Terms Relating to Measurement Act and Weighing Systems

Glossary

GLP (Good Laboratory Practice)

A system of controls related to the implementation and management of safety testing of medicines and pharmaceuticals as laid down by the FDA (U.S. Food and Drug Administration) and Japan's Ministry of Health, Labour and Welfare. Equipment must be inspected, cleaned and maintained appropriately, and testing, calibration and standardization, whichever of these is required, must be implemented appropriately for equipment used for measurement and analysis. It is also laid down that standard operating procedures (SOP) that clearly indicate implementation methods and plans, etc. must be prepared and, when these are implemented, that the date of implementation, details and person-in-charge must be recorded and the documented record archived.

GMP (Good Manufacturing Practice)

A system of controls relating to the production control and quality control of medicines and pharmaceuticals as laid down by the FDA (U.S. Food and Drug Administration) and Japan's former Ministry of Welfare (currently Ministry of Health, Labour and Welfare). To enable the permanent production of products that meet target quality, validation of all required processes must be implemented and a system of management including education and training must be set in place. Periodic inspection, calibration and maintenance of measuring instruments associated with testing and inspection and the keeping of these records are also obligatory.

HACCP (Hazard Analysis Critical Control Point)

This means, comprising HA (hazard analysis) and CCP (critical control point), is for ensuring food safety. Namely, it is a system of predicting the occurrence of all kinds of hazards (biological, scientific and physical) in processes from manufacturing of raw materials through to delivery to the consumer, and of monitoring critical control points in processes to prevent these hazards from occurring. This system comprises seven principles including hazard analysis, validation and the establishment of record keeping procedures.

ISO 9000 Series

A family of quality control and quality assurance standards established by the ISO (International Organization for Standardization).

QS-9000

A quality system standard developed by a joint effort of the "Big Three" automakers — General Motors, Chrysler and Ford — that is applied when parts and materials are supplied to these automakers and truck manufacturers. It is based on the ISO 9000 Series with additional requirements specific to the automobile industry that make screening of technical capabilities stricter.

ISO/IEC 17025

This is stipulated as the JIS Q17025 standard in Japan. It lays down general requirements for when calibrating organizations or laboratories attempt to receive certification for their capabilities to conduct specific testing or calibration. It differs with certification according to the ISO 9000 Series in that screening of technical capabilities is included in the requirements.

ISO 14001

An international standard relating to environmental management systems and environmental auditing by the ISO (International Organization for Standardization) that came into effect for the purpose of minimizing the impact on the global environment and promoting corporate voluntary involvement in environmental conservation. Shimadzu Corporation Sanjo Works acquired ISO 14001 certification in June, 1997.

JCSS (Japan Calibration Service System)

A system for screening and certifying the capabilities of businesses that calibrate weighing equipment. The National Institute of Technology and Evaluation (NITE) certifies private-sector businesses, such as Shimadzu Corporation. Certified calibration operators are entitled to supply weight standards, etc. whose traceability to national standards is assured. Calibration Certificates with the JCSS logo mark prove that traceability to national standards has been acquired.

JCSS weights

Weights supplied with the Calibration Certificates with the JCSS (Japan Calibration Service System) logo mark.Certified calibration operatorswho have been certified by the Japanese government (Ministry of Economy, Trade and Industry) are entitled to calibrate weights and issue these certificates. In other words, the JCSS logo mark indicates that traceability to national standards has been obtained.

OIML (International Organization of Legal Metrology)

An organization established in 1955 for the purpose of promoting the global harmonization of measurement laws. The new measurement law enacted in Japan in 1993 adopts the majority of recommendations of this organization.

MRA (Mutual Recognition Arrangement)

An international agreement by which two or more countries agree to recognize calibration data compliant with national measurement standards in one member country as equally compliant in another. Calibration Certificates issued by agreeing countries are mutually valid as well.

PRTR (Pollutant Release and Transfer Register)

A system for ascertaining an overall picture of chemical substances released to the environment in all processes from production through to transportation, use and final scrap, for reducing released amounts, and for obtaining fundamental data for environmental conservation.

SI Units

An international system of units used throughout the world based on the principle of one unit for representing one amount when expressing weight, length and other amounts. The basic unit of weight is "kg." There are seven basic units for length, time, current, etc. in addition to weight, and each of these is laid down as kg, m, s, A, K, mol, and cd.

SOP (Standard Operating Procedures)

Procedures standardized for implementation processes and methods for test operations, maintenance and management of instruments, etc., mainly to keep the consistency of safety test procedures on medicines and pharmaceuticals.

Standard weights

Weights used for validation or inspection of balances (specific weighing equipment) that are used for transaction and certification. Since the measurement law was revised in 1993, general businesses are no longer allowed to receive the standard equipment inspection for standard weights (in Japan). (Namely, they are unable to own these weights.) Only balance manufacturers, certifying/inspecting bodies, licensed measurers, etc. are allowed to receive the standard equipment inspection.

Difference between weights and plumbs

"Weights" are material measures for mass, and their physical and weight properties, that is, shape, dimensions, material, surface shape, nominal values, and maximum permissible error are stipulated in the OIML/R111. Generally, nominal value refers to the sequence 1 g, 2 g, 5 g, 10 g, 20 g, 50 g, and so forth. "Plumbs" are items that fall outside the scope of this definition.

Certified calibration operators

Certified calibration operators, who have been certified by the Japanese government (Minister of Economy, Trade and Industry), are entitled to supply general users with standards that have obtained traceability to national standards. As proof of this, certified calibration operators can hand over Calibration Certificates with the JCSS logo mark. Certified calibration operators conduct calibration using specific secondary standard equipment that has already been calibrated by the Japanese government or a designated calibrating organization. Shimadzu Corporation was the first company to be designated as such an operator in Japan in the weighing sector.

Periodic inspection

Inspection that is required by the GLPGMPISO 9000 and other standards and is performed periodically to see if weighing equipment in use is compliant with preset specifications.

Measurement traceability

The property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons, all having stated uncertainties. A system that clarifies the fact that the path of calibration is unbroken from measurement results through to national measurement standards.

Daily inspection

Inspection that is required by the GLPGMPISO 9000 and other standards and is performed once or twice per day before weighing equipment is used.

Uncertainty

An assessed range in which the true value for the measured value exists (JIS Z8103). A new scale that was formulated mainly by the Comité International des Poids et Mesures or International Committee of Weights and Measures (CIPM) for unifying the assessment of the reliability of measurement data to solve the lack of coherency in conventional concepts of "error" and "accuracy" in various different fields of technology and countries. The various uncertainty factors influencing measurement accuracy are evaluated and each of these individual values is combined to obtain the uncertainty. Standards such as ISO 9000 and ISO 17025 state that the assessment of uncertainty is mandatory.

Validation

Verification that structural facilities in a manufacturing plant and its operation procedures, processes and production control and quality control methods (measurement accuracy) are appropriate to maintain the quality required of products manufactured, and documentation of the validation results.

For Research Use Only. Not for use in diagnostic procedures.

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