Quality Management System in Manufacturing: Understanding the Basics

Quality is the lifeblood of any successful manufacturing organization.  

It’s the sound of a door closing on a luxury car, the low purr of its engine, the flawless paint finish shimmering in the sun. 

But quality isn’t something that just happens by chance. Manufacturers with a reputation for world-class quality also have world-class quality management systems that safeguard against defects while continuously pushing the upper limits of quality.  

In this guide, we explore the basics of quality management systems for manufacturers. We’ll explore: 

• What a quality management system in manufacturing is and why it’s crucial in today’s competitive landscape 
• The tangible benefits it brings to your operations 
• How the QMS relates to ISO’s 7 Quality Management Principles 
• Key components of an effective quality management system in manufacturing 

We’ll also examine the ongoing transition in manufacturing from paper-based quality systems to targeted digital solutions, including how to implement a QMS that drives continuous improvement.  

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What is a Quality Management System in Manufacturing?  

A QMS is a formal system with documented processes, procedures and responsibilities for achieving quality objectives and policies. The key word here is “documented,” underscoring the importance of documentation and recordkeeping in quality.   

A systematic approach to implementing a QMS helps manufacturers meet customer and regulatory requirements while continuously improving its effectiveness and efficiency. It also ensures that everyone in the organization understands their role in achieving quality objectives. 

Quality Risks and the Need for a QMS

Ineffective or disparate paper-based quality processes create significant risks in manufacturing organizations today, with common challenges in areas such as: 

• Identifying non-conforming processes and hidden factory issues 
• Low visibility into quality metrics, including leading indicators 
• Effectively resolving problems in a timely manner 
• Ensuring compliance with regulations and standards 
• Verifying the effectiveness of employee training 

Left unchecked, these challenges can lead to non-conformances, defects or deviations. If those problems are not caught before shipping, you’ll be dealing with customer complaints, expensive product recalls and rework. Companies without an effective QMS also put themselves at risk of costly regulatory violations and penalties.  

All of this can lead to a damaged reputation and loss of key business contracts. Implementing a robust QMS empowers you to identify quality problems early and continuously optimize your processes. Companies can use data to spot patterns and take corrective action before issues snowball out of control, freeing up resources for other strategic priorities like product innovation. 

Benefits of a Quality Management System in Manufacturing 

Quality management systems provide numerous benefits, all leading to one central goal: increasing customer satisfaction. QMS automation in particular holds the key to breakthrough improvements in quality, eliminating many inefficiencies inherent in paper-based manual tracking systems.  

Below, we explore some of the top benefits manufacturers can expect to gain from implementing an automated QMS. 

Visibility

A QMS provides a clear, comprehensive view of your quality processes and any issues that need attention. You can easily access and analyze quality data from various stages of production and make informed decisions quickly to limit the scope and cost of potential problems. 

Efficiency

Through the standardization of processes and documenting procedures, a QMS reduces errors, minimizes waste and optimizes resources. An automated QMS makes it easier to identify and eliminate bottlenecks in your process, leading to improved productivity and cost savings. 

Trend and Pattern Tracking

With QMS software, manufacturers can centralize quality data in one place. This enables you to track trends and patterns over time, identify areas for improvement and mitigate the risk of quality escapes. 

Root Cause Identification

When problems arise, a QMS provides you with the tools to determine the root cause more effectively, whether you’re conducting a 5 Whys, 8D or Fishbone analysis. By having all relevant information centralized, you can quickly analyze data, identify the source of the issue, and implement targeted corrective actions. 

Fewer Audit Findings 

A robust QMS reduces the likelihood of external audit and customer audit findings. Standardizing your processes and maintaining proper documentation helps demonstrate compliance and give customers and external auditors confidence in your operations. 

Improved Quality Metrics

A QMS helps reduce defects, minimize customer complaints and improve on-time delivery. This, in turn, can have a positive downstream effect on metrics such as scrap, overall equipment effectiveness (OEE) and cost of quality. Consistently meeting or exceeding quality requirements and targets is the key to ensuring customer satisfaction—the driving goal of quality. 

Effective Issue Management

With a QMS in place, you can ensure that you are addressing and resolving quality issues quickly. Establishing clear procedures for problem identification, escalation and resolution helps minimize the risk of problems falling through the cracks, leading to a more proactive quality culture across your operations. 

