Modules · For the quality manager
Operational risk, safety, counterfeit, and FOD
Open: Quality Events > Operational Risk & Product Integrity. Purpose: record an operational risk, safety occurrence, suspected counterfeit issue, or foreign-object finding with its assessment and control. Authorized quality staff manage closure.
Select the correct kind
| Kind | Typical use |
|---|---|
| Operational risk | A process or floor exposure that needs assessment and control |
| Product safety | An occurrence or condition affecting product safety |
| Counterfeit or suspect part | Suspected authenticity or sourcing problem requiring control and evaluation |
| Foreign object debris | A foreign-object finding, removal, and prevention of recurrence |
- Choose Log event and enter the identifying information and the kind.
- Describe the Assessment: what happened or could happen, affected population, severity, and evidence considered.
- Describe the Control: segregation, removal, process restriction, verification, or other measures actually taken.
- Describe the Residual condition: what remains after control and the basis for the conclusion.
- Choose Save under Assessment and control, review all three required areas, then choose Close event.
The field wording adapts to the kind, but the closure gate requires assessment, control, and residual information. An empty residual field is not an acceptable way to imply that all risk disappeared.
Coordinate with other records
A suspect batch may also need an NC for product disposition, a traceability item to identify affected lots, and a Quality Event if coordination extends to shipped product. Use precise references in the available fields. Check each module's actual status instead of assuming the PI record changes it.
Planning & Objectives holds broader business risks and opportunities. Product Integrity holds the operating issue and its control. For example, dependence on one supplier is a planning risk; a suspected counterfeit component received today is a Product Integrity occurrence.
The module does not calculate an RPN or make external GIDEP, MDR, or OASIS submissions. Document the assessments and external references your procedure requires.
Completion check: affected items are identified, the physical or process controls have actually happened, residual conditions are addressed, and necessary parallel records remain assigned until complete.
In the user guide
This article is chapter 29, "Operational Risk and Product Integrity", of the NormaQMS User Guide (NORMA-UG-001), which is under Help > User guide. Chapter numbers in the text refer to that guide.