Nonconforming product is defined as product that does not conform to customer requirements, applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work, your own organizational activities or product shipped to customers. Your documented process for nonconforming product must include controls and responsibilities to identify, contain it,(i.e. prevent further processing or use), keep records of the nature and other details of the nonconformity, notify appropriate personnel and customers, where appropriate, evaluate what disposition action needs to be taken, carry out timely disposition, determine policies for release for further processing or shipment to the customer, obtain customer concessions and deviation permits, rework and re-verification, waivers and approvals of supplier materials, etc. Product or material found with no identification or its quality status is not known, must be treated as nonconforming product and controlled by the above procedure. If you find that nonconforming product has been shipped, without a customer concession, notify the customer immediately and use your procedure, to effectively contain and resolve the situation to your customer’s satisfaction. Where required, use the customer prescribed form for recording and controlling nonconforming product. An authorization refers to written permission (number or code) to ship or manufacture nonconforming product. The permission is usually very specific about product, quantity and time frame during which nonconforming product can be shipped. The authorization number or code must identify each container shipped under the authorization. A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions.
In the case of nonconforming products identified during manufacturing, obtaining customer authorization for concession becomes crucial. Customer authorization for concession is required when an organization wishes to proceed with the manufacturing or delivery of nonconforming products with the explicit approval of the customer. This approval allows the organization to deviate from the agreed-upon product specifications, standards, or contractual requirements. Nonconforming products may be identified during the manufacturing process through various quality control measures such as inspections, testing, or process monitoring. The organization must evaluate the nonconforming products to understand the nature and severity of the nonconformity. This evaluation will help determine whether the nonconforming product poses a risk to the product’s performance or safety. If the nonconformity is deemed significant, and the organization believes the product can still be used or delivered with some agreed-upon deviation, they will initiate a concession request. The concession request should include details about the nonconformity, its potential impact on the product, the proposed deviation or actions to address the nonconformity, and the rationale for seeking customer authorization. The organization will contact the customer to explain the situation, the identified nonconformity, and the proposed actions to address it. They will request the customer’s approval for the concession. The customer will evaluate the concession request and consider various factors such as the criticality of the nonconformity, the potential impact on their operations or end-users, and their contractual agreements with the organization. Based on the evaluation, the customer will decide whether to grant authorization for the concession or not. The decision may involve some negotiation or discussions between the organization and the customer to reach an agreement. If the customer approves the concession, the organization should document the customer’s decision, including the agreed-upon deviation or actions. This documentation serves as evidence of the customer’s approval. With the customer’s approval in hand, the organization can proceed with the agreed-upon actions, such as continuing manufacturing, making necessary adjustments, or providing additional testing or validation. It’s essential for organizations to have a well-defined process for managing nonconforming products and seeking customer authorization for concession when needed. This ensures that potential risks are appropriately communicated and addressed, and customer expectations are met, maintaining a strong relationship with the customer and adherence to quality standards.
Clause 8.7.1.1 Customer authorization for concession
The organization are to obtain a customer concession or deviation permit prior to further processing for “use as is” and rework dispositions of nonconforming product whenever the product or manufacturing process is different from that which is currently approved. If sub-components from non conforming products are reused in the manufacturing process, that sub-component reuse are to be clearly communicated to the customer in the concession or deviation permit. The organization are to maintain a record of the expiration date or quantity authorized under concession. The organization also ensures compliance with the original or superseding specifications and requirements when the authorization expires. Material shipped under concession should be properly identified on each shipping container. This requirements also applies to purchased product. The organization must approve any requests from suppliers before submission to the customer.
The organization must have prior written customer authorization whenever the product or process is different from that currently approved. This may seem a very onerous requirement since it stops you changing almost anything without customer approval. In the context of nonconforming product, it applies to any action you take to eliminate the nonconformity other than scrapping and regrading the item, if permitted. Any rework and repair procedure has to be approved in the product approval submission. Obviously to improve performance continuously you must change something, but not the product’s physical and functional characteristics, the key process parameters, or the dimensions and tolerances of the tools and gages used. The requirement also applies to your supplier. Therefore you will need a product approval submission from each of your subcontractors and will need to put in place procedures to regulate deviations from the approved standard. An example where this may be quite common is where specified materials become unobtainable and alternatives need to be selected, or where there is a slight change in the material specification. IATF 16949 allows for such a situation but you must seek prior authorization. It means that before you deviate from approved specifications for production items you must obtain authorization to apply the process. You will need a process for conveying the information to the customer, obtaining approval, and keeping records of the expiration date or quantity authorized. Concessions or waivers are issued only on specific quantities or for a specific duration, therefore cannot be open-ended. You also need a system of identifying the concessed product up to shipment in order that the shipping staff can apply the same identity to the shipping containers.
