3.2 The Integral Concept of Traceability
103
The most immediate meaning of traceability is related to tracing or
tracking, and is included in its definition in the ISO Vocabulary for Quality
Management and Quality Assurance (see Box 3.2). This meaning is also
consistent with the definitions given in renown linguistic works such as the
Oxford English Dictionary and Webster's Third New International Dictionary,
which contain entries not only for the noun traceability ("the quality of
being traceable"), but also for the adjective traceable ("capable of being
traced" or "suitable or of a kind to be attributed") and for the verb to trace ("to
follow or study out in detail step by step" or "to follow the course, development
or history of").
__ Box 3.2
The Quality Management and Quality Assurance Vocabulary (ISO 8402), issued by the International Standards Organization (ISO) in 1994, defines traceability in generic terms as "the
ability to trace (know) the history, application or location of an entity (a product, process,
service, organization) by means of recorded identifications." In the Vocabulary, this definition
is completed by the following two technical explanatory notes:
(1) The word "traceability· has three major meanings, namely:
• Tracea bility of a product is related or can be referred to the origin of the starting
materials and pieces, the history of its production, and its distribution and location
after it has been delivered or distributed.
• Traceability of calibration applies to the relationship of measuring equipment to
national or international standards, to primary standards, to fundamental constants or
physical properties, or to reference materials.
• Traceability of data acquisition is related to the data produced and computations
made around the "quality loop' ; frequently in compliance with the "quality requirements· of a specific institution.
(2) Every aspect of the applicable traceability requirements (e. g. time intervals, source or
identification point) should be clearly specified.
Traceability should thus be approached in a global manner in the technical field; using it for
the sole purpose of characterizing individual aspects (e.g. a result in Analytical Chemistry) is
definitely a poor strategy.
In the analytical chemical field, traceability is realized as the history of the
production of a result or of the performance of a system (a laboratory, instrument, apparatus, reference material, etc.), which should be clearly, comprehensively documented by qualified personnel under internal supervision or
the external control of national or international organizations.
In the metrological field, references are no doubt the landmarks of the
"history" inherent in the etymological definition of traceability. Such a definition is thus closely related to the standards used in the comparisons involved in
chemical, physical, biochemical and biological measurements. Figure 3.1 illustrates the traceability concept as a combination of the etymological standardbased approaches.
103
The most immediate meaning of traceability is related to tracing or
tracking, and is included in its definition in the ISO Vocabulary for Quality
Management and Quality Assurance (see Box 3.2). This meaning is also
consistent with the definitions given in renown linguistic works such as the
Oxford English Dictionary and Webster's Third New International Dictionary,
which contain entries not only for the noun traceability ("the quality of
being traceable"), but also for the adjective traceable ("capable of being
traced" or "suitable or of a kind to be attributed") and for the verb to trace ("to
follow or study out in detail step by step" or "to follow the course, development
or history of").
__ Box 3.2
The Quality Management and Quality Assurance Vocabulary (ISO 8402), issued by the International Standards Organization (ISO) in 1994, defines traceability in generic terms as "the
ability to trace (know) the history, application or location of an entity (a product, process,
service, organization) by means of recorded identifications." In the Vocabulary, this definition
is completed by the following two technical explanatory notes:
(1) The word "traceability· has three major meanings, namely:
• Tracea bility of a product is related or can be referred to the origin of the starting
materials and pieces, the history of its production, and its distribution and location
after it has been delivered or distributed.
• Traceability of calibration applies to the relationship of measuring equipment to
national or international standards, to primary standards, to fundamental constants or
physical properties, or to reference materials.
• Traceability of data acquisition is related to the data produced and computations
made around the "quality loop' ; frequently in compliance with the "quality requirements· of a specific institution.
(2) Every aspect of the applicable traceability requirements (e. g. time intervals, source or
identification point) should be clearly specified.
Traceability should thus be approached in a global manner in the technical field; using it for
the sole purpose of characterizing individual aspects (e.g. a result in Analytical Chemistry) is
definitely a poor strategy.
In the analytical chemical field, traceability is realized as the history of the
production of a result or of the performance of a system (a laboratory, instrument, apparatus, reference material, etc.), which should be clearly, comprehensively documented by qualified personnel under internal supervision or
the external control of national or international organizations.
In the metrological field, references are no doubt the landmarks of the
"history" inherent in the etymological definition of traceability. Such a definition is thus closely related to the standards used in the comparisons involved in
chemical, physical, biochemical and biological measurements. Figure 3.1 illustrates the traceability concept as a combination of the etymological standardbased approaches.