(ix)];
_____ (xix) procedures for audit and review;
_____ (xx) a description of the laboratory's policy regarding the use of the NVLAP logo;
_____ (xxi) a statement of the laboratory's policy for establishing and changing calibration intervals for equipment it controls; and
_____ (xxii) a statement of the laboratory's policy concerning the technique(s) to be used for determining measurement uncertainty and calibration/verification adequacy.
_____ (3) The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements of the quality system. Such audits shall be carried out by trained and qualified staff who are, wherever possible, independent of the activity to be audited. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibration or test results, the laboratory shall take immediate corrective action and shall immediately notify, in writing, any client whose work may have been affected.
The audits shall be objective and be conducted internally or on contract. The audits shall include both general criteria (documents, records, and policies) and technical compliance (test methods and practices and calibration procedures).
_____ (4) The quality system adopted to satisfy the NVLAP requirements shall be reviewed at least once a year by the management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements.
_____ (5) All audit and review findings and any corrective actions that arise from them shall be documented. The person responsible for quality shall ensure that these actions are discharged within the agreed time scale.
_____ (6) In addition to periodic audits the laboratory shall ensure the quality of results provided to clients by implementing checks. These checks shall be reviewed and shall include, as appropriate, but not be limited to:
_____ (i) internal quality control plans, such as control charts and other available statistical techniques; NOTE: Measurement assurance techniques are acceptable means to control the measurement process and consistently produce the highest quality measurements.
_____ (ii) participation in proficiency testing or other interlaboratory comparisons [see also (b)(2)(x), (c)(2)(xiv), (g)(3)];
_____ (iii) regular use of certified reference materials and/or in-house quality control using secondary reference materials;
_____ (iv) replicate testings using the same or different methods;
_____ (v) retesting of retained items;
_____ (vi) correlation of results for different characteristics of an item.
(d) Personnel [see also (c)(2)(v)]
_____ (1) The testing laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.
_____ (2) The testing laboratory shall ensure that the training of its personnel is kept up-to-date.
_____ (3) Records on the relevant qualifications, training, skills, and experience of the technical personnel shall be maintained by the laboratory.
(e) Accommodation (facilities) and environment
_____ (1) Laboratory accommodation, calibration and test areas, energy sources, lighting, heating, and ventilation shall be such as to facilitate proper performance of calibrations or tests.
NOTE: Laboratory design will be, to the maximum extent practical, in accordance with the guidelines found in the NCSL Recommended Practice #7, Laboratory Design, July 25, 1993.
_____ (2) The environment in which these activities are undertaken shall not invalidate the results or adversely affect the required accuracy of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.
NOTE: It is expected that environments which do not meet generally accepted norms, such as those found in NCSL Recommended Practice #7, yet which exhibit the stability required to apply necessary correction factors, will be specified by the laboratory for the purpose of assessment of compliance with its own procedures to achieve its stated uncertainties.
_____ (3) The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, voltage, temperature, and sound and vibration levels, as appropriate to the calibrations or tests concerned.
_____ (4) There shall be effective separation between neighboring areas when the activities therein are incompatible.
_____ (5) Access to and use of all areas affecting the quality of these activities shall be defined and controlled.
_____ (6) Adequate measures shall be taken to ensure good housekeeping in the laboratory.
NOTE: While it is the laboratory's responsibility to comply with relevant health and safety requirements, this is outside the scope of this assessment.
(f) Equipment and reference materials
(1) The laboratory shall:
_____ (i) be furnished with all items of equipment (including hardware, software, and reference materials) required for the correct performance of calibrations and tests; _____ (ii) in those cases where the laboratory needs to use equipment outside its permanent control, including rented, leased and client-owned equipment, ensure that the relevant NVLAP requirements are met.
_____ (2) All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of the 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, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests.
_____ (3) Each item of equipment including reference materials shall, when appropriate, be labeled, marked or otherwise identified to indicate its calibration status.
_____ (4) Records shall be maintained of each item of equipment and all reference materials significant to the calibrations or tests performed. The records shall include:
_____ (i) the name of the item of equipment, software, or reference material; _____ (ii) the manufacturer's name, type identification, and serial number or other unique identification;
_____ (iii) date received and date placed in service;
NOTE: For initial NVLAP accreditation, the date received and the date placed in service are not considered mandatory requirements for inclusion in laboratory records, although this is encouraged as good laboratory practice.
