Are You Choosing an EQMS for the Semiconductor & Chip Manufacturing Sector? Here’s What to Look For.

Each industry has its own quality requirements based on unique characteristics, risks, raw materials used, and the availability of skilled workers. However, some quality requirements are common across industries. This blog is part of a series from ComplianceQuest that examines the quality requirements of different industries and how to mitigate risks to improve quality, performance, cost management, and resource optimization.

The first blog in this series was Choosing a QMS for a Medical Device Company, and the second was Choosing a QMS for the Manufacturing Sector.

Semiconductors and chips are ubiquitous in appliances, medical devices, automobiles, airplanes, and several consumer electronics products. In fact, chips are the underlying brain that powers the operations of various devices and equipment used in telecommunications, computing, military systems, transportation, healthcare, etc.

These chips—also called integrated circuits (ICs) or microchips—are made using elements like silicon or germanium. A process called doping alters the conductivity of these materials by adding small amounts of impurities. The manufacturing of semiconductor devices, or wafer fabrication, involves a series of complex processes that can take from several weeks to several months. These processes include:

• Wafer preparation
• Pattern transfer
• Doping
• Deposition
• Etching
• Testing
• Packaging

The end product, silicon wafers, is microscopically small, but any defect can severely impact their performance and reliability, making quality critical to wafer fabrication.

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Quality Management Challenges Faced by Chip Manufacturers

One of the key characteristics of the semiconductor industry is its dependence on global supply chains.

Here are some of the major challenges and how a robust QMS can help address them:

• Supplier Management: Meeting regulatory requirements, ensuring timely deliveries, keeping costs under control, improving performance, and enabling innovation are critical challenges. Greater visibility into supplier systems is needed to minimize risks. Effective supplier management involves real-time information exchange, integrated quality management with Product Lifecycle Management (PLM), documentation, audits, and inspections to ensure supply chain efficiency, compliance, and timely delivery of reliable products.

• Communication and Collaboration: The entire life cycle is spread across different organizations in various locations. Providing standard operating procedures and a unified platform for engagement with different vendors is essential. Understanding market trends is also critical for predicting and fulfilling future demand, making capacity planning important for reliable production and mitigating supply risks.

• Managing Costs: Various industries that purchased chips/semiconductor components have traditionally followed just-in-time production and procurement strategies. However, the COVID-19 pandemic caused a severe chip shortage, affecting production across various industries. Chip manufacturers need better visibility into demand and supply without compromising on cost and quality. Robust strategies are required to create a more predictable lifecycle, ensuring quality is not compromised for quantity or profitability.

• Preventive Maintenance: Equipment failures can disrupt production cycles and prove costly. Preventive maintenance helps plan downtimes for equipment care, ensuring material compatibility, space optimization, cleanliness, compliance, and ease of maintenance. Selecting systems and components that optimize processes can prolong the life and accuracy of equipment without affecting production schedules.

• Maintaining Competitive Advantage: The semiconductor industry is evolving rapidly. Efficiency and innovation are key to maintaining a competitive edge. Automating processes frees up resources for value-added activities, while continuous improvement of core processes enhances efficiency, reduces production costs, and accelerates time-to-market.

Given the constant changes in the semiconductor industry and the complexity of the manufacturing process, integrating quality across the lifecycle - from concept and design to final production and supply is essential.

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A Quality Management System (QMS) for the semiconductor industry should include the following key capabilities:

Transparency and Visibility in Quality Metrics at Every Stage of the Product Lifecycle:

Quality leaders and managers must oversee various stages to ensure processes align with internal and external standards. This minimizes the risk of nonconformance and non-compliance, which can result in wastage, rework, and other issues. A Product Lifecycle Management (PLM) solution helps integrate all functions related to chip manufacturing for greater visibility.

Integrating Processes for Better Collaboration and Communication:

Semiconductor design and manufacturing involve different teams working with various software such as CAD CAM, ERP, SCM, CRM, etc., which often don't communicate with each other. This can create data silos and hinder collaboration. A cloud-based PLM provides a unified platform with a single view of all relevant data, facilitating faster decision-making, reviews, and approvals with an audit trail. It reduces deviations, lowers manufacturing costs, fosters innovation, and speeds up time-to-market.

Risk-Based Approach to Semiconductor Manufacturing:

With changing regulatory and market environments, semiconductor manufacturers must adopt a risk-based approach. This helps identify, assess, and rank risks by severity and frequency – and prioritizes resource allocation for risk mitigation.

Efficient change control ensures changes are implemented after a risk and cost-benefit assessment. Root cause analysis and CAPA can be triggered for continuous improvement in case of quality events.

Ongoing Supplier Performance & Quality Management:

The semiconductor shortage highlighted the importance of having alternative sources for raw materials and understanding supplier strengths and weaknesses. Periodic inspections and audits of supplier facilities ensure they meet quality and quantity requirements. A PLM integrated with QMS provides access to an authorized supplier list to address deficiencies immediately. Given that the brand and manufacturer are often different, visibility into supplier processes is crucial, especially as the compliance burden lies with the OEM.

ComplianceQuest offers an integrated Digital Quality+ Platform aligned with ISO standards. It is cloud-based and built on Salesforce, enabling semiconductor and hi-tech manufacturers to integrate their product lifecycle with quality management to improve efficiency and productivity. This proactive approach fosters a culture of quality focused on preventive measures rather than reactive responses.

To learn how ComplianceQuest PLM+EQMS can fit your needs, request a demo: https://www.compliancequest.com/online-demo/