Are you wondering how to implement non-conformity management within your company to maintain impeccable quality of your products and services?
Then you’re in the right place — AirProcess will guide you!
In this article, we will explore non-conformity management in detail following a five-step guide:
- Detection and identification of non-conformities.
- Handling of non-conformities.
- Analysis of possible causes.
- Implementation of corrective actions.
- Follow-up of actions and continuous improvement.
By the end of your reading, you will be able to:
- Identify and handle non-conformities effectively.
- Implement sustainable corrective actions.
- Integrate NC management into a process of continuous improvement.
Without further ado, let’s start with a definition!
1) What is a non-conformity (NC) in a process?
A non-conformity (NC) is a deviation from a standard, a specification, or a predefined expectation in the management of business or service processes.
This deviation can concern product quality, regulatory compliance, or internal procedures.
2) Why address a non-conformity?
a) Impact on customer satisfaction
Addressing a non-conformity is an essential step to maintain and improve customer satisfaction.
Indeed, when products or services provided do not meet the customers’ expectations or specifications, this can lead to complaints and product returns.
For example, an electronics component manufacturer that discovers a non-conformity in a batch can avoid massive complaints by identifying and fixing the issue before shipment.
Thus, if this company handles non-conformities quickly and effectively, it ensures that its customers receive compliant, high-quality products, which naturally increases their satisfaction and loyalty.
b) Reducing costs related to complaints and incidents
Proactive management of non-conformities significantly reduces costs associated with complaints and incidents.
When non-conformities are detected and corrected upstream, correction costs are generally much lower than those incurred by product recalls or compensations.
For example, in the automotive industry, detecting a non-conformity in a part before final assembly can avoid extremely high recall costs.
Moreover, effective non-conformity management minimizes production downtime.
c) Compliance with ISO standards and other frameworks
Compliance with ISO standards, such as ISO 9001, is important if you want to obtain and maintain their quality certifications.
For example, ISO 9001 requires that you establish processes to identify, document, and handle your non-conformities.
By meeting these requirements, you not only comply with international standards, but you also improve your quality management system.
This includes rigorous documentation of deviations, implementation of corrective and preventive actions, and conducting regular internal process audits.
For example, an ISO 9001 certified company that effectively handles its non-conformities is better prepared for external audits, which strengthens its credibility and market position.
3) The different types of non-conformities you will encounter
a) Minor non-conformity
A minor NC is a deviation that does not significantly affect the product or service quality.
For example, a slight color variation in a batch of textiles may be considered a minor non-conformity.
This type of non-conformity can often be corrected quickly with small adjustments without requiring major changes to the production process.
Therefore, corrective actions for minor non-conformities may include immediate adjustments to production parameters or a simple revision of quality control procedures.
Example of a minor non-conformity and its handling
Imagine an electronics component manufacturer discovers that some microchips show slight voltage variations that do not meet exact specifications but do not compromise product functionality.
To handle this minor non-conformity, the company could adjust the production machine parameters, enforce more rigorous quality control for future batches, and document the issue and its resolution to prevent recurrence.
b) Major non-conformity
A major non-conformity is a deviation that has a significant impact on the quality, safety, or regulatory compliance of a product or service.
For example, an automotive part with incorrect dimensions that could compromise vehicle safety is a major non-conformity.
Major non-conformities require more substantial and often costly corrective actions, such as product recalls, process modifications, or a complete overhaul of manufacturing procedures.
Example of a major non-conformity and its handling
In the pharmaceutical industry, discovering batches of medication containing incorrect amounts of active ingredients constitutes a major non-conformity.
To address this issue, the company must immediately stop production, initiate a recall of affected batches, and conduct a thorough investigation to identify the root cause.
Corrective actions may include updating formulation procedures, providing additional staff training, and installing new quality control equipment.
c) Why is it important to document every non-conformity?
Documenting every non-conformity is a best practice for three reasons.
1️⃣ First, documentation ensures complete traceability of problems encountered and the corrective actions implemented.
