Standard Operating Procedure

Introduction

Standard Operating Procedures are written documents that describe, in great detail, the routine procedures to be followed for a specific operation, analysis, or action. Consistent use of an approved Standard Operating Procedure ensures conformance with organizational practices, reduced work effort, reduction in error occurrences, and improved data comparability, credibility, and defensibility. Standard Operating Procedures also serve as resources for training and for ready reference and documentation of proper procedures.

SOPs play a crucial role in quality assurance and it is therefore essential that they are understood and followed by all end-users in a manufacturing facility. Failure to do this leads to warning letters being issued. Consequently, well constructed SOPs are critical to error prevention. Moreover it is essential that competency-based SOP training needs to be implemented to ensure employees’ understanding of the procedures.

This course will instruct participants on how they can create procedures to achieve consistently predictable results. PTI’s training course will help develop the necessary skills to write procedures that are understood and followed. This course will enable delegates to apply powerful proven techniques such as flowcharting, graphics incorporation, and step-by-step task analysis.

Benefits Of Attending The Course

The course enables the delegates to:

	Discover gaps and overlaps in existing SOPs
	Apply proven writing techniques to SOP development
	Optimize organization and formatting of SOPs for ease of use
	Implement effective document controls, including change control
	Integrate SOPs with other corporate and site documents

Who Should Attend?

It will be most appropriate for the Quality Assurance, Quality Control, Manufacturing Supervisors, Technicians, GMP compliance and QA/Compliance to attend this course. Teams are encouraged to attend for maximum benefit.

Brief Course Outline

Day 1 (AM)

Day 1 (PM)

Standard Operating Procedures

	Explore different methods of writing SOPs
	Compare practice throughout the industry and how your SOP process has been defined

Identify the role of SOPs as part of the documenting system

	Define SOPs and their real objectives
	Determine how SOPs should be blended with the other operations in your plant
	Understand how SOPs should be integrated with other documentation
	Explore why different SOPs are needed, who actually uses them, why, how and when

Examine the different controls which govern SOPs and how they control documentation

	Pinpoint the main control systems for documentation
	Decipher what main types of controls are used for managing intra-control
	Explore and discover the need for change control

Evaluate your SOP requirements and organize your team accordingly

	Examine different methodologies for assessing SOP needs
	Look at different ways of performing gap and overlap analysis for existing SOP systems
	Determine which members of your team are most appropriate for specific tasks
	Define who should write, sign and take responsibilities for the SOP
	Minimize any overlap between the tasks
	Critique procedures written by others and make suggestions for improvement
	Assess how you can use flow charting to create SOPs that are meaningful

Day 2 (AM)

Day 2 (PM)

Establish and define your SOP format

	List the typical components of the SOP template
	Examine the special heading required for work functions
	Identify which areas in your current practice need addressing

Understand the writing techniques for your SOPs

	Explore different writing techniques that are used throughout the industry
	Identify common pitfalls in writing
	Look at useful techniques and phrases that can be used when writing SOPs

Introduce different ways of presenting and formatting SOPs

	Analyse the variety of formats and presentation styles for SOPs
	Incorporate flow-charts and graphics to make the presentation of your SOPs more effective
	Identify the way you can make different SOPs easier to understand

Examine the management aspects of your SOPs

	Describe what needs to be managed
	Explore the cost of an SOP system
	Look at how you can measure an SOP’s effectiveness

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