| Section: |
7.4.2 g |
Section Title: Requirements for Nonconforming Product |
| 9100 C Clause |
Purchasing Information: Purchasing information shall describe the product to be purchased including, where appropriate,
g) requirements regarding the need for the supplier to:
- notify the organization of nonconforming product,
- obtain organization approval for nonconforming product disposition,
- notify the organization of changes in product and/or process, changes of suppliers, changes of manufacturing facility location and,
where required, obtain organization approval, and
- flow down to the supply chain the applicable requirements including customer requirements
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| Generic Expectation |
The Buyer and the supplier, along with all the subtiers in the chain, need to have clearly defined and accepted methods of reporting any supplier nonconformances and methods of disposition approval; notification and/or approval of any process, sub-tier, equipment or location changes; and a method to assure the flow-down of any other Buyer (Customer or Organization) requirements. The Buyer needs to assure their organization has established and delineated clear process procedures for the approval of Supplier responsible nonconformances.
- It is expected that the supplier will create a notification to the Buyer through an internal nonconformance reporting system. Additionally, the supplier should notify the Buyer using a timely "Notification of Escape" (e.g. Reference 9131) for any product that is considered non-conforming that has been delivered to any and all Buyers. The supplier will also need to provide details of the products’ nonconformance, quantities, the actual or potential extent of the severity and impact on the Buyer's product, if known.
- At any level, if the decision of safety, reliability, impact to next assembly, or deviation (from design) cannot be made by the organization, the organization should provide timely contact to the customer for their assistance.
- The supplier will need to obtain the Buyer's dispositon of the products' nonconformance or the Buyer will need to provide an approval for the supplier to disposition the product(s)
- The supplier will need to notify the Buyer if any changes are made in the product; the manufacturing processes such as equipment, methods, inspection techniques, etc. (including special processes such as heat treat, plating, welding, coating, etc); any changes in the subtier suppliers used to produce or service the product; any changes of location used to produce or service the product; and if so required, obtain the Buyer's approval.
- The Buyer of the product or service will flow-down requirements effecting the procurement. If the Buyer is not the final customer, they will also need to flow-down any applicable requirements from their customer that are imposed throughout the entire supply chain. It is in turn expected that the supplier will flow-down both the Buyer's and their own requirements to any sub-tiers. |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
The Buyer will need to assure the supplier acceptance of the requirements for the notification, mitigation and actions needed to assure any nonconformance is reported to buyers of their products. |
| A COTS or Standard Parts Supplier will not normally be authorized to submit a non-conformance or re-grading request to Buyer for review or approval. The suppliers are obligated to sell conforming products only. |
A Raw Material Supplier will not normally be authorized to submit a non-conformance or re-grading request to Buyer for review or approval. The suppliers are obligated to sell conforming products only. |
It is understood that the Build-to-Print supplier is required to produce products or services conforming to the Buyer's set of requirements.
A documented acknowledgement of the requirements for reporting and/or Buyer approval of non-conformances, are clearly understood and accepted.
A Build to Print supplier authorized by the Buyer, may submit non-conformances to the Buyer for their disposition of the contracted product or service. The Buyer may also authorize the supplier to disposition some level of non-conformance, if so qualified. |
A Supplier contracted to design and build products may be authorized to disposition non-conformances without submittal for approval to the Buyer within the limitations defined in contractual requirements. A Supplier documented acknowledgement of the requirements for reporting and/or approval of non-conformances are clearly understood and accepted.
