Example Sample1 Manufacturing Process Flow.
ExampleSample1 Manufacturing process flow.SeepReceive raw materialfrom supplier and testMfg.STUAssemblyTestMfg.ABCDescription1. Incoming material QC（Visual Inspection）(Quality conformance inspection)3. Test１（Visual Inspection)(Electric resistance measurement )4. Assembly 2（Welding process）（Coating）Cleaning5. CleaningCleaning / Packaging /LabelingTestMfg.DEFISO Class 76. Test 2（Visual Inspection)(Leakage current measure)7. ized packaging process）8. Test 3（Visual Inspection）（Bio burden testing）DescriptionSterilization (EOG）9. Sterilization(BI testing)(Determination ofresidual ethyleneoxide)Test10. Test4(Visual Inspection)2. Assembly 1（Injection molding t11. Test 5（Visual Inspection）Packaging / Labeling12. Outer containersFinal Inspection13.Final Inspection（Visual Inspection）Decision on whether theproducts an be shippedRegistration0
ExampleSample2 Mutual relations of QMSMarketing AuthorizationHolder（JKL, Ltd.）AgreementQMS(ABC, Co.）実地調査MNO, Co.(Registration)Design facilityGHI Distribution Center（Inspection・Storage）ABC Mfg. site(Registration)Main assembling plantSTU, Mfg. site.Assembling plantAgreementJKL Distribution Center(Registration)（Distribution Center）QMS(DEF, Co.)DEF, Mfg. site(Registration)（Sterilizer）：Same QMS：Informationexchange1
ExampleForm2 Outline of MAH/RMS (1/2)Outline of manufacturing siteAs of DD/MM/YYName of mfg . siteAddress of mfg. siteRegistration numberDate of initial registrationRegistration periodNumbers of employees (including part time employees)Total:Mfg. department :QA/QC department :Number of mfg. products (Number of products exported to Japan should be described in parenthesis.)Class IClass IIClass IIIClass IVNumber of productsProduct utilizingmedicine/cellular andtissue-based productSpecified biological productProduct utilizing nanomaterialsMicro machineProduct absorbed intohuman bodySpecial designated medicaldevice2
ExampleForm2 Outline of RMS (2/2)If export , please describe your export destination and trade name of the products except Japan.Export destinationTrade name of the productChanges history of mfg. site(please select items, and specifydetails.) Changes of product / mfg. process (if important) Changes of QMS organization Changes of top management or management representative Others () No ChangeDetailsNot applied article 4 and article 83 of QMS ordinance (MHLW Ministerial Ordinance No.169 in 2004)History of QMS inspections by regulatory authorities and registered certification body over the past 5 years.Name regulatoryauthorities/registeredcertification bodyInspection dateThe products subject tothe inspectionInspection resultsType of Inspection(On-site or Desk-top)Name, address, and applicable mfg. process of critical suppliersNameAddressApplicable mfg. process3
ExampleForm3 Products list for roval(certification)No.classificationDate ofapproval(Certification)Expirydate* Mfg. siteregistration123456* If sterilizer or distribution center are different, write these mfg. site’s name.4
ExampleSample3 Layout of RMSLocation map of RMSAerial photographor location map ofRMS.Site boundary ofRMSS BuildingQ BuildingDistinguish abuilding affecting asubject of product.T BuildingR BuildingMedical devices mfg. building5
ExampleSample4 Floor plan of RMS(1/2)a passage wayManufacturingManufacturingISO Class 7differentialpressure( 10Pa)SterilizerPeople flowReceivingMaterial zer 1Sterilizer 26
ExampleSample4 Floor plan of RMS(2/2)Representative list of mfg. equipmentNo.Manufacturing EquipmentModel１Injection Molding EquipmentSK-123２Welding ・・・Representative list of inspection equipmentNo.Inspection EquipmentModel１Gage Blocks123F２MicroscopeF111３Electronic scaleSEW124・・・・・・・・・7
ExampleSample5 organization chartABC company Organization ChartPMDA TAROPresident and CEOTop ManagementHumanResourceKIKOU JIROQuality & Regulatory ent mentQAdepartmentMfg. site AQCdepartmentMfg. site BPurchasingdepartment8
ExampleSample6List of documents identified with QMSQMSSection 2QMSArticle 5General equirements forQMSArticle 6Documentation of QMSDocuments identified with theArticleQMS6.1.16.1.16.1.26.1.56.2Article 7Quality ManualArticle 8Control of DocumentsArticle 9Control of Records8.2・******************9.2Control ofRetentiondocumentsperiodNameNumberQuality policyQuality objectivesThe quality manualAny other documentationspecified by the laws, others andordinances related to the PMD Act.Seihin hyojun syoProcedure about control ofdocumentsProcedure about control ofrecords***************9
