Introduction (Please read)

NOTE: The product produced by any lab exercises is made available on “as is” basis and is not intended to be used, sold or given away.  Furthermore, any files, data or other information is available “as is.”  The project is intended to be unfinished, and so there will be errors and omissions in much of the data.  Do not run any CNC or other files on your equipment without proper testing.  USE THIS DATA AT YOUR OWN RISK.

If you want to know how pocket knives are manufactured in production quantities, see: How It’s Made: Pocket Knives

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Notebook

ISO 9000 Certification
ISO 13485 Certification
FDA Approval

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
PART 820    QUALITY SYSTEM REGULATION

Teamcenter (Seimens)

Engineering Change ECR/ECN

CAD File Name Formats

Purchase Orders

Model Creation (reverse engineering)

Machining

Tool Number Assignment (Haas TM1)

Cutting Speeds and Feeds

Tap Collet List (Procunier)

Haas TM-1 Mill (Manuals and settings)

Bill of Materials

M01-000 – Assembled Knife

• 1     M01-001   Blade
• 1     M01-002   Lockside Handle
• 1     M01-003   Plainside Handle
• 6     M01-004   Handle Capscrew
• 1     M01-005   Blade capscrew
• 1     M01-006   Lockside Liner Discontinued
• 1     M01-007   Plainside Liner
• 1     M01-008   Stop
• 1     M01-009   Spacer
• 2     M01-010   Washer
• 1     M01-011   Clamshell Package
• 1     M01-012   Package Insert
• 1     M01-013   RFID Tag
• 1     M01-014   User’s Manual
• 1     M01-015   Thumb Stud

 

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES

PART 820 QUALITY SYSTEM REGULATION