Maintain Standard Operational Procedures

Standard operating procedures (SOPs) are written documents that describe step-by-step in detail how a procedure should be done. SOPs describe both technical and administrative operational elements of an organisation. The standard operating procedure manual for food safety is to a large extent the documentation for a food safety management system. The SOPs contained in the manual is used during an internal audit to measure the actual procedures and processes that are employed.

The development and use of SOPs are an integral part of a successful quality management system. It provides individuals with the information to perform a job properly and facilitates consistency in the quality and integrity of a product through the consistent implementation of a process or procedure within the organisation. SOPs can also be used as a part of personnel training programs since they should provide detailed work instructions. When historical data are being evaluated for current use, SOPs can be valuable for reconstructing project activities.

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 data comparability, credibility, and legal defensibility.

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Drafting Standard Operating Procedures

Standard operating procedures are often compiled into standard operating procedures manual. The different standard operating procedures in a manual are typically related to managing one specific outcome or objective and are normally related to each other. The SOP manual related to food safety will for instance hold systematic and sequential procedures related to each of the steps that the organisation will follow in order to ensure food safety.

It is important that each producer examines every aspect of the GAP list and associated HAACP plan and draft specific operating procedures that will ensure food safety principles are adhered to in line with his food safety management system. An SOP manual should be organised to ensure ease and efficiency of use and to be specific to the organisation that develops it. There is no one correct format – internal formatting varies with each organisation and with the type of SOP being written. An SOP should be written with sufficient detail so that someone with a basic understanding of the field can successfully reproduce the activity or procedure when unsupervised.

SOPs should be written by individuals knowledgeable about the activity and the organisation's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can also be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical. The organisation should have a procedure in place for determining what procedures or processes need to be documented.

The first step in an SOP manual is to determine the policies of the organisation regarding:

• Food Safety
• Traceability
• Good Agricultural and Production Practices
• Quality and Quality Management
• Environmental awareness and conservation
• Social awareness

Validating Reviewing Standard Operating Procedures

SOP's should be reviewed and validated by one or more individuals with appropriate training and experience with the process. It is especially helpful if the draft SOP's are tested by an individual other than the original writer before the SOP's are finalised.

The finalised SOP's should be approved as described in the organisation’s quality management plan. Generally, the immediate supervisor, such as a section or branch chief, and the organisation’s quality assurance officer review and approve each SOP. Signature approval indicates that an SOP has been both reviewed and approved by management. SOP's need to remain current. Therefore, whenever procedures are changed, SOP's should be updated and re-approved.

SOPs should be also systematically reviewed on a periodic basis to ensure that the policies and procedures remain current and appropriate, or to determine whether SOP's are even needed. The review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer followed, it should be withdrawn from the current file and archived. The review process should not be overly cumbersome, or SOP's will never get reviewed. The frequency of review should be indicated by management in the organisation’s quality management plan, which should also indicate the individual(s) responsible for ensuring that SOP's are current.

Checklists

Many activities use checklists to ensure that steps are followed in order. Checklists are also used to document completed actions. Any checklists or forms that is 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.

Remember that the checklist is not the SOP, but a part of the SOP. In some cases, detailed checklists are prepared specifically for a given activity. In those cases, the SOP should describe, at least generally, how the checklist is to be prepared, or on what it is to be based. Copies of specific checklists should be kept in the file with the activity results or with the SOP.

Standard Operating Procedure Document Control and Tracking

Each organisation should develop a numbering system to systematically identify and label their SOPs, and the document control should be described in its quality management plan.

Generally, each page of an SOP should have control documentation notation. A short title and identification (ID) number can serve as a reference designation. The revision number and date are very useful in identifying the SOP in use when reviewing historical data and is critical when the need for evidentiary records is involved and when the activity is being reviewed. When the number of pages is indicated, the user can quickly check if the SOP is complete. Generally, this type of document control notation is located in the upper right-hand corner of each document page following the title page.

The organisation should maintain a master list of all SOPs, and this file should minimally include the date of the current version. This list may be used when audits are being considered or when questions are raised as to practices being followed within the organisation.