High consequence
Potential safety, regulatory, major functional or severe customer impact. Immediate containment and escalation are normally expected.
Do not close the issue. Close the risk.
A practical engineering approach to classify an issue, contain the risk, find the physical and systemic causes, implement the right change and prove effectiveness.
ISSUE MANAGEMENTEVIDENCE
FRAMEFact • scope • impact
CONTAINProtect customer / line / project
CAUSEPhysical • process • system
CLOSEValidation • change • traceability
GRAVITYRisk and impact
ROOT CAUSEEvidence, not opinion
ACTIONContain → correct → prevent
ECR / ECOControlled change
1 — FRAME THE ISSUE
An issue starts with facts, not a solution.
WHAT
Describe the non-conformity
What is observed? On which component, interface, vehicle, process or condition?
WHERE
Define the scope
Which variants, suppliers, sites, batches, configurations or milestones are affected?
WHEN
Establish the chronology
First detection, recurrence, recent changes, trials, tooling or configuration evolution.
HOW
Quantify the effect
Measure the deviation and separate confirmed facts from hypotheses.
2 — CRITICALITY
Criticality is a decision, not a label.
A robust classification considers the consequence of the issue and the urgency of controlling it. PRATIXUS uses a generic engineering lens: safety/regulatory impact, customer/function impact, production/quality impact, launch timing, propagation/scope and detectability. The exact company-specific gravity rules must always be taken from the applicable programme standard.
Launch / industrial risk
Issue threatens tooling, capacity, quality maturity, validation, PPAP, line readiness or a key milestone.
Controlled engineering deviation
Limited scope and impact, with a defined correction path and evidence showing the risk remains controlled.
3 — SOLVE
Contain first. Then find the real cause.
CONTAIN
Protect the customer and project
Stop propagation, identify suspect population, define temporary controls and verify their effectiveness.
ANALYSE
Separate physical and systemic causes
Reproduce the phenomenon, compare good/bad conditions, challenge hypotheses and use evidence.
CORRECT
Implement the robust solution
Correct design, tooling, process, supplier condition or control plan as appropriate.
PREVENT
Protect the next project
Update standards, lessons learned, requirements, checks and controlled engineering data.
4 — CHANGE & TRACEABILITY
When the solution changes the product, control the change.
Problem statement
Keep the observed issue, scope, gravity, owner, decisions and evidence visible.
Engineering decision
Assess the proposed change, affected product definition, stakeholders, validation and implementation path.
Controlled implementation
Connect the approved solution to the product data, effectivity, implementation and downstream impacts.
5 — CLOSE THE LOOP
An issue is closed when the evidence closes the risk.
Closure should demonstrate that the corrective action works, the affected population is controlled, the required validation is complete and the engineering change or process update is traceable.