Overview of Quality Management System
9
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Improvement projects across the business to reduce waste and improve efficiency Develop and execute first stage of FDA Strategy Considerations to extend ISO 13485 scope to additional product lines
Transcript of Overview of Quality Management System
Overview of Quality Management System
2
Management System Status
2013
• ISO 9001 implemented and achieved – ISO 9001 covers cell line products and derived reagents
• ISO 13485 implemented and achieved - ISO 13485 covers selected reagent products (GDNA and FFPE)
Early 2014
• ISO 9001 and ISO 13485 retained and non-conformities reduced
• ISO 13485 with CMDR (Canada) achieved
• Significant improvements seen in the Quality Management System
Mid 2014
• Improvement projects across the business to reduce waste and improve efficiency
• 21 CFR 820 (US) Strategy in consideration
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Management System Status
Late 2014
• ISO 9001 and ISO 13485 retained and zero non-conformities raised
• Further improvements and maturity seen in the Quality Management System
2015
•Develop and execute first stage of FDA Strategy
• Considerations to extend ISO 13485 scope to additional product lines
Key drivers for Horizon’s Quality Management System?
1. Productivity/Efficiency2. Predictability3. Communication
Productivity/ Efficiency
Communication
QMS
Predictability
Product Inspection Flow
Cell Culture
Pellet
Inventory For Sale
Cell Culture Production Batch Record Inspection
Pellet Production Batch Record Inspection
Generating Bulk Stock
QC to specifications
Temporary Inventory / Stock
Batch Record Inspection
Release For Sale
Three Levels of Inspection (Independence is aimed for at all levels)
Second ScientistSenior Scientist /
QCQC / Production
Manager
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Non-conformance and Corrective/Preventive Actions
Incident Report -Record observation
- Assess impact
- Complete corrections
Trend
- Repeat incidents
- Repeat Root Causes
- Decide to escalate
Action Report -Record trends
- Identify corrective and preventive actions
- Verify and monitor effectiveness
BP-20-03-01 Incident and Action Management
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Document Control
BP-21-01-01 Control and Retention of
Records
BP-21-01-02 Management
System Document
Control
RD-02-10-08 Product Change Control
BP-02-10-06 Design Change Control
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Supplier Management and Goods-in Inspection
Perform supplier audits and continuing assessment
Supplier Audit
Schedule
Material Prioritisation (Risk Based)
BP-12-01-01 Purchasing & Supplier Management
BP-12-02-01 Receipt of Purchased Materials
Goods-in Inspection
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Equipment Control Lifecycle
EQ• Define
requirements
• Approve budget
IQ / OQ•Test
requirements
•Controls and training
PQ•Confirm
process performance
Routine Use
Disposal
INCIDENT OR BREAK DOWN
ROUTINE CALIBRATION/ MAINTENACE
