HF-MES-manual/en/business/quality.md

Quality and Traceability

1. Function Overview

The Quality Management module implements full-process quality control from raw materials to finished products, including incoming inspection, in-process inspection, finished product inspection, quality exception handling, and traceability management, ensuring stable and controllable product quality.

Core Functions:

Function	Description
Inspection Standards	Inspection items and standards definition
IQC Inspection	Incoming quality control
IPQC Inspection	In-process quality control
FQC/OQC	Finished/Outgoing inspection
Quality Exception	Defective product handling, MRB management
Quality Traceability	Forward/Reverse traceability

2. Quality Management System

2.1 Quality Management Process

Total Quality Management Process:

Raw Material Inspection → Production Process Control → Finished Product Inspection → Outgoing Inspection
    │                      │                      │                      │
    ▼                      ▼                      ▼                      ▼
   IQC                   IPQC                   FQC                   OQC

2.2 Quality Management Principles

Principle	Description
Prevention First	Move quality control to design and production stages
Total Participation	Quality is everyone's responsibility
Process Control	Focus on every step of the production process
Continuous Improvement	Continuously optimize quality management system
Data Driven	Make decisions based on data analysis

3. Inspection Standard Management

3.1 Inspection Standard Definition

Inspection Standard Components:

Component	Description
Inspection Type	IQC/IPQC/FQC/OQC
Inspection Item	Specific item to inspect
Inspection Method	How to perform inspection
Judgment Standard	Criteria for pass/fail determination
Inspection Equipment	Required inspection equipment
Sampling Plan	Sampling quantity and rules

3.2 Inspection Item Types

Item Type	Description	Example
Visual Inspection	Visual check	Color, shape, surface quality
Dimension Inspection	Dimension measurement	Length, width, height, diameter
Function Inspection	Function test	Electrical performance, mechanical performance
Performance Inspection	Performance test	Life, reliability
Safety Inspection	Safety test	Insulation, withstand voltage

3.3 Inspection Standard Creation

Creation Steps:

1. Go to [Quality Management] → [Inspection Standards]
2. Click [New Inspection Standard]
3. Fill in standard information:
   • Standard code
   • Standard name
   • Applicable product
   • Inspection type
4. Add inspection items
5. Define inspection methods
6. Set judgment standards
7. Save inspection standard

[Tip] Inspection standards need approval before becoming effective.

3.4 Sampling Plan

Sampling Standards:

Sampling Standard	Description	Application Scenario
GB/T 2828.1	Normal inspection single sampling plan	Regular inspection
GB/T 2829	Periodic inspection sampling plan	Periodic sampling
AQL Sampling	Acceptable quality level sampling	Large batch inspection
100% Inspection	Full inspection	Critical items

AQL Standard Example:

Inspection Lot Size	AQL 1.0	AQL 2.5	AQL 4.0
26-50	3	5	7
51-90	5	7	10
91-150	8	12	18
151-280	13	18	25

4. Incoming Quality Control (IQC)

4.1 IQC Process

IQC Complete Process:

┌──────────┐    ┌──────────┐    ┌──────────┐    ┌──────────┐
│ Arrival  │───▶│Receiving │───▶│   IQC    │───▶│ Judgment │
│ Receive  │    │Document  │    │ Inspection│   │          │
└──────────┘    └──────────┘    └──────────┘    └──────────┘
                                                               │
                                                               ▼
                           ┌──────────────────────────────────┐
                           │       Non-conforming Handling     │
                           │  ┌──────┐ ┌──────┐ ┌──────┐   │
                           │  │Return │ │Concession│ │Scrap │   │
                           │  │       │ │Acceptance│ │      │   │
                           │  └──────┘ └──────┘ └──────┘   │
                           └──────────────────────────────────┘

4.2 IQC Inspection Execution

Inspection Steps:

1. Supplier delivery arrives
2. Warehouse clerk creates receiving document
3. System automatically pushes inspection task to IQC
4. IQC inspector receives inspection task
5. Execute incoming inspection:
   • Verify delivery note against order
   • Visual inspection
   • Quantity verification
   • Sampling inspection
6. Record inspection data
7. Determine inspection result

Inspection Judgment:

