雀巢质量审核文件(英文)

雀巢质量审核文件(英文) Audit to RM Vendor Bangkok Starch-2007 Audit type: Raw Material Vendor Audit(Initial) Audit trigger: Vendor Approval Status: Released Planned date: 18.07.2007 09:00 to 18.07.2007 17:00 Date: 18.07.2007 09:00 to 18.07.2007 17:00 Audit result Audit result: Complying with Reservation Subsequent audit required: Next audit: 18.07.2012 Audit object vendor 100128418 Bangkok starch Industrial Co.,Ltd/Ban Vendor plant 100128418A BANGKOK STARCH INDUSTRIAL CO.,LTD/NAK Vendor confidence level MEDIUM Medium Material Risk Level Low Low Persons Involved Role Description Telephone Audit administrator Ricardo Luna Approver Jean-Yves Gagnepain Audit coordinator Preeya Ponbamrung lead auditor Preeya Ponbamrung auditor Nanthawat Ubsri auditor Thitiworada Nintanawongsa Pers.Resp.f.Actions Christine Audit location Bangkok starch industrial co.,LTD 24 GP 14 PETCHKASEM RD., RAIKING, SAMPHRAN, NAKORNPRATHOM, 73210, THAILAND Tel: Fax: E-mail: Contact: Christine HSU-marketing Manager Mr. Somwang Chuangcharoendee-Plant Manager Miss. Rattana Aungsutawin-QA Manager Material detail Rice Flour Material Group: R65 starch and Derivatives Used in Nestle Products: Breakfast Cereal, Other Beverages Audit scope Nestle Quality Management System-Food Safety Management System and Regulatory Compliance Manufacturing of Rice Flour Audit summary Bangkok Starch Industrial Company Limited was established in 1978. Their goal and objective is to produce the best quality starch and rice flour using the abundant natural resources in Thailand and supply globally. Furthermore, the company has developed into the world’s largest manufacturer of Alpha Starch, with 85% exported to various countries. Marketed under the “Thai Flower” brand, our products have won numerous international awards, including Asian Food Award, and first Place of the Spain’s Quality Award, and are well recognized among food, marine-feed and mosquito coil industries worldwide. Overall audit outcome is “Complying with Reservation” according to there are the serious gap on pest prevention which had been closed and there is some pending major gaps which has to be closed within 90 day as well. Generally of quality management system and food safety management system is well design and maintained in good level. Inspection by QA people and capability of QA lab can guarantee the consistency of product quality, Suggestion for the improvement on the area of pest prevention and foreign bodies prevention byu improving the design and installation of production machine and converyer. Regularly inspection is also recommended, Subsequence audit is not required and next audit should be in year 2012 as the classification of low risk material from this vendor. corrective and preventive actions The Corrective and Preventive Actions mentioned in the following list are linked to gaps whose rating should be interpreted according to the following table: critical issues threaten food(consumer) or obvious occupational(employee) safety. These issues must be fixed immediately and/or entail immediate suspension of production and /or recall of product. Serious issues are related to compliance with regulations or to potential safety problems or impact on the business or efficiency. Immediate corrective actions are needed and specific follow-up is to be carried out at the Market Technical Management level. Major issues are related to compliance with regulations or to potential safety problems or impact on the business or efficiency. These issues must be fixed as soon as possible (always within 3 months)and followed up at the Facilities' Management level. Minor relates to quality issues(including business/efficiency).They must be fixed according to a defined action plan. related to Description Person responsible TB Compl by layout design,zoning and services layout design, roof leakage Christine Hsu 18.01.2008 zoning and services Observation: Found water standing at the floor beside semi-product packing machine MINOR ABC.Leakage is from the roof. Recommendation: Fixing the roof and leakage should be completed. FOREIGN BODIES No cover for CONTROL Maintenance of conveyer(blender Christine Hsu 18.01.2008 processing lines no.2 DEF) observation: Minor There are no cover for conveyer below roller at the blender 2 of line DEF.Review grease dosing and cleaning after grease dosing. Recommendation: Recommend to install the cover for conveyer below roller at blender 2 of line DEF.Review grease dosing and cleaning after grease dosing. Pest prevention Pest Pest infestation in Christine Hsu 20.07.2007 prevention process area Observation: serious Found pest infestation and many insects under filter press platform. The platform is beside final sieving before bulk filling. Recommendation: Review pest prevention and cleaning method. Imediaterly action should be taken withen one week. Pest prevention Pest Red ants in Christine Hsu 18.10.2007 prevention semi-FG warehouse Observation: major Found red ants in semi-finished good(bulk pack) warehouse. Recommendation: Should improve pest prevention program.Frequency and pest control plan by subcontractor should be reviewed. FORERGN BODIES Using wire & rope CONTROL foreign bodies to tide hose and Christine Hsu 18.10.2007 control pipe observation: MAJOR Factory is using wire, rope to tide the hose and stainless pipe above rice soaking tank no.D(20).Soaking tank is abouve stone milling step. Recommendation: Should not use wire and rope to tide the hose and for tmporary fixing purpose No guard for Foreign Bodies control conveyer of wet Christine Hsu 18.10.2007 foreign bodies control cake observation: There is no guard or cover for conveyer of wet cake from dewatering to MAJOR conveyer of flash drying. Moter of the roller is beside this conveyer. Recommendation: Installation for the guard along the line of wet cake transferring conveyer is recommended. Foreign Bodies Control Using thread for Christine Hsu 18.10.2007 foreign bodies control bag sewing at filler Observation Using thread of finished goods bag sewing for fasten the clamp at filler of MAJOR mixer room. recommendation: Forbidden using of thread for temporary fixing should be enforced packaging pallet put Storage and transport Christine Hsu 18.01.2008 too close to wall Observation: MINOR Found the packaging pallet in warehouse is place too close to the wall but ware is controlling that the pallet should be far from wall 18inch. Recommendation: Rearrangement for the pallet in warehouse should be done to allow the cleaning and pest inspection. Quality of flour for Allergen management Christine Hsu 18.01.2008 line flushing Observation: During waiting for justification on the quantity of flour for line flushing to OBSERVATION prevent allergen cross-contamination and adding in the allergen management procedure.Validation should also be available. Recommendation: The quantity of flour for line flushing which has been validated for prevention on allergen cross contamination during product change over should be included in the procedure.Record of allergen validation should also be available. Calibration Test equipment imporper calibration Christine Hsu 18.01.2008 and calibration range Observation: Calibration range of temp.gauge of flash dryer ABC,number TC-1-03-01 is MINOR not covered all actual usage range. Calibration is done at 100-200 degree C., actual usage is 120-230 degree C. Recommendation: Calibration should be done to cover actual usage range for each equipment. Tag status for Status control Christine Hsu 18.01.2008 rework observation: Tag status is not applied at the pallet of semi-product from production MINOR breakdown.No production date and lot number for blue/ white PP woven bag, this palett is beside the flash dryer. Recommendation: Tag status should be applied for all processing steps as required by the procedure. Lot identification lot No lot identification identification/coding and Christine Hsu 18.01.2008 on packaging product tr Observation: There is no production date and expiry date on packaging and COA of rice OBSERVATION flour which will be delivered to Nestle. Recommendation: Must put the production date and expiry date of the product on packaging as mandatory requirement from material specification. waste water Waste management Christine Hsu 18.01.2008 analysis Observation: There is no TDS analysis for waste water by lab IQA but the Thai Industrial MINOR Standard's wastewater quality is controlling the TDS,3000mg/L. Recommendation: Wastewater analysis should be done to cover all parameter schich required by law. Audit Questions Question Description Detemination Act.req.Valuation 1 1.TQL for Raw Materials Vendors Audits Action required: complying 1 Quality management and documentation Quality management and documentation 1.1 Quality system Action required: Quality system as ISO9001:2000 has been implemented and certifed by Certification International(UK) Limited.Last certification valid until 16th June 2008 Quality policy and food safety management policy and objective are in place. Management review and internal audit will be conducted twice a year. The result of review and internal audit are available. HACCP is also certified and implemented.Last HACCP Certification valid until 13th February 2010. Title of HACCP certification:Manufacture of rice starch, modified riced starch products, modified tapioca starch products and other modified starch products. 