2-9. Creating and Revising Standard Operating Procedures (SOPs): Workflow and Approval System

Standard Operating Procedures (SOPs) are important documents that enable safe and efficient business operations and prevent industrial accidents and quality defects. Their creation and management are required by laws and regulations, particularly in the manufacturing, chemical, and pharmaceutical industries, and are essential from the perspective of complying with ISO standards and GMP (Good Manufacturing Practices). Inadequate SOP preparation can lead to on-site variations, accidents, and compliance violations, so it is essential to establish a proper creation and revision flow and approval system.

1. Basic flow of creating an SOP

The SOP creation process will proceed as follows:

1. Identifying the scope of work: Clarifying the tasks and processes to be covered.

2. On-site investigation and interviews: Collect procedures and precautions from the actual workers.

3. Drafting: Draft based on a standardized format (title, purpose, scope, procedures, precautions, relevant laws and regulations, etc.).

4. Review and revision: The relevant departments (safety and health, quality control, production, etc.) review the content and reflect any risks or areas for improvement.

5. Approval process: Finally, the manager or management approves it and issues it as an official document.

2. The importance of revision flow

SOPs are not something that are created once and then finished; they must be revised promptly if there are equipment updates, changes to laws and regulations, or improvements to work procedures. The general steps for revision are as follows:

- Consider whether revisions are necessary (triggered by legal amendments, accidents, audit findings, etc.)

・ Drafting and reviewing revision proposals

- Approval and publication of revised versions

・Recall of old versions and replacement with the latest version

・ Publicizing the revised content and providing education and training

If revisions are neglected, old procedures may continue to be used at the site, which could lead to serious accidents or regulatory violations. Therefore, it is effective to make it a rule to review them periodically (e.g., at least once a year).

3. Establishment of an approval system

To ensure the reliability of SOPs, a clear approval system is essential. A typical process is as follows:

・ Created by: On-site department

・Checkers: relevant departments such as safety and health, quality control, and legal affairs

・ Approver: Department head or management (person in charge)

By clarifying the approval system, responsibility becomes clear and audits and government investigations can be handled appropriately. In addition, by introducing an electronic approval system, approval history can be saved and revision management can be made more efficient.

4. Measures to increase effectiveness

SOPs are only meaningful if they are actually used on-site. Rather than being formal documents, it is important to include photos and illustrations and make the content easy for on-site workers to understand. It is also important to ensure that everyone understands and complies with the SOPs through education and training, and to have a system in place to check compliance during audits.

Properly creating, revising, and approving standard operating procedures (SOPs) is the foundation for fostering a safety culture in the workplace, ensuring quality, and ensuring compliance.