Client profile
South Asian pharmaceutical container glass producer — 2 furnaces, 4 forming lines, vials and ampoules, USP Type II/III, supplying domestic and export pharma markets. Anonymised under NDA.
The problem
First-ware quality on the SKU 14-mix averaged 78% — far below the 95%+ regulatory expectation under cGMP. Persistent customer rejections on dimensional defects in the first hour after each changeover. The plant had committed to a regulatory remediation plan with the customer; the next quarterly customer audit was 8 weeks away.
What we found
Two issues. (1) Mould preheat seasoning was inconsistent across 3 of the 14 SKUs — the SKUs in question had moulds preheated in a shared preheat oven where slot allocation varied. (2) Forehearth setpoints had not been re-validated for the SKU mix in over 18 months; gob temperature variance was ±9°C against a target of ±3°C for pharma-grade glass.
What we did
Re-validated forehearth setpoints across all 14 SKUs in week 1 with on-site forehearth specialist. Drafted SKU-specific mould preheat standards in week 2 with mould room and quality. Drafted 9-stage Lifecycle standards across crews in weeks 3–4. Ran 12 changeovers under coaching during weeks 5–8. Internal coaches led the final 4 changeovers.