1.2 Quality documentation manufacture system Action required: Documentation system base on the requirement of ISO9001, GMP and HACCP has been established.Controlling of the documentation system by following the Document Control Procedure. 2 Good Manufacturing Practice(GMP) Good Manufacturing Practice(GMP) 2.1 Layout design, zoning and services Action required: Factory 1 is for processing plant(second cleaning, processing, packing) Factory 2 is for modified starch plant Factory 3 is pre-cleaning plant. FG warehouse, packing room, packaging storage and processing acid storage are separated from processing plant. Entrance to plant 1 and plant 2 is design to comply with GMP requirement. Changing room of employee, boot changing area, hands washing basin and boot washing bath are provided at the entrance. Entrance to plant 1 and plant 2 is design to comply with GMP requirement. Changing room of employee, boot changing area, hands washing basin and boot washing bath are provided at the entrance. Semi finished good stock will be packed in 25kg.woven bag at plant 1 and will be repacked upon the order in the pacing room at the FG warehouse. This packing room is the same room and same line with mixed flour for industrial purpose.Allegen control procedure has been implemented and satisfied. See allegen element for the detials of validation the prevention of cross contamination. Some facility e.g.platform of the machine are unreachable area and not easy to clean. The pest still found in these area.See also pest prevention element. 2.2 Maintenance of processing lines Action required: X Complying with preventive maintenance plan FM-TEC-009/1 Reservation Some protective guard for the machine and the conveyer The machine list is by the processing line. need more maintenance and Monthly maintenance is fixed for all machine. installation. The re-surveying for the point of usage of the Record of maintenance is available food grade lubricant and grease and the pint which Mapping and identification for the point of use of the food grade required the protection has to grease and lubricant is also applied. The letter of guarantee of be done. food grade lubrication chemicals are available. 2.3 Incoming materials action required: Raw Material Specification RR=Regular Rice Complying Grain(SP-QC-0098) The specification requires spec.on Moisture, Particle Size, Whiteness, Black Sport and new/old of the grain, Specification on the chemical and microbiological contaminant base on SP-QC-015. Random checking for the Aflatoxin once a month for each supplier(random farmer)by using GT test kit and verify the Aflatoxin by sending sample to outside lab service one a year per supplier as well. Raw Material Inspection QP-QC-009.Sampling will be done for every truck.If found many of the weevil in the grain on the truck, fumigation will be used(using Aluminium Phoshide) prior to unloading. Monitoring of microbiological in raw material rice grain will be done every 6 months and check the E.co, Samonella, Strapphylococcus aureus, Bacillus cereus. 2.4 Processing steops Action required: Raw material recerving >Pre-cleaning by seiving and magnetic trap>packing in big bag> deliver by the truck to plant1>unloading>washing by water>pump into soaking tank> soaking Material husked rice will be passed through the precleaning 3-4hour,500kg/batch>washing process at plant 3 by the gravity seiving, magnetic trap and will and drain >stone be delivered to plant 1. milling >magnetic trap>PH adjustment by HCl>dewatering by filter press>griniging>add coarse flour>flash dryer>cooling > seiving 70mesh &100mesh >stock packing(WIP) stock Precleaned rice will be cleaned again by washin in water in the 25kg/bag>tipping>magnetic bath. trap>seiving>packing FG>storage FG Raw material receiving>Pre-cleaning by seiving and magnetic trap> packing in big bag>deliver by the truck to plant 1>unloading>washing by water>pump into soaking Inspection of the rice flour tank>soaking 3-4hour,500kg/batch>washing and drain>stone temp at drying(FM-RF-002), milling>magnetic trap>PH adjustment by HCl>dewatering by every half hour. filter press > griniging> add coarse flour >flash dryer>cooling?seiving 70mesh&100mesh>stock packing(WIP) Stock 25kg/bag >tipping >magnetic trap> seiving>packing FG> moisture will be check every Storage FG hour(FM-QC-005) FG will be checked and Inspection of the rice flour temp at drying(FM-RF-002),every half recorded in Rice Flour Daily hour. Report(FM-QC-037) Process parameter has been Moisture will be check every hour(FM-QC-005) identified and used per each kind of product. FG will be checked and recorded in Rice Flour Daily Report(FM-QC-037) Process parameter has been identified and used per each kind of product. WI-RF-005 Flour Mixing and Flour Drying Instruction. 