SPL-204 genealogy and quantity review Filled fictional example — adapt to your procedure and actual evidence. SOURCE PACK - The 10.000 kg pre-split source observation and the gross/tare or net basis of every destination measurement. - The three child identities, the sample record, the parent residual and the split-event relationships. FINDINGS Children: C-204-A 4.000 kg; C-204-B 3.500 kg; C-204-C 2.400 kg. Together: 9.900 kg. Other explained material: S-204-01 sample 0.050 kg and residual in C-204 0.030 kg. Reconciliation: 10.000 − 9.980 = 0.020 kg unresolved, using net mass throughout. Parent identity: C-204 remains present with 0.030 kg. A child’s later split would be a new event and generation. NEXT WORK AND CLOSURE EVIDENCE Split operator Action: Check source and destination observations for a supported omission or transcription issue. Evidence needed: Original measurements establish any correction; child weights are not adjusted simply to balance the total. Inventory owner Action: Keep the parent residual and all child relationships traceable. Evidence needed: Each child points to C-204 and SPL-204; repeat scans resolve the same container. Reconciliation reviewer Action: Assess the 20 g difference against the process’s measurement and handling rules. Evidence needed: A supported explanation or explicit assessed outcome; no universal loss allowance is assumed. CONCLUSION The genealogy identifies the three children, sample and remaining parent. Quantity reconciliation still has a 20 g question. Children do not acquire permission for use merely because their labels and parent links exist. WORKED EVIDENCE REVIEW Reconstruct the net masses and follow the next generation. Keep the measurement basis beneath each net quantity. A fictional ticket for C-204-A might show 4.180 kg gross and 0.180 kg tare, giving 4.000 kg net. A ticket for C-204-B might show 3.720 kg gross and 0.220 kg tare, giving 3.500 kg net. Those are supporting observations for the worked values, not additional quantities to include in the split balance. Capture the actual container-specific tare rather than copying a nominal empty-container value without evidence. The 20 g residual deserves a measurement and handling assessment. Check source transcription, the population of destinations and whether their measurements are comparable before choosing a response. Reporting resolution alone does not establish measurement uncertainty or a permitted loss. If the responsible reviewer accepts a residual under the actual procedure, retain the numerical difference and the supporting decision; an accepted assessment does not turn unexplained material into measured waste. For a separate follow-on event, suppose C-204-A later splits into A1 of 2.000 kg and A2 of 1.950 kg with 0.050 kg remaining in A. That event balances its own 4.000 kg source. The original SPL-204 must still show C-204-A receiving 4.000 kg, while a current-inventory view follows A’s descendants and residual. Summing both A’s historical 4.000 kg and its descendants as current stock would count the same material twice. EU GMP Chapter 4 §§4.8–4.9 addresses contemporaneous, traceable records and alterations that retain the original information. The split design applies that record-history principle to a pre-split quantity, later descendants and supported corrections; the chapter does not prescribe this parent/child schema. European Commission: GMP Chapter 4, §§4.8–4.9: https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf Two different questions about the follow-on split Review question: What did SPL-204 transfer to child A? Population to use: C-204-A at the original event Quantity accounted for: 4.000 kg; unchanged by the later split Review question: Where is A’s material after the later split? Population to use: A1 + A2 + remaining A Quantity accounted for: 2.000 + 1.950 + 0.050 = 4.000 kg Review question: Did the later split resolve SPL-204’s residual? Population to use: Original source and destinations plus any new evidence about that event Quantity accounted for: No; the original 0.020 kg question remains Review question: Does relabeling A1 create more material? Population to use: Existing A1 identity and its label history Quantity accounted for: No new child or quantity solely from a label reprint