Food Control 22 (2011) 2047e2051

Contents lists available at ScienceDirect

Food Control
journal homepage: www.elsevier.com/locate/foodcont

Food supplier qualication by an Italian Large-scale-Distributor: Auditing system and non-conformances

Patrizia Losito a, *, Pierina Visciano b, Marisa Genualdo a, Giorgio Cardone a
a b

Chemiservice Srl, via Vecchia Ospedale Strada Privata 11, 70043 Monopoli (BA), Italy Department of Food Science, University of Teramo, Piazza Aldo Moro 45, 64100 Teramo, Italy

a r t i c l e i n f o
Article history: Received 17 January 2011 Received in revised form 25 May 2011 Accepted 31 May 2011 Keywords: Food suppliers HACCP Checklist Auditing Non-conformances

a b s t r a c t
Nowadays government and purchasers are constantly setting increasing stringent requirements for food quality and safety, this means that production and distribution companies in the food and beverage sector must have full control over all incoming and outgoing goods. In particular food suppliers for Largescale-Distributors have to meet many specic requirements and to undergo audits in order to assure the hygienic and sanitary quality of their products. This study offers an example of a checklist used by an Italian Large-scale-Distributor for investigating the status of its food suppliers in order to detect nonconformances; it also provides information on HACCP system management in Italian food industries. Results collected during 85 audits are shown. Large food plants show a better application of HACCP principles than small sized enterprises. 2011 Elsevier Ltd. All rights reserved.

1. Introduction It is the responsibility of the food industry to develop and implement an HACCP system which is an operation-specic internally managed system of preventative control that identies, evaluates and controls hazards of signicance to food safety. It can be considered an efcient tool for both industry and health authorities to prevent food-borne diseases if it is based on understanding and proper implementation (Ramrez Vela & Martn Fernndez, 2003). Food companies are closely monitored by their customers who want to be condent that the food being purchased is safe. In this regard, they are usually asked to pass an independent audit to check whether good manufacturing practice, good hygiene practice and HACCP principles are fully implemented and strictly followed in each step of the process. Audits are carried out by qualied second party auditors usually engaged in outsourcing; dates and modalities are arranged with company owner or production manager or HACCP consultant. The role of the inspector is to audit the system and the process by which it was developed and to verify the monitoring procedures. There are many important hygienic matters related to food quality and safety that are necessary for the effective application of the

HACCP system. These include, among others, the application of food hygiene at production level; building and equipment design and maintenance; water quality; cleaning and sanitizing programmes; pest control; personnel hygiene and employee training (Bas , Ersun, & Kivan, 2006). However, no information is available concerning the auditing system carried out by a Large-scale-Distributor on food suppliers and detected non-conformances. The main objective of this study was to investigate the checklist used and the non-conformances put in evidence by auditors engaged by an Italian Large-scaleDistributor aimed to monitor food suppliers according to hygienic and sanitary requisites. 2. Materials and methods This survey was carried out from 2005 to 2010 involving 85 foodstuffs suppliers for an Italian Large-scale-Distributor. Assessments were consisted of oil-mills (20), bakery (15), dairy (15), meat (11), wine (9) and pasta producers (5), catering services (3), confectioners (2), vegetable and/or sh preserve producers (3), frozen food logistic platforms (1) and honey producers (1). All plants were located in Central-Southern Italy and small enterprises were distinguished from large ones. Small plants were those included in European Union denition of micro-enterprises while large plants were all the others (Commission Recommendation 2003/361/EC). The visit was conducted by personnel trained in HACCP and prerequisite programs, conducting the auditing and

* Corresponding author. Tel.: 39 080 4136433; fax: 39 080 748486. E-mail address: losito@chemiservice.it (P. Losito). 0956-7135/$ e see front matter 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.foodcont.2011.05.027

