Title

Roll out a document control system

Why

In phase 1 the Biosafety Manual was developed. In phase 1, phase 2 and phase 3 many SOPs have been and will be developed with the aim to standardize the activities performed in the laboratory and to assure the quality. Moreover, later in phase 2 the Laboratory Service Manual will be developed and in phase 3 the Quality Manual. As time goes by new knowledge becomes available on how to make procedures more efficient and optimize performance, requiring periodic adaptation of SOPs. The laboratory organization will also change, demanding adaptation of the Quality Manual. The same applies for the Biosafety Manual. To ensure that SOPs, Quality Manual chapters and Biosafety Manual chapters stay up to date a document control system needs to be developed.

What

Set up a document review schedule. The document control log is the most important tool in the document review schedule: in the document control log the authorization date of each document is indicated and the date before which each document must be reviewed and, if necessary, revised. The Quality Officer must coordinate the review of documents: he/she must assign the author and reviewers to start the reviewing process for the document to be reviewed. Review of documents must be done on a yearly basis in the beginning, a period which can be prolonged to two years once the quality management systems has matured (the time it takes for a quality management system to mature is difficult to define because this can vary per laboratory).


The review process consist of reading the document, including its appendixes and forms by the author and checking whether it still describes the way things are organized/the procedure as they are actually carried out in practice. When deviations from the situation in practice are detected, the document is adapted by the author and he/she must describe the changes in the remarks section at the front page of the SOP. During the review the author must also check if the references to other documents, to locations and to pieces of equipment are still correct. The reviewers must subsequently review the new version of the SOP in the same way as they reviewed the SOP after it was first written. The same applies to the authorizer.


When the new version of the document is reviewed and authorized for release, the Quality Officer replaces all copies of the old version at all locations as indicated in the document control log/on the front page of the SOP. He/she archives one copy in the quality documents archive that is to be established in the next activity. The previous version of the SOP in the archive is clearly marked as "replaced" with the date on which it was replaced and the initials of the Quality Officer. Other copies of the previous version of the SOP are destroyed.


Part of the document control activities is also going through the laboratory archive to filter out the documents that can be destroyed because they have exceeded the time they need to be archived as indicated in the Document Retention List (produced earlier in phase 2). This needs to be done once per year.

How & who

Quality Officer:

  1. Set up the document review schedule according to the description above.

Back to Roadmap Activity Overview
This activity belongs to the QSE Documents & Records

 

ISO15189:2007: 4.3.1 4.3.2
ISO15189:2012: 4.3 5.5.3
ISO15190:2003: