Theory of quality management system

Obey Rules, establish a new rule if needed

Laws, regulation, Quality standards established by scientific data

 Keep a document introduced as evidence

Traceable records shall be kept.
Identification and recall of harmful lot of products
Identification of the cause of violation

 Establish Standard operating Procedures (SOP)

Worker shall implement their work according to the procedure.
 PDCA cycle

PDCA (plan–do–check–act) is an iterative four-step management

method used in business for the control and continuous improvement
of processes and products.
Plan; Establish objectives and processes required to deliver the desired results.

Do; The do phase allows the plan from the previous step to be enacted. Small
changes are usually tested, and data is gathered to see how effective the
change is.

Check; During the check phase, the data and results gathered from the do
phase are evaluated. Data is compared to the expected outcomes to
see any similarities and differences.

Act; If the change based on the evaluation of check phase provide the better
result, the management system will be implemented by revised action.
Good manufacturing practices (GMP) are the practices required in order to conform to the
guidelines recommended by agencies that control the authorization and licensing of the
manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary
supplements and medical devices. These guidelines provide minimum requirements that a
manufacturer must meet to assure that their products are consistently high in quality.

Improvement Decision of the rule

Review of the rule

Evaluation Documentation

Record keeping
Check Implementation
 What is food safety management?

“From Farm to Table”

Proper management shall be implemented at all stages though

the food supply chain.

Food processing Market

Farm Consumer
Factory Restauran
t
GAP GMP+HACCP GHP

Food supply chain

HACCP？ HACCP

GAP GMP

Farm Food Processing Factory

 What is HACCP?
Hazard Analysis Critical Control Point System

Hazard Analysis
To identify the hazard which threatens safety of the food

Critical Control Point

To find the most effective production process that can prevent
the hazard
To determine the management practice and implement
according to the practice
 12 Steps and 7 Principle of HACCP
Step１ Assemble the HACCP Team
Preliminary

Step２ Describe the food and its distribution

Step３ Describe the intended use and consumers of the food
Step４
task

Develop a flow diagram which describes the process

Step５ Verify the flow diagram

Step６ Conduct a hazard analysis (Principle 1)

Step７ Determine critical control points (CCPs) (Principle 2)
HACCP Plan

Step８ Establish critical limits (Principle 3)

Step９ Establish monitoring procedures (Principle 4)
Step 10 Establish corrective actions (Principle 5)
Step 11 Establish verification procedures (Principle 6)
Step 12 Establish record-keeping and documentation
procedures (Principle 7)
Step 1 Assemble the HACCP Team

 The first task in developing a HACCP plan is to assemble a HACCP

team consisting of individuals who have specific knowledge and
expertise appropriate to the product and process.
 It is the team's responsibility to develop the HACCP plan.
 The team should be multi disciplinary and include individuals who
have the professional knowledge such as engineering, production,
sanitation, quality assurance, and food microbiology.
 The team should also include local personnel who are involved in the
operation as they are more familiar with the variability and limitations
of the operation.
Step 2 Describe the food and its distribution

 The HACCP team first describes the food.

 This consists of a general description of the food, ingredients,
and processing methods.
 The method of distribution should be described along with
information on whether the food is to be distributed frozen,
refrigerated, or at ambient temperature.

Step 3 Describe the intended use and consumers of the food

 Describe the normal expected use of the food.

 The intended consumers may be the general public or a
particular segment of the population (e.g., infants,
immunocompromised individuals, the elderly, etc.).
Step 4 Develop a flow diagram which describes the process

 The purpose of a flow diagram is to provide a clear, simple outline of

the steps involved in the process.
 The scope of the flow diagram must cover all the steps in the
process which are directly under the control of the establishment.
 In addition, the flow diagram can include steps in the food chain
which are before and after the processing that occurs in the
establishment.
 The flow diagram need not be as complex as engineering drawings.
 A block type flow diagram is sufficiently descriptive
 Also, a simple schematic of the facility is often useful in under-
standing and evaluating product and process flow.
Example of a Flow Diagram for
the Production of Frozen
Cooked Beef Patties
Example of flow diagram
Step 5 Verify the flow diagram

 The HACCP team should perform an on-site review of the

operation to verify the accuracy and completeness of the
flow diagram.
 Modifications should be made to the flow diagram as
necessary and documented.

After these five preliminary tasks have been completed, the

seven principles of HACCP are applied.
Step 6 Conduct a hazard analysis (Principle 1)

 After addressing the preliminary tasks discussed above, the HACCP

team conducts a hazard analysis and identifies appropriate control
measures.
 The purpose of the hazard analysis is to develop a list of hazards
which are of such significance that they are reasonably likely to
cause injury or illness if not effectively controlled.
 Hazards that are not reasonably likely to occur would not require
further consideration within a HACCP plan.
 It is important to consider in the hazard analysis the ingredients and
raw materials, each step in the process, product storage and
distribution, and final preparation and use by the consumer.
Continue…..

