Which Guidelines Can Assist Sop Authors in Writing Instructions That Are Easy to Read and Follow

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10 simple rules on how to write a standard operating procedure

• Susanne Hollmann,
• Marcus Frohme,
• Christoph Endrullat,
• Andreas Kremer,
• Domenica D'Elia,
• Babette Regierer,
• Alina Nechyporenko,
• on behalf of Price Action CA15110

x

• Published: September three, 2020
• https://doi.org/10.1371/journal.pcbi.1008095

Figures

Abstruse

Research publications and information present should be publicly bachelor on the internet and, theoretically, usable for anybody to develop further enquiry, products, or services. The long-term accessibility of enquiry data is, therefore, central in the economy of the research production process. Even so, the availability of information is not sufficient by itself, but also their quality must exist verifiable. Measures to ensure reuse and reproducibility need to include the entire enquiry life cycle, from the experimental design to the generation of data, quality control, statistical analysis, interpretation, and validation of the results. Hence, loftier-quality records, especially for providing a string of documents for the verifiable origin of information, are essential elements that tin act every bit a certificate for potential users (customers). These records also improve the traceability and transparency of data and processes, therefore, improving the reliability of results. Standards for data acquisition, analysis, and documentation have been fostered in the last decade driven by grassroot initiatives of researchers and organizations such every bit the Research Data Brotherhood (RDA). Nevertheless, what is still largely missing in the life science academic research are agreed procedures for complex routine research workflows. Here, well-crafted documentation like standard operating procedures (SOPs) offer clear direction and instructions specifically designed to avert deviations as an accented necessity for reproducibility.

Therefore, this paper provides a standardized workflow that explains step by step how to write an SOP to exist used as a starting signal for appropriate research documentation.

Commendation: Hollmann Southward, Frohme K, Endrullat C, Kremer A, D'Elia D, Regierer B, et al. (2020) 10 simple rules on how to write a standard operating process. PLoS Comput Biol 16(nine): e1008095. https://doi.org/10.1371/periodical.pcbi.1008095

Editor: Scott Markel, Dassault Systemes BIOVIA, UNITED STATES

Published: September 3, 2020

Copyright: © 2022 Hollmann et al. This is an open up access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in whatever medium, provided the original author and source are credited.

Funding: This work has been funded by Price (European Cooperation in Science and Technology) CA15110. The funders had no office in written report blueprint, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Nowadays, digital technologies are integral to how knowledge is produced and shared, and science is organized. Data availability is a disquisitional feature for an efficient, progressive, and, ultimately, self-correcting scientific ecosystem that generates credible findings and has become a relevant chemical element of scientific integrity [one]. Nonetheless, the anticipated benefits of sharing are achieved only if data are of reliable quality and reusable [ii,3]. Despite this need, it has been shown that fewer than one-third of (biomedical) papers can exist reproduced in full general [four,5]. Farther studies showed that suboptimal information curation, unclear analysis specification, and reporting errors could impede reuse and analytic reproducibility, undermining the utility of data sharing and the brownie of scientific findings [vi–ix]. Standard operating procedures (SOPs) for industrial processes to achieve efficiency, quality, and uniformity of operation have existed since a long fourth dimension ago. SOPs ensure that the user operates following consequent processes that encounter all-time practice standards. Moreover, the utilise of SOPs ensures that processes are reviewed and updated regularly and that researchers inside and outside the aforementioned group or institute are enabled to reproduce or reuse results to enlarge the written report or for other studies. Despite their importance, the need for the use of standards in life science research has emerged every bit crucial for the quality and reproducibility of enquiry findings only in recent years [9]. The question of data quality and reproducibility poses new scientific and societal challenges for individual researchers, universities, scientific organizations, infrastructure facilities and funders, and the broader society [10]. The scientific community started to talk well-nigh a crisis of reproducibility and its dramatic touch on the economy and credibility of the research organisation [ix,11] around 2016. Many community-driven initiatives such as the Research Information Brotherhood (RDA) [12] and the European Commission prompted a serial of initiatives in support of the scientific community to cope with problems related to the demand of new tools and strategies to improve the harmonization of standard initiatives [xiii–14] and the implementation of standards in the daily enquiry work to meliorate inquiry quality and data reuse. Since and so, many steps forwards have been made in different fields of biological inquiry [15–20].

