Protocol for validation of FSMS

1. Introduction

The aim of this protocol is to provide an easy step by step procedure that explains how a

company with a certain Food Safety Management System (FSMS) can increase the level of

its validation activities as illustrated in the FSMS Diagnostic Instrument (FSMS-DI) self-

assessment tool.

In the FSMS-DI, different activities can be distinguished within validation: validation of

preventive measures, validation of intervention systems and validation of monitoring

systems. In line with this, the protocol for validation of FSMS is divided into these three sub-

categories.

First, the definition of validation according to the FSMS-DI and to other different standards

will be presented. Following this, the protocol will be outlined.

2. Definitions

A. According to the FSMS-DI (developed within Pathogen Combat) (Luning et al.,

2008, 2009)

Validating refers to the assurance activity ‘validation’ which means that the effectiveness

of the technological and managerial measures aimed at controlling food safety are

checked in advance (before you implement/use the measure). This checking should be

done in a reliable and valid way which means that it should be: 1) supported by scientific

evidence; 2) specific for the food production circumstances; and 3) judged in an objective

way (e.g. by real data and or independent people).

A1. Validation of preventive measures

It refers to validation of the effectiveness/adequacy/efficacy of the hygienic design of

equipment and facilities, cooling facilities, sanitation program, personal hygiene

requirements, raw material control, and product specific measures. These are often

established in specific prerequisite programs (PRP).

A2. Validation of intervention systems

1

It refers to the validation of the effectiveness/adequacy/efficacy of the physical

interventions, packaging interventions and or biological/chemical interventions.

A3. Validation of monitoring systems

It refers to the validation of the monitoring of critical control points (correct location,

selection of the correct parameters to monitor, adequacy of measuring equipment to

monitor, etc).

There are three different levels at which validation can be performed and these are

shown in the grid below.

Table 1. Grid to assess the validation activities (Luning et al, 2009)

Grid to assess ‘validation activities’

Indicator Assumed mechanism Basic level (1) Medium level (2) Advanced level (3)

Sophistication of validating - preventive equipment and facilities - sanitation and personal hygiene programs

A scientific evidence-based, systematic, and independent validation of effectiveness of selected preventive measure will result in an effective control system, which will contribute product safety assurance

-effectiveness preventive measures validated based on historical experience, data, - not explicitly judged by experts, - on ad hoc basis, and findings scarcely (not) reported

- effectiveness preventive measures validated based on expert knowledge, regulatory documents, and historical results - by (internal) expert - on regular basis and after system modifications; findings documented (e.g. expert report)

- effectiveness preventive measures validated based on specific scientific sources (like scientific data/literature on validation studies, predictive modeling), historical results, and own experimental trials; - by independent experts, - on regular basis and after system modifications, findings reported and activities in well-documented procedures

Sophistication of validating effectiveness intervention equipment and intervention methods

Similar as for preventive measures

- similar for intervention systems as for preventive measures

- similar for intervention systems as for preventive measures

- similar for intervention systems as for preventive measures

Sophistication of validating monitoring systems (CCP and control points)

A scientific evidence-based, systematic, and independent validation of CCP determination and establishment of control circles will result in an effective FSMS, which will positively contribute to product safety assurance

- validation based on historical experience and/or common knowledge, - not explicitly judged by experts, - ad hoc basis; findings (not) scarcely reported

- validation based on comparison with regulatory documents (like specific hygiene codes), - by expert - on regular basis; findings documented (e.g. expert report)

- validation based on specific scientific sources (reviews, historical data on hazards, reports foodborne illnesses, data on survival or multiplication, epidemiology, etc.), - by independent expert - on regular basis and after system modifications; findings reported and activities in well-documented procedures

B. According to the Codex Alimentarius General Principles of Food Hygiene

(2003):

2

Validation is obtaining evidence that a control measure or a combination of control

measures, if properly implemented, is capable of controlling the hazard to a specified

outcome.

C. According to ISO 22000:2005:

Validation is obtaining evidence that the control measures managed by the full HACCP

plan and by the full Operational PRP’s are capable of being effective.

It is noteworthy to mention that a control measure is: an action or activity that can be

used to prevent or eliminate a food safety hazard or to reduce it to an acceptable level.

Moreover, an HACCP plan and Operational PRP´s are basic conditions and activities that

are necessary to maintain a hygienic environment throughout the food chain suitable for

the production, handling and provision of safe end products and safe food for human

consumption.

D. According to ISO 9001:2008

ISO 9001:2008 refers to the definition of validation in ISO 9000:2000 which defines it as

the confirmation through the provision of objective evidence that requirements for a

specific intended use or application have been fulfilled. In other words, validation refers to

the evaluation of a design to establish that it fulfils the intended use requirements.

