Challenges, dilemmas, and quality criteria for safety reviews

Five generic dilemmas shared by most safety reviews are identified, namely the complexity dilemma, the specialisation dilemma, the criteria dilemma, the independence dilemma and the ethical dilemma. These dilemmas are not always made sufficiently transparent, which may lead to a too optimistic view of what can be achieved by safety reviews. A two-dimensional characterisation of safety reviews is suggested; the dimensions are the degree of independence and the scope of the review. In conclusion ten quality criteria are proposed that can be used to cope with the dilemmas of conducting safety reviews. (practical matter article)