_____ (iv) current location, where appropriate;
_____ (v) condition when received (e.g., new, used, reconditioned);
_____ (vi) copy of the manufacturer's instructions, where available;
_____ (vii) dates and results of calibrations and/or verifications and date of next calibration and/or verification;
_____ (viii) details of maintenance carried out to date and planned for the future;
_____ (ix) history of any damage, malfunction, modification, or repair;
_____ (x) measured value observed for each parameter found to be out of tolerance during calibration/verification.
(g) Measurement traceability and calibration
_____ (1) All measuring and testing equipment having an effect on the accuracy or validity of calibrations or tests shall be calibrated and/or verified before being put into service. The laboratory shall have an established program for the calibration and verification of its measuring and test equipment. The program will ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval or is otherwise judged to be unreliable.
_____ (2) The overall program of calibration and/or verification and validation of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available. Calibration certificates shall, wherever applicable, indicate the traceability to national standards of measurement and shall provide the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified metrological specification.
NOTE: Traceability to national standards includes traceability to standards maintained or defined at national laboratories in foreign countries where applicable. In these cases, traceability is achieved via international standards. This includes intrinsic standards of measurement where available. Where applicable, the methodology of the Guide to the Expression of Uncertainty in Measurement: 1993, shall be used as the basis for expression of uncertainty of the measurement. NIST Technical Note 1297; January 1993, Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results, is a practical application document written around the Guide to the Expression of Uncertainty in Measurement. Where detailed procedures are not used to quantify and combine uncertainties (i.e., use of test accuracy ratio concepts), the sources of uncertainty shall be tabulated and demonstrated to be acceptable for the measurement undertaken.
NOTE: A significant number of intrinsic standards, such as the Josephson Array Voltage Standard and the Iodine-Stabilized Helium-Neon Laser Length Standard, have been developed and are now being used by many national standards laboratories and some industrial laboratories. These standards are based on well-characterized laws of physics, fundamental constants of nature, or invariant properties of materials, and make ideal stable, precise, and accurate measurement standards if properly designed, characterized, operated, monitored and maintained. Where intrinsic standards are used, the laboratory should demonstrate by measurement assurance techniques, interlaboratory comparisons, or other suitable means, that its intrinsic standard measurement results are correlated with those of national or international standards.
_____ (3) Where traceability to national standards of measurement is not applicable, the laboratory shall provide satisfactory evidence of correlation of results, for example by participation in a suitable program of interlaboratory comparisons or proficiency testing [see also (b)(2)(x), (c)(2)(xiv), (c)(6)(ii)].
NOTE: Traceability requirements may also be satisfied by: (i) internationally accepted standards in the field concerned;
(ii) suitable reference materials; (iii) ratio or reciprocity measurements; or (iv) mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned.
_____ (4) Reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated.
_____ (5) Reference standards of measurement shall be calibrated by a body that can provide traceability to a national standard of measurement. There shall be a program of calibration and verification for reference standards.
_____ (6) Where relevant, reference standards and measuring and testing equipment shall be subjected to in?service checks between calibrations and verifications.
_____ (7) Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.
(h) Calibration and test methods
_____ (1) The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of items and for calibration and/or testing, where the absence of such instructions could jeopardize the calibrations or tests. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be maintained up?to?date and be readily available to the staff.
_____ (2) The laboratory shall use appropriate methods and procedures for all calibrations and tests and related activities within its responsibility (including sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement, and analysis of calibration and/or test data). They shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations or tests concerned.
NOTES: (i)Calibration procedures shall contain the required range and tolerance or uncertainty of each item or unit parameter being calibrated or verified. In addition, the procedures shall contain the generic description of the measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specifications for performing the measurement of the calibration or verification, and/or representative types (manufacturer, model, option) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations/verifications concerned.
(ii)The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement is not affected. Well-defined and documented measurement assurance techniques or uncertainty analyses may be used to verify the adequacy of a measurement process. If such techniques are not used, then the collective uncertainty of the measurement standards shall not exceed 25 percent of the acceptable tolerance (e.g., manufacturer's specification) for each characteristic of the measuring and test equipment being calibrated or verified.
