Therefore decision making processes can adapt in their reliance on decision maker’s judgement and analytical reasoning method, or known as formal analysis, to meet their goals of good decision making. No doubt both can be correct as long as they are used at the right time and the right applications. To date, experts in the industry have been arguing about the chicken or the egg question that ‘is effective QRM implementation facilitating better and well versed decisions’ or ‘are logical and evidence based decisions leading to a successful QRM process’.
#What is the goal when making risk control decisions how to#
Now the challenge is how to use decision making and apply it to each step in Quality Risk Management as outlined in the guidance for industry, ICH Harmonised Guidelines Q9, which commonly acknowledged by the US FDA as well as by the EU. Every step of this systematic process in managing risks will revolve around lots of sound, credible decision makings.
Typical systematic quality risk management involves no other than assessment, control, communications and finally review of risks on the overall pharmaceutical product quality across its product life-cycle. Therefore it is important for us to have some basic intelligence on the chances of failure of the factors affecting the pharmaceutical manufacturing systems to leverage its performance from limited resources and to balance the risk on the most critical systems.
Quality Risk Management (QRM) has played a mandatory role in shaping an overall and continuing process of minimizing risks in product quality throughout its lifecycle as part of the regulatory requirements in pharmaceutical industry.