CSA N299.2:2019 pdf download.Quality assurance program requirements for the supply of items and services for nuc ear power plants, Category 2
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 E on risk evaluation for changes and impacts); and
c) provide customer access to the applicable premises or working areas, including those of the subsuppliers, for the purpose of surveillance, AHJ requirement verification, and audit.
Notes:
1) Customer representatives may perform evaluations, surveillance, and audits 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 procedures 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 manuals.
7.1.1 The supplier shall document, implement, and maintain a process for top management review. Top management shall perform management reviews with sufficient frequency to ensure their continuing suitability and effectiveness in meeting the requirements of the QA program. The process used to review the status and adequacy of the QA program shall be stated in the QA manual. The review shall analyze appropriate data to demonstrate the suitability and effectiveness of the QA program in meeting the requirements of this Standard, with the objective of continually improving the QA program. The top management review process shall specify actions required and assignment of personnel to implement and confirm the effectiveness of the actions taken. Upon completion of the top management review,the results shall be documented.
Notes:
1) The internal audit function is not a substitute for a management review.
2) Management reviews are carried out by top management and not delegated to other personnel.
3) Typically reviews are performed annuall; however, companies may choose a higher frequency to avoid missed opportunities for identifying and correcting adverse quality trends (e.g., customer complaints, internal/external audits, internal nonconforming items, and rework).CSA N299.2 pdf download.