Food Quality
Control
Quality Assurance &
Management
Systems
Chapter 4
OUTLINE
• Quality Assurance & Management Systems:
-
Introduction.
- Important Definitions.
- Classification of Quality Assurance & Management Systems:
✓ Basic Safety Systems (GPs: GMP & GHP).
✓ Advanced Safety Systems (HACCP).
✓ Integrated Food Safety Management Systems (ISO 22000).
✓ Basic Quality Management Systems (ISO 9001).
✓ Advanced Quality Management Systems (ISO 9004).
1
introduction
▪ In order to cope with market needs and
legal requirements, Food Industries have to
satisfy both safety and quality criteria for
their products.
▪ Remember:
The
reasoning
behind
separating food safety from food quality
was due to the need to place the concept of
safety first and above all the other quality
aspects.
2
Introduction
Quality
Management
Safety
The management with
regard to quality
Quality
Planning
Quality
Assurance
Quality
Control
Quality
Improvement
setting quality objectives
and specifying necessary
operational processes to
achieve the quality
objectives
providing
confidence that
quality
requirements will
be fulfilled
fulfilling quality
requirements
increasing the
ability to fulfil
quality
requirements
3
Important Definitions
Definitions
▪ Food Quality Control:
✓ General: the maintenance of quality at levels and tolerance limits
acceptable to the buyer while minimizing the cost for the vendor.
✓ Scientific: the utilization of technological, physical, chemical,
microbiological, nutritional and sensory parameters to achieve the
wholesome food.
▪ Food Safety: the extent to which those requirements relating
specifically to characteristics that have the potential to be
harmful to health or cause illness or injury are met.
4
• Quality control (the roof).
• With either poor quality control, or even
none at all, the house would be exposed to
the elements and degrade over time.
• Same like a system without quality control
would likely not meet its quality needs and
the external confidence would decrease.
• Quality assurance (the house itself).
• It sets up more specific ideas around
how the house will look and function.
• It’s also what most people see and
admire, what they put their confidence
in as to whether or not they believe the
house will meet their needs.
• Quality management (QM) (the
foundation of a house).
• It sets up your goals for everything inside
the house with parameters for what is
expected.
• It’s hard to set a house up for success
without a good foundation, the same way
quality would suffer in a company with
poor QM.
5
Important Definitions
Definitions Cont.
▪ Quality Management System (QMS):
A set of coordinated activities to direct and control an organization in
order to continually improve the effectiveness and efficiency of it
performance.
▪ Quality Assurance:
The control, evaluation and audit
of a food processing system that
provides confidence that quality
requirements will be fulfilled.
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Quality Assurance &
Management Systems
▪ Food quality management has become
increasingly important, why?
This is due to the changing consumer
requirements, increased competition,
environmental issues and governmental
interests.
▪ Therefore, the food sectors utilize
various quality assurance systems to
successfully implement quality and
safety in their products.
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Quality Assurance &
Management Systems
▪ Food Quality Assurance Systems are necessary at every stage of
the food chain, and in every sector of the food industry, Why?
To ensure both, the quality and safety of food.
▪ Food Quality Assurance Systems implementation and follow-up:
1. Governments’ responsibility:
✓ Establish standards and legislations (laws and regulations).
✓ Establish enforcement programmers and agencies.
2. Food Industries’ responsibility:
✓ Implement quality assurance systems (ensure compliance
with standards and legislations).
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Quality Assurance &
Management Systems
9
Quality Assurance &
Management Systems
10
Quality Assurance &
Management Systems
▪ Some QA systems are obligatory/
legal by law and some are
voluntary;
that
is
to
be
implemented by the food chain
industries.
▪ The distinction between obligatory
and voluntary systems is based on
the safety (hazard-free products)
being the quality of food required
by law.
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Quality Assurance &
Management Systems
▪ Obligatory/ legal standards are set up by law
or through regulations and represent the
minimum standards of quality.
▪ Voluntary standards generally represent
consumer image, trademark, symbol of
product quality.
12
Quality Assurance &
Management Systems
Quality Assurance &
Management Systems
Obligatory Systems:
Safety Assurance
Systems
Voluntary Systems:
Quality & Management
Systems
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Quality Assurance Systems
Safety Assurance Systems
▪ There are obligatory systems that were established to assure
food safety.