3. The validation protocol

The validation protocol is divided into three parts: Part 1: the validation of preventive

measures; Part 2: the validation of intervention processes; and Part 3: the validation of

monitoring systems.

PART 1: Validation of preventive measures

First of all, in order to validate preventive measures, one needs to know what preventive

measures are and select what is going to be validated. So, what are preventive measures?

Preventive measures are designed and established with the objective of preventing

the entry and/or growth of pathogens in the food production system. They are:

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hygiene design of equipment facilities and tools, cooling facilities, sanitation programs

and personal hygiene requirements (Table 1, Annex I).

The next step is to select a preventive measure to be validated from those mentioned in the

definition. For instance, let’s suppose we select cooling facilities to validate. Then, the next

question, considering the definition of preventive measures and our selected measure to

validate, is: what is preventing the entry and/or growth of pathogens in the cooling

facilities?

Cooling facilities are aimed at preventing growth and therefore, the cooling capacity is

the main factor.

So now we know that the cooling capacity is determining the prevention of the growth of

pathogens and contributing to food safety. But the following question comes up: how do we

measure the effectiveness of the cooling facilities (with regard to its cooling

capacity)? In other words, how do we validate this measure?

The validation of the cooling facilities (the effectiveness of the control of temperature)

can be done at three different levels: Level 1(basic), Level 2 (medium) and Level 3

(advanced) (see Table 1):

At Level 1, the validation is based on historical experience and data is not explicitly

judged by experts. The findings are scarcely (or not) reported.

Therefore, to validate the cooling capacity at Level 1 the procedure is the following:

1. Make an inventory of knowledge about effectiveness of cooling facilities based on

the company´s own historical data (i.e. which temperatures are best suited to

control the growth of pathogens while keeping the product´s properties).

2. Select the most appropriate cooling capacity (postulated temperature) in

accordance to the inventory and implement it.

3. Measure the average temperature of the cooling facilities and the food product

and give the average ± an upper/lower limit. Measurements should be taken over

a planned period (i.e. a warm period and a cold period) and the thermometer

should be calibrated.

4

4. Adjust temperature if

a) Failure of the system (not reaching the postulated temperature)

b) Modification of the system

c) New regulatory information

This will entitle a validation of the cooling capacity at Level 1. If one wants to upgrade this

level or directly implement the validation at Level 2, please proceed.

At Level 2, the validation is based on expert knowledge, regulatory documents, and

historical results. It is carried out by an (internal) expert on a regular basis and after

system modifications. The findings are documented.

Therefore, to validate the cooling capacity at Level 2 (and to upgrade form Level 1 to

Level 2), the procedure is the following:

1. Make an inventory of knowledge about effectiveness of cooling facilities (i.e.

which temperatures are best suited to control the growth of pathogens while

keeping the product under appropriate conditions) based on:

a) An independent expert opinion such as companies installing cooling

facilities in Belgium:

AIR-CLIMA BVBA (Singel 7 2550 Kontich +32 34 51 34 90)

AMEEL KOELTECHNIEK BVBA (Houthulstseweg 90, 8920

Langemark Poelkapelle +32 57 44 82 71)

ARCO NV (Brandstraat 20 9160 Lokeren, +32 93 49 05 46)

COPELAND SA (Rue Trois Bourdons 27 4840 Welkenraedt +32

87 30 54 04)

DEBIT ET FROID SA (Avenue Du Marquis 25 6220 Fleurs +32 71

80 06 10)

KOELINSTALLATIES VAN DRIESSCHE NV (Wurmstraat 50 9940

Evergem +32 93 57 43 39)

b) Regulatory documents like Reg (EC) 852/2004, Reg (EC) 853/2004, and

Specific Codex Alimentarius standards (www.codexalimentarius.net/, i.e.

Code of hygiene of hygiene practice for refrigerated packaged foods with

extended shelf life CAC/RCP 46-(1999)) in order to know which product

temperature you should obtain.

c) Guidelines: EU Commission:

5

Guidance document on the implementation of certain provisions of

Regulation (EC) No 852/2004 on the hygiene of foodstuffs.

http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance

_doc_852-2004-new_en.pdf

Guidance document on the implementation of certain provisions of

Regulation (EC) No 853/2004 on the hygiene of food of animal

origin.

http://ec.europa.eu/food/food/biosafety/hygienelegislation/

guidance_doc_853-2004-new_en.pdf

d) Historical results of the company (i.e. registered refrigeration temperature

over a warm/cold period of 1 month in the cooling facilities and food

products in the company)

2. Select the most appropriate cooling capacity and implement it.

3. Measure the average temperature of the cooling facilities and the food product (±

upper/lower limit) in both a planned period (i.e. month, warm/cold period) and after

modifications of the system. The thermometer should be calibrated.

