Quality risk management definitions

ICH Guideline Q9 is the reference document on quality risk management for pharmaceutical preparations [1]. Therefore in this chapter mostly ICH Q9 definitions are used. Many of them are identical to those of the International Standards Organisation (ISO, see also Sect. 35.7.2). 

The link between the ecological/ecotoxicological risk assessment and the risk management frameworks is demonstrated. The ecological risk assessment consists of seven interactive elements (Fig. 17). The quantitative and descriptive science used to conduct ERA (Table 5) does not answer, in a direct way, the question of what should be done to manage the risk. Science determines adversity, but the public determines acceptability (Fig. 18). But acceptable risk is a highly subjective and relative term. It is time and space-specific and depends upon definitions of quality of life and robustness of the environment. 

Medication errors have been defined in many ways, depending on research methodologies, incident reporting systems, risk management, or total quality improvement systems. USP uses the broad definition of medication error from the NCC MERP ... 

In this section we propose an implementation of the most important part of the Plan phase consisting in the definition of an appropriate global management plan QSE. Our idea is to use the risk management as integrating factor and to consider the different interactions between policies, objectives and resources of the quality, security and environment standards. We first give a brief overview on related work. 

Conversely, if the supplier s Quality Management System is very well written and there is documented evidence that the supplier adheres to it, the definition of risk levels might be relaxed a bit in the Function Risk Assessment. If the supplier s own acceptance testing is well documented and thorough, the Validation Plan should document the intent to reference some of the supplier testing in lieu of internal tests. It is not necessary to specify exact tests to be used at this point that can wait until the test plans are being prepared later on. 

Council on Practice, Quality Management Committee. Identifying patients at risk ADA s definitions for nutrition screening and nutrition assessment. J Am Diet Assoc 1994 94 838-839. 

So here is an attempt at a definition. Clinical decision intelligence is the application of IT to help gather, understand, and act on all available data in clinical practice, healthcare management and administration, and medical research, and where appropriate the automatic utilization of data to control certain clinical and research processes. Its aims are to encourage best practices to improve the quality of patient care by enhancing speed and efficiency to reduce safety risks and needless costs in clinical treatment, diagnosis, management, and administration to monitor and log interactions for accountability, culpability, liability and repudiation and to facilitate biomedical research and pharmaceutical development where based on inclusion of clinical and related data. 

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