Development of a validation scheme for metals and metalloids

Status:

ongoing 05/2021

Aims:

Measuring procedures for determining the concentration of hazardous metal/metalloid substances in the air of working areas must satisfy requirements set out in DIN EN 482:2020 and DIN EN ISO 21832. These requirements must be supported by a schema for validating procedures for measuring hazardous substances. Further requirements set out in the TRGS technical rules for hazardous substances (including TRGS 402, TRGS 900, TRGS 910) applicable in Germany must also be taken into account and implemented. In consideration of these requirements, a validation schema is to be developed which

• provides the user with information on the form and scope of sampling tests based on the assessment benchmark for the hazardous substance under consideration and
• specifies the boundary conditions and interpretation of the tests to be performed.

The validation schema must state the required documentation both of the preliminary considerations for selection of the sampling tests, and of their results. The processes for interpreting the measured values must be comparable. This is to be ensured by a harmonized process employing a calculation file set up for the validation schema.

The validation schema must be comprehensible to all users to permit a harmonized, transparent procedure. It must be available in its latest version to all users at all times. It is therefore uploaded to the Q.Wiki quality management platform, together with an Microsoft Excel calculation program (process data sheet).

Activities/Methods:

All units whose tasks include the analysis of metallic hazardous substances in particulate form were to be involved by project management in design of the validation schema. DIN EN 482:2021, DIN EN ISO 21832 and DIN 32645 were to serve as reference standards. Consideration was to be given to the facilities available at the IFA for the practical performance of sampling tests. The validation schema was to be uploaded to the Q.Wiki QM platform.

During this process, a user-friendly Excel calculation program (process data sheet) for interpretation of all sampling tests and other relevant process data was to be developed in order for the particular requirements for the validation of metals/metalloids to be met.

The Excel calculation program was also to be made available through Q.Wiki.

Users were to receive training in use of the validation schema and the Excel calculation program.

Results:

The validation schema for metals was released for users on the Q.Wiki QM platform. The process data sheet in the form of an Excel calculation program was adapted to the requirements for validation in the area of metals analysis, and likewise released on Q.Wiki. The users were provided with training in use of the validation schema and the procedure data sheet, and are informed by e-mail of new developments as required. A checklist was developed for formal assessment of the performance of each new measuring procedure developed. This checklist was coordinated with other organizations publishing procedures for workplace measurements (DFG; AG-Analytik at the BG RCI). The checklist is also intended for release on Q.Wiki and will be uploaded there for validated measuring procedures. In the future, the process data sheet will be presented to the Leuna laboratory in the BG RCI and made available as required.

Last Update: