Document Control_TB 01-03_V1.0.doc
Table of Contents
1. PURPOSE 2
2. SCOPE 2
3. RESPONSIBILITIES 2
4. CROSS REFERENCES 3
5. PROCEDURES 3
5.1 Preparing SOPs 3
5.2 Numbering Documents 4
5.3 Document indexing 4
5.4 Revising Documents 4
5.5 Using SOPs 5
5.6 Access and location of SOPs 5
5.7 Document Retention 6
5.8 Obsolete Documents 6
5.9 Electronic Documents 6
6. QUALITY ASSURANCE AND QUALITY CONTROL 6
7. REFERENCES 7
8. CHANGE HISTORY 7
1. PURPOSE
To assure that Quality Management System documents used by ______ TB Laboratory employees are properly developed, approved, active and located where needed. This SOP describes procedures of identification, collection, indexing, access, storage, maintenance and safe disposal of quality and technical records. The following types of documents are controlled by the document control procedure:
§ Quality Manual, Standard Operating Procedures (SOPs) and forms, Quality Plans and Test Plans
§ Work instructions
§ Regulations, standards and other reference materials
2. SCOPE
This procedure applies to the control of documents, including electronic and external, affecting quality such as methods, regulations, directives, procedures and instructions, pertaining to the ______TB Laboratory Quality Management System (QMS).
3. RESPONSIBILITIES
This SOP applies to all laboratory technical staff, Quality Manager and the Head of the ______TB Laboratory:
Responsibility / TaskQuality Manager (QM) or Quality Manager Officer (QMO) / § Implements and maintains document control system,
§ Coordinates reviews and revisions of quality system documents,
§ Maintains Master Index to ensure active and revised documents are provided to staff. Master Index must contain, Document Number, Title, Revision Level and Review date.
§ Archives superseded or obsolete documents.
§ Reviews SOP prior to use
§ Ensures that all routine operations and activities are documented by SOPs.
§ Creates or delegates creation of documents.
Laboratory technical staff / § Responsible for verifying that the official version of the document is used by checking the Document Control List kept by the QM or QMO.
§ Reviews and determines need for new procedures or revision of procedures and to convey that need to their immediate supervisor or QM or QMO.
§ May also initiate changes and creation of documents by completing a Document Change Request (DCR) form,
§ It is the responsibility of the author of an SOP to include sufficient detail that the process or procedure can be followed by another person when needed.
Head of the ______TB Laboratory / § Approves and authorizes all technical standard operating procedures
4. CROSS REFERENCES
See: / Document Matrix_TB 01-01_V1.0.docArchival Log_form.doc
Document Control List_form.doc
Document Change Request _form.doc
Location:
5. PROCEDURES
5.1 Preparing SOPs
· Identify the need for an SOP or the revision of an existing one by informing the supervisor or QM or QMO.
· Once the need for a particular SOP is established, it should be drafted immediately.
· SOPs are drafted by the laboratory or supervisory staff qualified to perform the procedure. Next the SOP is reviewed by other staff, where possible and then approved by the appropriate authorities. Circulation to staff prior for review/comment is advisable prior to acquiring management approval.
· The SOPs should be written to describe methods or processes in sufficient detail so as to ensure the quality and integrity of the data or procedure to be followed.
· When writing SOPs, the detail may include both procedural requirements (exact instructions) and guidance information (general information) on the procedure.
· Procedural requirements must be followed exactly, while guidance information is used to help perform the procedure; it is not a mandatory requirement and therefore it does not have to be followed exactly.
· Procedural requirements can be distinguished from guidance elements, based on the context they are used (e.g. MUST or SHALL indicate the action as a procedural requirement and command statements)
· Follow the ______TB Laboratory standard format for margins, font and font size.
· Official SOP’s will have a header and footer, dated signatures on the front page.
· Use an outline format and include alpha and/or numeric characters to indicate levels of information.
· The SOP/Documents must include the following if appropriate:
o Header and footer, detailing:
o SOP number assigned by the QM or QMO, is based on defined categories
o Page number in the format: Page X (current page) of Y (total number of pages)
o Revision number (new SOPs will be indicated by the use of a 1 and subsequent revisions will be marked 2,3,4 etc.)
o Release date (date when procedure has been approved by all parties for use)
o Title page
o Identifier/Title
o Table of contents
o Policy, Purpose and Scope
o Principle (Technical documents)
o Definitions (if any terms need to be defined) and Abbreviations
o Personnel responsibilities
o Health and safety warnings and cautions (primarily for technical SOPs)
o Interferences (primarily for technical SOPs)
o Equipment and Supplies (primarily for technical SOPs)
o Procedural Steps
o Data and Records Management
o Co-applicable documents
o Quality Assurance and Quality control
o References
o Document revision history
5.2 Numbering Documents
· Documents are numbered sequentially based on assignment to a specific category:
o 01 – Laboratory Quality
o 02 – General Procedures
o 03 – Specimen Handling
o 04 – Microscopy Procedures
o 05 – Culture and Drug Susceptibility Testing
o 06 – Molecular Methods
o 07 – Equipment Use and Maintenance
· Type of document:
o SOP – Standard Operating Procedures
o EM – Equipment Manuals
o FR – Forms
o EOI – Equipment Operation Instructions
o TX – Text books
· The document number will appear as ______TB Laboratory, followed by 3 digit number for category, 2/3 letters for type of document and 3 digits for number within type.
