Risk Assessment: Risk Identification: What might be the risk?

isk? Risk Analysis: What is the probability of the occurrence of the risk? Risk Evaluation: What might be the impact of the risk identified and analyzed? Risk Control: Whether to reduce and/ or accept the risk? Reduce the risk to an acceptable level using analysis like benefit-cost analysis.

Risk management methodology Quality risk management supports a scientific and practical approach to decision-making. It provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity and sometimes detectability of the risk. Traditionally, risks to quality have been assessed and managed in a variety of informal ways (empirical and/ or internal procedures) based on, for example, compilation of observations, trends and other information. Such approaches continue to provide useful information that might support topics such as handling of complaints, quality defects, deviations and allocation of resources. Quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a companys ability to deal with risks, and might affect the extent and level of direct regulatory oversight. In addition, quality risk management can facilitate better use of resources by all parties.

Quality the degree to which a set of inherent properties of a product, system or process fulfils requirements (see ICH Q6a definition specifically for "quality" of drug substance and drug (medicinal) products.) Quality risk management a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle Risk the combination of the probability of occurrence of harm and the severity of that harm

Failure Mode Effects Analysis Failure Mode Effects and Criticality Analysis Fault Tree Analysis Hazard Analysis and Critical Control Points (HACCP)

Hazard Operability Analysis (HAZOP) Preliminary Hazard Analysis

Potential Applications of QRM: Documentation Training and Education Quality defects Risk Communication Auditing/ Inspection Periodic Review Change Management/ Control Continual Improvement Inspection and Assessment

Microsoft Office Project Task scheduling Task execution Assigning cost and resources Monitoring cost & schedule

Quality management is concerned with controlling activities with the aim of ensuring that products and services are fit for their purpose and meet the specifications. Producing products of the required quality does not happen by accident. There has to be a production process which is properly managed. Ensuring satisfactory quality is a vital part of the production process. Risk related considerations have also become increasingly important as companies strive to enhance their brand and protect the interests of their employee, customers and shareholders. Quality management can be defined as managing the entire organization so that it performs perfectly in all the dimensions of product and services that are important to the customer. The quality of a service or product determines whether a customer will remain a customer or will move to a competitor. Quality management therefore uses quality assurance and control of processes as well as products to achieve more consistent quality. Having a good quality system

in place will ensure that your products, services are of the highest standards, your customers are happy and the future of your organization is heading in the right direction.