An assessment (either Quality or Functional Safety) should give confidence in the product to industrial End Users, and Automotive OEM and Tier-1.
exida puts at the disposal of its customers its own experience, to successfully support every single assessment. Support on behalf of exida is not limited to the pre-assessment phase. exida will accompany the customer during the formal assessment phase upon request, backing his decisions and offering the pertinent explanations. The assessment shows the compliance of the product with the product requirements and standards, and of the conformity of the process with the standards requirements. The assessment results are contained in the Assessment Report (public in case of Certification) and in the Assessment Recommendations Report (confidential).
An Assessment Report usually contains the following main elements:
Technical description of the system.
List of technical safety properties.
Description of the compliance with the technical objectives of the standard.
Description of the compliance with the process objectives of the standard.
Explicit list of the deviations, if any.
An Assessment Recommendations Report contains all the actions suggested for improvement; these actions are submitted for consideration and are not compulsory, because a recommendation always makes reference to acceptable deficiencies so, by definition, it is not a reason strong enough to fail at an assessment. Nevertheless, it is a good practice to implement all the identified improvements considering the suggested actions.
An assessment is a serious activity and must be done on a project level considering the technical and process requirements.
Automotive assessments are typically performed in Europe by the OEM, and the reason for this is that OEM has legal responsibility. An OEM assessment maybe supported by a third-party assessor, but third-party certification will not exempt from legal responsibility. The homologation body must perform the assessment against the ECE directives that are far less stringent in comparison with ISO 26262 requirements.
For planning an assessment, it is important to consider these outcomes:
Be prepared for the arrival of multiple assessors (SPICE assessor for the processes, recently supported by Functional Safety experts; technical safety assessor from the OEM for the project; homologation body assessor).
Allocate functional safety engineers (PE) in each section who will be in charge of explaining the functional safety concepts to the assessors.
Compile the project evidence documentation in advance.
Perform internal assessment audits to train and prepare all the people involved.
We provide consulting, assessment, cybersecurity, alarm management, product testing and certification under a number of Functional Safety, Security and SW Quality standards, such as IEC 61508, IEC 61511, ISO 26262, ISO 13849, IEC 62061, ISA Security Compliance Institute (ISCI), ASPICE