3. ISO 14971 and ICHQ9 comparison
As you can see there is no much difference between ICH
Q9/Q10 and ISO 14971 other then the arrangement. Since
ISO 14971 is optional in US and is mandatory across the
world and due to subtle changes (as per me) in the
documents FDA considers ISO 14971 as a good compliance
with its Risk Management regulations.
Also another thing to note here is since ISO 13485 refers to
ISO 14971 in section 7.1 it is generally considered that
being ISO 13485 certified is adequate, but increasing
number of Medical device and Pharmaceutical companies
are seeing this opportunity as a marketing strategy to
improve the growth and market share.
5. Helpful Risk management tools during
lifecycle of the product line
As you can see form the previous slide there is no single tool which
can help efficacy of the Quality Risk Management system instead
several tools like Quality function deployment (QFD), Preliminary
Hazard analysis during Design input which looks at previous product
risks along with Design FMEA and Process FMEA and Fault Tree
Analysis have to be used for a robust Risk Management System. Also
during post production phase any CAPA implementation has to be
associated with a strong rationale of its impact on the already
validated QRM.
Also Post market surveillance, Customer feedback all have to act as
a continuous feedback to the living Document of QRM of any
product lifecycle.
