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Control of Nonconforming Products or Services Procedure Sample


Here's a sample Control of Nonconforming Products or Services Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how nonconforming products or services are identified, evaluated, and managed to prevent their unintended use or delivery.
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Control of Nonconforming Products or Services Procedure

Purpose:

This Control of Nonconforming Products or Services Procedure is established to ensure that non-conforming products or services are identified, evaluated, segregated, and properly managed to prevent their unintended use or delivery. The objective is to maintain the quality of products and services delivered to customers.

Scope:

This procedure applies to all employees and departments within the organization responsible for the production, inspection, and delivery of products or services.

Responsibilities:

1. Employee Responsible for Identification: Any employee who identifies a nonconforming product or service is responsible for reporting it immediately to their supervisor or the Quality Assurance department.
2. Supervisor: Supervisors are responsible for investigating nonconformities, ensuring segregation, and initiating corrective actions.
3. Quality Assurance Department: The Quality Assurance Department is responsible for overseeing the nonconforming product or service process, conducting root cause analysis, and ensuring corrective actions are effective.

Procedure:

1. Identification of Nonconforming Products or Services:

a. Any employee who identifies a nonconforming product or service during production, inspection, testing, or any other stage of the process must immediately cease further processing or delivery of the nonconforming item.
b. The employee completes a Nonconformance Report (NCR) providing details of the nonconformity, including its nature, location, and any relevant information.
c. The NCR is submitted to the supervisor and Quality Assurance department for further investigation.

2. Investigation and Evaluation:

a. The supervisor and Quality Assurance department review the NCR to determine the severity of the nonconformity and its potential impact on quality, safety, or compliance. 
b. They conduct a root cause analysis to identify the underlying reasons for the nonconformity. 
c. Based on the investigation, the supervisor and Quality Assurance department determine whether the nonconformity poses a risk to customers, regulatory compliance, or the organization's quality objectives.

3. Segregation and Control:

a. Nonconforming products or services are segregated from conforming items to prevent accidental use or delivery.
b. Segregated items are clearly marked as nonconforming and placed in designated storage areas.
c. Access to nonconforming items is restricted to authorized personnel only.

4. Corrective Action:

a. If necessary, corrective actions are initiated to address the root causes of nonconformities.
b. Corrective actions are documented, and responsible parties are assigned to implement them.
c. The effectiveness of corrective actions is monitored and verified.

5. Disposition:

a. Once corrective actions have been implemented and verified, the Quality Assurance department determines the disposition of nonconforming items.
b. Nonconforming items may be reworked, repaired, scrapped, or returned to suppliers, depending on the nature of the nonconformity and customer requirements.
c. All actions taken and decisions made regarding nonconforming items are documented for future reference and audit purposes. 

Record Keeping: 

The organization maintains records of all nonconformities, including Nonconformance Reports (NCRs), investigation findings, corrective actions, and disposition decisions. 

Review and Audit: 

This Control of Nonconforming Products or Services Procedure shall be reviewed and audited periodically to ensure its effectiveness and compliance with ISO 9001:2015 requirements.

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Please customize this procedure to align with your organization's specific processes and requirements. Additionally, ensure that you follow any relevant industry-specific regulations or standards that may apply to the control of nonconforming products or services.

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