_____ (3) Where methods are not specified, the laboratory shall, wherever possible, select methods that have been published in international or national standards, those published by reputable technical organizations or in relevant scientific texts or journals.
_____ (4) Where it is necessary to employ methods that have not been established as standard, these shall be subject to agreement with the client, be fully documented and validated, and be available to the client and other recipients of the relevant reports [see also (k)(2)(x)].
_____ (5) Where sampling is carried out as part of the test method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples [see also (k)(2)(ix)].
_____ (6) Calculations and data transfers shall be subject to appropriate checks.
_____ (7) Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration or test data, the laboratory shall have written procedures which ensure that:
_____ (i) the NVLAP requirements are complied with; _____ (ii) computer software, computers or automated equipment is documented and adequate for use;
_____ (iii) procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity of data entry or capture, data storage, data transmission and data processing;
_____ (iv) computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration and test data [see also (f)(1)];
_____ (v) it establishes and implements appropriate procedures for the maintenance of security of data including the prevention of unauthorized access to, and the unauthorized amendment of, computer records.
_____ (8) Documented procedures shall exist for the purchase, reception and storage of consumable materials used for the technical operations of the laboratory [see also (m)(2)].
(I) Handling of calibration and test items
_____ (1) The laboratory shall have a documented system for uniquely identifying the items to be calibrated or tested, to ensure that there can be no confusion regarding the identity of such items at any time [see also (k)(2)(v)].
_____ (2) Upon receipt, the condition of the calibration or test item, including any abnormalities or departures from standard condition as prescribed in the relevant calibration or test method, shall be recorded. Where there is any doubt as to the item's suitability for calibration or test, where the item does not conform to the description provided, or where the calibration or test required is not fully specified, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory.
_____ (3) The laboratory shall have documented procedures and appropriate facilities to avoid deterioration or damage to the calibration or test item, during storage, handling, preparation, and calibration or test; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a calibration or test item or portion of an item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned [see also (e)].
_____ (4) The laboratory shall have documented procedures for the receipt, retention or safe disposal of calibration or test items, including all provisions necessary to protect the integrity of the laboratory.
_____ (5) Tamper-resistant seals shall be affixed to operator-accessible controls or adjustments on measurement standards or measuring and test equipment which, if moved, will invalidate the calibration. The laboratory's calibration system shall provide instructions for the use of such seals and for the disposition of equipment with damaged or broken seals.
NOTE: Tamper-resistant seals are sometimes affixed to equipment to prevent unauthorized access to areas where adjustments or critical components are located.
(j) Records
_____ (1) The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. It shall retain on record all original observations, calculations and derived data, calibration records and a copy of the calibration certificate, test certificate or test report for an appropriate period. The records for each calibration and test shall contain sufficient information to permit their repetition. The records shall include the identity of personnel involved in sampling, preparation, calibration or testing [see also (c)(2)(iv)].
EXCEPTION: The retention of all original observations, calculations, and derived data in the calibration record system is not a mandatory requirement for calibration laboratories, although it is encouraged as good laboratory practice.
_____ (2) All records (including those listed in (f)(4) pertaining to calibration and test equipment), certificates and reports shall be safely stored, held secure and in confidence to the client [see also (b)(2)(ix), (c)(2)(xviii)].
NOTE: The period of retention shall be specified in the quality manual.
(k) Certificates and reports
_____ (1) The results of each calibration, test, or series of calibrations or tests carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, in accordance with any instructions in the calibration or test methods. The results should normally be reported in a calibration certificate, test report or test certificate and should include all the information necessary for the interpretation of the calibration or test results and all information required by the method used [see also (k)(4)(i)].
NOTE: It is recognized that the results of each calibration do not always result in the production of a calibration certificate or report. Whenever a certificate or report is produced, the above requirements shall be met.
(2) Each certificate or report shall include at least the following information:
_____ (i) a title, e.g., "Calibration Certificate," "Test Report" or "Test Certificate"; _____ (ii) name and address of laboratory, and location where the calibration or test was carried out if different from the address of the laboratory;
_____ (iii) unique identification of the certificate or report (such as serial number) and of each page, and the total number of pages;
_____ (iv) name and address of client, where appropriate;
_____ (v) description and unambiguous identification of the item calibrated or tested [see also (I)(1)];
_____ (vi) characterization and condition of the calibration or test item;
_____ (vii) date of receipt of calibration or test item and date(s) of performance of calibration or test, where appropriate;
EXCEPTION: Although it is encouraged as good laboratory practice, the requirement for inclusion of the date received is not mandatory for calibration laboratories.