This documentation can also be used for internal and external audits, such as ISO certifications like ISO 9001.
2️⃣ Second, rigorous documentation helps identify trends and recurring weaknesses in the production process, which facilitates continuous improvement processes.
3️⃣ Finally, it ensures that all stakeholders are informed of the problems and the solutions adopted, improving communication and cooperation within the organization.
For example, a company that systematically documents its non-conformities can analyze the data to detect recurring patterns and implement more effective preventive measures.
4) How to prevent non-conformities in your company?
a) Prevention strategy
Prevention involves putting proactive strategies in place aimed at avoiding deviations in processes before they occur.
To do this, one of the first steps is to establish clear and detailed procedures for each production or service process.
If you use quality manuals and control checklists, you can standardize your operations and thus reduce deviations between your specifications and the results obtained.
Additionally, continuously training your employees on quality best practices and specific product requirements can be a real competitive advantage.
Thus, if you are in a mechanical parts manufacturing industry, you must train your operators on measurement techniques and quality control to ensure each part meets the specifications.
b) The importance of internal audits and preventive actions
Internal audit is one of the pillars of preventing non-conformities.
This means that if you conduct regular audits, you can identify weak points and potential deviations before they become major problems.
For example, an internal audit in a food production plant could reveal raw material handling practices that do not meet food safety standards, allowing corrective measures to be taken before products are shipped.
Preventive actions, such as risk analysis and the implementation of preventive controls, are also essential.
Using tools like the Pareto chart or Failure Mode and Effects Analysis (FMEA) helps prioritize risks and implement targeted actions to mitigate them.
5) Your 5-step action plan for managing non-conformities
a) Step 1: detection and identification of the NC
1) Methods for detecting non-conformities
Non-conformities can be detected in different ways:
1️⃣ Internally: through regular quality controls at each production phase, from design to order preparation, or via periodic product and process audits.
Also, if the company can identify an anomaly itself, this demonstrates the effectiveness of its quality control system.
2️⃣ Externally: through negative feedback or customer complaints.
In this case, detection occurs when the product is already in the customer’s hands, which can harm the company’s image.
This indicates that the quality procedure must be revised to reduce the non-conformity rate.
2) Causes of non-conformities
They can occur and are often due to various factors:
Human factors.
1️⃣ Communication issues or misunderstandings: you receive a special customer order.
Due to poor communication between the sales department and the production workshop, the exact specifications of the order are not clearly transmitted, resulting in a non-conforming product that does not meet the customer’s expectations.
2️⃣ Insufficient training: in a food production plant, a new employee who is poorly trained in food safety procedures does not correctly follow equipment sterilization steps.
This can lead to product contamination, which constitutes a major non-conformity.
3️⃣ Errors in task execution: on an automotive production line, an operator does not correctly install an engine part due to excessive fatigue or inattention.
This error can compromise the vehicle’s safety and performance.
4️⃣ Non-compliance with legal requirements: you are a toy manufacturer and do not meet safety standards imposed by legislation in force, such as the use of non-toxic materials.
As a result, the toys produced contain substances dangerous to children, leading to product recalls and legal sanctions.
Organizational factors.
1️⃣ Introduction of a new product: you introduce a new product to the market.
However, due to a lack of coordination between design and production teams, some specifications are not correctly implemented, causing defects in the first production batches.
2️⃣ Staff turnover: personnel changes occur in your company.
A new employee, still in training, does not fully master internal procedures, which leads to errors in the final assembly of products.
3️⃣ Failure of an external supplier: you rely on an external supplier for basic components.
Due to a failure by this supplier, the components delivered do not meet the required quality standards, resulting in non-conformities in the finished products.
b) Step 2: handling the NC
Once an NC has been identified, you must handle it.
You must then make the right decision depending on the situation by asking yourself: does this NC require corrective actions or preventive measures?
1) Corrective and preventive actions
The Corrective and Preventive Actions (CAPA) aim to improve the organization’s processes and protocols by eliminating non-conformities.