Judgment Result	Description	Handling Method
Qualified	Accept for storage	Direct receiving
Concession Acceptance	Special release	Requires approval
Rejected	Return to supplier	Return to supplier

4.3 IQC Inspection Record

Inspection Record Information:

Record Item	Description
Inspection No.	IQC inspection document number
Supplier	Material supplier
Material Code	Material being inspected
Material Batch	Material batch number
Arrival Quantity	Arrival quantity
Sampling Quantity	Sampled quantity
Qualified Quantity	Qualified quantity
Defective Quantity	Defective quantity
Qualification Rate	Qualified quantity/Sampling quantity
Inspection Conclusion	Qualified/Unqualified
Inspector	Person performing inspection
Inspection Time	Inspection time

5. In-Process Quality Control (IPQC)

5.1 IPQC Types

Inspection Type	Timing	Description
First Article Inspection	At start of each batch	Inspection of first product
Patrol Inspection	During production	Regular patrol inspection
Sampling Inspection	Per sampling plan	Random sampling inspection
Last Article Inspection	At end of each batch	Inspection of last product

5.2 First Article Inspection

First Article Inspection Process:

Start Production → First Article Production → First Article Inspection → Qualified → Mass Production
                           │
                           ▼
                     Unqualified
                           │
                           ▼
                  Root Cause Analysis & Correction

First Article Inspection Timing:

Timing	Description
Shift Change	First after shift handover
Material Change	First after material change
Process Change	First after process adjustment
After Equipment Repair	First after equipment repair

5.3 Patrol Inspection Management

Patrol Inspection Points:

Inspection Item	Check Content	Check Method
Process Parameters	Temperature, pressure, time	Check equipment parameters
Material Usage	Correct material usage	Verify material identification
Operation Method	Standard operation	Observe operation process
Product Appearance	Normal appearance	Visual inspection
Equipment Status	Normal equipment operation	Check equipment running status

Patrol Inspection Record:

Record Item	Description
Inspection Time	Inspection time
Inspection Station	Station being inspected
Inspector	Person performing inspection
Inspection Item	Item being checked
Check Result	Inspection result
Abnormal Description	Issues found (if any)

6. Finished Product Inspection (FQC/OQC)

6.1 FQC (Final Quality Control)

FQC Inspection Content:

Inspection Category	Inspection Item
Visual Inspection	Color, marking, packaging
Dimension Inspection	External dimensions
Function Inspection	Electrical performance test
Safety Inspection	Safety item test
Reliability Inspection	Aging test, etc.

6.2 OQC (Outgoing Quality Control)

OQC Inspection Content:

Inspection Item	Description
Quantity Verification	Verify outgoing quantity
Visual Check	Check packaging appearance
Marking Check	Check labels and markings
Random Sampling	Sampling per sampling plan
Documentation Check	Check accompanying documents

6.3 Finished Product Receiving Process

Receiving Conditions:

FQC Passed → OQC Passed → Packaging Complete → Finished Product Receiving

Receiving Requirements:

Requirement	Description
Inspection Complete	FQC/OQC inspection must be completed
Inspection Qualified	Inspection result must be qualified
Batch Identification	Must have batch identification
Packaging Complete	Packaging must be intact
Quantity Accurate	Quantity must be accurate

7. Quality Exception Handling

7.1 Defective Product Classification

Defect Category	Description	Handling Method
Visual Defect	Color, shape, surface defects	Rework/Scrap
Dimension Defect	Dimension out of tolerance	Rework/Downgrade
Function Defect	Function not meeting standard	Rework/Scrap
Performance Defect	Performance not meeting standard	Rework/Downgrade
Safety Defect	Safety hazard	Scrap

7.2 MRB Handling Process

MRB Process:

┌──────────┐    ┌──────────┐    ┌──────────┐    ┌──────────┐
│Defective │───▶│   MRB    │───▶│ Review   │───▶│ Disposal │
│Identify  │    │  Initiate│    │ Judgment │   │ Execution│
└──────────┘    └──────────┘    └──────────┘    └──────────┘

MRB Disposal Methods:

Disposal Method	Description	Approval Requirement
Rework	Return to process for reprocessing	Requires approval
Downgrade	Use at lower grade	Requires approval
Concession Acceptance	Accept under special circumstances	Senior management approval
Scrap	Direct scrap	Requires approval
Return	Return to supplier	Contact supplier

7.3 Quality Exception Handling Steps

Handling Steps:

1. Discover quality issue
2. Isolate non-conforming products
3. Label non-conforming products
4. Create MRB document
5. Quality review
6. Determine review result
7. Execute disposal plan
8. Confirm disposal

[Tip] Non-conforming products must be stored in isolation to prevent misuse.

