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Standard operating procedures

Written instructions that document the “who”, “what”, “where” and “when” of an activity.

DESCRIPTION

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity carried out by an organisation. SOPs address the who, what, where and when of an activity.1,2 The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used.1,2

PURPOSE & LINK TO INTEGRITY

The development and use of SOPs is an integral part of a successful quality system, as they provide individuals with the information to perform a job properly, minimise variability and facilitate consistency and standardisation of the quality and integrity of a product or end result through consistent implementation of a process or procedure within the organisation, even if there are temporary or permanent personnel changes.

SOPs can indicate compliance with governmental requirements and can be used as a part of a personnel training programme, since they should provide detailed work instructions. They minimise opportunities for miscommunication and can address safety concerns. When historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project activities when no other references are available. In addition, SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility, and legal defensibility.1

KEY REQUIREMENTS

HOW TO

When developing SOPs, one should consider the following aspects:1,2

  • SOPs should be written in a concise, step-by-step, easy-to-read format.
  • They should be clear, complete, consistent and controlled. The information presented should be unambiguous and not overly complicated. SOPs should not include vague wording but should be formulated as precisely as possible.
  • SOPs need to remain current to be useful. Therefore, whenever procedures are changed, SOPs should be updated and re-approved.
  • Use a checklist of a consolidated set of work instructions for complex procedures.
  • Procedures should be written in chronological order.
  • Troubleshooting should be included where applicable.
  • Use the same format, font and tone for all SOPs.
  • The SOPs should be made up of the sections
    a) purpose, b) references, c) materials, d) procedure,
    e) forms and documentation.
  • Envision areas where deviation from SOPs may occur and address these.

KEY GUIDING DOCUMENTS

Bethmann, no year, Standard Operating Procedures, TACONIC, USA

EPA, 2007, Guidance for Preparing Standard Operating Procedures, United States Environmental Protection Agency (EPA), USA, http://www.epa.gov/sites/production/files/2015-06/documents/g6-final.pdf, accessed 07.12.2015

Homeland Security and Safecom, no year, Writing guide for Standard Operating Procedures, Homeland Security and Safecom, USA, http://www.dhs.gov/sites/default/files/publications/Writing%20Guide%20for%20Standard%20Operating%20Procedures.pdf, accessed 07.12.2015

FURTHER  READINGS

Gleason, 2013, Standard operating procedures (SOPs) – a quick guide

Grusenmeyer, no year, Developing effective Standard Operating Procedures, Cornell University, USA

Lorette, no year, How do I write a standard operations procedures manual?

FULL REFERENCES

  1. EPA, 2007, Guidance for Preparing Standard Operating Procedures, United States Environmental Protection Agency (EPA), USA, http://www.epa.gov/sites/production/files/2015-06/documents/g6-final.pdf, accessed 07.12.2015
  2. Bethmann, no year, Standard Operating Procedures, TACONIC, USA
Last updated 12 April 2019

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