Non-conformance is a reality for most businesses–maybe it’s a product that doesn’t meet your standards, or a process that’s missing a critical step. In some industries, the rate of non-conformance can be as high as 10% to 25%, usually because of issues in the process or simple human error. However, these are important to address and resolve. Otherwise, it might affect the safety of your consumers and exposes your business to reputational damage and financial penalties.
This guide will walk you through how to manage non-conformance systematically and reduce its occurrence. You’ll also find out how to write a non-conformance report, which is important for documentation and compliance.
What is non-conformance?
Non-conformance is when a product, process, or service fails to meet established standards or specifications. These standards might come from internal company policies, industry regulations, or customer agreements.
Here are some examples:
- Product: A table manufactured 1 inch shorter than the specified size in the design
- Process: Missing documentation of employee training on quality control
- Service: An IT support technician taking longer than the agreed upon response time
Non-conformances signal a problem that needs to be addressed, and there should be a proper plan in place to handle them. You can see them as an opportunity showing you where you can still improve your processes. With a strong quality management system, it’s very much achievable to drive down the rate of non-conformances and consistently deliver excellent products and services.
Minor vs. major non-conformances
A practical way to categorize non-conformances would be based on their severity and scope:
Minor non-conformance
Minor non-conformance tend to be the most common. On the positive side, they don’t significantly impact the quality, but it’s still important to resolve them so they don’t escalate into larger issues. They’re often small and isolated, such as:
- Typos in documents
- Maintenance form missing a time stamp
- A small scratch on a product that is allowable
The danger is when these add up, since they normalize non-compliant behavior.
Major non-conformance
Major-non conformances are actually serious issues that pose a risk to quality and even safety and compliance. These have widespread implications, and they often point to critical flaws in the organization’s processes or infrastructures. Examples include:
- Incorrect labeling on pharmaceutical products
- Bacterial contamination in processed meat
- Skipped aircraft maintenance procedures
These require immediate attention, as they have more harmful effects for the organization. Usual causes would be lapses in training, insufficient quality checks, or not following important procedures consistently.
Here are some more examples:
How to identify and address non-conformances
Non-conformance management requires a thorough, step-by-step process that aims to get to the heart of the issue:
1. Identify the non-conformance.
First, you’ll need to pinpoint and describe the non-conformance. You might notice non-conformances through routine audits or automated quality control systems, or even customer complaints. To prevent these from going unnoticed, employees should be trained to recognize potential issues, with clear protocols for reporting.
Once a non-conformance is noticed, document the details, such as the date, location, and nature of the issue.
2. Contain the issue.
The next immediate step would be to limit the scope and impact of the non-conformance right away. This way, the problem doesn’t spread to other areas. This might mean:
- Halting production
- Isolating the defective product
- Freezing a service delivery phase
- Restricting access to the affected area
This acts as a short-term safeguard, giving you time to investigate and address the root cause while minimizing further disruptions.
3. Investigate the root cause.
To resolve a non-conformance, it’s essential to figure out why it happened in the first place–addressing the root cause rather than the surface-level symptoms. A defective product might seem like an operator error at first glance, but it turns out it’s actually because of unclear instructions or faulty equipment.
There are already techniques for this, like the simple but effective “5 Whys.” You can also try fishbone diagrams, where you brainstorm possible causes like people, methods, and machines. This also involves getting input from several people, especially those directly involved with the issue, so you can get a comprehensive perspective.
4. Implement corrective actions.
After determining the root cause, you can then implement corrective actions to resolve the issue. The goal here is to restore compliance and make sure the problem doesn’t happen again. This might take the form of:
- Improving processes
- Implementing more rigorous training
- Clarifying or updating documentation
- Setting routine audits and maintenance
- Conducting stricter testing
Teams who are implementing the corrective actions need clear instructions and specific timelines. Here are some considerations to keep in mind:
5. Monitor and verify.
The final step is to track the implementation of actions and review their effectiveness over time to see if they’ve genuinely resolved the issue. Verification conducting follow-up audits, getting employee feedback, or analyzing key performance indicators (KPIs) to assess whether the changes are working.
This isn’t a one-time event but rather an ongoing process. By doing regular audits or inspections, you can confirm that no new issues have come up, closing the loop in managing the non-conformance.
Writing a non-conformance report (NCR)
A non-conformance report (NCR) is mainly used in construction, manufacturing and project management to document work or a product that has not met the required quality standards. However, it is also frequently used in production and transportation.
These reports are part of the quality control process. Quality managers aim to reduce risks by implementing corrective measures. In addition, the non-conformance report helps to prevent similar situations from recurring in the future.
A checklist for the NCR reporting with standardized questions facilitates the work of the responsible person and ensures that all relevant points are observed.
For pre-made NCR checklists that you can easily edit, check out these templates from Lumiform.
Key elements of the non-conformance report
The non-conformance report template is used, as mentioned above, to record any non-compliance or deviation from the plan as it occurred and create a corrective actions request, as well as to prevent similar incidents from recurring. It is also used to define solutions with a customer and to document any corrective changes made.
An efficiently designed checklist for the non-conformance report essentially contains the following key elements, mirroring the process above:
- Detailed observations on nonconformities
- Corrective measures to be taken
- The correction process
- The closure of the case
What requirements should a non-conformance report fulfill?
A NCR report in accordance with a uniform format is mandatory for the documentation of deviations, as these can have a negative impact on the project. A non-conformance report records quantifiable deviations or divergences or quantifiable differences from a baseline or an expected value. These are then examined in a deviation analysis.
For this to be possible, the non-conformance report must therefore provide a complete, accurate and clear record of the divergence. To ensure this, a checklist for the audit report should finally include the following content and scope:
- Indicate the objectives, scope and relevant targets
- Clients, participants, dates and places
- Detected deviations with the corresponding proofs
- Summary list of corrective actions to be taken
- Final evaluation of deviations
Use efficient digital tools for your non-conformance report
If deviations occur, many paper forms are usually passed back and forth between managers and project team members to report them. However, it is difficult to document observations without the possibility of taking photographs.
This process is time-consuming and costly. In addition, many risks remain unresolved and unsupervised over time. The use of a digital inspection application such as Lumiform counteracts such problems.
Every kind of quality and safety inspection is carried out with it simply by tablet or phone – online or offline. The desktop software is used to create checklists and later to evaluate the data collected on site. This significantly reduces the risk of quality losses, industrial accidents, documentation errors and damage to reputation.
The benefits of Lumiform for the non-conformance report at a glance:
- With more than 12,000 ready-made templates, you can immediately start working digitally.
- Non-conformance reports are generated automatically. This saves the complete post-processing.
- The efficiency of internal processes is increased. Through more efficient communication within the team, with third parties and with management, as well as faster reporting of incidents, you can solve incidents up to 4 times faster.
By switching to Lumiform, you’ll not only simplify the non-conformance reporting process but also empower your team to address issues proactively and boost standards for quality and safety. Try it now!