Add value to your ISO 26262 development with confirmation measures
Verification activities have long been of critical importance in safety related development activities. The confirmation measures in the ISO 26262 are used to evaluate the correctness of a workproduct towards the rules of ISO 26262. In product development lifecycle, confirmation review checks if the requirements of the standard set for a work product have been satisfied by the work product that is actually created.
For every workproduct, the ISO 26262 provides a list of requirements on what a work product should contain. (Work product: Documented evidence that the requirements of ISO 26262 have been followed during product lifecycle. Each requirement of the ISO 26262 is an activity and the workproduct should contain evidence that the activity has been performed.). Confirmation measures are effective tools to identify any gaps in development and to recover these gaps systematically.
In essence, the confirmation review checks the following: Does the work product follow rules of ISO 26262, if yes, the work product confirms to the ISO 26262. If not: Is suitable tailoring rationale is provided for the gap? If not: A gap is identified and must be addressed towards compliance.
Although the process sounds easy in theory, confirmation reviews come with a host of challenges:
- More often, the confirmation reviews are pushed to the end of the development cycle. Any gaps identified towards confirmation might lead to changes with high impact.
- Guaranteeing correct independence to perform the confirmation review. Higher ASIL development demand a higher degree of independence which might be challenging to satisfy.
- Confirmation reviews without sufficient independence and authority might budge due to management pressure or time constraints
In case the work product does not fully confirm to development requirements rules, we need to check if there is a suitable tailoring approach provided on the safety plan. Since the tailoring approach defines the activities to be followed and thereby the requirements of a particular work product, it must be checked that the work product satisfies the tailoring approach and if the tailoring approach is even correct.
Often confirmation reviews are confused with verification reviews. The verification review is where the work product is technically judged, which is different from the scope of a confirmation review. There are approaches where a verification review and a confirmation review can be combined to be effective with time but should be done with sufficient care to ensure independence. Too deep a confirmation review can become a verification review and too generic it becomes a process audit.
With a few easy steps, confirmation reviews can become a real value addition:
- As soon as the ASILs for safety goals/requirements are identified and agreed, plan confirmation reviews appropriately and ensure independence. Higher the ASIL higher the independence demand. This gives sufficient time to source review resources.
- Focus on objectives oft he confirmation review (ISO 26262 Part - 2, Appendix C)
- Plan confirmation reviews at appropriate intervals. Spacing the confirmation reviews (between work products) provides ample time to address gaps (especially well before Assessments!) if identified and does not have high impact on resources.
- In case of highly distributed developments, it is recommended to perform the confirmation reviews of appropriate work products prior to the start of sourcing procedures.
- Keeping a record of the resolution of gaps identified in confirmation reviews will help assessments and audits.
- If possible and as long as independence criteria is met, combining confirmation reviews and verification reviews could potentially save time and resources.
- In case of major process improvements, keep traceability towards lessons learned documents and follow up. This can be evidence of maturity and adds to the safety culture.
- ISO 26262 places strong emphasis on quality management and if required, confirmation reviews can check the compliance of the work products to the 'Supporting Processes' of Part - 8.
- In cases of 'Development Interface Agreements' with restrictions on critical document sharing, suppliers performing CRs at correct level of independence can ensure IP protection and provides assurance to customers.
- A well executed confirmation review gives confidence to supplier and customer that appropriate process is followed and confirmed independently.
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