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Line Numbering Schemes & Related Practices in Manufacturing

Table of Contents Author......................................................................................................................................... i Preface ....................................................................................................................................... iii Figures ........................................................................................................................................ xi Appendix .................................................................................................................................... xii Acronyms ................................................................................................................................... xiii

Chapter 1 Looking Ahead

Undefined vs. Defined Line Item Number (LIN) Schemes ................................................ 1 Value Engineering ................................................................................................................. 1

Line Item Number (LIN) – Scope of Use ............................................................................ 2 MRP vs. ERP – Considerations............................................................................................ 2

Verification & Validation Process ....................................................................................... 3 Bar Code Symbologies ......................................................................................................... 4

Chapter 2 Compliance Standards & Controls

Overview – The Management Process .................................................................... 5 Operating, Build, Process, & Regulatory Compliance .......................................... 6 QMS Manual – Three Parts ................................................................................................ 6 Volume I - Policies ........................................................................................................ 7 Volume II Directives.............................................................................................................. 7 Volume III – Data Collection ................................................................................... 8

Internal Audits ...................................................................................................................... 8 Document Control System(s) ............................................................................................... 8

Chapter 3 Document Creation, Processing, & File Conventions

Overview - Relational Database Records Software (e-forms) .......................................... 10 Departmentalizing eForms, Data Files & Directives.......................................................... 11 Workflow – e-Form Routing ............................................................................................... 12 Electronic Signatures – trusted third party authenticity................................................... 14 File Naming & Storage Convention Directives .................................................................. 14

Security Considerations ...................................................................................................... 15 GAAP Compliant Records – Naming & Saving PDF Records.......................................... 15 Archiving Records – scheduled backups ........................................................................... 15

Records Retention Policy ..................................................................................................... 16 Verification & Validation .................................................................................................... 17

Chapter 4 Human Resources - Training

HR Basics – as it relates to QMS compliance............................................................... 19 Task Assignments, Training, and Certification ................................................................. 20 Training Curriculums by Assembly & Process ................................................................. 20 Job Description, Performance Criteria, & Reporting........................................................ 22

Performance Reviews & Corrective Action ....................................................................... 22 Security Protocols ................................................................................................................. 23

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Chapter 5 Multiple Build Level Line Item Numbers Overview ................................................................................................................................ 24 Determining Build Level Requirements for Your Company ........................................... 24

LIN Record ............................................................................................................................ 24 LIN Assignments – Designated Engineer ........................................................................... 25 LIN Assignment Logs – Redlining & Conversion ............................................................. 25 Three Level Build LIN Scheme .......................................................................................... 26

Top Assemblies ..................................................................................................................... 26 Sub Assemblies....................................................................................................................... 27 Components............................................................................................................................ 28 Expensed Items ..................................................................................................................... 29

Chapter 6 Work Measurement

Overvicw ..................................................................................................................... 30 Prime Cost Direct Labor (DL) by Value Added Assembly ............................................. 30

Capacity Planning & Scheduling Deliveries ...................................................................... 31 Electronic Manufacturing Service (EMS) Charges ........................................................... 33

Chapter 7 Indirect Cost – Calculating FOH burden rates

Overview ..................................................................................................................... 34 Factory Overhead Burden (FOH) - Calculating the Rate ................................................ 34 Bill of Material (BOM) & Applied Cost Report ................................................................ 35 Standard vs. Actual Costing ................................................................................................ 35

Variance ................................................................................................................................ 36 Summary Gross Margin Reports ......................................................................................... 36

Chapter 8 Accounting for Cost

Overview .................................................................................................................... 37 Accrual Method – FIFO vs. LIFO ...................................................................................... 37 New Factory Purchases – Subsidiary Ledger .................................................................... 37 Applied Cost vs. Ending Inventory ..................................................................................... 38

Inventory Turns .................................................................................................................... 38

Chapter 9 Property Management Overview ................................................................................................................................ 39 Property Records - by Tag No. ............................................................................................ 39 Tooling & Test Fixtures ....................................................................................................... 40 Storage – Tool Cribs & Locked Cabinets ........................................................................... 40

Chapter 10 Vendors Overview ................................................................................................................................ 41

VRN Vendor Record Number – Identification Scheme ................................................... 41 CDA (Confidential Disclosure Agreement) ......................................................................... 42 Vendor Qualification – Survey Questionnaire vs. Inspection .......................................... 42 Vendor Traceability Practices – Billing, Shipping, Labeling ............................................ 42 Approval Process – Performance Review .......................................................................... 42

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Chapter 11 Purchasing

Overview .................................................................................................................... 43 Master Build Schedule – Cash flow Planning Tool ........................................................... 43 RFQ (Request for Quotation) ................................................................................... 44 North American Component Search Engines ........................................................ 44 PO (Purchase Order) – Form Design ................................................................................. 44 WO (Work Order) – for outside value-added processes.................................................... 45 Buying as an OEM ................................................................................................................ 45 NCNR (Non-Cancelable Non-Returnable) Agreements..................................................... 46 LCR (Landed Cost Report) – Net + Total Freight-In ....................................................... 46 Duty Drawback – HTS, ECCN, & COO by LIN ............................................................... 47 LTC (Lot Trace Code) – Receiving Log Entry .................................................................. 47 Discrepancy Reports – Performance Review...................................................................... 47