It is understood that a design supplier is required to produce products or services conforming to the Buyer's set of requirements. |
| It is not expected that a COTS or Standards supplier will need to have any changes to manufacturing process, equipment, sub-tier suppliers, or facilities reported to, or approved by the Buyer. |
The Buyer needs to roll-down the contractual documents regarding the supplier's obligations to define and submit any changes that are planned or implemented by the Supplier. The changes referenced could impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. The supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
The Buyer needs to roll-down the contractual documents regarding the supplier's obligations to define and submit any changes that are planned or implemented by the Supplier. The changes referenced could impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. The supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
The Buyer needs to roll-down their contractual requirements regarding the supplier's obligations to define and submit any changes that are planned or implemented by Supplier. In regard to supplier designed products, it is best that there be an approved Quality Plan that denotes all aspects to be agreed upon. The changes referenced would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. The supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
| If the Buyer is not the final customer of the product or service, the Buyer's customer requirements must also be rolled-down to any applicable supplier used. |
| Supplier (Seller) |
The supplier will need to understand and accept the Buyers' requirements for the notification, containment, mitigation and actions needed for any nonconformance of products sold to the Buyer. |
The supplier and the Buyer will need to create an understanding of the requirements for the notification, mitigation, containment, and actions needed for any nonconformance of products sold to the Buyer. There should be an agreement of the accept/reject criteria, the levels of major/minor (if applicable) and the methods for submitting non-conformances for the Buyer's review and approval. Supplier's disposition authority vs the Buyer's approval requirements needs to be clearly defined as well. |
| A COTS or Standard Parts Supplier is not normally authorized to submit a non-conformance or re-grading request to the Buyer for review or approval. These suppliers are obligated to produce and/or sell conforming products only. |
A Raw Material Supplier will not normally be authorized to submit a non-conformance or re-grading request to the Buyer for review or approval. These suppliers are obligated to produce and/or sell conforming products only. |
It is understood that the Build-to-Print supplier is required to produce products or services conforming to the Buyer's set of requirements. A documented acknowledgement that requirements for reporting and/or Buyer approval of non-conformances, are clearly understood and accepted. A Build to Print supplier authorized by the Buyer, may submit non-conformances to the Buyer for their disposition of the contracted product or service. The Buyer may also authorize the supplier to disposition some level of non-conformance if so qualified. |
A Supplier contracted to design and build products may be authorized to disposition "Minor or Class 2" non-conformances without submittal for approval to the Buyer, dependent upon the contractual requirements. "Major or Class 1" non-conformances are to be dispositioned and approved by the Buyer. A Supplier documented system to address and an acknowledgement of the requirements for reporting and/or approval of non-conformances are clearly understood and accepted. |
| It is not expected that a COTS or Standards supplier will need to have any changes to manufacturing process, equipment, sub-tier suppliers, or facilities, reported to or approved by the Buyer. |
The supplier should expect the Buyer will roll-down the contractual documents regarding the obligations to define and submit any changes that are planned or implemented by Supplier. The changes referenced would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. It is noted that the supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
The supplier should expect the Buyer will roll-down their contractual requirements regarding the supplier's obligations to define and submit any changes that are planned or implemented by the Supplier. In regard to supplier designed products, it is best that there be an approved "Quality Plan" that denotes all aspects to be agreed upon. The changes referenced would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc.
It is noted that the supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
| The Buyer may not be the final customer of the product or service, in that case, the Buyer will also roll-down their customer's requirements and those subsequently need to be rolled-down to any applicable supplier used. |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
The Buyer will need to contractually submit to the supplier, the requirements for the notification, containment, mitigation and actions needed to assure any escaped nonconformance is reported to the buyers of their products. This may be by direct language or codes applied in the contract or by referenced documentation. An acceptance by the supplier or a negotiated set of requirements may result but will need to form a part of the contract as well. |
| COTS or Standard Parts suppliers are obligated to produce and/or sell conforming products only and are not normally authorized to submit a non-conformance or re-grading request to Buyer for review or approval. If so authorized, the Buyer should have a documented procedure and a record of any occurence along with the Engineering disposition proving acceptance. |
Raw Material suppliers are obligated to produce and/or sell conforming products only and are not normally authorized to submit a non-conformance or re-grading request to Buyer for review or approval. If so authorized, the Buyer should have a documented procedure and a record of any occurence along with the Engineering disposition proving acceptance. |
A Buyer of product from a Build-to-Print supplier will need to have a documented procedure as evidence of a process of supplier submittals of any nonconformances. The Buyer will also need documented dispositions by authorized individuals. This data should then be returned to the supplier for the implementation of the dispostion. The Buyer should then provide a final acceptance or delegate that acceptance; the documentation to prove acceptable product will need to be available to the Buyer and Regulatory Authorities. |
A Buyer of a Supplier Designed product will need to have a documented procedure as to the level of authorities for dispositioning nonconformances. The Buyer would also need to document the specific authority granted to each supplier/product and the approved personnel that can make those dispositions. There should be records of supplier nonconformance submittals and dispositions. The Buyer is responsible for the final acceptance through their Engineering or delegation process. |
