Recording procedures and activities of the laboratory in documents is one of the most important elements in quality management (write what you do and do what you write). Documenting all activities is a major factor facilitating standardization and diminishing variance of the activities.
In this phase and phase 1 most of the activities of the laboratory need to be documented. However, as the laboratory process is constantly changing due to new developments, the activities that are documented today may be obsolete over a year. This is why there should be a system that constantly monitors the documents of the laboratory and renews them when necessary.
In this phase a document control system will be established. This system enables the laboratory to review, revise and update all the standard operation procedures (SOPs) and from phase 3 onwards also the quality manual in which the policies and procedures are recorded on a yearly basis.
To create unity in the format and structure of the documents, all SOPs need to have the same layout and all documents need to be grouped with documents of the same nature (i.e. analysis SOPs are grouped together, as well as equipment SOPs and procedure SOPs). This grouping of documents is not recorded in standards; the laboratory needs to find out for itself how its documents can most logically be grouped (e.g. one laboratory may have grouped all its forms in a separate folder while another laboratory maintains all its forms as appendices to SOPs).
To keep oversight, all documents of the laboratory need to be coded. One part of this code indicates the group to which a document belongs, which number the document has in this group, and another part indicates the version number of the document. An example may best explain this:
Mind that the system explained in the above examples is to get a grasp of how a coding system could work. If another system is preferable in the local situation, then that system can be used as a coding system is not specifically required by the ISO or any other international standard/guideline.
Make sure that this SOP is read by all relevant personnel members.
Activities related to Phase 2 - Documents and Records
Up to now all templates of SOPs provided in this implementation guide already had space allocated for filling out the version number, name of the laboratory, location, etc. These parameters should now be introduced in every SOP the laboratory has written up to now.
All SOPs (and later the quality manual chapters) of the laboratory should be reviewed and, when necessary, revised annually. The author, verifiers and authorizers as mentioned on the cover page of each SOP (meaning that these should be appointed for every SOP/quality manual chapter) should review the SOP to investigate if it is still up to date. With every revision the version number of a document increases.
Update all SOPs written up to now (also in phase 1) to comply to the following requirements:
SOPs are written in compliance to the SOP of SOPs
- SOPs are all coded and have a version number
- All SOPs have the same layout
All documents have a cover page including:
- A table indicating author, verifiers, and authorizers is included at the beginning of each SOP
- A table indicating the date the SOP became effective and the date the SOP has to be revised (one year ahead of the date the SOP became effective)
- A table with room for a description of changes in this version compared to the previous version.
- A distinction is made between equipment SOPs, procedure SOPs, and analytical SOPs.
- SOPs are verified by verifiers. The verifier is the person appointed to check the document on correctness and completeness. There can be more than one verifier per document. The persons that are appointed as verifier of a certain document is depending on the document and can thus vary per document.
- SOPs are authorized by authorizers. The authorizer is the person appointed to validate a specific document. Who is the authorizer depends on the document and can thus vary per document.
All personnel of the laboratory must be informed if an SOP is updated (via email or quality meetings etc.). These notifications are archived in a file on document control.
Also develop a document control log. This document provides the overview and status of all documents in the document control system. The format of the document control log should be a table consisting of two parts: one for current documents, one for retrieved documents.
Part one (current documents) should have the following column titles:
- Record number
- Current version number
- Effective per (date)
- Replace before (date)
- Distributed to (place where copies are stored)
- Continued per (date)
Part two (expired documents) should have the following column titles:
- Record number
- Code (previous version)
- All previous versions
- Effective per (only the latest retrieved version)
- Replaced per (only the latest retrieved version)
- Destroy date (10 years ahead)
Besides this document control log, the SOPs should be made readily accessible and communicated to the relevant staff (in meetings upon introduction/updating of SOPs).
