It’s World Quality Month (WQM) and that means taking time to reflect and recognize the impact that good quality management has on products and processes.

What is good quality?  We’ll look at 10 core traits of world quality management leaders and how you can incorporate these traits into your own organization to maintain a competitive edge.

1. An Enterprise QMS

One of the things great quality leaders have in common is the system they use to manage their processes. An effective enterprise QMS will provide greater control over your quality processes and automate and integrate common solutions such as corrective action, document control and employee training.

A modern QMS will also be flexible enough to adapt to an organization’s processes, rather than the other way around. An effective quality management software system should seamlessly enable your existing business processes.  This makes it easy for users to get acclimated, which improves efficiency. In addition, a modern quality management system will also improve compliance with regulatory agencies by automating the tracking and control of compliance- related activities.

2. Risk-based Methodologies

Risk management is a critical aspect in businesses in any industry. Quality leaders incorporate risk into their processes, integrating core processes with risk management so that risk touches on all areas within the enterprise.

Solutions enabling risk management equip organizations to take a systematic and repeatable approach to managing their risk. Automating this approach provides a more predictable method for mitigating risks, identifying trends and managing risk-based change across the enterprise.

3. Collaboration throughout the Supply Chain

To be successful, quality cannot be managed in a silo, particularly when suppliers and other third parties are involved.  Suppliers must have insight into your quality specifications for them to provide an effective product. Efficiently managing suppliers through audits and scoring provides organizations visibility to which suppliers are meeting your standards and which may have gaps .

Collaboration across operational units also prevents other critical areas from being siloed, including R&D, clinical, others. The result is a faster time to innovation with lower costs.

Having visibility and connectivity across your supply chain will provide you with the information you need to provide high-quality products for your customers and ensure that suppliers are meeting compliance with all regulatory initiatives.

4. A Culture of Quality

A company-wide commitment to quality aligns the teams within your organization with the same goal—to ensure a high-quality product or process with a focus on patient or customer safety.

Everyone in the company should be focused on quality, from the executive level to the plant floor.  By making quality everyone’s responsibility, you’ll encourage collaboration and avoid quality gaps due to internal factors.

5. Enterprise Application Integration

To successfully reach business objectives, quality leaders know that cross-functional engagement alone won’t suffice. Today’s modern quality management systems integrate with enterprise applications, such as SAP, Salesforce and Oracle.

Leveraging enterprise level data provides greater visibility, collaboration,  and expands the value of your investment.  Connecting relevant processes across the company and supply networks exchanges actionable data that can improve accuracy, response times and root cause analysis.

6. Continuous Improvement Approach

Long-term business success thrives on a continuous improvement approach. Continuous improvement is an ongoing method of improving processes and products by increasing quality. If you can improve continually, you’ll reap the benefits of greater flexibility, better process performance and better adaptability to new situations.

To instill an effective continuous improvement approach throughout the organization, quality leaders don’t look at it as a process, but rather as an elemental part of the way they do business. In doing so, it becomes a part of the company culture rather than simply a program.

7. A Process-Based Approach 

A process-based approach is a collaborative effort that drives efficiency and effectiveness throughout all processes within your organization.

ISO 9001:2015 focuses on taking a process approach, which enables more consistent and predictable results.  Companies that take this approach will ensure that all responsible parties have visibility into each step of the process from start to finish.

This approach provides a well-rounded perspective, better visibility into all of your business activities, and enables you to know what’s working or what’s not.

8. Evidence-Based Decision Making

Great quality leaders don’t make decisions based on assumptions, they make them based on the facts. Reporting and analytics tools enable organizations to utilize their data towards evidence-based decisions.

A pragmatic approach to using hard data to find trends validates the quality and compliance gaps that need to be addressed.  Since quality doesn’t rely on gut feelings, having the facts helps drive better decision-making.

9. Effective Change Management Process

Change is an essential component of growth, and in order to grow in the right direction, a systematic change management process is needed.

Companies that have a dedicated change control plan are better able to adapt to market and customer needs. In fact, quality improvement relies on change to increase quality in the end- product or process. Change management software helps by automating the way you manage, track and make changes throughout your entire organization. 

10. Knowing the COPQ

The Cost of Poor Quality (COPQ) is the monetary value that a defective product has cost your company. COPQ includes hard costs like fines, shipping fees, new product costs and labor hours. It also includes soft costs like rising insurance rates, legal fees and stock prices. Quality leaders track their organization’s COPQ and track and measure internal failure cost (discovered before the product reaches the customer) or external failure cost (discovered after it was in the customer’s hands).

While difficult to calculate, COPQ also includes customer retention and attrition. Knowing your COPQ correlates to the importance of having a solid quality management process in place and shows the true cost of nonconformance.

Take an Everyday Approach to Quality 

World quality leaders take an everyday approach to quality, ingraining it within their organization and extending across their entire enterprise. This holistic approach to quality ensures visibility into all aspects of your operations and gives you the data needed to make the changes that will promote continual improvement.

As we celebrate World Quality Month, take a moment to review your quality processes and identify any areas needed for change.

Reach out to AssurX to learn how we can help.