9.4 Standard Operating Procedures (SOPs)
Robin L. Potter
A standard operating procedure (commonly referred to as SOP) is a specific type of document that consists of instructions for controlled processes. Controlled processes include steps or procedures that must be performed consistently and accurately each time that they are performed due to safety, quality control, or testing considerations. SOPs help organizations maintain consistency in the performance of critical tasks by many employees. The SOP informs the reader about the procedure’s authorization, frequency, purpose, scope, and revision history. It also contains a description of the equipment needed and the steps that must be followed in a specific sequence.
Often used in contexts where testing requirements are stringent and where safety is top of mind, these documents help employees maintain quality and safety in their work. Specifically, SOPs are used in the following areas (de Sain & Sutton, n.d.):
- Manufacturing
- Testing Methods
- Quality Testing Methods
- Maintenance
- Calibration
- Equipment Use
For example, SOPs are required in the pharmaceutical industry to regulate how drugs are manufactured, handled, stored, distributed, sold, transported, labelled, and destroyed. These documents form part of departmental audits by regulators, so they must be frequently and regularly updated.
In addition, SOPs can be used in business, such as in finance, human resources, administration, customer service, and marketing (Brampton Small Business Enterprise Centre, n.d.). In essence, the document guides professionals in performing their responsibilities in a standardized or uniform manner. More importantly, in the sciences, manufacturing, and quality assurance, SOPs enable organizations to comply with the standards established by laws, regulations, and policies. Review the video below about the importance of having and following a SOP.
(The Importance of a Standard Operating Procedure, 2022)
SOP Format and Components
The format of SOPs is standardized in that typically, within an organization, the SOP format is uniform across the organization. The title page must contain a standardized header (See Figure 9.4.1). Though there may be some variance across organizations within an industry, the page 1 header usually includes the following elements:
Table 9.4. 1: Components of page 1 of SOPs
Component |
Description |
|
Title |
The SOP title—written using specific and concrete language
Example: Standard Operating Procedure for the Testing of COVID-19 Samples |
|
Company name |
The name of the company that created the SOP | |
SOP number |
A unique identifying number used for tracking purposes | |
Pagination |
Page number, along with the total number of pages
Example: 1 of 5 |
|
Applicable to |
Employee roles to whom the SOP would apply: e.g., supervisor, lab technician | |
Effective date |
The date when the SOP went into use | |
Version number |
A number indicating the document version | |
Originator and date |
The person who originated the document | |
Verifier and date |
The person who verified the document prior to circulation |
|
Authorizer and date
|
The person who authorized the release of the document |
You can see by the example in Figure 9.4.1 below how the various components for page 1 of SOPs are typically distributed.
|
Figure 9.4.1: Sample SOP title page header.
The body of the SOP typically contains these components:
Table 9.4.2: Typical sections of SOP documents
Components |
Description |
Purpose |
Briefly states the purpose of the document. |
Scope |
Delimits the scope of the document: the procedural elements it covers and does not cover. |
Responsibility |
Describes the responsibilities of person roles who would likely be involved in supervising or performing the process. |
Frequency |
Indicates how frequently the procedure must be completed |
Safety notices |
Includes caution, danger, and warning notices as applicable to the procedure. |
Definitions/abbreviations |
Clarifies any important technical terminology used in the SOP |
Associated documents |
Lists documents used to inform the creation of the SOP; may include laws, codes, regulations, material safety data sheets (MSDS), safety data sheets (SDS), and the like. |
Equipment and materials required |
Lists any equipment or materials required for the tasks to be performed; includes personal protective equipment. |
Procedure |
Explains in a numbered sequence the steps that are required to complete a task. |
Version history |
Includes a chart indicating the revision numbers and dates. |
References |
Lists the resources used to create the SOP. |
Knowledge Check
To view sample SOPs, click on the following links:
- SOP for the Calibration and Maintenance of Weigh Balances (U.S. Environmental Protection Agency (2017).
- Operational Procedures: Calibration procedures for common equipment used by the CFIA Inspectorate
- Manitoba. (2020, November). SOP for Protocol Swabbing (Adult and Pediatric).
Format Requirements
SOPs must be created using standardized formatting consisting of the following:
- Include the SOP title and number, company name, and page number on every page.
- Format the page number as follows: page X of Y—page 1 of 5.
- Single-space all text, and add a line space between bullet/listed items.
- Number all the parts of the SOP as follows: (e.g., 1, 1.1, 1.1.1, 2, 2.1, 2.1.1. . .) and nest (indent) sub-steps.
- Use bold to highlight headings.
SOP Language and Style
Like any set of instructions, SOPs must be clear and straightforward, so use language that is precise and specific to convey information relating to the procedure. Follow these tips for creating an effective SOP style (see examples in Table 9.4.3):
- Use clear, specific, and concrete language.
- Choose straight-forward vocabulary.
- Use a concise, active, and direct approach.
- Use the imperative mood by preferring the action word for each step.
- e.g., “Place the tachometer trigger on one half of the rotor unit.”
Table 9.4.3: Examples of vague and specific wording
| Vague Wording | Specific Wording |
| for a few minutes | for 5 minutes |
| add a few drops at a time | add 0.1 ml at a time |
| store in the freezer | store at -20°C to -30°C |
| incubate | incubate at 37±1°C |
| spin down the sample | spin at 10,000 rpm for 10 mins at 2-8°C |
The SOP Lifecycle
SOPs are created to address the need for compliance to laws, regulations, or policy and serve to establish norms for the performance of specific types of tasks. These documents, then, are created with careful attention to task requirements, compliance exigencies, quality control, and revision protocols.
Include these steps when creating an SOP:
- Clearly identify and define the need and audience for the SOP.
- Complete a thorough task analysis so as to create a complete procedure.
- Submit the draft document for review by various stakeholders including managers and users.
- Test the document and obtain feedback via survey, interviews, and/or observation.
- Revise the document and submit it to a quality assurance review.
- Ensure the document is compliant to laws, regulations, and policies so as to pass audits.
- Track revision dates.
- Control old SOP versions (may involve collecting and destroying outdated SOPs).
For more information about instructions generally, please refer to Chapter 9.3: Instructions.
Knowledge Check
References
Brampton Small Business Enterprise Centre. (n.d.). What is a standard operating procedure? https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf
De Sain, C. & Sutton, C. V. (n.d.). Standard operating procedures (SOP): Content, format, and management. http://hrvillage.in/docs/584_1.pdf. Document no longer available online.
Inspection Canada. (2019, December 12, updated). Operational Procedures: Calibration procedures for common equipment used by the CFIA Inspectorate https://inspection.canada.ca/inspection-and-enforcement/guidance-for-food-inspection-activities/sample-collection/calibration procedures/eng/1540301411823/1540302234709
Manitoba. (2020, November 25, rev.). SOP for Protocol Swabbing (Adult and Pediatric). SOP # CO-1. https://sharedhealthmb.ca/files/covid-19-sop-swab.pdf
US Environmental Protection Agency, Office of Pesticide Programs. (2017, March 2, rev.). Standard operating procedure for calibration and maintenance of weigh balances.
SOP Number: EQ-03-08. Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD. https://www.epa.gov/sites/production/files/2018-01/documents/eq-03-08.pdf