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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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Atomic Absorption Spectrometer Varian

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Gamma-ray spectrometer SEIKO EG＆G

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Celtic FOSS

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ICP-MS Shimadzu

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HPLC Shimadzu

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LC-qTOF/MS Shimadzu

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GC-ECD Shimadzu

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GC-MS Ａｇｉｌｅｎｔ

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LC-MS/MS Ａｇｉｌｅｎｔ

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Incubator EYELA

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Incubator SANYO（panasonic） Autoclave TOMY

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NMR Varian

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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

46Copyright© 2015 Japan Food Research Laboratories All Right Reserved

Japan food Research Laboratorieshttp://www.jfrl.or.jp

Thank you for your kind attention.