2) CAPA processes
The CAPA process includes several steps that must be executed effectively.
Thus, every action taken is documented rigorously in a repository to promote continuous quality improvement.
Important: Compliance with ISO 9001:2015 requirements is essential for the proper execution of CAPA.
3) You must react quickly
When a non-conformity is detected, you must react and proceed in two steps:
- Contain the problem: reduce risks, for example by alerting the customer, immediately isolating the defective product, or adjusting the ongoing process.
- Take immediate corrective actions: plan and execute the necessary steps to restore process or product conformity.
4) Practical case
Isolation and inspection of products: you identify a batch of products showing manufacturing defects.
These products are immediately removed from the production line, labeled “Defective”, and moved to a special inspection area.
The quality control team performs a detailed analysis to determine the cause of the defect. If the problem is isolated to this batch, the products are either repaired or disposed of depending on the defect’s severity.
Revision of production processes: following the discovery of a non-conformity in a product series, you implement a complete review of the production process.
Production steps are reassessed, and adjustments are made to prevent recurrence of the error.
For example, you might modify machine parameters or introduce additional control points to ensure future conformity.
Product recall and communication: if a non-conformity is discovered after products have been shipped, you immediately launch a product recall.
All affected customers are informed by email and phone, and clear instructions are provided for returning defective products.
At the same time, an investigation is conducted to determine the origin of the problem and corrective actions are put in place to prevent recurrence.
Staff training: if the non-conformity is linked to a human error, you organize a training session for the personnel concerned.
The training content focuses on correct procedures, standards of quality, and best practices.
For example, in a manufacturing plant, operators receive training on the correct use of equipment and the importance of regular checks.
Improvement of safety protocols: after detecting a non-conformity related to insufficient safety procedures, you implement new safety protocols.
This may include updating work instructions, installing new safety equipment, and conducting regular safety audits to ensure all measures are followed.
c) Step 3: analysis of possible causes
1) Identifying the root cause
To analyze the causes of a non-conformity, you must answer the question: “What caused this non-conformity?”
This step is key to preventing recurrence of problems.
Indeed, without precise identification of causes, it is impossible to implement lasting solutions.
Cause analysis must be factual and detailed, covering all aspects of the non-conformity.
2) Cross-functional collaboration
The relevant department, in collaboration with the quality and safety manager, must identify and evaluate the causes of the non-conformity.
A detailed report should be written to document these causes.
3) Non-conformity report
The non-conformity report, or non-conformity form, is a key document to deepen the problem handling.
This report must describe the anomaly clearly and concisely, specifying:
- The nature of the non-conformity.
- The people involved in the anomaly.
- The process step where the anomaly occurred.
- The time and place of the incident.
d) Step 4: implementation of corrective actions
1) Implementing corrective actions
Once the cause is identified, it’s time to implement corrective actions that will have a long-term impact.
As with immediate corrective actions, it is necessary to:
- Assign specific responsibilities to each actor.
- Define action deadlines.
- Use methodologies appropriate to the situation.
- Document demonstrable evidence.
2) Importance of documentation
Documenting each non-conformity and the actions taken is essential to:
- Maintain complete traceability of problems and solutions.
- Identify recurring trends and weak points in the production process.
- Inform all stakeholders, thereby improving communication and cooperation within the organization.
e) Step 5: follow-up of actions and continuous improvement
1) Evaluating the effectiveness of actions
Once the corrective actions are in place, monitor their effectiveness.
This follow-up consists of verifying whether the measures taken have truly resolved the non-conformity and prevented its recurrence.
For this, a thorough follow-up of the entire production chain must be organized.
Each process step is reviewed in collaboration with all stakeholders to ensure the non-conformity does not reoccur.
2) Using dashboards for monitoring
Dashboards are tools that enable monitoring of corrective actions and continuous improvement.
They allow visualization and analysis of data related to non-conformities, corrective actions, and process performance.
