1

Use of an ATP Swab Test in Food Factories and Commercial Kitchens:

Enforcement of HACCP for Prevention of Contamination and Food Poisoning

This is a summary of a special lecture given by Mr. Mitsuo Kato,

Foods Design Co., Ltd., at the 111th Lumitester Seminar held by Kik-

koman Biochemifa Company at Nihonbashi Shakaikyoiku-kaikan,

Chuo-ku, Tokyo, on July 24. Lumitester is the name of the ATP Swab

Test device of Kikkoman Biochemifa Company.

An ATP Swab Test has profound effects on validation of general hy-

giene control

(1) A “clean environment” is required in homes and food factories

To cook food safely at home requires safe cooking ingredients cooked

in a clean kitchen with little or no contamination. In the same way, food

factories and commercial kitchens purchase raw materials and produce

safe food products in a clean environment. Food factories with a clean en-

vironment are often referred to as “food factories where 5S or 7S activities

are performed” and “food factories where prerequisite programs (PRPs)

of Hazard Analysis and Critical Control Points (HACCP) or general hygiene

control are stringently enforced”. Factories with a clean environment have

markedly less contamination by foreign items such as insects or fungi, and

less secondary contamination by microorganisms. To im-

prove and ensure safety, heated cooking is conducted in

homes, and similarly processes such as heating that ensure

safety are critical control points (CCPs) in food factories.

(2) Evidence-based HACCP and PRP

The concept of hygiene control is similar in homes and

food factories, but the difference is that hygiene control

in food factories must be evidence-based. For PRPs, evi-

dence of the cleaning frequency and procedure is impor-

tant. Moreover, both determining procedures and verify-

ing who can work in compliance with these procedures

(referred to as “competence”) is also important. For exam-

ple, for cleaning procedures for a conveyor oven, evalu-

ating the competence level of each worker is important,

such as “XX can effectively clean the oven in a short time”.

Details of evaluation of competence are described below.

CCPs such as those in a heating process, including tem-

perature and time of heating, are also determined based

on evidence. Not many processes are designated as CCPs

in food factories, but examples include heat cooking and

metal detector tests. Most operations are PRPs, and only a

few are designated as HACCP, but failure in a CCP may lead

to a major accident, which makes control of CCPs extreme-

ly important.

(3) Importance of PRPs underlying HACCP

The underlying goal of HACCP is to make food facto-

ries clean and reduce the risks of contamination by foreign

items and bacteria. If achieved, this will lead to a marked

reduction in claims of foreign substance intake and food

poisoning. CCPs that can ensure final food safety are found

by hazard analysis (HA) in HACCP. In brief, PRPs make the

environment clean as a whole, while HACCP removes haz-

ards from the food product itself (refer to Fig. 1). HACCP

Mitsuo KATOFoods Design Co., Ltd.

Figure 1: Relationship between PRP and HACCP

Heat sterilization and metal detec-

tor test steps ensure safety

Hazard AnalysisCriticalControlPoint

Steps that ensure safety=CCP

= HACCP

Underlying cleaning.ATP Swab Test validates cleanlinessFinding sites that fail the test improves cleaning methods

PRP (general hygiene management)Making the production

environment clean

Prerequisite

Reducing foreign objects, dust and bacteria, lead-ing to reduced claims of foreign subject intake

and reduced risks for food poisoning.

2

will be made obligatory in the near future. However, if PRPs un-

derlying HACCP are not achieved, addressing HACCP only does

not eliminate foreign objects, fungi, or hair from food products.

This requires cleaning and validation of the cleaning, and in this

area the ATP Swab Test (hereinafter referred to as the ATP Test)

has profound effects. The first time validation is performed, the

cleanliness of many sites will be rejected by the ATP Test. This leads

to a consideration of how to improve cleaning by making it faster,

more effective and more efficient. That is, the results of an ATP Test

allow a review of cleaning procedures and increase the number of

competent (skilled) workers. In this way, the number of sites that

fail the ATP Test will decrease, PRPs underlying the HACCP system

will be better validated, and the HACCP system will be more ef-

fective.

Key points to be considered when establishing a PRP System

When establishing a total HACCP system to deal with obligato-

ry HACCP rules, 10 PRP items, 7 principles and 12 steps of HACCP,

and 6 management items should be considered (Table 1). In this

article, several points to note when establishing and an operating

a PRP system are described, with a focus on cleaning related to

the ATP Test.

(1) Sorting and ordering: recommendation for a “lingering

warehouse”

Sorting and ordering facilitate cleaning and maintenance,

which leads to reduction of time and labor for these activities

and results in cost-saving. HACCP is often misunderstood to be

expensive; however, actually, HACCP is profitable. For example,

recently, a full-scale sorting was done in a workplace and most

of the goods on a shelf were discarded. Then, people thought

that if the shelf existed, unnecessary goods would be stored, and

the shelf itself was discarded. As a result, time for cleaning was

reduced markedly. For sorting, I recommend use of a “lingering

warehouse”, where all goods that are not usually used, but may

be used some day, are stored for a year, and one year later, goods

that have not been used at all are discarded. In sorting and order-

ing, goods should be divided into those that are ① usually used

onsite (e.g. thermometers, measuring tools, and sterilized bot-

tles), ② used once or twice daily (e.g. cleaning and maintenance

tools), and ③ not usually used (e.g. machine parts, packing mate-

rials and labels not used daily). Goods of type ① may be stored in

production sites, but the concept of “product zones” advocated

by the American Institute of Baking (AIB) should be considered.

These are places where foods are exposed (including upper and

lower sides of lines) and require especially strict hygiene control.

At a minimum, goods of type ① should be stored near product

zones, whereas those of type ② may be stored in corners of pro-

duction rooms or in passage ways. Goods of type ③ should not

Outline

1 Assemble the team Assemble the project team

2 Environment, building, equipment Check performance of environment, building, equipment, and set anti-contamination measures

3 Improving cleaning and maintenance Facilitating cleaning and maintenance

4 Implementing and validating cleaning and maintenance Setting each frequency, implementing cleaning and maintenance, validating effects

5 Waste Preventing contamination with drainage water

6 Anti-insect, anti-rodent Preventing invasion and growth of insects and rodents

7 Flow lines and zoning Setting reasonable flow lines and zoning in each facility

8 Management of raw materials, products Dealing with foods and materials hygienically

9 Utility Safe, stable supply of water, power sources, air conditioning

10 Personal hygiene, education and training, competence

Periodically perform education and training on personal hygiene, and establish a personal competence evaluation system

7 principles and 12 steps of HACCP

1 Traceability Tracing products from raw materials through production to shipping

2 Recall procedures and practice Establishing and using recall procedures

3 Labelling and publication Preventing labeling errors, labeling correct contents of products

4 Cooperation with suppliers Ensuring safety by cooperation with suppliers

5 Systems for operation and improvement Establishing systems for finding problems, improving procedures, and preventing recurrence of problems

6 Review meeting with top management Reporting important items with top management, and seeking directions from top management

Man

agem

ent

PRP

Table 1: Establishing a total HACCP system

3

be stored onsite, but should be kept in warehouses.

(2) Making cleaning-free spaces and facilitating cleaning

In sorting and ordering, the first thing to consider is to make

cleaning-free spaces. For example, a space between a sink and a

wall becomes cleaning-free by blocking the space. An overflow in

a sink becomes cleaning-free by covering it with aluminum tape

or stainless steel tape. Removing such a space and making it clean-

ing-free facilitates sorting and ordering. The second thing to con-

sider is how to facilitate cleaning. Measures include ensuring items

are ≥15 cm from the floor or from a wall, arranging underneath a

worktable so as to facilitate cleaning, and placing goods on a car-

riage, rather than directly on the floor. The principles for distances

from the floor and wall are shown in Fig. 2. If there is a space of

15 cm from a wall, sweeping with a broom is possible. AIB rec-

ommends 45 cm of space, since this allows a worker to enter and

clean the space (Photograph 1). Accumulated dirt and dust near

walls often lead to contamination with foreign objects. In a work-

place, a change from an arrangement of four worktables attached

to walls to the four tables attached to each other in the center of

*Too small a height from the �oor leads to contamination by splashing water, foreign objects, and soil bacteria*Too narrow a space from walls often produces contamination sources

Separate by at least 15 cm, and by 45 cm if possible

Preventing contam-ination by splash-ing water requires a height of 60 cm

Ensure a height of the caster-level of ≥15 cm

The safest height is the level of the worktable

Inserting a caster

If a worktable has su�cient strength, remove the lowest shelf and insert a caster to facilitate cleaning.

*Equipment should be arranged to facilitate cleaning and maintenance (ISO/TS 22002 5.4).*Raw materials and products should be stored o� the �oor, with su�cient space between materials and walls to allow inspections and prevent infestation by rodents and insects (ISO/TS 22002 5.7).*Raw materials and products should be stored away from walls and ceilings by at least 45 cm (AIB 1.2 Storage standards/1.2.1.4).

The height of the lowest shelf should be at least 15 cm, which allows for cleaning.Figure 2: Height from the floor, space from walls

A height of ≥15 cm from the floor facili-tates cleaning of the inner side

Arrange underneath worktables to facili-tate cleaning

Block spaces to avoid creating contami-nation sources

Place the predetermined number of tools at predetermined positions for simple control

Do not place goods on the floor directly Leave a space of ≥15 cm from the wallPhotograph 1: Measures to shorten cleaning time (“Improving cleaning and maintenance”)

4

the workplace facilitates cleaning of the walls (Fig. 3).

(3) Cleaning: recommendation for bubble washing

Following the considerations described above, I recommend

conducting bubble washing at as many sites as possible. In bub-

ble washing, bubbles made of a detergent and water are sprayed,

left to stand for about 20 minutes, and then rinsed with water or

hot water. Bubble washing is applicable to the whole room, in-

cluding floor, walls, and vinyl curtains, machines with complicated

structures and decomposed parts of machines. Recently, bubble

type washing machines of various sizes have become available. A

large machine costs about one million yen, a medium-sized one

is about 120,000 yen, and a small machine is about 30,000 yen.

By using this kind of machine, cleaning operations that needed

a few workers can be performed by one worker. In a factory, a

cleaning operation that previously took 2 hours and 5 workers was

completed in 50 minutes by 2 workers after introducing bubble

washing; thus, cost-saving was achieved. After cleaning, drying

with an air conditioner, electric fans, or a dehumidifier can prevent

growth of fungi. Drying can be automatically operated with a tim-

er-setting, and the worker may leave for home. Moreover, bubble

washing does not require scrubbing, and lifetimes of floor, walls,

and machines are lengthened. If there is hesitancy to introduce

bubble washing, it is first better to try bubble washing in part of a

factory by borrowing the bubble washing machine from the soap

company. The effects of cleaning are validated by an ATP Test. The

ATP Test results allow definition of the optimal cleaning frequency

and procedure with the best cost-performance.

(4) Cleaning: two benchmark values for the ATP Test

Each cleaning procedure (e.g. high-pressure cleaning, decom-

position cleaning, and bubble washing) must be documented.

Cleanliness level is a challenging problem for food factories, since

a perfectly clean level is ideal, but not practical. All sites in a food

factory are divided into two categories: ① sites where food is ex-

posed (not many), and ② sites where food is not exposed, and

the benchmark values for the ATP Test at these respective sites

are ≤500 relative light units (RLU)*1 and ≤ 1,000 RLU using Lumi-

tester*2.

*1 RLU is the unit of the amount of luminescence, unique to the ATP Swab Test.*2 Lumitester is a measurement device made by Kikkoman Biochemifa Company

that is used in the ATP Swab Test.

(5) Four frequencies of cleaning entered into two types of

checklists

The four frequencies of cleaning and maintenance are daily,

weekly, monthly, and yearly; and there are two types of checklists:

daily/weekly, and monthly/yearly (Table 2). If cleaning frequency is

not defined, nobody cleans. This frequency should be temporarily

defined as daily or weekly, cleaning should be implemented, and

results should be entered into checklists. During this process, the

optimal frequency for each site becomes apparent.

Making factories clean using the ATP Test

(1) A three-step procedure is used for making factories clean

using the ATP Test.

① Step 1: Inspect various sites

First, various sites should be inspected with an ATP Test. For

example, 100 sites are cleaned and inspected, and sites at which

cleaning requires improvement become apparent. Initially, many

sites will fail the ATP Test, and workers will complain, but, from

my experience, the number of failing sites will be reduced by im-

proving cleaning. In particular, the frequency and procedures of

cleaning should be reviewed and improved at every site, based

on the ATP Test results. Improvement in a factory as a whole takes

several months or years. However, by improving procedures to en-

able more effective cleaning in a shorter time, the number of sites

failing the ATP Test will certainly be reduced. In my experience, 50

of 100 sites initially fail the ATP Test, and improving this situation

takes 3 months. This is a typical situation and improving cleaning

cannot be achieved immediately.

② Step 2: Inspect at 10 sites weekly

When the number of sites failing the ATP Test is reduced, the

next step is to inspect 10 sites weekly. If the date and sites to be in-

spected are predetermined, only those sites may be cleaned care-

fully beforehand. Therefore, they should be randomly determined

and inspectors should also be designated randomly to avoid the

Dirt and dust accumulated, cleaning is di�cult

In the new arrangement, less dirt and dust accumulates, cleaning is facilitated, and cost-saving is achieved

Change the arrangement of four worktables

Figure 3: An arrangement where dirt and dust accumulated near walls

5

same inspector inspecting the same site. In Step 2, PRP levels will

be much improved compared with those in Step 1, but a few sites

may still fail the ATP Test and further improvement is required.

③ Step 3: Inspect at 10-20 sites monthly

When PRP levels have been further improved and the idea of

PRP has been established, inspections should be performed at 10-

20 sites monthly. The date and sites to be inspected should be ran-

domly determined. If a few sites still fail the ATP Test, improvement

is still required. In this chain from Step 1 to Step 3, it is important to

record ATP Test results and monitor trends. The ATP Test may be

considered to be too expensive, but the cost will be much lower

than the gains obtained by subsequent cost-saving.

(2) Use of a video of a manual

Cleaning operations must be maintained to avoid returning

to previous cleanliness levels. Thus, cleaning procedures must be

documented. If a cleaning procedure is changed, the change must

be reflected in the manual. As a manual, I recommend utilization

of a video shot using a smartphone. Allow the most competent

worker to clean while explaining the key points of the procedure.

The video will be the best educational tool for other workers.

(3) Competence evaluation system

The competence of each worker should be quantified and

recorded in a competence table. The table consists of the com-

petence for production and the competence for validation and

audit. As an example, whether the worker is able to perform the

ATP test, belongs to competence for validation and audit.Work-

ers who are experienced and can educate other workers receive

a score of 3 points, those who can perform the procedure with-

out instructions receive 2 points, and those who can work under

instructions receive 1 point (Table 3). As a rule, each team must

include at least one worker with a score of 3 points and one with

2 points to ensure a safe procedure. If the total points for a team

(last row of Table 3) is too small, the number of workers with scores

Location Managing contents Implemented Mon Tue Wed Thu Fri Sar NotePrecooking room, filling room; floor, under wall Cleaning

On the roster

Precooking room, filling room; equipment

Cleaning/maintenance

On the roster

Smoking machine, prepara-tion room

Cleaning/maintenance

On the roster

Mixing room CleaningOn the roster

Washing room CleaningOn the roster

Room temperature ware-house; Receiving entrance, wastes

CleaningOn the roster

Freezer CleaningOn the roster

Cooling room/chilling room CleaningOn the roster

Weighing/Packing room; floor, under wall Cleaning

On the roster

Weighing/Packing room; equipment

Cleaning/maintenance

On the roster

Metal detector CalibrationPacking

test record

Outer packing room; floor CleaningOn the roster

Packing material room CleaningOn the roster

Shipping entrance, Waste warehouse, Passageways Cleaning

On the roster

Washing room CleaningOn the roster

Equipment for cooking and packing ATP Test

Managing staff

Vehicles, shipping area Cleaning/maintenance Sales staff

All of the 2nd floor CleaningPart-time

worker

Circumference/parking area CleaningPart-time

worker

In charge validation None

Daily/weekly management record, between XX YY, ZZZZ and X’X’ Y’Y’, Z’Z’Z’Z’

Cook

ing p

laces

Pack

ing p

laces

Man

agin

gSa

les

Circ

umfe

renc

e/2n

d floo

r

Location

Precooking room, filling room; upper wall, ceiling

Upper wall Product warehouse

Factory as a whole Freezer Ceiling/ Illumina-

tion/ Duct

Contents Cleaning Cleaning Cleaning

Checking/inspection/calibration/exchange

Cleaning Cleaning

Frequency Monthly Monthly Monthly Monthly Semiannually Semiannually

In charge On the roster

On the roster

On the roster

Managing staff

All cooking workers Outsourced

Jan.

Feb.

Mar.

Apr.

May

Jun.

Jul.

Aug.

Sep.

Oct.

Nov.

Dec.

Monthly/yearly management record, XX YY, ZZZZ

In charge validation None

Table 2: Two types of checklist summarizing four frequencies of cleaning

6

of 3 or 2 points must be increased. Moreover, the higher the total

points of each worker (rightmost column of Table 3), the more the

safety and product quality are improved, leading to higher prof-

its. Some companies connect the competence of part-time and

side-job workers to their hourly wages. To improve and broaden

competence, education and training are required, but if workers

have broadened competences, variation in competence may be

reduced, which leads to cost-saving.

Use of an ATP Test in monitoring important PRPs (OPRPs)

Many food companies establish heat cooking as a CCP. How-

ever, steady control of CCPs alone cannot ensure product safety

because if contaminated items such as plastic containers, gloves,

and scissors contact thermally sterilized products, the products

may also be contaminated. Thus, hygiene control of equipment

that may contact these products is an important PRP, and such a

PRP-related operation is defined as an Operation PRP (OPRP) in ISO

22000. For example, a rule might be established that cleanliness

of lines with which thermally sterilized products may come into

contact is validated with an ATP Test daily before initiating produc-

tion, and if the site fails the ATP Test, the lines must be recleaned

until the ATP Test is passed before initiation of production. Such a

DepartmentWork-

er’s name

Precooking Cooking Cooling/packaging Picking Delivering Validating

facilityValidating products

Internal audit Personal

total pointsProduction Validation and audit

Cooking department

A 3 3 3 2 3 3 3 20

B 2 1 3

C 2 2 1 1 2 8

Packing department

F 2 1 3 3 2 2 2 1 16

G 1 2 1 2 2 8

H 2 1 2 1 1 1 8

Managing department

K 1 2 1 3 3 3 13

L 2 1 2 2 2 9

M 1 2 1 4

Sales department

R 3 3 1 1 8

S 2 2 4

T 1 2 3

Total points of the operation team

13 12 13 13 13 12 13 15

Quantify competence of each worker

3, experienced and can educate other workers; 2, can perform procedure without instructions; 1, can work under instructions

Competence, evaluation, education and training (ISO 22000 6.2.2)

Start to register compe-tence in CCP and OPRP

Relating personal total points to hourly wage

The higher the competence score, the more stable the procedure

If possible, the total points are divided into points for pro-duction and points for validation and audit.

Set individual competence goal

Establishing a rule that an operation team must include at least one worker with 3 points and one with 2 points leads to a safe pro-cedure.

Table 3: An example of a competence evaluation table

rule can be used only with an ATP Test, since the test can numer-

ically indicate the result in situ, whereas determining fail or pass

in a common culture test takes a few days. As shown in Fig. 4, a

PRP requires a site to be clean visually; however, an OPRP requires

passing of in situ tests such as an ATP Test. Case examples of im-

plementation of an ATP Test for an OPRP are given below.

[Case 1: Meat product]

In a sausage factory, raw sausage is smoked (heat sterilization

CCP

OPRP

PRP

Validating the temperature of heat sterilizationDetermining safety using a metal detector

Cleaning important sitesPassing an ATP Test allows initiation of operations

General cleaningVisual cleanliness only is required

Figure 4: Sites that need to be especially clean are designated as OPRPs and are controlled

7

CCP) and packed. In the packing process, it is

essential that the smoked sausage is not con-

taminated by the environment. Therefore, the

packing process is designated as an OPRP, and

cleanliness of scissors and plastic containers are

validated at ≤500 RLU in an ATP Test (some com-

panies use ≤200 RLU) (Photograph 2).

[Case 2: Precut vegetables]

In precut vegetable factories, there is no

heating process. Therefore, in some factories,

the process in which precut vegetables are

washed with electrolyzed water is controlled

as a CCP. The following dehydration and pack-

ing processes are designated as OPRPs: clean-

liness of the inside of dewatering bins used in

dehydration and containers and shovels used in

packing are inspected with an ATP Test with a

benchmark value of ≤500 RLU (Photograph 3).

[Case 3: Japanese confectionery]

In dora-yaki factories, anko is put on a baked

sponge cake, and dirt must not be present in the

equipment used to make anko and to put it on

to the cake. Therefore, cleanliness of anko-filling

tanks and nozzles is inspected with an ATP Test

using a benchmark value of ≤500 RLU, as an

OPRP. Cleaning of belts of the dora-yaki pack-

ing line are inspected with an ATP Test with a

benchmark value of ≤500 RLU, also as an OPRP

(Photograph 4).

[Case 4: Boxed lunches, ready-made dishes,

school lunch, cooking large quantities of food]

In boxed lunch factories, each item of cook-

ing equipment used in the heating process is

designated as a CCP. After heating, ready-made

dishes are put into a box. The important point

is cleanliness of the boxes, especially cleanliness

of reusable boxes. Therefore, cleanliness levels of

the inside of reusable boxes are inspected with

an ATP Test with a benchmark value of ≤500

RLU, as an OPRP (Photograph 5).

[Case 5: Meat]

In factories where meat is packed, there is no

heating process. Therefore, cleanliness of blades

Center temperature,

75-85°C

ATP Test: ≤500 RLU

ATP Test: ≤500 RLU

Concentration, temperature,

and sterilizing time of electro-

lyzed water

ATP Test: ≤500 RLU

Center temperature,

75-85°C

ATP Test: ≤500 RLU or lower

Surface temperature: 7°C or lower

ATP Test: ≤500 RLU

Recording ATP Test sites and results

Photograph 2: OPRP in a sausage factory: cleanliness of items such as scissors and plastic containers used in packing after heat sterilization is inspected with an ATP Test

Photograph 3: OPRP in a precut vegetable factory: cleanliness of inside of dewatering bins, boxes and shovels used in packing process is inspected with an ATP Test

Precooking → Smoking (heat sterilizing) (CCP) → Cooling → Packing (OPRP) → Metal detector test (CCP)

Precooking → Primary cleaning → Sterilizing/cleaning (CCP) → Dehydrating (OPRP) 　　　　　　　　　　　　　　　　　　　　　　　　→ Packing (OPRP) → Metal detector test (CCP)

Anko and sponge cake (CCP) → Anko filling machine (OPRP) → Belts, before packing (OPRP) 　　　　　　　　　　　　　　　　　　　　　　　　　　 → Packing → Metal detector test (CCP)

Photograph 4: OPRP in a dora-yaki factory: cleanliness of anko-filling machine, nozzles, and belts in packing step is inspected with an ATP Test

Precooking → Cooking (each machine) (CCP) → Cooling (OPRP) → Inspecting cleanliness of inside of boxes (OPRP) → Putting into boxes (OPRP) → Metal detector test (CCP)

Photograph 5: OPRP in a boxed lunch factory: cleanliness of inside of reusable boxes is inspected with an ATP Test

Precooking → Inspecting cleanliness of slicing equipment and tools (OPRP) → Measuring surface temperature (OPRP) → Packing → Metal detector test (CCP)

Photograph 6: OPRP in a meat factory: cleanliness of blades of slicers is inspected with an ATP Test

8

[Case 6: Seafood product]

In factories where shredded raw squid is

produced and packed, there is no heating

process. Therefore, the temperature of steri-

lized water (ozone water) and sterilizing time

are controlled as CCPs, and cleanliness of

cutting boards and knives used in cutting of

squid, and blades of multi-slicers are inspect-

ed with an ATP Test with a benchmark value

of ≤500 RLU, as an OPRP (Photograph 7).

[Case 7: Food service facilities providing raw

food]

In food service facilities providing raw food,

an ATP Test can be used at various sites and

locations: precooking baskets and trays for

salad vegetables; cooking tools for non-heat-

ed dishes, including knives, cutting boards,

and trays, and their storage locations; and

tableware after cleaning and drying (Photo-

graph 8).

Supplement: The product zone is an especial-

ly important space

A spot-check for a client found a high bac-

terial level in a seafood-paste product shipped

by a factory, and the factory was penalized by

stopping delivery for a month. In this factory,

fish meat was pasted, shaped, steamed (heat

sterilization CCP), cooled, and packed. After

investigation, the cause of the high bacterial

level was suspected to be dew condensation

that contaminated the heated product be-

fore packing. Thus, as anti-dew condensation

measures, humidity was reduced by electric

fans and the upper sides of packing machines

were covered. As described above, a place

where the product is exposed is referred to as

a product zone and requires especially strict

anti-contamination measures. In this case,

dew condensation contaminated the product

in the product zone.

Key Points in establishing a HACCP Sys-

tem (7 principles and 12 steps)

As described above, a HACCP system will

Multi-slicer for shredded raw squid

Concentration, temperature,

and sterilizing time of electro-

lyzed water ATP Test: ≤500 RLU

Precooking baskets

for salad vegetables

Inside of tablew

are after

cleaning and dry

ingStorage location of non-heated

dishes

Tray for salad vegetables

Knives, cutting

boards, and tra

ys for

non-heated dish

es Use food material-speci�c

cutting boards

ATP Test: ≤500 RLU

Photograph 7: OPRP in a shredded raw squid factory: cleanliness of cutting boards, knives, and blades of slicers is inspected with an ATP Test

Photograph 8: Tools and sites for ATP testing at a food service facility providing raw food

Step 1 Assemble a team of specialists

Step 2 Describe raw materials and products

Step 3 Identify the intended use of the final product

Step 4 Develop a flow diagram that describes the production process

Step 5 Verify the flow diagram on-site

Step 6 (Principle 1) Conduct a hazard analysis

Step 7 (Principle 2) Determine critical control points (CCPs) and important PRPs (OPRPs)

Step 8 (Principle 3) Establish critical limits

Step 9 (Principle 4) Establish monitoring methods

Step 10 (Principle 5) Establish corrective actions

Step 11 (Principle 6) Establish verification procedures

Step 12 (Principle 7) Establish record-keeping and documentation procedures

Table 4: Twelve steps of HACCP

of slicers used to make meat is inspected with an ATP Test with a benchmark value

of ≤500 RLU and surface temperatures of meat are measured with a standard value

of ≤7°C, both as OPRPs (Photograph 6). The meat factory used almost 100 testing

swabs daily in the first year, with enormous effects on cleanliness.

9

have more effect after foreign items (insects, fungi, bacteria, etc.)

are reduced by cleaning. A HACCP system is composed of the 12

steps shown in Table 4. The key points in addressing the 12 steps

are as follows.

Step HazardPRP

OPRP CCP

Critical limit Monitoring/Measuring method Corrective action Name of

recordSelective control

1 PorkQuality/Temperature on receiving

PRPFreshness/Foreign object/0-5°C

Visual inspection/Surface thermometer

Returning goodsReceiving record

2 Mixedflavoring

Mixing error/ Humidity PRPAccurate mixing/ Humidity-free

Solubility test/Visual inspection

Returning goodsflavoring test record

3 Ice Contamination of water PRP Tap water standardsConcentration of sodium hypochlorite

Notification to local authorities

Internal factory record

4 Sheepcasing

Quality/Temperature on receiving

PRPFreshness/Foreign object/0-5°C

Visual inspection/ Surface thermometer

Returning goodsReceiving record

5 Packingmaterials

Foreign object/dust PRPFree from foreign object/ dust

Visual inspection Returning goodsReceiving record

6.8 Coolingstorage

Temperature error/ Bacterial propagation

PRP 0-4°CAutomatic recording thermometer

Inspection/repairAutomatic record

7.9Roomtemperature storage

Quality deterioration of flavoring

PRPflavoring storage warehouse/25°C or lower

Automatic recording thermometer

Inspection of air-conditioner during summer season

Automatic record

10 Shaping(splitting)

Foreign object ingress/ temperature rising

PRPAdmission requirement/ room temperature

Automatic recording thermometer /ATP Test

Adjusting air-conditioner/ re-cleaning equipment

Automatic record

11-13 Weighing weigh error PRP Accurate weighing

Verification in the next step

Re-weighingCooking record

14Shredding/mixing

Foreign object ingress/ insufficient emulsifying

PRP

Admission requirement /contamination of equipment/emulsification

Visual inspection/ temperature verification/ ATP Test

Re-cleaning or discarding equipment

Cooking record

Selective control

with ATP Test

15 FillingForeign object ingress/ temperature rising

PRP

Admission requirement/contamination of equipment/room temperature

Automatic recording thermometer Inspection/ATP Test

Adjusting air-conditioner /re-cleaning equipment

Automatic record

16 Smokeheating

Insufficient heating CCP 72°C or more Center thermometerchanging to freezing and boiling

Cooking record

17 ShoweringForeign object ingress/ contamination by bacteria

OPRPCleaning/sterilization/clean water

Visual inspection/water test/ATP Test

Re-showeringPacking record

18 Cooling Insufficient cooling OPRPMaking product temperature 10°C or lower within 2 hours

Temperature of the cooling room/ temperature of product

Adjusting refrigerator/elongating cooling time

Packing record

19 Separating(cutting off)

Foreign object ingress/ contamination by bacteria

OPRPFree from foreign objects/ cleanliness of equipment

Visual inspection/ATP Test

Re-cleaning equipment

Packing record

20 Weighing/Packing

Foreign object ingress/ contamination by bacteria

OPRPFree from foreign objects/cleanliness of equipment

Visual inspection/ATP Test

Re-cleaning equipment

Packing record

21Labeling/inspectingproduct

Printing error/metal object ingress

CCPAccurate printing/free from metal objects

Pointing and calling/metal detector test

Re-printing/cause tracking and improving

Packing record

22 Outerpacking

Foreign object ingress/quantity error

PRPFree from foreign objects/total weight

Visual inspection/ measuring total weight

Re-packingPacking record

23 Storing Improper temperature PRP 0-4°CAutomatic recording thermometer

check and repairAutomatic record

24 Shipping

Contamination of vehicles/temperature during transport

PRP

Maintenance of inside of vehicles/1-6°C of temperature during transport

Measuring temperature during transport

check and repairVehicle temperature record

The benchmark value of the ATP Test is ≤200 RLU.Step 4: Sheep casing must be used within 4 months after receiving.Step 14: Emulsifying red meat, fat, and water must be completed at 8-12°C.

Step 6: Conducting hazard analysis (Principle 1)

Step 7: Determining CCPs and OPRPs (Principle 2)

Step 9: Establishing CCP monitoring/measuring methods (Principle 4)

Step 10: Establishing corrective actions (Principle 5)

Step 8: Establishing critical limits (Principle 3)

Table 5: Examples of control programs using PRPs, OPRPs, and CCPs

[Step 1] Assembling a team of specialists

The key point is to develop an organizational chart of each op-

erational team, including top management and leaders, and pur-

chasing and sales staff because safe raw materials must be pur-

chased in the HACCP system. I am often asked “How long does

10

it take to establish a HACCP system?”, and I always answer that it

takes at least 2 years. If completion in a year is attempted, on-site

workers cannot catch up with the changes and establishment of

the HACCP system will fail. A gradual approach over about 2 years

is recommended.

[Step 2] Describing raw materials and products

The key points are to determine the objective products for

HACCP, and to organize information on the products and raw ma-

terials. For PRP, the objective is the factory as a whole; however, for

HACCP, the objectives vary depending on the product. A plurality

of products are produced in common food factories, but I recom-

mend starting with one product. For example, if a boxed lunch,

ready-made dish, or school lunch factory has 3 lines for ① fried

products (using a conveyor fryer), ② grilled products (using a con-

veyor oven), and ③ braised products (using a braising pan), it is ad-

visable to start with one of the lines. If a HACCP system is success-

fully established for one line, then address another line. Also, the

MHLW recommends stepwise introduction of HACCP programs

depending on types of products, and preparation for obligatory

HACCP is possible in this way. Safety information for raw materials

should be organized in compliance with ISO 22000, which requires

this information to be classified based on ① biological, chemical,

and physical properties, ② composition of materials and additives,

③ sources, ④ production method, ⑤ packing and delivering

methods, ⑥ storage conditions and shelf life, ⑦ preparation or

handling before use or production, and ⑧ acceptance/rejection

criteria or specification. Safety information should be sorted into

sheets and safety should be verified.

