What documents need to be written?

The DCB 0129/0160 standards require the manufacturer/healthcare organisation to produce three project-specific documents. These are often known as the ‘deliverables’. These are as follows:

1. Clinical Risk Management Plan – A document which sets out at the start of a project what you are going to do to assure the product. It makes sure that the project is organised, agrees up front the intentions and level of rigour and allows you to know when you have completed the exercise.

2. Hazard Log – A structured list of potential scenarios which could result in harm to an individual. For each hazard, the impacts, causes and controls will be documented, and the level of clinical risk for the hazard evaluated. The hazard log forms the data on which the rest of the assessment is based.

3. Clinical Safety Case Report – A document which presents the claims, argument and evidence to demonstrate that a product is acceptably safe. The Safety Case typically contains narrative and explanation and refers out to other project materials to build the justification for the conclusions drawn.

Note that the standard also requires the a Clinical Risk Management Process is constructed. This is a wider document which describes corporately how the organisation manages clinical risk and meets the requirements of the applicable Standard.

Category: The Clinical Risk Assessment