Chapter 12 Design, Build & Process Documentation

DHF (Design History File) – by Product (Device) ................................................... 49 OTS (Off-the-Shelf) Items – Datasheets .................................................................. 49 Engineering Prints – for Fabricated LINs .............................................................. 49 PQM (Parts Qualification Manual) – file convention ............................................ 50 DMR (Device Master Record) Binder – by Product (Device) ................................. 50 RCN (Routing Control Number) – scheme ......................................................................... 51 PCN (Process Control Number) - scheme by LIN reference ............................................ 52 DLN (Device Label Numbers) - scheme ............................................................................ 53

Chapter 13 Change Control & Sustained Engineering

Overview ..................................................................................................................... 54 ECO Levels vs. LIN Revisions .................................................................................. 54

ECO Engineering Change Orders ................................................................................... 54 Sustained Engineering – for Design & Configuration Control ........................................ 55 Product Configuration Records – Traceability by MN/Lot/SN ....................................... 55

Chapter 14 Inventory Control

Overview .................................................................................................................... 56 Classifying Inventory ........................................................................................................... 56 Physical Space Planning & Inventory Tools ..................................................................... 57 Inventory – Signage & Identification .................................................................................. 59 Material Handling - Electrostatic Discharge (ESD) .......................................................... 59 Mobile Handheld Barcode Scanner – syncing it with PC App or Excel .......................... 60

Security .................................................................................................................................. 60 Customer Supplied Property................................................................................................ 61 Receiving – Parts Qualification Manual (PQM) ................................................................ 61 Inspection - Visual vs. Test (Ref. PCN) .............................................................................. 61 Transfer Protocols – FIFO via Lot/Date Codes ................................................................ 61 Kitting & Shortage Reports ................................................................................................. 62 Reserve Kits - Quarantine & Release ................................................................................. 63 Material Transfer Receipt - for EMS or Job Shops .......................................................... 63 Physical Inventory Record – Fiscal Period Ending ........................................................... 63 Daily Receiving & Shipping Logs ........................................................................................ 64

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LTC Scheme .......................................................................................................................... 64

Chapter 15 Line Documents

Overview .................................................................................................................... 65 Production Plan ................................................................................................................... 65 Prints & Process Directives ................................................................................................. 66 Process Travelers – by SN (Performance Monitoring) .................................................... 66 TCP Test Control Procedure ............................................................................................... 67 Test Certs – by SN ................................................................................................................ 67 Containerization/Labeling Checklist .................................................................................. 67 DHR - Device History Record ............................................................................................. 69

Chapter 16 After-Sales Service

Overview .................................................................................................................... 70 Domestic vs. International Warranty Service ........................................................ 70 Translation Services................................................................................................... 71 Collecting & Tracking Complaints – for Corrective Action ................................. 71 Configuration Control & Support ....................................................................................... 71 Service Record – by Ref. RGA ............................................................................................ 71 Recalls – Query Affected LIN by LTC ................................................................................ 73

Retrofit Kits .......................................................................................................................... 73

Chapter 17 Complaints

Overview .................................................................................................................... 74 Complaint Log ...................................................................................................................... 74 Records – based on FDA MDR requirements .................................................................... 76

Trend Analysis ...................................................................................................................... 77 Corrective Action .................................................................................................................. 77

Chapter 18 GNA – Budgeted Expenses Overview ................................................................................................................................ 78

Administration Department ................................................................................................ 79 Sales Department – Marketing & Sales .............................................................................. 79 Engineering – Design & Sustained Engineering ................................................................ 80

Chapter 19 Administration Department Overview ................................................................................................................................ 81

Org Chart – Delegation ........................................................................................................ 81 Legal ...................................................................................................................................... 81

Patents & Patent Stratergy .................................................................................................. 82 Trademarks ........................................................................................................................... 84 IT ............................................................................................................................................ 85

Finance – its relation to production and marketing .......................................................... 85

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Chapter 20 Sales Department Overview................................................................................................................................. 87

Customer Account Numbers ................................................................................................ 87 Credit & Collection Management ........................................................................................ 87 Export Control – Snap-R Filings ......................................................................................... 88

Marketing............................................................................................................................... 88 Sales ........................................................................................................................................ 89

Customer Acquisition Cost ................................................................................................... 89

Chapter 21 R&D

Overview ..................................................................................................................... 91 ELN Electronic Lab Notebook.................................................................................. 91 Product Definition Phase – FRD (Functional Requirements Document .............. 92 Development Plan....................................................................................................... 92 Product Development Phases .................................................................................... 92 V&V – Verification & Validation ............................................................................. 93 Regulations: Clinicals & 510(k) ................................................................................ 94Primary vs. Selective Demand Products .................................................................. 94

Chapter 22 Conclusion

Overview .................................................................................................................... 95 Entrepreneur – by definition ............................................................................................... 95

Business Planning ................................................................................................................. 95 Business Development & Stages of Financing .................................................................... 95 Sources of Capital ................................................................................................................. 95 Terms of Capitalization ....................................................................................................... 96 Historical Events that Adversely Impacted Manufacturing.............................................. 98

Overcoming Impediments..................................................................................................... 100 Trends in Product Development & Production .................................................................. 102 Final Message – the real world ........................................................................................... 102

References .............................................................................................................................. 103

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List of Figures

Chapters 1-22

Figure Description Page

2.1 Management Process 53.1 Formdocs* eForms Suite Tabs 12 3.2 QMS Volume II Directives – Format 13 3.3 Formdocs* Security Features 14 5.1 LIN for Top Assembly 26 5.2 LIN for Sub Assembly 27 5.3 LIN for Components 28 5.4 LIN for Expensed Items 29 9.1 Property Tag Number 39 10.1 VRN Vendor Record Number 41 11.1 Discrepancy Report Number 48 12.1 RCN Routing Control Number 51 12.2 PCN Process Control Number 52 12.3 DLN Device Label Number 53 13.1 ECN Engineering Change Number 54 14.1 Inventory Stores Layout 57 14.2 Mobile Bar Code Scanner – Screen 60 15.1 UDI Label – Medical Supply Chain Standard 68 20.1 Customer Account Number 88

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Appendix Page A QMS Volume III – eForm Suites 104 A.1 Sample File Storage Convention 111 B Hub & Stoke Diagram 112 C Japanese Keiretsu Diagram 112 D Pyramid Organizational Chart 113 E Matrix Organizational Chart 113 F Product Deployment Flowchart 114 G Product Life Cycle 114 H Document Transfer & Build Kit Process – Flow Chart 115 I Build Process – Flow Chart 116 J Final Test & Containerization – Flow Chart 117 K.1 Verification & Validation – Water Falls Method 118 K.2 Verification & Validation – Development Life Cycle Process 118 L.1-2 Inventory Area Signage – Aisle Markers 119 L.3 Wire Mesh Shelving 120 L.4 Wire Cage Sections 121 L.5 In-house Tote Container 122 L.6 Off-Site Ammo Case 122 L.7 Rack, Bin, Bag, & Reel Nest Labels 123 L.8 Handheld Mobile Computers – Barcode Scanners 124 M.1 Julian Week Calendar 125 N DCR (Document Control Record) Logs 126 O QMS Matrix – ISO 9001 | ISO 13485 Cross Reference Indexes 127 P QMS Page Headers – Policies & Directives 128 Q List of Reference QMS & Build Standards 129 R Sub-Assembly BOM – DM, Freight-In, DL 130 S Top-Assembly BOM – DM, Freight-In, DL, & FOH 131 T Material Shortage Report 132 U.1 ECO (Engineering Change Order) Form 133 U.2 ECO Form – Records Control & Validation Page 134 V.1 Task WO (Work Order) – Part 1 135 V.2 Task WO – Part 2 – with Sample Formdocs* Connectivity 136 W Sample Work Measurement Report 137 X ECO Configuration Record 138 Y Production Lot Record 139 Z FOH Burden Rate Record – Calculation for FOH Burden 140


Acronyms ToC Table of Contents DHF Design History Files (a record of all deisgn controls) DMR Device Master Records (all build & process control documents) DHR Device History Records MDR Mandatory Device Reporting DLN Device Label Number DCR Document Control Record ECM Enterprise Content Management (convention for records on LAN or Cloud server) QSR Quality System Regulations (FDA 820 GMP(c) Subparts A through O) QMS Quality Management System (ISO 9001:2016) as updated SOP Standard Operating Procedures (Directives laid out in your QMS – Part II) ECN Engineering Change Notice ECO Engineering Change Order CDA Confidential Disclosure Agreement NDA Non-Disclosure Agreeement MDA Mutual Disclosure Agreement LIN Line Item Number (Multiple Build Level Assembly ID# for Mfg.) SKU Stock Keeping Unit (Product ID# for Sales) BOM Bill of Materials DM Prime Cost Direct Material PQM Parts Qualification Manual (Specs for every part in the top assembly build) DL Prime Cost Direct Labor FOH Factory Overhead GNA G&A General Administrative (i.e. Administration, Marketing, & Engineering) FASB Financial Accounting Standards Board (i.e.GAAP is one of their core standards) GAAP Generally Accepted Accounting Practice (records with a seed & ending number/period) FIFO First In First Out (i.e. with respect to accrual method in inventory use & accounting) LIFO Last In First Out (used during period of inflation and control by IRS & Internationally) PCN Process Control Number (a processing directive-separate from operating directives) WIP Work In Process (WIP inventory, meaning partially assemblied) TCP Test & Calibration Procedure ESD Electro-Static Discharge – (ESD protected, as in anti-static or conductive handling) OTS Off-the-Shelf (item sourced from a vendor & identified by a Type No & Datasheet) HTS Harmonized Tariff Schedule (item classified for import tariff) ECCN Export Control Classification Number (issued by USDoC/BIS – Snap-R Program) BIS Bureau of Industry Security (in charge of export control) COO Country of Orgin LoC Letter of Credit (Most secure is a – Irrevocable Confirmed Letter of Credit) MRP Material Requirements Planning ERP Enterprise Resource Planning EDI Electronic Data Interchange (software used to automate supply chain logistics) XML Extensible Markup Language (formatted to allow humans & machines to read data) GUI Graphical User Interface (Leaning it usually requires an investment of time) SDK Software Development Kit (for the purpose of developing custom applications) IFU Instructions for Use (product User Guide or Manual) IFM Imstructions for Maintenance (typically referred to as a Service Manual)

