|
Consumer complaints
Customer · External failure
|
5,487
|
$2.33M
|
↑ +90% |
Spike 2.1× avg
|
|
Calibration checks
Maintenance · Appraisal
|
5,164
|
$129k
|
↑ +117% |
No activities for 2 months
|
|
Scrap: bulk out of spec
Production · Internal failure
|
1,648
|
$2.77M
|
↑ +83% |
Cost fields 36% empty
|
|
Filler preventive maintenance
Maintenance · Prevention
|
1,733
|
$875k
|
↑ +203% |
Cost fields 31% empty
|
|
Retailer chargebacks and fines
Customer · External failure
|
1,144
|
$4.25M
|
↑ +83% |
|
|
In-process ABV checks
Production · Appraisal
|
97,549
|
$2.15M
|
↑ +156% |
|
|
Re-blend rework
Production · Internal failure
|
1,018
|
$2.01M
|
↑ +77% |
|
|
Incoming raw material testing
Lab · Appraisal
|
9,450
|
$1.98M
|
↑ +96% |
|
|
Finished goods release
Lab · Appraisal
|
22,647
|
$1.92M
|
↑ +95% |
|
|
Deviations
Quality · Internal failure
|
2,055
|
$1.25M
|
↑ +81% |
|
|
Product recalls
Customer · External failure
|
1
|
$1.2M
|
— |
|
|
Microbial limits testing
Lab · Appraisal
|
6,118
|
$887k
|
↑ +60% |
|
|
Leaking pump rejects
Production · Internal failure
|
25,231
|
$883k
|
↑ +82% |
|
|
Returns
Logistics · External failure
|
1,394
|
$880k
|
↑ +65% |
|
|
Downgraded and expired stock
Logistics · Internal failure
|
812
|
$867k
|
↑ +78% |
|
|
Gel viscosity checks
Lab · Appraisal
|
43,201
|
$778k
|
↑ +153% |
|
|
Process validation
Engineering · Prevention
|
79
|
$757k
|
↑ +220% |
|
|
OOS investigations
Lab · Internal failure
|
615
|
$738k
|
↑ +94% |
|
|
Distributor field claims
Customer · External failure
|
730
|
$685k
|
↑ +64% |
|
|
Fill volume and weight checks
Production · Appraisal
|
107,696
|
$646k
|
↑ +154% |
|
|
Line stoppages
Production · Internal failure
|
1,113
|
$579k
|
↑ +78% |
|
|
GMP training
HR · Prevention
|
4,128
|
$495k
|
↑ +210% |
|
|
Pump and closure leak tests
Production · Appraisal
|
33,931
|
$475k
|
↑ +66% |
|
|
Stability programme
Lab · Appraisal
|
1,093
|
$459k
|
↑ +69% |
|
|
Label verification
Packaging · Appraisal
|
50,737
|
$457k
|
↑ +64% |
|
|
Supplier qualification (ethanol, IPA) (2)
Purchasing · Prevention
|
102
|
$429k
|
↑ +231% |
|
|
Supplier qualification (ethanol, IPA)
Purchasing · Prevention
|
101
|
$405k
|
↑ +235% |
|
|
Environmental monitoring
Lab · Appraisal
|
10,721
|
$343k
|
↑ +149% |
|
|
Returns EU distributors
Logistics · External failure
|
500
|
$298k
|
↑ +56% |
|
|
Calibration plan
Maintenance · Prevention
|
3,066
|
$291k
|
↑ +194% |
|
|
Water system testing
Lab · Appraisal
|
4,839
|
$290k
|
↑ +157% |
|
|
Internal GMP audits
Quality · Prevention
|
86
|
$275k
|
↑ +207% |
|
|
CAPA execution
Quality · Internal failure
|
449
|
$269k
|
↑ +86% |
|
|
Amazon listing suspensions
E-commerce · External failure
|
34
|
$239k
|
↑ +7% |
|
|
FDA 483 remediation
Regulatory · External failure
|
43
|
$194k
|
↑ +54% |
|
|
Retained samples
Lab · Appraisal
|
21,799
|
$174k
|
↑ +66% |
|
|
Quarantined batches
Quality · Internal failure
|
660
|
$172k
|
↑ +66% |
|
|
Label reprints
Packaging · Internal failure
|
1,204
|
$169k
|
↑ +68% |
|
|
Change control reviews
Quality · Prevention
|
645
|
$168k
|
↑ +200% |
|
|
Methanol and benzene risk assessments
Quality · Prevention
|
177
|
$159k
|
↑ +153% |
|
|
FMEA
Engineering · Prevention
|
60
|
$144k
|
↑ +216% |
|
|
Packaging design reviews
R&D · Prevention
|
95
|
$76k
|
↑ +207% |
|
|
Customer audit findings
Customer · External failure
|
23
|
$34k
|
↑ +109% |
|
Total cost of quality
About TCoQ