Looking to Enhance Product Quality in Manufacturing & Life Sciences? Here are 8 Best Practices to follow

A leading contract manufacturer specializing in mission-critical electronics has been producing high-reliability PCB assemblies since 1995. Operating from a state-of-the-art facility in North America, the company sought to enhance its quality and product lifecycle management capabilities. Key focus areas included improving design quality management and streamlining processes for managing parts, part revisions, BOMs, and ECR/ECO/ECN. Additionally, the company aimed to strengthen its Approved Manufacturer List (AML), project management, and design control capabilities, such as requirements management, FMEA, control plans, and product risk assessments.

To achieve these improvements, the company wanted to streamline its operations across R&D, engineering, manufacturing, supplier management, and customer-facing teams. The goal was to implement a unified solution that would reduce administrative overhead, improve data accessibility, boost productivity, and ensure regulatory compliance.

The product leadership team at the contract manufacturing company shared, “Having a single platform to streamline design controls, product lifecycle management, and quality management has been a game-changer for us. It has enhanced our ability to collaborate effectively, with increased visibility across teams and departments."

Another ComplianceQuest customer, a global biotherapeutics company, faced the challenge of automating QMS processes at their new preclinical manufacturing plant in Seattle. Specializing in technologies that drive innovative antibody discovery and accelerate development, the company needed a quality platform with a robust feature set, user-friendly interface, and deep compliance capabilities. The solution had to integrate CAPA, change management, document management, equipment management, nonconformance, supplier management, and training—all on a single platform. Like others, they aimed to streamline processes, improve cost efficiency, ensure ease of compliance, and support well-trained teams.

For a leading preclinical oncology CRO, the challenge lay in managing a hybrid system of electronic and paper-based records, which led to poor visibility, traceability, and transparency. This resulted in inefficiencies and manual bottlenecks. They needed an integrated PLM and QMS solution to provide full visibility and create a single source of truth across all locations for better decision-making.

Maintaining high product quality in manufacturing is crucial in today’s highly competitive landscape. It requires the continuous improvement of quality systems and production processes. To achieve this, manufacturers should adopt these eight best practices:

• Total Quality Management
• Lean Manufacturing
• Supplier Quality Management
• Regular Audits and Inspections
• Statistical Process Control
• CAPA (Corrective and Preventive Action)
• Training & Employee Involvement
• Advanced Quality Control

Best Practices for Improving Product Quality in Manufacturing

Practice 1: Implementing Total Quality Management (TQM)

Total Quality Management (TQM) is a quality management approach that helps manufacturers continuously improve their product quality, strengthening competitive advantage, effectiveness, and flexibility.

Essential practices of TQM include:

• Customer-centric approach
• Total employee involvement through empowerment and ownership
• Integration with high-quality standards for products and/or services
• Process-centric approach
• A strategic and systematic approach
• Continual improvement
• Data-driven decision-making
• Relationship management between employees and customers

The benefits of integrating PLM with a quality management system include eliminating delays, streamlining processes, ensuring traceability, and centralizing BOM information. This approach enhances collaboration and communication by offering insights into current issues, vendors, and corrective actions.

Practice 2: Adopting Lean Manufacturing

Key factors in reducing manufacturing costs and making products more viable include streamlining processes, waste reduction, and resource optimization. Lean Manufacturing, introduced by Toyota in the 1950s through the Toyota Production System (TPS), has since gained popularity across industries due to its impact on waste reduction, improved efficiency, faster cycle times, and lower material costs. The core principles of lean manufacturing include:

• Value: Defining the right value for the product to ensure it’s viable to manufacture and meets customer expectations.
• Value Stream: Ensuring the effective utilization of resources throughout the product life cycle while eliminating waste.
• Flow: Maintaining a smooth, end-to-end process flow to ensure timely delivery of products and services.
• Pull: A demand-driven pull system that requires efficient communication and flexibility to be effective.
• Perfection: Achieving continuous process improvement, or 'Kaizen,' through regular assessment of key performance metrics.

Practice 3: Robust Supplier Quality Management

Supplier management is a strategic imperative, crucial for the timely delivery of quality products and services, risk mitigation, and cost optimization. By managing supplier relationships effectively, manufacturers can enhance operational efficiency, reduce production costs, and improve performance. The four key factors in supplier management include:

• Supplier Onboarding: Although many suppliers may offer the same raw materials, selecting and onboarding the right vendors is critical to ensure quality from the earliest stages of the product life cycle.
• Performance Evaluation and Management: Continuous monitoring and evaluation of supplier performance are vital to sustaining high quality and driving continuous improvement. Track key performance indicators (KPIs) and take prompt action when addressing underperforming suppliers.
• Risk Assessment and Mitigation: Business continuity and financial stability depend on consistent monitoring of supplier-related risks and the implementation of mitigation strategies to address potential issues.
• Communication and Collaboration: Building supplier relationships on open communication and trust is essential for effective problem-solving, value addition, and fostering innovation.