▪ These systems include: Basic safety systems (Prerequisite
systems) & Advanced safety systems (HACCP).
▪
Basic safety systems (Prerequisite systems) include: GMP, GHP,
GLP, GKP, GAP, & GCP.
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Quality Assurance Systems
1. Basic Safety Systems - Prerequisite programs
▪ Prerequisite programs: are programs and practices that are put
in place to maintain a sanitary environment and minimize the
risk of introducing a food safety hazard.
▪ The two prerequisite programs for HACCP
are generally: Good Manufacturing Practice
(GMP) & Good Hygiene Practice (GHP).
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Quality Assurance Systems
Prerequisite programs- gmp
▪ Good Manufacturing Practice (GMP): A set of
Guidelines specifying activities to be undertaken and
conditions to be fulfilled in food manufacturing
processes in order to assure that the food produced
meets the standards of food safety.
▪ GMP covers all aspects of production
from the starting materials, premises
and equipment to the training and
personal hygiene of staff.
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Quality Assurance Systems
Prerequisite programs- gmp
(10 principles)
1. Writing procedures
2. Following written
procedures
3. Documenting for
traceability
4. Validating works
5. Designing facilities
and equipment
10. Auditing for
compliance
9. Component control
8. Cleanliness
7. Job competence
6. Maintaining facilities
and equipment
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Quality Assurance Systems
gmp- Principles of GMP
1. Writing procedures
▪ The first principle of GMP is: to develop detailed step-by-step
procedures, in writing, that provide a "road map" for consistency
in performance.
▪ Importance of written procedures:
Allow for workplace standards to be clearly
established, ensuring that a job or procedure is
performed in the same way each time, with each
step followed as set out in the written instructions.
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Quality Assurance Systems
gmp- Principles of GMP
2. Following written procedures
▪ The written procedures will only be effective if they are followed to
the letter (Following written procedures).
▪ Therefore: It is important that no shortcuts or
modifications (even to save time and make
easier) be permitted, Why?
Bcoz any deviation from the written instructions
may adversely affect consistency in product
quality.
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Quality Assurance Systems
gmp- Principles of GMP
2. Following written procedures Cont.
▪ When can I deviate or modify some written procedures?
▪ Only with the approval of a supervisor or the Quality Department.
“ Ideas for improvement are always encouraged”
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Quality Assurance Systems
gmp- Principles of GMP
3. Documenting for traceability
▪ The third GMP principle is Documenting for traceability.
▪ It asks for prompt and accurate documentation of work,
thus allowing for compliance with regulations and the
ability to trace any problems.
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Quality Assurance Systems
gmp- Principles of GMP
3. Documenting for traceability Cont.
▪ Importance of accurate records:
1. Provide a way to evaluate what happened if
there is ever a problem or complaint
regarding a product.
2. This record keeping also chronicles the
precise steps taken relating to GMP
regulations.
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Quality Assurance Systems
gmp- Principles of GMP
4. Validating works
▪ This GMP principle notes the importance of validating that all
systems and processes are working as they are meant to.
▪ How this is achieved?
Through documentation and properly following
the written procedures, thus ensuring that
quality and consistency are carried out
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according to plan.
Quality Assurance Systems
gmp- Principles of GMP
4. Validating works Cont.
▪ Examples on things that need validation:
1. New facilities and equipment.
2. Significant changes to existing systems.
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Quality Assurance Systems
gmp- Principles of GMP
5. Designing facilities and equipment
▪ This fifth GMP principle outlines the importance of integrating
productivity, product quality and employee safety into the design
and construction of the company's facilities and equipment.
▪ Importance of this step:
Reinforces the goals of
quality and consistency
at all stages of the
process.
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Quality Assurance Systems
gmp- Principles of GMP
5. Designing facilities and equipment Cont.
▪ Help:
1. Remove unnecessary traffic in the production area which could
result in a hazardous environment.
2. Segregate materials, products, & their components to minimize
confusion and potentials for mix-ups and errors.
▪ Very important to control the following within a food production
plant so that it does not impact product quality:
Air, Water, Lighting, Ventilation, & Temp.
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Quality Assurance Systems
gmp- Principles of GMP
6. Maintaining facilities and equipment
▪ Here: equipment and facilities must be properly maintained, with
documented written records to back up any work done.
