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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 13 important activities to improve product quality rather than on low-risk activities that have little to no impact. There are four basic elements that should be included in a quality risk management plan. The first element is to perform an analysis of the identified risk associ- ated with the operations. For example, if your product is being produced using an older manufacturing line, there is a risk that the line will experience frequent breakdowns. The second step is to evaluate the risk in terms of its impact on your ability to supply a quality product. In this case, frequent shut downs can lead to product rejections, yield loss, and potential drug short- ages. Once the risk has been identified and the impact evaluated, controls to mitigate the potential situation need to be identified and implemented. Some of the possible mitigation control strategies might include en- suring there are appropriate change parts for the line in inventory or plans to qualify the product production on a new more modern manufacturing line. The last key element needed is data input and man- agement. The data evaluated should be able to indicate if and when you need to employ one of your control strategies. In this simple scenario, an increase in down time on the line or a steady decrease in yield could be indicators that the manufacturing line is headed for a catastrophic failure and steps need to be taken to pre- vent a drug shortage situation. The above discussion is only an example of a risk assessment in one area of an operation. Other areas of the process need to be evaluated for potential vul- nerabilities and risk. These areas include an evalua- tion of the reliability of raw material suppliers, stability and compliance of contractual suppliers (e.g., contract manufacturing organizations, contract test organiza- tions), age and reliability of laboratory test equipment, etc. In other words, a solid, well-written and dynamic quality risk management plan will evaluate the overall organization, identify high-risk vulnerabilities, identify strategies for mitigation of the high-risk vulnerabilities, and rely on data to perform continuous monitoring of the vulnerabilities. And, the plan will provide the ap- propriate documentation and rationale for the decisions. Implementing a quality risk management plan in an organization can also be challenging. It needs to be introduced and discussed with all applicable function personnel involved in the operations including, but not limited to, finance, manufacturing, regulatory affairs, purchasing, auditing, and senior management. The plan should be dynamic and should be modified as situations change. Let's say you produce a product and you have a single-source supplier for one of your excipients. You have audited the supplier and have identified some sig- nificant gaps in their quality system. You identify this vulnerability in your quality risk management plan and indicate it is a high-risk item because of the lack of com- pliance of the excipient vendor. One of your mitigation strategies might be to qualify an alternate supplier for the excipient. Once you have qualified that alternate supplier, you need to update your plan to downgrade the risk because you have taken the appropriate steps to mitigate it and eliminate the identified vulnerability. Quality risk management plans are important be- cause they help improve a company's ability to provide quality product to patients. They are contingency plans with identified actions that help to ensure a continuous supply of product to the market that meets the expec- tations of being safe, effective, and available. They are dynamic documents that require integration into and data inputs from all departments in order to be success- fully implemented at a company. Reference 1. ICH, Q9 Quality Risk Management (ICH, November 9, 2005). PT