Implementation guidelines risk management

ISO 2005. Risk Management General Guidelines for Principles and Implementation of Risk management. N 5. Preliminary version. 2005. 

On risk reduction, the RC-GC commits signatories to utilise clean and safe technology, establish partnership across the value chain, minimise waste, and assess product stewardship practices, whilst GPS recommends measures to complete risk characterisations and risk management recommendations for chemicals in commerce, establish global product stewardship guidelines and develop a management system approach for implementation. 

AIChE created the Center for Chemical Process Safety (CCPS) in 1985 after the chemical disasters in Mexico City, Mexico, and Bhopal, India. The CCPS is chartered to develop and disseminate technical information for use in the prevention of major chemical accidents. The center is supported by more than 100 chemical process industry sponsors that provide the necessary funding and professional guidance to its technical committees. The major product of CCPS activities has been a series of guidelines to assist those implementing various elements of a process safety and risk management system. This book is part of that series. 

The WHO Guidelines (2004) devote an entire chapter to the topic of drinking water safety planning. It is recommended that a risk assessment and risk management approach should be implemented in the design and operation of water supply systems, additional to the verification of water safety by sampling. The risk assessment and risk management approach should extend from source to tap , that is, the entire water supply chain. This is considered further in Chapter 6 in the context of risk assessment in plumbosolvency control. 

ISO 31000. 2009. Risk management. Principles and guidelines on implementation . Geneva International Organization for Standardization. 

Medicinal products must be fit for their intended use, comply with the requirements of Market Authorization and not place patients at risk because of inadequate safety, quality or efficacy. These objectives are easy to state, but to achieve them requires a comprehensively designed and correctly implemented system of quality assurance. It is important that this is documented and its effectiveness monitored. Records must be kept that are open to inspection by validating bodies, and there must also be procedures for selfinspection and quality audit that allow appraisal of the quality assurance system. Management must be adequately trained and their responsibilities minutely defined. Two key posts are the Heads of Production and of Quality Control. These posts are required by the guidelines to be independent of one another. 

Other, more specific studies reach a similar conclusion. For example Pegna and Terracina (2004) point out the absence, until quite recently, of any practical guidelines or criteria on managing chemical risks in relation to cxunpliance with the Italian laws to implement EU Directives on chemical agents. 

QRM finds its way into medicines regulations as it is seen as a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. A structured and documented management of risks is a requirement in EU GMP as well as in the European Pharmacopoeia (Ph. Eur.). A guideline with a description of QRM elements together with appropriate tools is to be found in ICH Q9, mainly directed at manufacturing. Finally implementation of QRM in the Pharmaceutical Quality System is briefly elaborated. 

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