Four Ways to Prevent or Minimize Nonconformance in a Quality First Organization

What is Nonconformance?

Nonconformance (NC) is an ISO 9000 audit designation indicating the quality management system or a portion of it does not meet the requirements established by ISO 9000. Non-conformance is a sign that something went wrong in a service, process, product or in the system itself by not meeting a certain set of specifications.  The existence of a nonconformance implies that some aspects of a company’s standard operating procedures are not being followed or need to be modified or even updated.

These deviations can be identified through internal and external audits, customer complaints, material inspection or routine testing. A non-conformance report is then prepared. The purpose of the report is to document the details of a deviation from expectations. The report helps define the problem in a clear, logical and concise way so that management can take steps to implement changes. ISO 9001:2015 no longer requires a documented procedure, but one must still keep records of the nonconformity and what was done to correct it.

Nonconformance could lead to rework, product recall, and decreased productivity. Corrective actions are reactive – the steps you take once the problem has occurred.  Preventive actions are not only to prevent a particular instance of non-conformance from re-occurring, but also to prevent one from ever occurring.

Here are Four Ways to Prevent or Minimize Nonconformance:

1. Management Review

Management review is akin to getting your car serviced every year even when there are no overt signs of problems. Management reviews are generally conducted once a year and present an opportunity to review the company’s existing quality policy as well as set new objectives for the rest of the year. New objectives can be invaluable for minimizing nonconformance.

Product changes, new requirements, new processes, change management etc. are all reviewed. The management review process can identify and correct any current or incipient deficiencies before they might be revealed by an audit or incident. Routinely reviewing the organization’s process helps spur continuous improvement. A system should be in place for implementing any resulting plans for improvement or corrective action and verifying their effectiveness.

2. Review

A review is usually a ‘senior management’ exercise. Keeping this in mind, it’s important to conduct a similar exercise with the actual employees who are involved in the day-to-day process. These employees have an in-depth understanding of various processes and how they are related. They have vast knowledge about the product and more importantly about past non-conformance issues. They very well could have been first to respond to a crisis and would have played a crucial role in analyzing the situation and solving an issue. On the flip side, this discussion could reveal a knowledge gap crucial to fixing nonconformance. An end-to-end understanding is crucial in setting up new objectives to minimize non-conformance. Also, understanding the process followed by lower-level employees could highlight pain points and provide key insight into potential areas of nonconformance, those which cannot be identified in a management review or audit.

3. Internal Audit

An audit is simply another form of testing i.e. comparing things as they are to how they ought to be. Internal Audits need to be scheduled at regular intervals to check whether the quality system conforms to requirements and to ensure the system’s efficacy. Unlike an external audit, all the processes need not be audited at the same. Internal audits can be conducted as a series of smaller audits, with different processes audited at different times. The frequency of audits can also be set depending on the process in question. With changing internal and external dynamics, the criteria for the audit can be decided prior to the audit rather than the planning stage. Any previous findings, past audit conclusions, and pre-defined questions all become valuable data. Observations raised during internal audits could be classed as preventive actions as they can suggest improvements within the system to prevent non-conformances from occurring in the future.

4. Feedback

While all customer complaints are recorded and must be actioned, customer feedback also plays a role in minimizing non-conformance. Feedback from customers helps to understand potential non-conformance issues and is an opportunity for improvement. Customer suggestions may prevent any issues from being raised in the future. Negative as well as positive feedback is valuable data. Spending time to analyze could help spot trends and patterns. Feedbacks help to dig into the root cause of the issue which may not always be obvious (else it would have been picked up in audit testing). Understanding the root cause can help differentiate a temporary lapse from a process flaw.

No system is perfect, therefore problems with the system i.e. non- conformance will occur.  The aim is to resolve the non-conformance as quickly as possible and prevent any recurrence. Recording non-conformities helps analyze negative trends, examine root causes, and eliminate the cause of the problems. Corrective actions should also include the longer-term actions to ensure the problem will not occur again.

While corrective actions are reactive, preventive actions are pro-active. A preventive action can prevent the occurrence of an issue or stop it from becoming too severe. A preventive mindset helps to reanalyze the product and process, get a different perspective and help improve the system as a whole in a timely manner.

