This document applies to the preparation of a Standard Operating Procedure (SOP) within the Human Metabolome Project regarding common procedures, like: laboratory compounds analysis, chemical acquisition procedures, sample identification, biosafety certification, obtaining ethics approval, sample collection, et cetera.
This document describes how to write an SOP and illustrates the format design and guidelines for the preparation of all Human Metabolome Project SOPs.
3. Procedure Description:
This procedure -How to Write a Standard Operating Procedure- provides a rule to format and structure all future SOPs for the Human Metabolome Project, to establish a consistent approach for the SOP writing process.
All SOPs must contain the following:
3.1. Header/Footer: The standard format is a Header with the SOPís title, number, and version ID. The Footer contains the SOPís author name, page number of, creation and approval dates.
3.2. Scope: The scope is to whom and what the document applies.
Example: This document applies to SOPs writing.
3.3. Objective: The SOP aims to harmonize the procedures carried out.
Example: This SOP sets formatting standards.
3.4. Procedure: The SOP describes the steps to perform the procedure. Where necessary will refer to supplementary documentation (i.e. when there are a large number of steps).
3.5. Materials: The SOP describes the materials used.
Example: A procedure involving a chemical compound (i.e. Glucose) will indicate purity, concentration, amount, and any other pertinent information.
3.6. Equipment: The SOP describes equipment, its function and operational steps.
Example: How to measure pH with the pH meter.
3.7. Documentation: The SOP brings up all supplementary documents, and cross-references with other SOPs, as well as their location both electronically and hardcopy.
3.8. Safety: The SOP addresses all safety issues regarding the task.
Example: The SOP describes any necessary steps to perform a safe work (i.e. wear a mask) as well as the location of the Materials Safety Data Sheets (MSDS).
3.9. Records: The SOP states where to annotate and keep records (electronic and hardcopy).
3.10. Responsibilities: The SOP assigns responsibility for the procedure. Name and dated signatures are mandatory for SOP author, reviewer, and approval.
3.11. Signatures:††††††† Authors, Reviewers, and Authorizing signatures should be attached at the end of the document, with date of approval.
4.1. This document gives detailed instructions to consistently perform the work, in a consistent and repeatable fashion. It may be useful for training; however, is not intended to replace it.
4.2. When the process involves numerous steps, SOPs should be written to describe sub processes (i.e. a buffer preparation, necessary for an analysis), and cross referenced by title/ID.
5.1.The SOP should be divided in sections (where appropriate):
5.2.2. Maintain style and consistency across documents to assist in their readability.
5.2.3. State scope and objective at the beginning.
5.2.4. Give a descriptive title. Provide a tentative ID.
5.2.5. Illustrate the procedure by dividing it in small steps, described in one sentence.
5.2.6. Avoid a long list of bulleted items (<12).
5.2.7. Emphasize topics where mistakes are more likely to occur.
6.1.1. Follow this procedure to write SOPs.
6.1.2. Submit a draft for review and approval.
6.1.3. Cite reviewers and distribution list.
6.2.1. Provide feedback and (if) necessary corrections.
6.3.1. The SOP requires approval from Dr. David Wishart.
This SOP was written by:††††††††††††††††††††† Dan Tzur___________________________
This SOP was formatted by:†††††††††††††††† Dan Tzur___________________________
This SOP was reviewed by:††††††††††††††††† __________________________________
This SOP was authorized by:††††††††††††††† Dr. D Wishart† _______________________