主要ポイント
- Quarantine physically and in the system before notifying the supplier.
- Document the deviation with sampling evidence and photographs.
- Notify within the contractual claim window, in the contractual form.
Contain first
Physically segregate the lot, block it in the inventory system and identify any material already released into production. Containment failures turn a single non-conforming lot into a much wider traceability exercise.
Build the evidence file
Sampling records, laboratory report with method references, photographs, transport documents and the certificate of analysis. The credibility of a claim rests almost entirely on whether the sampling was documented and representative.
Disposition and root cause
Decide disposition against the written procedure, then pursue root cause with the supplier. A claim closed with a credit note and no root-cause analysis usually produces the same deviation again.
実施手順
- Quarantine the lot physically and in the inventory system.
- Identify and trace any material already used.
- Assemble the evidence file including sampling documentation.
- Notify the supplier within the contractual window and form.
- Agree disposition and, where relevant, refer to the umpire laboratory.
- Close with documented root cause and corrective action.
確認事項
- Quarantine effective in both physical and system terms
- Evidence file complete before notification
- Notification within the contractual claim window
管理すべきリスク
- Claim time-barred because notification was late
- Retention sample unavailable, leaving the result unsupported
- Material consumed during the investigation, destroying evidence
よくある誤り
- Calling the supplier before the evidence file exists
- Accepting a credit note without root-cause analysis
- Releasing quarantined material under production pressure
よくある質問
Can a non-conforming lot ever be used?
Where the deviation is nutritional rather than safety-related, a documented concession with reformulation and a price adjustment is common practice. Safety-related deviations should not be resolved by concession.
When should an umpire laboratory be used?
When the supplier's result and yours conflict materially and the contract provides for it. Refer within the contractual time limit using the sealed sample.