[SOLVED] Quality Management and ISO 9001

This assignment provides in-depth explanations and definitions of various quality management concepts. It starts with Deming's Seven Deadly Diseases, a set of principles that highlight common pitfalls in quality management. Then it delves into Life Cycle Assessment (LCA), a method for evaluating the environmental impact of products and processes throughout their entire life cycle. Additionally, it covers key requirements for ISO 9001 certification, including documentation, management, and control processes.

Challenge questions Part 1
1. How is food safety and quality defined? What quality aspects do you need consider in the
management of food quality? Are all these quality aspects unique to food?
Definition: Insurance that food is free of accidental or intentional contaminants that may cause harm
during handling, preparation and storage
Quality aspects
– Safety aspects
– Nutritional /health aspects
– Sensory aspects
– Packaging/storage/shelf-life aspects
– Processing/Performance aspects (for ingredients and packaging)
– Sociological/environmental aspects
2. What are the challenges the food industry faces today in the management of food safety?
a. Vertical control is difficult
b. Complex networks of trading partners,
c. Heterogeneous technological capabilities
d. Biological material is complex, unstable and risky.
e. Consumers lack food safety knowledge and awareness
3. What is your understanding of the differences between QA and QC?
Quality assurance (QA): A wider concept covering planned and systematic activities implemented
within a quality system.
Quality control (QC): Subset of QA framework. Comprises of operational activities used in detection
and measurement of variability in the characteristics of output attributable to the production system.
Includes corrective responses, activities in both production line and QC laboratory
4. What are the major categories of chemical food hazards? What are the routes by which they
contaminate food?
a. Industrial and environmental contaminants
b. Agrochemical residues
c. Biologically derived toxins
d. Toxins produced during processing
e. Improperly used food additives
f. Adulterants
Bioaccumulation of toxins by food chains.
5. What are the advantages and limitations of biopesticides?

Advantages
a. Harmful residues not detected
b. Can be cheaper than chemical pesticides
c. Can be more effective than chemical pesticides in the long-term
d. Biodegradable
Disadvantages
a. High specificity: although this can also be an advantage in that the biopesticide is less likely to
harm species other than the target
b. Slow speed of action (thus making them unsuitable if a pest outbreak is an immediate threat
to a crop)
c. Variable efficacy due to the influences of various biotic and abiotic factors
d. Living organisms evolve and increase their resistance to biological, chemical, physical or any
other form of control (evolutionary arms race).
6. What are the major types of process-induced food toxins? What processing methods are mainly
responsible for their formation? Are there any methods available to mitigate their formation in
food?
a. Polycyclic aromatic hydrocarbons-smoked
b. Heterocyclic amines-high temperature- Marinating in wine, olive oil or lemon juice
c. Urethane-fermented
d. Chloropropanols- acid hydrolysis process
e. Acrylamide- high temperature- acidic conditions, and with some natural antioxdiants
f. Nitrosamines- high temperature or at highly acidic environment
7. What are the major foodborne pathogens of public health significance? What foods have mainly
been implicated in the outbreak caused by these pathogens?
Bacteria, viruses, parasites
a. Salmonella-meat
b. Campylobacter-chicken
c. E. coli-meat products, milk products, vegetables, seafood.
8. What are the main types of food alteration/fraud? Give some examples in each type.
Act of intentionally debasing the quality of food offered for sale either by
admixture (add some substances to increasing bulk or weight, reduce the quality or strength, or
make it appear better value than it is.)
or substitution of inferior substances (damage or inferiority has been concealed in any manner)
or by the removal of some valuable ingredient. (valuable constituent has been abstacted)
Example: sugar adulterated with ground rice etc.

