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Qaqc Manual Artemis

This document outlines the food safety plan of Artemis Salt Corporation. It discusses the rationale for salt iodization in the Philippines and the objectives of the food safety plan. The plan covers general requirements for salt iodization plants including personnel requirements, facility requirements, and personal safety and sanitation guidelines. Personnel must be qualified and trained in production, quality control, and supervision. Facility requirements include adequate grounds and buildings, utilities, and separation of raw materials and finished products areas. Workers must maintain clean protective clothing and follow sanitation procedures.

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0% found this document useful (0 votes)
154 views

Qaqc Manual Artemis

This document outlines the food safety plan of Artemis Salt Corporation. It discusses the rationale for salt iodization in the Philippines and the objectives of the food safety plan. The plan covers general requirements for salt iodization plants including personnel requirements, facility requirements, and personal safety and sanitation guidelines. Personnel must be qualified and trained in production, quality control, and supervision. Facility requirements include adequate grounds and buildings, utilities, and separation of raw materials and finished products areas. Workers must maintain clean protective clothing and follow sanitation procedures.

Uploaded by

Kim Balagtas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 29

ARTEMIS SALT CORPORATION

Food Safety Plan


1.0 Introduction

1.1 Rationale

Republic Act 8172, which is An Act Promoting Salt Iodization Nationwide or


ASIN Law, was enacted to mobilize the different government agencies, non-
government organizations, international organizations, and the food industry toward
a common objective of total elimination of Iodine Deficiency Disorder (IDD) through
salt iodization. IDD, which includes goiter, hypothyroidism, cretinism, mental
abnormality and miscarriage among others, has been a major health problem
affecting children, pregnant, and lactating women. To ensure that the salt consumed
by the population is properly iodized and of prescribed quality, the operating
procedures, product standards, process standards, and quality control points of the
salt iodization process should be standardized. The Manufacturers Manual on Salt
Iodization (MMSI) is prepared in response to the need for a standardized manual that
would aid the salt manufacturers in the production of quality iodized salt.

1.2 Scope

The manual covers a systematic presentation of the salt iodization process


and all aspects related to it for the general understanding of salt manufacturers. It
includes discussion on the general requirements of a salt iodization company (i.e.
personnel requirements, sanitary and safety system), the pre-iodization, iodization
and post-iodization process, and total quality control management at the plant.

1.3 Objectives

1
General Objectives
• The manual would serve as a reference material for salt manufacturers
on the proper method of salt iodization to ensure that the iodized salt
made available for public consumption conform to the standards
specified in the ASIN Law.

Specific Objectives
The manual was prepared with the following specific objectives:
• To inform the salt manufacturer on the general requirements of a salt
iodization business
• To help salt manufacturers understand the pre-iodization, iodization,
and post-iodization processes
• To educate the manufacturers on the quality control system essential
in salt iodization
• To provide record keeping guidelines necessary in a salt manufacturing
company
• To present forms to be used for keeping company records.

2.0 General Requirements

Republic Act 8172, also known as the ASIN Law, specifies the basic
requirements for the establishment of a salt iodization plant. Operators of salt
iodization plants should comply with these requirements before they are granted
license to operate.

2.1 Personnel Requirements

The basic functions needed to maintain a salt iodization plant are shown below. The
number of persons assigned to each task may vary depending on the production
capacity of the plant.

2.1.1 Supervision

2
The task of supervising the production operations of the plant is done by the
Production Supervisor.

He/she has the following responsibilities:


• Oversee the smooth flow of the salt iodization process
• Ensure that production output meets the demand requirements
• Make certain that the plant follows a good safety and sanitation
system
• Prepare action plans to improve the efficiency of the production
process

A Production Supervisor should have the appropriate qualifications:


• A background on managerial/supervisory training
• Educational background and/or training and/or experience on salt
iodization technology
• Training on safety and good housekeeping

2.1.2 Quality Monitoring

The monitoring of the quality of raw materials and iodized salt throughout
the production process is accomplished by a Quality Control Officer.

His/her responsibilities include the following:


• Ensure that the quality of the raw materials used in the production of
iodized salt meets the set standards
• Guarantee quality iodized salt by making sure that the iodine content
of the salt conforms to the standards
• Make sure that the packaging and labeling of iodized salt follows the
guidelines set by the government

A Quality Control Officer should have the following qualifications:

3
• Educational background and/or training and/or experience on quality
control and quality assurance management
• Experience and/or training on salt iodization technology

2.1.3 Production

Production pertains to the set of processes involved in the iodization of salt.


