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) selfassessment 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 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)
- 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)

Advanced level (3)

- 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 - preventive equipment and facilities - sanitation and personal hygiene programs

A scientific evidencebased, 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

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 evidencebased, 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):

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 PRPs 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 PRPs 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: 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, lets 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 companys own historical data (i.e. which temperatures are best suited to control the growth of pathogens while keeping the products 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. 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: 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 welldocumented procedures. Therefore, to validate the cooling capacity at Level 3 (and to upgrade form Level 2 to Level 3), the procedure is the following:

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/ information (i.e. Installation companies, Suppliers:

b) Technical

http://www.europages.nl/) c) Expert knowledge: http://www.scopeknowledge.com/Default.aspx (i.e.in Belgium: Chausse de Charleroi, 175B-5030 Gembloux Tel: +32 81 61.68.60/ +32 496 33.21.00 E-mail: [email protected]) 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 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) to

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:

1. Design the experiment (product, condition and microorganism) 2. Use microbiological strains as inoculants 3. Select test procedures (i.e. ISO standards) 4. 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. 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, lets 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?

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 companys 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:

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 o Codex Alimentarius standards for products which undergo pasteurization, www.codexalimentarius.net/; USFDA pasteurized milk:

http://www.fda.gov/Food/FoodSafety/ProductSpecificInformation/MilkSafety/NationalConferenceonInterstateMilk ShipmentsNCIMSModelDocuments/PasteurizedMilkOrdinance200 7/default.htm; o Regulation (EC) 853/2004 (Section IX, Chapter II) Commission Regulation (EC) 2074/2005 (Amending Regulation 853/2004,

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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 72C for 15 seconds); (2) A low temperature for a long time (at least 63C 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 135C 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 30C in closed containers or for 7 days at 55C 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.

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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 welldocumented 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:

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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 72C. 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 72C).

Pasteurisation: a food industry practical guide (2nd Ed.2006), CCFRA guideline n51.

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

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3. Select the most appropriate temperature-time combination (considering the coldspots) 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, lets suppose we want to validate the determination of a Critical Control Point (CCP), or CCP analysis. A CCP

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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).

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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 692008, 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

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5. Note the findings in an expert report

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

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 Sperber, W. H., 2005. HACCP does not work from Farm to Table. Food Control 16, 511514. 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, 325332. 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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19

Annex I
Table 1. Grid to assess design level of preventive measures Indicator Sophistication of hygienic design of equipment and facilities Adequacy of cooling facilities Assumed mechanism A more advanced hygienic design decreases chance on (cross) contamination, which will positively contribute to food safety More adequate cooling facilities better maintain strict temperature conditions to prevent growth, which will positively contribute to food safety A full-steps and tailored sanitation program with appropriate cleaning agents, supported with appropriate instructions better prevents contamination, will positively contribute to food safety Higher and more specific personal hygiene requirements with specific instructions reduce chance on contamination, which will positively contribute to food safety Low level 1) Equipment and facilities basically not designed according to EHEDG guidelines or comparable criteria 1) building and building connected installations Domestic/general cooling facilities. Principal capacity not known nor tested Medium level Standard hygienically designed equipment (EHEDG/comparable criteria) as available by equipment suppliers, not integrated in hygienic designed facilities. Industrial cooling facilities. Information about principal cooling capacity from suppliers, not tested for specific food production circumstances Complete programme and differentiated for equipment and facilities. Cleaning agents selected based on advices of suppliers. Idem for instructions about use and frequency. High level Integrated hygienic design of equipment and facilities (EHEDG criteria), and modified for companies specific food production characteristics in collaboration with equipment and cleaning suppliers. Industrial cooling facilities specifically modified for companies specific food production circumstances. Cooling capacity tested by temperature check of products, for different circumstances 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. High requirements, for all food operators, on clothing, personal care and health. Tailored facilities to support personal hygiene. Specific training and hygiene instructions

Specificity of sanitation program

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

Extent of personal hygiene requirements

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

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Table 2. Grid to assess design level of intervention method Indicator Adequacy of intervention equipment Assumed mechanism More capable intervention equipment enables less unpredictable process variation and better compliance to standards, which will positively contribute to food safety Low level Standard intervention equipment, process capability not known. No information about process capability in equipment specifications. Medium level 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 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) 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 High level Intervention equipment specifically modified for companiesspecific food production circumstances and process capability is tested. Information is welldocumented 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). Intervention method is modified companies specific food production system characteristics. Reduction level is known by testing with experiments and is welldocumented.

