B-440 material reconciliation and outstanding evidence Filled fictional example — adapt to your procedure and actual evidence. SOURCE PACK - Actual issue and destination records for the same batch, material and quantity boundary. - Evidence of received returns, measured waste and samples; identify any category totals that already include another destination. FINDINGS Source: ISS-440: 25.000 kg physically issued. The 30.000 kg reservation is excluded from the physical balance. Explained destinations: 22.400 kg consumption + 2.300 kg received return + 0.200 kg waste + 0.050 kg sample = 24.950 kg. Open physical difference: 0.050 kg has no supported destination. Separate planning item: 5.000 kg of the reservation was not issued. It is not missing physical material. NEXT WORK AND CLOSURE EVIDENCE Material reconciliation owner Action: Trace each destination to its original observation and check for omissions, duplicate entries or mixed units. Evidence needed: An attributable explanation or an assessed unresolved difference; do not create a balancing waste entry. Warehouse receiver Action: Verify RET-440’s 2.300 kg physical receipt and container/location identity. Evidence needed: Receipt evidence supports the return. Any material-use restrictions are assessed separately. Planning owner Action: Resolve the unused allocation independently of REC-440. Evidence needed: The allocation history explains the unissued 5.000 kg without changing the physical issue. CONCLUSION The supported physical balance is short by 0.050 kg. If later evidence resolves it, link that evidence and record a new assessment. A mathematically balanced total is still separate from correct lot identity and batch disposition. WORKED EVIDENCE REVIEW Investigate the 50 g with measurements that can resolve it. Start with the source and destination measurement records, including gross, tare, net, container identity, unit, instrument and observation time. The first question is whether the figures describe the same material at the same boundary. In the illustrative return ticket below, 2.550 kg gross less 0.250 kg tare supports the existing 2.300 kg net return. Copying gross as net would make the explained total larger by 0.250 kg; it would not explain a 0.050 kg loss. If an original signed measurement instead supports a transcription correction, link that evidence and record a revised assessment. A later reweigh is a new observation: examine intervening sampling, transfers and handling before using it to correct the earlier amount. A convenient numerical difference is not evidence that the earlier reading was wrong. The 0.050 kg residual is 0.2% of the 25.000 kg issued. That percentage is a description, not an acceptance limit. Use the procedure’s chosen quantity basis, measurement capability and handling criteria to assess the difference. A balance displaying three decimal places does not prove accuracy to one gram. Preserve an explicitly assessed residual when appropriate rather than manufacturing a waste event. For human-medicine production, EU GMP Chapter 5 §5.8 addresses yield checks and quantity reconciliation against acceptable limits. It supplies no universal loss percentage. This example keeps the physical-material calculation explicit so the responsible team can apply its actual process limits and supporting evidence. European Commission: GMP Chapter 5: https://health.ec.europa.eu/document/download/4a1fdb4f-6f6f-49c4-b264-8056e5bbe078_en?filename=chapter_5.pdf Evidence checks for the unresolved B-440 quantity Check: Return measurement basis Illustrative evidence: 2.550 kg gross − 0.250 kg tare = 2.300 kg net Effect on the assessment: Supports RET-440 as written; residual remains 0.050 kg Check: Sample/waste overlap Illustrative evidence: SMP-440 is included in the waste source list Effect on the assessment: Remove duplicate attribution only after establishing the actual population; recalculate Check: An original ticket disagrees with transcription Illustrative evidence: Ticket and container identity support a different recorded net quantity Effect on the assessment: Review a controlled correction; retain old value and source evidence Check: A reweigh differs by 50 g Illustrative evidence: Later observation without intervening movement evidence Effect on the assessment: Investigate the timeline; do not automatically overwrite the original return