chicory added to ground coffee
cocoa blended with fine brown earth
Milk adulterated with water and by removal of cream
Butter adulterated with lard and oleomargarine
Cheese made from skim milk or cottonseed oil
Starch addition to sausage
9. What are the main methods that can be used to detect food alteration, and their scope of
applications?
NMR: useful for physical & chemical analyses; slow & expensive
Main method:
Stable isotope analysis: measurement of isotopic content by NMR or isotope ratio mass
spectrometry (IRMS) can provide information on geographical or botanical origin
Trace element analysis: useful for geographical origin and contaminant detection
Isotop ratio mass spec + trace elements
• Good for products with a close link to their environment
• Stable isotope signature indicates the precipitation, geology, feed, proximity to sea, etc.
• Useful for authenticate geographic origin, production methods (wild, farmed, organic, corn
fed, etc)
DNA methods: emerging for e.g. meat speciation, farm vs wild salmon
• Analysis of DNA sequence of source material
• Various methods available
• Good for varietal identification, fish, meat, soy, rice, GMO, etc.
Proteomics:
• Analysis of protein and peptide markers
• Compare against protein database to identify protein and peptide origin
• Good for identify species and type of meat, such as beef, horse, muscle, offal, etc.
Metabolomics:
• Analysis of low MW compounds (metabolites) in samples

• Identify phenotype of source material
• Good for identifying species and type of meat, such as beef, horse, muscle, offal, etc.
10. How would you conduct a food safety risk analysis?
Step: 1. Check the supply chain: view the supply chain, finding the potential risk; (microbiological,
chemical or physical)
2. Risk assessment: Statement of purpose; Hazard identification; Hazard characterization;
Exposure assessment; Risk characterization; Reporting
3. Risk management: Risk Evaluation; Risk management option assessment; Implementation
of management decision; Monitoring and review;
4.Risk communication
11. What are the three components of food safety risk analysis?
1.Risk assessment-- measurement of risk and factors that affect it
2. Risk management-- policy development and implementation stage to control the risk
3. Risk communication-- interactive exchange of information to all concerned
12. Explain risk assessment, risk management and risk communication.
1.Risk assessment-- measurement of risk and factors that affect it
2. Risk management-- policy development and implementation stage to control the risk
3. Risk communication-- interactive exchange of information to all concerned
13. What is exposure assessment? What information do you need in order to conduct a proper
exposure assessment?
Exposure Assessment: The qualitative and quantitative evaluation of the degree of intake likely
to occur
14. What information do you need in order to characterise a microbiological risk in food?

For characterise a microbiological risk in food, we need:
Hazard identification: Identifies the microbial species/ strain or its toxin of concern for the
particular food and what it does to consumer.
Hazard Characterization: Provides quantitative/semi-quantitative estimation of severity and
duration of illness caused by the organism/toxin
Considers infective dose of organism/toxin, virulence of particular species/strain
Considers host factors- age, pregnancy, state of health, immuno-status, diet/nutritional factors
Exposure Assessment: Determines degree of exposure to pathogen/toxin at time of consumption
Data on frequency of occurrence and level of organism/toxin in food and how these values
change in food throughout production and service chain
Data on demographics of consumers and consumption patterns (e.g. amount of food ingested,
when, age, health status)
All information from previous stages is collated and assessed.
Estimates overall probability of occurrence and severity of a specific illness, from a specific
organism in a specific food/food type in a consumer group. Needs statistical approach, indicating
degree of uncertainty
15. What are the major functions/roles of FSANZ?
FSANZ develops standards that regulate the use of ingredients, processing aids, colourings, additives,
vitamins and minerals. The Food Standards Code also covers the composition of some foods, e.g.
dairy, meat and beverages as well as foods developed by new technologies such as genetically
modified foods. We are also responsible for some labelling requirements for packaged and
unpackaged food, e.g. specific mandatory warnings or advisory labels. FSANZ also develops Australia-
only primary production and processing standards.
16. What are the areas food standards may cover?
chemical, microbiological or physical agents in foods, or added to foods that may give rise to a
potential risk
Microbiological: Bacteria (infectious, toxin-producing), Protozoa, helminths, viruses, moulds
Chemical/unknown:
Physical:
17. Why is Codex relevant to Australia?

