ASFL Device Reduces Restart Scrap, Lifts OEE and FPY on Line
Conclusion: For Consumer Foods Site A (N=2 lines), deploying ASFL restart controls on the case packer, vacuum sealer, and shrink tunnel cut restart scrap from 4.2% to 1.5% (N=280 restarts, 10 weeks) and raised OEE from 60.0% to 71.2% while FPY rose from 92.1% to 97.6%. Value: Changeover fell from 38 to 24 minutes; energy intensity moved from 0.19 to 0.17 kWh/pack; MTBF increased from 26.4 to 34.7 hours; MTTR held at 22 minutes; payback in 11 months. Method: SMED parallelization, recipe locks with parameter interlocks, and airflow re-zone across the shrink tunnel. Evidence: ISO 13849-1 PL d safety functions verified; GS1 aggregation enabled at case; SAT #SAT-24-118 completed; electronic records per Annex 11 / 21 CFR Part 11 mapped to IQ/OQ/PQ (IQ #IQ-24-067, OQ #OQ-24-068, PQ #PQ-24-069).
| Metric | Baseline | Result | Sample/Confidence |
|---|---|---|---|
| Restart scrap (%) | 4.2 | 1.5 | n=280 restarts; 95% CI ±0.3 |
| OEE (%) | 60.0 | 71.2 | n=12 weeks; ±1.1 |
| FPY (%) | 92.1 | 97.6 | n=124 lots; ±0.6 |
| Changeover (min) | 38 | 24 | n=46 events; ±2 |
| Energy (kWh/pack) | 0.19 | 0.17 | n=1.8M packs; ±0.005 |
Prior Improvement Attempts and Lessons
Case Snapshot
Key conclusion: Isolated fixes did not hold; integrated logic across upstream infeed, the ASFL device controller on the vacuum sealer, and downstream accumulation sustained restart performance. Data: pre-project corrective actions (operator SOP refresh and seal-bar change) yielded only a temporary 0.6% scrap dip (4-week window). Clause/record: CAPA #CF-23-441 trended 3 recurring restart defects (misaligned bag, under-vacuum, tunnel wrinkle). Steps: 1) Map failure modes (FMEA), 2) correlate scrap to restart events, 3) bind recipes to line-clearance checks, 4) buffer release tied to seal-bar temperature window, 5) PLC restart countdown with camera verify. Risk boundary: restart scrap must remain ≤2.0% at 95% confidence. Consumer queries such as “mason jar vacuum sealer nearby” do not apply to this industrial context and were excluded from scope.
Data: With the commercial ASFL vacuum sealer added to a servo-synchronized infeed, defects per million (ppm) on restart fell from 780 to 260 (N=124 lots). Clause/record: Deviation #DEV-24-112 closed with operator retraining and recipe locks. Steps: 1) tie vacuum ramp to product mass, 2) validate seal dwell by SKU, 3) gate infeed until tunnel air is within ±3 °C of setpoint, 4) camera verify bag registration, 5) release only after GS1 label checksum passes. Risk boundary: no-start if seal-bar life <80% remaining or if ASFL vacuum sealer bags are out of spec (thickness ±5 µm). Lessons: local fixes drift; locking interdependencies within the line controller sustains results.
FAT Protocols and Acceptance Criteria
Key conclusion: FAT needed to simulate hot, warm, and cold restarts with controlled defects, then verify acceptance before shipment. Data: FAT #FAT-24-052 executed 36 restart series across three SKUs; acceptance required ≤2.0% restart scrap, FPY ≥97.0%, and leak rate ≤0.3% (dye test, n=600). Clause/record: ISO 13849-1 PL d achieved on stop-escape logic; HACCP/HARPC hazards (seal integrity, foreign matter) logged in HACCP Plan #HACCP-24-009. Steps: 1) calibrate vacuum sensor, 2) verify temperature uniformity ±2.5 °C, 3) run ramped restart profiles, 4) challenge GS1 case aggregation, 5) run mock recalls. Risk boundary: shipment blocked unless Annex 11 audit trail completeness ≥99.5% and recipe checksum verified.
Data: At SAT (N=2 sites), OQ demonstrated FPY 97.8% and restart scrap 1.6% at 20–22 °C ambient. Clause/record: OQ #OQ-24-068 step 3.2 validated camera-trigger latency ≤12 ms; PQ lots (n=64) met kWh/pack target ≤0.18. Steps: 1) IQ verification of wiring and safety interlocks, 2) OQ restart matrix by SKU, 3) PQ with real operators across three shifts, 4) post-SAT training signed under LMS #TRN-24-031. Risk boundary: procurement avoided substitutions flagged as “food vacuum sealer sale” items; only qualified components per AML Rev 12 were permitted to protect validation status and payback assumptions. Technical note: seal dwell and vacuum ramp were tuned for ASFL vacuum sealer bags with 60–80 µm films.
Wear Parts Life and Inspection Rules
Key conclusion: Predictive replacement tied to counters and condition signals stabilized restarts. Data: seal-bar Teflon set life averaged 1.2M cycles (CI ±90k), vacuum pump vane kits at 5,000 hours, and conveyor drive belts at 9,400 hours; MTBF for the ASFL controller I/O module logged at 46,000 hours. Clause/record: PM Program #PM-24-017 in CMMS with Annex 11-compliant e-signatures; safety validated to ISO 13849-1 PL d on guard interlocks. Steps: 1) life counters on bars and pumps, 2) infrared spot-check weekly, 3) vibration trend on pump bearings, 4) calibrate temperature probes monthly, 5) gauge R&R on vacuum sensors quarterly. Risk boundary: run-stop enforced when seal-bar life <5% or pump vacuum drops below 88 kPa at 20 °C.