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Acronyms – cont’d

SN Serial Number ( identifying a unit or a record with a SEED and ENDING number) MN Model Number (further designated by ECO level for maintenance purposes) RMA Return Material Authorization RGA Return Goods Authorization VRN Vendor Record Number RCN Routing Control Number PQM Parts Qualification Manual (Data sheets or prints for all part within an assembly) LTC Lot Trace Code (an indication that controls the flow and use of inventory for FIFO) EOQ Economical Order Quantity MSR Material Shortage Report NRE Non-Reoccuring Expense (Additional one time cost for custom parts) WMR Work Measurement Report V&V Verification & Validation MRD Market Requirements Document PRD Product Requirements Document FRD Functional Requirements Document – detailed specifications & compliance standards SDLC System Development Life Cycle TTL Technology Transfer License USPTO United States Patent & Trademark Office WIPO World Intellectual Property Organization PatFT USPTO Patent Full-Text and Image Database AppFT USPTO Patent Application Full-Text and Image Database PTAB Patent Trial & Appeal Board TESS Trademark Electronic Search System echnology TEAS Trademark Electronic Application System TTAB Trademark Trial and Appeal Board CAC Customer Acquisition Cost LTV Long Time Value CPT Current Procedural Terminology CMS Centers for Medicare & Medicaid Services HCPCS Healthcare Common Procedure Coding System (used to secure payment for services) NPV Net Present Value (a formula used for capital budgeting) ROI Return on Investment

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Appendix A - Typical List of Control Forms Found in a Manufacturing Enterprise

To support the information in this book you can obtain fillable eforms put up in Formdocs*, MS Excel*, and fillable PDF files by going to www.eformtemplates.com Formdocs* is a relational database program that allows you to create fillable eforms with a serialized recordset. It’s relatively inexpensive and allows you to add filler licenses as your company grows.

A fully functional 15 day free trial program is available on the Formdocs* website at: www.formdocs.com

These eforms are indexed and listed below by Department using the designated numbers that appear on the Org Charts in Appendix, section D&E.

In addition to making the task of bringing order to the manufacturing process easier, these eforms will help you to prepare for ISO 9001 or ISO 13485 compliance and the process of drafting a three part QMS manual. The relevant compliance requirements are footnoted for these two QMS standards by section and subpart.

Those records that reference Multiple Build Level Line Item Numbers (LIN) are highlighted below*. We advise you obtain the General ISO 9001 and any Particular standards for your industry to see how these data collection forms listed in the departmental indexes below relate to your business.

The Formdocs* eforms can be easily modified in the Formdocs* Designer module, while MS Excel and fillable PDFs can be modified in those respective programs. Formdocs* eforms use a database lookup file to store field data for each serialized eform record while MS Excel and PDF forms require a master and a naming convention for each saved record.

1 ISO 9001:2015 [(4.4)] | ISO 13485:2016 [(4.2.2)] 2 ISO 9001:2015 [(7.5.1), (7.5.2),(7.5.3.1), (7.5.3.2)] | ISO 13485:2016 [(4.2.5)] 3 ISO 9001:2015 [(7.5.3-b), (8.4.1-2), (8.54)] | ISO 13485:2016 [(4.2.4), (4.2.5)(7.5.11)] 4 ISO 9001:2015 [(9.1.3-f), (9.3-c)] | ISO 13485:2016 [(8.4), (5.6)]

1 ISO 9001:2015 [(4.1)] (Specific reference to Contract Review was removed after ISO 9001:1994) No reference to Patents or control and maintenance of them in ISO 13485:2016

2 ISO 9001:2015 [(7.1.6)] | ISO 13485:2016 [(No subpart]

Department/ Forms Suite File Type Order No

01-Administrator:

01-Admin. Mgmt Suite: 1 Form Record

Formdocs*

01-01-001-A

2 Access & Security Log 3 Visitors Log & Badges 4 Independent Contractors 4 Contractor Log

Formdocs Formdocs Formdocs Formdocs

01-01-002-A 01-01-003-A 01-01-004-A 01-01-005-A

02-Legal: 01- Legal Forms Suite:

