The quality assurance checks the quality of the product. This is first of all an almost trivial statement. Depending on the definition of the term “product”, however, differentiate the responsibilities clearly. Do we monitor a production process or are we considering the assurance of quality in a software and electronics development? The following blog deals with quality assurance in the development of software and electronic hardware. It will be worked out where the difference lies in the quality assurance of functional safety projects and non-functional-safety projects.
The basis of all quality assurance processes also today is the ISO 9001. The key principle is that the quality assurance must be independent from the project. In small and medium sized companies the quality assurance therefore is reporting directly to the company owner or the top-level management. But even in large companies, the quality assurance is organized in parallel to the project. Therefore it is independent organized.
The quality tasks are divided into the following 4 points:
The contents of the quality planning, quality control and quality inspection are documented in a quality plan or quality manual.
Insofar there are no differences between functional safety projects and non-functional-safety projects. The differences can be seen when the content of the quality inspection is analyzed.
Traditionally, creating and performing tests and reviews are parts of the quality inspection. That quality assurance checks the technical quality of the product to be developed, and it also monitors the development processes.
When companies, which previously worked in non-functional-safety projects wants to improve the organization so that they can also fulfill the needs of functional safety projects, then they often recognize that it may be beneficial when they separate the technical quality assurance and the process quality assurance. Such situations very often lead to the decisions that the technical quality assurance is no longer part of the quality assurance department. Instead this task is either taken over by a separate test and verification department or its part of the development department.
Does this make sense? Here I can say a resounding “YES”. In a functional safety project the effort of testing and verification is significantly increased, compared to an non-functional-safety project. Newcomer in the world of functional safety may find that the testing and verification includes a complexity which is comparable to the software and hardware development itself. For this complex verification task, the quality department is normally not prepared. The many levels of testing and test methods, which have to be implemented in a functional safety project, require a detailed Know-how, which can often be provided only by specialized test engineers only.
This leaves the quality assurance, in many organizations that must meet the functional safety standards, the monitoring of development processes. However, a key point, then, is to monitor the verification processes also. In particular, in the Aviation industry this task is called the “Verification of Verification”. Although this task must be fulfilled in all industries, this term is not common outside of Aviation. However, the review and test processes must be at least spot-checked by the quality assurance department.
If projects according to criteria of functional safety are carried out, then the technical product quality assurance should be outsourced from the quality assurance department. For this very extensive activity a technical expertise is required, which does not exist traditionally in a quality assurance department.
The advantage of such an approach lies in the fact that thus the processes of product verification can be independently verified. Quality assurance can focus their expertise on monitoring and optimizing workflows.
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