4. Adjust temperature if

a) Failure of the systems (not reaching the postulated temperature)

b) Modification of systems

c) New regulatory information

5. Note down the findings in reports.

This will entitle a validation of the cooling capacity at Level 2. If one wants to upgrade this

level or directly implement the validation at Level 3, please proceed.

At Level 3, the validation is based on specific scientific sources, historical records and

own experimental trials. It is done by independent experts, on a regular basis and after

system modifications. The findings are reported and the activities are sketched in well-

documented procedures.

Therefore, to validate the cooling capacity at Level 3 (and to upgrade form Level 2 to

Level 3), the procedure is the following:

6

1. Make an inventory of knowledge about effectiveness of cooling facilities based on:

a) Scientific literature (freely available)

http://highwire.stanford.edu/lists/freeart.dtl

http://www.ojose.com/

http://scholar.google.com/

b) Technical information (i.e. Installation companies, Suppliers:

http://www.europages.nl/)

c) Expert knowledge:

http://www.scopeknowledge.com/Default.aspx (i.e.in Belgium:

Chaussée de Charleroi, 175B-5030 Gembloux Tel: +32 81

61.68.60/ +32 496 33.21.00 E-mail:

chandra@scopeknowledge.com)

d) The use of mathematical expressions to describe microbial behaviour in

food (i.e. growth and inactivation models): Predictive modelling for

microbial outgrowth. There are free software packages available to

support companies:

http://www.arserrc.gov/mfs/PATHOGEN.HTML

(http://ars.usda.gov/services/docs.htm?docid=6786, PMP)

http://www.ifr.ac.uk/Safety/GrowthPredictor (Growth Predictor)

http://www.foodsafetycentre.com.au/riskranger.php (Risk Ranger)

e) Challenge testing to provide information about the microbiological status of

a product during its normal or expected life before consumption. It mainly

comprises the direct inoculation of a food with a microorganism. It is possible

to test both food safety (i.e. specific pathogen in a food) and food stability (i.e.

microorganism determining shelf-life). For this:

1º. Design the experiment (product, condition and microorganism)

2º. Use microbiological strains as inoculants

3º. Select test procedures (i.e. ISO standards)

4º. Interpret the results (i.e. legislative requirements critical limit)

f) Storage tests are used in end products to predict growth or death of

specific microorganisms. They are used in cases in which the microorganisms

of interest are known and present in sufficient numbers. It can be used to

mimic a possible handling situation after distribution of the product or even to

put the product under abused conditions.

7

For example, pasteurized milk could be stored under extreme

conditions (i.e. high temperature, long time) and Bacillus cereus

counts (ISO 7932) could be analyzed to see the possible risk of

these storage conditions for human exposure.

2. Select the most appropriate cooling facility (postulated temperature) and

implement it.

3. Measure the average temperature of the cooling facilities and the food product (±

upper/lower limit) in a specific planned period and after modifications of the

system. The thermometer should be calibrated.

4. Adjust temperature if

a) Failure of the systems (not reaching the postulated temperature)

b) Modification of systems

c) New scientific or regulatory information

5. Document well the findings. It is important to write down in detail the exact

validation procedure, the proof of calibration, the temperatures, etc.

This will entitle a validation of the cooling capacity at Level 3. Level 3 is the highest level as

in the FSMS-DI; the next step is continuous improvement.

PART 2: Validation of intervention systems

As in the validation of preventive measures, in the validation of intervention systems, it is

necessary to know what intervention systems are and select what is going to be validated.

So, what are intervention systems?

Intervention processes (systems) are planned and implemented to eliminate or

reduce the presence of pathogenic bacteria to acceptable levels. It comprises the

intervention equipment, the maintenance and calibration program for the intervention

equipment and the intervention method (Table 2, Annex I).

Now the intervention process to be validated must be selected. For example, let’s suppose

we choose to validate an intervention method and suppose this is pasteurization. Then, the

next question is, what is eliminating or reducing the presence of pathogens to

acceptable levels in pasteurization?

8

Pasteurization requires the appropriate combination of time and temperature which

eliminates or reduces the presence of pathogens to acceptable levels.

So now we know that the time and temperature of the pasteurization process are determining

the eradication or reduction of pathogens to acceptable levels and contributing to food safety.

But the following question comes up: how do we measure the effectiveness of the

pasteurization process? In other words, how do we validate this intervention process?

