Unit 7 - Lesson 2 - Quality Management Flashcards
What is quality?
Quality is the conformance to specifications that reflects the needs of our customers
Difference between Quality Control and Quality Assurance
QC - check at end of process - Product Centered
QA - Q along process - Process Centered
QA approach
quality management uses tools and techniques to identify and remove the causes of unwanted variation
QA in general
approach manages quality through the way in which the business operates general
QC
involves inspection and measurement
What is TQM
Total Quality Management (TQM) developed in 1980s
Total Quality Management (TQM) Principals
- Quality can and must be managed.
- Everyone has a customer and is a supplier.
- Processes, not people, are the problem.
- Every employee is responsible for quality.
- Problems must be prevented, not just fixed.
- Quality must be measured.
- Quality improvements must be continuous.
- The quality standard is defect free.
- Goals are based on requirements, not negotiated.
- Life cycle costs, not upfront costs.
- Management must be involved and lead the TQM process.
- Plan and organise for quality improvement.
Total Quality Management (TQM) Principals
- Quality can and must be managed.
- Everyone has a customer and is a supplier.
- Processes, not people, are the problem.
- Every employee is responsible for quality.
- Problems must be prevented, not just fixed.
- Quality must be measured.
- Quality improvements must be continuous.
- The quality standard is defect free.
- Goals are based on requirements, not negotiated.
- Life cycle costs, not upfront costs.
- Management must be involved and lead the TQM process.
- Plan and organise for quality improvement.
Definition of a Quality Management System (QMS)
Mnt systems ensure that their products consistently meet the needs of their customers
Documents in typical Quality Management System
Policy
Procedures
Standard Operating Procedures
Records
Documents in typical Quality Management System
Policy
Procedures
Standard Operating Procedures
Records
What is the key document for QMS
Quality Policy - outlines exactly what the systems should achieve
Procedure QMS docs examples
Raw material specs
Product / recipe specs - alwyas account for some natural variation
Processing standards - target plus range
Standard operating procedures
Production - Know as Standard Operation Procedures (SOPs) or Work Instruction (WIs)
Quality - quality control activities eg hyrdometer
Records QMS
Must be kept
Monitor actual vs expected
International Organisation for Standardisation (ISO)
Founded in 1926
International Federation of the National Standardising Associations. It was renamed ISO after World War II.
NOT TO BE CONFUSED WITH INTERNATIONAL STANDARDS ORGANIZATION
What is ISO 9000
2015
For quality management and quality assurance. For companies document quality system elements that needed to be implemented in order to maintain an effective quality system.
ISO System Principles (ISO 9000 & 9001)
- Customer Focus
- Leadership
- Engagement of People
- Process Approach
- Improvement
- Evidence-based decision making
- Relationship management
The Implementation Steps of a QMS
- Familiarise yourself with ISO 9001
- Establish a plan for implementation
- Identify responsibilities, policies, and objectives
- Develop documentation
- Launch the QMS
- Review your performance
- Certification
- Implement and sustain continuous (continual) improvement
Benefits from formal QMS
Improved business credibility and image.
Increased access to market and competitiveness.
Improved efficiency through a reduction in quality failure.
Easier compliance with food safety regulations.
Simpler integration with health and safety, food safety, integrity, and environmental systems and standards – ISO 14001, for example.
Improved organisation-wide quality awareness.
Reduced workload in management of quality with changes in management/ownership.
Better long-term supplier-customer relationships.
What is HACCP
Created b Dr Howard Bauman (for NASA)
“Hazard Analysis and Critical Control Points”
What does HACCP do?
IDs foor safety hazard
physical (e.g. glass), allergenic (e.g. nuts), chemical (e.g. toxins), and biological (e.g. food poisoning bacteria) food safety hazards in production processes.
HACCP Principles
Principle 1 – Conduct a hazard analysis
Principle 2 – Identify the critical control point (CCP)
Principle 3 – Establish critical limits
Principle 4 – Monitor CCPs
Principle 5 – Establish corrective actions
Principle 6 – Verify
Principle 7 – Establish recordkeeping
What are HACCP Critical Control Points?
as a step or procedure in the manufacturing process, where control is essential in order to prevent, eliminate, or reduce a hazard to an acceptable level.
Hazard Analysis steps
as a step or procedure in the manufacturing process, where control is essential in order to prevent, eliminate, or reduce a hazard to an acceptable level.
What does the HACCP Decision tree help map?
Whether a process point is a CCP
What is Good Manufacturing Practice (GMP)
basic environmental and operational conditions required to manufacture safe foods.
Make sure food products handled safely
GMP covers what?
- Enviro
- Personel practices
- Shipping, Handling Storage
- Pest Control
- Sanitation
6, Equipment maintenance - Recall & Traceability
- Water Safety
Two main components of GMP?
Written programs
Implementation
Good Lab Practice (GLP) examples
Equipment effectiveness Calibration Validation Training Safety Sampling design Traceability