By using a dashboard, you can track key performance indicators (KPIs) in real time, such as the NC rate, processing time, and the effectiveness of corrective actions.
For example, a dashboard could show a progressive decrease in NCs after implementing new quality control procedures, thus confirming the effectiveness of the actions taken.
These dashboards also facilitate communication within the organization by providing clear and precise information to all stakeholders.
They help identify trends and weak points, allowing preventive measures to be taken to avoid future NCs.
6) Implementing corrective actions
To implement effective corrective actions, start with an in-depth analysis of the root causes of NCs.
This step will allow you to identify the true reasons behind the deviations, so you can develop sustainable solutions.
Using methods like the 5 Whys, the Ishikawa diagram, or Failure Mode and Effects Analysis (FMEA) can be particularly useful.
For example, if a non-conformity occurs regularly in a manufacturing process, root cause analysis may reveal that the source of the problem is a poorly calibrated machine or inadequate maintenance procedures.
a) Which methods to use to plan corrective actions?
Now that the root causes are identified, planning corrective actions should be structured and methodical.
The SMART method (Specific, Measurable, Achievable, Relevant, Time-bound) is often used to define clear and feasible corrective actions.
For example, if the analysis showed that staff training is insufficient, a SMART corrective action could be: “Organize a two-day training on quality procedures for all production operators by the end of the month.”
Each corrective action must be documented with assigned responsibilities, precise deadlines, and performance indicators to measure effectiveness.
b) How to monitor the effectiveness of implemented corrective actions?
Monitoring the effectiveness of corrective actions ensures that the measures put in place actually resolve the non-conformities.
This can be achieved using monitoring dashboards and key performance indicators (KPIs).
7) Continuous improvement and audits
a) How to integrate non-conformity management into continuous improvement?
To integrate non-conformity management into a process of continuous improvement, you must view non-conformities as opportunities for refinement rather than failures.
Root cause analysis of each identified non-conformity enables the implementation of effective corrective actions and prevents recurrence.
For example, in a food production company, a non-conformity related to contamination can lead to revising and improving equipment cleaning procedures.
Therefore, by systematically documenting and analyzing each non-conformity, you can identify recurring trends and adjust your processes accordingly, thereby fostering continuous improvement.
b) What are the benefits of regular internal audits?
Regular internal audits offer several advantages for an organization.
They allow detection of deviations and non-conformities before they become major problems.
For example, an internal audit in a mechanical parts production plant could reveal gaps in machine maintenance, enabling preventive measures before production defects appear.
Internal audits also strengthen the quality culture within the company, encouraging rigor and adherence to procedures.
They prepare the organization for external audits and reinforce customer and stakeholder confidence in the reliability and quality of products or services provided.
c) How to prepare your company for ISO certification audits?
Preparing a company for ISO certification audits involves several key steps.
First, ensure that all processes are documented and compliant with the requirements of the applicable ISO standard, such as ISO 9001.
Next, it is recommended to carry out regular internal audits to identify and correct potential NCs.
Adequate employee training on the requirements of the standard and internal procedures is also necessary.
For example, before an ISO 9001 audit, the company can organize training sessions for employees on the importance of documentation and corrective actions.
Finally, it is useful to conduct pre-audits to simulate official audit conditions and identify areas needing further improvement.
8) Why should you digitalize non-conformity management?
a) Advantages of digitalizing NC management
Digitalizing non-conformity management brings many benefits, notably in terms of traceability, performance, and error reduction.
By digitizing these processes, it becomes possible to track each non-conformity precisely and in real time.
For example, using a management software centralizes all information related to non-conformities, making data access and analysis easier.
Furthermore, digitalization automates many repetitive tasks, which reduces the risk of human error.
This translates into shorter processing times and better responsiveness to issues.
b) Using management software
Software like AirProcess plays a major role in managing non-conformities.
They offer specific features to document, track, and analyze non-conformities in a structured way.
AirProcess, for example, allows recording each incident, assigning responsibilities, setting deadlines, and tracking the progress of corrective actions.
