The standard requires the supplier to provide for the disposition of nonconforming product and for notification to the functions concerned. Disposition means to dispose of or decide what to do with the nonconforming item, whether to use it, repair it, scrap it, etc. The disposition of nonconforming product refers to the decision-making process and actions taken by an organization when dealing with products or materials that do not meet specified requirements or quality standards. Disposition involves determining what to do with the nonconforming items to ensure they are appropriately handled and do not compromise the organization’s commitment to producing high-quality products or services. By providing for the disposition of product you need to determine the action to take and notify those who are to carry it out. You cannot merely accumulate nonconforming items in a quarantine area. Apart from anything else they occupy valuable space and could present a hazard as they deteriorate. To implement this requirement you will need a form or other such document in which to record the decision and to assign the responsibility for the remedial action. The disposition process typically involves several options for managing nonconforming products, and the appropriate action depends on the severity of the nonconformity, the potential impact on product safety or performance, and any applicable regulatory or customer requirements. Here are some common disposition options:
- Scrap or Reject: Nonconforming products that cannot be salvaged or repaired are usually scrapped or rejected. This means the items are removed from further processing or distribution to prevent them from reaching the customer.
- Rework or Repair: For nonconforming products with minor issues or defects that can be corrected, rework or repair may be a suitable disposition. The organization will perform necessary corrective actions to bring the product into compliance with the required standards.
- Use as Is with Customer Concession: In some cases, nonconforming products may still be usable or safe with certain deviations from the requirements. If the customer agrees, a concession is obtained, allowing the product to be used as is with specific conditions.
- Return to Supplier: If the nonconformity is due to supplier-related issues, the organization may return the nonconforming products to the supplier for resolution or replacement.
- Segregation or Quarantine: Nonconforming products may be placed in a segregated or quarantined area to prevent accidental use or distribution until a disposition decision is made.
- Analysis and Investigation: For significant or recurring nonconformities, the organization may conduct a thorough analysis and investigation to identify root causes and implement corrective and preventive actions.
The disposition process is a critical part of the organization’s quality management system. It ensures that nonconforming products are managed appropriately, preventing the delivery of defective items to customers and protecting the organization’s reputation for delivering quality products or services. The process often involves collaboration among different departments, such as quality assurance, production, and supply chain, to make well-informed decisions and take appropriate actions.
Clause 8.7.1.1 Nonconforming product disposition
The organization are to have a documented process for disposition of nonconforming product not subject to rework or repair. For product not meeting requirements, the organization must verify that the product to be scrapped is rendered unusable prior to disposal. The organization are not divert nonconforming product to service or other use without prior customer approval.
When nonconforming products are not suitable for rework or repair, it is essential for the organization to have a documented process for their disposition. This documented process outlines the steps, responsibilities, and actions to be taken when dealing with nonconforming products that cannot be brought into compliance with the required standards. Here are the key elements that should be included in the documented process for the disposition of nonconforming product not subject to rework or repair:
- Identification and Segregation: The process should outline how nonconforming products are identified, and the steps to segregate them from conforming products. Proper identification and segregation prevent accidental use or distribution of nonconforming items.
- Assessment and Classification: The process should specify the criteria for assessing the severity and impact of nonconformities. This assessment helps in classifying nonconforming products into different categories based on their significance.
- Disposal Methods: The documented process should list the available methods for disposing of nonconforming products that are not subject to rework or repair. Common disposal methods include scrapping, destruction, or returning the items to the supplier.
- Decision-Making Authority: The process should clearly define the roles and responsibilities of individuals or teams involved in making disposition decisions. This ensures accountability and consistency in the decision-making process.
- Customer Communication: If the nonconforming products affect customer requirements, the process should outline how the organization communicates with the customer about the disposition decisions and any potential impacts on their operations.
- Documentation and Records: The process should require the proper documentation of disposition decisions, including the rationale behind the chosen method. Maintaining accurate records is essential for traceability and auditing purposes.
- Escalation Procedures: The process should include escalation procedures for exceptional cases or situations where nonconforming products have significant consequences. This ensures that critical decisions receive appropriate attention and consideration.
- Continuous Improvement: The documented process should also include a mechanism for continuous improvement. This involves analyzing the disposition data and feedback to identify opportunities for enhancing the nonconforming product management process.
Having a well-documented process for the disposition of nonconforming products not subject to rework or repair ensures that these items are handled in a systematic and controlled manner. It helps the organization prevent the unintended use of nonconforming products, protect customer satisfaction, and maintain compliance with quality standards and regulations. Additionally, the process supports the organization’s commitment to delivering high-quality products and services to its customers.
