关键要点
- Follow one real lot end to end rather than touring the plant generally.
- Deviation records reveal more than clean areas do.
- Check the laboratory's method scope and calibration practice.
Trace one lot end to end
Select a recent lot and follow it backwards: finished certificate, laboratory worksheet, process records, raw material receipt and supplier certificate. Gaps in that chain matter far more than housekeeping impressions.
Process control points
For processed ingredients, look at temperature and time control, moisture control, magnet and sieve management, and how process deviations are detected. Ask to see the records for a period that includes a known upset, not a selected good week.
The laboratory
Confirm which parameters are tested in-house and which are outsourced, the methods used, calibration and reference-material practice, and how results outside specification are handled before a certificate is issued.
操作步骤
- Agree the inspection scope and the lot to be traced in advance.
- Review the quality manual and deviation log on arrival.
- Trace the selected lot through records and physical flow.
- Assess storage, segregation and contamination controls.
- Review the laboratory scope, methods and calibration records.
- Close with a written findings list and agreed corrective actions.
需要核查的内容
- Complete record chain for the traced lot
- Deviation log with evidence of closure, not only detection
- Laboratory method scope matching the parameters on your specification
需管理的风险
- Inspection limited to a guided tour with no record review
- Out-of-specification results resolved by retesting until a result passes
- Storage areas allowing cross-contamination between materials
常见错误
- Announcing scope so narrowly that only prepared areas are seen
- Not requesting records for a period containing a known problem
- Leaving without a written, dated findings list
常见问题
Is a third-party inspection equivalent to a buyer visit?
A competent third party can perform the same technical review, provided the scope is written by the buyer. A generic inspection scope produces a generic report.
What single record is most revealing?
The deviation or non-conformance log. A plant with no recorded deviations is not a plant without problems — it is a plant that does not record them.
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