A product risk analysis has a direc

A product risk analysis has a direct relation to those product functions with effect on patient
safety. The process risk analysis highlights the risks having an influence on the realisation of
product functions. A process risk analysis shall be based on the results of a product risk
analysis.
If risks concerning product safety are discovered within a process risk analysis, the results
derived from this risk analysis have to be transferred to the respective product risk analysis
including a re-evaluation. For establishing risk analyses, please see the manuals for SCIO
FMEA (BPP HC-DIV 749) and SCIO Methods (BPP HC-DIV 001656)
The results of risk analysis are transferred into appropriate specifications and performance
specifications. For active medical devices, the list of parts subject to particular quality
requirements is compiled on this basis.
4.6.1 Product risk analysis
Product risk analysis considers the functional relationships of a system down to the
characteristics of the components and their realisation in production. The goal of product risk
analyses is to demonstrate product safety of the product related to the application according
to its Intended Use. The starting point for a product risk analysis is a requirement profile or
an application workflow, based on the Intended Use of the product. Furthermore, ISO 14971
may support to identify the characteristics of a Medical Device and the hazards related to its
use.
4.6.2 Process risk analysis
Process risk analysis is used to analyse the flow of a process to produce a system in detail
and to define user requirements for processes and machines / production equipment. The
goal of process risk analyses is to ensure that products (finished goods or components) are
produced free of defective characteristics and process efficiency is not negatively affected.
The starting point for a process risk analysis is a process flow chart. An example is
demonstrated in SOP HC-DDDD-G-4-1-05-140-01 “Example for Process Flow chart as basis
for process risk analysis”.