Out-of-Specification Investigation
What happens when a result falls outside its limit. The batch stops. Re-testing is permitted only under a recorded investigation, never as a search for a better number.
Document control
| Document reference | LZ-SOP-QC-02 |
|---|
| Revision | 3 |
|---|
| Effective from | June 27, 2026 |
|---|
| Next review due | June 27, 2027 |
|---|
| Document owner | Quality Control |
|---|
| Covers | OOS investigation |
|---|
Provisions
- An out-of-specification result places the batch on hold immediately; it is not released, listed or shipped
- Phase one checks the laboratory: method, instrument, standard, calculation, and whether the original result is invalidated
- Re-analysis requires a written rationale approved before the sample is re-run, and the original result is retained
- Repeating a test until it passes, without an approved rationale, is a deviation in itself
- A batch not resolved by investigation is rejected and returned to the manufacturing source
- The compound shows an in-progress status on its product page rather than a verified claim while it is on hold
Scope. This document forms part of the Lyze Labs quality system and applies to
research reference material supplied for in vitro laboratory use. It is not a
marketing authorisation, a regulatory approval, or a claim that material may be used
in humans.
Document control. LZ-SOP-QC-02 is an internal controlled document reference in
the Lyze Labs namespace. It is not an accreditation or certification number issued by
an external body. A superseded revision is archived rather than destroyed, so what was
in force on any given date can be established.
Related documents