Common Causes of Nonconformity in ISO 9001 and Corrective Action

An interesting study has revealed that ISO 9001 certification accounts for about 60% of nonconformities identified during system audits. These nonconformities can range from minor oversights to major failures that threaten the integrity of a company’s Quality Management System (QMS).

Understanding the causes and impact of these nonconformities is crucial for businesses looking to maintain compliance and improve their processes. 

Let’s take a closer look at common causes of ISO 9001 nonconformity and how addressing them head-on can safeguard your business's reputation and growth.

Understanding the Impact of ISO 9001 Nonconformity

Nonconformity in the context of ISO 9001 refers to a failure to meet specified requirements within the ISO 9001:2015 quality management system. ISO 9001 is a globally recognized standard for quality management systems (QMS) that helps businesses ensure consistency, efficiency, and customer satisfaction. 

For manufacturing businesses, it is crucial to maintain high standards of product quality and process reliability.

Nonconformities are typically identified through audits, regular inspections, internal assessments, or feedback from customers. When nonconformity is detected, it indicates that a certain aspect of the quality system is not functioning as it should, which could negatively impact the product, service, or overall business operations. The major impacts of nonconformity are as follows:

• Legal and Regulatory Risks: Nonconformities can lead to fines, penalties, or even suspension of operations due to failure to meet legal or regulatory standards.
• Disrupted Deliveries and Deadlines: Nonconformities can cause production delays, impacting your ability to meet customer deadlines and harming relationships.
• Rising Operational Cost: Unresolved nonconformities result in rework, waste, and inefficiencies, driving up costs and cutting into profits.
• Product Rejections and Revenue Loss: Defective products may be rejected, leading to financial losses and damaging your company's reputation.
• Erosion of Customer Trust: Persistent nonconformities reduce customer satisfaction and loyalty, threatening term business deals.

Addressing nonconformity is essential to maintaining compliance and improving business processes. For this, you need to identify the common causes of nonconformity.

Six Common Causes of ISO 9001 Nonconformity 

From leadership gaps to technical issues, various factors cause ISO 9001 nonconformities. While some issues stem from simple oversight, others arise due to the transition to ISO 9001:2015.

However, many common trends, such as ineffective risk management and poor documentation practices, persist regardless of the update. Here are six key causes of ISO 9001 nonconformity that can disrupt your quality management system.

1.Failure to Identify and Define Interested Parties

One of the most common nonconformities in Clause 4 is the failure to identify and define the needs and expectations of interested parties—those who affect or are affected by the QMS. It eventually impacts the effectiveness of the quality management system and business goals.

Failing to define these expectations clearly can result in gaps in the quality management system that affect product quality, customer satisfaction, and even legal or regulatory compliance. Additionally, not considering the perspectives of all stakeholders may lead to missed opportunities for improvement or risk management. 

2.Inadequate Process Monitoring and Measurement

Another common issue under Clause 4 is the failure to monitor and measure processes effectively. This involves not establishing proper metrics or failing to track key performance indicators (KPIs) for QMS processes. Without this monitoring, it’s difficult to identify:

• Inefficiencies 
• Areas of improvement
• Quality issues

Leading to noncompliance with ISO 9001:2015 requirements. In some cases, organizations focus on the wrong indicators, failing to track data that directly reflects quality, efficiency, or customer satisfaction. Additionally, inconsistent data collection and analysis can result in noncompliance with ISO 9001:2015 requirements for consistent monitoring. To avoid this issue, businesses should establish clear, measurable goals and ensure that data is collected accurately and consistently.

3.Ineffective Risk Management 

Clause 6 mandates comprehensive risk evaluation across all operations, including supply chain management. A frequent nonconformance here is not properly evaluating risks in areas like warehousing, third-party suppliers, or changes in operational processes. While some businesses may focus on risk at the strategic level, they often neglect to incorporate risk management into day-to-day operations, especially with regard to processes and suppliers. 

An ineffective risk management system can expose the organization to risks such as supply chain disruptions, legal challenges, and even product failures. To meet ISO 9001:2015’s requirements, companies should conduct regular risk assessments and ensure that mitigation strategies are in place for both foreseeable and unforeseen issues.

4.Use of Inaccurate Measuring Tools 

A frequent nonconformity under Clause 7 involves using inappropriate or poorly calibrated measuring devices. This results in inaccurate measurements, which can compromise product quality and affect compliance with ISO 9001.

Even many companies conduct audits that are either too infrequent or lack the depth needed to uncover systemic issues. Some audits are merely a formality rather than a proactive tool for continuous improvement, leading to missed opportunities for corrective action. 

To address this, businesses should develop a robust internal audit program, and the right tools are used and properly maintained is essential to avoid this issue.

5.Lack of Proper Documentation

Under Clause 8, organizations must control operations, including first-piece and receiving inspections. A common nonconformity is the failure to document these inspections properly or when there is no clear process for evaluating and approving vendors. This can take the form of incomplete, outdated, or unclear documentation, which makes it difficult to demonstrate how the QMS meets the established requirements. 

In some cases, employees may be unclear about the processes or standards they are required to follow because documentation is either too vague or inconsistent. Poor record-keeping also hinders organizations during audits, where auditors rely on clear, complete records to verify compliance. Businesses must ensure that all documentation is thorough, up-to-date, and easily accessible to relevant stakeholders. 

To ensure seamless, organized, and compliant documentation, opt for BPRHub’s Document HUb feature.

6.Failure to Implement Corrective Actions 

Clause 10 focuses on continual improvement, including the need for corrective actions. A frequent issue here is recording customer complaints without fully defining, documenting, or implementing corrective actions in response. Without taking action on the root causes of nonconformities, the same issues can reoccur, preventing continuous quality improvements.

To effectively address these common causes of nonconformities, they are categorized into two types based on their impact on the business: major nonconformities and minor nonconformities. Let’s explore their differences.

Major v/s Minor ISO 9001 Nonconformities

The distinction between major and minor nonconformities exists to help organizations prioritize corrective actions based on the severity of the issue. Understanding this difference is essential for resource allocation and effective resolution.

Major Nonconformities

Major nonconformities are serious issues that can compromise the entire QMS and prevent an organization from achieving or maintaining ISO 9001 certification. These issues usually stem from failures to meet key ISO 9001 standards, such as poor process controls, inadequate risk management, or lack of leadership commitment. They often indicate deeper, systemic problems that affect the organization’s ability to deliver quality products or services consistently.

Minor Nonconformities

Minor nonconformities, while still important to address, have a limited impact on the overall functioning of the QMS. These typically include issues like missing or incomplete records or non-compliance with less critical procedures, such as improper filing of audit reports or incomplete training documentation. These are isolated issues that do not significantly disrupt product quality or customer satisfaction but still represent areas for improvement within the organization.

Understanding the distinction between major and minor nonconformities is crucial, but effectively addressing them requires a structured approach. Let’s explore the corrective actions necessary to resolve nonconformities and prevent their recurrence.

Corrective Action: A Step-by-Step Framework to Handle Nonconformities

Corrective actions are steps taken to address nonconformities identified within the Quality Management System (QMS) and prevent them from recurring. The goal is not only to fix the immediate issue but also to identify its root cause and eliminate it to improve overall system effectiveness.

Here’s a simple framework for implementing corrective actions:

1.Identify the Nonconformity

The first step is recognizing and documenting the nonconformity through inspection, audits, or customer feedback. This includes capturing details such as what the problem is, where and when it occurred, who is affected, and its impact on product quality or customer satisfaction.

2.Root Cause Analysis

Corrective actions should target the root cause of the nonconformity, not just its symptoms. Tools like the "5 Whys" or Fishbone Diagram are used to trace the underlying cause. Identifying all possible contributing factors helps ensure that corrective actions address the true source of the problem.

3.Implement Corrective Action

A corrective action plan is a structured approach that outlines the steps required to eliminate the causes of nonconformity and prevent similar issues from arising in the future. The plan should be comprehensive, measurable, and aligned with organizational goals for quality improvement.

Corrective Actions May Include:

a. Revising Processes to Eliminate Weaknesses

Often, nonconformities arise because existing processes are inefficient or inadequate. In these cases, process revision becomes a crucial corrective action.

Examples of process revisions may include:

• Redesigning Workflows: Streamlining or reordering steps to eliminate bottlenecks, inefficiencies, or areas of confusion.
• Standardizing Procedures: Creating or updating standard operating procedures (SOPs) to ensure uniformity and consistency across operations.
• Improving Quality Control: Introducing additional quality checks at critical stages of production or service delivery to catch potential defects before they affect the final product.
• Optimizing Resource Allocation: Ensuring that the right resources (e.g., manpower, materials, machinery) are available where and when needed to meet quality standards.

b. Implementing Training Programs to Fill Knowledge or Skill Gaps

Nonconformities can often stem from gaps in employee knowledge or skills, particularly if workers are not adequately trained or are unaware of updated procedures. Training programs can address these gaps and prevent future mistakes.

Types of training actions may include:

• On-the-job Training: Providing employees with hands-on experience and real-time guidance to address specific skills or process-related issues.
• Formal Classroom Training: Offering structured training sessions on key topics like quality standards, new processes, safety protocols, or customer service.
• Cross-Training: Encouraging employees to learn multiple roles or processes to improve flexibility and prevent errors caused by lack of expertise.
• Refresher Courses: Periodic training to ensure employees stay up-to-date with industry standards, internal process changes, and best practices.