With an intuitive interface and advanced reporting tools, it facilitates data visualization and decision-making based on accurate information.
c) Integration steps into the quality management system
Integrating AirProcess into the quality management system involves several steps.
First, you must train teams to use the software.
Next, configure the software according to the company’s specific needs, using a workflow engine to define workflows and tracking criteria.
Finally, it is recommended to perform internal audits to verify proper tool usage and its effectiveness in managing non-conformities.
9) How to use AirProcess to manage and trace non-conformities
a) Key features of AirProcess
1) Adopt flexible forms
AirProcess allows creating customized forms for data entry.
For example, fields such as text, date, multiple selection, and attached files facilitate collecting detailed information.
2) Benefit from customizable workflows
You can define tailored workflows for each stage, including detection, root cause analysis, implementation of corrective actions, and follow-up.
For example, a workflow could start with entering a non-conformity, followed by an evaluation by the quality manager, then a corrective action assigned to a specific team.
3) Take advantage of views and dashboards
AirProcess enables creating customized views and real-time dashboards.
You can visualize key performance indicators (KPIs) such as the non-conformity rate, processing time, and the effectiveness of corrective actions.
b) Integration steps into the quality management system
1) Analyze your needs
Assess your company’s specific management needs and define AirProcess functional requirements.
2) Configure your forms and workflows
Create forms adapted to the different types of non-conformities encountered.
Define workflows by specifying steps, actors, and possible decisions.
3) Set up your dashboards
Configure dashboards to monitor non-conformities and corrective actions.
Ensure data is updated in real time and accessible to relevant stakeholders.
4) Train and raise awareness among stakeholders
Train employees to use AirProcess and raise their awareness of the importance of managing non-conformities.
Organize training sessions on internal procedures and ISO requirements.
10) Conclusion
In conclusion, NC management is a pillar of quality management.
It not only ensures customer satisfaction by guaranteeing product and service conformity, but also reduces costs associated with complaints and incidents.
Compliance with ISO standards and other frameworks strengthens the company’s credibility on the market, while rigorous documentation of non-conformities and corrective actions contributes to continuous process improvement.
Proactive non-conformity management, supported by regular internal audits and the integration of preventive strategies, is crucial for any organization aiming for operational excellence.
By considering each non-conformity as an opportunity for improvement, companies can not only correct current problems but also prevent their recurrence, thereby strengthening their quality management system.
Have you ever identified a non-conformity in your company that allowed you to turn a potential failure into an improvement opportunity?
FAQ
1) How can artificial intelligence help manage non-conformities?
Artificial intelligence (AI) plays a key role in NC management by automating anomaly detection and analyzing root causes.
It can quickly identify anomalies in production processes from large volumes of data, thus reducing reaction time and human errors.
AI also facilitates predicting non-conformities using machine learning algorithms, enabling anticipation of problems before they occur.
Finally, it optimizes implementation and monitoring of corrective actions by providing real-time analyses and interactive dashboards, thereby improving the efficiency of quality management processes.
2) What are the long-term benefits of rigorous non-conformity management?
The long-term benefits of rigorous management are numerous and significant.
First, it improves customer satisfaction by ensuring products and services meet expectations and standards.
This leads to customer loyalty and an enhanced company reputation.
Next, proactive management reduces costs related to complaints and incidents, minimizing financial losses and production disruptions.
Finally, it facilitates compliance with ISO standards and other quality frameworks through precise documentation and appropriate corrective actions, strengthening the company’s credibility and market position.
3) What are the financial impacts of effective non-conformity management?
The financial impacts of effective management are multiple and significant.
First, by detecting and correcting deviations quickly, companies reduce costs related to product recalls and customer complaints.
Second, rigorous management minimizes production downtime, which optimizes operational efficiency.
Finally, compliance with ISO standards and other frameworks, thanks to accurate documentation and appropriate corrective actions, helps maintain quality certifications, thereby reinforcing the company’s credibility and competitiveness in the market.