The validation of the pasteurization intervention process (the effectiveness of the

control of time-temperature) can be done at three different levels: Level 1 (basic),

Level 2 (medium) and Level 3 (advanced) (see Table 1):

At Level 1, the validation is based on historical experience and data is not explicitly

judged by experts. It is carried out on an ad hoc basis, and the findings are scarcely (or

not) reported.

Therefore, to validate the pasteurization intervention at Level 1 the procedure is the

following:

1. Make an inventory of the target pathogens and/or indicator microorganisms that

you want to reduce to acceptable levels with pasteurization. For instance, if we

chose to pasteurise milk, a target pathogen could be Listeria monocytogenes.

2. Make knowledge inventory about the effectiveness of pasteurizing based on

historical knowledge (i.e. which time-temperature combination is best suited for

the reduction of Listeria monocytogenes to acceptable levels while keeping the

product properties according to the company’s history).

3. Select the most appropriate temperature-time combination of pasteurization

(according to the first step) and implement it.

4. Measure the average time-temperature of the pasteurizer and give a ±upper/lower

limit over a planned period of time. The thermometer/chronometer should be

calibrated.

5. Adjust the Temperature-Time combination if:

9

Failure of the system (not reaching the temperature and time combination

and/or reduction of pathogens)

Modification of the production process

Modification of the product

New regulatory information

This will entitle a validation of the intervention method at Level 1. If one wants to upgrade this

level or directly implement the validation at Level 2, please proceed.

At Level 2, the validation is based on expert knowledge, regulatory documents, and

historical results. It is carried out by an (internal) expert on a regular basis and after

system modifications. The findings are documented.

Therefore, to validate the pasteurization intervention at Level 2 (and to upgrade form

Level 1 to Level 2), the procedure is the following:

1. Make an inventory of the target pathogens and/or indicator microorganisms that

you want to reduce to acceptable levels with pasteurization. For instance, if we

chose to pasteurise milk, a target pathogen could be Listeria monocytogenes.

2. Make an inventory of knowledge about the effectiveness of pasteurization (i.e.

which time-temperature combination is best suited for the reduction of Listeria

monocytogenes to acceptable levels while keeping product properties) based on:

a) Independent experts (i.e. scientists from research institutes, quality control

experts, etc.)

b) Regulatory documents

o Codex Alimentarius standards for products which undergo

pasteurization, www.codexalimentarius.net/;

o USFDA pasteurized milk:

http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/M

ilkSafety/

NationalConferenceonInterstateMilkShipmentsNCIMSModelDocum

ents/PasteurizedMilkOrdinance2007/default.htm;

o Regulation (EC) 853/2004 (Section IX, Chapter II) Commission

Regulation (EC) 2074/2005 (Amending Regulation 853/2004,

10

Annex VII); Commission Regulation (EC) 1664/2006 (amending

Regulation (EC) No 2074/2005). Which specify the following:

Pasteurisation is achieved by a treatment involving:

(1) A high temperature for a short time (at least 72ºC for 15

seconds);

(2) A low temperature for a long time (at least 63ºC for 30

minutes); or

(3) any other combination of time-temperature conditions to

obtain an equivalent effect, such that

the products show, where applicable, a negative

reaction to an alkaline

Ultra high temperature (UHT) treatment is achieved by a

treatment:

(1) Involving a continuous flow of heat at a high temperature

for a short time (not less than 135ºC in combination with a

suitable holding time) such that

There are no viable micro-organisms or spores

capable of growing in the treated product when

kept in an aseptic closed container at ambient

temperature; and

It is sufficient to ensure that the products remain

microbiologically stable after incubating for 15

days at 30ºC in closed containers or for 7 days at

55ºC in closed containers or after any other

method demonstrating that the appropriate heat

treatment has been applied.’;

c) Historical records of the company

3. Select the most appropriate temperature-time combination (considering possible

cold spots) and implement it.

4. Measure the average time-temperature of the pasteurizer and give a ±upper/lower

limit. Measurements should be taken over a planned period and the

thermometer/chronometer should be calibrated. Additionally, analyze the

presence/absence (or enumerate) the target pathogen.

11

5. Adjust temperature if

a) Failure of the systems (not reaching the postulated temperature-time

combination)

b) Modification of production system

c) Modification of the product

d) New regulatory information

e) Target pathogen requirements not reached

6. Note down the findings in reports.

This will entitle a validation of the intervention method at Level 2. If one wants to upgrade this

level or directly implement the validation at Level 3, please proceed.

At Level 3, the validation is based on specific scientific sources, historical records and

own experimental trials. It is done by independent experts, on a regular basis and after

system modifications. The findings are reported and the activities are sketched in well-

documented procedures.