2048

P. Losito et al. / Food Control 22 (2011) 2047e2051 Table 2 List of non-conformances concerning Hygienic practices with relative rates. Non-conformances concerning Hygienic practices BUILDING Lack of protection from animals, pests or environmental contaminants Non-conformances of wall requisites Non-conformances of doors requisites Non-conformances of ceiling requisites Possible cross-contamination on line Non-conformances of other structural requisites Failed sanitation of surrounding areas Non-conformances of oor requisites Failed partition of the establishment Non-conformances of windows requisites No partition between dirty and clean areas SERVICES Non-conformances of sanitary Non-conformances of personnel changing facilities Non-conformances of waste containers Defaults of lighting system Defaults of ventilation system Bad upkeep of air system Lack of positive pressure air system Failed waste removal Errors in potable water providing Possible contamination of internal laboratory Errors in non-potable water utilization INSTALLATIONS Defaults of measurement instruments and calibration Absence of metal detector Insufcient protection of product from contaminations Bad status of maintenance of plant Insufcient number of hand washing apparatus No weight control on line Difcult visual control of surfaces Inadequate materials of plants construction SANITATION AND HYGIENE Failed periodic control of sanitation programme Inadequate performance of sanitary products Inadequate utilization of sanitary products Failed application of a permanent sanitation programme Non-conformances in sanitation facilities Inadequate use of sanitation instruments Defaults of sanitation general degree PEST CONTROL Failed application of a permanent rodent control Failed application of a permanent insect control Failed periodic control of rodents Failed periodic control of insects Defaults of use and storage of pest control means and instruments Major (%) 2.8 1.3 1.2 0.8 0.7 0.7 0.6 0.5 0.5 0.4 0.1 1.2 1.1 0.9 0.8 0.8 0.7 0.5 0.4 0.3 0.3 0.1 3.6 3.0 3.0 2.6 1.8 0.7 0.6 0.4 1.3 0.7 0.6 0.5 0.5 0.3 0.3 3.2 1.9 1.6 0.5 0.2 Minor (%) 1.3 3.6 1.2 1.0 1.6 0.5 1.3 2.4 1.1 1.1 0.4 1.4 2.5 2.6 1.0 0.2 1.1 0.5 0.5 0.2 0 0.1 3.7 5.4 2.2 1.4 1.7 1.6 0.5 0.7 2.0 0.2 0.8 1.7 0.5 1.2 0.6 2.2 1.2 1.4 0.7 0.1

administrating a checklist with 15 items divided into two blocks regarding Hygienic Practices and Management Systems, respectively. In particular, the rst block included 5 parts with questions related to establishments, services and sanitation procedures, whereas the second one included 10 parts related to process ow diagram, implementation of HACCP program with the management of non-conformances, personnel hygiene practices and procedures, organization structure and documentations (Table 1). The audit form was closely related to Tables 2 and 3. All data were collected through examination of documents and records, interviews and direct observation of activities performed in food industries. At the second stage of the survey the external auditors lled in a report with the main non-conformances highlighted during their visit. Two main categories of non-conformances (majors and minors) were established. A major non-conformance occurred when there was a substantial failure of procedures and/or a critical failure to comply a food safety or legal issue, whereas there was a minor non-conformance in case of failures not regarding the product conformity (e.g. records not completed and led as per procedures). Within few days, the auditor was required to provide a copy of the audit report to the Large-scale-Distributor who provided identication of areas requiring improvement and demanded that the supplier applied corrective actions. Depending on the circumstances, the supplier and the Large-scale-Distributor agreed upon methods and time needed for corrective actions. Supplier selection and management depended on his reply. If the non-conformances were very serious and could result in unsafe food, the Large-scaleDistributor refused the inclusion of that supplier on the list of qualied suppliers. 3. Results and discussion As result of the auditing system many non-conformances were detected in all establishments, up to a total of 1014 and 837 for major and minor non-conformances, respectively. Major nonconformances involved Management Systems at higher rate (56.5%) and were referred especially to production, whereas minor non-conformances were often observed in Hygienic Practices (55.7%). The rates of non-conformances found for each part of the checklist were reported in Table 1. A complete list of non-conformances regarding Hygienic Practices(Table 2) and Management Systems (Table 3) with relative rates for major and
Table 1 Parts of the checklist used in the auditing system and rates of major and minor nonconformances. Major nonMinor nonconformances (%) conformances (%) Hygienic practices Buildings (Prerequisite) Installations (Prerequisite) Pest control (Prerequisite) Services (Prerequisite) Sanitation and hygiene (Prerequisite) 15.6 9.5 7.3 7.0 4.1 17.1 15.3 5.6 10.3 7.4