8. Quality Traceability

8.1 Traceability Content

Traceability Data Elements:

Traceability Element	Traceability Content
Material Origin	Raw material supplier, batch
Production Process	Process, equipment, personnel
Quality Data	Inspection records, defective products
Equipment Data	Equipment parameters, status
Environmental Data	Production environment conditions

8.2 Forward Traceability

Forward Traceability Process:

Material Batch → Semi-finished Batch → Finished Product Batch → Customer

Traceability Query:

1. Input finished product batch number
2. Query finished product production information:
   • Production work order
   • Production process
   • Production time
   • Operator
   • Equipment used
3. Query materials used:
   • Material batch
   • Supplier
   • IQC inspection result
4. Continue tracing upstream materials

8.3 Reverse Traceability

Reverse Traceability Process:

Finished Product Batch → Semi-finished Batch → Material Batch → Supplier

Traceability Query:

1. Input material batch number
2. Query material usage:
   • Work orders used in
   • Processes used in
   • Finished product batches produced
3. Query finished product destination:
   • Shipping records
   • Customer information

8.4 Traceability Query Example

Query Scenario: Customer complaint about quality issue in a product batch

Traceability Steps:

1. Query using batch number provided by customer
2. Trace this batch's:
   • Production work order information
   • Production status at each process
   • Material batches used
   • Material suppliers
   • Quality inspection records
3. Analyze quality issue root cause
4. Determine impact scope
5. Notify affected customers
6. Develop improvement measures

Traceability Result Example:

Item	Information
Finished Product Batch	LOT-20260410-001
Product Model	PCB-1000
Production Work Order	WO-20260410001
Production Date	2026-04-10
Production Line	SMT-A Line
Operators	Zhang San, Li Si
Materials Used	Solder batch LOT-S-001 (Supplier: Company A)
Inspection Records	First article qualified, patrol inspection qualified
Shipping Records	Shipped to Customer B, quantity 1000PCS

9. Quality Statistics and Analysis

9.1 Quality Indicators

Core Quality KPIs:

Indicator	Calculation Formula	Target Value
Incoming Qualification Rate	IQC Qualified Lots/IQC Total Lots × 100%	≥98%
Process Qualification Rate	IPQC Qualified Quantity/IPQC Total Inspected × 100%	≥99%
Finished Product Qualification Rate	FQC Qualified Quantity/FQC Total Inspected × 100%	≥99.5%
Defective Rate	Defective Quantity/Total Production × 100%	≤1%
Batch Traceability Rate	Successfully Traced Batches/Total Batches × 100%	100%

9.2 Quality Reports

Report Type	Description	Target User
IQC Daily Report	Daily incoming inspection statistics	IQC Team Leader
IPQC Daily Report	Daily in-process inspection statistics	IPQC Team Leader
Quality Monthly Report	Monthly quality summary report	Quality Manager
Defect Analysis	Defect root cause analysis	Quality Engineer
Trend Analysis	Quality trend analysis	Quality Supervisor

9.3 SPC Statistical Process Control

Control Chart Monitoring:

Control Chart Type	Monitoring Content	Application Scenario
X-bar Chart	Mean value monitoring	Measurement data
R Chart	Range monitoring	Measurement data
P Chart	Defective rate monitoring	Count data
C Chart	Defect count monitoring	Count data

异常判定规则:

Rule	Judgment Condition	Description
Rule 1	1 point outside control limits	Single point abnormality
Rule 2	9 consecutive points on same side of center line	Shift abnormality
Rule 3	6 consecutive points increasing or decreasing	Trend abnormality
Rule 4	14 consecutive points alternating up and down	Periodic abnormality

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End of Quality and Traceability