There are recommendations providing guidelines for maintaining reproducible results past just applying simple rules. Those rules include the utilize of error annotations for produced data that are viable for evaluating the impact and credibility of single data associated with the generated results. Furthermore, it is essential to use annexes when research projection results are published. Annexes aid the traceability of findings and the reproducibility of performed experiments and can be linked to the aforementioned error classifications. Input files, forth with data of the practical software versions, perfectly fit into annexes and play a pivotal role for reproducing results. Finally, adopting these simple rules in the routine research practice inside an SOP format aid the transparency of results and exert a decisive impact on scientific reproducibility [21]. Against this background, the implementation of a minimal quality assurance (QA) system equally a systematic approach to review practices and procedures is inherent logical [22]. QA systems enable the users to identify possible improvements and errors and provide a mechanism for their utilize, for example, by developing and deploying a failure mode and effects assay (FMEA) [23]. The footing of each quality system is a high-quality record providing a cord of documents for the verifiable origin and quality of data. Also, the full general documentation improves the traceability and transparency of research findings to evidence the reliability of results. Such quality control systems should be based on and be in line with good laboratory practices (GLP), well-divers and validated protocols, and comprehensive SOPs [24–25]. The advantages of implementing SOPs in the daily workflow of bookish researchers might not be immediately obvious and enlighten everyone. At first, information technology seems to be unnecessary and avoidable extra work. Indeed, without appropriate preparation, the setup of an SOP is time-consuming and does non appear to be a relevant asset. However, because each SOP describes one procedure simply and not a serial of complex procedures the efforts to exist done remain viable. For this reason, nosotros provide yous here with "x Simple Rules on How To Write an SOP" that will enable you lot to produce a reliable and verifiable set of your research data.

Results

The Ten Rules

Fig ane demonstrates the workflow of SOP writing forth the line from its preparation, validation, and approval to its implementation and follow-upwards processes, which will be detailed in the following x rules.

Rule 1: Knowing when to write an SOP

SOPs are ever needed when critical processes or workflows demand to exist repeated in a reproducible way or when defined procedures are obliged by compliance guidelines. In other words, SOPs are vital instruments for maintaining consequent quality. Hence, every research institution which faces such processes, compliance requirements or has demand for quality should be encouraged to develop new or follow existing SOPs. Crosscheck inside your establishment for templates. There is no need to reinvent the wheel. Oft templates are existing in your institution, merely their beingness might not exist well communicated. Contact your data or quality managing director for information. In that location also often exists a shared team server or cloud, containing all internal SOPs being accessible for each appropriate member or user, respectively. If your institute or department does not have official templates, inquire other groups if they already take SOPs in use. If so, your colleagues should be happy to share their noesis with you. If there is no template available, you have a pioneering role. In this case y'all tin run a quick online search for SOP templates to be used as a starting betoken. It is wise to involve the technicians of your lab too as the leader of your group or section and the quality manager and/or data manager of your institution. The initial stride is at present to draft a encompass sail and discuss the content of the SOP with the relevant stakeholders (reviewers and approvers) of your establishment (Rules iii and six). Depending on the peculiarity of research you lot can choose an appropriate SOP format or develop your own. The resulting unique template can and then be further used by all members of your group, department, or institution and past your wider community of practice.

Rule 2: Write the introduction: depict 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. Identify the specific reason you decided to write your SOP. Which specific process do you lot address? Which specific procedures will be covered, and which are not covered? Clarifying what the specific focus of your certificate is will facilitate the apply of your SOP by your colleagues. Richie Norton writes, "Simplicity is complex. Information technology'southward never simple to keep things simple. Simple solutions crave the almost advanced thinking" [26]. The way y'all frame the information describing the process matters. Consider "less is more than." Trying to tackle besides much at in one case will mostly simply lead to confusion. Represent the complex aspects of a process in a mode to make it as simple equally possible to make information technology also understandable even for users who are not from your field.

