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**