| It is not expected that a COTS or Standards supplier will need to have any changes to manufacturing process, equipment, sub-tier suppliers, or facilities, reported to or approved by the Buyer. |
The Buyer should have a copy of the contractual documents regarding the obligations to define and submit any changes that are planned or implemented by Supplier. Buyer should have documented approval for any Supplier changes, as contractual required. |
The Buyer should have a documented copy of the contractual requirements regarding the obligations to define and submit any changes that are planned or implemented by Supplier. If the changes referenced would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. a documented submittal to the Buyer should be available as well as the Buyer's acceptance prior to implementation. |
The Buyer should have a documented copy of the contractual requirements regarding the obligations to define and submit any changes that are planned or implemented by Supplier. If the changes referenced would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. a documented submittal to the Buyer should be in evidence as well as the Buyer's acceptance. It is best that there be an approved "Quality Plan" that denotes all aspects to be agreed upon. It is noted that the supplier may need to have approval prior to implementation dependent on the Buyer's requirements. |
| The Buyer may not be the final customer of the product or service, in that case, the Buyer will roll-down all the customer's requirements and the supplier needs to subsequently roll those requirements to any supplier used. |
| Supplier (Seller) |
The Supplier will need to have a copy of a contract denoting the Buyer's requirements for the notification, containment, mitigation and actions needed to assure any escaped nonconformance is reported to the buyers of their products. This may be delineated by direct language or codes applied in the contract or by referenced documentation. An acceptance by the supplier or a negotiated set of requirements may result but will need to form a part of the contract. |
| COTS or Standard Parts suppliers are obligated to produce and/or sell products conforming to the standards or engineering represented to the Buyer. They are not normally authorized to submit a non-conformance or re-grading request to Buyer for review or approval. If so authorized, the supplier should have a documented procedure and a record of any occurence along with the Engineering disposition proving acceptance of the authorization. |
Raw Material suppliers are obligated to produce and/or sell conforming products only and are not normally authorized to submit a non-conformance or re-grading request to the Buyer for review or approval. If so authorized, the supplier should have a documented procedure along with a record of any occurence \with the Engineering disposition proving acceptance of the authorization. |
A Build-to-Print supplier will need to have a documented procedure as evidence of a process for submittals to the Buyer of any non-conformances. The supplier will also need to retain documented dispositions by the Buyer's authorized individuals. The supplier needs to comply with the disposition and submit the product to the Buyer for acceptance, if contractually required . If MRB delegation is awarded, an agreed to Buyer / Supplier MRB Plan is desired to document the delegation limitations, authorized personnel, and communication of MRB dispositions to the Buyer. |
A Design and Build supplier will need to have a documented procedure as evidence of a process for approvals and any required submittals to the Buyer. The supplier will also need to retain documented dispositions by their internal MRB activity, any Buyer dispositions and the Buyer's granted authorities. If the Buyer grants a limited authority, the supplier needs to show evidence they complied with the level granted. Any non-conformances exceeding the approved limitation should be submitted to the Buyer for disposition. Any product should have evidence of a final acceptance. An agreed to Buyer/Supplier MRB Plan is desired to document the delegation limitations, authorized personnel, and communication of MRB dispositions to the Buyer. |
| It is not expected that a COTS or Standards supplier will need to have any changes to manufacturing process, equipment, sub-tier suppliers, or facilities, reported to or approved by the Buyer, so there may not be any objective evidence of this element. |
The supplier should have a copy of the contractual documents regarding the obligations to define and submit any changes that are planned or implemented by Supplier. Supplier should have documented Buyer approval for any changes, as contractual required.
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The Build to Print supplier should expect to have the Buyer's contractual documents regarding the obligations to define and submit any changes that are planned or implemented by Supplier. Changes referenced that would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. should have a documented submittal to the Buyer that would meet the contractual requirement. It is noted that the supplier may need to have approval prior to implementation and dependent on the Buyer's requirements, there should be objective evidence if this requirement is imposed. |
The Design and Build supplier should expect to have the Buyer's contractual requirements regarding the supplier's obligations to define and submit any changes that are planned or implemented by Supplier. In regard to supplier designed products, it is best that there be a documented, approved Quality Plan that denotes all aspects to be agreed upon. Changes referenced that would impact product, manufacturing techniques or processes, equipment, supply base, facilities, etc. should have a documented submittal to the Buyer that would meet the contractual requirement. It is noted that the supplier may need to have approval prior to implementation and dependent on the Buyer's requirements, there should be objective evidence if this requirement is imposed. |
| The Supplier should have evidence that any and all of the Buyer's requirements are subsequently rolled-down to any applicable supplier used. |
| There should also be evidence that Supplier furnished an acknowledgement of the contract and its requirements to the Buyer. |
| N/A |
N/A |
If a Build to Print supplier has a limited MRB Delegation from the Buyer, the supplier should have evidence of the MRB Process approval; approved MRB personnel in both Engineering and Quality; nonconformance submittal requirments and periodic reports, audit data, etc. |
If a Design and Build supplier has an MRB Delegation from the Buyer, the supplier should have evidence of the MRB Process Approval, approved MRB personnel in both Engineering and Quality, the nonconformance submittal requirements and periodic reports, audit, etc. |
| Examples (Best Practices) |
Organization (Buyer) |
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