| Section: |
7.2.2 e |
Section Title: Evaluation of Risk |
| 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:
risks (e.g., new technology, short delivery time scale) have been identified (see 7.1.2). |
| Generic Expectation |
When reviewing contracts and / or requirements for delivery of product or service, consideration must be give to the risks involved with being able to deliver product that meets customer needs. This includes sufficient time to do all the necessary steps of design, manufacture, testing and delivery. Does the time allotted take into account state of the art technologies that may not yet be proven on a production scale or other factors as material availability or long lead times for tooling or equipment to meet specified delivery dates? |
| Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
| Specific Expectation |
Organization (Buyer) |
See 7.4.2 Purchasing Information.
Item ordered is off-the-shelf or catalog item and within current lead time indicated by supplier. |
See 7.4.2 Purchasing Information a) Item ordered is within scope of supplier's advertised capabilities, and b) Contractual documentation acknowledgement received from supplier. |
| Supplier (Seller) |
a) Contractual documentation review documented and no exceptions or risks identified.
b) Item ordered is available off-the-shelf and/or can be manufactured within current lead time. |
a) Contractual documentation review documented and no exceptions or risks identified.
b) Item ordered is available off-the-shelf and/or can be manufactured within current lead time.
c) Perform an evaluation of processes never performed before and evaluate the ability to execute processes (i.e. new manufacturing processes; new materials never been used). |
a) Contractual documentation review documented and no exceptions or risks identified.
b) Item ordered is available off-the-shelf and/or can be manufactured within current lead time.
c) Perform an evaluation of processes never performed before and evaluate the ability to execute processes (i.e. new manufacturing processes; new materials never been used; new design technology). |
| Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
Supplier acknowledgement that contractual document requirements can be met. |
| Supplier (Seller) |
Contractual document review documented and no exceptions or risks identified.
Contractual document acknowledgement copy sent to buyer. |
Evaluation of the risk of product criticality against the current control system (documented evidence) i.e., Risk Mitigation Plan where appropriate.
Contractual document acknowledgement copy sent to buyer. |
Evaluation of the risk of the design and production capability based on product criticality (documented evidence) i.e., Risk Mitigation Plan where appropriate.
Contractual document acknowledgement copy sent to buyer. |
| Examples (Best Practices) |
Organization (Buyer) |
ARP9134 - Supply Chain Risk Management Guideline |
| Supplier (Seller) |
ARP9134 - Supply Chain Risk Management Guideline |
ARP9134 - Supply Chain Risk Management Guideline.
Evidence of a Risk Mitigation Plan or process to evaluate risk. |