Prevention can also be thought of as risks and opportunities. Identifying the potential source of problems, their effects and the likelihood of occurrence is the first step in risk management. This is followed by analyzing whether the associated costs with reducing the risk are worth it. Mitigating risks and avoiding unnecessary costs are some of the biggest and obvious reasons to minimize non-conformance.

Effectively managing nonconformances and preventive actions is an integral part of an organization’s continuous improvement plan. This should result in fewer defective products and processes and more satisfied customers.

Quality nonconformance systems have compliance, content, and collaboration management initiatives and strategies at their core. A good nonconformance management software should assist everyone, from management to the day-to-day employee, in the common goal of better quality. ComplianceQuest’s salesforce-based EQMS system is designed for easy collaboration. It helps companies across the supply chain with their quality and compliance needs through a highly scalable, multi-tenant, enterprise cloud system.

What is a Non conformance Report?

A Non conformance Report is a formal document that identifies and communicates instances of nonconformance or deviation from established quality requirements. Nonconformances can occur at various stages of a product's lifecycle, from design and manufacturing to post-market activities. The purpose of an NCR is to:

• Identify and document the nonconformance.
• Investigate the root cause of the nonconformance.
• Define CAPA to address the nonconformance.
• Assign responsibilities and establish timelines for resolving the issue.
• Ensure that necessary corrective actions are implemented and verified.
• NCRs are vital for maintaining product quality, safety, and regulatory compliance.

They are commonly used in industries with strict quality standards, such as manufacturing, healthcare, pharmaceuticals, and aerospace.

Who can Issue a Non conformance Report?

The responsibility for issuing an NCR typically falls on individuals or teams involved in quality control, compliance, or auditing. Here are some key roles that can issue NCRs:

• Quality Inspectors: Individuals responsible for inspecting and testing products during manufacturing can identify nonconformances and initiate NCRs.
• Quality Assurance Professionals: Quality assurance teams, often responsible for overall quality management, are authorized to issue NCRs when nonconformances are detected.
• Internal Auditors: Auditors who perform internal audits of processes, systems, or products can issue NCRs based on audit findings.
• Regulatory and Compliance Personnel: Personnel responsible for ensuring compliance with industry standards and regulatory requirements are crucial in issuing NCRs related to compliance issues.
• Customer Representatives: In some cases, customers or end-users of products may identify nonconformances and submit NCRs to the supplier or manufacturer.
• Management and Supervisory Roles: Managers or supervisors who oversee production, quality, or compliance may also be authorized to issue NCRs.

Tips for Writing an Effective Non conformance Report

Writing an effective Non conformance Report is crucial for properly documenting and addressing the issue. Here are some tips for creating an NCR that serves its intended purpose:

• Clear and Detailed Description: Provide a clear and detailed description of the nonconformance. Include relevant information such as the product or process, location, date, and specific deviations from quality standards or requirements.
• Root Cause Analysis: Conduct a thorough investigation to identify the root cause of the nonconformance. Clearly explain why and how the nonconformance occurred.
• Impact Assessment: Assess the potential impact of the nonconformance on product quality, safety, compliance, or customer satisfaction.
• Corrective and Preventive Actions: Specify corrective actions to address the immediate issue and preventive actions to prevent similar nonconformances in the future. Define responsibilities and timelines for implementing these actions.
• Supporting Evidence: Include any relevant documentation, photographs, test results, or other evidence that supports the nonconformance report.
• Regulatory and Standard References: Reference applicable regulations, standards, or quality requirements related to nonconformance. This helps ensure that corrective actions are aligned with regulatory and quality compliance.
• Cross-functional collaboration: Involve relevant stakeholders from different departments or teams, such as quality, engineering, and production, to ensure a holistic assessment of the nonconformance.
• Clarity and Conciseness: Write the NCR clearly and concisely, avoiding unnecessary jargon or technical language. Ensure that the report is easily understandable by those who need to take action.
• Approval and Review: Ensure the NCR is reviewed and approved by appropriate personnel or authorities, such as quality managers or compliance officers, before proceeding with corrective actions.
• Timely Submission: Submit the NCR promptly after the nonconformance is identified. Timeliness is crucial for addressing and resolving the issue effectively.
• Track and Follow-Up: Implement a system for tracking the status of corrective and preventive actions and follow up on their completion to ensure resolution.