To identify risks first potential hazards should be identified. Think freely and think of worst case scenerario’s: what might go wrong?
List all potential hazards that might possibly arise in e.g. your distribution process, and do not stop and think of measures already taken.
Input for your list could be generated from your quality system, for example:
a) Non conformities that were registered and categorized in the last 1 or 2 years;
b) Customer/user comments/feedback registered and categorized in the last 1 or 2 years;
c) Incidents of near incidents that have been identified;
d) Serious adverse reactions or events that occurred in the last 1 or 2 years;
e) Outcome of internal / external audits or inspections;
f) Other quality registrations;
g) Experience and ‘gut feeling’ of employees in the process;
h) Other sources from your organisation.