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How to Write a Standard Operating Procedure (SOP)

SOP on How to write a Standard Operating Procedure

What is Standard Operating Procedure?

An SOP is a set of instructions or steps someone follows to complete a job safely, with no adverse impact on the environment (and which meets compliance standards), and in a way that maximizes operational and production requirements.

Write SOPs for any processes an individual or group performs: unloading raw materials, manufacturing products, shutting down an operation, repairing a faulty electrical circuit, working with patients in a hospital, working in food service, performing activities in a firehouse, and thousands of other workplace activities.

 Critical SOP Document Specifications:

The page header should include the name of the Organization, address and if possible the department or group. The header will then include the SOP number, title, Version number, page number, and effective date. Often, the author’s name of the SOP is in the header.

At the end of the SOP, indicate a section for documenting SOP reviews with space for reviewer’s signature and date signed. If the SOP is to be archived or retired, add a line to document this purpose. The page footer should include the complete file name and path.

  • Document Title
  • Document Class(Policy, Procedure,Process,Directive, etc.)
  • Document Number,
  • Revision Number Version,
  • Copyright
  • Division
  • Location
  • Department
  • Area
  • Effective Date,
  • Author

 SOP Document Outline Structure:

Purpose:

The purpose statement identifies the goal of the SOP. It answers the question of why the SOP is being written. For example, “The purpose of this Standard Operating Procedure (SOP) is to specify the processes used to manage SOPs”. The Purpose statement needs to be detailed enough so that the intended user can recognize what the document covers.

  • Explain the objective the SOP is intended to achieve.
  • 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 in order to maintain quality control of processes and products

Scope:

The scope of the SOP identifies who needs to follow the procedure and what the procedure covers. It should help the reader to identify what is (and what is not) covered in the procedure.

  • Explain the objective the SOP is intended to achieve.
  • Write a scope for the SOP. To do this,answer these questions: Which specific operations or tasks within an operation will be covered? Which are not covered?
  • Who is the SOP written for?

General Requirements:(Overall Task Description)

State the personnel, departments, groups, contractors,and/or subcontractors responsible for both performing and complying with the SOP. State the person or group responsible for assuring the appropriate personnel are trained on the SOP.

  • Develop  an overall task description.
  • Include the number of people required for the task, their skill levels, the equipment and supplies required, any personal protective or safety equipment required, and a description of how the finished product or result should look.
  • If you need to give some background information,or list any warnings or precautions before performing a procedure, this section is the place to list them. Warnings and Cautions should be set out from the regular text by using bold, italics, underlining, or color (or combination).

Responsibilities

State the personnel, departments, groups, contractors,and/or subcontractors responsible for both performing and complying with the SOP. State the person or group responsible for assuring the appropriate personnel are trained on the SOP.

Definitions

Define terms and acronyms that people reading the SOP would not generally know and that would require clarification. If a definition is needed, and one exists in the regulations, use the regulation definition.

  • Define terms and concepts when needed. Place health and safety warnings prominently in the SOP.

Materials and Equipment

List all of the materials and equipment needed to complete the procedure. If the procedure is written to operate a specific piece of equipment, make sure the user guide for the machine is listed in the References section, and that users have been trained on operating the equipment prior to performing the procedure.

Policy/Procedure(s)

Explain the procedure in simple steps. Carefully think about how a procedure is performed from the very beginning.

Draft the SOP in a flow diagram to help visualize the entire process. Describe specifically what to do, not how to do it.

Then state who does each step and where it is recorded to be certain that whoever is performing the procedure can prove that they have done it.

Describe each task in detail. In this section include the following:

  • Specific order in which activities are done
  • Timing sequences and times allowed
  • Materials or tools used and howtheyare used
  • Safetyor health considerations
  • References to other associated SOPs

Note: Keep in mind that the average person is uncomfortable following a long list of steps for the following reasons:

  • A long list looks formidable, which makes the task daunting and tedious for many people who then don’t want to perform the steps.
  • A long list is difficult for your eyes to follow. You forget where you are on the list, which can lead to mistakes.
  • A long list scares people and makes them nervous or anxious to”get it over with.”
  • A long list can hide steps that should be performed with caution.
  • A long list is difficult for writers to write while ensuring that the sequence is clear.

The solution to SOPs that involve along list of steps is to break up the steps into logical sections of about 10 steps per section, such as “Getting ready for the process,” “Initial steps,” “Final steps.”

Regulatory Review

State how often the SOP is reviewed, and/or under what circumstances it is to be revised and indicate who is responsible for reviewing the SOP.

Contingencies (Corrective Actions)

State what happens if the SOP cannot be followed and requires contingencies. Identify who needs to be notified of contingencies and what documentation is required.

Likewise, state what happens when an SOP is incorrectly followed. Include short-term and long-term corrective action measures and how to document the actions.

References

List related SOPs, any supporting documentation necessary to understand and correctly follow the procedure, and any applicable regulations and regulatory guidelines.

Attachments

List applicable forms that are required to be completed in the SOP. Attach any documents used in support of the SOP, e.g., flowcharts, work instructions, pictures or diagrams, forms and labels.

Document History Table

A separate document should sufficiently detail changes made to an SOP, what parts were affected and when the changes become effective.

Follow an uniform format for tracking SOP changes; indicate who made the revision, date of revision and the new version number.

Properly archive an outgoing version and all existing copies to avoid unnecessary confusion.

Additional Information

Our end-to-end standard operating procedure (SOP) software suite contains various standard operating procedure (SOP) templates to organize your content for Standard Operating Procedure, Work Instructions, Processes and Protocols.

The standard operating procedure (SOP) software includes many standard operating procedure (SOP) templates including:

  1. SOP Template
  2. Work Instruction Template
  3. Equipment Template
  4. Product Knowledge Template
  5. Trouble Shooting Template
  6. Policy Template
  7. Training Template
  8. On-Boarding Template
  9. Manufacturing Template
  10. Workshop Template
  11. Process Template
  12. Standard Protocol Template
  13. HACCP Template
  14. Software Application Template
  15. Technical Operations Template
  16. Administrative Directive Template
  17. Quality Template
  18. Preventive Maintenance Template
  19. Instructor-led Training Template

If you are interested in more information about our standard operating procedure (SOP) software, browse our website at www.princetoncenter.com or contact us at sales@princetoncenter.com

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