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to prevent any deviation from stated quality specifications quality specifications should be integrated
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TM-00034:1
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TM-00033:3
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TM-00033:4
parameters and aspects
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* **
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UHT
etc. pH etc.
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Source:Eurocitrus
TM-00033:12
Source:Eurocitrus
TM-00033:13
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TM-00033:15
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TM-00033:17
AQL
AQL 1:100 100000/ml 1:100 10000/ml 0 1:100 1000/ml 00 1:100 100/ml 000 Action Goal
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TM-00033:19
Departments involved in QA
Quality control Production Maintenance Marketing Senior management
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TM-00034:2
QACP
HACCP
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TM-00034:4
ISO 9000
Quality Manual Quality Procedures Work Instructions
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TM-00034:5
Quality Assurance
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HACCP/QACP
HACCP deals with public health issues
QACP deals with product spoiling issues
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TM-00034:8
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HACCP
RULES and RECOMMENDATIONS
Global : Codex, ILSI, ICMSF, assign HACCP for product safety. USA: FDA, Inspection programme EU: Hygien directives + Industry directives (Fish, meat, milk based products) EEC 93/43 Countries: Own
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TM-00034:10
HAZARDS
Biological : Pathogenic micro-organisms ex. Salmonella sp., Staphylococcus aureus Residues of agents ex. cleaning/ disinfection/ sterilizing, pesticides, allergens, veterinary residues, packaging migration etc. Foreign materials ex. screws, nuts, glass etc.
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TM-00034:11
Chemical :
Physical :
HACCP GOALS
SAFE PROCESS COMPETITION INCREASED CONFIDENCE COST EFFICIENCY DECREASED QUALITY DEVIATION
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TM-00034:12
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HACCP
END PRODUCT
HAZARD ANALYSIS
Raw material
Processing
Aseptic Transfer
Packaging
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TM-00034:14
HACCP
Raw Material Processing
END PRODUCT
Aseptic Transfer Packaging Storage& Distribution
HACCP
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TM-00034:15
HACCP
Raw Material Processing
END PRODUCT
Aseptic Transfer Packaging Storage& Distributio n
Preparation Sterilisation
FOREIGN SUBTANCES
HACCP
Raw Material Processing
END PRODUCT
Aseptic Transfer Packaging Storage& Distribution
Risk Identification
FOREIGN SUBTANSCES
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TM-00034:17
HACCP-CHECKLIST
Important steps for HACCP implementation:
1. Create a HACCP-team 2. Define the scope of the study 3. Define the hazard/risk 4. Describe the product 5. Describe the use of the product 6. Make a flowchart 7. Verify the flowchart 8. Identify all hazards/risks 9. Make a list of preventive actions for the hazards / risks
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TM-00034:19
HACCP-CHECKLIST cont.
Important steps for HACCP implementation:
10. Identify all control points 11. Define all critical limits 12. Create a supervison system for each CCP 13. Establish corrective actions for deviation from a CCP 14. Train personnel in the subjects of hygiene and HACCP 15. Describe verification routines 16. Create a filing and documentation system 17. Describe routines for revision
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be)
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Quality System
Quality Assurance HACCP/QACP
Quality System
Other Factors
ISO 9000
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Quality System
all quality related aspects should involve Senior Management Middle Management
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TM-00034:26
Quality System
all quality related aspects should involve Senior Management Middle Management
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TM-00034:27
Homogenization
Homogenization
Long-Life Product
Aseptic Packaging
Aseptic Transfer
Sterile Product
Source:BvB Doc
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TM-00034:29
Control Point
Control Parameter
Control Process
Source:BvB Doc
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Time
Flow Rate
Homogeniser Constant
Control Point
Control Parameter
Control Process
Source:BvB Doc
TM-00034:31
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Proper Cleaning
Gaskets
Membranes
Cracks& pinholes
Control Point
Control Parameter
Control Process
Source:BvB Doc
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TM-00034:32
Proper Cleaning
Gaskets
Membranes
Cracks& pinholes
Control Point
Control Parameter
Control Process
Source:BvB Doc
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TM-00034:33
UHT Sterilizer
Piping
Aseptic Tank
Piping
Aseptic Filling
Automatic Timer
Automatic Timer
Source:BvB Doc
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TM-00034:34
Steam
Heating
Packaging Mtrl
Sterile Surrounding
Maintaining Sterility
Tight Packages
Steam Barrier
Sterile Air
Long-LIfe Products
Source:BvB Doc
Control Point Control Parameter Control Process
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TM-00034:35
Packaging Material Sterilization Control Points and Parameters TBA/8,TBA/9,TBA/19 and TBA/21
Packaging Mtrl Sterilization
Chemical
Concentration
Contact
Contact Time
Contact Temperature
30 to 50%
Dip-In
6.4 s
65C
Control Point
Control Parameter
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TM-00034:36
Sterile Surrounding
Sterilization
Steam
Temperature
Maintaining Sterility
Temperature
Sterile Air Overpressure
Chemical
Concentration
Contact
Air Flow
Temperature
Source:BvB Doc
Control Point Control Parameter Control Process TM-00034:37
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Machine Design
Temperature
Automatic Thermosensor
Compressor
Automatic Manometer
Constant
Control Point
Control Parameter
Control Process
Source:BvB Doc
TM-00034:38
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