Standard Operating Procedures (SOPs) are defined as a set of written instructions about how a task is needed to be performed in compliance with the organization's, as well as regulatory requirements. SOPs are detailed instructions that are written down to help bring about uniformity of a specific function's performance. The importance of writing and enforcing effective SOPs lies in the fact that they help organizations - no matter in which business they are - get a proper set of instructions on how to carry out a particular task in a particular situation.
Standard Operating Procedures are needed for the most obvious need they fulfill: They help people in the organization carry out the tasks they are required to. SOPs also help boost efficiency when they are implemented thoroughly and consistently.
In addition to ensuring consistency of tasks; SOPs also help achieve good quality in the product or service, becomes part of a GxP, helps to delegate thoroughly, and provides a platform for auditing, among other needs it fulfills.
The need for writing and enforcing effective SOPs is also important because SOPs are among the most regularly audited documents by the FDA and other regulatory agencies. SOPs are also up for audit by an organization's auditors and customers.
In the context of SOPs required for the regulated industries in the US, those involved in writing and enforcing effective SOPs need to keep in mind the fact that they have to comply with requirements set out by the FDA. This is obvious, and goes without saying, because it is the FDA whose regulatory requirements need to be met by the regulated industries.
So, writing and enforcing effective SOPs has to make sure it meets the core FDA criterion, which is the proof of "establish". To the FDA, the proof of "establishing" lies in defining, documenting and implementing the way these SOPs work. The FDA expects these SOPs to define, to document and to implement, which is a core part of writing and enforcing effective SOPs.
This brings us to the next important element of SOPs: Enforcing them. The implementation part of writing and enforcing effective SOPs is considered more important by the FDA, because it considers useless any SOPs, no matter how convincingly or painstakingly written they may be, unless they are being implemented in accordance with the compliance requirements. Writing and enforcing effective SOPs are thus twin aspects that need to be very carefully carried out with each other.
Writing and enforcing effective SOPs is incomplete if it fails to lead its implementers to ask and address these points: