Quality risk management examples

Quality risk management (QRM) is illustrated by practical examples about logistics, equipment, pharmaceutical care on the wards and clinical pharmacy. 

Risk acceptance can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified. For some types of harms, even the best risk control might not entirely eliminate risk. In these circumstances it might be agreed that an appropriate quality risk management strategy has been applied and that quality risk is reduced to a specified (acceptable) level. This (specified) acceptable level will depend on many parameters and should be decided on a case-by-case basis. For in every case specific measures are created for diminishing the risks, for instance in-process controls may contribute significantly to decrease the risks of extemporaneous preparation, see Sect. 34.6. Examples of parameters... 

ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality, most of them directed to complex manufacturing situations. Very useful Briefing Packs [2] offer an explanation as to how to use the QRM tools as well as training. 

Environmental quality standards for chemical substances in groundwater and soil are important for many soil quality decisions. Examples include emission reduction measures during the marketing authorization of chemicals, soil and land use decision making and risk management, as well as soil remediation. 

Some risk management professionals have multiple resumes, with each version emphasizing particular qualities. For example, one version may stress say design experience, whereas another may place a greater emphasis on field operational work. 

In Sect. 2.4.1 the CE system in the food industry with its different aspects and elements is discussed. Some examples of innovation activities are presented in terms of the framework presented in Sect. 2.3. In Sect. 2.4.2 essential properties are discussed of the food production system that is the result of or needs to be taken into account in a CE system in the food industry. Many food products are developed with a specific quality claim. To market and produce such products and to maintain the required quality level, safeguards are needed in terms of risk management through contracts. Two extremes of such contracts will be briefly discussed. 

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