Designing Fit-for-Purpose GCP SOPs: The Cost of a Document

A back-of-the-envelope calculation, based on our experience writing thousands of SOPs, on the cost of a policy, SOP, Work Instruction, form, or template. Imagine a mid-sized pharmaceutical company writing a cross-functional records retention SOP or policy.  We have six different functions working on the document, with 100 people total who need to train on that document.   We multiply that by a typical number of documents: Thus, a mid-sized organization is devoting over 40,000 hours a year to its quality processes. Since people work about 2,000 hours per year, that's almost 20 FTEs per year.  If the organization has 1000 employees, that's 2% of the workforce.  On average, each person is devoting one week out of a year to SOPs. In a small biotech, let's assume four different functions are working on an SOP that 20 people have to train on: And now we multiply by a more modest number of procedures: That's two FTE years for a small biotech. In a company with 100 people, that's the equivalent of 2% of the workforce - about the same as a large company. Is the equivalent of 2% of the workforce too much to dedicate to SOPs? That depends.  If those SOPs are enabling compliance and promoting efficiency, it may be well worth the cost. But because SOPs have a real cost, we will be even more efficient if we eliminate documents with redundant content.