Role and Competency Navigator
An organisation chart says what people do. It does not say what they answer for, which decision is theirs alone, what pressure reliably arrives, or what the role is mistaken for by everyone around it. Those four are the job.
Accountability is stated before activity throughout, because the gap between them is where roles are misread — the releasing person does not manufacture or test anything, and is the only point at which the whole chain is judged at once. Adjacency is shown in both directions and is deliberately not symmetric: who a role draws on is a different list from who draws on it, and seeing only the first leaves you unaware of who depends on you. Where the model is thin it says so — 5 of the 12 roles carry a neighbourhood written for them, and the other 7 show a generic pattern that is labelled as generic every time it appears. Titles, reporting lines and competency spans vary widely between organisations; nothing here is a job description or a grading structure. For the roles a specific kind of company actually needs first, see the startup operating blueprint.
Named releasing person
The person who decides that a batch may be used, on evidence they did not generate and cannot fully re-perform.
The disposition decision on each batch, personally and non-delegably. Not the manufacture, not the testing — the decision.
Release, reject, quarantine, or release with conditions. Also the decision to stop.
Disposition records, release conditions, rejection rationales.
Schedule pressure at the end of a quarter, on a batch with an open investigation and a clinical site waiting.
A rubber stamp at the end of the process, rather than the only point where the whole chain is judged at once.
Several years in quality operations, with deviation and investigation experience.
Formally designated, qualified against defined criteria, and named in the quality system.
Head of quality
Competency, over time
The same four stages apply to every role in the model. The spans are typical, not required — a person can sit at one stage for a decade and be excellent there.
Executes under supervision against a written method. Competence is demonstrated per task, and the honest measure is whether they know when to ask.
Performs the role unsupervised, recognises the abnormal, and can explain a record to someone who was not there.
Handles the cases the procedure does not cover, and can defend a decision made where the evidence was incomplete.
Decides what good looks like for others, and is answerable for the consequences of that definition.
Draws on
What this role needs from others to do its own job.
- Deep familiarity with what makes evidence sufficient
- Understanding of how deviations actually arise
Drawn on by
Who depends on this role — a different list, because the debts are not symmetric.
- The judgement about evidence sufficiency
- The reasoning behind impact decisions
- Understanding of what evidence supports a claim
- Understanding of the release tension
- Product 04Requirement-to-Evidence Trace: the release decision terminates the trace
- Product 09Inspection Readiness Simulator: the release question is the integrating one
- Decision CaseWFI release under schedule pressure
A synthetic role model for orientation. Titles, reporting lines and competency spans vary widely between organisations; nothing here is a job description, a grading structure or a qualification standard.