_____ (viii) identification of the calibration or test method used, or unambiguous description of any non-standard method used;
_____ (ix) reference to sampling procedure, where relevant [see also (h)(5)];
_____ (x) any deviations from, additions to or exclusions from the calibration or test method, and any other information relevant to a specific calibration or test, such as environmental conditions [see also (c)(2)(xv), (h)(4)];
_____ (xi) measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified;
_____ (xii) a statement of the estimated uncertainty of the calibration or test result, where relevant;
_____ (xiii) a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue [see also (c)(2)(vi)];
_____ (xiv) where relevant, a statement to the effect that the results relate only to the items calibrated or tested;
_____ (xv) a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory;
_____ (xvi) a statement that the report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government;
_____ (xvii) the signature of an approved signatory for all test and calibration reports endorsed with the NVLAP logo;
_____ (xviii) special limitations of use; and
_____ (xix) traceability statement.
_____ (3) Where the certificate or report contains results of calibrations or tests performed by subcontractors, these results shall be clearly identified [see also (l)].
_____ (4) Particular care and attention shall be paid to the arrangement of the certificate or report, especially with regard to presentation of the calibration or test data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of calibration or test carried out, but the headings shall be standardized as far as possible [see also (k)(1)].
_____ (5) Material amendments to a calibration certificate, test report or test certificate after issue shall be made only in the form of a further document, or data transfer including the statement "Supplement to Calibration Certificate (or Test Report or Test Certificate), serial number ... (or as otherwise identified)," or equivalent form of wording. Such amendments shall meet all the relevant requirements of item (j).
_____ (6) The laboratory shall notify clients promptly, in writing, of any event such as the identification of defective measuring or test equipment that casts doubt on the validity of results given in any calibration certificate, test report, or test certificate or amendment to a report or certificate.
NOTE: Such notification shall quantify the magnitude of error created in the calibration results. The laboratory shall notify customers promptly, in writing, of any customer's measuring and test equipment found significantly out of tolerance during the calibration/verification process. Measurement data shall be reported so that appropriate action can be taken.
_____ (7) The laboratory shall ensure that, where clients require transmission of calibration or test results by telephone, telex, facsimile or other electronic or electromagnetic means, staff will follow documented procedures that ensure that the NVLAP requirements are met and that confidentiality is preserved.
_____ (8) Whenever a laboratory accredited by NVLAP issues a calibration or test report which contains data covered by the accreditation and also data not covered by the accreditation, it must clearly identify in its records, and in the report to the client, specifically which calibration or test method(s), or portion of a calibration or test method(s), was not covered by the accreditation. The laboratory must also inform the client, before the fact, when calibrations or tests requested are not covered by the accreditation.
NVLAP policy regarding calibration and test reports issued by an accredited laboratory, which reference the laboratory's accredited status, requires that any calibration or test report containing data from calibrations or tests which are not covered by the accreditation include:
_____ (i) a statement at the beginning of the report prominently indicating, "This report contains data which are not covered by the NVLAP accreditation"; and _____ (ii) a clear indication of which data are not covered by the accreditation (or recognition).
The laboratory must not misrepresent its accreditation or recognition. When a client requires or requests accredited services and any of the requested services are not covered by the accreditation, the client must be so advised. If a laboratory is recognized by OWM but is not accredited, it must not represent itself as accredited.
(l) Subcontracting of calibration or testing [see also (k)(3)]
_____ (1) Where a laboratory subcontracts any part of the calibration or testing, this work shall be placed with a laboratory complying with these requirements. The laboratory shall ensure and be able to demonstrate that its subcontractor is competent to perform the activities in question and complies with the same criteria of competence as the laboratory in respect of the work being subcontracted. The laboratory shall advise the client in writing of its intention to subcontract any portion of the testing to another party.
_____ (2) The laboratory shall record and retain details of its investigation of the competence and compliance of its subcontractors and maintain a register of all subcontracting.