Practice 4: Conducting Regular Audits and Inspections

Audits and inspections are essential for proactive risk management and addressing quality issues within the PLM. Audits help identify systemic challenges, while inspections focus on detecting quality problems in products or incoming raw materials. These can be conducted in response to specific events or scheduled periodically to improve compliance with internal and external standards. Regular audits and inspections ensure process and product health by integrating quality at every stage of the product life cycle, preventing risks from escalating into major quality issues.

Effective audits and inspections involve:

• Observing operations
• Interviewing personne
• Assessing compliance
• Reporting noncompliance and nonconformance

Practice 5: Utilizing Statistical Process Control (SPC)

SPC is a powerful tool for monitoring and improving manufacturing processes through quality data measurement and control. By identifying potential problems and analyzing existing issues, SPC helps implement CAPA and track progress to ensure the effectiveness of solutions. It promotes continuous improvement by uncovering root causes and providing actionable insights.

SPC involves:

• Collecting and recording data from sources such as machinery, ERP, CRM, and SCM
• Using control charts to visualize and analyze data
• Analyzing data to make informed, actionable recommendations

Practice 6: Implementing Swift Corrective and Preventive Actions (CAPA)

Even with the best efforts, errors, nonconformances, and variations can still occur. CAPA ensures corrective actions are taken to resolve these issues and prevent their recurrence through preventive actions. The three critical steps in CAPA that drive continuous improvement include:

• Root Cause Investigations: It’s crucial to identify the true root cause of an error, as the apparent cause may only be a symptom.
• Take a Risk-Based Approach:Use data to uncover the root cause and anticipate potential issues, taking preventive action to avoid future incidents.
• Enhance Employee Productivity: Leverage root cause investigations to improve employee awareness, boost compliance, and foster a culture of quality across the organization.

Practice 7: Emphasizing Employee Training and Involvement

Effective employee training is fundamental to ensuring that quality initiatives succeed. When employees are educated and empowered, they are more likely to comply with SOPs and policies. This leads to a virtuous cycle where deviations are quickly addressed, and corrective actions improve overall compliance.

Businesses must invest in training management systems that:

• Identify skill gaps
• Personalize training
• Continuously assess and upskill employees to improve performance and contributions.

With increased involvement, empowered employees can take ownership of tasks, report anomalies, and contribute to the company’s growth through insightful inputs.

Practice 8: Using Advanced Quality Control Tools and Technology

While there is no gainsaying the role of experienced and engaged employees, they can add more value in improving quality control when their skills are augmented by advanced technology such as AI, automation, and data analytics.

Some of the advanced quality control tools and techniques include:

• Failure Mode Analysis: This enables identifying risks of failure by analyzing the production process. Control measures can be implemented to mitigate those risks or minimize the impact.
• Statistical Control: A commonly used technique across industries, this technique uses statistics to control and improve production processes.
• Calibrating Measurement Instrument: Quality control uses equipment to measure and analyze products and ensure they are fit for release. This measuring equipment must be calibrated periodically to ensure the accuracy of the measurement and minimize variations between batches.

equipment must be calibrated periodically to ensure the accuracy of the measurement and minimize variations between batches.

Conclusion: How ComplianceQuest’s Digital Quality⁺ Platform Enables These Best Practices

The three enterprises mentioned at the start of this blog each selected ComplianceQuest’s cloud-based Digital Quality⁺ Platform to elevate their product lifecycle and quality management processes. Grounded in the belief that quality should be integrated into every phase of the product lifecycle, ComplianceQuest enables organizations to identify and resolve potential challenges early on, resulting in smoother product design and production workflows and reliable outcomes.

CQ’s integrated PLM, QMS, and SRM Solutions will streamline, automate, and digitally transform the end-to-end product lifecycle from vision to product success.

The ComplianceQuest platform supports a holistic approach to improving product quality by enabling seamless, end-to-end workflow integration. Leveraging advanced technologies like automation and AI, it boosts productivity and delivers actionable insights for better decision-making. To find out more, request a demo: www.compliancequest.com/online-demo