Management systems Production (HACCP) 27.8 Post-production (HACCP) 11.0 Purchasing (HACCP) 4.8 Personnel (Prerequisite) 4.2 Equipments (Prerequisite) 3.0 Non-conformances (HACCP) 2.8 Corrective actions (HACCP) 1.7 Orders (HACCP) 1.2 Organization (Possible Quality System) 0 Documentation (Possible Quality System) 0

19.4 6.3 5.1 4.1 3.2 3.1 1.4 1.7 0 0

minor non-conformances is reported. The normalized rates of major and minor non-conformances for each plant category are shown in Figs. 1 and 2, respectively. A brief comment on the nonconformances detected at higher rates (more than 2%) could be interesting. The most representative among major non-conformances were a failed documentation for scales calibration (3.6%), a missing or incomplete programme for pest control (3.2%) and some defaults in risk assessment (3.2%). The absence of metal detector was considered a major non-conformance (3%) only in the establishments where there were no other facilities for the control of physical hazards (e.g. ltering, sieving, bottle blowing, etc.) but it was a minor non-conformance in the other cases (5.4%). As to Hygienic Practices, several major non-conformances were observed. In some establishments (2.8%) the doors didnt assure a complete closing to prevent the entrance of animals and pests; the status of maintenance of equipments and facilities was often faulty (2.6%), for instance the surface covering at contact with foods was scraped off; instrument calibration system was never applied (3.6%);

P. Losito et al. / Food Control 22 (2011) 2047e2051 Table 3 List of non-conformances concerning Management system with relative rates. Non-conformances concerning Management system PURCHASING Lacking or insufcient suppliers selection Failed raw material quality control Lack of contract specications Failed foodstuffs management Lacking or insufcient foodstuffs control at arrival PRODUCTION Defaults of analytical programme Defaults of specic analytical assays Lacking or insufcient risk assessment Lacking or insufcient HACCP plan monitoring Lacking or insufcient recording operations Lacking or insufcient monitoring documentation Defaults of process qualication Defaults of CCP identication Defaults of critical limits awareness Defaults of packaging storage Defaults of HACCP plan management Defaults of critical limits compliance Defaults of HACCP plan Defaults of critical limits denition No memorandum or instructions on line Defaults of nal product requirements Defaults of nal product control Lacking or insufcient check operations Defaults of process ow chart Defaults of monitoring and archives registration Defaults of control procedure Lack of HACCP plan correction procedure Non-conformances of nal product Defaults of detailed process procedure POST-PRODUCTION Defaults of traceability system Defaults of product storage Lacking or insufcient means of transport control Defaults of product labelling Defaults of product transport Lacking or insufcient carriers control Defaults of product storage control Defaults of product storage management Defaults of product recall system Lacking or insufcient carriers selection Defaults of product protection Defaults of product identication NON-CONFORMANCES Lacking or insufcient isolation of non-compliant products Defaults of non-compliant products management Lack of an isolation area for non-compliant products PERSONNEL Defaults of personnel general formation Defaults of personnel dressing Lacking or insufcient personnel recording Defaults of personnel diseases notication Lacking or insufcient personnel qualication Defaults of personnel sanitary formation Defaults of personnel sanitary rules Lacking or insufcient personnel job description ORDERS Control of foodstuffs orders No archives of orders and suppliers contract Defaults of orders EQUIPMENTS Failed disposable measurement instruments Lacking or insufcient control of measurement instruments Lack of selection of calibration external operators Defaults of calibration Lack of documentation of calibration Failed instruments management Lack of identication of calibration system Lacking of calibration re-establishment Major (%) 1.6 1.3 1.0 0.6 0.4 3.2 2.3 2.0 1.9 1.8 1.7 1.6 1.5 1.3 1.3 1.2 1.1 1.0 0.9 0.8 0.8 0.7 0.7 0.6 0.5 0.5 0.4 0.3 0.1 2.5 2.2 1.5 1.1 0.9 0.8 0.6 0.6 0.4 0.2 0.2 0.2 1.7 0.6 0.5 1.5 0.6 0.6 0.4 0.4 0.3 0.3 0.2 0.7 0.3 0.2 1.1 0.5 0.4 0.3 0.2 0.2 0.1 0.1 Minor (%) 2.2 0.8 1.6 0.6 0 2.5 3.0 1.0 1.0 0.8 0.6 0.2 0.7 0.6 0.6 0.5 1.0 0.7 1.0 0.8 0.7 1.2 1.0 0.2 0.2 0.2 0.5 0.1 0.2 1.4 1.3 0.4 1.2 0.4 0.2 0.4 0.1 0.4 0.4 0.1 0.1 1.7 0.6 0.8 1.3 0.6 0.2 0.7 0.1 0.6 0.4 0.1 0.8 0.7 0.1 0.2 1.2 0.2 0.5 0.4 0.2 0.2 0.1 Table 3 (continued). Non-conformances concerning Management system No parting of not calibrated instruments CORRECTIVE ACTIONS Lacking or insufcient assessment of non-conformances Lacking or insufcient control of corrective actions Lack of adequate corrective actions No documentation of non-conformances and relative corrective actions ORGANIZATION Quality System organization management DOCUMENTATION Quality System documentation management Major (%) 0.1 0.9 0.4 0.3 0.1