Therefore, to validate the pasteurization intervention at Level 3 (and to upgrade form

Level 2 to Level 3), the procedure is the following:

1. Make an inventory of the target pathogens and/or indicator microorganisms that

you want to reduce to acceptable levels with pasteurization. For instance, if we

chose to pasteurise milk, a target pathogen could be Listeria monocytogenes.

2. Make an inventory of knowledge about the effectiveness of pasteurization (i.e.

which time-temperature combination is best suited for the reduction of Listeria

monocytogenes to acceptable levels while keeping product properties) based on:

a. Scientific literature (freely available)

http://highwire.stanford.edu/lists/freeart.dtl

http://www.ojose.com/

http://scholar.google.com/

For example, in the case of Listeria monocytogenes, the following

documents could be considered:

12

o Risk assessment approaches to setting thermal processes in

food manufacture (ILSI, 2009; www.ilsi.org). The following was

extracted:

D-value (decimal reduction time): time required at a

constant heating temperature to reduce the number of

organisms or spores by a factor of ten. The D-value of

L.monocytogenes is: 15-20 seconds at 72ºC.

z-value (kinetic value): temperature difference required to

effect a ten-fold change in the D-value (the D value will be 1

log higher or lower when it is heated z °F lower or higher,

respectively).

Po value (integrated lethal rate): Pasteurization Po 2

The acknowledged safe harbour for L. monocytogenes in

pasteurized milk is a 6D reduction (120 sec at 72ºC).

o Pasteurisation: a food industry practical guide (2nd Ed.2006),

CCFRA guideline n°51.

b. The use of mathematical expressions to describe microbial behaviour in

food (i.e. growth and inactivation models): Predictive modelling for

microbial outgrowth. There are free software packages available to

support companies:

http://www.arserrc.gov/mfs/PATHOGEN.HTML

(http://ars.usda.gov/services/docs.htm?docid=6786, PMP)

http://www.ifr.ac.uk/Safety/GrowthPredictor (Growth Predictor)

http://www.foodsafetycentre.com.au/riskranger.php (Risk Ranger)

c. Challenge testing to provide information about the microbiological status

of a product during its normal or expected life before consumption. It

mainly comprises the direct inoculation of a food with a microorganism. It

is possible to test both food safety (i.e. specific pathogen in a food) and

food stability (i.e. microorganism determining shelf-life). For this:

1. Design the experiment (product, condition and microorganism)

2. Use microbiological strains as inoculants

3. Identification of cold spots

4. Select test procedures (i.e. ISO standards)

5. Interpret the results (i.e. legislative requirements critical limit)

d. Historical records

13

3. Select the most appropriate temperature-time combination (considering the cold-

spots) and implement it.

4. Measure the average time-temperature of the pasteurizer and give a ±upper/lower

limit. Measurements should be taken over a planned period and the

thermometer/chronometer should be calibrated. Additionally, analyze the

presence/absence (or enumerate) the target pathogen.

5. Adjust temperature-time combination if

a) Failure of the systems (not reaching the postulated temperature-time

combination or not reducing pathogens to acceptable levels)

b) Modification of production system

c) Modification of the product

d) New regulatory information

e) Target pathogen requirements not reached

6. Document well the findings. More specifically, write down in detail the exact

validation procedure, the proof of calibration (dates), the temperature-time

combination and the results.

This will entitle a validation of the cooling capacity at Level 3. Level 3 is the

highest level as in the FSMS-DI; the next step is continuous improvement.

PART 3. Validation of monitoring systems

In line with Part 1 and Part 2, the first question that is asked when wanting to validate

monitoring systems is: what are monitoring systems?

Monitoring systems are made to provide information on the product and process

conditions. Monitoring systems entitles: CCP analysis, limits and tolerances

assessment, measuring equipment, analytical equipment, calibration and verification

program, sampling design and measuring plan and corrective actions (Table 3, Annex

I).

Now, a monitoring system to be validated must be selected. For example, let´s suppose we

want to validate the determination of a Critical Control Point (CCP), or CCP analysis. A CCP

14

is defined as a point, step, or procedure at which control can be applied and a food-safety

hazard can be prevented, eliminated, or reduced to an acceptable level. So, the next

question is how do we measure the effectiveness of the determined CCP(s)?

The validation of the monitoring system can be done at three different levels: Level 1

(low), Level 2 (average) and Level 3 (high) (see Table 1):

At Level 1, the validation is based on historical experience and data is not explicitly

judged by experts. It is carried out on an ad hoc basis, and the findings are scarcely (or

not) reported.

Therefore, to validate the determination of the CCP(s) at Level 1, the procedure is the

following:

1. Make an inventory of knowledge about the effectiveness of the CCP based on

historical knowledge (i.e. if it is truly a point in which control is undertaken and

contributes to food safety).