Supporting Quality Excellence Frameworks

A QMS is an essential tool for companies pursuing process excellence using frameworks  such as Lean, Six Sigma or Total Quality Management (TQM). Documenting processes, gathering data, tracking results—all of these are simplified with an automated QMS, so that teams have more time to focus on strategy rather than administrative tasks. 

Driving Quality Culture

A robust QMS supports quality culture by giving you the tools to proactively solve problems, demonstrating an authentic commitment to quality. When your team sees the  

Quality Standards and Regulations in Manufacturing

Manufacturers today are subject to numerous quality standards and regulations that outline the requirements for a quality management system in manufacturing.  

At the top of the standards list is ISO 9001, which is the most recognized quality management standard in the world. While manufacturing organizations are not required by law to follow this standard, in many instances OEM customers require their suppliers to be ISO 9001-certified.  

Following that, there are industry-specific quality standards, such as: 

• ISO13485 for medical device manufacturing quality management 
• ISO 22000 for food manufacturing quality management 
• IATF 16949 for automotive manufacturing quality management 
• AS9100 for aerospace manufacturing quality management 

In terms of quality regulations, the U.S. Food and Drug Administration has established regulations for medical device quality, pharmaceutical quality and food quality.  

ISO Quality Management Principles

ISO has published guidance on what it considers the seven core quality management principles, which manufacturers can use as a reference when implementing a QMS.   

The seven ISO quality management principles are: 

1. Customer focus: Understanding and meeting customer needs, both current and future, is crucial for sustained success. This principle emphasizes exceeding customer expectations. 
2. Process approach: Employees must understand their work is part of an interconnected process. This approach provides more consistent and predictable results while improving efficiency and effectiveness. 
3. Leadership: Leaders at all levels need to be united in purpose. This principle emphasizes a top-down approach to ensure all employees are engaged in achieving the organization’s quality objectives. 
4. Engagement of people: Successful organizations instill the belief that quality is everyone’s job. This principle recognizes that involving employees leads to a better outcome. 
5. Continuous improvement: Quality management is not a one-and-done task to be checked off a list. This principle focuses on the need to continuously drive innovation, performance enhancement and quick responses to changes. 
6. Evidence-based decision-making: Data-driven decision-making is the gold standard in quality. This approach reduces guesswork and is more likely to deliver the desired result.  
7. Relationship management: This principle recognizes the interdependence between an organization and its stakeholders, including customers and suppliers. 

These principles form the foundation of effective quality management systems and guide organizations in their pursuit of excellence. 

QMS Software Solutions and Components 

If you are looking to implement QMS software in your plant, there are two key types of software to consider: enterprise QMS systems and point solutions that target a specific process.  

An enterprise QMS typically comes with a full range of modules or solutions used in different quality processes. When companies roll out an enterprise QMS, they typically focus on a handful of core solutions. These four solutions form the foundation of the QMS and broadly align with the Plan-Do-Check-Act process: 

• Document control 
• Employee training 
• Audits and inspections 
• Corrective action 

From there, an enterprise QMS may offer a list of other solutions, either packaged together or sold individually. Examples include complaint handling, deviation and non-conformance management, supplier quality management and more.  

Point solution software vendors typically target just one process, aiming for deep functionality in that area. While an enterprise QMS can be attractive due to its wide range of capabilities, linking together multiple specialty solutions has become more common using application programming interfaces (APIs).  

Integrated Point Solutions vs. Enterprise QMS?  

So, how do you know what’s right for your company? Both options offer manufacturers several benefits, including improved efficiency, regulatory compliance, data management and real-time monitoring of quality issues.  

However, implementing an enterprise QMS comes with challenges. The initial outlay is typically larger, and implementation can be a lengthy process. If functionality in a given solution doesn’t align with your process, you may be left trying to shoehorn your process to fit the software. The problem is that this can erase any efficiency gains you’ve made over time fine-tuning your quality processes, making flexibility essential. 

For many manufacturing companies, deploying point solutions individually is a less costly option that allows them to target specific processes with advanced functionality.  

One top 50 automotive supplier, for example, deployed EASE plant floor audits over concerns that its high-frequency layered process audit program wasn’t delivering sufficient results. After implementing the software, the manufacturer achieved several quality improvements, including: 

• Increased audit completion rates, which are a leading indicator of quality performance 
• 73% lower internal PPM and lower scrap costs 
• Fewer external findings 
• GM and Ford quality awards two years in a row 

Plan-Do-Check-Act in Action

The Plan-Do-Check-Act (PDCA) cycle, popularized by William Deming and based on the earlier Shewhart Cycle, is a cornerstone of continuous improvement in quality management.  

Let’s break down each component and illustrate it with a hypothetical example from Acme Company, a fictional automotive parts supplier: 

1. Plan: Facing a spike in defects in their brake pad production line, the supplier sets a goal of reducing brake pad defects by 30% within six months. As part of the planning process, the quality department convenes a team to review the data and process documentation while also conducting a 5Y root cause analysis on the problem. 
2. Do: Acme then implements several measures that include:  

• Updating the process SOP by adding an extra step to prevent the defect 
• Providing additional training to operators 
• Adding a new question to their plant floor audit checklist to verify compliance with the new process 

3.    Check: Over the next few months, Acme monitors the problem by: 

• Reporting defect rates weekly  
• Tracking progress against the 30% reduction target 
• Monitoring plant floor audit results to ensure operators are following the new SOP 

What they discover is that while overall defects have decreased by 20%, process data shows there are still instances where operators aren’t following the new process. 

4.    Act: Based on their findings, Acme:  

• Reviews the training records to identify any operators who haven’t received training 
• Modifies the training program to emphasize the new process step 
• Increases the frequency of verification through plant floor audits 

This cycle continues, with each iteration building on the insights and improvements from the previous one. By consistently applying the PDCA cycle, Acme not only achieves its initial goal but also establishes a culture of continuous improvement. 

The Role of AI in Quality Management 

According to LNS Research, there is widespread recognition of AI’s potential to enhance information-gathering tasks in quality processes. The research suggests that generative AI has significant growth potential in supporting quality roles.  

The research identifies several promising use cases for AI in quality management. These include: 

• Alerting users to condition changes that could impact product quality  
• Streamlining batch release record collection  
• Facilitating knowledge capture and transfer during new product development or discovery phases  
• Providing suggested actions for corrective and preventive actions (CAPA)  and customer complaints 

Many QMS vendors have already incorporated AI into some portion of their platforms, for example using it to categorize complaints and narrow down potential root causes.  

For those ready to dip a toe in, experts at LNS research say to expect efficiency rather than immediate cost savings—at least not for now. Companies can use generative AI to reduce some the administrative burden associated with quality data collection, but it’s important for accuracy. Done right, this can allow teams to redirect resources to more creative, high-impact work.  

Implementing QMS Software in your Plant

Establishing and implementing QMS software is a complex process that requires careful planning and execution. While a full exploration of the topic is beyond the scope of this article, below are the key steps on a high level: 

1. Identify the need: Begin by building a solid business case that clearly articulates the benefits of transitioning to a QMS software solution. 
2. Build your team: Involve multiple stakeholders from various departments and secure leadership buy-in using your business case. 
3. Gather requirements: Determine the most important features your organization needs in a QMS software solution. Depending on your specific industry and operational needs, you might be looking for one or more specific capabilities such as: 

• Audit and inspection management 
• Deviation and nonconformance management 
• Supplier quality management 
• Complaint handling 
• Change control  
• Risk management  
• Failure Mode and Effects Analysis (FMEA) capabilities 

4.    Narrow down vendors: Consult colleagues, leverage resources like Gartner reports and review sites, and evaluate how potential vendors align with your priority capabilities. Consider key features like adaptability, ease of use, ability to integrate emerging technologies, and flexible licensing and hosting. 

5.    Request demos: Shortlist 2-3 vendors and schedule demonstrations of their products. 

6.    Choose your system: Make your final selection based on your initial criteria, but also consider factors such as vendor support, training resources and pricing structure. 

7.    Implementation: Collaborate with your chosen vendor to develop a rollout plan, which often involves piloting the system at one location before expanding to others. 

These steps help organizations select a QMS software that not only meets their current needs but also positions them for future challenges and opportunities in quality management. 

Whether you’re transitioning from paper-based processes or looking to optimize your existing digital systems, the right QMS solution can transform your operations. It’s not about finding a tool with the flashiest bells and whistles, but about finding the solution that meets your organization’s unique needs and challenges.  

From reducing defects and costs to streamlining audits and enhancing customer satisfaction, a well-implemented QMS is your pathway to process excellence in today’s competitive and ever-evolving manufacturing landscape.