Quality
It’s important to set up guidelines for those SOPs before they are written to ensure uniformity and that all legal and regulatory compliance requirements are satisfied.
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Generally, U.S. Food and Drug Administration (FDA) SOP requirements are concerned with ensuring quality within a company. Using proper SOPs helps companies comply with FDA requirements, and the SOPs themselves are used by the FDA to assess whether companies are compliant. The SOPs needed by a company are partially determined by what industry that company operates in. For example, a pharma company will need different SOPs than a food manufacturing company.
Every company should have a standard template to use for its SOPs. This helps ensure uniformity across all the documents and helps the SOP writer make sure he or she includes all necessary information.
Examine the standards that apply to your company and determine which ones affect the SOP in question. If certain sections or steps in the SOP are required by the standard, be sure to include those.
If the SOP reflects a practice that is already happening at your company, talk to the employees in charge of that task. Make sure the processes described in the SOP are what is actually carried out by employees.
Ideally, SOPs should be used by employees, but excessive text discourages some employees from reading the SOP. Be as concise as you can be without leaving anything out.
Once you’ve written the SOP, have the managers and employees involved with that procedure look it over. Find out if it’s accurate and if it covers all the regulatory requirements.
If the SOP is completely new or if there are new processes involved, pass it along to employees that need to be trained on it.
A well-crafted SOP offers clear direction and instruction specifically designed to avoid deviations—an absolute necessity for maintaining compliance and delivering quality products.
Describe the rationale and intent of the SOP in a couple of sentences.
Identify who and what the SOP applies to and include what is considered outside the scope of the SOP.
Define terms used in the SOP. Make sure these definitions are consistent across your company’s SOPs
List which roles are affected by the SOP. If too many roles are involved in a single SOP, it may be necessary to break the procedure down into multiple SOPs.
Write a detailed description of the steps involved in this process. Be sure to only include steps that are a part of the process and ensure that any steps required by regulations are included.
Keep track of changes made to the procedure and why those changes were made.
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