2. Select the most appropriate determination of CCP (according to the first step) and

implement it.

3. Measure the effectiveness of the CCP. For this the following questions should be

thought of:

Are all hazards covered?(Expected answer: Yes)

Is the safety outcome met (reduce the hazards to acceptable levels)?

(Expected answer: Yes)

4. Modify the CCP determination if:

Failure of the system (i.e. hazards not controlled, safety outcome not met)

Modification of the product

Modification of the production process

This will entitle a validation of the monitoring system at Level 1. If one wants to upgrade this

level or directly implement the validation at Level 2, please proceed.

At Level 2, the validation is based on comparison with regulatory documents. It is carried

out by an expert on a regular basis. Findings are documented (i.e. expert report).

15

Therefore, to validate the determination of CCP(s) at Level 2, the procedure is the

following:

1. Make an inventory of knowledge about the effectiveness of that CCP based on :

Independent expert knowledge

Regulatory documents (Regulation (EC) No 852/2004)

Guidelines:

o Codex Alimentarius Guidelines (CAC/RCP 1-1969, CAC/GL 69-

2008, www.codexalimentarius.net/)

o EU Commission Guidelines (http://europa.eu/):

1. Guidance document on the implementation of procedures

based on the HACCP principles, and on the facilitation of

the implementation of the HACCP principles in certain food

businesses

http://ec.europa.eu/food/food/biosafety/hygienelegislation/g

uidance_doc_haccp_en.pdf)

2. Guidance document on the implementation of certain

provisions of Regulation (EC) No 852/2004 on the hygiene

of foodstuffs.

http://ec.europa.eu/food/food/biosafety/hygienelegislation/g

uidance_doc_852-2004-new_en.pdf

2. Select the most appropriate determination of CCP (according to the first step) and

implement it.

3. Measure the effectiveness of the CCP. For this, the following questions should be

thought of:

Are all hazards covered?(Expected answer: Yes)

Is the safety outcome met (reduce the hazards to acceptable levels)?

(Expected answer: Yes)

4. Modify the CCP determination if:

Failure of the system (i.e. hazards not controlled, safety not met)

Modification of the product

Modification of the production process

5. Note the findings in an expert report

16

This will entitle a validation of the monitoring system at Level 2. If one wants to upgrade this

level or directly implement the validation at Level 3, please proceed.

At Level 3, the validation is based on specific scientific sources (reviews, historical data

on hazards, food-borne illness reports, etc.). It is carried out by an independent expert on

a regular basis and after system modifications. The findings are reported and the

activities are sketched in well-documented procedures.

Therefore, to validate the determination of CCP(s) at Level 3, the procedure is the

following:

1. Make an inventory of knowledge about the effectiveness of that CCP based on :

a) Scientific literature (freely available)

http://highwire.stanford.edu/lists/freeart.dtl

http://www.ojose.com/

http://scholar.google.com/

Anonymous. Good Practices for meat industry, 2004. FAO Animal

Production and Health Manual. FAO, Rome

Bolton, D.J. and Sheridan, J.J., 2002. HACCP for Irish Beef, Pork and

Lamb slaughter. Teagasc-The National Food Centre, Dublin

Codex Alimentarius Commission, 2003. Joint FAO/WHO Food

Standards Programme Food Hygiene - Basic Texts

Horchner, P. M., Brett, D., Gormley, B., Jenson, I., and Pointon, A. M.,

2006. HACCP-based approach to the derivation of an on-farm food

safety program for the Australian red meat industry Food Control, 17,

7, 497-510.

Jouve, J. L., 1999. Establishment of food safety objectives. Food

Control, 10, 303-305

Jeng, H.-Y.J. and Fang, T.J., 2003. Food safety control system in

Taiwan. The example of food service sector, Food Control, 14, 317–

322.

Lee, J. A. and Hathaway, S. C., 1998. The challenge of designing valid

HACCP plans for raw food commodities. Food Control, 9, 2-3, 111-

117.

Sperber, W.H., 1998. Auditing and verification of food safety and

HACCP. Food Control, 9, 157-162

17

Sperber, W. H., 2005. HACCP does not work from Farm to Table.

Food Control 16, 511–514.

Stewart, C.M., Tompkin, B.R. and Cole, B.M., 2002. Food safety: new

concepts for the new millennium. Innovative Food Science & Emerging

Technologies, 3, 2, 105-112.

Sun, Y.M. and Ockerman, 2005. A review of the needs and current

applications of hazard analysis and critical control point (HACCP)

system in food service areas. Food Control 16, 325–332.

