ISO 9001 Clause 8.7 addresses the need for organisations to identify, control, and deal with nonconforming products or services. Nonconformities—whether in the form of defective products, incomplete services, or anything that doesn’t meet specified requirements—can negatively affect customer satisfaction and regulatory compliance. This clause provides guidance on how organisations should handle nonconforming outputs to maintain quality and minimise risks.
In this blog post, we’ll explore what Clause 8.7 entails, why it’s critical for quality management, and how your organisation can implement effective strategies to control nonconforming outputs.
What is ISO 9001 Clause 8.7?
Clause 8.7 outlines the requirements for controlling nonconforming products or services. Nonconformities may arise at any stage of production or service delivery, from design and development to delivery or post-delivery. This clause requires organisations to take prompt action to identify, segregate, and address nonconforming outputs to prevent them from reaching customers or causing further issues.
The objective is to prevent the use, delivery, or installation of products or services that do not meet specified requirements, ensuring that only conforming outputs are released to customers.
Key Requirements of Clause 8.7
To comply with Clause 8.7, organisations must implement several key actions:
- Identification of Nonconformities
- Establish a process to identify nonconformities as soon as they occur, whether during production, service delivery, or after release. This can include inspections, testing, and feedback from customers.
- Nonconformities may be identified through various means such as visual checks, audits, complaints, or performance data.
- Segregation of Nonconforming Outputs
- Once a nonconformity is identified, it must be separated from conforming products or services to prevent it from being inadvertently used, shipped, or delivered.
- This could involve marking, tagging, or physically isolating nonconforming items to ensure they are not mixed with approved outputs.
- Documentation and Investigation
- Document all instances of nonconformance, including the nature of the issue, its root cause, and any corrective actions taken.
- Investigate the cause of the nonconformity to determine whether it is a one-time occurrence or part of a larger pattern that requires systemic improvement.
- Corrective Actions and Disposition
- Determine the appropriate corrective action to take in response to the nonconformity. Depending on the situation, corrective actions may involve:
- Rework: Modifying the nonconforming product or service to bring it into compliance with the specified requirements.
- Acceptance with Concession: In some cases, it may be possible to accept the nonconforming product or service if the customer agrees to the deviation and a concession is granted.
- Rejection: If rework or concession is not feasible, the nonconforming product or service should be rejected and removed from the process.
- Ensure that the corrective actions taken are effective in preventing recurrence of similar nonconformities in the future.
- Determine the appropriate corrective action to take in response to the nonconformity. Depending on the situation, corrective actions may involve:
- Analysis of Nonconformities
- Conduct a thorough analysis of nonconformities to identify trends, root causes, and potential areas for improvement. This analysis should feed into the organisation’s continuous improvement efforts.
- Review historical data of nonconformities and establish preventive actions to address any patterns.
- Communication of Nonconformities
- Ensure that all relevant departments, teams, and stakeholders are informed about nonconformities. This helps to prevent further issues in the process and ensures that corrective actions are executed in a timely manner.
- Proper communication ensures that nonconformities are not ignored or missed, and necessary actions are taken across all areas of the business.
Why is Clause 8.7 Important?
The control of nonconforming outputs is essential for several reasons:
- Prevents Defective Products or Services from Reaching Customers: By identifying and addressing nonconformities early, organisations can prevent defective products or services from reaching customers, avoiding dissatisfaction or complaints.
- Improves Customer Satisfaction: By ensuring that only conforming products and services are delivered, organisations can increase customer satisfaction and trust, leading to better customer retention and loyalty.
- Reduces Rework and Costs: Timely identification and control of nonconformities prevent the need for expensive rework or recalls, helping to reduce costs and improve efficiency.
- Maintains Compliance: In some industries, nonconforming products can have serious consequences, such as regulatory violations or legal liabilities. Proper control helps organisations maintain compliance with industry regulations.
- Supports Continuous Improvement: A structured approach to handling nonconformities helps organisations learn from their mistakes and take corrective actions that improve quality in the long term.
How to Implement Clause 8.7 Effectively
To successfully implement Clause 8.7, organisations should adopt several best practices:
- Establish Clear Procedures for Handling Nonconformities
- Develop a documented procedure for identifying, recording, and managing nonconformities. This procedure should define roles and responsibilities, steps for investigation, and methods for corrective actions.
- Ensure that staff members are trained to recognize and handle nonconformities as part of their daily tasks.
- Regular Inspections and Testing
- Implement routine checks and tests to identify nonconforming products or services early in the production or delivery process. This proactive approach allows for quick action before a problem escalates.
- Use quality control tools, such as statistical process control, to identify patterns or trends in nonconformities.
- Implement Root Cause Analysis
- When nonconformities are identified, conduct a root cause analysis to understand the underlying issue. Use techniques such as the 5 Whys or Fishbone diagrams to identify the true cause of the problem.
- Implement corrective actions that address the root cause, not just the symptoms, to prevent recurrence.
- Track and Document Nonconformities
- Keep detailed records of all nonconformities, including the corrective actions taken and the results of those actions. This documentation is essential for audits and analysis.
- Ensure records are accessible for review and learning, as they may highlight areas for improvement or provide insight into recurring problems.
- Monitor Effectiveness of Corrective Actions
- After implementing corrective actions, monitor their effectiveness to ensure that nonconformities are no longer occurring. If the corrective actions are not successful, revisit the root cause and adjust the approach as necessary.
- Track improvements over time and use data to refine processes further.
- Foster a Culture of Continuous Improvement
- Encourage employees at all levels to be proactive in identifying and resolving nonconformities. This promotes a culture of continuous improvement and helps reduce the occurrence of issues.
- Use nonconformities as learning opportunities to enhance overall quality management processes.
Final Thoughts
ISO 9001 Clause 8.7 ensures that organisations have the right processes in place to control nonconforming outputs, preventing defective products or services from reaching customers. By identifying, documenting, and addressing nonconformities promptly, organisations can maintain product quality, reduce costs, and enhance customer satisfaction.
Implementing a robust system for managing nonconformities also supports continuous improvement efforts, ensuring that your organisation remains committed to delivering quality products and services that meet or exceed customer expectations.