1 Contract Record* Formdocs 02-01-001-A 1 Contract Log Formdocs 02-01-002-A 2 Patent Status Record Formdocs 02-01-003-A 2 TTL-Tech Brief* Formdocs 02-01-004-A

http://www.eformtemplates.com/

http://www.formdocs.com/

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1 ISO 9001:2015 [(4.4), (4.4.2), (5.2.2), (5.4.2), (7.5), (7.5.3)] | ISO 13485:2016 [(4.2.2), (4.2.4), (4.2.5)] 2 ISO 9001:2015 [(7.5.3)] | ISO 13485:2016 [(4.2.5)]

1 ISO 9001:2015 [(7.1.2), (7.2), (7.3)] | ISO 13485:2016 [(6.2)] 2 ISO 9001:2015 [(7.2), (7.3), (7.4)] | ISO 13485:2016 [(5.5.3), (5.6.3), (6.2)]

1 ISO 9001:2015 [(4.4.2), (5.2.2), (7.1.2), (7.1.6), (7.2), (7.3), (7.4)] | ISO 13485:2016 [(4.2.2)]

05 – Finance 05-Cash Mgmt Suite:

1 Sales Order Log* Excel 05-01-001-A 2 GNA Budget Excel 05-01-002-A 2 Gross Margin Report* Excel 05-01-003-A 2 Cash Flow Plan Excel 05-01-004-A 2 Disbursements & Receipts Journal Excel 05-01-005-A 2 AP Schedule Excel 05-01-006-A 2 AR Aging Report Formdocs 05-01-007-A 2 Account Statement Formdocs 05-01-008-A 2Allocation Journal – Standard Costing* Formdocs 05-01-009-A 1 ISO 9001:2015 [(8.2), (8.2.3.1)] | ISO 13485:2016 [(7.2)] 2 ISO 9001:2015 [(7.1.1), (7.1.3), (8.2.2)] | ISO 13485:2016 [(6.1), (6.3), (7.2.3)] Note: As it relates to resources and customer satisfaction (excluding any reference to cost or budgets)

03-IT: 03-DCR Mgmt Suite:

1DCR Document Record Formdocs 03-01-001-A 1 Policy Log Formdocs 03-01-002-A 1 Directives Log* Formdocs 03-01-003-A 2 Data Collection Log Formdocs 03-01-004-A

04 - HR 04-HR Mgmt Suite:

1 Employment App Fillable PDF 04-01-001-A 1 Job Description Formdocs 04-01-002-A 1 Recruiting Record Formdocs 04-01-003-A 1 Test Log Formdocs 04-01-004-A 1 Interview Record Formdocs 04-01-005-A 1 Employee Record Formdocs 04-01-006-A 1 Consigned Items Record Formdocs 04-01-007-A 1 Employee Log Formdocs 04-01-008-A 2 Performance Review Formdocs 04-01-009-A 2 Exit Interview Formdocs 04-01-010-A

04-Personnel Training Suite: 1 Course Curriculum* Formdocs 04-02-001-A 1 Certificate of Training* Formdocs 04-02-001-A 1 Training Plan/Video List* Formdocs 04-02-001-A 1 Certification Log* Formdocs 04-02-001-A 1 Video Log* Formdocs 04-02-001-A

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05-Payroll Suite: 1Time Record Formdocs 05-02-001-A 1Annual Payroll Record Formdocs 05-02-002-A 1 Consolidated Payroll Excel 05-02-003-A 1Vacation & Comp Time Record Formdocs 05-02-004-A 1 ISO 9001:2015 [(7.1.2)] | ISO 13485:2016 [(6.2)] Note: As it relates to manpower needs and capacity planning for product delivery and customer service)

1 ISO 9001:2015 [(8.2.1), (9.1.2)] | ISO 13485:2016 [(7.2.3), (8.2.1), (8.2.2)] Note: As it relates to customer satisfaction, feedback, and complaint handling

07- QA Quality Administration 07-QMS Suite:

1 Policy Sheet Fillable PDF 07-01-001-A 1 Directive Sheet* Fillable PDF 07-01-002-A 1 ToC Policy Matrix Formdocs 07-01-003-A 1 ToC Directive Matrix Formdocs 07-01-004-A 1 ToC Forms Matrix Formdocs 07-01-005-A 1 ISO 9001:2015 [(4.3), (5.2.1), (5.2.2), (7.5)] | ISO 13485:2016 [(4.1), (4.2.1), (4.2.2)]

1 ISO 9001:2015 [(8.5.5), (8.7), (9.1.2), (10.2)] | ISO 13485:2016 [(8.2.2), (8.2.3), (8.3.2), (8.3.3), (8.3.4)] 2 ISO 9001:2015 [(10.2)] | ISO 13485:2016 [(8.2.3), (8.3.2), (8.3.3), (8.3.4), (8.5.2)]

1 ISO 9001:2015 [(9.2)] | ISO 13485:2016 [(8.2.4)] 2 ISO 9001:2015 [(8.4)] | ISO 13485:2016 [(7.4.1)] 3 ISO 9001:2015 [(10.2)] | ISO 13485:2016 [(8.5.2)]

