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This post was last edited by Majestic Ultraman. Edited on 2023-8-5 13:04. 1. Classification of records: Laboratory records are generally divided into two main categories: quality records and technical records. 1) Quality records: Refer to the records generated during the activities of the laboratory management system. Including but not limited to records of management reviews, internal audits, contract reviews, evaluations of qualified suppliers, complaints and appeals, corrective actions, preventive actions, personnel training and assessment, supervision by quality supervisors, document distribution, document revisions, and meeting attendance records. 2) Technical records: The accumulation of data and information obtained from tests. They indicate whether the inspection has met the specified quality or process parameters. This may include tables, contracts, checklists, work notes, internal and external test reports, and customer letters, etc. 2 Forms of records: Records generally appear in tabular form; alternatively, they can be in textual form. When necessary, physical samples, photographs, audio recordings, video recordings, disks, etc., may also be used. These can be stored on any type of medium, or a combination of such media. The media on which records are stored can include paper, magnetic media, electronic media, optical discs, photographs, and samples, etc. 3 Requirements for record preparation – General requirements: In accordance with the quality manual, procedure documents, and traceability requirements, plans shall be made regarding the records needed in the management system. Additionally, uniform regulations shall be established concerning the labeling, cataloging, format, content of table titles, approval procedures, and other requirements related to records. While preparing the procedure documents, record forms appropriate for each procedure should be developed separately; if necessary, these forms can be attached at the end of the procedure documents. Sufficiency and effectiveness of records: Records should reflect as comprehensively as possible the product development process and outcomes, as well as the operation status and effectiveness of the quality management system, in order to provide the necessary information for quality management and quality assurance activities. But this does not mean that the more records there are, the better; the principle is to ensure that actions are documented, traces can be followed, and there is evidence for verification, thereby reflecting the spirit of objectivity, standardization, accuracy, and timeliness. Standardization of records: The methods, formats, media, writing instruments, binding, fonts, and so on used for records should all be standardized, regulated, and documented. A uniform format facilitates filling in information, as well as statistics and analysis, and it also lays the foundation for further use of computers in information management. The records must be filled out in a standardized, accurate, and clear manner to meet the requirements for verification and quality improvement. Practicality of records: When determining the content of each record, its practicality should be taken into account. Archiving and storage must comply with specified requirements to ensure easy retrieval of records and facilitate information sharing. Information that cannot provide evidence for quality management and quality assurance should not be included in the records. The design of the record format should include sufficient information while also minimizing the amount of writing work for the person who enters the records. The authenticity and accuracy of records: Only when records truly and accurately document information can they provide a scientific basis for carrying out quality management and quality assurance. Distorted, inaccurate, or unclear records lose their usefulness, and can even lead to loss of control over product quality and flawed leadership decisions. To this end, when determining the format and content of records to ensure ease of storage, retrieval, analysis, and control, clear specifications must be established for record identification, and management procedures for records should be developed if necessary. 4 Contents of the record: name, number, time of recording, location of recording, and signature of the person who made the record. The recorded items are listed in chronological order; they generally include the item name, actual data, or a description of activities, etc. Comments or evaluations by the recorder, the basis for the recorder’s judgment, and other matters that need to be recorded. The inspection original records shall be designed item by item in accordance with the requirements of the inspection methods specified in the product standards, method standards, or work instructions; the content of such records should include all the information that is required to be recorded as stipulated in the standards or work instructions. 5 Design of record tables: Format design. There is no fixed format for records, so it is difficult to establish a uniform pattern; the format should be determined according to needs. On the basis of meeting the requirements, the format and content of the records should be determined in accordance with one’s own needs. The number of records also varies depending on the nature and size of the organization; it is not advisable to blindly copy someone else’s record format. Records used in daily work can be identified by assigning numbers, without the need to use controlled stamps. Review and approval: Compile all record forms and organize relevant departments and personnel to conduct a review. The focus of the review is on the integrity of the management system, as well as the internal connections and coordination among various forms, the consistency in their format, and the completeness of their content. After reviewing and making the necessary modifications, submit it to the supervising leader for approval. Compile them into a booklet: assign uniform numbers to all templates for control, compile them into a booklet, and issue it for implementation. When necessary, requirements or instructions for filling out certain more complex record forms should be specified. Format changes: When personnel in the laboratory have suggestions for modifying the record format, they should submit them in writing. Once approved, the original drafting department shall make the necessary changes, which must then be reviewed and approved by the original approver. When the original reviewer and approver leaves their position, the person who takes over their duties shall carry out the review and approval. A document change notice should be issued for document changes. The document change notice shall specify the notice number, the name of the file being changed, the details of the changes, the date on which the changes are implemented, as well as the signatures of the person who made the changes, the reviewer, and the approver.