§ 280.7 - Recordkeeping requirements.

(a) Each laboratory accredited under subparts C, D, or E or § 280.104 of this part shall retain for 5 years after the performance of a test all records pertaining to that test concerning the inspection and testing, and certification, of fasteners under the Act and this part. The final test report or the test records maintained by the laboratory shall contain sufficient information to permit the test to be repeated at a later time if a retest is necessary. The laboratory shall maintain the test report and a record of all original observations, calculations, and derived data. The records shall include the identity of personnel performing the testing. Procedures for storage and retrieval of records must be documented and maintained in the laboratory's quality manual.

(b) Manufacturers, importers, private label distributors, and persons who significantly alter fasteners shall retain for 5 years after the performance of a test all records pertaining to that test concerning the inspection and testing, and certification, of fasteners under the Act and these regulations.

(c) Original records required. Persons required to keep records under this part must maintain the original records in the form in which that person receives or creates them unless that person meets all of the conditions of paragraph (d) of this section relating to reproduction of records. Original laboratory test reports described in §§ 280.5, 280.6, 280.13 and 280.15(b) of this part must be kept.

(d) Reproduction of original records. A person required to keep records under this part may maintain reproductions of documents other than laboratory test reports instead of the original records using any photographic, photostatic, miniature photographic, micrographic, automated archival storage, or other process that completely, accurately, legibly and durably reproduces the original records (whether on paper, microfilm, or through electronic digital storage techniques). The process must meet all of the requirements of paragraphs (d)(1) through (d)(9) of this section.

(1) The system must be capable of reproducing all records on paper.

(2) The system must record and be able to reproduce all marks, information, and other characteristics of the original record, including both obverse and reverse sides of paper documents in legible form.

(3) When displayed on a viewer, monitor, or reproduced on paper, the records must exhibit a high degree of legibility and readability. (For purposes of this section, legible and legibility mean the quality of a letter or numeral that enable the observer to identify it positively and quickly to the exclusion of all other letters or numerals. Readable and readability mean the quality of a group of letters or numerals being recognized as complete words or numbers.)

(4) The system must preserve the initial image (including both obverse and reverse sides of paper documents) and record all changes, who made them and when they were made. This information must be stored in such a manner that none of it may be altered once it is initially recorded.

(5) The regulated person must establish written procedures to identify the individuals who are responsible for the operation, use and maintenance of the system.

(6) The regulated person must establish written procedures for inspection and quality assurance of records in the system and document the implementation of those procedures.

(7) The system must be complete and contain all records required to be kept by this part or the regulated person must provide a method for correlating, identifying and locating records relating to the same transaction(s) that are kept in other record keeping systems.

(8) The regulated person must keep a record of where, when, by whom, and on what equipment the records and other information were entered into the system.

(9) Upon request by the Bureau of Export Administration or NIST, the regulated person must furnish, at the examination site, the records, the equipment and, if necessary, knowledgeable personnel for locating, reading, and reproducing any record in the system.

(e) Destruction or disposal of records. If the Bureau of Export Administration, NIST or any other government agency makes a formal or informal request for any record or records, such record or records may not be destroyed or disposed of without the written authorization of the agency concerned. This prohibition applies even if such records have been retained for a period of time exceeding that required by paragraphs (a) or (b) of this section.

(f) All persons required to keep records by this part must furnish those records when requested to do so by an employee of the Bureau of Export Administration or NIST.