Hi Everyone,
SOPs are very important documents to build a strong quality system. Let us discuss How to write SOPs, what should be included to avoid FDA audit ?
For example:
I think Procedures is the most important part in any SOP document.Before starting to write, decide the exact purpose of the procedure. Once you have decided the exact purpose of the procedure, make sure everything you write contributes to that purpose for the medical device you are developing.
Share what do you think!
The SOP documents are important in the process of Design Transfer in ensuring the device will be able to be created following a routine. All parts of the SOP play a significant role in the document. I agree with you that the procedures are important because they ensure that the purpose is fulfilled. Also, the procedure includes the steps necessary for the work to be completed. I do feel that the responsibilities section is also very important. The responsibility distribution needs to be done to make sure that each part is completed to best of their ability. If the responsibilities are not assigned properly, then the work will not be completed properly.
SOPs layout the details for the standards a company implements in the procedures and processes. SOPs that I have worked with include a purpose, procedure, documents/ fixtures affected, forms and attachment sections. All SOPs should be written in a concise format that does not lead to questions. When an auditor reviews an SOP they will look up all the documents associated with that SOP so make sure to reference the accurate documents. An auditor might even take the SOP to the production floor and see if the operators are following what is stated in the SOP. Therefore, when writing the procedure section of an SOP go to the production floor to see how the operators go about a completing a process. Include images in the SOP to make things clear and understandable to those who never heard about a fixture or process.