▪ Importance of this step:
Minimizes any safety concerns
and avoids any potential issues
relating to contamination and
quality control.
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Quality Assurance Systems
gmp- Principles of GMP
7. Job competence
▪ Job competency must be clearly demonstrated by each employee
relating to his job.
▪ GMP requires an employee to be completely competent in his role.
▪ However, the definition of competence may vary for different
people.
▪ Therefore it's important that clearly defined and developed job
competencies are in place relating to each job.
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Quality Assurance Systems
gmp- Principles of GMP
7. Job competence Cont.
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Quality Assurance Systems
gmp- Principles of GMP
7. Job competence Cont.
▪ How to make competent employees?
By training all employees which include:
1. Basic training on the theory and
practice of GMP.
2. Specific training relative to their
role.
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Quality Assurance Systems
gmp- Principles of GMP
8. Cleanliness
▪ The importance of this eighth GMP principle: is to ensure a
product is protected from contamination.
▪ The first step in achieving this is to make cleanliness in the
workplace a daily habit.
▪ The degree of cleanliness needed depends on the type of product
being manufactured.
▪ That’s why standards must be put in place to ensure the
appropriate cleanliness guidelines are followed.
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Quality Assurance Systems
gmp- Principles of GMP
9. Component control
▪ This principle involves building quality directly into products via
the systematic control of components and processes relating to
each product.
▪ Quality control includes:
Manufacturing, packaging, labeling, distribution and marketing.
▪ By placing clearly defined controls over all these areas and
keeping accurate, timely records = quality is built into all
stages of production.
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Quality Assurance Systems
gmp- Principles of GMP
9. Component control Cont.
▪ Check all materials/
components before they
enter the plant.
▪ For employees: Must establish records &
producers to make sure they preform
same job every time.
▪ Must have a master record that:
1.outlines the specifications &
manufacturing procedures.
2. Have individuals batch/ history
(conformance).
Approved materials/
components
▪ Identify materials/
components and store in
quarantine areas for
sampling & testing.
Raw
Materials
Controls
▪ Rejected materials/ components must
be identified and stored in secure
area (to prevent accidental use).
Manufacturing
Process
Controls
3. Have written schedule & procedures for
cleaning & maintaining the equipment and
areas.
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▪ Controls must be against
contamination, mix-up, &
errors (Records).
Holding &
Distribution
Controls
▪ Assign a batch/ lot number
to each product (to enable
traceability).
Packaging,
Labeling, &
Controls
▪ Make sure packaging &
labeling areas are empty
before each new batch.
Quality Assurance Systems
gmp- Principles of GMP
10. Auditing for compliance
▪ Finally, how to determine how well GMP is
being implemented?
▪ Is by conducting planned periodic audits to
assess the success of compliance with
GMP regulations.
34
Quality Assurance Systems
gmp- Principles of GMP
10. Auditing for compliance Cont.
▪ Types of audits:
1. External audits: Audits preformed by external bodies such as
the Food & Drug Administration (FDA).
2. Internal audits: In-house audits & self-inspections, done
periodically by independent & qualified people.
Remember: “Audit” itself is a checking system, not a quality
assessment.
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Quality Assurance Systems
gmp- Principles of GMP
▪ So GMP in Food Industry covers:
1.
2.
3.
4.
5.
6.
7.
8.
Personnel
Plant & grounds.
Sanitary operations.
Sanitary facilities & controls
Equipment and utensils
Processes and Controls
Warehousing and distribution
Maximum defect action level
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Quality Assurance Systems
Prerequisite programs- gHp
▪ Good Hygiene Practice (GHP): A set of
Guidelines specifying activities to be undertaken
and hygienic conditions to be fulfilled and
monitored at all steps of the food chain in order
to assure that the food safety is met.
▪ Sanitary Standard Operating Procedures
(SSOPs): is a written document of
procedures or programs used to maintain
equipment and the environment in a
sanitary condition for food processing.
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Quality Assurance Systems
Prerequisite programs- gHp
▪ Aim of GHP:
To implement the essential principles of food hygiene applicable
throughout the food chain (including primary production
through to the final consumer).
▪ Why?
To achieve the goal of ensuring
that food is safe and suitable for
human consumption.
