Appendix U: Criteria for Development of Standard Operating Procedures (SOP)

In this manual, there are a number of sections where the laboratory is required to prepare standard operating procedures (SOPs). This appendix is intended to provide guidelines on the development of such documents. It is not mandatory to follow these procedures. The lab may seek the advice of EHS when developing an SOP.

Introduction

What is a Standard Operating Procedure (SOP)?

A standard operating procedure (SOP) document is a comprehensive set of instructions written to provide employees with guidelines to follow to complete a job safely. SOP should be written in a manner that provides the user with a clear set of guidelines that ensure the task is performed as desired by the institution and that meet regulatory compliance standards.

Institutions write SOPs for the following reasons:

• to provide individuals who perform operations with all the safety, health, environmental, and operational information required to perform a job properly;
• to ensure that operations are done consistently to maintain quality control of processes and products;
• to ensure that processes continue and are completed on a prescribed schedule;
• to ensure that no failures occur in manufacturing and other processes that would harm employees or anyone in the surrounding community;
• to ensure that approved procedures are followed in compliance with company and government regulations;
• to serve as a training document for teaching users about a process;
• to serve as a historical record of the how, why, and when of steps in a process for use when modifications are made to that process and when a SOP must be revised;
• to serve as an explanation of steps in a process that can be reviewed in incident investigations that seek to improve safety practices and operating conditions.

Purpose and Scope of this Document

The purpose of this document is to provide guidance and a template for drafting SOPs.

Developing an SOP

Except for the simplest operations, an SOP must be developed for each of the operations for reasons described above. An SOP is best developed by a team that includes:

• the worker
• the job supervisor
• a safety and health professional, etc.

When an SOP has been properly written, the result is satisfactory completion of the work with regard to efficiency, risk, and safety.

The first step in preparing to write an SOP should have the worker demonstrate how he or she will accomplish a particular procedure. The worker must be someone who is already doing that job or who has done similar work.

The supervisor acts as an advisor to monitor the required efficiency and contributes necessary information about the correct use of the equipment involved. The safety person notes the hazards of the job and lists the protective equipment that should be required.

The SOP should include identifying information (e.g., title and/or number) and all the procedure’s steps, including associated hazards and precautions. Precautions for the employee’s overall health and safety must be addressed, especially in terms of training and personal protective equipment and what to do in emergencies. The SOP also must address the precautions needed to prevent any impacts to the environment, whether it is the immediate workplace environment, the waste disposal system, or the surrounding community.

Note: Detailed information does not need to be provided on some of the areas where there is already another document describing the procedure.For example, when describing the operation of a particular piece of equipment, a notation could be included that refers to the operating manual for that equipment or another SOP describing the operation. In these instances, it is important to ensure that these referenced documents are readily available.

SOP Template

No standard SOP templates exist nationally, so each institution develops its own. The template presented at the end of this SOP is compliant with the requirements of Good Laboratory Practices (GLP) and will be used for all SOPs developed by the Office of AVPRC and is strongly recommended for use by others.

General Information

This is the top section of the SOP template and includes information about:

• Unit: The unit that develops and owns the SOP.
• SOP Title: The full title of the SOP.
• SOP number: Based on a standard numbering system.
• Version: The version of the SOP with V1.0 as the initial number and each subsequent revision having a new number such as V1.1.
• Implementation Date: The date the current version of the SOP went, or will go, into effect.
• Approval: The name and title of the individual who is responsible for approving the SOP. The responsible individual must sign or initial this section to indicate approval.
• Page Number: Indicates the page number using the notation “Page 1 of X.”
• Expiration date: If the SOP is for a given operation that is for a specific duration, it should indicate that date; otherwise it should note “until revoked.”

Purpose and Scope

There should be brief statement on the purpose and scope of the SOP.

