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UWI BIOCHEMISTRY - BC35F QUALITY ASSURANCE. Prepared by A. E. Waite. Quality Quality Control Quality Assurance Quality Manual Quality Planning Customer Inspection Specifications Acceptable Quality Levels. Objective Evidence Acceptance Sampling Conformity Corrective Action
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UWI BIOCHEMISTRY - BC35FQUALITY ASSURANCE Prepared by A. E. Waite
Quality Quality Control Quality Assurance Quality Manual Quality Planning Customer Inspection Specifications Acceptable Quality Levels Objective Evidence Acceptance Sampling Conformity Corrective Action Preventive Action Control Limits Standards Validation QUALITY ASSURANCE – BC35FTERMS USED IN QUALITY ASSURANCE
QUALITY ASSURANCE – BC35F Requirements for a successful QA Programme: • Management Commitment to Quality • Provision of resources • Overall support • Co-operation and involvement by staff (“Buy-In”) • Clearly Defined Objectives
QUALITY ASSURANCE – BC35F Factors to be Considered in the QA Programme: • Quality of Raw Material • Manufacturing processes • Product Specification • Statutory Regulations • Equipment and other Resources
QUALITY ASSURANCE – BC35F Responsibilities • Inspection and Testing • References & Control • Accuracy of Test Results • Record Keeping • Timely Dispatch of Results • Certificates of analysis/Conformance • Identification of Quality Defects • Correction of Quality Defects • Prevention of Defects
QUALITY ASSURANCE – BC35F Support Activities • Market Surveys • Packaging Considerations • Storage Facilities • Maintenance of Manufacturing Equipment
QUALITY ASSURANCE – BC35F Inspection and Testing • Raw material • Grape juice, ginger, coffee, botanicals, pimento, honey, sugar, caramel, flavours (A & N) colouring agents, chemicals (treatment, cleaning) • Water • Source (city, wells) • Treatment ( Softening, deionization, reverse osmosis) • Analyses • Conductivity • pH • Sensory • chlorine • Product
QUALITY ASSURANCE – BC35F QA Analyses – Product • Measurement of • Alcoholic strength • Colour • Turbidity • Specific gravity/brix • Acidity • Metabislufite • Organoleptic/Sensory Evaluation • Stress Tests • Microbiology • Gas Chromatography
QUALITY ASSURANCE – BC35F EQUIPMENT • Routine maintenance • Calibration programme • Use and safeguard of instruments against accidental change in status • Re-testing when instruments are found out of calibration • Standardization of reagents • Establishing shelf life
QUALITY ASSURANCE – BC35F Statistical Tools • Sampling Plans • Control Charts Quality Audits and System Review • Product • Process • System
QUALITY ASSURANCE – BC35F Quality Assurance Personnel • Quality Assurance Manager • QA Co-ordinator • QA Supervisor • QA Analyst • Laboratory Technician • Laboratory Assistant