QA criterion | Activity | PCD (MQAS level ≥2), % |
General quality assurance requirements | QA system | 6/11 (55) |
Documentation system | 7/11 (64) | |
Computerised systems | 6/9 (67) | |
Human resources | 6/11 (55) | |
Self inspection | 6/11 (55) | |
Continuous product qualification | Product qualification | 3/5 (60) |
Manufacturing site assessement | 2/5 (40) | |
Qualification decision (qualified sources monitoring) | 3/5 (60) | |
Quality control and reception | Control at reception | 9/11 (82) |
Quality control | 5/11 (45) | |
Storage and handling specific products | Warehouse organisation | 8/11 (73) |
Physical storage conditions | 4/11 (36) | |
Management of the cold chain | 4/11 (36) | |
Stock control | 10/11 (91) | |
Handling non conformity products | 5/11 (45) | |
Dispatch and transport | Dispatch | 7/11 (64) |
Transport | 5/10 (50) |
MQAS, Model Quality Assurance System; QA, quality assurance.