Production Personnel are responsible for the actual manufacturing of salt,
from the receipt of raw materials until the packaging and distribution of the
finished products.

They have the following responsibilities:


• Ensure the receipt of quality raw materials
• Follow the proper salt iodization process
• Perform proper packaging and labeling
• Abide by the safety and sanitary guidelines

Production personnel should have the following qualifications:


• Educational background and/or training and/or experience on salt
iodization
• Training on the use of salt iodization machines
• Proper orientation on good housekeeping, sanitation and safety during
production

2.2 Facilities Requirements


These are the minimum requirements of a salt iodization plant as set by the Food and
Drug Administration (FDA).

2.2.1 Grounds

4
The grounds should be free from conditions that may result to the contamination of
the raw materials and finished products. The plant grounds should be able to
accommodate the following requirements:
• Proper installation of iodizing machines

• Adequate space for proper waste disposal that is far from the
production area to prevent possible contamination of salt

• Preventive measures that would avoid contamination of salt due to


dusty roads, yards, or parking lots through the use of waterproof and
dustproof covers, fence or wall enclosures, etc.

• Cleaning and maintenance of the grounds and the production area


should be done on a regular basis
• Properly installed drainage system to prevent contamination due to
water leakage, foot-borne filth, or insects or pathogenic
microorganisms.

5
• The entry and keeping of domestic animals (i.e. dogs, cats, birds)
should not be allowed within the processing plant

• The use of insecticides and rodenticide sprays during operations


should be strictly prohibited. Instead, use adhesive insect traps or
electronic insect lamps.

2.2.2 Building and Construction Layout


The plant should be designed such that all business operations and sanitary
handling procedures are performed smoothly and efficiently. The layout
should allow the smooth flow of production materials to prevent delays. A
salt iodization plant should have the following:

• Sufficient space to place the salt iodization machine

• Sufficient space to separately store the raw materials and finished


products. A separate area should be provided for receiving raw
materials to prevent mix-up with finished products

• Flooring, ceiling and walls that allow adequate cleaning such as sawali
or cemented flooring and concrete walls.

• Light bulbs that provide adequate lighting

• Properly installed fixtures, ducts and pipes to prevent contamination


of raw materials, finished products or any food contact surfaces
• Adequate ventilation

2.2.3 Utilities

The salt iodization plant should provide the following utilities:


• Ample supply of potable water

6
• Comfort room/s which provide hand-washing and toilet facilities
located in such a way that they are not exposed or directly open to
the production area. Toilet facilities should always be clean.

• Properly installed plumbing to provide sufficient amount of water to


required locations
• Good power supply

2.3 Personal Safety and Sanitation

All workers should maintain personal cleanliness and take all necessary precautions
to prevent the contamination of the salt with any foreign matter. The following
guidelines are set to promote proper personal safety and sanitation:
• Protective clothing (i.e. gloves, apron) should be worn at all times

7
• Nail polish, pins, curlers, jewelry, and other loose attachments should
not be worn during production
• Pens, pencils, watches, etc. should not be carried in pockets above the
waistline
• Chewing gum and smoking are not allowed inside the production area

• Wearing gloves does not excuse the employee from washing his
hands. Hands should be thoroughly washed at the following times:
− When reporting for production duty
− After every break (i.e. coffee break, snacks,
lunch)
− After picking object from the floor
− When coughing or sneezing
− After blowing nose
− After using toilet facilities
Safe personnel conduct should be strictly observed. Playing around, running and
other unnecessary habits are not allowed in the production area.

2.4 Production Machines

8
An effective and efficient salt iodization plant should make use of the different salt
iodization machines that are applicable to their type of operation. The following are
examples of iodization machines that may be used for a continuous type operation.

Continuous Type Operation


A. Mobile Continuous Spray

Figure 2.1 Continuous Spray (Mobile Type)


Source: Salt Iodization for Elimination of Iodine Deficiency, Mannar and
Dunn

Table 2.1 Properties of a Continuous Spray (Mobile Type)


Function To spray and mix Potassium Iodate solution
with salt.
Description The machine consist of the following parts:
• Feed Hopper
• Spraying unit with compressor
• Inclined screw mixer with power

9
unit
• Support structure
• Control unit
Capacity 1.5 - 2 tons per hour
Energy 1HP single phase electric motor, 220 V
Requirement

B. Stationary Continuous Spray

Figure 2.2 Continuous Spray (Stationary Type)


Source: Salt Iodization for Elimination of Iodine Deficiency, Mannar and
Dunn

10
Table 2.2 Properties of a Continuous Spray (Stationary Type)
Function To spray and mix Potassium Iodate solution
with salt.
Description The machine consist of the following parts:
• Feed Hopper
• Spraying unit with compressor
• Inclined screw mixer with power
unit
• Support structure
• Control unit
Capacity 1.5 - 2 tons per hour
Energy 1HP single phase electric motor, 220 V
Requirement

2.2.5 Other Production Equipment


Other basic equipment and utensils needed in a salt iodization plant are:
• Iodine tank with Iodine level window and safety chain for cover and
compressor with automatic switch and pressure gauge

• Weighing scales for weighing of fortificant, plastic pail and salt.

11
• Plastic container for fortificant measurement, 20 liter pail
(calibrated preferably) and wooden/stainless ladle for the preparation
of fortificant

• Stop watch or timer for calibration of salt flow rate and fortificant
spraying rate;

• New Polypropylene woven sacks with high density polyethylene film


lining for bulk packaging of iodized salt.

12
• Packaging machines such as bag closer and threads for bulk packaging.

• Sealing machines for retail packaging

2.2.6 Quality Control Facilities


In order to monitor the quality of salt and ensure the correct iodine content
on processed goods, the plant should have access to any of the quality control
facilities such as:

13
• Laboratory that makes use of titration method to test the iodine
content
• WYD test kits

1. Titration Method

The titration method for salt iodine analysis is a quantitative chemical


testing for the presence of iodine in the salt sample. The use of this testing
method requires a certain degree of analytical skills and adequate funds to
set up and maintain a laboratory. Titration method is appropriate for
medium to large salt manufacturers (e.g. greater than 1000 tons per year)
as part of their quality control management. This method is also used by
government agencies responsible for quantifying the iodine content when
monitoring salt production at plant, household, market, and household
levels.

Note that in order to obtain a business permit, FDA requires the salt
manufacturer to test the iodine content of their salt in their titration
laboratory or in any FDA recognized titration testing center.

(Refer to Annex A: Titration Method for Iodine Analysis for a more


comprehensive discussion on the procedures for using this method.)

14
B. WYD Iodine Checker

Figure 2.6 WYD Iodine Checker


Source: Monitoring Supply of Iodized Salt in Laos, see Annex B

The WYD Iodine Checker, developed by the Salt Institute of China


National Salt Industry Corporation, is used to measure the iodine level
in salt at the point of production. The WYD Checker is a small and
portable instrument that provides reliable performance with close
correspondence to established titration methods.

(Refer to Annex B: WYD Kit for Iodine Concentration Analysis for the
procedures on how to use WYD Kit.)

15
3.0 Salt Iodization Process

The manufacturing process of iodized salt includes the total process from receipt of
raw materials to preparations before iodization, actual iodization process, packaging,
and storage of the finished product.

What is Salt Iodization?

It is the process of adding iodine to salt to help targeted populations in having


sufficient intake of iodine. The recommended fortificant is Potassium Iodate
(KIO3) which is more stable in Philippine conditions. It is in powder form and is
dissolved in water to form the fortificant solution. It is then sprayed into salt
and mixed to produce iodized salt

16
Objective
To enable the factory to consistently iodize salt within the standards set by the
Food and Drug Administration (FDA)

17
3.1 General Process Map

3.2 Phase 1: Pre-Iodization Process

To ensure stability of iodine, salt to be iodized must meet the following


recommended specifications:

Purity Requirements
Moisture Max 4.0% for refined salt
Max 7.0% for unrefined salt
Sodium Chloride (NaCl) Min 97.0% dry basis
Calcium Max 2.0%
Magnesium Max 2.0%
Water insoluble matter Max 0.2%
Codex Alimentarius Commission Standards for Salt

Heavy Metal Contaminants


Arsenic (As) 0.5 ppm
Cadmium (Cd) 0.5 ppm
Lead (Pb) 2.0 ppm
Mercury (Ag) 0.1 ppm
Codex Alimentarius Commission Standards for Salt

(If raw salt does not conform to standards, REJECT and return to supplier or
sell raw salt for industrial use.)

18
Procedure 1 - Receipt of Raw Salt

Step 1 - Test Moisture by Feel


Salt is ready
for iodization

3. Salt
sticks No
on
hand?

Yes
1. Get salt from 2. Rub salt between
stockpile fingers or squeeze
Salt is rejected
by hand and should be
re-dried or
NOTE! sold for other
Make sure hands are dry before purpose
performing moisture test by feel.

Step 2 – Visual Check on Purity of Salt


1. Compare the color of the raw batch of salt with the standard raw salt used for
iodization.

• REJECT if raw batch of salt has a darker shade (grayish or slightly yellow)

REJECT!

• Sell raw salt for industrial use.

2. Inspect raw materials for lumps.

19
Procedure 2 - Preparation Before Iodization
Step 1 - Check Equipment
1. Equipment and Apparatus Check - Daily

a. Clean iodization machine and other tools

a. Check flow rate of sprayer.

b. Clean spray nozzle to ensure consistent spraying of fortificant

Step 2 - Prepare Fortificant


Potassium Iodate

20
Fortificant must conform to the following specifications:
Food grade, white, odorless
Purity Min 99.0%: Max 101.1% after drying
Heavy metals as Lead (Pb) Max 10.0 ppm
Arsenic (As) Max 3.0 ppm
Chlorate Passes test, limit about 0.01%
Iodide Passes test, limit about 0.002%
Moisture Max 0.5%

Food Chemicals Codex

(If fortificant does not conform to standards, REJECT and return to supplier.)

Fortificant Preparation

Person Responsible: Any of the following officers:


• Laboratory Technician
• Production Leader
• Warehouse Checker

For continuous salt iodization, the concentration of the solution is dependent on the
flow rate of salt being discharged and the flow rate of KIO3 solution being sprayed.

21
Determining the Required Fortificant Concentration
1. Set the target iodine level of salt based on FDA standard (30 to 70 ppm),
example: 30ppm
Calibrate the salt flow rate (refer to Annex C) or check the Machine Calibration
(excel) file and get the latest calibration conducted (see ample below).

3. Calibrate the iodine sprayer flowrate (refer to Annex D) or check the Sprayer Calibration
(excel) file get the latest calibration conducted (see ample below).

22
4. Compute for the required fortificant concentration using the formula below
(show formula and example)

Formula:
target iodine level (ppm) x flow rate of salt
(kg/min)
KIO3 solution concentration = --------------------------------------------------------------------
0.595 x 1000 x Flow rate of sprayer (ml/minute)

Example:
GIVEN: Target iodine level = 30 ppm,
Salt flow rate = 300 kg/min
Iodine flow rate = 500 ml/min

30 ppm x 300 kg/min 9,000

23
% KIO3 = ---------------------------------- = --------------- = 0.03 = 3%
595 x 500 ml/min 297,500

2. Compute for the amount of KIO3 to be dissolved per 20 liters of water


Example:
Amount of KIO3, grams = 3% x 20 liters = 0.61 kg or 610 grams per 20 liters of
water

3. Prepare the fortificant. Refer to ANNEX C for details of the procedure

Note: For easier computation, use the Fortification Preparation file (excel file) below.
Input the target ppm, salt flow rate and fortificant flowrate on the yellow cells and
the required fortificant concentration and the weight of fortificant to be dissolved
per 20 liters of water will be computed automatically on the green cells.

Fortificant Preparation
Filename: Fortificant Preparation

1) Before the start of operation for the day, do the following


a) Set the target ppm for the day and record into the table below
b) Refer to the latest machine calibration record and input the latest flowrate into the table below
c) Refer to the latest sprayer calibration record and input the latest flowrate into the table below
d) The worksheet will automatically compute the required iodine concentration and the required amount of P

Date
Planned ppm 30
Salt Flow rate (kg/min) 300
Iodate Flow Rate (ml/min) 500
Required % Fortificant 3.0%
Solution
Amount of Iodine (kg) to be 0.61
Dissolved per 20 liters

(Refer to Annex E: Fortificant preparation)

24
PRE-IODIZATION PROCESS
Step 3 - Quality Level Check

This step is done to determine the capability of the iodization process to meet the FDA standards on
salt iodization. It is conducted to determine existing quality level. It is also conducted when there is
a major change in the salt iodization machine or sprayer, which can affect the mixing of the iodized
salt such as:
1. If there is a milling operation
• Replacement of screen
• Change or re-sharpening of milling blades
2. Change or repair of screw mixer
3. Change of nozzle
4. Repair/Replacement of compressor, pressure gauge or automatic switch.

Flow Diagram For Quality Level Check for Continuous Type Machine

Iodine
Sampling Recording Evaluation
analysis

1. Run the machine, keeping a fixed machine speed and flow rate of iodate.
2. Load salt to the machine, ensuring the hopper is always loaded to avoid lack of salt in the
screw conveyor

1. Sampling Procedure
Collect 1 sample every pre-determined interval (1 or 2 minutes) until 30 running samples are
taken (refer Annex F)
.
2. Iodine Analysis/Testing
Test the samples using the WYD iodine checker to determine iodine content (see Annex B -
Procedure for iodine content determination using WYD iodine checker)
Artemis Salt Corporation Food Safety Plan Authorised by: / /

3. Recording
Record the iodine values (ppm) in the Quality Level Check (excel) form. See sample below.

4. Evaluation of result
a. Analyze the data in the excel file
b. Average and median ppm should be close.
c. Standard deviation should be less than 8.3ppm
d. % of samples within FDA standards should be 100%

3.3 Iodization Process


For Continuous Type Machines (1.5 - 2 tons per hour)
1. Start the machine and start loading salt into the feed hopper. Start the sprayer.
Continue loading salt into the machine at a steady rate

2. Collect the iodized salt at the end of screw mixer

3. 3. Collect one sample (per machine) of iodized salt every hour from the sack and put into
plastic bags and label with date and time.

Page 26
Artemis Salt Corporation Food Safety Plan Authorised by: / /

4. Analyze the iodine content of the salt sample using the WYD iodine checker (refer to
procedure).

5. . Record the result of the testing in the Daily Production Monitoring (excel) file. See sample
below.

Daily Production Monitoring


Reminder: This form is to be filled-up for the week starting Monday to Saturday

Date 10-Jan 11-Jan


Sample No. 1 2 3 4 5 6 7 8

Iodine Level (ppm) 23.1 45.8 56.5 47.0 48.2 36.4 39.4 68.6

Moving Range 22.7 10.7 9.5 1.2 11.8 3 29.2

Total Weight of Salt Iodized 60,000 56,000


for the Day (kilos)

6. If a sample or several samples do not meet FDA standard (20 to 70 ppm), conduct analysis
and use appropriate tools (such as Fish Bone diagram below) to identify the cause/s and take
the appropriate action.

Example
CAUSES EFFECT
Fortificant Iodization Spraying
Preparation Machine System

Wrong
Wrong amount Poor mixing calibration of
of fortificant capability sprayer
flowrate
Wrong
KIO3 not completely calibration of Clogged or
dissolved salt flowrate defective
nozzle
Iodine level of sample
outside of FDA
Defective standard 20-70 ppm
Delegation of duty Incorrect pressure gauge
to person who is method and/or switch
not trained or used
responsible Incorrect Leaking
sampling hoses and
or testing connections

Manpower Process Spraying


System

Post-Iodization Process
Page 27
Artemis Salt Corporation Food Safety Plan Authorised by: / /

1. Use packaging that conforms to recommended standards


• New Polypropylene woven sacks with high density polyethylene film lining
1. The packaging should conform to FDA labeling standards, having the ff. information:
a. Name of product, IODIZED SALT, printed in bold capital letters
b. Name and address of the manufacturer
c. Net weight in metric units
d. Iodine compound used
e. Chemical additives, if any,
f. Open date marking, e.g. BEST BEFORE, or CONSUME BEFORE (date)
g. Lot identification code, re-packers must use manufacturer’s lot identification code
h. Storage instructions

2. Ensure packaging is done under hygienic conditions to prevent contamination.

STORAGE
• Storage area for raw materials and finished product should be kept clean to prevent
contamination from dust and filth.
• The temperature and humidity of the storage area should be maintained in a manner to
minimize loss of iodine.

• Packs of iodized salt should be palletized and should not be stored directly on the
floor.

DISTRIBUTION

FIRST IN FIRST OUT principle should be followed in releasing iodized salt from storage

Page 28

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