In manufacturing organizations, when a non-conformance occurs, a quality analyst or dedicated personnel is required to generate a non-conformance report (NCR). Non-conformance arises when a product, process, or service does not adhere to quality and compliance requirements. This blog post will explore the following topics:
What Is a Non-Conformance Report (NCR)?
A non-conformance or non-conformity report (NCR) is a document comprising the details about the product, process, or services that deviated from the quality standards. The report is generated for the non-conformance and documents details such as corrective actions, investigation, and more. Deviations can occur in any area, such as production, operations, or quality control department.
Manufacturers should follow a non-conformance procedure to ensure issues are addressed correctly and deviation is rectified.
Types of Non-Conformance Reports
Manufacturing companies need reports that fit their needs. Non-conformance reports consist of the details in a structured way. These reports need to be specific for a manufacturer with the context of their specific industry requirements, and organizational needs.
Non-conformance reports can be generated based on the impact and severity of non-conformances on a product, process, or service. Commonly, non-conformance levels are classified as minor and major:
1. Minor Non-Conformance
These are the deviations that do not significantly affect the product, process, or services. Minor non conformance report include the deviation from defined standards. Actions to rectify the deviation need to be reasonable and managed and controlled. Example of minor non-conformance – The item has a scratch that will not affect the form, fit, or function.
2. Major Non-Conformance
Major non-conformances are the deviations that disrupt the manufacturing operations. They can relate to safety, performance, or quality. After identifying non-conformance, supervisor should issue major non conformance report. Major non-conformance require an immediate action to rectify the defect as it severly impacts the product, process, or services. Manufacturers might have to make changes to control and manage the deviation. Example of major non-conformance – A medice device fails a voltage test and production needs to be halted. A sheet of steel does not have the right thickness and will not allow for proper bends.
What Does the Non-Conformance Report Include?
Non-conformance reports commonly consist of the information below. However, the NCR reports need to meet the unique needs and requirements of the company. Typical non-conformance (NCR) report consists of the following:
- Details of the key people involved in the non-conformance process
- Date and time of the non-conformance observation
- Reference document or document number
- Lot number and product details
- Priority of the non-conformance
- Details of the affected vendor/customer/department
- Quality control test details (if any)
- The root cause of the non-conformance
- Corrective actions and preventive actions details
- Signature of the person verifying or documenting the non-conformance
Non-Conformance Report NCR Template
Utilize the eWorkplace Apps’ non-conformance report template to record the details related to NC transaction. Gather the data and document the details and build a comprehensive NCR report.
Why Non Conformance Report?
Manufacturers can leverage the non-conforming reports to ensure the product, process, or a service go through proper quality control checks and meet the specifications. If not, actions can be taken at right time to avoid adverse effects of the deviations occured.
1. Ensure Product Quality
Non-conformance reports ensure that the organizations are able to identify the issues at an early stage and take necessary actions at the right time. It helps to maintain quality standards and prevent defective products from being shipped and delivered to customers. NCRs control the deviations to prevent the recurrence of deviations in the future.
2. Root Cause Analysis and Prevention
NCRs allows companies to investigate the root causes of non-conformances. A comprehensive non-conformance report enables organizations to analyze the issue, reason of its occurrence, and implement corrective and preventive measures. Documenting non-conformances allows manufacturing companies to analyze trends and root causes. It leads to corrective actions that enhance overall product, process, and service quality.
3. Mitigate Risks
Non-conformance reports with structured documentation and findings enable companies to ensure that the product, process, or service deviations are addressed correctly. If not addressed, it can lead recalls, legal liabilities, and safety risks. With NCRs, companies can address the deviations promptly and mitigate the risk of deviations from recurrence, and reduce the potential impact on the business.
4. Regulatory Compliance
Industries like food, pharmaceuticals, and aerospace are highly regulated and require strict adherence to compliance and quality standards. Non conformance reports serves as a documented proof of how non-conformances are handled. An organized NCR process demonstrates the companies commitment to comply with quality standards and industry regulations.
5. Improve Process Efficiency
Manufacturers can identify patterns with non-conformance reports and implement strategies. NCRs help to detect inefficient areas in the company and improve the product, process, or service. It allows companies to enhance process efficiency by reducing waste and rework, optimize resources, minimize costs, and streamline workflows.
6. Continuous Improvement
NCRs drive continuous improvement by providing a structured approach for identifying and resolving inefficiencies. Non-conformance reports with valuable insights into deviations or patterns causing deviations enable companies to enhance their overall efficiency over time. It is vital for maintaining product quality and stay compliant making NCRs an integral part of any robust quality management system.
When Non Conformance Report?
The severity and impact of the non-conformance must be analyzed to control the process and issue NCRs. Non Conformance Report should be issued in the cases such as:
- Product, process, or service fails to meet the defined quality standards and compliance requirements.
- Product or process does not meet the safety standards and may raise potential safety or hazard issues.
- Improper documentation that will lead to further deviations and quality issues in the product, process, or service.
- Suppliers or vendors do not meet the required compliance requirements.
- Defective equipment or machine malfunction.
How Can eWorkplace Apps’ Quality Management Help Manufacturers Manage NCRs?
eWorkplace Apps provides a comprehensive Quality Management Suite (QMS) for Acumatica cloud-based ERP to help manufacturers and distributors streamline their quality process. NC CAPA module capability within eWorkplace Apps’ QMS software allows one to document non-conformance details and generate non-conformance reports quickly. It helps to ensure all the non-conformance procedures are followed and documented promptly. Manufacturers can perform quality control tests and document SOPs to ensure the product meet specifications. In case of deviation, the QMS system with NC CAPA enables them to control deviations beyond quality control testing.
Contact us or Acumatica partner to learn more about eWorkplace Apps’ Quality Management Suite.
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