SOP – 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 SOP - Standard Operating Procedure Training
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 The SOP - Standard Operating Procedure Training ?
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 SOP - Standard Operating Procedure Training Outline
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Day 1 (AM) |
SOP - 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
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Day 1 (PM) |
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
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Day 2 (AM) |
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
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Day 2 (PM) |
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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