Quality
Quality at every step.
Quality isn't a final inspection. It is a system extending across receipt documentation review, processing, testing, traceability, packaging and release.
The Quality System
- 01
Receipt Documentation Review
J4 reviews required donor eligibility and tissue records supplied by recovery partners before processing.
- 02
Process Control
Processing follows approved procedures with program-defined in-process checks.
- 03
Environmental Monitoring
Controlled environments are monitored to defined program requirements.
- 04
Quality Testing
Testing is performed per procedure at defined stages of processing.
- 05
Traceability
Records link received tissue, lot, process and distribution history.
- 06
Product Release
Release occurs only after documented review against defined criteria.
- 07
Complaint / CAPA
Complaints and nonconformances are documented, investigated and addressed through applicable corrective and preventive action processes.
- 08
Regulatory Oversight
Program requirements are reviewed against the applicable regulatory framework.
Partner Review
Evidence matched to the program.
Quality conversations are most useful when tied to a defined tissue, configuration and manufacturing scope. J4 assembles the applicable facility, process, product and regulatory information for qualified review.
- Quality system overview
- Scoped to the program under review
- Facility & process information
- Shared as appropriate to the program
- Product documentation
- Provided for applicable configurations
- Registration & licensing
- Shared when applicable and verified
Documentation availability and disclosure depend on program scope, product status and confidentiality requirements.