2 Management of Functional Safety

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This part of the ISO generally covers three topics as shown in the V-Cycle:


2.V-Cycle-Management of Functional Safety.png


The objective of ISO26262: Management of Functional Safety as stated in the norm:

"The objective of this clause is to define the requirements for the organizations that are responsible for the safety lifecycle, or that perform safety activities in the safety lifecycle." (ISO26262-2 part 5.1)


QM basis

This means that your organization has to meet certain requirements in order to be able to produce a safety-relevant product. This will be the first step to gain compliance to the ISO26262. Before starting to implement ISO26262 into your organization it is highly recommended to have your Quality Management properly in place. Please refer to the ISO/TS 16949 for QM related norms. ISO26262 will easily build on top of an ISO/TS16949 basis. Having implemented ISO/TS16949 is even highly recommended before starting to implement ISO26262 but is, however, not a hard prerequisite.


Automotive SPICE

Also Automotive SPICE would provide very good step towards ISO26262 compliancy as it shares a lot of requirements. From SPICE level 2 or 3 the transition to ISO26262 will not have a big impact anymore. The only disadvantage is that Automotive SPICE only covers the software domain, so it can only contribute to the following phases: - Product development: System level - Product development: Software level - Supporting Processes

Management of Functional Safety

Bear in mind that it is also possible to delegate the management of functional safety to an external party. If you are a supplier, you can let your customer take care of the management of functional safety regarding your item.

It is always a good practice to have your safety case reviewed by an external party so that the review report can be handed over to the customer. The advantage is that not all documents in the safety case (like FMEA or test procedures) have to be handed over to the customer. This contributes to IP protection.

A DIA (Development Interface Agreement) can clearly define the boundaries in responsibility of the Item's development. It is highly recommended to always use a DIA for all documents which are part of the safety case. The RASIC* chart can help you setting up a DIA.

  • RASIC: Responsible, Accountable, Supportive, Informed, Consulted

Hint: Take a look at the templates as they always contain a RASIC chart.


IMPORTANT:

- All documents shall be signed and reviewed. - At LEAST three authorized persons should sign important documents like the HARA.


2-5 Overall Safety Management

The objective of this clause is to define the requirements for the organizations that are responsible for the safety lifecycle. This also counts for the organizations that perform any safety activities in the safety lifecycle.

Planning, documenting and coordinating the safety activities of all phases of the safety lifecycle are typical management tasks which have to conform to the requirements put in this clause.


2-6 Safety management during the concept phase and the product development

This clause mainly has two objectives. The first objective is to define the safety management roles and responsibilities, regarding the concept phase and the development phases in the safety lifecycle. The second objective is to define the requirements for the safety management during the concept phase and the development phases, including: - planning and coordination of the safety activities - progression of the safety lifecycle, - the creation of the safety case - execution of the confirmation measures.


2-7 Safety management after the item's release for production

The objective of this clause is to define the responsibilities of the organizations and persons related to the functional safety after the item's release for production. This concerns the general activities for ensuring the required functional safety of the item during the lifecycle subphases after the release for production.


Next Chapter (2-5)