Design History File (DHF)
Ability to apply Design History File (DHF) practices and professional judgment to deliver reliable outcomes in quality & regulatory contexts.
What each level means
The P1–P5 scale is shared across every skill, but what each level means changes with the skill. This is what it looks like in practice.
P1
Describes the process, controls, stakeholders and basic decisions involved in Design History File (DHF).
P2
Executes standard Design History File (DHF) activities accurately within established controls and escalates exceptions.
P3
Owns complex Design History File (DHF) cases/processes, improves controls and coaches colleagues.
P4
Sets cross-team standards and governance for Design History File (DHF), integrating risk, metrics and stakeholder needs.
P5
Defines enterprise strategy or external practice for Design History File (DHF) and develops other experts.
Source: PROCOMER FTZ employer benchmark