Standard Operating Procedures (SOPs) are procedure level practices for key day to day functions and activities and provide the foundation for effective food safety and quality programs.SOPs and SSOPs are required as part of prerequisite programs in Hazard Analysis Critical Control Point regulations. They help to identify the control points, as well as their limits, to control and validate the process.
SOPs should be:
- Simple– concise, easy to understand, and easy to followso that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised
- Detailed– step-by-step instructions so anyone can perform the task
- Sustainable– should represent how sustainable practices are embedded in day to day operations
- Scalable– should have room for improvement or changes; it needs to be periodically reviewed to ensure they are accurate and up-to-date, reflecting any product or process changes.
How to create an SOP?
- Firstly, determine what procedures and processes need to be documented.
- Identify the individuals, the subject matter experts who actually perform the work or use the process, to write down these SOPs. A team approach can be followed, especially for multi tasked processes where the experiences of a number of individuals are critical.
- The experience requirement for performing an activity should be noted in the section on personnel qualifications.
- Any checklists or forms included as part of an activity should be referenced at the points in the procedure where they are to be used and then attached to the SOP.
- SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized.
- The finalized SOPs should be approved as described in the organization’s Quality Management Plan or its own SOP for preparation of SOPs.Signature (or E-Signature) approval indicates that an SOP has been both reviewed and approved by management.
- Each organization should develop a numbering system to systematically identify and label their SOPs, and the document control should be described in its Quality Management Plan.
- The organization should maintain a master list of all SOPs. The QA Manager (or designee) is generally the individual responsible for maintaining a file listing all current quality-related SOPs used within the organization.
- It should also designate where, and how, outdated versions are to be maintained or archived in a manner to prevent their continued use, as well as to be available for historical data review.