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7 Signs that your Quality Management Process is Failing

01 Aug 2023

Do you often receive product recalls requests? Is your mailbox getting more complaints than appreciation from the customers? Are you constantly facing compliance issues due to unorganized Quality Management Process? Each of the mentioned issues can cost a fortune to your business in terms of money and reputation.

The most common problem that regulated industries experience that they realize the glitches in the quality processes and systems after the damage is done. Reacting at this stage won’t be of much help either. That’s why, it is highly recommended for enterprises to take a proactive approach than being reactive.

Being proactive involve keeping an eye on the alarming signs that reflect the performance of your quality management processes.

7 alarming signs that your Quality Management Process is Failing:

1. Your Audits Findings Are Generally Nonconformances

If you are among the companies who don’t take audits seriously, you will likely invite more significant troubles, including compliance and regulatory actions. You should regularly measure your processes against the best practices defined in the regulatory requirements through internal audits. It will give you complete insights on what’s working and what’s not, fostering an environment of continuous improvements in the organization.

You can also use a powerful, cloud-based audit management software to manage end-to-end audit processes on a centralized platform. There are software applications that let you create and customize the audit checklists to make your job easier. The best part about cloud-based software is the accessibility of your audit records from anywhere, anytime.

2. Your Critical Processes Are Still on Paper

The most frequent FDA findings are about documentation failures. The use of a paper-based system is the primary reason for this. Neither can you maintain extensive paper-based files, nor can you dispose of them in a controlled manner. It is time-consuming and labor-intensive work. It’s high time that enterprises upgrade to the cloud-based document management system. Even the FDA recommends using electronic document management systems and eSignature for manageable documentation without manual intervention, which is more vulnerable to errors.

The cloud-based document management systems are the smarter alternative to traditional document systems. They provide you better control and confidence in managing the business and customers’ critical data efficiently.

3. Your Quality Policy Documents Are a Mystery

Another important reason cited for the failure of quality management process is improper missing quality policies for the everyday processes like packaging and labeling, validation, inspection, and much more. It makes it difficult for your teams to ensure batch consistency when they don’t have clear directions or benchmarks to follow. It can lead to catastrophic events, especially in regulated industries. The management must distribute the quality policy documents across all the locations and make sure that every employee is on the same page about the quality expectations.

The simplest solution here will be a training management software that allows you to create and track quality policies training.

4. Your SOP’s and Training Materials Are Not Readily Available         

Like policy documents, SOPs and training materials should be readily available to the quality teams they are intended for. If any FDA inspector or auditor finds out that your teams are working with an outdated SOP or are not trained on the new equipment, you will likely receive a warning letter. And that’s something no organization will ever want.

That’s where the cloud-based systems become even more significant. Your quality teams can readily access the updated documents on a single platform using their login credentials. Isn’t cloud technology is something you need to improve your quality management processes?

5. Your Organization Lacks a Culture of Quality

Even when everyone in the organization knows that the quality is non-negotiable, no one understands it as an individual responsibility. It is surprising to find organizations that still consider quality as the responsibility of a person or a particular team. With the focus on quality so high, the organizations must encourage a culture of quality where everyone is responsible for quality.

An enterprise quality management solution that can help create a closed-loop quality system to streamline the key processes, fostering a culture of continuous improvements and quality across the organization.

6. Your CAPA Process Takes Too Long to Resolve Quality Issues

Ineffective CAPA processes are another reason behind FDA warnings received by regulated industries. The most common scenario is overlooking investigations due to numerous tasks lined up for a single resource. The traditional CAPA system doesn’t allow you to set up automated alerts or follow-ups to get the issues resolved on time. However, next-generation CAPA management software can help reduce the process cycle time.

An effective CAPA management software can ensure timely planning, investigation, and resolution activities while storing all the records on a centralized platform as evidence for audits and other regulatory inspections.

7. Your Customer Complaints Are Continuously Increasing

Continuously increasing customer complaints is a clear sign of an unorganized quality management process. It will harm your reputation and make it difficult for you to attract new customers. Just like CAPA processes, you must regularly follow-up on the complaints investigations and action plans implemented. Complaints management software can be of great help. It will help you track the status of every complaint to ensure a timely resolution of complaints. The advanced trend analysis enables you to understand the trend of complaints to prevent similar complaints in the future.

You must act upon these alarming signs before the situation goes out of control and impacts your operational excellence too.

Impact of Poor-Quality Management Processes    

When you have mis-managed quality processes, your organization’s operational excellence is likely to suffer.

With the time, your employees will also lack motivation and will not engage in the critical activities like before. It will eventually decrease the productivity and retention rate. More will be the defects and rework; lower will be the interest and engagement from your employees. Most importantly, there will be no more continuous improvements in the organization, which is key for maintaining and increasing quality standards.

Poor quality management practices may also harm your business reputation among partners, stakeholders, suppliers and customers. It will impact the future growth also. And, overlooking all this impact can lost many business opportunities since you will be busy with handling recalls and rework, customer complaints, or other quality problems caused by unorganized processes. The money and time will also start falling less to invest in other core activities.

The only solution is to streamline your quality management process using a powerful quality management software.

But what holds organizations back from the much-required change?

It is the resistance that keeps most of the organizations from changing the on-going processes even when they know the change could bring significant benefits. Change itself sounds uncomfortable to the people. On the top of that, if the organization don’t have a standardized change management process, the change can become challenging.

Therefore, if you have realized that your quality management process is falling flat, it’s time to change. You can also utilize a change management software for streamlining and standardizing the change management processes.

How an Integrated Quality Management Software Takes Care of Everything?

Improving process and product quality can become simplified with an integrated quality management software since it allows you to create a closed-loop quality system. It also fosters a culture of continuous improvements, compliance, and excellence.

Always remember “The costs of poor quality are tangible; they will cost you customers and money, and ultimately affect the success of your business”.

Qualityze Enterprise Quality Management Software (EQMS) streamlines all your critical processes to ensure consistent quality. It connects all your quality systems together, enabling you to manage all your data on a centralized platform without any hassles.

Qualityze Enterprise Quality Management Solution helps meet your quality, compliance, and regulatory requirements by leveraging Industry best practices with standardized, repeatable processes through easy-to-configure, predefined workflow templates.

With Qualityze, you can have better control on nonconformance management, CAPA management, Document Management, Change Management, Supplier Quality Management, Training Management, Audit Management, Complaints Management, Inspection Management, Calibration Management, and Equipment Maintenance Management.

Built upon the world’s most secure and reliable platform,, Qualityze enables your quality teams to manage end-to-end quality from anywhere around the globe.

The Bottom Line

If you don’t have streamlined quality management processes, you will find gaining competitive edge very challenging.

You cannot afford a poor-quality management system especially when the customers are getting increasingly demanding. To maintain your brand reputation, you must take care of your customers’ expectations.

The easiest way to bring your quality management process back on track is by investing in a robust, secure, and reliable quality management software. It will help you gain the required traceability and visibility of the critical data you need to make business decisions.

If you wish to know more about the benefits of implementing an integrated quality management system, please get in touch with our customer success team on 1-877-207-8616 or email at and we will be right there for you.



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