What problem it solves
Turn product/process characteristics and risks into executable checks with method, sampling, frequency and reaction plan.
Connected system
QAPP links the method with ownership, evidence, actions and upstream/downstream quality records.
Inputs
- Product and process characteristics
- Specifications/tolerances and characteristic classification
- Method and measurement system
- Sampling and frequency
- Reaction plan and ownership
Method flow
- Link each control to the process and risk it addresses.
- Define the control method and measurement system.
- Set sample size and frequency.
- Define reaction before the deviation occurs.
- Review the plan when the process, risk or lessons learned change.
QAPP implementation
| Need | QAPP implementation |
|---|---|
| Structure | Controlled fields, revisions, linked records and required evidence. |
| Actions | Owner, due date, approval, escalation and effectiveness verification. |
| Traceability | History of changes and links to related Quality / CI / Analytics records. |
AIAG alignment
AIAG separated Control Plan into a standalone 1st Edition manual. The official source highlights APQP linkage, Safe Launch, highly automated applications and software use for developing and managing plans. QAPP can connect the control directly to the execution form and deviation reaction.
Open official source →Common mistakes
Do not treat the digital form as proof that the method was applied correctly. The method requires competent analysis, representative evidence and customer-specific requirements where applicable.