Dominion 3: Ready the document structure

Every single SOP should consist of 3 sections:

1. The encompass page
2. The sequence of steps or tasks (metadata) for the given procedure (Rule 4)
3. A listing of references and definitions (Rule 5)

The embrace folio

The cover page represents a control block used to house the document control information required to configure direction and compliance standards.

It should contain the post-obit information (Fig 1):

• administrative information about the institution and/or department
• a title that conspicuously identifies the activeness or procedure
• an SOP identifier (ID) number (or versioning) with its category (Table 1)
• page number and full number of pages of the SOP
• the date of outcome (or of versioning)
• possible safety instructions
• the names of individuals who prepared and approved the SOP
• the proper noun of the reviewers, including the date of the review
• a description of the purpose and field of application
• the name and function of the author
• the name and role of the approver

There are standardized abbreviations to describe elements of the respective SOP on the cover page. Tabular array 2 provides a list of typical abbreviations for an SOP category.

It is recommended to use a digital object identifier (DOI) for the identification of the SOP in accordance with ISO 26324:2012 [27].

Each post-obit page should take a heading and/or footing annotation mentioning (Table 3)

• administrative data almost the institution and/or section
• short title of the SOP
• page number and total number of pages of the SOP
• date of approval and/or version number

A version number can exist assigned in accordance with semantic versioning [28] recommendations as guidelines used in source command systems similar GitHub [29].

The presentation of dates, including date of issue, versioning, date of review, and blessing should exist in accordance with the format specified in ISO 8601 [xxx].

The final step in creating your SOP template should involve a notation on the styles, fonts, and margins that you intend to employ. You tin can download a full template SOP at Zenodo as a writable PDF [31].

Dominion 4: Fill in the content

The process.

Outset at page ii to compile the metadata. In this step you describe the activities and the sequence of steps or tasks for the given procedure. Always consider the aim of the SOP; this volition help you lot to focus on the specific procedure you describe. All the same, an SOP may contain multiple SOPs provided that each one is cited past number and full information is provided. Every user should be able to understand your work instructions. As George Orwell said, "Skillful [writing] is like a windowpane" [32]. Consider the knowledge and skills of potential users and the level of particular to present the process clarification. Long preambles should be avoided. Piece of work instructions should follow a single way and follow a stepwise process strictly. Balance the level of detail, avert unnecessary specification (e.thousand., "blue-cap tubes") and alternatives; if alternatives are necessary, explicate what dictates which action. Ensure consistency in terms of terminology, layout, media, and method and, equally much as possible, avert polysyllabic words, complex sentences, jargon, acronyms, or as well many terms (without explaining them). To facilitate handling of the dissimilar data types and formats within the aforementioned workflow, the impact of such diversity to the usability of data and metadata should be minimized. Consider the unlike work cultures and different circumstances within people'south piece of work and explain and describe the how and what to practice. To optimize the construction of you SOP.

• suspension the process into sections
• suspension the sections into specific steps
• number the steps or add bullet points for clarity.

Describe each task in detail, including timeframes and tools required to consummate assignments and achieve expected outcomes.

Rule 5: References and definitions: Specify tools required for the task

The workflow elements may involve different types of resources and tools. Depending on a item chore, the selection of tools can also comprise modeling and simulation tools, information repositories, and compiler construction tools. Exercise non forget to add relevant references. Reference materials tin include normative documents, instructions, and standards as well as research papers, graphical material, photographs, and even different SOPs. Provide all definitions of terms and abbreviations that are to be used in the procedure. Harmonize and align with standard terminologies used within your field. These should be provided as an addendum.

Rule 6: Ready responsibilities and nominate reviewers and approvers

Reviewers should be nominated and appointed responsible for each particular job. These persons should have appropriate scientific cognition and expertise besides every bit experience in the field. Normally, the initial SOP-writer(s) is/are responsible for monitoring and reviewing the SOP. They will ensure that the SOP reflects the tasks described in the certificate. Open word on controversial aspects related to the SOP should be allowed among reviewers to guarantee a proper revision. Changes to SOPs should preferably be made by the creator. Each change needs once more to be reviewed and approved by the responsible persons and by an increment of the revision number (Rule eight). The team of reviewers should concord on a timeframe to monitor and align the current state-of-the-art SOP.