06 - Sales 06-Sales Suite:

1 Credit Application PDF 05-01-001-A 1 Credit Report Formdocs 05-01-002-A 1 Sales Order Acknowledgement* Formdocs 05-01-003-A 1 Proforma Invoice* Formdocs 05-01-004-A 1 Invoice* Formdocs 05-01-005-A 1 Pack List* Formdocs 05-01-006-A 1 RGA – Return Goods Authorization* Formdocs 05-01-007-A 1 CM – Credit Memo* Formdocs 05-01-008-A 1 Ship Memo – for samples, etc.* Formdocs 05-01-009-A 1 Customer Database Formdocs 05-01-010-A

07-Complaint Forms Suite: 1 Complaint Log* Formdocs 07-02-001-A 1 Incident Disposition* Formdocs 07-02-002-A 2 Recall Notice* Formdocs 07-02-003-A 2 Recall Log* Formdocs 07-02-004-A

07-QMS Audit Forms Suite: 1 Internal Audit – Part I Fillable PDF 07-02-001-A 1 Internal Audit – Part II Fillable PDF 07-02-002-A 2 CM/EMS Audit Fillable PDF 07-02-003-A 3 Corrective Action Record Formdocs 07-02-004-A 3 DCR Workload Audit Formdocs 07-02-005-A

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08- Production 08-Purchasing Suite: 1 Vendor Record Formdocs 08-01-001-A 1 Vendor Qualification Survey Fillable PDF 08-01-001-A 1 RCN – Routing Control Record* Formdocs 08-01-001-A 1 RFQ – Quotation Request* Formdocs 08-01-001-A 1 Purchase Order* Formdocs 08-01-001-A 1 Order Requisition* Formdocs 08-01-001-A 1 ISO 9001:2015 [(8.4), (8.4.1), (8.4.2), (8.4.3)] | ISO 13485:2016 [(7.4), (7.4.1), (7.4.2), (7.4.3)]

1 ISO 9001:2015 [(8.2.2), (8.5.1), (8.5.2)] | ISO 13485:2016 [(7.2), (7.2.1), (7.4.2), (7.4.3), (7.5.8), (7.5.9.1)]

08-Asset Control Suite: 1 Property Record Formdocs 08-03-001-A 1 Calibration Order* Formdocs 08-03-002-A 1 Tool Crib Receipt* Formdocs 08-03-003-A 1 ISO 9001:2015 [(7.1.3), (7.1.5), (7.1.5.1), (7.1.5.2)] | ISO 13485:2016 [(6.3), (7.5.1), (7.5.6), (7.6)]

08-Mfg Operations Suite: 1 MBS – Master Build Schedule* Excel 08-04-001-A 1 Resource Requirements Formdocs 08-04-002-A 1 Task Assignment Record* Formdocs 08-04-003-A 1 FOH Burden Rate Record Formdocs 08-04-004-A 1 WMR – Work Measurement Report* Formdocs 08-04-005-A 1 EMS Work Order* Formdocs 08-04-006-A 1 ISO 9001:2015 [(7.1), (7.1.1], (7.1.2), (7.2), (8.1)] | ISO 13485:2016 [(6.1), (6.2), (6.3), (7.5.1)]

1 ISO 9001:2015 [(8.5.5), (10.2)] | 1 ISO 13485:2016 [(7.5.4), 7.5.6), (7.5.10), (8.2.1), (8.2.2), (8.3.3), (8.3.4), (8.4), (8.5.1), (8.5.2), (8.5.3)] Note: These completed Records go in DHR Packet Envelope and/or DHR Digital Archives by MN/Lot/SN

09-Engineering: 09-ELN Suite: 1 ELN Electronic Lab Notebook* Formdocs 09-01-001-A 1 ISO 9001:2015 [(7.1.6), (8.3.3), (8.3.5)] | ISO 13485:2016 [(7.3.3), (7.3.4)]

08-Inventory Control Suite: 1 MSR – Material Shortage Report* Excel 08-02-001-A 1 Consigned Material Request* Formdocs 08-02-001-A 1 Daily Receiving Log* Excel 08-02-003-A 1 Discrepancy Report* Formdocs 08-02-001-A 1 Daily Shipping Log* Excel 08-02-001-A 1 Inventory Count Report* Excel 08-02-001-A 1 Mobile Device Form – Barcode Scanner* Formdocs 08-02-001-A

08-After Sales Service Suite: 1 Rec’g Report* Formdocs 08-05-001-A 1 Service Quote* Formdocs 08-05-002-A 1 Service Order Invoice* Formdocs 08-05-003-A 1 Critical Spares List* Formdocs 08-05-004-A 1 Retrofit Directive* Formdocs 08-05-005-A

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1 ISO 9001:2015 [(8.3.5)] | ISO 13485:2016 [(7.3.4)] 2 ISO 9001:2015 [(7.1.5)] | ISO 13485:2016 [(7.6)] 3 ISO 9001:2015 [(8.5.3)] | ISO 13485:2016 [(7.5.10)] 4 ISO 9001:2015 [(8.7.1), (10.2)] | ISO 13485:2016 [(8.3), (8.3.1), (8.3.2), (8.3.3), (8.5.2), (8.5.3)]

09-Design Suite: 1 Print Log – by Assembly* Formdocs 09-03-001-A 2 FRD – Design Input Document* Formdocs 09-03-002-A 1 ISO 9001:2015 [(8.3.4)] | ISO 13485:2016 [(4.2.4), (4.2.5), (7.3.10)] 2 ISO 9001:2015 [(8.3.3)] | ISO 13485:2016 [(7.1), (7.3.3)]

09-Process Control Suite: 1 PCN – Process Control Record* Formdocs 09-04-001-A 1 PCN – Directive* Fillable PDF 09-04-002-A 1 PCN Log * Formdocs 09-04-003-A 1 PCB Assembly* Formdocs 09-04-004-A 1 Wire Chart* Formdocs 09-04-005-A 1 ISO 9001:2015 [(8.4), (8.4.1), (8.4.2)], (8.5.1)] | ISO 13485:2016 [(7.4), (7.4.1), (7.4.2), (7.5.1)]

09-LIN Assignment & Maintenance Suite: 1 LIN Record* Formdocs 09-05-001-A 1 LIN Top Assembly Assignment Log* Formdocs 09-05-002-A 1 LIN Sub Assembly Assignment Log* Formdocs 09-05-003-A 1 LIN Parts Assignment Log* Formdocs 09-05-004-A 1 LIN FOH Expensed Item Assignment Log* Formdocs 09-05-005-A 1 ISO 9001:2015 [(7.5.3), (8.5.2)] | ISO 13485:2016 [(4.2.5), (7.5.8), (7.5.9)]

09-Device Labeling Suite: 1 DLN Record* Formdocs 09-06-001-A 1 DLN – Device Label Log* Formdocs 09-06-002-A 1 ISO 9001:2015 [(8.2.1), (8.2.3.1), (8.5.2)] | ISO 13485:2016 [(7.2.1), (7.2.2), (7.5.8), (7.5.9), (7.5.11)] Note: This includes labels for product literature, container documentation, wrappers or box labeling, website content, YouTube, or social media releases and their respective revisions.

09-BOM Costing Suite: 1 Landed Cost Record* Formdocs 09-07-001-A 1 BOM - Sub Assembly* Formdocs 09-07-002-A 1 BOM - Top Assembly* Formdocs 09-07-003-A 1 ISO 9001:2015 [(8.4), (8.5.1), (8.5.2)] | ISO 13485:2016 [(7.3.4), (7.4), (6)]

09-Lab Records Suite: 1 ERN-Engineering Report* PDF 09-02-001-A 1 Project Time Record* Formdocs 09-02-002-A 1 ERN Report Log* Formdocs 09-02-003-A 2 Calibration Record - by instrument Formdocs 09-02-004-A 3 Customer Supplied Items Report* Formdocs 09-02-005-A 4 NCR – Non Conformance Report* Formdocs 09-02-006-A

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09-Change Control Suite: 1 ECN - Engineering Change Notice* Formdocs 09-08-001-A 1 ECO – Engineering Change Order* Fillable PDF 09-08-002-A 1 ECO – Addendum* Formdocs 09-08-003-A 2 Configuration Record* Formdocs 09-08-004-A 2 Production Lot Record* Formdocs 09-08-005-A 1 ISO 9001:2015 [(8.3.6), (8.5.6)] | ISO 13485:2016 [(7.3.9)] 2 ISO 9001:2015 [(8.5.2)] | ISO 13485:2016 [(7.5.8), (7.5.9)]

1 ISO 9001:2015 [(8.3.1)] | ISO 13485:2016 [(4.2.3), (7.3.1), (7.3.10)] 2 ISO 9001:2015 [(8.3.4)] | ISO 13485:2016 [(7.3.6), (7.3.7)] 3 ISO 9001:2015 [(8.2.3), (8.3.5), (8.3.6)] | ISO 13485:2016 [(7.3.5), (7.3.9)] 4 ISO 9001:2015 [(8.6)] | ISO 13485:2016 [(7.3.8)] Note: See Chapter 12 for a complete summary index of the DHF sections

1 ISO 9001:2015 [(8.5.1)] | ISO 13485:2016 [(7.5.1)] Note: See Chapter 12 for a typical DMR file set

09-DHR – Device History Records Suite: 1 Process Traveler* Formdocs 09-11-001-A 1 Work Order* Formdocs 09-11-002-A 2 TCP Master* Formdocs 09-11-003-A 2 Test Cert Formdocs 09-11-004-A 3 Container Check List Formdocs 09-11-005-A 2 Certificate of Conformance Formdocs 09-11-006-A 1 ISO 9001:2015 [(8.5.1), (8.5.2), (8.6)] | ISO 13485:2016 [(7.5.1)] 2 ISO 9001:2015 [(9.1.1)] | ISO 13485:2016 [(8.1), (8.2.6)] 3 ISO 9001:2015 [(8.5.1), (8.6)] | ISO 13485:2016 [(7.5.1)]

