Ten simple rules on how to write a standard operating procedure(1)
Standard operating procedures (SOPs) for industrial processes to achieve efficiency, quality, and uniformity of performance have existed. SOPs ensure that the user operates following consistent processes that meet best practice standards. Moreover, the use of SOPs ensures that processes are reviewed and updated regularly and that researchers inside and outside the same group or institute are enabled to reproduce or reuse results to enlarge the study or for other studies. the implementation of standards in the daily research work to improve research quality and data reuse. Simple rules in the routine research practice within an SOP format aid the transparency of results and exert a decisive impact on scientific reproducibility. The implementation of a minimal quality assurance (QA) system as a systematic approach to review practices and procedures is inherent logical.
Rule 1: Knowing when to write an SOP
Depending on the peculiarity of research you can choose an appropriate SOP format or develop your own. The resulting unique template can then be further used by all members of your group, department, or institution and by your wider community of practice.
Rule 2: Write the introduction: describe the purpose (the why)
An essential aspect of any SOP is introduction and purpose forming. The introduction section specifies the need and capability of the procedures for the research environment in which the process is being established. Simplicity is complex. It’s never simple to keep things simple. Simple solutions require the most advanced thinking.
Rule 3: Set up the document structure
Every single SOP should consist of three sections: 1) the cover page: configure management and compliance standards, 2) the sequence of steps or tasks (metadata) for the given procedure, and 3) a list of references and definitions.
Rule 4: Fill in the content
Consider the knowledge and skills of potential users and the level of detail to present the process description. Long preambles should be avoided. Work instructions should follow a single style and follow a stepwise process strictly. Balance the level of detail, avoid unnecessary specification and alternatives.
Rule 5: References and definitions: Specify tools required for the task
Reference materials can include normative documents, instructions, and standards as well as research papers, graphical material, photographs, and even different SOPs.
Rule 6: Set up responsibilities and nominate reviewers and approvers
Reviewers should have appropriate scientific knowledge and expertise as well as experience in the field.
Rule 7: Test with a colleague: Perform training
The test person should be able to run the experiment without any support.
Rule 8: Review and approve
The SOP is clear for everybody. Issues or reasons for deviations as well as necessary changes or modifications in the SOP should be discussed with and signed by all involved stakeholders and supervisors, respectively.
Rule 9: Update document: Specify validation and periodic review date
An SOP must be regularly to keep it up to date and useful for current and future use. All SOP should be validated and reviewed periodically to improve the document and reflect any changes that have been made or are necessary. All changes should be entered into a revision form, which comprises version number, change data, reason and description for change, reviewers’ data, and signatures.
Rule 10: Publish
The people performing the work should have easy access to the work instructions anytime and anywhere, most easily accomplished by setting up a secured team server or cloud on which all latest versions are uploaded.