12 Signs That Your Quality Management Process is Failing

For truly successful companies, quality management revolves around continuous improvement. It is not only about quality performance at a given time or a particular batch of production, but also the ability to build a sustainable process to truly trust the quality system that has been implemented.

World-class quality management must be metrics-oriented and collaborative, using periodic audits to ensure the process is continuously made better.

Of course, we should not forget that quality management is also a regulatory requirement, especially in some industries such as medical devices, pharma, and general manufacturing. A modern EQMS system is essential to build a culture of quality excellence and increase employee engagement to improve customer delight, enable innovations, and sustain growth. Without the right EQMS, it is impossible to build a QMS workflow that one can truly trust.

However, despite best efforts, there can be quality failures that result in product recalls, complaints, wastage, rework, and so on. These can lead to higher costs of manufacturing, have a negative impact on brand/reputation, and affect financial performance.

Often failures in the quality management system come to light only when a problem is reported in the product or service. This is a reactive approach and can be harmful in the long run. Instead, it is important to take a proactive approach that identifies potential errors and rectifies processes to prevent failures and deliver as expected.

In this blog, we highlight a few “signals” that may indicate your Quality Management System is not working as intended. This is certainly not an exhaustive list, but if you notice even one of these in your enterprise, it’s time to act. An audit of the entire QMS workflow is a good place to start.

Some Typical Signs That Your Quality Management is Failing

12 signs that warn of possible failure of the quality management process include:

Sign #1. You are Not Audit-Ready: If you fail a surprise audit, it is a clear sign that you are not audit-ready and that your quality management needs to be improved. Audit readiness is one of the most important benefits of a “well implemented” quality management system. Identify best practices and benchmarks in your industry, measure your performance against those and implement these to improve your quality score. A cloud-based EQMS like ComplianceQuest can enable visibility into all data and processes – and keep you audit-ready.

Sign #2. Your Documents are Not Accessible: A good quality management process incorporates document management. It helps with efficient document lifecycle management from the time of creation to reviews and approvals, storing, retrieving, archiving, version control, and removing outdated documents. Document management is an essential part of the quality management system, required also for regulatory purposes. Therefore, pay attention to your document management system to get a measure of your quality management system. If you are still using a paper-based system, this can add to the complexity. A cloud-based solution can help to automate the process and improve the quality management system by several notches. The regulatory bodies such as FDA and standards such as ISO also recommend the use of Electronic Document Management Systems and eSignature to reduce manual intervention and improve document management.

Sign #3. Employees Lack Awareness of Quality Processes: Every employee must know the quality policy of the employer and implement them in their processes to ensure the expected quality. Provide them with the policy document and the required training so that they can implement standard operating procedures in their functional areas. A Training Management Software will help to identify skill gaps and create and deliver training allows, ensuring policies are implemented diligently.

Sign #4. Quality is Viewed as the Job of Just the Quality Team: Often, employees complete their tasks without understanding the seriousness of the SOPs and quality policy. They think quality performance is the responsibility of the quality team alone. This makes quality reactive where issues are addressed after a problem occurs. Businesses need to encourage a culture of quality where employees proactively participate in Quality Management by adhering to SOPs. It should have a system of engagement rather than records where employees provide inputs for quality improvement in their areas and participate actively to ensure the expected outcome. A cloud-based solution can help to empower employees with data related to their areas of responsibility and identify deviations.

Sign #5. There are Too Many Recalls and Complaints: Complaints and product recalls indicate problems with the quality management system. The feedback obtained from them must be incorporated to continuously improve quality through root cause analysis and CAPA. An integrated enterprise quality management solution can help leverage complaints to continuously improve the quality management system.

Sign #6. Your CAPA is Ineffective: When a problem occurs, the business must implement Corrective Action and Preventive Action to resolve the issue in the present and prevent future recurrence of the problem. Often, though, root cause analysis and CAPA processes get into cold storage due to other priorities taking over. A cloud-based solution can automate the process, send alerts, and ensure that the process is on track till its effectiveness has been proved.

Sign #7. You Have a Paper-based QMS: The challenge with a paper-based system is the difficulty in keeping track of files and progress. For instance, if a root cause analysis has been initiated following a quality event, it is not easy to track the progress and whether there has been a finding. It is difficult to track the progress of tasks assigned and the results. In large organizations with operations across different geographies, standardization can become difficult. A cloud-based QMS solution can help with tracking and analyzing activities effectively to reduce quality issues.

Sign #8. Change Management is Difficult: As businesses grow, there is a constant need to change processes and approaches to suit the size and complexity of the activities. However, in a manual system, it is hard to understand the impact of changes on the different processes and anticipate challenges that need to be addressed before they become an issue. This can be made easy with a cloud-based solution that helps to understand the interdependencies and put in controls and measures to minimize the risks introduced by the changes.

Sign #9: Unable to Implement a Risk-Based Approach: In today’s uncertain environment, identifying and managing risks is crucial. For this, businesses need clear visibility into internal and external risks to make informed decisions. They need to be able to identify the right measures and controls to Mitigate the Risks and analyze the cost-benefit analysis of these measures. A cloud-based solution can provide the required data to make these decisions and mitigate the risks.

Sign #10. Lack of Unified Data for Quality Decisions: Quality improvement efforts need data from across processes. It needs a holistic view of enterprise-wide data to be able to take meaningful decisions. Integrating with enterprise systems such as ERP, CRM, SCM, etc. is critical. In a manual system or legacy systems with data silos, this can be challenging. A cloud-based, integrated system is essential to provide a unified view of processes and make quality management effective.

Sign #11. Unable to Track Performance Effectively: Establishing, tracking, and monitoring key performance metrics are essential to ensure that quality management is performing as expected. This requires data and visibility into processes. A cloud-based solution can help break these silos and provide a single source of truth to measure KPIs and course correct in case of deficiencies.

Sign #12. Supplier Management is a Challenge: Supplier management is a crucial aspect of quality management, as input quality affects the output. Right from the time of onboarding suppliers based on their capability to align with the business’s goals to ensuring they deliver as per requirements and can handle changes effectively, there needs to be a synergy between the two partners. In manual or legacy systems, this can become difficult and quality issues recurrent. A cloud-based solution can help overcome these challenges by integrating with the Supplier Management Solution to ensure quality from the word go.

ComplianceQuest’s enterprise-wide Quality Management System is a cloud-based solution that integrates enterprise data to provide a unified view and simplify quality management. It enables automated workflows of all key aspects such as audit, document, risk, change, training, equipment, and so on to ensure quality is integral. This helps with improving employee engagement in quality management for greater effectiveness.

To know how you can improve your quality management, request a demo: https://www.compliancequest.com/lp/eqms/