Operational Procedure / QP-02 / Rev. 11/19/23 / Pg. 1 of 2
PURPOSE
The purpose of this procedure is to define the method and assign responsibilities for the establishment, storage, and retention of records.
IIAPPLICATION
This procedure applies to all records demonstrating conformity of products, processes, and the quality management system as listed in the Quality System Records Retention List.
IIIPROCEDURE
1General
Records are established and maintained to provide evidence that products, processes and the quality system conform to requirements, and that the quality system is effective. At a minimum, these records are intended to meet all the requirements of the latest edition of ISO9001.
Completion of records
Various procedures and process flowcharts, as well as the ISO 9001 Standard require the completion of specific records. Records are completed by the person performing the task, operation, or activity. Records are entered into storage by the same function that is responsible for establishing the record, unless designated otherwise.
3Identification, Storage, Protection, Retrieval, Retention and Disposition
Identification:
Records are identified and retained according to the Quality Systems Records Retention List. As applicable, records identify or reference the product, person, or event to which they pertain and records are dated, and identify the function or person who established the record.
Storage:
Records are stored in either paper or electronic format as defined in the Quality Systems Records Retention List
Protection:
Paper records are stored in the office in file folders and cabinets in a manner to protected the records from any deterioration that would render the records unreadable. Electronic records are stored in our computer system and backed up on a regular basis to ensure availability.
Retrieval:
Electronic and hardcopy records are indexed in an appropriate manner to facilitate ease of retrieval. This includes clear identification of files, folders, file cabinet drawers, electronic folders, etc. Any employee with legitimate business reasons may retrieve records. Certain records such as employee training and personal files will have restrictedaccess.
Retention:
Records are retained for time periods judged reasonable for business purposes or otherwise defined by external authorities governing this industry. The minimum retention periods are defined in the Quality Systems Records Retention List.
Disposition:
All paper records are disposed of using the appropriate disposal based on the nature of the record, including shredding if applicable. Electronic records are deleted in a manner to prevent unwanted retrieval by a third party.
VREFERENCED DOCUMENTS
Quality System Records Retention List