Unit 7 - Lesson 2 - Quality Management Flashcards

1
Q

What is quality?

A

Quality is the conformance to specifications that reflects the needs of our customers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Difference between Quality Control and Quality Assurance

A

QC - check at end of process - Product Centered

QA - Q along process - Process Centered

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

QA approach

A

quality management uses tools and techniques to identify and remove the causes of unwanted variation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

QA in general

A

approach manages quality through the way in which the business operates general

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

QC

A

involves inspection and measurement

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is TQM

A

Total Quality Management (TQM) developed in 1980s

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Total Quality Management (TQM) Principals

A
  1. Quality can and must be managed.
  2. Everyone has a customer and is a supplier.
  3. Processes, not people, are the problem.
  4. Every employee is responsible for quality.
  5. Problems must be prevented, not just fixed.
  6. Quality must be measured.
  7. Quality improvements must be continuous.
  8. The quality standard is defect free.
  9. Goals are based on requirements, not negotiated.
  10. Life cycle costs, not upfront costs.
  11. Management must be involved and lead the TQM process.
  12. Plan and organise for quality improvement.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Total Quality Management (TQM) Principals

A
  1. Quality can and must be managed.
  2. Everyone has a customer and is a supplier.
  3. Processes, not people, are the problem.
  4. Every employee is responsible for quality.
  5. Problems must be prevented, not just fixed.
  6. Quality must be measured.
  7. Quality improvements must be continuous.
  8. The quality standard is defect free.
  9. Goals are based on requirements, not negotiated.
  10. Life cycle costs, not upfront costs.
  11. Management must be involved and lead the TQM process.
  12. Plan and organise for quality improvement.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Definition of a Quality Management System (QMS)

A

Mnt systems ensure that their products consistently meet the needs of their customers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Documents in typical Quality Management System

A

Policy
Procedures
Standard Operating Procedures
Records

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Documents in typical Quality Management System

A

Policy
Procedures
Standard Operating Procedures
Records

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is the key document for QMS

A

Quality Policy - outlines exactly what the systems should achieve

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Procedure QMS docs examples

A

Raw material specs
Product / recipe specs - alwyas account for some natural variation
Processing standards - target plus range

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Standard operating procedures

A

Production - Know as Standard Operation Procedures (SOPs) or Work Instruction (WIs)
Quality - quality control activities eg hyrdometer

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Records QMS

A

Must be kept

Monitor actual vs expected

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

International Organisation for Standardisation (ISO)

A

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

15
Q

What is ISO 9000

2015

A

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.

16
Q

ISO System Principles (ISO 9000 & 9001)

A
  1. Customer Focus
  2. Leadership
  3. Engagement of People
  4. Process Approach
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management
17
Q

The Implementation Steps of a QMS

A
  1. Familiarise yourself with ISO 9001
  2. Establish a plan for implementation
  3. Identify responsibilities, policies, and objectives
  4. Develop documentation
  5. Launch the QMS
  6. Review your performance
  7. Certification
  8. Implement and sustain continuous (continual) improvement
18
Q

Benefits from formal QMS

A

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.

19
Q

What is HACCP

A

Created b Dr Howard Bauman (for NASA)

“Hazard Analysis and Critical Control Points”

20
Q

What does HACCP do?

A

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.

21
Q

HACCP Principles

A

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

22
Q

What are HACCP Critical Control Points?

A

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.

23
Q

Hazard Analysis steps

A

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.

24
Q

What does the HACCP Decision tree help map?

A

Whether a process point is a CCP

25
Q

What is Good Manufacturing Practice (GMP)

A

basic environmental and operational conditions required to manufacture safe foods.

Make sure food products handled safely

26
Q

GMP covers what?

A
  1. Enviro
  2. Personel practices
  3. Shipping, Handling Storage
  4. Pest Control
  5. Sanitation
    6, Equipment maintenance
  6. Recall & Traceability
  7. Water Safety
27
Q

Two main components of GMP?

A

Written programs

Implementation

28
Q

Good Lab Practice (GLP) examples

A
Equipment effectiveness
Calibration
Validation
Training
Safety
Sampling design
Traceability