Quality Management Flashcards
Quality Control
Product-centered, reactive approach. Exists as an important part of quality assurance.
Quality Assurance
Process-centered, proactive approach. Involves tests, processes, documentation, corrective action, improvements, and audits to ensure quality standards are defined and met. Focus on continuous improvement.
TQM
Total quality management
Formal quality management systems
-Policy defines what will be done
-Procedures define by whom & to what standard
-Standard operating procedure defines the “how” of production and outlines which analyses to complete of quality
-Record keeping for evidence and measurements
ISO 9000
- Customer focus
- Leadership focus
- Engagement of people
- Process approach
- Improvements
- Evidence based decision making
- Relationship management
PDCA
Plan, do, check, act
ISO 9001 Implementation
- Familiarize yourself with ISO 9001
- Establish plan
- Identify responsibilities, policies, and objectives
- Develop documentation
- Launch the QMS
- Review performance
- Certification
- Continuous improvement
HACCP
Hazard analysis and critical control points. Identifies food safety hazards in production process
HACCP Principles
- Hazard analysis
- Identify critical control points
- Establish critical limits
- Monitor CCPs
- Establish corrective actions
- Verify
- Establish record keeping
CCP, Critical control points
A step or procedure in the manufacture process where control is essential in order to prevent, eliminate, or reduce a hazard to an acceptable level.
GMP, Good manufacturing practice
Basic environmental and operational conditions required to manufacture safe foods. Written programs and implementation.
GLP, Good laboratory practice
The practices we follow to ensure the validity of our lab data (equipment effectiveness, calibration, validation, safety, sampling design, traceability, etc)