References

This section should list any additional resources that may be useful in performing the procedures. These may include:

• Regulations: Regulatory references should be listed here.
• Policies: All relevant BU policies should be listed here.
• Other SOPs: SOPs referred to in any other section of this SOP should be listed here
• Supplementary Documents Policies

Definitions

Definitions for the major terms used in the SOP should be included to provide the reader a clear understanding. Spell out the acronyms fully and show the abbreviations in ( ); this format should also be followed each time a new term is introduced in any part of the SOP.

Roles and Responsibilities

If the particular procedures require that individuals from various sections participate, the roles and responsibilities for each should be clearly defined. For example, if a procedure requires a cage washer to deliver clean cages to the rooms before the technicians responsible for changing the cages can do so, define the roles. If EHS must perform hazard evaluation as part of the SOP, EHS’s role and responsibility should be defined.

Special Requirements

Equipment and Supplies Required

This section should list all equipment and supplies needed for performing the task or procedures. In a SOP with an extensive supply list, it might be more appropriate to include the supplies in the description of each procedure.

Safety Requirements

This section should define all health, safety, and environmental protection measures that must be followed while performing the procedures, including spill and accident response procedures relevant to the particular operation defined in the SOP.

Training

Clearly define all the training requirements (i.e., courses), including the schedule for training (e.g., prior to the start of performing the procedures), re-training frequency, and how to obtain the courses.

Monitoring Requirements

This section should define the need, frequency, and methods of conducting personnel or environmental monitoring.

Personnel Protective Equipment (PPE)

List all the PPE required for performing this task, identifying which are mandatory and which are recommendations for further enhancing employees’ health and safety.

Medical Surveillance

Clearly define the medical surveillance requirements for the procedures, if any.

Other Prerequisites

List any other prerequisites that exist for performing the procedures. These could include requirements for being familiar with companion polices, professional or special operating permits, etc.

Applicable Locations

List all locations where this SOP is applicable (e.g. all barrier facilities, all research laboratories, areas where nano-particles are used, Rooms 111, 222 and 333 only, etc.)

Procedures or Instructions

This is the most important component of the SOP and requires a complete and step-by-step description of how the function should be performed.

When developing this section, consider the possibility of using the document as a training tool for new employees. Therefore, the details included should be such that after reading the document, a new employee could obtain a high level of understanding of how the function is performed.

Include the equipment used as part of this section and reference any SOP or operating manuals required.

Note>: Some SOP might include a listing of all equipment used at the start of this section.

The title of any manufacturer’s manuals, good practices, and professional organization guides, available or used in this procedure, should be listed here. The location of these documents should also be noted.

Note: To avoid the need for frequent updating of the procedures, each program should designate a permanent location that acts as a reference library.

Forms

The SOP should include all the forms required by the SOP. It is recommended that:

• All forms are included as attachments to the main SOP with a clear reference in the “Procedures and Instruction” or “Record Management” sections. This will make revisions of the SOP simpler if forms are changed.
• A form numbering system is established that correlates to the SOP numbers.

Record Management

This section incorporates record management practices, including location of active records, archived records, and record retention times.

SOP Revision History

It is extremely important to track the history of the SOP and document all its revisions. This expectation should be integral part of all SOP development and maintenance processes.

The SOP should be reviewed by the team that created when:

• There is a change in regulatory requirements
• Operating procedures have changed significantly
• Forms used or the record management system has changed
• Introduction of new facilities, equipment, risks, hazards, or processes
• At least annually

The following pages provide a template for use:

1. Purpose and Scope
2. References
   • Regulations
   • BU Policies
   • Other SOP
   • Supplementary Documents
3. Definitions
4. Roles & Responsibilities
5. Special Requirements
   • Equipment and Supplies Required
   • Safety Requirements
   • Training
   • Monitoring Requirements
   • Personnel Protective Equipment (PPE)
   • Medical Surveillance
   • Other Prerequisites
6. Applicable Locations
7. Procedures and Instructions
8. Forms
9. Records Management
10. SOP Revision History