QMS Software Validation: New Requirements ISO 13485

Many medical device companies are told the importance of quality but aren’t actually aware of the impact poor quality can have on a business. Quality is more than just ensuring compliance with regulatory standards but should be a strategic business focal point. The Cost of Poor Quality (CoPQ) can lead to a significant financial loss and ultimately negatively impact the overall success of a medical device company.

In this blog we’ll explore the concept of CPQR, its implications, and provide expert strategies to promote successful and sustainable quality for your medical device company.

Cost of Poor Quality 

Let’s first explain what the Cost of Poor Quality (CoPQ) really means. CoPQ refers to the total financial impact a company faces due to defects, inefficiencies, and non-compliance within its processes. This includes expenses related to rework, scrap, regulatory fines, product recalls, customer complaints, and lost business opportunities. 

Essentially, it encompasses the hidden and visible costs that arise when quality standards are not met, emphasizing the importance of proactive quality management to reduce risks and maintain compliance.

Cost of Quality  

CoPQ should not be confused with the term Cost of Quality (CoQ), also known as the Total Cost of Quality. Under the umbrella of CoQ, there are two categories: Cost of Good Quality (CoGQ) and Cost of Poor Quality (CoPR). CoGQ refers to the investment required to ensure products meet regulatory and quality standards before reaching the market. This includes costs associated with prevention (such as training and process improvements) and appraisal (such as inspections and testing) to minimize defects and compliance risks.

Difference Between CoGQ and CoPQ

People oftentimes have the misconception that the CoPQ should be the focal point of quality management when really CoPQ and CoGQ should both be prioritized. The main differences between two methods come down to timing and approach. CoGQ involves investing in strong quality measures before an incident arises, whereas CoPQ involves dealing with the consequences of quality problems.

Understanding the importance of both of these quality management methods are key to a strategic business in order to mitigate poor quality costs and promote a foundation for continual quality improvement.

Elements Of The Cost of Poor Quality 

When defining the cost of poor quality for your business, decide on a structure that best fits your business needs. Specifically, the following elements should be considered:

• Customizing Cost Categories – Adapting cost definitions to align with an organization’s specific needs, incorporating input from various departments.
• Prioritizing Failure and Appraisal Costs: Emphasizing failure-related expenses to drive cost reduction and enhance customer satisfaction, while effectively managing appraisal costs.
• Gaining Management Support and Data Alignment: Securing leadership buy-in and agreement on cost classifications before initiating data collection.
• Identifying Hidden Poor Quality Costs: Recognizing often-overlooked expenses, such as redesign efforts and process modifications, as part of the cost of poor quality.
• Addressing Controversial Cost Categories: Managing disputed cost areas strategically by focusing on key opportunities for reduction while minimizing unnecessary conflicts.
  
  

Business Implications

The Cost of Poor Quality (COPQ) in the medical device industry has significant business implications, affecting financial performance, regulatory compliance, and brand reputation. 

High failure costs from defects, rework, and recalls lead to increased operational expenses and potential legal penalties. 

Regulatory non-compliance can result in warning letters, product seizures, or loss of market approval, delaying revenue and damaging trust with customers and stakeholders. 

Negative impact on customer satisfaction is a common result of poor quality, leading to lost business opportunities, reduced market share, and long-term reputational harm. 

Real-World CoPQ Example:

A compelling example is Dexcom’s recent experience with its continuous glucose monitoring (CGM) systems. The FDA issued a warning letter after the company implemented a change to its sensor coating process without adequate validation or documentation. As a result, Dexcom faced public scrutiny, reputational damage, and potential delays in product availability due to regulatory fallout. The situation highlights how a seemingly small change—when handled without a quality-first mindset—can escalate into a major business disruption. The direct and indirect costs associated with the event exemplify how CoPQ can undermine even well-established companies.

This case reinforces the idea that quality should not be viewed as just a regulatory hurdle, but as a critical component of business strategy. Proactive quality management and alignment across cross-functional teams are essential to avoid preventable mistakes that carry significant costs.

7 Ways to Mitigate the Cost of Poor Quality 

Investing in proactive quality management helps mitigate the above risks, ensuring compliance, efficiency, and sustained business success. The following are some key strategic approaches to setting up strong quality measures and reducing the cost of poor quality:

1. Implement a Robust QMS – Integrating a robust Quality Management System (QMS) promotes the streamlining of quality processes and helps ensure regulatory compliance. 
2. Promote a Quality Culture – Create an environment where employees recognize the value of quality and the impact CoPQ can have on a business to empower strong quality management in your organization.
3. Establish an Effective CAPA Process – Implement a Corrective and Preventive Action (CAPA) module into your QMS to ensure problems are identified in a timely manner, prioritized based on severity, and addressed promptly. 
4. Integrate Effective Change Management – Integrating a change management module into your QMS can promote data-driven decisions and smooth transitions through the regular assessment of quality costs and impact of changes.
5. Analyze Customer Feedback – Regularly evaluate the feedback received from customers to ensure the expectations of your customers are met and improve quality measures when needed in order to improve customer satisfaction.
6. Boost Supplier Oversight – Frequently evaluate supplier performance and leverage supplier management tools to boost supplier performance.

7. Conduct Quality Audits – Conducting regular quality audits can help identify any issues before they arise and result in costly problems.

Don’t Suffer From The Cost of Poor Quality 

Implementing proactive quality measures as listed above, promote a more holistic approach to quality management, mitigating the Cost of Poor Quality and positively impacting your business’ goals, mission, and overall success.

Not Sure Where to Begin? Look to Rook!

Our team of seasoned quality professionals are dedicated to spreading the importance of quality management and are well versed in how to promote good quality practices. We understand how overwhelming quality management can be, especially when it comes to knowing where to even begin.

Our quality experts can:

• Serve as remote Quality Manager
• Create and implement a custom QMS tailored to your organization’s needs
• Provide quality training for your employees
• Conduct a gap analysis to determine areas of improvement in your QMS

Kyle Rose

#RiskManagement #softwaretesting #softwarevalidation #medicaldevicesoftware #ISO134852016