Nonconforming product software made easy.

Nonconforming products are those that deviate from a specification, standard or expectation so that the end result does not meet requirements. Other names for nonconforming products include nonconformance and nonconformity.

There are a variety of ways that nonconforming products are identified, including regular evaluations against key performance indicators (KPIs), inspections, audits and customer feedback.

In ISO 9001, handling nonconforming products is crucial to maintaining quality standards. Key processes involved include:

1. Identification: Clearly defining what constitutes a nonconforming product. This involves establishing criteria against which products are evaluated for conformity.
2. Documentation: Properly documenting nonconformities, including details such as the nature of the nonconformity, its location and any associated documentation or records.
3. Evaluation: Assessing the significance of the nonconformity to determine its impact on product quality, safety or regulatory compliance.
4. Segregation: Physically segregating nonconforming products to prevent unintended use or delivery. This may involve quarantine areas or designated storage locations.
5. Investigation: Investigating the root cause of the nonconformity to identify underlying issues in the production process, materials or other factors.
6. Disposition and Approval: Identifying the disposition of the nonconforming product such as scrap, use as is, rework, etc., and approving the disposition and follow-up action of completing the required disposition.
7. Record Keeping: Maintaining records of nonconformities, corrective actions and their outcomes for traceability and continuous improvement purposes.

By following these processes, organizations can effectively manage nonconforming products, minimize risks and maintain customer satisfaction and compliance with ISO 9001 requirements and beyond.

1. Safety Hazards: Nonconforming products may pose safety risks to users or consumers if they do not meet specified quality or performance standards. This could result in accidents, injuries or even fatalities.
2. Compliance Violations: Nonconforming products may fail to meet regulatory requirements or industry standards. This can lead to compliance violations, fines, legal actions and damage to the reputation of the manufacturing organization.
3. Customer Dissatisfaction: Nonconforming products may fail to meet customer expectations in terms of quality, functionality or reliability. This can result in customer complaints, returns, warranty claims and loss of customer trust and loyalty.
4. Production Delays: Nonconforming products may disrupt production processes, leading to delays in manufacturing schedules and shipment deadlines. This can impact overall production efficiency, increase costs and affect customer satisfaction.
5. Waste and Rework: Nonconforming products may need to be scrapped or reworked to bring them into compliance. This results in wasted materials, resources and labor, increasing production costs and reducing profitability.
6. Supply Chain Disruptions: Nonconforming products can cause disruptions throughout the supply chain, affecting suppliers, distributors and other stakeholders. This can lead to delays in product delivery, inventory management issues and strained relationships with business partners.
7. Reputational Damage: Persistent issues with nonconforming products can damage the reputation of the manufacturing organization. Negative publicity, social media backlash and word-of-mouth criticism can tarnish the brand image and impact future sales and partnerships.
8. Loss of Market Share: If nonconforming products persistently affect quality and reliability, customers may switch to competitors' products that offer better quality assurance. This can result in a loss of market share and competitiveness in the industry.

Addressing nonconforming products effectively is essential to mitigate these risks and ensure the long-term success and sustainability of manufacturing operations. This involves implementing robust quality management systems, conducting thorough root cause analyses, implementing corrective actions and continuously improving processes to prevent recurrence of nonconformities.

Several common standards address nonconforming products, including FDA 21 CFR Part 820, ISO 9001:2015 and ISO 13485: 2016.

FDA 21 CFR Part 820 requires manufacturers to establish and maintain procedures to control product that does not conform to specified requirements. The procedures address the identification, documentation, evaluation, segregation and disposition of nonconforming product.

ISO 9001 standards seek to prevent the unintended delivery or use of a nonconforming product (or service) by ensuring manufacturers control and correct nonconformities. It also requires an organization to evaluate the need for actions that will prevent the recurrence of a nonconformity.

ISO 13485 requires medical device manufacturers to address nonconforming products and ensure they are not distributed for use. The process needs to be documented and corrective actions undertaken.

QT9 QMS has 25-plus interconnected modules that come standard, including a Nonconforming Products module that connects with other key applications, such as audits, risk management, customer complaints, deviations and supplier management. Its cloud-based platform allows you to easily communicate and synchronize records with anyone, anywhere.

QT9’s QMS software is a highly rated, affordable, easy-to-use quality management system that excels at all of the processes that go into providing high-quality goods and services that are FDA and ISO compliant.

With QT9 QMS you get unlimited scalability and traceability at a great price, so you can bring quality products and services to market in the most efficient way.