What issues should be considered when updating system documents? Typical issues with 5-file control
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What issues should be considered when updating system documents? How should revisions or updates to the format of the corresponding record table be handled? When updating the system, special attention should be paid to the new provisions added in the revised guidelines to ensure compliance with them; a comparison table can be used to match the contents of the provisions in the old and new versions. A request for file version change is required. Revisions to the format of the record form are limited to partial changes; such revisions also require approval, along with an explanation showing the differences before and after the revision. Pay attention to the number of revisions indicated in the table’s numbering. If the format of the record form needs to be changed due to errors in the establishment of the system processes, the system documents must be revised first, after which the corresponding records can be altered. 2 What should be done if the file numbers change after the system is upgraded? Using a comparison table to map old and new version numbers of documents allows tracing back to the previous version. All system documents after the revision are issued under control again. If the numbering rule changes, it is necessary to explain the current numbering rule in the system documents. 3 How is the archival period for laboratory documents determined? The file archiving period shall meet the requirements of relevant guidelines, laws and regulations, as well as customer requirements. CNAS requires that records be retained for at least 6 years. All documents that are still in use and within their valid period must be kept indefinitely. Invalid documents are generally kept as needed. Records related to personnel and equipment must be retained for an additional 6 years after the personnel leave or the equipment is scrapped. 4 How should laboratory documents be archived for easy retrieval? Prepare a list of documents (electronic and paper catalogs), store the documents in a categorized manner, and organize them in chronological order, by sequence number, or according to the order of the processes involved. Managed by a dedicated person, with coding for retrieval. 5 When do laboratory documents become invalid? How should invalid documents be handled? Once the new version of the documents is implemented, all previous versions become invalid, including system documents, testing standards, and equipment manuals. Documents marked as void should be promptly removed from the place where they are used and taken back, and destroyed in accordance with regulations, with records of such destruction kept. If documents marked void are to be used only for reference for other reasons, they need to be labeled as retained to prevent misuse.
6 What should be noted when reviewing laboratory documents? Reviewing laboratory documents requires ensuring that they comply with guidelines and relevant laws and regulations, checking the completeness and accuracy of their content, and confirming their technical feasibility and operability. Review records should be documented and signed, and in line with the document control system, to ensure transparency and traceability in the modification and revision process. 7 Under what circumstances do laboratory documents need to be changed? Lab documents need to be revised in situations such as when guidelines, laws, regulations, standards, etc. change and the documents cease to meet the required standards; when there are significant changes in the laboratory’s processes, equipment, personnel, etc., rendering the existing documents no longer applicable; or when problems or accidents occur in the laboratory, which necessitate the revision, improvement, or supplementation of the documents. Before making changes to a file, review and approval are required. Under what circumstances does a laboratory need to create new documents? Situations in which a laboratory needs to create new documents include when it undertakes new business activities, testing projects, or services, and requires the development of corresponding management processes and methods ； Changes in the laboratory’s location, equipment, personnel, etc. have rendered the existing documents ineffective ； When a laboratory needs to conduct new research or exploration, it is necessary to create corresponding documents and records. Before creating a new document, it is necessary to understand and study the relevant guidelines, laws, and regulations to ensure that the new document meets the requirements. At the same time, review and approval are required. 9 How should laboratory documents be regularly reviewed and updated? Laboratory documents need to be regularly reviewed and updated to ensure their relevance and completeness. System documents, standard documents, etc. need to be reviewed at least once a year ； Work instructions, method documents, etc. need to be reviewed regularly on a set schedule or as required by the laboratory. During the review process, aspects such as the practicality, accuracy, and completeness of the documents need to be considered, with timely revisions and additions made. At the same time, after the update, it needs to be issued under controlled conditions again, and the relevant personnel must be informed. .