_____ (3) A NVLAP-accredited laboratory intending to subcontract testing or calibration work that will be performed and reported as meeting NVLAP procedures and criteria must:
_____ (i) have in its quality manual a subcontracting policy compatible with the NVLAP policy, with a description of the procedures for administering and implementing those actions to demonstrate the conformance and consistency of the subcontracted laboratory to perform according to NVLAP procedures; _____ (ii) place the subcontracted work with a laboratory that maintains accreditation established by NVLAP shown by a current NVLAP Lab Code, or provide and maintain current records that demonstrate that the subcontracted laboratory is competent to perform the test(s) or calibration(s) and that it operates in a manner consistent with and in conformance to NVLAP criteria for accreditation;
_____ (iii) clearly identify in its records, and in the report to the client, exactly which data were obtained by the NVLAP-accredited laboratory and which data were obtained by the subcontractor, NVLAP-accredited or not;
_____ (iv) inform its client, before the fact, that it intends to subcontract for completion of all or a portion of the client's work; and
_____ (v) include at the beginning of the report the name, address, and contact person of the subcontracted laboratory(ies), and one of the following statements, as appropriate:
if NVLAP-accredited "This report contains data which were produced by a subcontracted laboratory ACCREDITED (NVLAP LAB CODE) for the calibration or test methods performed"
if not NVLAP-accredited
"This report contains data which were produced by a subcontracted laboratory NOT ACCREDITED for the calibration or test methods performed."
The requirements of this section do not supersede any regulation, law, contract specification, or other related conditions which require NVLAP accreditation.
(m) Outside support services and supplies
_____ (1) Where the laboratory procures outside services and supplies in support of calibrations or tests, the laboratory shall use only those outside support services and supplies that are of adequate quality to sustain confidence in the laboratory's calibrations or tests.
_____ (2) Where no independent assurance of the quality of outside support services or supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified requirements. The laboratory should, wherever possible, ensure that purchased equipment and consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with any standard specifications relevant to the calibrations or tests concerned [see also (h)(8)].
_____ (3) The laboratory shall maintain records of all suppliers from whom it obtains support services or supplies required for calibrations or tests.
(n) Complaints [see also (c)(2)(xvii)]
_____ (1) The laboratory shall have documented policy and procedures for the resolution of complaints received from clients or other parties about the laboratory's activities. A record shall be maintained of all complaints and of the actions taken by the laboratory.
_____ (2) Where a complaint, or any other circumstance, raises doubt concerning the laboratory's compliance with the laboratory's policies or procedures, or with the NVLAP requirements or otherwise concerning the quality of the laboratory's calibrations or tests, the laboratory shall ensure that those areas of activity and responsibility involved are promptly audited in accordance with item (c)(3).
(o) Measuring and test equipment (M & TE)
NOTE: This section applies to the control of measuring and test equipment (M & TE) used to assure that supplies and services comply with prescribed customer requirements. It is based in large part on the requirements found in government audit standards such as MIL-STD 45662A, and is found in Part II of the ANSI/NCSL Z540-1-1994 standard.
_____ (1) General requirements for M & TE
_____ (i) The supplier shall establish and document a system to control the calibration/verification of M & TE. _____ (ii) M & TE used to determine compliance with customer technical specifications shall be calibrated or verified in accordance with sections 285.33(b) through (n).
_____ (iii) The supplier shall have a program to recall for calibration or verification, or remove from service, M & TE that has exceeded its calibration interval, has broken calibration seals, or is suspected to be malfunctioning because of mishandling, misuse, or unusual results.
_____ (iv) All operations performed by the supplier in compliance with these requirements shall be subject to customer verification at unscheduled intervals.
_____ (v) The supplier shall carry out, or arrange to have carried out, periodic quality auditing of the calibration and verification system in order to ensure its continuing effective implementation and compliance with these requirements.
Based on the results of the audits and any other relevant factors, such as customer feedback, the supplier shall review and modify the system as necessary. Plans and procedures for the audits shall be documented. The conduct of the audit and any subsequent corrective action shall also be documented.
_____ (2) Detailed requirements for M & TE
_____ (i) Calibration system description: The supplier shall provide and maintain a written description of the calibration/verification system covering M & TE and measurement standards. The description shall be sufficient to satisfy each requirement of section 285.33(o) and any deviations shall be submitted with supporting documentation to the customer for approval. _____ (ii) Adequacy of measurement standards: Measurement standards used by the supplier for calibrating M & TE and other measurement standards shall comply with the requirements of items (f)(1), (g)(1), and (h)(2).
