Most Common Internal/External Audit Observations on Risk Management

[v9991]

opportunities of review occur at respective time-points
*) internal audit schedule provides an perspective/verification from inhouse-independent reviews.
**) external audits could be from consultants/certification-bodies, and of course regulatory agencies...
what are the most common internal&external audit observations on the risk management file.
a) with respect to the QRM process...(not performed at right time, not evaluated...not constitute right team...not on all products etc.,etc.,)
b) with respect to the QRM tools (inadequate assessment of failure modes - root causes etc.,)
c) with respect to the follow-through on risk management/action-plans (risk communication, linking with manufacturing controls etc.,)

[ssz102]

what do you want to say?
i don't understand

[v9991]

In Reply to Parent Post by ssz102

what do you want to say?
i don't understand

what are the most common internal&external audit observations on the risk management file.

for example...

a) with respect to the QRM process...(not performed at right time, not evaluated...not constitute right team...not on all products etc.,etc.,)
b) with respect to the QRM tools (inadequate assessment of failure modes - root causes etc.,)
c) with respect to the follow-through on risk management/action-plans (risk communication, linking with manufacturing controls etc.,)

[mrkjmg]

there can not be a common observations .... but
they study your product application first; on basis of that they will review risk policy, evaluation and risk identified.

NCs, CAPA, customer complaints, etc . . will be reviewed by them.

[Mikishots]

In Reply to Parent Post by v9991

what are the most common internal&external audit observations on the risk management file.

According to a seminar I attended with QMI-SAI Global, they are:

1. Risk management is not implemented across process, contracts, supply chain, planning, production etc.
2. There are no defined risk management tools or methodologies in place.
3. Lack of mitigation plans and review of actions.
4. Lack of risk management for critical items.

These are based on the first six months of the AS9100C audits they conducted.

Hope that helps.