Monday report, 2 Nov: three critical or major deviations past their 30-day limit
Saved example
Three major or critical deviations are past their 30-day limit and two batches have been on hold for weeks, so these need decisions this week. Last week's yield rose to 98.0% and six batches were released, but release lead time stayed above the 10 working day limit. October right first time (61.9%) and on-time CAPA closure (80.0%) are also below their limits.
Needs attention this week
- DEV-26-0347
Critical line clearance deviation on Line 2, 38 days open and past its limit since 25 Oct, holding batch B2609-007. Close the investigation and decide the batch disposition this week.
Who: Head of QA and Head of ProductionBy: this week
- DEV-26-0345
Major capsule fill weight deviation on Line 3, 49 days open and past its limit since 14 Oct, holding batch B2609-017. Complete the impact assessment so the batch can be dispositioned this week.
Who: Head of QA and Head of ProductionBy: this week
- DEV-26-0346
Major cold room deviation in the warehouse, 41 days open and past its limit since 22 Oct. Agree the closure plan and sign-off date this week.
Who: Head of QA and Warehouse managerBy: this week
- DEV-26-0348
Major HPLC audit trail deviation in QC reaches its 30-day limit on Thu 5 Nov. Complete the audit trail review and close it before the limit.
Who: Head of QA and QC managerBy: Thu 5 Nov
- CAPA-26-103
Engineering CAPA raised from DEV-26-0334 is still open and due Tue 3 Nov. Confirm completion or agree a revised date with QA.
Who: Engineering managerBy: Tue 3 Nov
Last week, 26 to 30 October
| Figure | Last week | Week before | Limit |
|---|---|---|---|
| Batches packed | 2 | 8 | |
| Yield | 98.0% | 97.4% | ≥ 97% |
| Right first time | 1 of 2 | 6 of 8 | |
| Batches released | 6 | 3 | |
| Release lead time | 13.7 wd (Outside the limit) | 11.7 wd | ≤ 10 wd |
| Deviations opened | 1 | 1 | |
| OOS results | 1 (0 confirmed) | 1 (0 confirmed) |
Open on Monday morning
- Deviations open83 past the 30-day limit
- Batches waiting for release133 for more than 10 wd
- CAPAs open101 due this week
October closed
| Figure | October | September | Limit |
|---|---|---|---|
| Batches finished | 21 | 20 | |
| Yield | 97.7% | 91.7% | ≥ 97% |
| Right first time | 61.9% (Outside the limit) | 65.0% | ≥ 80% |
| Release lead time | 12.6 wd (Outside the limit) | 10.3 wd | ≤ 10 wd |
| CAPAs closed on time | 80.0% (Outside the limit) | 100.0% | ≥ 90% |
| OEE Line 1 | 76.0% | 76.7% | ≥ 75% |
| OEE Line 2 | 81.5% | 68.4% | ≥ 75% |
| OEE Line 3 | 79.9% | 59.4% | ≥ 75% |
| Unplanned downtime | 70 h | 106 h |
Went well
- Yield of batches packed last week was 98.0%, up from 97.4% the week before, and above the 97.0% limit.
- Six batches were released last week, up from three the week before, and CAPA-26-102 remains on track for 11 Nov.
All 22 numbers in this email were checked against the counted figures.
