2. Carry out a risk analysis

As seen in the previous step, the risks of failure relate to the five components of activity control: materials, means, methods, environment and manpower.

The approach is similar to FMECA (see Understanding FMECA [FIC 1290] ): if we think in terms of process finality, we are interested in the deliverable (output data) provided by the process. This output is naturally intended for an organization's customer, a company supplier or another QMS process.

A process output thus becomes an input for its external (an interested party) or internal (another process) recipient within the organization.

Risk analysis methods are covered in the Define risk analysis methods sheet