laboratory management for food safety - vinalab.org.vn · quality management system(iso 9001 ......
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Setsuko SakaoSection of Quality Assurance
Japan Food Research Laboratories
Laboratory Management for Food safety
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Japan Food Research LaboratoriesJ F R L
Our foundation was approved by MAFF (Ministry of Agriculture, Forestry and
Fisheries) about 55 years ago
1247 staffs as of April 1st 2015
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Our Quality Principles
1. Independence and Impartiality
2. Accuracy and Quickness
3. Technological improvement and Quality Assurance
Neutrality & Justice
Improvement quality &
reservation intechnical
exact & quick
AnalysisExamination
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The activities of JFRL
Nutritional analysis Protein Fat Carbohydrates
Dietary Fiber MineralsVitamins
Biological safety testCytotoxicity test,
Acute toxicity test, Mutagenicity test,Implant test
Environmental analysis Dioxins, Pesticides, Effect test
for aquatic animals and plantswater quality test
Trace analysisResidue pesticides, Animal drugs, Antibiotics, Synthetic antibacterial
agents, Endocrine disrupters,Melamine Mycotoxin, GMO
Pharmaceutical testDrugs, Quasi-drugs, CosmeticsPharmacopoeia(JP,EP,USP)
Training and Education Consulting, Workshop
Hygienic test Heavy metals, Microbial tests,Food additives, Radio activity
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Our test results help the decision of Japanese government
APPROVAL
JAS Japanese Agricultural Standard
HACCP
REGISTERED LAB.
Food Sanitation Law
Health Promotion Law
Water Supply Law (Tap water Quality test)
Metrology Law
Instant Noodle
Food for Specified Health Uses
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Components of the analytical system
Quality management system(ISO 9001)
Laboratory activities designed to produce accurateworks and a high-quality product
Laboratory accreditation
(ISO/IEC 17025)
Formal recognition of a laboratory by an
independent, science-based organization indicating
that the laboratory is competent to perform specific
tests.
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Laboratory accreditation(ISO/IEC 17025)
Scope of accreditation in JFRL
・ Salmonella spp.・ Radioactive cesium in food Cs-134, Cs-137・ Food nutrients (Moisture, Protein, Lipid, Ash, Carbohydrates,
Energy, Na, K, Sugars, VitaminA,B1,B2,C,D,E,K, Organic acid)・ Pesticides residues in food・ Dioxins in foodstuff ・ Food and Food additives, etc., Apparatus or Containers and
Packaging ・ Veterinary drugs and feed additives residues in food
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Food Sanitation Law in Japan
Chapter I General ProvisionsChapter II Food and Food AdditivesChapter III Apparatus and Containers and PackagingChapter IV Labeling and AdvertisingChapter V Japanese Standards of Food AdditivesChapter VI Guidelines and Plans for Monitoring and GuidanceChapter VII InspectionsChapter VIII Registered Conformity Assessment BodiesChapter IX BusinessChapter X MiscellaneousChapter XI Penalties
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(Notification basis) Total number of foods etc. imported into Japan
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Quarantine stations of The MHLW
平成27年度 (2015)
受理検疫所 32検疫所 ●うち,検査課を有する6検疫所 ◎輸入食品・検疫検査センター ☆食品衛生監視員 406名
Inspection order by the MHLW(Ministry of Health, Labour and Welfare)
厚生労働大臣による検査命令
The requirements of order inspection
Outbreak of Health Hazard
The same country, same kind of foods (Examples:O-157,Aflatoxin etc.)