2049

Minor (%) 0.1 0.7 0.5 0.1 0.1

0 0

0 0

foodstuffs hygienic production was not always ensured (3%); the pest control was not monitored or totally non-existent (3.2%). The major non-conformances related to Management Systems concerned the production, i.e. the risk of physical or chemical contamination of foods was not considered or underestimated (2%); also the analytical plan was especially applied on microbiological assays (3.2%); in many cases (2.3%) the shelf-life tests failed or were completely skipped. In post-production it was often observed that the storage conditions were not appropriate (2.2%) or the traceability system did not meet the legal requirements, e.g. packaging was not traceable or products were not labelled at all in the store (2.5%). Among the minor non-conformances that occurred at higher rates were the deciencies in structural prerequisites (3.6%) or in the analytical programme (3%); the bad status of maintenance of plant concerned in particular oors (2.4%) and walls (3.6%). The handling and waste storage conditions did not always comply with the hygienic rules (2.6%); the changing facilities for personnel were not adequate in the 2.5% of the cases. The failure of instrument calibration was considered a minor non-conformance in the 3.7% of the investigated establishments when they could not show to the auditor the SIT (Servizio di Taratura in Italia e Italian Calibration Service) certicate, whereas the absence of metal detector began a minor non-conformance (5.4%) because the physical risk was controlled by other operations such as ltering or sieving. Regarding to the production some deciencies, such as a failed application of the analytical programme described in the HACCP plan (2.5%) and product shelf-life evaluated only by sensorial test (3%), were reported. It can be highlighted that some non-conformances were common to all suppliers instead some others were more specic and linked to the production. An example of the latter case could be the non-compliance with the criteria established by European regulation for plate count and somatic cell count in raw milk intended for dairy products (EC Regulation 853/2004). The insufcient protection of product from contamination was frequently detected in bakeries since end products were often stocked in dirty open plastic boxes leant directly on the oor. As to vegetable oil producers, many of them did not performed any analysis regarding phytosanitary residues, heavy metals and other substances whose limits are ruled by law in force. Wine producers often did not assess the presence of ochratoxin A in their products. No other correlation between the type of food supplier and the observed non-conformances was detected. In all kind of plants, common nonconformances could be considered for example the insufcient number of personnel cabinets and the habit of not labelling semiprocessed products or raw materials moved to not original packages. One of the most critical non-conformances reported in this study is that the HACCP team should consider not only the potential biological hazards, but also all the potential chemical and physical

major non-conformances
100.0 90.0

normalized rates (%)

80.0 70.0 60.0 50.0 40.0 30.0

21.5 32.2

20.0 10.0 0.0

16.1 10.5 6.4 4.7 2.9 2.4 2.4 0.6 0.2

er ve s

oi ls

iry

in e

in g

m ea

st a

ke

ne

ne

te r

pa

ba

tio

pr es

ta b

ca

ho

le

nf ec

ge

co

ve

Fig. 1. Normalized rates of major non-conformances for each plant category.

minor non-conformances
100.0 90.0 80.0

normalized rates (%)