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Quality Assurance Systems
Prerequisite programs- gHp
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Quality Assurance Systems
Prerequisite programs
▪ Both GMP and GHP constitute a precondition in a food
enterprise for implementing the HACCP system.
The relationship between these
three food systems, where HACCP
is a broader category which
incorporates its prerequisites GMP
and GHP.
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Quality Assurance Systems
Advanced Safety System-HACCP
▪ What is HACCP:
41
Quality Assurance Systems
Advanced Safety System-HACCP
▪ Definition of HACCP:
A systematic food safety assurance method to identify, evaluate
and control of food hazard.
▪ History of HACCP:
Developed by NASA and U.S. Army, why?
To ensure that the foods developed for astronauts are free of
pathogens and safe for consumption.
Then later, HACCP were applied to all food company that care
about consumers safety.
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Quality Assurance Systems
Advanced Safety System-HACCP
▪ HACCP System:
The principles of HACCP system have been
adopted by the Codex Alimentarius Commission
and guidelines to its application are provided in
an Annex to the General Principles of Food
Hygiene (FAO and WHO, 2003).
The system consists of 12 stages of implantation, of
which 5 are preliminary tasks and 7 are HACCP
principles.
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44
Quality Assurance Systems
Advanced Safety System-HACCP
▪ Difference between prerequisites (GMP & GHP) and HACCP:
✓ While prerequisite programs may impact upon food safety,
they also are concerned with ensuring that foods are
wholesome and suitable for consumption.
✓ However, HACCP plans are narrower in scope, being limited to
ensuring foods safe to consume.
45
Quality Assurance Systems
Voluntary Implemented systems
▪ Maintenance and / or introduction of the remaining qualities
of food (nutritional, sensory and convenience values) is
not requested by law, but by consumers desires.
▪ These voluntary systems include:
✓ Quality Assurance Control Points (QACP).
✓ Quality Management
ISO-9000).
System
(QMS;
✓ Total Quality Management (TQM).
46
Quality Assurance Systems
Quality Assurance Control
Points - QACP
▪ Quality Assurance Control Points (QACP): One of the quality
assurance systems in food production.
▪ QACP was created based on the HACCP concept.
47
Quality Assurance Systems
Quality Assurance Control
Points - QACP
Differences
Concerned
Measuring
Example
QACP
HACCP
Quality assurance (not
safety)
Determine the assurance
control points, parameters,
and their critical values
Sweetness in terms of
amount of sugar
Safety
Determine the critical
control points, parameters,
and their critical limits
Temperature in Celsius
degrees
QACP
HACCP
48
Quality Assurance Systems
Quality Assurance Control
Points - QACP
Similarity
QACP
HACCP
Unique for each company
Unique for each company
Must be introduced
individually for each
enterprise and production
line
Must be introduced
individually for each
enterprise and production
line
QACP
HACCP
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50
Quality Assurance Systems
GMP/ GHP
Basic safety
systems
Food Hygiene
HACCP
Advanced safety
systems
Food Safety
QACP
Quality assurance
systems
Food Quality
51
Quality management Systems
- QMS (ISO) & TQM
1. Quality Management Systems (QMS)
▪
ISO 9000 series: including ISO 9000 and ISO 9004.
ISO 9001: the most recognized and implemented quality
management system standard in the world (ISO 9001: 2015).
▪ ISO 14000 series: environmental management systems.
▪
▪
▪
ISO 13485: quality management systems for medical devices.
ISO 19011: auditing management system.
2. Total Quality Management Systems
▪
TQM: Total Quality Management.
52
Quality management Systems
- QMS (ISO)
1. ISO 9000 Standards
▪ ISO = International Organization for Standardization.
▪ ISO 9000 series: Represents the requirements
which have to be addressed by every enterprise to
assure the reliable production and timely delivery of
goods and services to the marketplace.
53
Quality management Systems
- QMS (ISO)
1. ISO 9000 Standards Cont.
▪ Many food chain actors require their suppliers to
become registered to ISO 9000, that’s why?
Those who register for ISO 9000 find that their
market opportunities have increased.
▪ Remember: Although ISO 9000 series are very
popular, yet they are not and will never become
obligatory.
54
Quality management Systems
- QMS (ISO)
55
Quality management Systems
- QMS (ISO)
1. ISO 9000 Standards Cont.
▪ ISO 9000 series had a major revision
in 2000 when 3 standards (9001,
9002, 9003) were combined into one
called ISO-9001.