Raspor, P., 2008. Total food chain safety: how good practices can

contribute? Trends in Food Science & Technology, 19, 8, 405-412.

b) Reports on food-borne illnesses (www. efsa .europa.eu )

c) Epidemiological data (www.who.int/en/)

d) Historical data on hazards

2. Select the most appropriate determination of CCP (according to the first step) and

implement it.

3. An independent expert measures the effectiveness of the CCP on a regular basis

and after system modifications.

4. Modify the CCP determination if:

a) Failure of the system (i.e. hazards not controlled, safety outcome not met)

b) Modification of the product

c) Modification of the production process

5. Document well the findings. More specifically, write down in detail the exact

validation procedure, the findings, etc.

This will entitle a validation of the cooling capacity at Level 3. Level 3 is the highest

level as in the FSMS-DI; the next step is continuous improvement.

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Annex I

Table 1. Grid to assess design level of preventive measures

Indicator Assumed mechanism Low level Medium level High levelSophistication of hygienic design of equipment and facilities

A more advanced hygienic design decreases chance on (cross) contamination, which will positively contribute to food safety

Equipment and facilities1) basically not designed according to EHEDG guidelines or comparable criteria1) building and building connected installations

Standard hygienically designed equipment (EHEDG/comparable criteria) as available by equipment suppliers, not integrated in hygienic designed facilities.

Integrated hygienic design of equipment and facilities (EHEDG criteria), and modified for companies’ specific food production characteristics in collaboration with equipment and cleaning suppliers.

Adequacy of cooling facilities

More adequate cooling facilities better maintain strict temperature conditions to prevent growth, which will positively contribute to food safety

Domestic/general cooling facilities. Principal capacity not known nor tested

Industrial cooling facilities. Information about principal cooling capacity from suppliers, not tested for specific food production circumstances

Industrial cooling facilities specifically modified for companies’ specific food production circumstances. Cooling capacity tested by temperature check of products, for different circumstances

Specificity of sanitation program

A full-steps and tailored sanitation program with appropriate cleaning agents, supported with appropriate instructions better prevents contamination, will positively contribute to food safety

Incomplete program not differentiated for specific equipment/facilities. Common cleaning agents not specific for production system. Instructions derived from information on label or company experience

Complete programme and differentiated for equipment and facilities. Cleaning agents selected based on advices of suppliers. Idem for instructions about use and frequency.

Complete programs, tailored for different equipment/facilities. Cleaning agents specifically modified and tested on effectiveness for companies’ specific food production system. Instructions on use and frequency based on test results.

Extent of personal hygiene requirements

Higher and more specific personal hygiene requirements with specific instructions reduce chance on contamination, which will positively contribute to food safety

Standard requirements for all employees on clothing (caps, gloves, jacks), personal care and health. Common washing facilities.No specific hygiene instructions

Additional task-specific requirements on clothing (own clothing, specific storage conditions), personal care and health. Special hand washing facilities. Basic hygiene instructions

High requirements, for all food operators, on clothing, personal care and health. Tailored facilities to support personal hygiene. Specific training and hygiene instructions

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Table 2. Grid to assess design level of intervention method

Indicator Assumed mechanism Low level Medium level High levelAdequacy of intervention equipment

More capable intervention equipment enables less unpredictable process variation and better compliance to standards, which will positively contribute to food safety

Standard intervention equipment, process capability not known. No information about process capability in equipment specifications.

‘Best standard’ intervention equipment available in practice, capability described in equipment specifications (provided by equipment suppliers). Equipment is principally capable to comply with standards & tolerances, not tested for own production system

Intervention equipment specifically modified for companies’specific food production circumstances and process capability is tested. Information is well-documented

Specificity of maintenance program for intervention equipment

More structural and tailored programmes for maintenance with specific instructions about frequency and tasks will cause less unexpected safety problems due to unreliable equipment, which will positively contribute to food safety

Maintenance is basically initiated by problems, ad hoc. No (clear) instructions about frequency and maintenance tasks; not well documented.

Maintenance program developed with support of, or by suppliers of equipment/tools. Specific instructions about frequency and maintenance tasks, well documented (at location or at equipment suppliers)

Maintenance program specifically designed for production process using data from regular inspections and breakdown analyses. Specific instructions on frequency maintenance tasks; well documented (at company).

Effectiveness intervention methods

More specific intervention methods reduce better contamination load of (raw) materials, which will positively contribute to food safety

Intervention methods are applied based on company knowledge, and experience; effectiveness not tested for own food production system characteristics, potential reduction level not known

Application of intervention method based on advices of specialised suppliers, but not tested for specific food production systems characteristics. Potential reduction level known based on literature or expert knowledge

Intervention method is modified companies’ specific food production system characteristics. Reduction level is known by testing with experiments and is well-documented.