Customer concession or deviation permits
Obtaining customer concession or deviation permits is critical when dealing with nonconforming products, especially in cases where the product or manufacturing process differs from the approved specifications. This process ensures that any deviations from the agreed-upon requirements are formally communicated, evaluated, and approved by the customer before proceeding with further processing. The goal is to maintain transparency and alignment with customer expectations while addressing nonconformities appropriately.Here are the key steps involved in obtaining customer concession or deviation permits for “use as is” and rework dispositions of nonconforming products:
- Identification of Nonconforming Product: Nonconforming products are identified through various quality control measures during the manufacturing process, such as inspections, testing, or process monitoring.
- Assessment of Nonconformity: The organization evaluates the nonconforming products to understand the nature and severity of the nonconformity, along with potential impacts on the product’s performance or safety.
- Concession or Deviation Request: If the nonconformity is significant, and the organization believes the product can still be used or reworked to meet requirements with some deviation, they initiate a concession or deviation request.
- Concession or Deviation Request Content: The request includes detailed information about the nonconformity, its potential impact, the proposed deviation or rework actions, and the rationale for seeking customer approval.
- Communication with the Customer: The organization communicates with the customer, presenting the nonconformity situation, the identified deviation or rework actions, and any potential risks or implications for the customer’s use of the product.
- Customer Evaluation: The customer evaluates the concession or deviation request and considers factors such as the criticality of the nonconformity, potential impact on their operations or end-users, and contractual agreements.
- Customer Concession or Deviation Permit: Based on the evaluation, the customer decides whether to grant a concession or deviation permit. The decision may involve negotiation or discussions to reach an agreement.
- Documenting the Customer Concession or Deviation: If the customer approves the request, the organization documents the customer’s decision, including the agreed-upon deviation or rework actions. This documentation serves as evidence of the customer’s approval.
- Implementation of Approved Actions: With the customer’s permit in hand, the organization proceeds with the approved actions, such as reworking the product or making necessary adjustments to meet the agreed-upon requirements.
By following this process, organizations ensure that deviations from approved specifications are properly addressed and customer approval is obtained before further processing, thus maintaining product quality, customer satisfaction, and compliance with contractual agreements. Additionally, maintaining clear documentation throughout the process is essential for traceability and auditing purposes.
Reuse of sub-components in the manufacturing process
when sub-components from nonconforming products are reused in the manufacturing process, it is crucial to communicate this reuse explicitly to the customer in the concession or deviation permit. Transparency and clear communication with the customer are essential to ensure they are fully aware of any deviations or potential risks associated with the nonconforming sub-components.Here’s why clear communication is important and how it can be achieved:
Importance of Clear Communication: By communicating the reuse of nonconforming sub-components, the customer becomes aware of the situation and can make informed decisions about the acceptability of the final product. The customer needs to understand any potential risks or implications that may arise from reusing nonconforming sub-components. This allows them to assess the impact on their processes, products, or end-users. If the customer’s agreement or contract requires adherence to specific quality standards or requirements, clear communication ensures compliance and avoids misunderstandings.
Achieving Clear Communication: The concession or deviation request should explicitly mention the reuse of nonconforming sub-components. Provide details about the sub-components, the reason for reuse, and the actions taken to mitigate any risks associated with the reuse. Avoid technical jargon or ambiguous terms in the concession or deviation permit. Use clear and easily understandable language to describe the situation and actions taken. Include any relevant documentation, such as inspection reports, testing results, or quality assurance records, to support the communication and provide evidence of the steps taken to address the nonconformities. Request the customer to acknowledge receipt and understanding of the concession or deviation permit. This acknowledgment can be in the form of a signed document or written confirmation. Offer contact information for a designated person within the organization who can address any questions or concerns the customer may have regarding the reuse of nonconforming sub-components.
By adhering to these practices, organizations can maintain transparency and build trust with their customers. It also helps in ensuring that customers can make informed decisions about accepting products that contain reused nonconforming sub-components, and it demonstrates the organization’s commitment to managing nonconformities responsibly.
