[ LOCATE · 2 OF 5 ]

CAPA and Quality Systems Manager

Runs the system that turns problems into changes. The measure of the role is not how many actions close on time — it is whether the same problem comes back.

8 FACETS · THREE ALTITUDES · FREE, NO ACCOUNT REQUIRED

What a role map is not

A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.

READ IT AT YOUR ALTITUDE

You make sure that when something goes wrong, the organisation finds the real cause, fixes it, and can show later that the fix worked.

YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM

COMES AFTER — UPSTREAM
Deviations, complaints, audit findings and adverse trends
YOU ARE HERECAPA and Quality Systems Manager
COMES BEFORE — DOWNSTREAM
Management review
Change control implementing the corrective action
WHERE YOU ARE

At the centre of the quality system, where every function’s problems arrive and every function’s changes originate.

COMES AFTER (UPSTREAM)
  • Deviations, complaints, audit findings and adverse trends
COMES BEFORE (DOWNSTREAM)
  • Management review
  • Change control implementing the corrective action
YOU DEPEND ON
  • Subject-matter experts who can establish what actually happened
  • Change control to implement anything structural
  • Data from complaints, deviations and trending to see recurrence
DEPENDS ON YOU
  • Senior management, whose review of quality-system effectiveness rests on this data
  • Inspectors and auditors testing whether problems are genuinely resolved
  • Every function relying on a recurring issue being taken off their plate permanently
YOU OWN
  • The investigation and CAPA process and its rigour standard
  • Effectiveness criteria, defined before closure rather than after
  • The refusal to close an action whose root cause was never established
YOU DO NOT OWN
  • The technical fix itself, which belongs to the process or system owner
  • Batch disposition
  • Resourcing decisions that determine whether a fix is achievable
YOU ESCALATE TO
  • The quality head, where a root cause is systemic rather than local
  • Management review, where recurrence indicates the quality system itself is not working
EVIDENCE YOU CREATE
  • Investigation reports with a stated root-cause methodology
  • CAPA records carrying effectiveness criteria and their verification
  • Quality-system performance data feeding management review

WHAT THIS ROLE CAN EVIDENCE · 1

competency-investigation-and-capa-effectivenessCan establish a root cause that survives challenge, distinguish correction from corrective action, and define an effectiveness criterion before the action closes — so that recurrence, not closure rate, is what the CAPA system is judged on.

Mapped to this role in the published registry. Nothing on this site assesses them yet, so this is what the standard says the work involves — never a claim about you.

WHERE THIS SITS

A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Quality Assurance pathway. No scenario exercises this role yet, so Practise comes later for it, then what any of it evidences. Skip any of them — the order does not change.

Your route →
SOURCE PACK · 4 PRIMARY SOURCES

The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.

THE FULL CAREER PATHWAY →

Quality Assurance

Responsibilities, key standards, the know/collaborate/escalate matrix, and a 30/60/90-day plan.