This is a complete guide to understand Major NC, Minor NC and OFI in different type of Audits (Major Nonconformity, Minor Nonconformity, and Opportunity for Improvement).
Usually, we perform audit to identify the problems in our product, process, system, and standards. So that we take corrective and preventive actions to improve them.
Auditors find out the problems in audit and they record those problems in terms of non-conformities in their audit report.
The seriousness of non-conformities depends on which type of non-conformity is?
Many engineers are try to become a auditor or facing audit in your organization. After audit some engineers are responsible to close those NC’s. Then they face challenges while closing those non-conformities.
Therefore, this is important to understand how those non-conformities works in audit and how we can deal with those NC’s.
Then let’s dive in,
What is nonconformity?
The nonconformity means any type of deviation from standards, requirements and procedures within scope of organization.
ISO defines the nonconformity as “non-fulfilment of requirement”.
Every organization are run on certain guidelines, standards, and procedures. When some activities are not according to those requirement and specifications, it indicates that there is a nonconformity.
Now the importance is depend on how critical those activity are.
Therefore, finding out those nonconformity helps to improve your product, process quality. Also ensures that your organization meets government/regulatory compliance and continuous improvement.
Now you may have a question how we can identify those non-conformity.
How to identify those nonconformities?
1. Review Standards and Requirements: Understand QMS standards and certifications, customer requirements, internal documents like procedures and policies, and regulatory compliances.
2. Conduct audit and Inspection: Perform regular internal and external audits. A detailed inspection of our product and process also helps to identify conformities.
3. Performance data: Review and analyze performance data from many sources such as customer feedback, product recall (Warranty and things) process performance data, capability studies. Customer complaint analysis also helps to identify and reduce those nonconformity.
Majority times we deal with nonconformities in terms of audit findings and audit results.
Audit conducted in our organization and those auditor gives us some NC’s. And we need to close those NC’s by fill-out NC closure report. Also there are the NC remark given as Major NC, Minor NC or OFI.
Therefore, we will se now the exact meaning of those NC and why auditor put sometimes Major NC, minor NC and OFI remark.
Types of Nonconformities
Nonconformities are categorized into three types:
- Major NC
- Minor NC
- Opportunities for improvement
Each type has different conditions and requires different approach of resolution.
Major Nonconformity (Major NC)
The Major nonconformity is a deviation in your product, processes, system to non-fulfillment of quality requirement, customer requirement, safety, and regulatory requirements.
This shows that we don’t have system or not effective system to meet customer and regulatory requirement. The consequences could be potentially serious.
Conditions of Major NC’s
- Affecting effectiveness of Quality Management System
- Gap in our processes which could result as non-complianc
- Can be serious for organization including customer complaints, regulatory action or harm to user in terms of safety.
Example of Major NC
In an automotive industry, audit conducted on a assembly line that produces safety critical component like brakes. Now the auditor observed that one of the component dimension not as per specification and safety standard. Those part were sent to the next process and at packaging stage.
Now based on the importance, this deviation directly impacting user safety and risk. Also meet customer requirements. Therefore the auditor gives the Major NC (Non-conformity) on this condition.
How to improve or close Major NC
1. Immediate action: Implement immediate corrective action to fulfill customer requirement and investigate root cause. This includes review procedures, standards and provide training, etc.
2. Root Cause Analysis: Find out root cause of the issue. It can be on both root cause of occurrence and systemic root cause.
3. Corrective action: Develop corrective action plan and implement those actions to avoid reoccurrence of NC.
4. Follow-up: Check effectiveness and sustenance of actions and do the follow-up audit.
Minor Nonconformity (Minor NC)
Minor nonconformity means the non-fulfillment of QMS/standard requirement but does jot leads to product, customer requirement and regulatory failure.
Therefore, it is one of the need for improvement and to avoid big problem due to this small issue.
Minor NC does not have an immediate impact, so it is easy to correct and close.
Conditions of Minor NC’s
- Does not majorly impact on QMS system and product safety or compliance.
- Many times related to procedures and documentation topics rather than system
Example of Minor NC
Auditor performing a audit in organization. He ask to show you the customer complaint register. Now he review the register and select one complaint. Then he ask you to provide so-and-so customer complaint 8D report. Then he check the study and lastely he found that the supporting documents FMEA is not been updated for customer complaint.
In this case the auditor now provide a minor NC as the documented system failed to update the FMEA after customer claim/complaint.
How to improve or close Minor NC
1. Address and correct issue: Take corrective action and resolve the issue/deviation.
2. Review procedures: Review and modify the procedure by updating action to prevent similar issues.
3. Training: Provide training to all responsible team and filled NC closure report. Send back those reports to the auditor and close the NC.
Opportunity for improvement (OFI)
An opportunity for improvement is the auditor suggestions to improve you system and processes. Usually, these suggestions are taken from industry best practices. The purpose of OFI is to increase or improve your product quality and system performance.
Auditors point out the area and give suggestions to improve it.
Example
Inspector uses the vernier caliper to do the inspection of parts 100%. Auditor consider in mind that the tolerance if far more and the characteristics not much affect the functional requirement. He suggest to use a Go-NoGo gauge to improve and accuracy of measurement system.
How to improve
This type of improvement is done through below steps.
- Evaluate the suggestion.
- Do feasibility check.
- Plan Implementation.
- Execute the plan.
- Review and standardize.
What are the differences between Major NC, Minor NC and OFI
Here is a table of differences between major nonconformity, minor nonconformity, and opportunity for improvement:
| Aspect | Major Nonconformity | Minor Nonconformity | Opportunity for Improvement (OFI) |
|---|---|---|---|
| Definition | Not meet requirement affects not effective QMS or regulatory compliance. | Less severe deviation with less impact on QMS effectiveness. | Suggestion for improvement. |
| Impact | Major impact on product quality, safety, or compliance. | Minimum impact on quality or compliance. | No immediate impact, but potential for future improvements. |
| Immediate Action | Immediate corrective actions required. | Corrective actions to address specific discrepancies. | Evaluate and plan improvements; no immediate action required. |
| Root Cause Analysis | Need to identify systemic root cause for issues. | Limited scope of root cause investigation. | Not necessary; focus is on potential improvement. |
| Documentation | Detailed documentation required for corrective actions and root cause analysis. | corrective actions and procedural changes. | Documentation of improvement plans and implementation results. |
| Responsibility | Typically involves senior management and cross functional team. | Often handled by process owners or respective departments. | Can be addressed by various teams; implementation might involve multiple stakeholders. |
Conclusion
Understanding and managing nonconformities is important to maintain a good quality management system. Also they helps to improve product, process and system within organization.
Major nonconformity are impacting customer requirement and compliance issues, while minor nonconformity is non fulfillment of document or system requirement and opportunity for improvement is the suggestion to improve our processes according to industry best practices and methods.