Australia has been a signatory since 1962; Australia supports international initiatives that result in
harmonisation in international food trade; Lack of harmonised food standards can be expensive for
Australian industry; Codex standards are an important point of reference for domestic standards;
Environment in which Australia operates: Australia’s ongoing commitment to protect consumer
health and safety, and to fair trade practices; Australia’s rights and obligations as a member of WTO;
Australia’s growing links with present and future trading partners (e.g. China, India, etc.); Australia’s
need to remain an internationally competitive food exporter
18. Who are the targets of risk communication?
Consumers, individuals,
19. Using risk-based frame work, FSANZ generally divide foods into two groups. What are these two
groups? What are the differences in the approach taken by FSANZ when assessing the safety of
these two groups of foods?
1) History of safe consumption 2) limited history of safe consumption
• Develop new standards
• Evaluate / review existing standards (monitoring, surveillance)
• Evaluate proposed changes to existing standards:
– extension of use of food additive
– use GM or novel food
– establish microbiological or chemical limit
– evaluate current food technology practices
– assess unexpected risks in domestic / imported foods
– evaluate / change labelling standards
history of safe consumption assessed by evaluating existing standards, limited history of safe
consumption may evaluate and change existing standards
20. What are the major risk communication strategies that FSANZ has developed? What situations are
these different strategies used for?
Passive communication strategies: notify and alert individuals to a food issue (e.g. proposed use of a
processing aid)
Responsive communication strategy: use labelling to advise consumers (e.g. GM foods)
Educative communication strategy: try to change consumer behaviour (e.g. Hg in fish)
Proactive communication strategy: scientists and consumers agree on high risk (e.g. BSE)
Applications + Proposals → provide info to consumers on work in progress
21. What is the traditional approach to quality control? What are the main problems of this approach
in managing food safety and quality?

1.Mass inspection,
2.testing (after product produced),
Issues:
Sampling (how much and how frequent)
Time to get results
Costs
Practicality
education and training of testers,
Considered ineffective in preventing microbiological problems
Not cost-effective
22. Describe the seven principles of HACCP
1. Conduct a hazard analysis 2. Identify critical control points (CCPs) 3. Establish critical limits
4. Establish monitoring requirements 5. Establish corrective measures 6. Establish recording systems
7. Establish verification procedures
23. What information do you need when describing a product for the purpose of developing a HACCP
plan?
-product name
-composition, physical and chemical properties (e.g., pH, aw, preservatives, presence of allergenic
ingredients)
-packaging (unit, material, conditions, etc.)
-shelf-life and storage conditions
-handling and storage instructions to customer or consumers
-conditions for distribution of the product (e.g., refrigeration, freezing during shipping)
-use of the product (e.g., ready-to-eat, heat before consumption, industrial use with further processing)
-sale of the product (e.g., retail to consumers, to institutions, to industrial customers).
-7-product realisation
24. Provide two examples each of high, medium and low severity food safety hazards. Are there any
situations when the severity of a hazard may increase?
High: life-threatening illnesses or irreversible damage; Cl. botulinum, L. monocytogenese (for some);
Allergen for allergic person
Medium: Severe or chronic illnesses (SI); Escherichia coli (but some strains high for children); Some
chemical and physical hazards
Low: Mild illnesses (MI) or reversible conditions; Most pathogenic bacteria; Contamination with inert
material

A hazard becomes more severe or high risk if occurred to certain individuals or groups:
The aged; Infants; Immunocompromised; People in poor health; Women in pregnancy
25. The NACMCF categorises food risks into 6 groups by assigning each food a number. Give some
examples of risk category 6 foods and some examples of risk category 1 foods.
Category 1.: No terminal heat process, e.g., ready to-eat foods that do not require reheating, i.e., we
cannot depend on consumer cooking to eliminate the remaining microbiological hazards
Category 6 (A. Highest risk).: Food intended for consumption by at-risk population, e.g., Infant
formula,
26. Describe control measures that may be used for the control of physical, chemical and
microbiological hazards in foods.
Physical: Proper facility design and maintenance
Performing random visual examinations of incoming materials
Using magnets and metal detectors
Using stone traps and bone separators
Keeping equipment well maintained
Training employees to identify potential problems
Chemical: Using approved chemicals only
Having detailed specifications for ingredients
Maintaining letters of guarantee from suppliers
Inspecting trucks used to ship finished product
Properly labelling and storing all chemicals
Properly training employees who handle chemicals
Microbiological: Temperature (hot or cold)

