Automated quality management software has been identified as the most powerful means of driving down non conformance rates within an organization. By allowing automated workflows to eliminate slow and error-prone manual processes, an organization can identify problems quickly, solve them quickly, and design an environment where problems are unlikely to recur. This article discusses the role of automated quality management software solutions in changing the way non conformance is handled by an organization.
Understanding the True Cost of Non Conformance
Before delving into the solutions available, let’s first appreciate the seriousness of the problem. A Non Conformance is defined as a deviation from a defined standard. While a Non Conformance might appear to be a minor operational inconvenience at first glance, in actuality, its impact goes far beyond the four walls of an organization. The Direct Costs associated with a Non Conformance include Rework Costs, Scrap Costs, and Replacement Costs. The Indirect Costs can be enormous. They include Customer Complaints, Loss of Business, Government Investigation Costs, and Reputational Costs that can take an organization several years to recover from. In industries such as Pharmaceuticals, Medical Devices, and Aerospace, where regulations are very stringent, a Non-Conformance can trigger a costly product recall by the government. Studies show that the Cost of Poor Quality can add up to as much as 5-30% of an organization’s revenue. Hence, investing in quality management software can prove to be a necessity rather than a luxury.
Why Manual Processes Fall Short?
Non-conformity is still managed with a combination of paper-based forms, spreadsheets, and email-based communication. Even though these tools are familiar and easy to use, they are fundamentally unsuitable for the requirements of modern quality management. Information is not available from one shift to another. Reports are ignored in inboxes. Timelines for investigations extend from days to weeks. Causes of non-conformity are never found because no one has a complete picture of the data.
The result is a quality management system that is always reacting and never improving. Without a systematic, centralised approach to managing non-conformity events, an organisation is doomed to repeat the same battles. Automated quality management software is designed to help organizations break the cycle.
How Automation Reduces Non-Conformance Rates?
The key to the power of automated quality management software is that it can add structure, speed, and intelligence to every part of the process for non conformance management. The following is how this makes a real difference in a measurable way.
- Faster detection through real-time reporting- The use of automated quality management systems allows workers to report a non conformance as soon as it is detected. The workers can do this from a mobile device or computer. The use of digital forms allows all relevant data to be captured accurately and in real-time. There is no delay in reporting that is experienced in a manual system.
- Intelligent Routing & Escalation– Once a non-conformance is recorded, the system can route the issue to the relevant person according to pre-defined business rules. Critical issues are escalated for immediate action, while less severe non-conformances are processed according to a normal workflow. Should a non-conformance not be actioned within a predetermined timeframe, the system can automatically escalate the issue to the relevant person for prompt action, thereby removing human barriers to resolution.
- Structured Investigation & Root Cause Analysis– Perhaps the biggest contribution that automated quality management systems can make is the structured approach to investigating non-conformances. Rather than leaving the effectiveness of the investigation to the judgment of the person investigating the issue, the system can prompt the user to use a variety of root cause analysis tools, from 5 Why analysis, Fishbone diagrams, to FMEA. This ensures that every non-conformance is thoroughly investigated, with actions taken on the actual root cause, not the symptoms.
- Structured investigation and root cause analysis- Perhaps the biggest contribution that automated quality management systems can make is the way they can ensure that every non conformance is thoroughly investigated, as opposed to the judgmental approach that is often followed without the aid of a system. Automated quality management systems can ensure that the quality teams are not only investigating every non conformance, but are doing so with the aid of tools such as 5 Why analysis, Fishbone diagrams, or FMEA.
- Seamless CAPA management- Corrective and Preventive Actions (CAPA) are the engines that drive the reduction of non-conformances over the long term. Automated quality management systems can ensure that every investigation is linked to a CAPA, which can not only manage the reactive quality actions, but can also ensure that the preventive actions, which are intended to prevent defects from occurring, are carried out within the system.
How Data-Driven Prevention Can Be the Next Level of Quality Management?
While decreasing non-conformance rates, it is not simply a matter of more efficiently handling each incident on a case-by-case basis. It is a matter of spotting trends, understanding systemic risk, and acting in anticipation of problems, not in reaction to them. This is where the analytical power of computerized quality management software provides its greatest return on investment.
In current QMS software, non-conformance data is collected on a variety of products, processes, suppliers, and facilities, and presented in a variety of formats, such as real-time graphs, Pareto charts, and trend reports. Quality managers may determine which products have the highest non-conformance rates, which suppliers have the most non-conforming materials, and which processes are most vulnerable to non-conformance. This information enables organizations to target their improvement efforts on those areas where they will have the most impact, and lower their overall non-conformance rates accordingly.
How to Strengthen Supplier Quality?
A substantial portion of nonconformances occurring in manufacturing environments begins with the material that is received into an organization. Automated quality management systems provide this level of visibility into supplier-related nonconformances, allowing organizations to send Supplier Corrective Action Requests (SCARs) and monitor supplier performance through objective scorecards.
This level of transparency changes the dynamic of supplier relationships. No longer do we need to go back and forth through email trying to manage quality issues between two parties. Suppliers are aware of exactly what is expected of them, can see their own performance trends, and are held accountable through a process that is well-defined and documented. This leads to measurable improvements in received material quality over time, reducing supplier-related nonconformances at the source.
How to Support Compliance and Audit Readiness?
For companies that are operating under the ISO 9001, FDA, IATF 16949, or similar quality management systems, non-conformance management is a primary quality management system requirement for compliance. With automated quality management systems, there is a complete, accurate, and unalterable history of every event, every investigation, every action, and every closing of a non-conforming event. This allows quality teams to instantly produce requested evidence of how a company handles non-conforming events, rather than wasting valuable time gathering information from disparate systems.
One of the biggest benefits of quality management systems, which is often not appreciated, is the confidence that every record within the system is accurate, complete, and ready for any audit, at any time. This not only reduces stress, which can lead to costly delays, but can also greatly minimize the risk of any potential quality management system audit findings.
Conclusion
One of the most valuable quality objectives an organization can pursue is to reduce its nonconformance rates. The cost savings, regulatory risk reduction, and customer satisfaction benefits that come with a sustained reduction in non-conformance events are significant. Automated quality management software is the most powerful solution an organization can leverage to achieve this goal. By accelerating detection, organising investigations, enforcing corrective actions, and revealing the data needed for systemic prevention, automated quality management software can turn nonconformance management into a competitive advantage.