_____ (iii) Environmental conditions: M & TE shall be used in an environment controlled to the extent necessary to ensure valid results. Due consideration shall be given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference, and any other factors affecting the results of measurements. Where pertinent, these factors shall be monitored and recorded and, when appropriate, correcting compensations shall be applied to measurement results.
_____ (iv) Intervals of calibration and verification: M & TE requiring calibration shall be calibrated or verified at periodic intervals established and maintained to assure acceptable reliability, where reliability is defined as the probability that M & TE will remain in-tolerance throughout the interval. Intervals shall be established for all M & TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process. Check standards must closely represent the item parameters normally tested in the process and the check standard must be verified periodically. Where intervals are used to ensure reliability, the interval setting system must be systematically applied and shall have stated reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration or verification. All exemptions from periodic calibration or verification shall 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 unreasonably impair the satisfaction of the customer's requirements.
_____ (v) Calibration procedures: Procedures used to calibrate/verify the supplier's M & TE shall comply with the requirements of items (h)(1) and (h)(2).
_____ (vi) Out-of-tolerance conditions: If any M & TE is found to be significantly out of tolerance during the calibration/verification process, the supplier's system shall provide for notification to the user and to the supplier's quality element, if appropriate, of the out-of-tolerance condition with the associated measurement data so that appropriate action can be taken.
_____ (vii) Adequacy of calibration system: The supplier shall establish and maintain documented procedures to evaluate the adequacy of the calibration system and to ensure compliance with these requirements.
_____ (viii) Calibration sources: M & TE requiring calibration shall be calibrated or verified by laboratories that comply with sections 285.33(b) through (n).
_____ (ix) Records: These requirements shall be supported by records documenting that established schedules and procedures are followed to maintain the adequacy of all M & TE. The records for M & TE requiring calibration shall include an individual record of calibration or verification, or other means of control, providing a description or identification of the item, calibration interval, date calibrated, identification of the calibration source, calibration results (data and/or condition status) and calibration action taken (adjusted, repaired, new value assigned, derated, etc.).
_____ (x) Calibration status: M & TE shall be labeled to indicate calibration or verification status. The label shall identify specific date calibrated (day, month, year, Julian date, or equivalent) and the specific calibration due date or usage equivalent. Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations. When it is impractical to apply a label directly to an item, the label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status. Tamper-resistant seals are affixed to operator accessible controls or adjustments which if moved will invalidate the calibration. The quality system shall provide instructions for the disposition of equipment with broken tamper-resistant seals.
_____ (xi) Control of subcontractor calibration: The supplier is responsible for assuring that the subcontractor's calibration system conforms to section 285.33 (I) to the degree necessary to assure compliance with contractual requirements. NVLAP accreditation of the subcontractor's laboratory can serve as the basis for compliance with this requirement.
_____ (xii) Storage and handling: M & TE shall be handled, stored, and transported in a manner which shall not adversely affect the calibration or condition of the equipment.
GENERAL OPERATIONS CHECKLIST
COMMENTS AND DEFICIENCIES
Instructions to the Assessor or Internal Auditor: Use this sheet to document comments and deficiencies. For each, identify the appropriate item number from the checklist. Identify comments with a "C" and deficiencies with an "X." If additional space is needed, make copies of this page (or use additional blank sheets).
Item No. Comments and/or Deficiencies
SPECIFIC OPERATIONS CHECKLIST
COMMENTS AND DEFICIENCIES
Instructions to the Assessor or Internal Auditor: Use this sheet to document comments and deficiencies. For each, identify the appropriate item number from the checklist. Identify comments with a "C" and deficiencies with an "X." If additional space is needed, make copies of this page (or use additional blank sheets).
Item No. Comments and/or Deficiencies
Preface, Acknowlegements and History
1. Program Summary
2. Glossary
3. General Information and Operational Requirements
4. Recognition Process
5. General Technical Requirements for Calibration Labs
6. Quality Assurance Requisition for Measuring and Test Equipment
7. Specific Technical Guidelines
8. References
Appendix A
Appendix B
Appendix C Part 1
Appendix C Part 2
Appendix D
Uncertainties Chart
Last Update (12/04/02)
Your comments and suggestions are solicited: Linda.Crown@nist.gov.
