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Inability of reaching the work place due to lockdown

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Guest user Created:   Jul 30, 2020 Last commented:   Jul 31, 2020

Inability of reaching the work place due to lockdown

What if, because of the lockdown, the authorized signatory and alternate authorized signatory cannot visit work place and/or reached to obtain their signature on test reports which need to be sent to customers?

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jul 31, 2020

A laboratory needs to address the risk of the event you describe. To answer your question, I would like to pose a few more questions - what does the signature of an authorised signatory on a report mean? What are they acknowledging or committing to, with their signature? Is it a solution for the laboratory to send the signatory the reports (hardcopy or electronic) for signature, away from the laboratory ?

How this situation is handled depends on a number of factors. You need to look at the consequence and implication of deviating; and see if a temporary or alternative arrangement can be made.  Firstly consider context depending on the sector. It will depend on the purpose  - the need of the customer (what the results are being used for) Consider if there are legislative requirements to be met for releasing of results? Can an interim result be released under the circumstances, if deemed suitable and this is included in a signed agreement ? Note that looking at the reporting step, the standard accommodates an agreement with the customer to report results in a simplified way. This does not however address the authorisation to release results.

Secondly consider issues in terms of accreditation, i.e. claiming technical competency for the result released on a report with the accreditation mark. One must also consider that the authorised signatory (or technical signatory) is a role with associated responsibilities required by the accreditation body for testing and calibration laboratories. The accreditation body requirements must be met. What ISO 17025 requires is that the laboratory has competent, authorised personnel, that the validity of results is ensured and that results are reviewed and authorised before released. The standard does not prescribe how the laboratory must achieve this, for example for an authorised signatory to wet sign a report. Whoever performs this role is signing that they are confident that the results are valid, that the management system is in control, with all the process, controls and checks in place. To do this they need access to all the necessary information and data for the result as a well as quality control and monitoring data for internal and external quality evaluation, in order to release results. If pandemic restrictions means that the signatory is not physically in the laboratory, they may be able to sign offsite, as long as they acknowledge the responsibility, are aware of the risks and meet the extra or temporary controls in place.  This could include having and recording discussion with personnel who performed the actual tests, prior to release.  Another control could be for the authorised signatory to perform some verification checks on return to the laboratory.

 

For further information on Ensuring the Validity of results, and reporting requirements, have a look at the ISO 17025 toolkit preview of the Quality Assurance Procedure at https://advisera.com/17025academy/documentation/quality-assurance-procedure/ and the Testing Report Procedure at https://advisera.com/17025academy/documentation/testing-report-procedure/

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Jul 30, 2020

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