[Step 3] Identifying the intended use of the final product

The key point is to quantify product safety, in compliance with

standards regulated by Laws such as the Food Sanitation Law. Vol-

untary standards can be used if not regulated by Laws.

[Step 4] Developing a flow diagram that shows production pro-

cesses as blocks

Hazard analysis for each block is performed in Step 6. Missing

processes in a flow diagram leads to imperfect hazard analysis,

and thus a correct flow diagram is extremely important.

[Step 5] Verifying the flow diagram on-site

The key point is to verify whether on-site production processes

are as shown in the flow diagram. Different processes from those

shown in the flow diagram are often seen, and thus, processes

must be verified on-site. Moreover, in an on-site inspection, care

should be taken to avoid, for example, a source of dust or dew

condensation in the upper side of product zones. If such a finding

is made, it should be improved immediately or, if this is not possi-

ble, it should be recorded on the list of unsolved problems.

[Step 6] Conducting a hazard analysis

[Step 7] Determining CCPs and OPRPs

[Step 8] Establishing critical limits

[Step 9] Establishing monitoring methods

[Step 10] Establishing corrective actions

In Steps 6 to 10, hazard analysis is conducted and CCPs are de-

termined as shown in Table 5. Since OPRPs are required by ISO

22000 only, they are not needed for an obligatory HACCP. Howev-

er, since each OPRP is important for safety, as described above, uti-

lization of OPRPs for voluntary standards is recommended. A PRP

may be based on visual cleanliness, rather than a quantified critical

limit, but such a limit is required for CCPs and OPRPs.

[Step 11] Establishing verification procedures

Verification is roughly divided into determining ① if the pro-

Requirements (objectives) of verification Procedure Frequency

1 Clean production environment(effective PRP) ATP Test result is within the tolerable level (e.g. weekly ATP Test) Daily, weekly, monthly, etc.

2 Safe product Bacterial count is within the tolerable level (e.g. daily bacterial rapid test), the expiration date set is appropriate

Daily, weekly, monthly, and yearly scientific measurement and sensory inspection, etc.

3 Verification of inspection tools(verification of accuracy)

Verification of accuracy of inspection tools, including thermometers, weighs, and sugar content meters Monthly, yearly, etc.

4 Cause of claims or recall Cause tracking Determined in each case

5 Maintenance of food safety system Reviewing the total HACCP system, including implementation, system, communication, and management of PRP and HACCP as a whole

Yearly review meeting (e.g. in May and November)

Table 6: Establishing verification procedures

11

duction environment is clean, ② if the product is safe, ③ if in-

spection tools have sufficient accuracy, ④ the causes of claims or

recall, and ⑤ if the food safety system can be maintained (Table

6). ③ is an important item among verification procedures because

inspection tools such as thermometers used in monitoring CCPs

and OPRPs may develop problems over time and must be verified

with various methods, as shown in Photograph 9.

[Step 12] Establishing record-keeping and documentation proce-

dures

The key points are to facilitate finding a record as needed and

to allow linkage of data (tracing data). Records should be stored in

personal computers by scanning paper forms.

In a food factory, 600 employees previously recorded their

health status on handwritten forms when entering every morn-

ing, and data aggregation required a lot of work. Now, they touch

a tablet computer and data are managed through cloud commu-

nication. Various recording systems can be easily established by

utilizing products such as a mailform on the internet (if this is of

interest, search for “how to establish a mailform”).

Final point

We include information on HACCP and hygiene control on the

website of our company, and we hold seminars and workshops.

Please look at this information at http://www.foodesign.net/

Accuracy verification with a standard mercury thermometerMeasuring the temperature of a bare hand with a standard ther-mometer → Measure the temperature with a thermometer to verify

Accuracy verification with ice water (0°C) or boiling water (100°C)

Accuracy verification with a standard thermometer

Accuracy verification by comparing several thermometers

Accuracy verification of weights

Photograph 9: Verification of accuracy of inspection tools

2-1-1, Nishi-shinbashi, Minato-ku, Tokyo 105-0003, JapanPhone　+81-3-5521-5481 Fax　+81-3-5521-5498

E-mailURL

biochemifa@mail.kikkoman.co.jphttp://biochemifa.kikkoman.co.jp/e/http://www.kikkomana3.com/

Originally published in Monthly magazine “HACCP” October 2017, © 2018 Kikkoman Corp. (PA-056-2Y180301)