Governance, Risk, and Compliance Handbook: Technology, Finance, Environmental, and International Guidance and Best Practices

CHAPTER 24

PLM TECHNOLOGIES: ROLE AND VALUE IN SUPPORTING PRODUCT COMPLIANCE

Richard Kubin

24.1 INTRODUCTION

24.2 PLM—WHAT IT IS, AND WHAT IT ISN'T

24.3 THE PRODUCT

24.4 THE REQUIREMENTS

24.5 THE PROCESSES

24.6 COMPLIANCE ASSURANCE SYSTEM

24.7 VALUE OF AUTOMATION AND SYSTEM CONTROL

24.8 REFERENCE ARCHITECTURE

24.9 CONCLUSIONS

NOTES

24.1 INTRODUCTION

Product compliance requirements have always been a factor in the design, manufacture, and sale of goods and services worldwide. Many of these are regulated by government agencies, such as those administered in the United States by the Federal Communications Commission (FCC), Food and Drug Administration (FDA), and Federal Aviation Administration (FAA), and are primarily aimed at protecting the public safety. There are also requirements to comply with other product- or policy-level criteria, which may be defined and controlled by the producing company. These may include quality and reliability, but may also include more esoteric requirements, such as the labor practices of companies supplying materials or manufacturing services. Recent regulations, like the European Union's Restriction of Hazardous Substances (RoHS)1 in electronic products, have had a large impact across the affected industries and their entire supply chains and have raised the visibility of both the requirements and the difficulties in meeting them.

The outs11ourcing and globalization of manufacturing add further complexity to product-level compliance, particularly ...