A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures.
Although the presentation may differ from the order described here, it must comply with Good Document Practice (GDP).
The following standard operating procedure sections are included for completeness; their inclusion in a specific standard operating procedure is a decision for site management.
At a minimum, the header should include the site details, title, document number, version number, and revision date.
- Site details may include the site or corporation’s logo or printed details.
- Document description can be “Standard Operating Procedure” or “Standard Operating Procedure Appendix.”
- The standard operating procedure number must be unique and comply with a documented numbering system.
- Title is the subject of the procedure. (Note: there is no value in restating the description.)
- Superseded standard operating procedure number is included for traceability. This information is especially helpful when a numbering system changes or the contents of a standard operating procedure change radically.
- Issue date is recorded because standard operating procedures may be issued in advance of the effective date, which is preferable because it allows for an orderly transition and time for training.
- Review date is noted to ensure that a review takes place before a standard operating procedure is no longer valid.
- Effective date is the first day on which a standard operating procedure is valid.
Every page should show the unique page number and the total number of pages contained in the standard operating procedure (i.e., Page X of Y). This might be included the header, the footer, or both places.
The standard operating procedure’s purpose, objective, and scope of systems, equipment, facilities, and/or process are best described in the introductory sections of the document.
Standard operating procedures must include an approvals section or page where owners can append their signatures and the date of their signing.
Additional sections:
- Table of Contents
- Definitions and Abbreviations
- Roles and Responsibilities
- Procedure
- Revision History
- References and Related Documents
- Appendixes and Attachments
Although generating and maintaining standard operating procedures can seem time-consuming, the best standard operating procedures adapt to contingencies without major modifications.
The value of producing standard operating procedures that are clear, concise, and intuitive is usually evident when things go wrong, at which time the cost of any corrective action may be greatly magnified.
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Resource Person: BARBARA PIROLA