Data: Inspection rules maintained FPY ≥97.5% across 12 weeks; unscheduled downtime stayed under 1.8% with MTTR 21–23 minutes. Clause/record: Nonconformance #NC-24-221 addressed a drifted thermocouple; corrective action updated calibration interval from 30 to 21 days. Steps: 1) visual check for bar flatness, 2) torque verify heater terminals, 3) leak test on changeover, 4) seal width measurement every 2 hours, 5) record photo evidence to QMS #QMS-24-003. Risk boundary: if seal width falls below 5.0 mm or porosity exceeds 1 pinhole per 3 m, automatic reject and hold are triggered; restart is locked until an engineer release is logged.
Business Continuity and Redundancy
Key conclusion: Redundancy and spares planning protected throughput during failures and validated the forecasted payback. Data: a bypass lane and quick-coupled spare sealer kept OEE above 68% during a planned pump overhaul; buffer sizing (120 seconds at nominal rate) allowed graceful restarts. Clause/record: Business Continuity Plan #BCP-24-014; SLA with pump vendor: MTTR ≤24 hours. Steps: 1) dual air supply with auto changeover, 2) UPS on ASFL PLC and HMI, 3) mirrored recipes in Part 11-compliant historian, 4) quarterly failover drill, 5) 30-day seal-bar and vane kits on hand. Risk boundary: line must clear within 6 minutes after brownout; otherwise controlled stop and staged re-introduction prevent surge scrap.
Data: Unplanned downtime averaged 1.6% over 12 weeks; spare-parts holding cost €7.8k offset by avoided downtime value €19.6k, yielding 11-month payback at 2-shift operation. Clause/record: Finance review FR-24-055 validated OpEx savings and energy intensity at 0.17 kWh/pack. Steps: 1) sensitivity analysis on scrap rate ±0.5%, 2) energy tariff scenarios, 3) labor model with SMED crew parallelization, 4) vendor SLA review, 5) quarterly audit of contingency drills. Risk boundary: if MTBF drops below 20,000 hours for critical modules, re-qualification of vendor parts is triggered and payback recalculated.
| Item | CapEx/OpEx (EUR) | Savings/Benefit (EUR) | Assumption/Sensitivity |
|---|---|---|---|
| ASFL controller + integration | 145,000 (CapEx) | — | ±10% vendor quote |
| Scrap reduction | — | 88,000/yr | ±0.5% scrap rate |
| Energy intensity | — | 12,400/yr | ±0.01 kWh/pack |
| Downtime avoided | — | 46,000/yr | ±0.2% uptime |
| Net payback | — | ~11 months | 2-shift, 230 days/yr |
Variability Sources and Sensitivity
Key conclusion: Most restart scrap sensitivity traced to film gauge variance, product temperature, and vacuum ramp timing. Data: moving from 70 µm to 60 µm films increased restart sensitivity by 0.4% scrap unless dwell was extended by 120 ms; products above 8 °C showed a 0.3% leak-rate uptick. Clause/record: SPC Chart Pack #SPC-24-077; HACCP CCP-2 (seal integrity) monitored with 30-minute checks. Steps: 1) measure incoming film gauge, 2) compensate dwell by gauge, 3) delay infeed until tunnel steady-state, 4) pre-vacuum pulse for high-moisture SKUs, 5) verify GS1 label scan before release. Risk boundary: abort restart if temperature deviation exceeds ±3 °C or predicted leak risk >0.4% based on model coefficients.
Q&A for Replicability
Q: what is the best mason jar vacuum sealer? A: For retail jars, dedicated jar-cap systems apply; this project used industrial flow-wrapping and a commercial ASFL vacuum sealer tuned for pouches and cases. Data: our sensitivity model explained 82% of restart scrap variance (R²=0.82) across 124 lots. Clause/record: SAT #SAT-24-118 Appendix B lists parameter windows. Steps: 1) validate jar thread specs if jars are ever introduced, 2) adjust vacuum ramp for headspace, 3) run dye tests before market release. Risk boundary: jar applications require separate validation. Technical note: ASFL vacuum sealer bags in 60–80 µm with EVOH layers met leak targets; contact times must be retuned if barrier stacks change.
| Clause/Standard | Control/Evidence | Audit Cadence |
|---|---|---|
| ISO 13849-1 PL d | Stop-escape interlocks tested; Safety I/O proof tests | Semiannual |
| GS1 (case aggregation) | Scanner checksum and parent–child serialization | Per lot |
| HACCP/HARPC | CCP-2 seal integrity checks and dye tests | Every 30 minutes |
| Annex 11 / Part 11 | Recipe audit trails; e-signatures (IQ/OQ/PQ) | Quarterly |
As a packaging systems integrator, we design the architecture, select equipment, install, commission, train, and support until metrics stabilize. The ASFL controls suite remains central to restart discipline, enabling repeatable OEE and FPY gains while containing energy and scrap. By standardizing recipes, serializing output per GS1, and verifying controls against ISO 13849-1 and Annex 11 records, the same approach can be replicated at additional sites with consistent payback horizons. For Site A, ASFL remains the reference configuration for new lines and the benchmark for restart performance.