ExampleSample7 Seihin Hyojyun SyoRequirementsReference documents(name, number, etc)1.Product family, Generic name(common name), Proprietary nameCopy of marketing approval2.The date of number of approval3.SpecificationsCopy of marketing approvalProduct Specification(P2/D2 DMF1 device requirement spec 73345)4.Operating methods and procedureProduct Manual 7233Location(sites)Mechanical Specification 7810(Spec-controlled environment area)5.Product design, drawings andspecifications or composition andcontentTest specification T78910(Electrical test specification, IPG)Product Specification P78910(DMF1 RV2 product configuration)6.Mfg methods and procedureMfg procedure(MT123, SOP04, SOP05)******************************8.Labeling and packagingProduct Specification 1234(P2/D2 DMF1 device requirement spec)******************************10
Sample8Implementation of validation statusValidation gN/AN/A1/3/2014ABCRe-ValidationInjection moldingmachine A-01Soldering1/1/20141/2/20141/3/2014ABCRepairing Solderingiron D-01, D-02Soldering iron D-01,D-02Welding1/1/20141/2/20141/3/2014ABCChange equipmentUltrasonic weldingmachine se newsterilizer(EOG)Sterilizer P-04N/A1/2/20141/3/2014ABCChange setting valueHeat Sealer P-01（Temp:105 110 ）Packing***************Reasons***Mfg equipment***11
Sample1 Manufacturing process flow. Assembly Test 1. Incoming material QC （Visual Inspection） (Quality conformance inspection) 2. Assembly 1 （Injection molding process） 3. Test1 （Visual Inspection) (Electric resistance measurement ) Assembly4. 2 （Welding process） （Co
This product provides a local flow indication and automatically signals the operator or PLC if flow is too high or too low. Uses of the Flow-Alert flow meter include: bearing lubrication, case drain verification, gun drill cooling, pump flow confirmation, etc. FLOW-ALERT FLOW SWITCH 6000 PSI / 414 BARS MAX GPM LPM OIL FIGURE 1- Flow-AlERt Flow .
To search the Cash Flow Process , follow these steps: 1. Navigate to the Cash Flow Process Summary page. 2. Enter the Name, Description, or Folder in Search Criteria. 3. Click the Search. Only Cash Flow Process that match the search criteria are displayed. 2.3 Create Cash Flow Process To create a new Cash Flow process, perform the following .
1. Man/ Worker type flow processchart. This flow process chart records what the worker does. 2. Material type flow processchart. This flow process chart records how the material is handled or treated. 3. Equipment type flow process chart This flow process chart records how the equipment or machine is used.
Flow Customizer. The Flow Customizer adopts Continuous Flow Manufacturing and Demand Flow Technology approaches. They provide the fundamentals for designing demand driven continuous and mixed-model production flow. The outcome of the Flow Customizer is to create Production Modules that are connected to each other through Kanban system.
Manufacturing Process Coloured Polishes Process Flow Diagram. www.entrepreneurindia.co 13. Tooth Paste Components of Toothpaste Typical Toothpaste Ingredients Manufacturing Process Process Flow Diagram 14. Shaving C
The process flow diagram above helps an individual understand how a project team is empowered. This is why process flow diagrams are useful as training tools. A process flow diagram also helps gain consensus on what the process is, in this case, for empowering a project team. One thing to note about the process flow diagram in Figure 1.
manufacturing process used. COMPOSITE MANUFACTURING PROCESS The manufacturing process defines what finishing for form and flow we will use for the core going into the kits and which kit option we decide to use. The manufacturing process also influences how vital tolerances are when joining the kit details in the mould. Wet lamination.
accounting techniques, their definitions, process, advantages, and benefits. KEYWORDS: Accounting, Activity Based Costing, Balanced Scorecard, Budgeting, Just in Time INTRODUCTION There is kind of agreement that accounting is the language of business; to figure out the financial position of an organization; identifying the level of gain or loss which is the result of business' operations, and .
