Hygienic and Sanitary

Practices for Food

General Manufacturing
– Advance Level
FSMS Planning

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FSMS Program

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Defining the process steps

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Process Information :

Flow Diagrams: Process flow

diagram

Indicating all ingredients, preparation steps, Serving,

Re usage, facilities for cleaning & Disinfection

Depicting storage & preparation,serving areas, personal

facilities, rodent & pest control devices

* Control and periodic verification(at least annual) of the

process information.
Process Flow Diagram

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 Develop Flow Diagrams

• Use Standard Symbols -

Document
Process
Activity

Multi-document

Decision
Connector

Storage
Terminator

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Typical Process Flow Diagram
Biscuit Manufacturing

Receiving of Raw Material

Quality Inspection

Storing

Issue to Production

Preparation of Sugar syrup

Sifting of Maida – 30 Mesh

Addition of Other Ingredients

Mixing (Creaming)

Dough Formation

Moulding, Cutting & Shaping

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Case Study 2

In your groups, make a flow diagram for the processes allocated

by the Tutor. Use flipcharts for presentation.

Preparation time: 20 mins

Presentation Time per group: 5 mins

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Developing an FSMS Plan

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Hazard

A biological, chemical or physical agent in,

or condition of, food with the potential
to cause an adverse health effect.

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Examples of Hazards…

1. Physical : Foreign material like hair, stone, dirt, metal, wood

2. Chemical : Oil, Grease, Pesticides, Toxins

3. Biological: Bacteria, Viruses, Moulds, worms, flies

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Sources of physical contamination
•People
•Packaging materials
•Machinery/Equipment
•Premises
•Pests
•Environment
•Raw materials
Sources of biological contamination

•Raw food
•People
•Equipment
•Air and dust
•Soil
•Pests
•Water
•food waste
Sources of chemical contamination

•Pesticides, preservatives, mould inhibitors

•Veterinary drugs
•Cleaning chemicals
•Food additives
•Perfume, scented soap
•Chemical reaction between metal and acidic food
•Machine oils
FSMS is

Rather than

Preventive and Pro active approach to control food safety

hazards.
FSMS Principles

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Hazard Analysis

The process of collecting and interpreting

information on hazards and
conditions leading to their
presence to decide which are
significant for food safety

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 Risk Assessment

Probability / Likely hood

High (3) Medium (2) Low (1)

Severity or Consequence

High (3) GMP

Medium (2) GMP GMP

Low (1) GMP GMP GMP

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Control Measure

Any activity that can be used to prevent , eliminate or reduce

to an acceptable level a food safety hazard.
What is a CCP?

A step where control can be applied and is essential to

prevent, eliminate or reduce a food safety hazard to
acceptable levels.
Determine the CCPs :

Modify Step
Q1. Are Control Measures Process or Is control at this step
in place for the hazard ? Product required for safety?
Yes No
Yes No

Q2. Does the Process Step

eliminate or reduce the Hazard Not a CCP
to an acceptable level ?
Yes No CCP

Q3. Could Contamination with

No Not a CCP
the Hazard occur at ,or increase Stop
to, unacceptable levels ?
Yes Critical
Q4. Will a Subsequent Process Control
Step eliminate or reduce the Point (CCP)
Hazard to an acceptable level ?
Yes No CCP
Not a CCP
Establish Critical Limit(s) :

• Establish target levels and tolerance which must

be met to ensure each CCP is under control

• Specify the criteria which MUST be met to ensure

that each hazard (which makes a Process Step a
CCP) is in “control”.

• E.g. Heating Temperature and time

• Double seaming effectiveness

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Establish a Monitoring system

• Establish a monitoring system to ensure control of the CCP by

scheduled testing or observations.
• Establish target levels and tolerance which must be met to
ensure each CCP is under control.
• Monitoring Procedures:
• What?
• When?
• Where?
• How?
• Who?

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Establish Corrective Action

• Establish corrective action, when a CCP is moving out of

control.
– Adjust the process to bring back under control
– Action plan for non conforming material

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Establish Verification Procedures :

Establish Verification Procedures,

consisting of:
- Verification of Monitoring
- Verification of Corrective
Action
Make practical plans for checking
whether the HACCP Plan is working
or not.

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Establish Documentation

Establish documentation concerning all procedures and

records

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 Case Study 3

In your groups, make a FSMS Plan for the process steps allocated
by the Tutor. Use flipcharts for presentation.

Preparation time: 45 mins

Presentation Time per group: 5 mins

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 Risk Assessment Matrix
Probability
1 2 3

1 2 3 1

Severity
2 4 6 2

3 6 9 3

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 Risk Assessment Matrix
Probability Criteria Severity Criteria Outcome decision criteria
Probability
1 2 3

Happens once a month Fatal/

1 2 3 1 3 3 High
(common) / Daily hospitalization

Significant

Severity Happens once a quarter Injury/ minor

2 4 6 2 2 2 Medium
(could happen) discomfort

Happens once in six

3 6 9 3 1 1 Customer complain Low Not significant
months (rare)

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 Hazard Identification and Assessment

Is there a significant (likelihood x Apply PRPs as appropriate.

Q. 1 No
severity) hazard at this step? STOP, proceed to next step in the process

Yes
In all cases, a control measure in a subsequent step in the process or in
Is it necessary to apply control the food chain will reduce the hazard to an acceptable level. Apply PRPs as
Q. 2 No
measures at this step? appropriate.
STOP, proceed to next step in the process.

Yes
Implement control measures (a) by modifying your own process, or
(b) have control measures in the process of the supplier of your raw
materials.
Q. 3 Are control measure already in place? No
If (a) and (b) are not feasible:
inform your customer about the possible presence of the hazard.
STOP, proceed to next step in the process.

Yes

Is there any failure of the control

measure
Categorize the control measure as an OPRP.
with a high risk (likelihood x severity)
1. Establish action criteria.
for the safety of the product?
2. Monitor (measure or observe) to detect failure.
Include the following:
The method and frequency shall be proportionate
- The effect on the hazard.
Q. 4 No to likelihood and severity of failure.
- Control measure specifically applied
3. In case of failure, assess the causes and consequences of the failure
to reduce
and when necessary manage effected product as potentially unsafe
to acceptable level?
(correction).
- Any subsequent control measures?
STOP, proceed to next step in the process.
- Single control measure or
combination? 40
 Yes

Categorize the control measure as an OPRP.

1. Establish action criteria.
2. Monitor (measure or observe) to detect failure.
Is it feasible to establish The method and frequency shall be proportionate
measurable critical limits and to likelihood and severity of failure.
monitoring 3. In case of failure, assess the causes and consequences of the failure
Q. 5 No
that enable and when necessary manage effected product as potentially unsafe
timely detection and (correction).
correction of all failure? 4. When possible, redesign the product, process or control measures.
5. Inform customers and/or consumers about the risk.
6. Take action to reduce the likelihood and severity of failure.
STOP, proceed to next step in the process.

Yes

Categorize the control measure as a

CCP.
1. Establish measurable critical
limits.
2. Monitor (measurement) to detect
any failure to meet critical limits.
3. In case of failure, manage effected
products as potentially unsafe.
STOP, proceed to next step in the
process.

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