Records developed during a product development project are usually archived for long-term storage when the project is completed. Achieving a reduction in volume of those records is desirable to minimize both preparation and storage costs. The content of the records to be archived and the format for archiving those records are addressed, seeking improvements over current practice. Special attention is given to files that originate in electronic form, e.g., software, safety analysis results, or word processor files.
While the governing documents for 10 CFR 50 Appendix B quality assurance (QA) programs do not address which portion of project record files should be retained for long-term storage, other industry documents supply useful guidance in this regard.
It is concluded that files containing information (including applicable codes and standards used in design) about the delivered product should be archived for long-term storage, while those that describe the process, such as procedures, audits, and QA manuals, that was followed to yield the quality product and files containing information about earlier developmental versions of the product need not be retained.
The use of compact disk (CD) technology for archiving project records has several advantages compared to using hard copy or microfiche. The volume of information is substantially reduced, the information is much easier to search and access, and, since so much information now originates in electronic form, the preparation of the CD form is more direct. Approaches to ensuring long-term retrievability and readability of CD files are discussed.