Specificity of maintenance program for intervention equipment

Effectiveness intervention methods

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 More specific intervention methods reduce better contamination load of (raw) materials, 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.

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

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Table 3. Grid to assess design level of monitoring system Indicator Appropriateness of CCP analysis Assumed mechanism 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 Low level 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 Medium level Hazard identification, risk analysis and allocation of CCPs based on hygiene codes for sector or executed by external expertise (consultancy) who work according to official Codex guidelines. CCPs determined by microbial product tests and or historical data 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 High level 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. CCPs determined by microbial product tests and modelling of hazard behaviour and/or challenge tests. 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 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. Conventional culture-based methods used (i.e. plate counts, most probable number, presence -absence tests) or

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 CCPs, 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

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

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

Adequacy of analytical methods to assess pathogen levels

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

Standard available measuring equipment complying with ISO (other international recognised) norms (accepted accuracy). Inline measurement (immediate response), often automated, information/data history available 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 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 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 A more complete and differentiated description of corrective actions linking severity of deviations to type of corrective actions will positively contribute to food safety

(inter)nationally acknowledged procedures is followed

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

Specificity of sampling design / measuring plan

Extent of corrective actions (CA)

Sampling design and measuring plans based on experience and in-house knowledge. No information about distribution of pathogens, samples are taken as spotcheck procedure CAs based on experience, and consensus within company. Incomplete descriptions process adjustment and or handling non-compliance products, no structural analysis of cause of deviation. CAs not differentiated for different deviations

modified quicker methods. Internationally validated methods are used (not accredited) Calibration and verification outsourced at equipment suppliers. Task and frequency based on international standards, not specific for food production system, documentation at equipment suppliers 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) CAs based on hygiene codes including process adjustment measures and handling noncompliance products, not adjusted for own process, product characteristics; ad hoc analysis of cause of deviation, no differentiated actions

modified quicker methods. Internationally validated and accredited methods are used Calibration and verification program specifically designed based on data from own food production system, according to international standards. Tasks and frequency in- house documented Sampling design and measuring plan based on statistical analysis of pathogen distribution in own food production process

CAs 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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References Codex Alimentarius Commission (CAC) (2003). Recommended International Code of Practice General Principles of Food Hygiene CAC/RCP 1-1969, Rev. 4

Codex Alimentarius Commission (CAC) (2008). Guidelines for the validation of food safety control measures. CAC/GL 69. FAO/WHO Codex Alimentarius Commission.

International Life Sciences Institute (ILSI) (2009). Risk assessment approaches to setting thermal processes in food manufacture. ILSI Europe, Risk Analysis in Microbiology Task Force (RA/45.1/MA09) ISO 22000:2005 (2005). Food safety management systems requirements for any organization in the food chain.

ISO 9001:2008 (2008). Quality management systems-requirements

Leaper, S. and Richardson, P. (1999). Validation of Thermal Process Control for Assurance of Food Safety. Food Control (10), 281-283.

Luning, P.A, Marcelis, W.J, Rovira, J., Van der Spiegel, M., Uyttendaele, M., Jacxsens, L. (2009). Systematic assessment of core assurance activities in a company specific food safety management system. Trends in Food Science and Technology (20), 300-312.

Luning, P.A., Bango, L., Kussaga, J., Rovira, J. and Marcelis, W. (2008). Comprehensive analysis and differentiated assessment of food safety control systems: a diagnostic instrument.

Mayes, T. (1999). How can the principles of validation and verification be applied to hazard analysis? Food Control (10), 4-5, 277-279.

Notermans, S., Gallhoff, G., Zwietering, M.H. and Mead, G.C. (1995). The HAACCP concept: specification of criteria using quantitative risk assessment. Food Microbiology, (12), 81-90. Notermans, S., Int Veld, P., Wijtzes, T. and Mead, G. C. (1993). A user's guide to microbial challenge testing for ensuring the safety and stability of food products. Food Microbiology (11), 145-157.

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