Keep the finding intact
Record what was observed, the relevant requirement, the affected process, and the evidence. Distinguish the finding itself from assumptions about its cause.
Separate immediate correction from prevention
Address the immediate condition and any affected product through your established procedures. Then examine why the system allowed the problem to occur or persist.
Make responsibility visible
- Describe the action in terms someone can carry out.
- Name the responsible owner and agreed due date.
- List the evidence that will show completion.
- Define how and when effectiveness will be checked.
Close the loop
A revised procedure or completed training session may be one part of an action. Follow-up should examine whether the underlying problem has been addressed and whether the change works in practice.
Use the worksheet to organize your team’s work and discuss technical or product-disposition questions separately with the appropriate qualified personnel.
This material is a preparation aid. Product-specific controls, limits, and conclusions require review of the actual application.