Quality Management Flashcards
Quality control
Product- cantered, reactive approach. Exists as an important part of quality assurance.
Quality assurance
Process-centres, 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
Developed by quality management consultants and academics to enable western countries to adopt Japanese quality management principles.
QMS
Quality management systems
Formal quality management systems
-policy defines what will be done.
- procedures define by whom and 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
Greek word for isos, meaning equal
International organisation for standardisation
ISO 9000
- Customer focus
- Leadership focus
- Engagement of people
- Process approach
- Improvements
- Evidence based decision making
- Relationship management
PDCA. (Developed by quality management consultant W.
Plan, do, check, act
IOS 9001 implementation
- Familiarise yourself with ISO
- Establish a plan
- Identify responsibilities, policies and objectives
- Develop documentation
- Launch the QMS
- Review performance
- Certification
- Continuous improvement
HACCP principles
- Hazard analysis
- Identify critical control points
- Establish critical limits
- Monitor CCPs
- Establish corrective actions
- Verify
- Establish record keeping
PRPs
Prerequisite programs
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 practices
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 m, calibration, validation, safety, sampling design, traceability, ect)