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Table 3. Grid to assess design level of monitoring system

Indicator Assumed mechanism Low level Medium level High levelAppropriateness of CCP analysis

A higher level of scientific evidence and a more systematic way to analyse hazards and associated risk together with actual testing of CCP will result in more reliable and accurate control points, which will positively contribute to food safety

Internal experience/knowledge used for hazard identification and risk evaluation; selection of hazards to be controlled based on internal discussions, no strict methodology used. CCP determination based on consensus and not tested in practice

Hazard identification, risk analysis and allocation of CCP’s based on hygiene codes for sector or executed by external expertise (consultancy) who work according to official Codex guidelines. CCP’s determined by microbial product tests and or historical data

Hazard identification, risk analysis and allocation of CCP executed by using own knowledge/experience, additional scientific literature and or expert knowledge, according to Codex guidelines. CCP’s determined by microbial product tests and modelling of hazard behaviour and/or challenge tests.

Appropriateness assessment of standards and tolerances

More complete specification of both standards and tolerances of as well process parameters as pathogen levels, supported by scientific based data will result in more accurate CCP’s, which will positively contribute to food safety

Standards for critical process and product parameters are specified but tolerances not clearly specified Assessments of critical process and product standards basically on historical data and or company experience

Standards and tolerances for critical process and product parameters both clearly specified.Assessment of critical process and product standards and tolerances derived from general hygiene codes and legal requirements

Standards and tolerances for critical process and product parameters both clearly specified.Assessment of critical process and product standards and tolerances derived from Process parameters derived from legal requirements, hygiene codes, literature, and tested and tailored for own production system

Adequacy of measuring equipment to monitor process/ product

More accurate and responsive equipment to monitor critical process and or product parameters will result in more adequate monitoring, which will positively contribute to food safety

No standardised measuring equipment (accuracy not tested). On-line measurement, not automated, no information/data history available

Standard available measuring equipment complying with ISO (other international recognised) norms (accepted accuracy). In-line measurement (immediate response), often automated, information/data history available

Specifically selected equipment and adapted to the companies’ specific production process, and tested on accuracy. In-line measurement (immediate response), automated, information history immediately visual.

Adequacy of analytical methods to assess pathogen levels

More sensitive, specific, repeatable, reproducible and rapid methods to assess pathogens will result in more

Conventional culture-based methods used (i.e. plate counts, most probable number, presence -absence tests). No

Conventional culture-based methods used (i.e. plate counts, most probable number, presence -absence tests) or

Conventional culture-based methods used (i.e. plate counts, most probable number, presence -absence tests) or

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adequate determination of pathogens, which will positively contribute to food safety

(inter)nationally acknowledged procedures is followed

modified quicker methods. Internationally validated methods are used (not accredited)

modified quicker methods. Internationally validated and accredited methods are used

Specificity of calibration program for measuring and analytical equipment

More structural and tailored programmes for calibration and testing of measuring and analytical equipment will cause less unreliable test data, which will positively contribute to food safety

Calibration and verification on ad-hoc basis.Tasks and frequency not clear, and not (well) documented.

Calibration and verification outsourced at equipment suppliers. Task and frequency based on international standards, not specific for food production system, documentation at equipment suppliers

Calibration and verification program specifically designed based on data from own food production system, according to international standards. Tasks and frequency in- house documented

Specificity of sampling design / measuring plan

A statistical underpinned and tailored sampling design, measuring plan increases reliability of information on actual product/process status, which will positively contribute to food safety

Sampling design and measuring plans based on experience and in-house knowledge. No information about distribution of pathogens, samples are taken as spot-check procedure

Sampling design and measuring plan based on common sampling plans for the specific sector (e.g. meat, chicken, etc) as available in literature (e.g. EU guidelines, or ICMS for foods)

Sampling design and measuring plan based on statistical analysis of pathogen distribution in own food production process

Extent of corrective actions (CA)

A more complete and differentiated description of corrective actions linking severity of deviations to type of corrective actions will positively contribute to food safety

CA’s based on experience, and consensus within company. Incomplete descriptions process adjustment and or handling non-compliance products, no structural analysis of cause of deviation. CA’s not differentiated for different deviations

CA’s based on hygiene codes including process adjustment measures and handling non-compliance products, not adjusted for own process, product characteristics; ad hoc analysis of cause of deviation, no differentiated actions

CA’s based on systematic causal analysis of own product/process deviations, concerns process adjustments and handling non-compliance products. Structural analysis of deviations, differentiated actions

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