Defining disposition responsibility
The organization are to define the responsibility for review and authority for the disposition of nonconforming product. The decision on product acceptance is a relatively simple one because there is a specification against which to judge conformance. When product is found to be nonconforming there are three decisions you need to make based on the following questions:
- Can the product be made to conform?
- If the product cannot be made to conform, is it fit for use?
- If the product is not fit for use, can it be made fit for use?
The authority for making these decisions will vary depending on the answer to the first question. If, regardless of the severity of the nonconformity, the product can be made to conform simply by rework or completing operations, these decisions can be taken by operators or inspectors, providing rework is economical. Decisions on scrap, rework, and completion would be made by the fund-providing authority rather than the design authority. If the product cannot be made to conform by using existing specifications, decisions requiring a change or a waiver of a specification should be made by the authority responsible for drawing up or selecting the specification. It may be sensible to engage investigators or quality engineers to review the options to be considered and propose remedial actions for the authorities to consider. In your procedures or the quality plan you should identify the various bodies that need to be consulted for each type of specification. Departures from customer requirements will require customer approval; departures from design requirements will require design approval; departures from process requirements will require process engineering approval, etc. The key lies in identifying who devised or selected the requirement in the first place. All specifications are but a substitute for knowledge of fitness for use-any departure from such specification must be referred back to the specification authors for a judgement.
Scrapping of Non conforming products
Ensuring that nonconforming products are rendered unusable before disposal is an essential practice in quality management. Properly scrapping and rendering nonconforming products unusable prevent any unintentional use or distribution, which could lead to potential safety hazards, customer dissatisfaction, or regulatory non-compliance.By rendering nonconforming products unusable, the organization eliminates the risk of these items mistakenly finding their way back into the production or distribution process, where they could cause issues or compromise product quality. Disposing of nonconforming products properly ensures that customers receive only products that meet the required quality standards. This helps maintain customer satisfaction and confidence in the organization’s products. In certain industries, there may be specific regulations regarding the disposal of nonconforming products. Ensuring proper disposal practices helps the organization comply with applicable regulations. In cases where nonconforming products contain proprietary or sensitive information, proper disposal ensures that such information is not accessible to unauthorized parties. Proper disposal practices may involve recycling or environmentally responsible methods, which contribute to the organization’s commitment to sustainability and environmental stewardship.
To ensure that nonconforming products are made unusable before disposal, the organization should consider implementing the following measures. Physically destroy the nonconforming products to render them unusable. This could involve cutting, crushing, shredding, or other methods that irreversibly alter the product’s form. Clearly mark or tag the nonconforming products as “Scrap” or “Unusable” to prevent accidental use. Store the nonconforming products in a secure area designated for scrap materials until they can be disposed of properly. Maintain records or documentation to verify that the nonconforming products have been made unusable before disposal. This documentation serves as evidence of proper handling and disposal practices.By following these practices, the organization can demonstrate its commitment to responsible product management and reinforce its dedication to quality, safety, and environmental responsibility.
Customer approval to divert nonconforming product to service or other use
The organization should not divert nonconforming products to service or any other use without prior customer approval. Nonconforming products are those that do not meet specified requirements or quality standards, and their use may pose risks to customer satisfaction, safety, and compliance. Prior customer approval ensures that the customer is fully aware of any nonconforming products that may be used in service or other applications. This allows the customer to make informed decisions based on their own risk assessments and requirements. Many customer agreements or contracts specify that only conforming products meeting the specified requirements should be used. Diverting nonconforming products without approval may breach contractual obligations. Nonconforming products may not perform as expected or meet safety standards. Using them in service or other applications without approval could lead to failures, accidents, or subpar performance. In some industries, there may be legal or regulatory requirements governing the use of nonconforming products. Diverting them without approval may lead to non-compliance with relevant regulations. Using nonconforming products without approval can damage the organization’s reputation and erode customer trust in their ability to deliver high-quality products or services.
To ensure proper handling of nonconforming products, the organization should follow these best practices:
- Segregation: Properly segregate nonconforming products from conforming ones to prevent accidental use or mixing.
- Disposition Process: Establish a documented process for the disposition of nonconforming products, including obtaining customer approval when necessary.
- Customer Communication: Clearly communicate with the customer about any identified nonconformities and seek their approval for concession or deviation if required.
- Rework and Repair: For nonconforming products that can be reworked or repaired to meet specifications, implement appropriate corrective actions and seek customer approval if needed.
- Proper Disposal: For nonconforming products that cannot be reworked or repaired, ensure proper disposal according to environmental regulations and organizational policies.
By adhering to these practices, the organization can effectively manage nonconforming products and maintain their commitment to quality, customer satisfaction, and compliance. It also fosters a strong relationship with customers, based on trust and transparency in product handling and decision-making.
