An SOP (Standard Operating Procedure) is a set of instructions assembled to help the organizations to carry out routine operations. It is a procedure specific to your operations which are necessary to be executed correctly and in a proper manner form. SOPs are mainly the first things asked at the time of inspection.
SOPs are required in regulated industries to give instructions for conducting a particular task. Organized and detailed procedures assure constancy of performance which is mainly important when a person is executing a task.
Procedures give an opportunity to state some processes and to ensure that the employees are trained properly. In an SOP you must state what needs to happen for an end result. You need a step-by-step process of narrating how to arrange the pattern, the speed and the time. You could also include more detailed steps or information like who, when and where.
REASONS YOU MAY NEED AN SOP
- Assure the agreement that standards are met
- Avoid Manufacturing failures
- Should be used for training
- To guarantee safety
- To cling to a schedule
WHAT ARE THE BENEFITS OF SOPs FOR MEDICAL DEVICES
- Document Control Facilitator
- Manufacturing
- Transporting and Storing Products
- Quality Engineers
- Risk Management
- Design Controls
- Training
- Supplier Management
WHY ARE SOPs EFFECTIVE
Well instructed SOPs are clear and have definite instructions So that any differences in the procedure are undoubtful.
The overall process that is to be followed should be stated.
One of the main things that make SOPs easy is when you use it with the help of the right tools.
The SOPs should be:
- Uncomplicated
- Well elaborated
- Demonstrated
- Adaptable
SOPs SKILLS
Writing and expanding operational procedures is a task that develops with time. Usually, these procedures are described as fairly technical. The internal &external auditors and the employees of all levels in the organization review these procedures.
Henceforth it is important to observe the language used while communicating an idea. Stay away from the state of confusion.
All of the sops should be registered clearly, according to the standard format. once your sops have been organised, you should regularly go through it to see whether they are being sufficiently followed. companies get warning letters by the FDA for not having sufficient sops.
