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

What is Nonconformance?

A nonconformance in a quality management context means a failure to meet defined requirements in a product, service, process, or system. It signals that standard operating procedures (SOPs) are either not being followed or may need revision. Nonconformance (NC) is also an ISO 9000 audit designation indicating that the quality management system, or part of it, does not comply with ISO 9000 requirements, highlighting areas where corrective actions may be necessary to restore compliance and quality.

These deviations are often uncovered through internal or external audits, customer complaints, material inspections, or routine testing. When a deviation is detected, a non-conformance report (NCR) is created to document the issue clearly and concisely, enabling management to take corrective action. Although ISO 9001:2015 no longer mandates a written procedure, organizations must still keep records of each nonconformity and the steps taken to address it.

Nonconformance can lead to rework, recalls, and reduced productivity. Corrective actions tackle problems after they occur, while preventive actions aim to stop them from happening—or from recurring—in the first place.

A nonconformance procedure provides a structured method to identify, analyze, and resolve issues. It includes root-cause analysis, implementation of corrective measures, and post-action review to verify effectiveness. An effective non conformance management process drives continuous improvement and ensures regulatory compliance.

This process is especially critical in industries such as manufacturing, healthcare, pharmaceuticals, and aerospace, where precision and strict adherence to standards are non-negotiable.

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. nonconformances 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.