CSA N299.4:2019 pdf download.Quality assurance program requirements for the supply of items and services for nuclear power plants, Category 4
4.1 General
The supplier shall
a) document, implement, and maintain a QA program in accordance with the requirements of this Standard;
b) inform the customer as early as reasonably possible of any significant item or service performance risks, or changes to the QA program or the organizational structure that could impact the conditions under which the supplier acceptance was granted (see Annex D on risk evaluation for changes and impacts);
c) upon request, submit the currently implemented QA documentation to the customer for evaluation; and
d) provide customer access to the applicable premises or working areas, including those of the subsuppliers, for the purpose of surveillance.
Notes:
1) Customer representatives may perform evaluations and survillance at buildings or premises where the customer's work is being performed. This right of access may extend to all subsuppliers in the supply chain such as agents, distributors, item manufacturers, and assembly and test facilities.
2) The right of access includes the right to review items and services, documents, records, and descriptions pertaining to the customer's work. However, suppliers have the right to refuse access to unrelated work being done for other customers, and to refuse access to items, services, or audits where their QA program is not applicable, as long as this is not in contradiction with the information contained in their QA documentation.
7.3 Tender and contract review
The supplier shall
a) review the contract before acceptance to detect and resolve differences from the tender and quote, and document the results of the review;
b) consider in the review whether
i) the requirements are defined, including the requirements for delivery and post-delivery activities, as applicable to the item or service;
ii) the statistical techniques/sampling plans to be used are acceptable to the customer; and
iii) identify for the customer before award of the contract which items will be supplied from inventory and demonstrate that the QA program, as specified, was implemented for the items at the time they were produced;
Notes:
1) The items to be identified are the contracted items agreed upon between the customer and the supplier.
2) Suppliers need to establish whether they have the necessary resources to meet schedules and costs, as difficulties regarding these aspects are likely to affect quality. Requirements for delivery and post-delivery activities, requirements of the AHJ applicable to the item or service, and any additional requirements that the supplier considers necessary should be included in the review.
c) translate contract, technical, and quality requirements on production documents after award of the contract, as applicable; and
Note: See Clause 7.13 on production.
d) review and accept subsequent contract changes after award of the contract by the applicable organizational functions. Personnel impacted by the changes shall be made aware of the changes,and applicable documents and work- in-progress shall be reconciled.CSA N299.4 pdf download.