Disclaimer: You should always verify that the eForm is fully functional. After verification, validation can be performed in actual practice by bringing everyone in the Workflow path together for a pilot run while keeping your present system in place. Repeat this V&V process until the Form is adequate for all your operating controls and recording needs. ISO 9001:2015 [(7.5.2), (7.5.3.1), (7.5.3.2)] | ISO 13485:2016 [(4.2.4), (4.2.5), (5.6.2), (5.6.3)]

Please be aware www.eformtemplates.com does not provide tech support. Contact Formdocs* with tech support questions and/or their tech support terms, SDK kit products, and any subscriptions.

09-DHF – Design History Files Suite: 1 DHF – Design Binder _ Part I Summary Formdocs 09-09-001-A 1 DHF – Design Binder Part II Detail Formdocs 09-09-002-A 2 V&V Matrix* Formdocs 09-09-003-A 2 Test Report Fillable PDF 09-09-004-A 3 Acceptance Criteria Formdocs 09-09-005-A 3 Certificate of Acceptance Formdocs 09-09-006-A 4 Design Transfer Formdocs 09-09-007-A

09-DMR – Device Master Records Suite: 1DMR Binder Part I Summary Formdocs 09-10-001-A 1DMR Binder Part II Detail Formdocs 09-10-002-A

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9 780966 112825

ISBN 0-9661128-2-2 $79.95

An in-depth guide to developing

Line Item Numbering Schemes & Related Practices in Manufacturing...

Overview...

This book takes a practical approach to developing, implementing, and validating a Line Item Numbering scheme. A multiple build level Line Item Numbers (LIN) scheme is one of the most pervasive things in any manufacturing enterprise. It helps identify and trace everything from design to sales, and all processes in between as well as after sales service. This includes inventory of raw materials, components, value added assemblies, WIP, and top assemblies or finished product. In fact, the task is so daunting, once completed most companies are struck with it for years to come, so before developing a LIN scheme its important to approach the exercise with as much knowledge in hand as possible. This book will explain how modern MRP and ERP software play a role in designing your LIN system, even if you’re not ready to bring such software tools on line anytime soon.

In recent years manufacturers and job shops have lined up to comply and secure certification under ISO 9001, the international standard for Quality Management Systems. This book will show how, a well designed LIN system plays a big role in bringing your company into compliance under such international standards as well as related federal regulations..This book will show you the purpose behind a “defined” LIN scheme for parts and multiple build level assemblies incorporating material, value added labor, and FOH burden as it all relates to BOMs, Economical Order Quantity (EOQ) purchases, cost accounting, and producing financial statements. More specifically, how a LIN scheme can help you divide period purchases between applied cost and ending inventory as well as calculating variance. It will also demonstrate how your LIN system can be used to identify resources in advance to plan plant capacity, labor needs, and schedule deliveries with confidence. Further, this book will draw on recognized practices and will cite industry recognized standards as they apply for follow-up reference. In fact, it will cover methods related to a LIN scheme for all those subjects listed below to improve the manufacturing process:

1 Quality System Manuals - Policies (commitment documents), Directives, and Data Collection 1 Developing & Maintaining a DCR Document Control Record system for operations 1 Drafting Conventions for File Naming, Storage, and Retrieval Methods as well as Security Procedures 1 Vendor Coding & Qualification 1 Numbering as it relates to structured Bills of Materials, multiple build-levels for determining costs, and financial accounting 1 Controlling ECOs and build level revisions 1 Sustained Engineering - how to maintain control over lot/batch shipments and build configurations for after sale service 1 LIN system and how is relates to FIFO accrual and movement of inventory as well as accounting 1 Inventory Stores Layout - related operations 1 Property Labeling - Asset labeling including tooling 1 Methods of recording HTS Codes for export, Duty Drawback claims, as well as UPN (Universal Product Numbering) 1 Product Labeling & Literature - making it part of your DLN Device (Product) Label Numbering system

As you begin to review the forms identified or referenced in this book you will see that in many cases it includes solutions that fill gaps left wide open by many MRP and ERP systems. Where MRP or ERP software may be out of reach due to high cost or where the application of such enterprise software is simply not practical for an enterprise with limited human resources, this book will show how a simple relational database e-forms program can satisfy your control requirements and generate serialized records to satisfy Generally Accepted Accounting Practices (GAAP) with seed and ending numbers for each financial or reporting period in question as well as appropriate uses of fillable PDF forms for other applications.

The line item numbering scheme you arrive at for your company may differ from the ones presented in this book, but my hope is that by the time you finish reading this book you will have a much better understanding of the objectives involved and the applications for which Line Item Numbers are used. If I have accomplished that, then this book has served its purpose.

5 4 9 9 5

9 780966 112825

ISBN 0-9661128-2-2 $49.95