Training should be tailored to address the root cause of the nonconformity. For example, if a lack of knowledge about proper product inspections caused the issue, targeted training on inspection procedures would be needed.

c. Updating Documentation or Control Systems to Ensure Better Process Consistency

Inadequate or outdated documentation and control systems often contribute to nonconformities. Ensuring that all processes, controls, and standards are properly documented is essential for preventing recurring issues.

Examples of documentation-related corrective actions include:

• Updating Work Instructions or SOPs: Revising internal manuals, guidelines, and checklists to reflect changes in procedures, quality standards, or legal requirements.
• Enhancing Control Systems: Implementing better control systems for tracking inventory, monitoring quality metrics, and capturing data on production processes. This may involve digital tools or software to improve real-time visibility and traceability.
• Strengthening Record Keeping: Ensuring all actions, decisions, and inspections are properly recorded and stored, making it easier to trace the history of the nonconformity and prevent recurrence.
• Improving Document Control: Implementing a more stringent document approval and review system to ensure that the most up-to-date procedures are followed and easily accessible.

d. Modifying or Replacing Equipment

In some cases, nonconformities may arise from faulty or inadequate equipment. If malfunctioning tools, machines, or technology contributed to the issue, corrective actions must address these equipment-related problems.

Steps to take might include:

• Routine Calibration and Maintenance: Implementing or enhancing maintenance schedules to ensure equipment is regularly checked, calibrated, and maintained for optimal performance.
• Upgrading or Replacing Equipment: If a particular tool or machine is consistently causing issues or is outdated, it may need to be replaced with more reliable or efficient alternatives.
• Employee Training on Equipment Use: Ensuring employees are properly trained on how to operate and maintain equipment, reducing the chances of human error leading to defects.
• Conducting Equipment Audits: Performing periodic audits of equipment performance to identify potential issues before they lead to non-conformities.

4.Verify Effectiveness

After implementing corrective actions, it’s essential to monitor their effectiveness. Verification methods can include audits, inspections, and analysis of performance metrics. If the corrective actions don’t resolve the problem, further adjustments may be necessary.

Ensure effective corrective actions with BPRHub’s Audit Hub feature to streamline audits and track performance metrics.

5.Update Risks and Opportunities

ISO 9001:2015 emphasizes that corrective actions should be assessed against risks and opportunities. This ensures that organizations consider potential future issues and adjust their strategies accordingly. Any changes made should be documented and communicated across relevant teams.

6.Prevent Recurrence

Finally, systems, policies, and procedures should be modified to prevent future nonconformities. This may include revising processes, improving training, or introducing new quality controls.

Let’s analyze how incorporating software like BPRHub can effectively address ISO 9001 nonconformities.

Overcoming ISO 9001 Nonconformities is a Breeze with BPR Hub

Implementing corrective actions for ISO 9001 nonconformities can be challenging. The process requires thorough root cause analysis, timely intervention, and ongoing monitoring to ensure compliance. This can overwhelm teams, especially when compliance must be maintained across complex operations.

BPRHub simplifies this by providing a Standard Hub that streamlines corrective action implementation. With real-time compliance checking and automated updates, BPRHub ensures continuous monitoring, notifying manufacturers of any nonconformities as they occur. This allows manufacturers to stay proactive, reduce manual effort, and maintain compliance effortlessly, ultimately enhancing operational efficiency.

With real-time compliance checks and automated updates of BPRHUb, stay ahead of ISO 9001 nonconformities.

FAQ’s

1.What are the causes of ISO 9001 nonconformity?

Ans: Common causes include ineffective risk management, inadequate process monitoring, failure to identify interested parties, poor documentation practices, use of inaccurate measuring tools, and failure to implement corrective actions.

2.What is a major non-conformity for ISO 9001?

Ans: A major nonconformity significantly impacts the entire quality management system, such as poor process controls or inadequate leadership commitment, and could prevent an organization from achieving ISO 9001 certification.

3.How can BPRHub help address ISO 9001 nonconformities?

Ans: BPRHub streamlines corrective actions and ensures continuous monitoring with real-time compliance checks and automated updates, helping businesses manage and resolve nonconformities efficiently.

4.How do corrective actions prevent ISO 9001 nonconformities from recurring?

Ans: Corrective actions address the root causes of nonconformities by revising processes, improving training, and updating systems, ensuring that similar issues do not arise in the future.

5.What are the main benefits of addressing ISO 9001 nonconformities promptly?

Ans: Promptly addressing nonconformities minimizes operational disruptions, reduces the risk of legal penalties, preserves customer trust, and prevents costly rework or product rejections.