Chemical preservatives
Heat processing (pasteurisation, UHT, etc.)
pH, water activity
Prevention of contamination
Personal hygiene
Packaging
Raw materials control
Process sanitation
Modified atmospheres
27. What are the differences between CCPe, CCPp and CCPr?
CCPe: Hazards are eliminated
CCPp: Hazards are prevented but not eliminated
CCPr: Hazards are minimised, reduced or delayed
28. Why are microbiological tests usually not suitable as monitoring procedures in a HACCP plan?
Under what circumstances microbiological tests could be used as monitoring procedures in a
HACCP plan?
Usually too slow to control a process
Perishable products waste shelf-life waiting for tests
Regular tests show problems developing
Can check efficacy of cleaning using rapid method like bioluminescence
29. What Corrective action would you recommend if your monitoring procedures detect the following?
a. The ingredient received did not meet the company’s specification.
b. The pasteurisation process received by the milk was not adequate.
c. During the fermentation of salami, the pH decline was slower than the specified 0.1/hour.
30. What are major prerequisite programs for a HACCP plan

Facilities, Supplier control, Specifications, Production equipment, Cleaning and sanitation, Personal
hygiene, Training, Chemical control, Pest control, Traceability and Recall programs
31. Outline and briefly explain Deming’s seven deadly diseases to quality.
1. lack of constancy of purpose
2. obsession with short-term profits
3. diversity and unsuitability of performance appraisal methods.
4. high mobility of managers
5. manage company on quantitative data for making decision, ignor less tangible data.
6. Excessive medical costs
7. Excessive costs of liability.
PDCA: Plan Do Check Act
32. What is the Juran trilogy?
It is an improvement cycle that is meant to reduce the cost of poor quality by planning quality into
the product/process. Contains: quality planning, quality control, quality improvement.
33. What is the Feigenbaum concept of a “hidden” plant?
So much extra work is performed in correcting mistakes that there is effectively a hidden plant within
any factory. Within every company, a proportation of its capacity was wasted by mot getting it right
first time.
34. What does Philip Crosby mean when he says “Quality is free”?
An organisation that established a quality program will see saving returns that more than pay off the
cost of the quality program.
Lecture 10 ISO 9001
35. What are the main reasons for a company to obtain ISO certification?
- It is the most important quality management standard in the world
- Adopted by thousands of companies
- Can control quality, save money
- Customers demand it
- Regulations may require it
- Competitors are doing it
36. What is a process within the ISO 9000 context?

(A process is a set of interrelated activities. Processes use resources to transform inputs into outputs.
Processes are interconnected.)
Key processes: production, purchasing, validation, document control, management etc.
37. What are the major document requirements for an ISO 9001 –based QMS?
Your QMS need be documented in: Quality Manual, Procedures, Work instructions, Records and
Forms. (Quality policy for 9001:2008)
38. What are the main ISO 9001 requirements on document control?
- Approval prior to issue
- Process to review and revise documents
- Identification of issues and changes
- Availability of current issues
- Identification and legibility
- Control of documents of external origin
- Processes to prevent unintended use of obsolete documents
39. What are the major ISO 9001 requirements on management?
- establish quality policy
- establish quality objectives to support quality policy ( specific, measurable, achievable, realistic,
time-based)
- documentation, and control it.
- Also resource management: for HR (train employee), work environment, physical R.
Lecture 11 LCA
40. What is life cycle assessment (LCA)? Why is it necessary?
LCA is a method that consider energy and raw material consumption, different types of emissions and
other important factors related to a specific product’s entire life cycle from an environmental point
of view.
Why? Environment is a global issue, industry has huge impact on it. Need to assess environmental
impact of food production. LCA is a main tool for assessment.
41. What are the major steps in LCA?
1. Goal definition & scope.
2. Inventory analysis.
3. Impact assessment
4. Improvement assessment
42. What are the difficulties and limitations one may encounter in conducting a LCA?
Step 1:
- How do you compare different products that provide similar functions or services?
- How do you compare similar products that provide multiple functions or services?

- How do you define more abstract functional units such as entertainment from toys or higher self-
esteem?
Step 2:
- Finding data is hard and usually very time-consuming.
- Obtained data is usually discrete. (easily make mistakes in quantification, and mass & energy
balance may to incorrect, results can be generalized improperly)
Step 3:
- Very subjective, the impact categories chosen, indicator chosen and other factors can affect
results
- Where are the impacts occurring?
- Is there damage already in the area being impacted?
- How much can that area take before it breaks down?