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Manufacturing Documentation

Manufacturing documentation ensures consistent, quality production. From work instructions to quality specifications, these documents guide operators, maintain standards, and support continuous improvement.

Documentation Hierarchy

Document Levels

Level 1: Policy
Level 2: Procedures
Level 3: Work Instructions
Level 4: Forms and Records

Quality Management System

ISO 9001 documentation structure:

  • Quality Manual: Overview of QMS
  • Procedures: How processes are managed
  • Work Instructions: How tasks are performed
  • Records: Evidence of activities performed

Work Instructions

Purpose

Work instructions provide step-by-step guidance for specific tasks:

  • Ensure consistency
  • Reduce errors
  • Support training
  • Enable compliance

Structure

# Work Instruction
# WI-MFG-001: Circuit Board Assembly

## 1. Purpose

This instruction describes the process for assembling
the [Product] circuit board.

## 2. Scope

Applies to all production assemblers at [Location].

## 3. Safety Requirements

⚠️ **ESD Protection Required**
Wear ESD wrist strap connected to grounded workstation.

⚠️ **Eye Protection**
Wear safety glasses during soldering operations.

## 4. Materials and Equipment

### Materials
| Item | Part Number | Quantity |
|------|-------------|----------|
| PCB | PCB-001 | 1 |
| Resistor 10K | RES-10K | 4 |
| Capacitor 100µF | CAP-100 | 2 |
| IC Chip | IC-555 | 1 |

### Equipment
- Soldering station (set to 350°C)
- ESD workstation
- Magnifying lamp
- Flux pen

## 5. Procedure

### 5.1 Preparation

1. Verify ESD wrist strap is connected and grounded.
2. Clean workstation surface.
3. Gather all materials per Section 4.
4. Verify PCB matches revision [X].

### 5.2 Component Placement

5. Place resistors R1-R4 in designated locations.

   ![Resistor Placement Diagram](images/resistor-placement.png)

   **Quality Check**: Verify orientation of each resistor.

6. Place capacitors C1-C2 with correct polarity.

   ⚠️ **CAUTION**: Negative terminal must align with marking.

### 5.3 Soldering

7. Apply flux to each component lead.

8. Solder each connection using proper technique:
   - Heat joint for 2-3 seconds
   - Apply solder to joint (not iron)
   - Remove solder, then iron
   - Allow to cool naturally

   **Acceptance Criteria**:
   - Smooth, shiny solder joints
   - Complete wetting of pad and lead
   - No bridges or cold joints

### 5.4 Inspection

9. Inspect all solder joints under magnification.

10. Verify component placement against reference.

11. Record inspection results on Form QC-001.

## 6. Quality Checks

| Check Point | Specification | Method |
|-------------|---------------|--------|
| Solder joints | IPC-A-610 Class 2 | Visual |
| Component placement | Per drawing | Visual |
| Electrical test | Per test spec | Automated |

## 7. Records

- Complete Form QC-001 for each unit
- Log any nonconformances in NCR system
- Retain records per retention schedule

## 8. References

- Drawing: DWG-PCB-001 Rev C
- Specification: SPEC-SOLDER-001
- IPC-A-610 Acceptability Standard

## 9. Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| A | 2024-01-01 | Initial release | J. Smith |

Visual Work Instructions

Use images effectively:

## Step 3: Install Bearing

[Photo showing bearing alignment]

1. Align bearing with housing bore
2. Press bearing until seated (see image)
3. Verify bearing is flush with housing surface

**Correct Installation:**
[Image of correct installation]

**Incorrect Installation:**
[Image of common errors with X marks]

Standard Operating Procedures (SOPs)

SOP Structure

# Standard Operating Procedure
# SOP-QC-001: Incoming Material Inspection

## 1. Purpose

This procedure establishes requirements for inspecting
incoming materials before use in production.

## 2. Scope

Applies to all raw materials and components received
at [Facility].

## 3. Definitions

| Term | Definition |
|------|------------|
| AQL | Acceptable Quality Level |
| COC | Certificate of Conformance |
| DMR | Discrepant Material Report |

## 4. Responsibilities

| Role | Responsibilities |
|------|------------------|
| Receiving | Verify shipment, notify QC |
| Quality Inspector | Perform inspection |
| Quality Engineer | Disposition nonconforming material |
| Purchasing | Communicate with suppliers |

## 5. Procedure

### 5.1 Receipt

5.1.1 Receiving verifies shipment against packing slip.

5.1.2 Receiving notifies QC of material arrival.

5.1.3 Material held in quarantine until inspected.

### 5.2 Documentation Review

5.2.1 QC Inspector reviews:
- Certificate of Conformance (COC)
- Test reports (if required)
- Material certifications

5.2.2 Verify COC data matches purchase order requirements.

### 5.3 Physical Inspection

5.3.1 Select sample per sampling plan (Table 1).

5.3.2 Inspect per incoming inspection checklist.

5.3.3 Record results in inspection system.

### 5.4 Disposition

| Result | Action |
|--------|--------|
| Accept | Move to inventory, label as accepted |
| Reject | Quarantine, create DMR |
| Conditional | Engineering review required |

## 6. Sampling Plan

**Table 1: Sample Size by Lot Size**

| Lot Size | Sample Size | Accept | Reject |
|----------|-------------|--------|--------|
| 2-8 | All | 0 | 1 |
| 9-15 | 3 | 0 | 1 |
| 16-25 | 5 | 0 | 1 |
| 26-50 | 8 | 0 | 1 |
| 51-90 | 13 | 1 | 2 |
| 91-150 | 20 | 1 | 2 |

## 7. Records

- Inspection results retained 7 years
- DMRs retained per quality records procedure

## 8. References

- ANSI/ASQ Z1.4 Sampling Procedures
- SOP-QC-002 Nonconforming Material

## 9. Approval

| Role | Signature | Date |
|------|-----------|------|
| Quality Manager | | |
| Operations Manager | | |

Specifications

Technical Specifications

# Material Specification
# SPEC-MAT-001: Aluminum Alloy 6061-T6

## 1. Scope

This specification defines requirements for aluminum alloy
6061-T6 bar stock used in [Product] manufacturing.

## 2. Applicable Documents

- ASTM B221 Standard Specification for Aluminum Alloy
  Extruded Bars, Rods, Wire, Profiles, and Tubes
- AMS 4150 Aluminum Alloy Bars, Rods, and Wire

## 3. Chemical Composition

| Element | Min (%) | Max (%) |
|---------|---------|---------|
| Silicon | 0.40 | 0.80 |
| Iron | - | 0.70 |
| Copper | 0.15 | 0.40 |
| Manganese | - | 0.15 |
| Magnesium | 0.80 | 1.20 |
| Chromium | 0.04 | 0.35 |
| Zinc | - | 0.25 |
| Titanium | - | 0.15 |
| Aluminum | Balance | - |

## 4. Mechanical Properties

| Property | Minimum |
|----------|---------|
| Tensile Strength | 45,000 psi |
| Yield Strength | 40,000 psi |
| Elongation | 8% |
| Hardness | 95 HB |

## 5. Dimensional Requirements

| Size Range | Tolerance |
|------------|-----------|
| Up to 0.500" | ±0.002" |
| 0.501" - 1.000" | ±0.003" |
| Over 1.000" | ±0.004" |

## 6. Surface Requirements

- Free from cracks, seams, and laps
- Surface roughness: 125 µin Ra max

## 7. Certification Requirements

Supplier shall provide:
- Mill test report with heat/lot number
- Chemical analysis
- Mechanical test results
- Dimensional inspection data

## 8. Marking and Packaging

- Material marked with alloy and temper
- Heat/lot number traceable
- Packaging to prevent damage during transport

Process Documentation

Process Flow Documentation

# Process Flow: CNC Machining

## Overview

Raw Material → Setup → Machining → Inspection → Finishing → Final QC

## Detailed Flow

### 1. Material Issue

- Receive material from stores
- Verify material certification
- Log material lot in traveler

### 2. Machine Setup

- Load program [Program Number]
- Install tooling per setup sheet
- Set work coordinates
- Verify first article

### 3. Machining Operations

| Op | Description | Machine | Time |
|----|-------------|---------|------|
| 10 | Face and turn OD | Lathe | 5 min |
| 20 | Bore ID | Lathe | 3 min |
| 30 | Mill features | Mill | 8 min |
| 40 | Drill holes | Mill | 2 min |

### 4. In-Process Inspection

- Dimensional check per drawing
- Surface finish verification
- Document on traveler

### 5. Finishing

- Deburr all edges
- Clean per SPEC-CLN-001
- Apply protective coating

### 6. Final Inspection

- 100% dimensional verification
- Visual inspection
- Functional test (if required)
- Complete quality records

Quality Records

Documentation Requirements

Records provide evidence of:

  • Materials used
  • Processes performed
  • Inspections conducted
  • Personnel involved
  • Dates and times

Traveler/Router

# Manufacturing Traveler
# Part: [Part Number]  Lot: [Lot Number]

## Material

| Material | Lot # | COC # |
|----------|-------|-------|
| Al 6061-T6 | 12345 | COC-2024-001 |

## Operations

| Op | Description | Operator | Date | QC |
|----|-------------|----------|------|-----|
| 10 | Turn OD | _____ | ____ | _____ |
| 20 | Mill features | _____ | ____ | _____ |
| 30 | Final inspect | _____ | ____ | _____ |

## Inspection Data

| Dimension | Spec | Actual |
|-----------|------|--------|
| OD | 1.000 ±.005 | _____ |
| Length | 2.500 ±.010 | _____ |

## Disposition

☐ Accept  ☐ Reject  ☐ Rework

Inspector: _____________ Date: _______

Summary

Manufacturing documentation requires:

  • Clear, step-by-step instructions
  • Precise specifications
  • Complete traceability records
  • Compliance with quality standards
  • Support for continuous improvement

Well-written manufacturing documentation ensures quality, consistency, and efficiency.