▪ ISO 9001: The international standard
that specifies requirements for a
quality management system (QMS).
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Quality management Systems
- QMS (ISO)
A. ISO 9001 Standards
▪ ISO 9001 made a radical change in thinking, how?
By actually placing the concept
management front and center.
of
process
▪ Process Management: Monitoring and optimization
of a company’s tasks and activities, instead of just
relying on inspection of the final product.
▪ ISO 9001 is the only standard in the family that can be certified
to (although this is not a requirement).
57
Quality management Systems
- QMS (ISO)
A. ISO 9001 Standards Cont.
▪ This standard is based on a number of quality management
principles including a strong customer focus, the motivation and
implication of top management, the process approach and
continual improvement.
▪ Using ISO 9001 helps ensure that
customers get consistent, goodquality products and services, which
in turn brings many business
58
benefits.
Quality management Systems
- QMS (ISO)
59
Quality management Systems
- QMS (ISO)
A. ISO 9001 Standards Cont.
✓ The relationship between ISO 9001 and HACCP.
▪ HACCP principles are often combined with
ISO 9001, why?
So that the technological and management
issues regrading food safety and quality are
achieved.
▪ Therefore, ISO 9001 can be helpful for the application of HACCP. 60
Quality management Systems
- QMS (ISO)
A. ISO 9001 Standards Cont.
61
Quality management Systems
- QMS (ISO)
B. ISO 9004 Standards
▪ ISO 9004 goes beyond ISO 9001, how?
By providing guidance on how one can continually
improve it’s business’ quality management
system.
▪ Beside benefiting the customers, ISO 9004 benefits
also: employees; owners; suppliers; society in
general.
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Quality management Systems
- QMS (ISO)
Requirements
of a Quality
Management
System (QMS)
ISO 9000
Standards
ISO 9001
Standards
ISO 9004
Standards
Describes
vocabulary
Describes
only the
requirements
Describes
guidelines for
improvements
Latest
ISO-9000: 2015
Latest
ISO-9001: 2015
Latest
ISO-9004: 2018
63
Quality management Systems
- TQM
2. TQM
▪ TQM = Total Quality Management.
▪ TQM: Is an integrative philosophy of management for continuously
improving the quality of products and processes focusing on
consumers satisfaction.
64
Quality management Systems
- TQM
2. TQM Cont.
▪ It is a continuous process by the
management and employees of a specific
organization to make sure future customer
satisfaction and customer loyalty.
▪ In other words, one satisfied and happy customer
indeed brings ten new customers along with him.
In comparison, one unsatisfied customer will
spread bad word of mouth and harm the existing
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environment and potential customers.
Quality Assurance Systems
Integrated food safety
management- iso 22000
▪ ISO 22000: Is a food safety
management private standard that
is developed based on the ISO 9001
approach.
▪ The standard ISO 22000 offers an
alternative to food organizations
which do not implement ISO 9001
and want to have an effective food
safety management.
66
Quality Assurance Systems
Integrated food safety
management- iso 22000
▪ ISO 22000: 2018 Certification is built around Seven Principles:
1. Analysis of food hazards: Biological,
chemical or physical.
2. Identification of critical control points:
Raw materials, storage, processing,
distribution and consumption.
3. Establishment of critical control limits
and preventive measures: For example,
minimum cooking temperature and time.
67
Quality Assurance Systems
Integrated food safety
management- iso 22000
▪ ISO 22000: 2018 Certification is built around Seven Principles:
4. Monitoring of these critical control
points.
5. Establishment of corrective actions.
6. Keeping records.
7. Systematic and regular auditing of the
system in place by independent third party
certification bodies.
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Quality Assurance &
Management Systems
“Management” refers to company
“Assurance” refers to product
IS0 22000
GMP/
GHP
HACCP
QACP
QMS
TQM
Basic safety
Total quality
Quality management management
systems
Advanced safety
Quality assurance
systems
Food Hygiene
systems
systems
systems
ISO 9000
Food Safety
Quality Improvement
Food Quality
Obligatory Systems
Voluntary Systems
69
Quality Assurance &
Management Systems
▪ Quality Control vs. Quality Assurance vs. Total Quality Management.
70