 When conducting a hazard analysis, safety

concerns must be differentiated from quality
concerns.
 A hazard is defined as a biological, chemical or
physical agent that is reasonably likely to cause
illness or injury in the absence of its control.
For example, if a HACCP team were to conduct a hazard analysis for the production of frozen
cooked beef patties, enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli)
in the raw meat would be identified as hazards. Cooking is a control measure which can be used to
eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this
product.
The hazard analysis summary could be presented in several different ways as below. Another could
be a narrative summary of the HACCP team's hazard analysis considerations and a summary table
listing only the hazards and associated control measures.

Example
Hazard to be
Control
Step Potential Hazard(s) Justification addressed in plan?
Measure(s)
Y/N

enteric pathogens have

Enteric pathogens: been associated with
5. Cooking e.g., Salmonella, outbreaks of foodborne Y Cooking
verotoxigenic-E. coli illness from undercooked
ground beef
Step 7 Determine critical control points (CCPs) (Principle 2)

 A critical control point is defined as a step at which control can be

applied and is essential to prevent or eliminate a food safety
hazard or reduce it to an acceptable level.
 The potential hazards that are reasonably likely to cause illness or
injury in the absence of their control must be addressed in
determining CCPs.
 Complete and accurate identification of CCPs is fundamental to
controlling food safety hazards.
 The information developed during the hazard analysis is essential
for the HACCP team in identifying which steps in the process are
CCPs.
Step 8 Establish critical limits (Principle 3)

 A critical limit is a maximum and/or minimum value to which a

biological, chemical or physical parameter must be controlled at a
CCP to prevent, eliminate or reduce to an acceptable level the
occurrence of a food safety hazard.
 A critical limit is used to distinguish between safe and unsafe
operating conditions at a CCP.
 Critical limits should not be confused with operational limits which
are established for reasons other than food safety.
 Example of CLs

Process Step CCP Critical Limits

Oven temperature:___° F
Time; rate of heating and cooling
(belt speed in ft/min): ____ft/min
5. Cooking YES
Patty thickness: ____in.
Patty composition: e.g. all beef
Oven humidity: ____% RH
Step 9 Establish monitoring procedures (Principle 4)

 Monitoring is a planned sequence of observations or

measurements to assess whether a CCP is under control
and to produce an accurate record for future use in
verification.
 Monitoring is essential to food safety management in that it
facilitates tracking of the operation. If monitoring indicates
that there is a trend towards loss of control, then action can
be taken to bring the process back into control before a
deviation from a critical limit occurs.
 Monitoring is used to determine when there is loss of
control and a deviation occurs at a CCP, i.e., exceeding or
not meeting a critical limit. When a deviation occurs, an
appropriate corrective action must be taken.
 It provides written documentation for use in verification.
Step 10 Establish corrective actions (Principle 5)

 An important purpose of corrective actions is to prevent foods

which may be hazardous from reaching consumers. Where there
is a deviation from established critical limits, corrective actions
are necessary.
 Therefore, corrective actions should include the following
elements:
(a) determine and correct the cause of non-compliance;
(b) determine the disposition of non-compliant product
(c) record the corrective actions that have been taken.
 Specific corrective actions should be developed in advance for
each CCP and included in the HACCP plan.
 As a minimum, the HACCP plan should specify
a. what is done when a deviation occurs,
b. who is responsible for implementing the corrective actions,
c. a record will be developed and maintained of the actions
taken.
 Individuals who have a thorough understanding of the process,
product and HACCP plan should be assigned the responsibility
for oversight of corrective actions.
 As appropriate, experts may be consulted to review the
information available and to assist in determining disposition of
non-compliant product.
Step 11 Establish verification procedures (Principle 6)

 Verification is defined as those activities, other than monitoring,

that determine the validity of the HACCP plan and that the system
is operating according to the plan.
 Example of HACCP plan

Corrective
CCP Hazards Critical limit Monitoring Verification Records
Actions

5. Cooking Enteric Oven Oven scrap the lot. Monthly Monitoring,

pathogens temperature temperature By HACCP Corrective
:___° F Belt speed Team Action
Time; rate of Records
heating and
cooling (belt
speed in
ft/min):
____ft/min
Step 12 Establish record-keeping and documentation procedures
(Principle 7)

Generally, the records maintained for the HACCP System should include the
following:

a. A summary of the hazard analysis, including the rationale for

determining hazards and control measures.
b. The HACCP Plan
c. Listing of the HACCP team and assigned responsibilities.
d. Description of the food, its distribution, intended use, and consumer.
e. Verified flow diagram.
f. HACCP Plan Summary Table that includes information for:
Steps in the process that are CCPs
The hazard(s) of concern.
Critical limits
Monitoring
Corrective actions
Verification procedures and schedule
Record-keeping procedures
g. Support documentation such as validation records.
h. Records that are generated during the operation of the plan.
 Management Program

Matching the program to each processing factory

Programs that are impractical or

impossible to execute sometimes cause
problems.