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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.
| Roles | Activity | Hours | Personnel | Total |
| Functions | Determination of need for document | 1 | 6 | 6 |
| Author | Document development | 6 | 1 | 6 |
| Functions | Off-line review (three rounds) | 3 | 6 | 18 |
| Functions | Review meetings (three rounds) | 3 | 6 | 18 |
| Author | Review management | 6 | 1 | 6 |
| Author | Comment consolidation and revision | 12 | 1 | 12 |
| QA | Formatting | 2 | 1 | 2 |
| QA | QC review | 2 | 1 | 2 |
| QA | Approval management | 1 | 1 | 1 |
| Functions | Curriculum identification | 0.5 | 6 | 3 |
| Training | Curriculum set-up | 1 | 1 | 1 |
| Functions | Training | 0.5 | 100 | 50 |
| Training | Training Oversight | 3 | 1 | 3 |
| TOTAL | 128 |
We multiply that by a typical number of documents:
| Document Type | # of Documents | x 128 Hours |
| Policies | 15 | 1920 |
| SOPs | 150 | 19200 |
| Work Instructions | 50 | 6400 |
| Forms | 50 | 6400 |
| Templates | 50 | 6400 |
| TOTAL | 315 | 40320 |
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:
| Roles | Activity | Hours | Personnel | Total |
| Functions | Determination of need for document | 1 | 4 | 4 |
| Author | Document development | 6 | 1 | 6 |
| Functions | Off-line review (three rounds) | 3 | 4 | 12 |
| Functions | Review meetings (three rounds) | 3 | 4 | 12 |
| Author | Review management | 6 | 1 | 6 |
| Author | Comment consolidation and revision | 12 | 1 | 12 |
| QA | Formatting | 2 | 1 | 2 |
| QA | QC review | 2 | 1 | 2 |
| QA | Approval management | 1 | 1 | 1 |
| Functions | Curriculum identification | 0.5 | 4 | 2 |
| Training | Curriculum set-up | 1 | 1 | 1 |
| Functions | Training | 0.5 | 20 | 10 |
| Training | Training Oversight | 3 | 1 | 3 |
| TOTAL | 73 |
And now we multiply by a more modest number of procedures:
| Document Type | # of Documents | x 73 Hours |
| Policies | 5 | 365 |
| SOPs | 25 | 1825 |
| Work Instructions | 5 | 365 |
| Forms | 15 | 1095 |
| Templates | 5 | 365 |
| TOTAL | 55 | 4015 |
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.
