standard operating procedure
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This document provides information on standard operating procedures (SOPs), including what an SOP is, why SOPs are written, different SOP formats, and how to write an SOP. An SOP is a set of instructions for completing tasks safely, meeting regulations, and optimizing processes. SOPs are written to provide training, ensure consistent and correct procedures, maintain regulatory compliance, and serve as records for audits and investigations. SOPs should include a title, purpose, scope, responsibilities, references, definitions, guidelines, and detailed procedures. Attachments of related documents may also be included.
standard operating procedure
- 1. • Standard Operating Procedure
- 2. • What is an SOP? • Why do we require SOP?
- 4. • Today’s Topic • What is an SOP? • Reasons for writing SOPs? • Different formats for SOPs • How to write SOP ?
- 5. WHAT IS AN SOP? • 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 regulatory compliance standards), and in a way that maximizes operational and production requirements Or • Detailed, written instructions to achieve uniformity of the performance of a specific function • SOPs get usually applied in pharmaceutical processing and for related clinical trials
- 6. WHY WRITE SOPs? • To provide people with all the information necessary to perform a job properly (i.e. a training tool) • To ensure that the procedures are performed correctly and consistently • To ensure compliance with university and government regulations • To serve as a checklist for auditors • To serve as an explanation of steps in a process so they can be reviewed in accident investigations. • To serve as a historical record of the how, why and when of steps in an existing process occurred (for inspectors and attorneys)
- 7. WHY WRITE SOPs? • To Ensure Safety • Maximize operational and production requirements • To Ensure Consistent Training • To Ensure Correct and Consistent Performance • To Ensure Regulatory Compliance • Because historically many have not exercised good sense and failed to provide adequate training and consistency in performance, product or process failures have resulted in harm to animals, research subjects and patients.
- 8. FORMATS FOR SOPs • You Need SOP on SOPs • An SOP is not a Policy • A policy tells you WHAT you will do, • An SOP tells you HOW you will do it!
- 12. How to write SOP? • WHERE TO START • Why Is An SOP Needed? • Who Is The Target Audience? • Will The SOP Be Inter-Departmental? • Who Will Write The SOP?
- 13. TITLE • This must describe in sufficient detail the focus of the SOP so that anyone can tell from the title the content of the SOP when searching a list of SOPs • This More Important Than You Think!
- 14. PURPOSE What You Want To Accomplish • This often will duplicate the title of the SOP: • Title: Writing, Review and Approval of Standard Operating Procedure • The Purpose of this procedure is to define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit or • To define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit
- 15. SCOPE • The scope defines the area to which the SOP applies: • This procedure applies to all policies and procedures used by the Quality Assurance Unit
- 16. RESPONSIBILITY • This states who has responsibility for training and execution of the SOP • It is the responsibility of the Quality Assurance Manager or designee to assure that all Quality Assurance Specialists are trained on and comply with this standard operating procedure
- 17. REFERENCES • List all references that serve as the basis for the SOP DEFINITIONS • List all definitions that are essential to an understanding of the SOP including all acronyms
- 18. SOME GUIDELINES Use words such as: Shall Must Will Do not use Should May Begin each activity with an active verb such as: Analyze Begin Check Delete Enter Start Store Submit
- 19. PROCEDURE 6.0 Procedure 6.1 Writing a new document 6.1.1 Any staff member shall submit a written draft to the QAU Manager for consideration 6.1.2 The Manager shall discuss the submitted draft with the submitting staff member to make any changes necessary prior to circulating a draft for review. 6.1.3 The Manager or designee shall circulate the draft to all appropriate QAU staff for review and comment.
- 20. ATTACHMENTS Any forms, logs or other documents that are essential to the execution of the SOP and mentioned in the SOP shall be attached to the SOP