2.5 rework management action required: reworking can be done only steps for adding coarse flour from final sieving. This coarse flour or the non conforming product will be added during grinding of wet cake before flash drying tower. as the flour characteristics have been changed after drying, so the reworking in normal product is impossible.Non-conforming product will be sold out as downgrade material. Reworking is under suppervision and approval of R&D department. Controlling of non-conforming product for rework is following QP-QC-001 2.6 Cleaning Action required: some unreachable area need Cleaning plan and procedure in place,Record of cleaning is some minor improvement for complying available. the cleaning and verification after cleaning. 2.7 Manufacturing personnel and training Action required: Yearly training plan is available.Yearly health check up is provided for all employees. Protective clothing as the hair cover, hygenic boots, mask, gown are provide for employee and visitor.Hands washing stations are also located at all processing entrance.Hygeinic soap, clean towel are available.Air shower room is also located at the entrance of production building 2.8 Pest prevention action required: 2.9 Foreign bodies control action required: There are no covers below Foreign material control program is in place to prevent foreign matter contaminate to product eg. Sieving, magnet, personal roller at blender2. The hygienepolicy. All glass light fixtures are covered. They are grease(food grade) is coming systematically checked to minimize the risk.Food grade out from this roller. The blender no.2 at line DEF. materials(e.g.lubricants, gaskets) are used where there is a risk of food contact. However there are some points should be Using of improper materials improved regarding foreign bodies prevention(Pls see details in for temporary. Fixing should CAR) be forbidden. 2.10 storage and transport action required: Storage of raw material rice grain at factory 3#. Minor improvement is need storage of processing aid, packaging material at the same for the palettising and racking complying with building as FG warehouse but separate the room,Cleanliness of the processing acid and reservation and pest control program in FG warehouse is satisfied. packaging material storage. 2.11 Security and access policies action required: Screening and identification of visitor prior to enter to factory at the guardhouse at factory entrance.Health questionnaire and company's rule have been informed to the visitor prior to enter production line as well. 3 Pathogen monitoring 3.1 Pathogen and environment monitoring Pathogen and environment monitoring complying 4 Allergens management action required: 4.1 Allergens management Allergens management procedure:QP-QC-018 This procedure is referring to the Food Allergen Labelling of USA(SP-QC-029) There is no the allergen for the production of Rice flour but there is the risk from cross contamination by using same packing line with mixed flour Currently considering risk from the material of mixed flour: Topioca starch(as sulphur dioxide),Skim milk as the allergen. Validation of the cleaning method once product changing over by using ALERT Total Milk Allergen Soreen Test which can check the milk allergen at minimum 5ppm. Validation the sulphur dioxide by lab analysis result. Last validation result did not provide the quantity of rice flour used for line flushing. 