- SOPs are written in compliance to the SOP of SOPs
In this phase a document control system will be established. One of the important aspects of a document control system is that the storage time of all different documents is known. For example: a retrieved SOP needs to be stored for 10 years and a copy of a patient report needs to be stored for 5 years.
The best way to create a good oversight to first determine the different types of documents that are used in the laboratory and then to determine the duration each document should be stored in the laboratory archive. Put this information in a matrix to get a good oversight. This matrix will become an annex of the SOP on Document Control that will be developed in the next step.
Example Document Retention List
The procedures regarding control of documents were not yet documented in an SOP (only the SOP of SOPs/Master SOP briefly describes that a system should be established regarding the control of documents). Therefore, write an SOP on document control that explains the procedures of identification, collection, indexing, access, storage, maintenance and safe disposal of quality and technical records. This system should involve all documents of the quality management system.
Examples of such documents are:
- Request forms
- Examination results and reports
- Examination procedures (SOPs)
- Laboratory work-books or sheets
- Accession records
- Calibration functions
- Quality control records (log sheets)
- Complaints and actions taken (requirement added in phase 4)
- Records of internal and external audits
- External quality assessment records/interlaboratory comparisons
- Quality improvement records (requirement added in phase 4)
- Instrument maintenance records, including internal and external calibration records)
- Lot documentation, certificates of supplies, package inserts
- Incident/accident records and action taken
- Personnel files
The SOP on Document Control must also define the length of time of archiving of all different types of documents and the method of destroying documents (preventing unauthorized people from viewing the document contents). This document retention list was made in the previous step.
If preferred, the document control SOP can be merged with the SOP of SOPs/Master SOP to contain all procedures regarding SOP development and maintenance in one document.
Make sure that this SOP is read by all relevant personnel members.
This facilitates identification of which SOPs are needed to cover the entire process.
The primary process consists of the pre-analytical level, the analytical level, and the post-analytical level. For a detailed explanation on process analysis refer to the CLSI GP26- A4 guideline Application of a Quality Management System Model for Laboratory Services. In chapters 6 (for GP26-A3 chapter 4 and 5) the Path of Workflow concept is explained; the contents of the complete primary process are provided.
The SLMTA provides an example table in which every process step is defined for an example laboratory including the steps which need to be documented in an SOP.
Based on the flowchart decide which activities need to be standardized in a procedure and draft a list of SOPs needed.
Subsequently assign staff members with the task to start drafting SOPs according to the SOP of SOPs. Assign staff members to draft SOPs for procedures they are most acquainted with.
Generic SOPs are available for reagent preparation for adaption to the local situation:
- Preparation of reagents for microscopy in a tuberculosis diagnostic laboratory
- Preparation of reagents for culture and drug susceptibility testing
- Preparation of plain egg-based media
- Preparation of Löwenstein-Jensen drug-containing media
- Maintenance of mycobacterial strains
- Reporting of test results
- Laboratory data archival
- Reception and accessioning – study specific sample flow procedures
- Digestion-decontamination of specimens using NALC-NaOH
- Preparation of PBS
- Preparation of MacFarland no. standards
- Preparation of 4% sodium hydroxide
- Preparation and dilution of bacterial suspensions
- MGIT lot-lot testing
- Preparation of blood agar (BA)
- Preparation of Middlebrook
- Preparation of 2.9% sodium citrate
- Preparation of formal milk
- Preparation of sterile saline
When appropriate: be sure to also make work forms that should be filled out to keep track of what has been done. This was already done in phase 1. For example: a workfom should be used for the preparation of media: how much has been prepared, what were the lot numbers of the reagents used, by whom was the media produced, etc. A folder should be made to store filled-out forms in. Use a different folder for every type of form.
Make sure that these SOPs are read by all relevant personnel members.
In this phase the assignment was given to prepare bench aids for equipment use. These bench aids need to be in accordance with procedures described in SOPs at all times. Since now many SOPs have been developed or are still in development, check if all bench aids are in concordance with the new SOPs.