Test equipment - traceability

Instruments must be calibrated to the appropriate site instrument calibration procedure using calibration and test equipment traceable to accepted national or international standards. Calibration procedures should be produced for each unique type of instrument. An instrument calibration procedure should ... 

Sec. 820.72 Inspection, measuring and test equipment - Use traceable calibration standards and maintain caiibration records for measuring equipment... 

All inspection, measuring, and test equipment is capable of the accuracy and precision necessary. Prior to use, all inspection, measuring, and test equipment is identified, calibrated, and adjusted as required. Calibration and adjustments are made are against standards of certified equipment, traceable to the National Institute of Standards and Technology (NIST, where no such standard exists, the basis used for calibration is documented). Inspection, measuring, and test equipment is identified with a suitable indicator or approved identification record to show the calibration status. 

As with all tests, frequent calibration of the test equipment using standard hardness blocks is a prerequisite for reliable hardness testing (see ASTM E18). Standard hardness blocks are available through commercial sources in the United States but do not have traceability to internationally accepted standards as in Europe. 

Calibration is based on the principle of traceability from a primary standard through intermediate standards to the test equipment, with estimates of the uncertainty which increases at each step in the chain. Wherever possible, bought in calibrations should be carried out by an accredited laboratory. It is perfectly acceptable for the test laboratory to do its own calibration but then they must maintain appropriate calibration standards and operate a measurement management system in accordance with IS01001213. One factor which has hindered full appreciation of the detailed needs of... 

Calibration standard Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. 

For the control/monitoring instrumentation, regulating devices, and any associated electrical equipment, predelivery testing and calibration is normally the responsibility of the instrument/equipment manufacturer and should be carried out to approved written procedures using calibration test equipment that is traceable back to agreed-upon national standards. The test equipment must have precision, accuracy, and repeatability that are higher than that of the instrument being calibrated. 

Calibration of the instrumentation will be performed over the complete instrument loop. During each loop calibration, all data must be documented on appropriate instrument and loop calibration sheets and submitted to the pharmaceutical manufacturer for review, approval, and record. Calibration test equipment must be traceable back to agreed-upon national standards and documented on each calibration result sheet. 

Calibration standards. Calibration standards used for inspection, measuring and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. 

Recalibration must be carried out to agreed upon standard procedures using calibration test equipment that is traceable back to national standards. All calibration tests must be fully documented, the results recorded, and the sheets signed off by an authorized person. Calibrated instruments must be provided with a full calibration certificate that details the test results and their limits of uncertainty. A detailed account of the calibration life-cycle processes can be found in the GAMP Good Practice Guide on Calibration ManagementP... 

The LAP equipment tester should have the equipment necessary to carry out the required challenge of the LAP systemJ This equipment should be in good working order and calibrated to a National Institute of Standards and Testing (NIST)-traceable standard at least annually, or more often as indicated by the manufacturer s specifications or equipment performance NIST-traceable calibration ensures the uniformity, accuracy, and serviceability of all test equipment as well as proper maintenance and care by the user. The NIST-traceability of equipment calibration is substantiated by a detailed calibration certification letter, issued by the calibrating authority for each piece of equipment. 

EAL-G 12 (1995) Traceability of measuring and test equipment to national standards. 

Calibration program summary. The instrument calibration program should describe calibration policy for validation of test equipment, pre- and post-calibration, and NIST traceability of calibration standards. The responsibility of calibration shall be defined. 

Critical measuring and test equipment identified as being critical parts of the quality system should be properly calibrated and maintained. Calibration should be traceable to recognized standards. This includes all in-process instruments identified as quality instruments, as well as test equipment used in the laboratory. Test equipment includes laboratory instruments such as spectrometers, viscometers and other apparatus, as well as reagents, buffer solutions and standard solutions. 

A more general approach, with somewhat more explicit requirements on supporting documentation, addresses the control, calibration, and maintenance of measuring and test equipment in support of industrial quality systems. Valuable guidance is provided by EAL-G12, Traceability of Measuring and Test Equipment to National Standards. [Note The title refers to the traceability of equipment, but the thmst of the document concerns the real issue which is the traceability of... 

EAL-G12 (1995) Traceability of measuring and test equipment to national standards. European cooperation for accreditation of laboratories, 1st edn, Nov 1995. www.european-accreditation.org/n 1/doc/EA-4-07.pdf. Accessed 4 Feb 2013... 

IV.60. Documented measures should ensure that tools, gauges, instruments, test software and other inspection, measuring and test equipment, and other devices used in determining conformity to acceptance criteria, are of the proper range, type, accuracy and precision. They should be properly handled and stored, controlled, calibrated and adjusted at specified intervals to maintain accuracy. Records of calibration should be maintained and be adequate for traceability of measurement, to national or international standards, when necessary. When deviations beyond prescribed limits are detected, an evaluation should be made of the validity of previous measurements and tests, and acceptance of tested items reassessed. 

IV.74. For the purposes of Appendix IV, the following terms, as defined in Safety Series No. 113 [IV.3], apply applicant, assessment, audit, controlled document, corrective action, design input, design output, examination, inspection. Item, maintenance/servicing, measuring and test equipment, non-conformance, objective evidence, procedure, procurement document, qualification, quality, quality elements, quality assurance programme, quality plan, repair, services, specification, supplier, traceability, user, and verification. 

Test equipment should be calibrated against traceable standards. The equipment used to conduct the tests should be uniquely identified and recorded in the test procedures to ensure that tests are repeatable and to assist with the investigation of anomalies. 

Traceability is also important to control processes. You may need to know which products have been through which processes and on what date, if a problem is found some time later. The same is true of test and measuring equipment. If on being calibrated a... 

Traceability. The manufacturer shall have reports of chemical analysis, heat treatment, and mechanical property tests for the main load carrying components of the equipment. 

Many of the technical requirements of the Standard are covered in Chapters 4 to 7. The analytical requirements, including choosing a method and method validation, are covered in Chapter 4. The other measurement requirements, such as calibration, traceability and equipment qualification, are dealt with in Chapter 5. Some of the general issues not covered elsewhere are mentioned in the following sections. It has already been mentioned that staff should be trained and proven to be competent to carry out the testing. This applies to permanent and contracted staff. The laboratory should have a job description for all members of staff. There are more stringent requirements on staff who are also able to provide customers with opinions or interpretation of the results. 

All personnel involved in GMP production of drugs have to take ownership of quality. It is a requirement that processes and equipment for drug manufacturing must be approved and operated by trained, qualified personnel. Quality-related activities have to be recorded to enable traceability of data and information. Deviations and excursions of processes and results from specified conditions or criteria have to be reported, investigated, and resolved. Drug products have to be tested and must meet specifications before being... 

The standard recognizes the factors that determine the correctness and reliability of test results human factors, accommodation and environment, methods, equipment, sampling, and the handling of test items. In this list, measurement traceability is mentioned, but in fact metrological traceability, with measurement uncertainty and method validation, are really subsumed in methods. (subsection 5.4). The effect of each of these factors on measurement uncertainty will differ considerably among kinds of tests. 

Corrosion rates are expressed in terms of inches per year of surface wastage and are used to provide a corrosion allowance in the design thickness of equipment such as vessels and pipes. Operators will often use data based on historical experience from plant operations to aid them in determining appropriate corrosion allowances. Alternatively, corrosion charts are widely available that give corrosion rates for many combinations of materials of construction and process fluids, and normally a range of values will be provided for various process temperatures. In some instances, particularly where there is a mixture of chemicals present, appropriate data may not exist and corrosion tests may be necessary in order to determine the suitability of equipment. Operators should be able to demonstrate the use of corrosion allowances in equipment specification and design. The sources of data used should be traceable. 

Testing/calibration equipment identification (e.g., traceable to national standards)... 

According to the definition [1] the traceability chain is the unbroken chain of comparisons or calibrations from the result of a measurement or the value of a measurement standard to the national or international standards, all having stated uncertainties. The uncertainty of each link in this chain (measuring analytical instrument, reference material or other measurement standard) changes over the course of time. Therefore, the calibration intervals of measuring equipment used in testing (analytical) laboratories [2, 3] and of measurement standards used for their calibration are very important. The same applies to the shelf-life of a certified reference material (CRM) as a measurement standard. So, taking into account these... 

Test laboratories should maintain traceability of their test results in order to claim competence. Traceability of the results can only be demonstrated if all quantities entered into the calculation of the end result are traceable or verified. For measurement results traceability is achieved, as required by the ISO 17025 Standard [1], by calibration of the measuring equipment. If results of model calculations are entered into the calculation of the end result they must be verified as well. Here, verification replaces traceability because results of model calculation are, according to the definition of traceability [2], not traceable. Analogously to the definition of traceability, verification is the process of relating the results of a calculation with a stated reference. Correction factors and their uncertainties, which are extracted by comparing the results of model calculations with the stated reference, take into account the difference between the results and the reference, and establish the evidence for the accuracy of the calculations. 

For measurements to be traceable to the SI, they need to be made using equipment that has been calibrated using measurement standards, that have themselves been calibrated using higher level standards that are traceable to the SI. Often such measurement standards are obtained from reference or calibration laboratories, simplifying the task of the testing laboratory. 

Traceability. One of the requirements of laboratory accreditation by the United Kingdom Accreditation Service (UKAS) is that all measurements necessary for the proper performance of a test should be traceable, where possible, to national standards of measurement. In practice this means that some laboratory equipment such as a balance, thermometer or pressure gauge, for example, must be regularly calibrated by an accredited specialist calibration company, if accurate weight, temperature or pressure measurements are necessary for the test. 

Instrumental and technical factors equipment within specification, working correctly, properly calibrated, procedures established for operational control and calibration, traceability of measurement to the criteria for test validity. 

---