Safety certification is an important milestone for any manufacturer that hopes to release a product to the marketplace. Failure on the part of manufacturers or certifiers to ensure product safety can result in loss of life and loss of revenues (through legal actions and through loss of customer confidence). Think about the billions of dollars that the auto industry alone has spent on product safety recalls.
A critical aspect of product development is to demonstrate that a given product, solution or service is safe to use before it gets released. Below are key steps to consider when developing a plan to enhance product safety:
- Evaluation through independent assessment is one of the central requirements of sound functional safety practice.
- Evidence needs to be presented to the independent assessor during the course of a product’s development in order to assure the assessor that the product or system being developed will be acceptably safe.
- The building of this “safety case” is progressive as the product development moves through different project phases, by providing proof at each stage that safety risks are reduced to an acceptable level.
- The safety case should focus not only on the technology aspects of the product in question, but also on processes, methods and compliance practices surrounding the offering.
The benefits to embracing the safety case approach include the following:
- Argumentation and documentation is organized and structured; information can be accessed quickly and easily by the stakeholder. Such a structure also facilitates review and challenge from others.
- Focus is broadened beyond just the technology by introducing an analysis of process, methods, and compliance.
- A well-documented safety case can serve as a springboard for launching other safety cases by leveraging a line of argumentation that has been successful in garnering approvals and release of products.
- A safety cases facilitates future product modifications. Once a product hits the market, new features, will often be added. The record provided by the initial safety case report can act as a reference that helps to catalog these new changes and modifications from a safety perspective.