5 HACCP&QMS/Applicaton HACCP&QMS 5.1 HACCP Action required: HACCP plan is available for all the products/lines(refer:HACCP-002:HACCP plan rice flour and HACCP-003:HACCP for tapioca starch and mixed flour). CCP-drying CL-Temp of dryer(at temp.gauge no.TC-1-03-01) Monitoring:temp. and Rpm for screw feeder Verification:Moisture in FG not more than 13 percent, aw not more than 0.7 Allergen was also taken into account in hazard analysis. CCP also be the release criteria for FG 5.2 QMS Quality control plan is a available for each process step.Records of inspection per the quality control plan is available. QA department do the inspection per the quality control plan. Monitoring also be put in the quality control plan. 6 Test equipment, laboratory organization Text equipment.laboratory organization and resources 6.1 Test equipment and cailbration All lab equipment is on the list of the equipment for calibration.FM-QC-055 The calibration plan is followed and records of calibration on file. Moisture analyser is calibrated yearly basis by external lab service. Viscometers(Brabender) are also calibrated at yearly basis. CCP thermometer was calibrated but not cover all actual usage range. 6.2 Laboratory methods Laboratory methods are documented and refer to international method. Analysis was done against the plan and documentation. All lab personnel are qualified. Preparation of chemical agent for using in the lab and controlling stock is complying with the good laboratory practices. PH measurement -WI-QC-002 Moisture Measurement -WI-QC-003 SO2 Analysis-WI-QC-026 Particle Size -WI-QC-001 Microbiological Analysis -WI-QC-018 Sensory evaluation also be done for release of RM and FG by qualified personnel. 7 Release procedure release procedure 7.1 status control Action required: There's the procedure for status control but not fully implemented Tag status should be fully especially for the product during the process. Tag status is not applied as the procedure. applied as the procedure stated. 7.2 Quality records Action required: Quality records are available, legible and easy to retrieve.Review of all quality records by authorised person. Records will be kept at least equal to product shelf life. 7.3 Finished products release procedure Finished products release procedure has been established.Normal release is authorised to QA department.Exceptional or Urgent Release(UR) is authorised to factory manager based on the consideration of QC manager, assistant factory manager and / or sales manager. 8 Product traceability and recall Product traceability and recall 8.1 Lot identification/coding and product tr Action required: Put the production date and expiry date and /or batch Packing date is used for product identification and product number on the packaging reaceability. must be omplemented. At least the detials as required by Nestle's material However, the production date or packing date and expiry date specification must be has not been put on the packaging of the material delivered to available on packaging and Nestle. Corrective action to comply with Nestle specification is can be linked to Coa and required. traceability. 8.2 Recall and crisis management Recall procedure QP-QC-013 last mock up recall testing on 5th Feb 2007,% revovery 99.5% within 24hours. Mock recall testing report -MF-QC-058 crisis management procedure is separated from the recall procedure and is under the responsibility of factory safety officer, The report of crisis management which required by government agency is available. 8.3 Identity preservation and control Action required: GM free product as in GMO Status document.Analysis result for GMO in rice grain is available. Last report by SGS Lab, 18 October 2006 by PCR test. Pls see also the attachment of GMO Status. 9 Environment Environment 9.1 Environmental management system action required: Environmental management system is not formally Implemented.Implementation of the environmental management is based on Thai regulation for industry. Report of inspection by accredited third party as required by regulation on working environment is available and complying with regulation. some improvement needed for the lighting in some production area. It is lower than the standard. 9.2 Waste management action required: Product waste will be sold out to farmer to be the feed.Packaging waste is managed by local municipal service.Wasterwater will be treated on site prior to discharge to public place. Quality of the waste water complying to Thai Industrial Standard. 10 Specific requirements Specific requirements 10.1 Halal/Kosher certifications action required: Halal certificate is available and this factory has been certified by The Central Islamic Committee of Thailand.Last certification is valid until 19th Novermber 2007. 10.2 Other legal requirements and certificaty action required: company has gone through all registration as required by Thai law. 11 Other not relevant