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Product Risks

Process Development

Product Risk Management Process

The process includes the analysis, compilation and maintenance of a product risk analysis according to ISO14971:

  • for a product with it's intended use

  • containing the analysis of risks (pre- and post mitigation),

  • utilizing different analysis views (e.g. customer interaction/ workflow, instrument process, hardware, software, disposables, reagents, manufacturing, environmental),

  • providing risk estimates according to defined criteria for e.g. severity, occurrence and detectability

  • and introducing mitigation measures, which may be defined as safety requirements.

A risk management plan defines the execution for a specific project, with:

- team organization
- intended use (platform & assays)
- interfaces to vendor risk management
- structure and content of the risk management file with plan and report break down
- methodology, format and forms for the risk analysis table (template)

The risk management process should integrate the management of software risks as needed (IEC 62304).

Event driven risk analysis for individual (design) changes is recommened from the end of the realization phase on. The assessment links and tracks into change control processes for requirements, V&V documents, version control of components and respective revalidation effort, and confirms successful mitigation of change w/o altering the product performance.

The risk management file follows a project specific hierarchical document organization, according to the refinement of the product into components, vendor ownerships and related processes (e.g. manufacturing, logistic). This structure also is applied for plans and reports (see below).

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