Difference between impact assessment and risk assessment and how to analysis?
Impact Assessment is only about, “whatever root cause is there is impacting our product quality directly or indirectly”.
Risk assessment is assessment of risk to the product quality by multiple actions, directly associated with product. FEMA, 5W1H tools are generally used for risk evaluation and mitigation accordingly.
Impact assessment is more about related to deviation happened and risk assessment is to be done when we are proposing change in system
I totally agree with Mr Negi.
Risk Analysis involves a multi faceted approach. A Permutation and combination of factors need to be taken into account for a risk analysis.
Impact analysis only concentrates on a particular factor affecting the quality of the molecule or a process or an activity.