Expiration date
When obtaining customer authorization for concession on nonconforming products, the organization must keep a record of the expiration date or the quantity authorized under the concession. This information is crucial for tracking and managing the use of nonconforming products and ensuring that the approved deviation is not exceeded. When the customer grants authorization for the concession on nonconforming products, the organization documents the specific details of the concession, including the expiration date of the authorization or the quantity of nonconforming products allowed to be used or processed. During the period covered by the concession, the organization carefully tracks and monitors the usage of the nonconforming products. This is to ensure that they do not exceed the approved quantity or continue using the concession after the expiration date. While utilizing the customer-authorized concession, the organization ensures that they comply with the original or superseding specifications and requirements provided by the customer. This means adhering to any specific conditions or constraints outlined in the concession permit. When the concession’s expiration date approaches, the organization plans to discontinue the use of nonconforming products after the authorized period. They should be prepared to return to the standard manufacturing process or seek alternative solutions that meet the original specifications. If there are any issues or changes affecting the concession, the organization communicates promptly with the customer. This includes situations where the authorized quantity has been used up or if there is a need for an extension of the concession period. If there is a need to continue using nonconforming products beyond the initial concession period, the organization seeks the customer’s approval for renewal or obtains a new authorization as appropriate. By diligently adhering to these steps, organizations demonstrate their commitment to maintaining compliance with customer requirements and handling nonconforming products responsibly. Keeping accurate records of customer authorizations and ensuring compliance with concession conditions helps maintain trust and strengthen the relationship between the organization and its customers.
Identifying materials shipped under concession
Properly identifying materials shipped under concession is essential for maintaining transparency and traceability throughout the supply chain. When nonconforming products are shipped to the customer with their explicit approval (concession), clear identification on each shipping container becomes crucial. This ensures that the customer is aware of the nonconforming nature of the products and can handle them appropriately upon receipt. Clear identification informs the customer that the materials being shipped are nonconforming products authorized for use under concession. This awareness allows the customer to take necessary actions based on their own procedures for handling nonconforming materials. Proper identification aids in tracking nonconforming products throughout the supply chain. It helps the customer and the organization to know which containers contain concessioned materials, making it easier to manage and control these products. Clear identification prevents unintended use or mixing of nonconforming products with conforming ones. It helps avoid confusion during the receiving and inspection process, ensuring that concessioned materials are treated differently from regular inventory. Properly labeled shipping containers provide documented evidence that the nonconforming products were shipped with customer approval. This documentation can be vital during audits or quality assessments. To achieve proper identification, the shipping containers can be labeled or marked in a way that clearly indicates the presence of concessioned materials. This might include using stickers, tags, or specific markings that differentiate the nonconforming products from regular shipments. The labeling should be easily visible and ideally include information such as “Concessioned Material – For Approved Use Only.” Furthermore, organizations should communicate with their customers regarding the proper handling and storage of concessioned materials. Providing clear instructions and guidelines ensures that the customer is aware of any specific requirements related to the use of nonconforming products authorized under concession. By implementing these measures, organizations can enhance their customer relationships, maintain product quality, and demonstrate their commitment to responsible nonconforming product management.
Supplier non conforming products
When dealing with nonconforming products or materials from suppliers, the organization must have a clear process in place to handle these situations effectively. As part of this process, any requests for concessions or deviations from suppliers should be carefully reviewed and approved by the organization before submission to the customer. By having a central approval process within the organization, they can ensure consistency in handling nonconforming products from different suppliers. This control helps in maintaining uniformity in the evaluation and resolution of nonconformities. The organization needs to assess the risks associated with using nonconforming products from suppliers. By reviewing and approving the supplier’s request for concession, the organization can ensure that any potential risks are adequately evaluated and managed. The organization needs to communicate effectively with the customer about any nonconforming materials received from suppliers. By reviewing the requests before submission, the organization can provide the customer with accurate and relevant information about the nonconformities and the actions taken to address them. In some industries, there may be specific regulations or standards governing the use of nonconforming products. By obtaining internal approval, the organization can ensure that they are complying with applicable regulations before seeking customer concessions. The approval process allows the organization to maintain strict control over the acceptance or rejection of nonconforming products. This ensures that only authorized nonconforming materials are used or processed as per the agreed-upon deviations. The organization’s internal approval process should involve relevant stakeholders, such as quality control personnel, procurement teams, and possibly representatives from engineering or production departments. It’s essential to thoroughly review the supplier’s request, assess the impact of the nonconformity, and determine the best course of action before submitting the concession request to the customer. By following this approach, the organization can demonstrate their commitment to maintaining quality standards and customer satisfaction while effectively managing nonconforming products received from suppliers. Additionally, it helps in maintaining clear documentation of the decisions made during the approval process, which is valuable for internal audits and compliance purposes.