Inspection OrderImmediately
Residue analysis
The monitoringprogram is reinforced
High risk possibilityof violation
Inspection OrderThe 1st timeviolation
Several timesviolation
Cancellation of Inspection Order
The prevent plans are confirmed at the exporting country
Fear of Health Hazard
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Inspection Orders(extracts)
検査命令品目一覧http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/150615-1.pdf
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CODEX Guidelines for the testing laboratories
1. Compliance with the general criteria for testinglaboratories laid down in ISO/IEC Guide 17025
2. Participation in appropriate proficiency testingschemes for food analysis
3. Whenever available, use methods of analysiswhich have been validated
4. Use internal quality control procedures
“Guidelines for the assessment of the competence of testing laboratories involved in the import and export control of food” (CAC/GL 27‐1997)
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Testing Guidelines of Food Sanitation Law (GLP) for
Registered Laboratories
Notification on 2008 July 9th (M H L W)
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Requirements (1)
Testing Guidelines of Food Sanitation Law
1 Purpose2 Organization3 The control of test Lab
4 The maintenance of the instrument
5 The reagents control
6 Animal control7 The hazardous reagents control8 The sampling manner9 The control of test procedure10 The results
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Requirements (2)Testing Guidelines of Food Sanitation Law
11 The reports
12 The sample handling
13 Internal audit
14 Internal Quality control
15 Proficiency testing
16 Data procedure
17 The record keeping
18 Training
19 External audit
20 Claims and others
Organization
Quality Assurance Unit Test Facility Manager
Animal testingSD
Sample Reception
Analysts AnalystsAnalysts
Microbiologicaltesting SD
Chemical analysisStudy director
(SD)
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Maintenance of the instrument(1)
Management logbook.
(Notebook)
Label
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Maintenance of the instrument(2)《Daily check sheet (Balance) 》
Records
Compliance Standards
Signature of maintenance staff
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《National Traceability Chart》
WEIGHT( mass standard )
Official calibration
Lab.
SI base units ↑
ILAC-MRA JCSS certified company
Standard mass std.
Mass std. for OQ ( Mass std. administrator)
Reference Standard
Working standard
InstrumentBalance Strength measuring instrument
Calibration
In-house Calibration
In-house Calibration
Performance Qualification
Operational Qualification Mass std. for PQ
Control in each section
Maintenance of the instrument(3)
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Purchase DQ
OQ
OQ PQ (Daily and annual check)
Identification for maintenance
Label of expiry date of annualcheck
Daily check logbook
Use for the analysis
abnormal condition
Slight
Isolation label to avoid
wrong use
Proper estimation
Parts exchange
Recovery from abnormal condition
Additional function
Transfer
Repair
: Indispensable step
: According to the conditions
Recovery treatment
Confirmation of apparatus
Maintenance of the instrument(4) 《Flow of maintenance》
IQ(purchase )
IQ(installation)
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《The role of Instrument Control personnel》
1. Prepare the Management Logbook2. Confirmation of IQ,OQ3. Review of PQ records and report to Study Director
(Monthly)4. Prepare the label of the instrument (Instrument No.,
Annual check completion label)5. Support of abnormal condition6. Installation of SOP7. User training of the correct handling of the
instrument
Maintenance of the instrument(5)
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Automatic filtration system JFRL original system
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Internal audit
Quality Assurance Unit(QAU) organizethe internal audit periodically and timely.
QAU check the SOP compliance
If necessaryThe corrective action program
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Control material(RM,SRM)
(Control limits Chart)
Recovery test(Spiked)
Duplicate test(Dispersion)
Negative and positive control
Double-blind test
Internal quality control
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Proficiency testing
Official proficiency testing (for registered Labs.)Food additives Heavy metal Pesticides residue Animal drugs Microbiological testsParalytic shellfish poison
Other overseas proficiency testingFAPAS/FEPASAOCS
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《Annual training plan》Training
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Section name
NameThe date of entered
JFRL
Date Training menu The teacher Approvalby the
manager
Evaluationby the
manager
Training 《Training log sheet》
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Training
Is the training plan of the year being made by testing facility manager?
Do the training plan include OJT program for each analyst for each analytical items?
Do the analyst have each training record?
Is the training (completion levels) confirmed by the study director?
Check list《Training check list》
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Training《Continuous training》
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External audit
Site inspection by the authorities and clients
110 external audits / year
periodically and timely.
Regional Bureau of Health and WelfareTokyo Metropolitan governmentConsumer Affaires Agency
MAFFinspect registered Lab.
Clients
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To assure and keep our data in high quality
4M+(material, machine, method, man) and mission
Traceability(Record and document’s management)
Good Maintenance of instruments, reagents, Standards. Scientific verification and validation
The internal audit of Quality Assurance Unit
The record without falsification
The clear system that shows who has the responsibility
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Japan food Research Laboratorieshttp://www.jfrl.or.jp
Thank you for your kind attention.