| Section: |
7.2.2 d |
Section Title: Special Requirements |
| 9100 C Clause |
Review of Requirements Related to the Product: The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: special requirements of the product are determined, (reference definition in § 3.2) |
| Generic Expectation |
When reviewing contracts and / or requirements for delivery of product or service, consideration must be given to those requirements identified by the customer or determined by the organization which have high risks to being achieved. |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
N/A |
See 7.4.2 Purchasing Information a) Define "special requirements" to the supplier |
See 7.4.2 Purchasing Information a) "Special requirements" as defined by the supplier to the organization |
| Supplier (Seller) |
N/A |
Supplier shall determine internal capabilities to comply with organization's special requirements |
a) Contractual documentation review to determine internal capabilities to comply with organization's special requirements and identify any potential associated risks.
b) Perform an evaluation of processes that approach limit of capabilities and evaluate the ability to execute technology and/or processes (i.e. new manufacturing processes; new materials never been used). |
a) Contractual documentation review to determine internal capabilities and identify any potential special requirements.
b) Perform an evaluation of processes that approach limit of capabilities and evaluate the ability to execute technology and/or processes (i.e. new manufacturing processes; new materials never been used). |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
N/A |
Supplier acknowledgement that contractual document requirements can be met. |
| Supplier (Seller) |
N/A |
Contractual document review documented and any exceptions or risks identified.
Contractual document acknowledgement copy sent to buyer. |
Evaluation of the special requirements against the internal capabilities (documented evidence) i.e., Risk Mitigation Plan where appropriate.
Contractual document acknowledgement copy sent to buyer. |
Evaluation of the special requirements determined through the design and production capability (documented evidence) i.e., Risk Mitigation Plan where appropriate.
Contractual document acknowledgement copy sent to buyer. |
| Examples (Best Practices) |
Organization (Buyer) |
N/A |
N/A |
N/A |
N/A |
| Supplier (Seller) |
N/A |
N/A |
Risk Mitigation Plan or process to evaluate risk. |
