| Section: |
7.4.1 d |
Section Title: Use of Customer-Approved Special Process Sources |
| 9100 Clause |
The organization shall:
ensure where required that both the organization and all suppliers use customer-approved special process sources; |
| Generic Expectation |
The expectation is for the buyer and/or seller to have a system that ensures, when required by the contract, that they only use special processors approved by the customer. Ref.AS9100 7.5.2: Validation of Processes for Production and Service Provision - Special Process is defined as any process for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
N/A |
Include the following definition in the contractual document for special processes: "Processes where the resulting output cannot be verified by subsequent monitoring or measurement." |
| Clearly describe, in the contractual document, the method by which the Seller can determine which organizations are approved for which special processes. |
| Ensure each approved special processor is positively and uniquely identified to prevent confusion among multi-site locations. |
| Include, in the contractual document, the process by which a Seller obtains approval by the Buyer for the use of special processors not on the Buyer's approved list. |
| Supplier (Seller) |
N/A |
The Seller's process ensures that methods for contract review include a process that checks for special process approval requirements by the Buyer. |
| The Seller's outsourcing of special processes includes a check for Buyer's approval requirements. |
| Acceptance of product includes verification that required special processes were performed by the Buyer's approved sources. |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
N/A |
Buyer maintains a list of processes considered as special processes. |
| Buyer maintains a list of approved sources for each defined special processor. |
| Both the definition and list of special processors are available to the Seller. |
| There is a process made available to the Seller for suggestions of additions to the approved list. |
| Revisions to the approved list are immediately available to the Seller. |
| Affectivity of the applicability of revisions to the approved list are documented and made available to the Seller. |
| Supplier (Seller) |
N/A |
The Seller's procurement process contains a requirement for certifications of special processes that identify the special processor for each applicable delivery. |
| A documented process by which the procurement and receiving inspection departments know the status of Buyer's approved special processors. |
| Verification during the final item acceptance process just prior to shipping items to the Buyer that special processes have been performed by Buyer approved sources and documentation is available. |
| Examples (Best Practices) |
Organization (Buyer) |
N/A |
The Buyer's contractual document contains instructions on where to obtain the current list of Buyer's special processors. |
| The procurement documentation package contains instructions on how to suggest revisions to the approved special processor list. |
| The procurement documentation package contains guidance on what to include with the items the evidence of compliance to special processor use. |
| Supplier (Seller) |
N/A |
A validation exists in the Seller's procurement process that identifies special processor approval requirements prior to order placement. |
| Documentation of evidence included with each item shipment that shows compliance with customer special processor source requirements. |
| Other party special process accreditation |
