Product Risk Assessment Guidelines
1. Background facts
- What is the product: what are its intended and known uses?
- Which managers hold design data, testing records, regulatory files, instructions, warnings, operator manuals, information on customer complaints, service records, etc?
- How many items of the product are in circulation?
- What information do users have (from any source) about how to use the product safely?
- Is the product used by the general public or by professionals?
- Is a third party certifier involved in design/production?
- What similar products are available to users?
2.Assessing the risk of the hazard
- What is the hazard?
- What causes the hazard?
- Does the hazard only occur in certain situations which may be defined?
- What are its effects?
- What is its incidence? Note that in order to answer this question it is necessary to know (a) the number of occurrences of the hazard (numerator) and (b) the number of times the product is used, (denominator) which may or may not be the number in circulation.
- Are special groups affected, eg children, the infirm, people in a particular geographical location?
- Are only special groups affected?
- How serious are the consequences, eg death, personal injury?
- Are the effects reversible?
- How predictable is the hazard?
- Is the hazard avoidable? What steps are possible or feasible to avoid it occurring?
3.In case of difficulty, it may be helpful to consider the following question in addition to those listed above:
- What, if anything, is the general and approved practice in this situation?
- What is the attitude of the regulatory authorities?
- Do competitor products have the same hazard or how do they avoid it?
- Would particular measures unnecessarily alarm users or the general public and present a greater risk to public safety (eg patients being afraid to take medicines of which the overall therapeutic benefits exceeds the risk of the hazard)?
- How damaging would the disclosure of the company's existing records on the problem appear if no action is taken and subsequently they form evidence in litigation over a failure to warn?
