Risk management processes are a regulatory requirement for health care products, including pharmaceutical products. It assures product quality, reliability and safety and it results in a situation where residual risk is within manageable or acceptable limits. Although tissues for transplantation are not exactly a pharmaceutical product, risk management may be a good tool for identification and controlling of associated risks.
Validation is another fundamental element of quality management on a GMP-GTP basis. Risk assessment is the appropriate tool to support decision-making regarding the specific validations that a tissue establishment needs to perform. The risk assessment will highlight the critical points in the process allowing the development of an appropriate validation plan.
Validations in GMP focus mainly on the critical steps in the production and test phase, in the context of pharmaceuticals for example. A similar approach should be taken in planning a risk assessment in order to define a tissue establishment validation programme.
Inspectors, and other authorities, are increasingly looking to see the evidence behind certain decisions on quality and safety. Risk assessments serve as documentation of the rationale for decisions. They support making better and more informed decisions on improving organisations and processes.
Moreover, regulators and authorities are more assured of an organisation’s ability to act competently in response to potential risks when they see evidence of a robust quality risk management system.
Risk assessments highlight where action should be taken to achieve improvements and where control can be eased in the context of a risk based rationale. The degree of control should reflect the degree of risk associated with each activity. Risk assessment is a useful tool for prioritisation of corrective action plans. For example, a list of corrective actions following an internal audit can be prioritised for action by an assessment of the quality risk associated with each non-compliance.