I have a question about the use of critical components and their use in determining the criticality of a system.
I was under the impression that when performing the CCA (Component Criticality Assessment), if a component was deemed critical then the system impact was “Direct Impact”. I am working with a company that has an SOP stating that an indirect impact system could also contain critical components. Is this the correct interpretation of the FDA regulations?[/color]
[COLOR=#000000]Also do you know how widespread the use of systems, SIA, and CCA is with pharma and medical device organizations? 50%?
All responses welcome.[/color]
In theory there is no critical component in an indirect system. However, there must be a control mechanism within a direct impact system that will detect the impact of a malfunctioning indirect impact system on the final product. If there is no such system, the critical control point (CCP) must either be created in the direct impact system, or the critical control point resides in the indirect impact system. You could consider that the component responsible for the CCP is a critical component. Formally you must not consider a system an indirect impact system if there is no appropriate impact control in the direct impact system. In that case, the indirect impact system must be treated as direct impact system.
CCA is not very common in the medical device industry.
Thank you jkuil for this answer, it helps alot.