Rule seven: Test with a colleague: Perform training

Congratulations! Past reaching this step you wrote your first SOP. Now it is time to check if the SOP is articulate and understandable for all potential users. Hence ask a colleague (information technology tin exist a researcher or a technician) to read the SOP and, if feasible, execute a examination run. Enquire the test person to be constructive and critical and wait for his or her feedback or questions. Consider that the test person should be able to run the experiment without whatever support. Do not interfere while testing to receive authentic feedback and to avoid falsifying the outcome.

Once written, it is essential that all staff is accordingly trained with and familiarized in the use of the new SOP. This tin can hands be integrated inside the annual rubber instructions or as role of a running seminar serial. Retraining should be conducted regularly just as well when in that location is a change in SOPs. Ensure that showing omnipresence at training is documented.

Rule 8: Review and approve

Once your SOP is tested, get in available for the reviewers' team for a final check. Once substantial comments are received, hash out them with your colleagues to ensure a successful outcome and that the SOP is clear for everybody. Include all relevant edits to improve the document. Repeat the process until the SOP is agreed past all stakeholders and, after, ship the document to the quality manager for approval afterwards. The last certificate should be sent to the assigned SOP approvers, who volition sign it. In example an SOP is out of date due to the introduction of new technologies or changes in the organizational structure, the SOP should be terminated, labelled (out of appointment), and archived for traceability. The new and valid version should be distributed. All valid versions should exist stored and accessible in a folder at a central location. By this, yous ensure that valid and approved SOPs be and every employee receives the data necessary for their work. To go along runway of whatever deviations from existing SOPs, the establishment and deployment of an exception log might be a powerful instrument. This log should ideally entail a documentation of whatsoever deviation, the reason for the difference, the effect, whatever troubleshooting which has been applied, and resolutions and appropriate communication. Regarding the latter, problems or reasons for deviations likewise as necessary changes or modifications in the SOP should be discussed with and signed by all involved stakeholders and supervisors, respectively [33].

Rule nine: Update document: Specify validation and periodic review date

Do not forget to review and update an SOP regularly to go along information technology upwardly to appointment and useful for current and future utilise. Your SOP should be validated and reviewed periodically to meliorate the document and reverberate any changes that have been fabricated or are necessary. All changes should exist entered into a revision grade, which comprises version number, change data, reason and description for change, reviewers' data, and signatures. The revised or updated document should be shared immediately with all respective users, while clarifying that the quondam SOP is outdated. The SOP compliance maintenance could exist easily implemented by using an electronic lab notebook (ELN), which might proceed track of all deviations automatically, dependent on software and functions.

In this case, ensure the interoperability of used formats to enable consign of the data into other systems. Furthermore, regular mandatory user training should be fix for the most important SOPs to ensure compliance.

Rule 10: Publish

Information technology's all very skillful to accept piece of work instructions, merely what is their value if they are merely available in your office when the users who demand them are somewhere else? The people performing the piece of work should have easy access to the work instructions someday and anywhere, nearly easily accomplished by setting upward a secured squad server or cloud on which all latest versions are uploaded. To add value to your SOP, make it available to a broad user community you should upload your SOP likewise in open access public repositories such as Zenodo [34], SEEK [18], OpenAIRE [35], FAIRsharing [36–37], or another.

Determination

Nowadays digital technologies and advanced computational methods are an integral part of daily laboratory practice. To best manage the generated information and avoid reproducibility issues, scientists demand to implement FAIR data principles, suitable DMPs, and appropriate documentation. The lack of reproducibility within laboratory research discourages successful implementation of the wide-spread adoption of research results in the scientific community. One manner to improve it is to provide consistency and traceability of existing standards and laboratory practices that are achievable with precise and clearly written SOPs.

Acknowledgments

This publication is based upon work from Toll Activeness CHARME CA15110 [14] supported by Cost (European Cooperation in Science and Technology). www.cost.european union.

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