Yes, SOPs should be used in research phase. If you are looking to produce a new product to market or making changes to current products in your product line, SOPs should be strictly followed. During the research phase, chances are the creation of the product or any ideas will need to follow certain processes that are already established within the company and documented through SOPS. For example, if your company sterilizes finished good packages, most likely your new product that you are generating or researching to create will need to follow the current SOP for sterilizing finished good packages.
The Standard Operating Procedures (SOP) as SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at any organization. I think SOPs is not required in the research role but its better to be created during the research phase. SOPs help you to evaluate more than what you’re doing now but also help you decide how to move forward.
SOPs should periodically evaluated against actual practices.
SOPs are grilled into engineers minds ever since their first day at work. Within the medical company I work at it is mandated to have SOPs for every fixture or process that is in place. It is not just focused on the research phases of developing a product. It is crucial to begin creating SOPs within the research development phase because it creates structure and consistency when developing a product. SOPs are guidelines which need to be followed to uphold the company’s standards. It not only creates traceability but also assurance that you are developing a product that can produce repeatable results. Within the research phase you come across many obstacles which will help direct you in creating an accurate SOP based on the results and process you are testing. An SOP helps the engineer or user check if they are utilizing the product accurately.
SOPs contain the regularly recurring work processes that are to be conducted within an organization. It states the activities that are to be performed to facilitate
consistency.The use of SOPs minimizes variation and promotes through repeatable results. These guidelines are excellent for research because results need to be repeatable, if the procedures themselves are solid and repeatable then that should transfer to the results. As stated above the SOP also helps each engineer in each step of development, accountability, and accuracy.
Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. I do believe that an SOP should be created for any testing created/done in the research phase because it gives detailed instructions on what the operators need to do in order to perform a certain task the same way every time. SOP help creates traceability, reliability, and repeatability. SOPs also help other engineers see if a test method has any flaws or needs improvement in certain areas in order to make the process more efficient. During my co-op now I am the charge of editing old SOPs and creating new ones for test methods that are being finalized. The hardest part about writing an SOP is writing directions in a clear and concise way so that a reader will be able to complete the SOP within questions. Pictures are a great way to also clarify any questions a future may have on the SOP.
I think a SOP should be used during the research phase but if not, I think it MUST be used during development. This way the engineers would be able have some sort of traceability to know that the processes used and design elements used during research to know that whatever is transferred are equivalent. For example, at my job we wanted to change the resin type used for our device casing. To do so we updated all of our documents (drawings, process documents, inspection documents, etc.) to an intermediate engineering status such that all sample material used to conduct verifications has was processed per released documents.
I agree with those who said that SOPs are not needed for the research phase of a project. It is important to remember that SOPs are very specific, detailed instructions that tell how you how to perform a routine procedure, and they are mostly used in manufacturing. Research is the opposite of routine, so SOPs for research would not make sense. I think what several posts above were referring to is just general company guidelines or procedures that explain how to go through the research phase of a project to ensure that the research team remains focused during the research phase. However, I would not refer to these as SOPs. These documents would be much higher on the Quality System hierarchy than an SOP.
When first reading this post, I thought yes SOPs should be used in the research phase as well as development phase. However, thinking more about it I think the research phase is when there is more creativity and you're trying new things, so it might not make sense at that stage to have the detailed procedure on how to perform detailed tasks because you're still in the research phase unless as Dr. Simon mentions in lecture, you're performing an assay or something repeatable. I do however think its imperative to have SOPs for the development phase.