70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0

34.0 23.9 12.5 8.6 7.9 4.2 3.1 2.5 1.9 0.8 0.6

ve

ge

producers

ta b

le

an d

fis

fro

ze

oi ls

iry

in e

st a

m ea

er ve

in g

ke

ne

ne

pa

te r

ba

pr es

ta b

ca

tio

ho

le

nf ec

ge

ve

ge

ta b

Fig. 2. Normalized rates of minor non-conformances for each plant category. Table 4 Number and mean of non-conformances in large plants. Type of food plant (n) Bakery (7) Dairy producer (13) Wine producer (5) Oil mill (9) Meat producer (7) Vegetable and/or sh preserve producer (3) Confectioner (1) Pasta producer (3) Catering service (1) TOTAL MEAN Number of major nonconformances 146 113 56 54 29 25 20 9 2 454 9.3 Number of minor nonconformances 122 83 46 85 31 25 7 25 5 429 8.7

hazards occurring in the production. Typical potential physical hazards include glass, bone, metal, wire, sand, dirt and stones, pest or parts of pest and the typologies of products here considered could often have this kind of hazards. Also the presence of chemical hazards could give unsafe foods especially in case of toxic or forbidden substances for which maximum residue levels have been established (Sperber, 2001). Tables 4 and 5 showed that in large food plants auditors detected fewer non-conformances than in small sized enterprises; it was likely due to a better awareness of the importance of a good application of HACCP principles. Often small plant managers justied failures by lamenting personnel deciency and/or lack of understanding of HACCP system (Bai, Ma, Yang, Zhao, & Gong, lu, 2007). 2007; Bas , Yksel, & avus og

ve

le

an d

producers

fis

co

fro

ze

fo o

da

ds

ry

ry

fo o

da

ds

ry

ry

P. Losito et al. / Food Control 22 (2011) 2047e2051 Table 5 Number and mean of non-conformances in small plants. Type of food plant (n) Bakery (8) Oil mill (11) Wine producer (4) Catering service (2) Dairy producer (2) Meat producer (4) Pasta producer (2) Confectioner (1) Honey producer (1) Frozen food logistic platform (1) TOTAL MEAN Number of major nonconformances 180 164 52 46 46 39 16 9 6 2 560 15.5 Number of minor nonconformances 169 123 23 17 15 30 11 8 7 5 408 11.3

2051

instrument able to regulate the qualication of food suppliers, as the recording of serious non-conformances by the auditing system can give rise to an unchallengeable decision of refusal. The abovementioned strict controls applied to foods suppliers conrm that the Large-scale-Distribution system assures food quality and safety more carefully than small food retailers. Acknowledgements The authors thank Dr Arianna Luisi, from Chemiservice Srl, Monopoli (BA), for her collaboration. References
Bai, L., Ma, C., Yang, Y., Zhao, S., & Gong, S. (2007). Implementation of HACCP system in China: a survey of food enterprises involved. Food Control, 18, 1108e1112. Bas , M., Ersun, A. S., & Kivan, G. (2006). Implementation of HACCP and prerequisites programs in food businesses in Turkey. Food Control, 17, 118e126. lu, T. (2007). Difculties and barriers for the impleBas , M., Yksel, M., & avus og menting of HACCP and food safety systems in food businesses in Turkey. Food Control, 18, 124e130. Commission recommendation 2003/361/EC of 6 May 2003 concerning the denition of micro, small and medium-sized enterprises. (20.05.2003). Ofcial Journal of the European Union, L 124. Regulation (EC) No 853/2004 of the European parliament and of the council of 24 April 2004 laying down specic hygiene rules for on the hygiene of foodstuffs. (30.04.2004). Ofcial Journal of the European Union, L 139/55. Ramrez Vela, A., & Martn Fernndez, J. (2003). Barriers for the developing and implementation of HACCP plans: results from a Spanish regional survey. Food Control, 14, 333e337. Sperber, W. H. (2001). Hazard identication: from a quantitative to a qualitative approach. Food Control, 12, 223e228.

4. Conclusions Nowadays the end product testing is considered ineffective to guarantee food safety and as a consequence a prevention based system has been developed. The HACCP system provides assurance of food safety by careful attention to product design and process control. The HACCP based audit can be a valid mean to prevent the most frequent hazards linked to foods. In the case of a Large-scaleDistributor the most important preventive action is directed to food suppliers in order to motivate and improve their food safety conception. In particular the audit report represents a very effective