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In the United States construction industry, contract agreements are usually written to allow the owner to withhold (retain) the final payment to the general contractor as "retainage". [3] The contractor is bound by the contract to complete a list of contract items, called a punch list, in order to receive final payment from the owner.
In 21CFR820.3(h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems". The FDA also specifies that a design review should include an independent reviewer.
Supplier evaluation is a continual process within purchasing departments, [4] and forms part of the pre-qualification step within the purchasing process, although in many organizations, it includes the participation and input of other departments and stakeholders.
The production contract for manufacture of a CI with a fairly complex, or difficult-to-manufacture, design is awarded to a new contractor or vendor. Re-auditing in these circumstances is advisable regardless of whether the contractor or the government controls the detail production design.
Basis of estimate (BOE) is a tool used in the field of project management by which members of the project team, usually estimators, project managers, or cost analysts, calculate the total cost of the project.
The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team.
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