Tab Article

Foreword
Table of Contents

1 Scope
2 Standards and Guidelines
3 Terms and Definitions

4 Statistical Process Management/Control (SPC)
4.1 Proactive Prevention over Reactive Detection
4.2 Process Improvement Cycle and Process Control
4.3 A Process Control System
4.4 Quality Control Loops

5 Requirements for SPC Applications
5.1 Introduction

5.2 Clear Product Specifications
5.2.1 Tolerancing and Responsibility Principles
5.2.2 Risk Analysis
5.2.3 Special Characteristics

5.3 Valid and Capable Measurement and Inspection Processes
5.4 Process Characterization
5.5 Production and Inspection Planning
5.6 Out-of-Control Action Plan (OCAP)
5.7 Control Plan

5.8 Roles and Competencies in SPC
5.8.1 Roles in SPC
5.8.2 Competencies in SPC

6 Overview of Methods
6.1 Preliminary Remark
6.2 Difference between Performance and Capability
6.3 Machine Performance
6.4 Process Capability and Performance Studies
6.5 Quality Control Charts
6.6 Outliers: Definition and Handling
6.7 Overview Table

6.8 Calculating Capability Indices
6.8.1 Evaluation of the Statistical Distribution
6.8.2 Calculation of Capability and Performance Indices

7 Machine Performance for Releasing Production Facilities
7.1 Preliminary Remark

7.2 Preparation
7.2.1 Sample Size
7.2.2 Material
7.2.3 Measuring System and Measurement Process
7.2.4 Operating and Production Conditions
7.2.5 Pre-Production Run (optional)
7.2.6 Special Circumstances

7.3 Conducting the Machine Performance Study
7.3.1 Statistical Analysis of Data
7.3.2 Traceability of Data
7.3.3 Storage and Blocking of Test Parts
7.3.4 Data Collection and Storage

7.4 Requirements for Machine Performance Indices
7.5 Special Cases
7.5.1 Multi-Stage Machining
7.5.2 Multidimensional/Multivariate Characteristics
7.5.3 Geometric Dimensioning and Tolerancing (GD&T) and Maximum/Least Material Condition (MMC/LMC)

8 Process Performance and Capability for Releasing Manufacturing Processes
8.1 Preliminary Remark
8.2 Data Collection and Sampling Strategies
8.3 Conducting the Process Capability Study
8.4 Time-Dependent Distribution Models (according to ISO 22514-2)
8.5 Requirements

9 Control Charts for Statistical Process Control and Ongoing Capability 
9.1 Different Control Concepts (Process-Related vs. Tolerance-Related)
9.2 Out of Control Conditions and Effectiveness of Control Charts
9.2.1 Retrospective Control Chart vs. SPC Control Chart
9.2.2 Stability Criteria
9.2.3 Action Plan in Case of Instabilities
9.2.4 Measures for Evaluating the Effectiveness of Control Charts. Types of Control Charts

9.3 Types of Control Charts
9.3.1 General Information
9.3.2 Which Control Chart is Recommended for which Application?
9.3.3 Variable Control Charts (Shewhart Control Charts for Continuous Characteristics)
9.3.4 Tolerance-Related Control Charts
9.3.5 Special Control Chart
9.3.6 Attribute Control Chart for Discrete Characteristics

9.4 Ongoing Performance and Capability
9.5 Special Cases

10 Application of Software
10.1 General Integration/Interfaces
10.2 Verification and Validation of Analysis Software

11 Documentation and Reporting
11.1 General Requirements
11.2 Example Reports

12 Traceability/Archiving