· The first approved version of an SOP will be numbered as 1.0. Reviews that result in minor changes are numbered as 1.1 etc. and 2.0 for major changes.
· The QM or QMO is responsible for assigning SOP numbers and determining category. Numbers are assigned sequentially and may only be used once, i.e., numbers cannot be re-used even if a procedure is eliminated or incorporated into another SOP.
5.3 Document indexing
Each document will be listed numerically on the Document Control List.
5.4 Revising Documents
· If the SOP does not accurately describe the procedure, then the SOP must be revised. Any change in the procedure must be incorporated into the SOP. However, prior to any change to the SOP, management must be advised of, and approve, the change.
· Finalized SOPs, containing typographical errors, printing errors, e.g. wrong page numbers or misaligned sentences) or any errors that do not affect the scope of the procedure may be corrected immediately and reprinted. These types of errors do not require full SOP revision, thus the revision number will not be generated and management approval is not needed. If the error occurs on the signature page then the signature page will be resigned. These types of corrections will be traceable since the historical file will reflect all corrections including typographical errors. Specifically, the historical SOP file will contain both the SOP with the correct pages as well as the pages containing the error. The page with the error will not be removed from the historical file.
· Additions can be made to an SOP via a clarification or an addendum.
· Clarifications and addendums must be attached to the applicable SOP until such a time that the SOP can be revised. Generally, the revision will be incorporated during the annual review process.
· Hand written amendments are acceptable, providing all copies of the document are clearly marked, initialed and dated. Explanation of the amendment should be documented. Formal revisions of these will be issued during annual review.
· When the SOP is revised, the revision number is updated. Revisions, clarifications and addenda are prepared by the appropriate personnel but must be approved by management.
· An SOP can be eliminated or made obsolete when it is no longer applicable. Management must approve the elimination of the SOP. Two or more SOPs can be consolidated; in this case one SOP supersedes the other, but management approval is required for consolidation of procedures.
· The signed copy of a revised SOP must be sent to the historical file for archiving.
5.5 Using SOPs
· Prior to performing a procedure for the first time, the individual must document in writing that they have read and reviewed the specific SOP.
· In addition, the laboratory technical staff should review all SOPs at least once a year to ensure that each SOP accurately describes the procedure in use. The review will be documented in writing in the form of signatures. SOP review signature logs will be maintained in the QM office.
· All procedures must be performed in accordance with the written SOPs.
· If a given procedure is not performed in accordance with the pertinent SOP, then all SOP deviations must be written to document the change in the procedure
· The Head of the ______TB Laboratory must be informed and must acknowledge in writing the occurrence of the SOP deviation and must determine the effect, if any, the deviation may have on the integrity of the data.
· All deviations must be filed with the test information.
5.6 Access and location of SOPs
· Appropriate SOPs will be placed in files to be found in a designated spot in each work area and shall be available to all concerned personnel. The files should not be located in the supervisor’s office. Removal of an individual SOP from a file requires the completion of a sign-out form located in the file. The section supervisor approves this.
· It is the responsibility of the QM or QMO to update each SOP file as individual SOPs are revised.
· Staff is required to read any revised SOP within 7 working days of issuance if the SOP is applicable to their work.
· Reading of the updated SOP requires signature on the SOP review sheet.
5.7 Document Retention and Archiving
· A historical file is created for each document that is approved by management and will be maintained in the archives by the QM or QMO.
· The historical file will consist of the original signed document and all subsequent modifications thereof including the current document.
· If a procedure is incorporated into another SOP (superseded) a copy of the superseded version is placed in the historical file of both SOPs.
5.8 Obsolete Documents
· Obsolete documents that a retained for reference or legal obligations are marked OBSOLETE and are kept separate from active documents. Obsolete electronic documents are removed from the network and are stored in media that are only accessible to authorized personnel. Any obsolete documents that need to be reactivated must be reviewed, approved and released in the same manner as newly established documents.
· At least one copy of all obsolete documents must be archived.
5.9 Electronic Documents
· Electronic documents are writing protected and controlled by the QM or QMO. Requests for revisions to electronic documents must be made to the QM or QMO. All electronic documents indicate the approval signatures required.
6. QUALITY ASSURANCE AND QUALITY CONTROL
· All SOPs are reviewed by QM or QMO/Head of the ______TB Laboratory with assistance from the applicable supervisor at least once a year in order to maintain relevance.
· Before January 31st of each calendar year, a list of all SOPs which have been revised are provided to the QM or QMO by the supervisors. Due to the large numbers of documents, different lab sections can be scheduled for review throughout the year and QM or QMO keeps documentation of this.
· For those SOPs that do not require a revision, documentation attesting to that fact must be submitted to the QM or QMO who in turn initials and dates the table located at the end of the original SOP.
· All manuals and SOPs distributed shall have copy numbers written in coloured pen.
· All signatures on documents shall appear in coloured pen to clearly distinguish them form copies.
7. REFERENCES
Quality Manual. ______TB LABORATORY. Current Version
8. CHANGE HISTORY
New version # / date / Old version # / date / No. of changes / Description of changes / Source of change requestPage 2 of 7