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Non-conformances are costly and risky for any business. They can result in loss of revenue, reputation, customer satisfaction, and legal compliance. Studies show that, as a general rule of thumb, a successful business will incur expenses associated with subpar quality that account for 10 to 15 percent of total operations. But what would the cost be for a business that doesn’t manage its non-conformance properly? In this blog post, we will explore what non-conformances are, and the different types, and provide you with practical tips to prevent them effectively.
What is a Non-Conformance?
A non-conformance is any deviation from established standards, procedures, or specifications. It represents a failure to meet expected quality or compliance requirements. Non-conformances can occur at any stage of a process, from design and production to delivery and service. They can affect the performance, safety, and satisfaction of customers, employees, and stakeholders.
Think of it as a red flag that signals a misalignment with the expected levels of operations. These deviations are the silent disruptors that can occur at any stage of your processes, spanning from the initial design stages through production, all the way to delivery and post-service phases.
What’s the Difference Between Non-Conformance and Non-Compliance?
Non-conformance and non-compliance are two terms that are often used interchangeably, but they have different meanings and implications. Non-conformance refers to a failure to meet the specifications or requirements of a product, service, or process and is usually detected by internal audits, inspections, or testing. Non-compliance, on the other hand, refers to a failure to adhere to the laws, regulations, or standards that apply to a product, service, or process.
While non-conformance does not always mean breaking the law or following rules, it can have an impact on the output’s performance, quality, or safety. Conversely, non-compliance may lead to legal penalties, fines, or punishments in addition to harming one’s reputation or losing confidence.
The Different Types of Non-Conformances
Non-conformances are not all the same. Depending on the severity and impact of the deviation, they can generally be classified into two separate categories – minor and major.
Minor Non-Conformance
A minor non-conformance is a deviation that doesn’t significantly jeopardize compliance, safety, or quality. Although it’s seen as less serious, remedial action can still be necessary. Small non-conformances are typically isolated incidents that have no bearing on the process, product, or service’s overall operation or performance. They might, however, result in significant non-conformances or unhappy customers if they are not quickly resolved.
For instance, common minor non-conformances could be:
- Missing documentation in a quality control report
- Minor labeling discrepancies on a product
- No separation of non-conforming products
- Machines not calibrated properly
While minor non-conformances won’t have an immediate impact on your organization’s certification status, they will be noted for your next external audit.
Major Non-Conformance
A high danger to safety, quality, or compliance is an indicator of major non-conformance. It constitutes a serious infraction of regulations, standards, or safety procedures and is typically a systemic problem that impacts the entire product, service, or process. Businesses threatened by major non-conformances have a higher likelihood of leading to legal penalties, fines, sanctions, reputational damage, or loss of trust.
Some of the more common major non-conformances are generally:
- A safety violation leading to an accident
- A product failing to meet regulatory standards
- Missing critical documentation
- Working in unsafe environmental conditions
- Failing to take corrective action on the root cause of an issue
Unlike minor non-conformances, major non-conformances will affect the certification status of your organization and may result in suspension or withdrawal of the certificate
4 Tips to Prevent Non-Conformances
Preventing non-conformances is not only a matter of compliance but also a matter of excellence. When we prevent non-conformances, we make a strong impact on the business such as improving your quality, efficiency, and customer satisfaction, as well as reducing your costs, waste, and risks.
1. Internal Audits
One essential tool for preventing non-conformances is internal auditing. They let you keep an eye on and assess your procedures, spot any weak points, and put fixes in place. According to studies, businesses that regularly carry out internal audits may save as much as $2.86 million.
To conduct effective internal audits, you should:
- The goals, parameters, and standards of your quality management system (QMS) should guide the planning of your audits.
- Make sure you cover all the pertinent facets of your operations and goods by using a checklist.
- Keep a record of your observations and conclusions, along with any non-conformances, and areas that might use improvement or best practices.
- Share the audit’s findings with management and any pertinent parties.
- Examine the efficacy of the remedial and preventative measures implemented to resolve the non-conformances.
Check out our free-to-download checklist library to get started mitigating non-conformances today.
2. Automate Your Alert System
Automation lowers human error and oversight, which helps you prevent non-conformances. An automatic alarm system allows you to:
- Get alerts promptly about any real or possible deviations.
- Assign and monitor preventative and remedial measures.
- Raise problems to the proper level of authority.
- Document and report on non-conformances and their resolution.
While enterprise-level companies could find it difficult to communicate about conformity, automated warning systems can greatly improve communication and teamwork throughout your company network, which will improve your connections with vendors, clients, and staff.
More specifically, this system allows you to streamline and fortify these connections by notifying for instance your suppliers promptly about any alterations in your specifications or requirements, ensuring a smoother production process.
Likewise, you can keep your customers informed of any delays or issues in your delivery or service, promoting transparency and customer satisfaction. And, with automated alerts, you can engage your employees more effectively in your quality improvement initiatives and encourage their valuable feedback, fostering a culture of continuous improvement and innovation.
3. Feedback
feedback. All with equal value, employee, supplier, and customer feedback are vital in gaining a stronger understanding of non-conformance threats. When you collect feedback, you’re more prepared to:
- Identify and address issues before they become non-conformances
- Enhance customer satisfaction and loyalty
- Improve employee engagement and performance
- Foster a culture of continuous improvement and learning
While collecting feedback is a major non-conformance prevention strategy, you must follow up on the feedback.
4. Build a Well-Structured Root Cause Analysis
Even though non-conformances happen sometimes, you can still learn from them and stop them from happening again. You need to carry out an organized root cause analysis to achieve that. An organized method called a root cause analysis is used to:
- Describe the issue and its extent. Is it a major or minor non-conformance?
- Gather and evaluate information and proof.
- Determine the underlying causes and influential elements.
- Create and assess potential fixes.
- Execute and oversee the selected course of action.
How Certainty Prevents Non-Conformances
Certainty Software is a valuable non-conformance management tool that streamlines data collection during internal audits and inspections, optimizes corrective and preventive action management with customizable notification systems and Action Workflows, and provides in-depth reporting to uncover risks before they become non-conformances. By using Certainty Software within your non-conformance process, you are taking a proactive approach to maintain compliance and quality standards.
If you want to learn more about how Certainty Software can help you prevent non-conformances and boost your quality assurance, contact us today for a free demo.
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