类别 全部 - analytics - innovation - compliance - safety

作者:Tom Nelson 2 年以前

84

Functional Components

The document outlines various critical components and processes integral to effective project and product management in industries such as manufacturing and technology. Emphasis is placed on compliance with standards like FDA and EMC, ensuring safety, and maintaining high-quality standards through audits and problem reporting.

Functional Components

Functional Components

Best Practices

BOM Structure
Revision
Naming
Numbering
Lifecycles

Integration

External
CRM
MES
ERP
sCAD
eCAD
mCAD
Learning Management System (LMS)
Standards (FDA, EMC, etc.)
Safety
Environmental

Supply Chain

Facilities
Organization Structure
Supplier Management
Sales Order
Purchase Order
Inventory Management
Work Order
Inspection Management
Validation
Audit
CAPA
Nonconformance
Problem Report

Change

Change Order (Rev Change Order)
Commercialization Change Order
Change Request (non-Rev Change Order)
Deviation

Configuration Management

Org BOM
Site/Subcon
Service
Manufacturing
Primary-Design
Catalog

Subtopic

External (Customer Facing)

Internal

Item

Material

Microprocessor

Geography
Configuration
Documentation
Collateral

Brochures

Records

Device Master Record (DMR)

Design History File (DHF)

Requirement

Design Verification

Design Validatin

Design Output

Design Input

Category

Standard
Risk Mgmt

PFMEA

DFMEA

Risk Analysis

Quality Management System (QMS)

ISO13485

ISO9001

Forms/Templates
Folders
Diagrams/Dwgs
Reports

Quality

Compliance

Reliability

Test

Training
Work Instruction (WI)
Standard Operating Procedure (SOP)
Specification
AML/AVL
Regulatory Compliance
MPN-Supplier Link
Structure
Formulation Management
Documents
Parts
Part
Product

Subassembly

Assembly

Kit
Software/Firmware
Optical

Lens

Display

Chemical

Substance/Ingredient

Solder

Ink

Epoxy

Mechanical

Frame

Label

Wrap

Wire

Package

Glass

Electrical

Integrated Circuit (IC)

Inductor

Resistor

Capacitor

Cable

Battery

Project Management

Proposal
Priority - Portfolio Management
Justification/CBA
Timeline
Costs
Resource Requirements

Innovation Management

Analytics & Reports
Proposals
Concepts
Requirements
Idea