SOP’s

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WRITING GOOD SOPs

Vipsit can assist you in working with your staff to develop a methodology that will generate Standard Operation Procedures (SOP’s) to help  instead of hinder  staff in doing the right thing.

Coming rom the GMP world, we have written more Standard Operation Procedures (SOP’s) than we care to think about. None of us are proud of the first 40-50 we each wrote. Over time we learned.

Stock Option Plan, Sales Order Processing, Senior Outreach Program, Stock Ownership Plan, State Operating Permit, Surgical Oncology Program, Street Opening Permit, School Organization Plan, Standard Operation Procedure, Senior Officer Present, Secure Online Payment, Streaked Optical Pyrometry, Short Optical Pulse,  System Optimization Plan, Ship Operational Program, Sterile Ophthalmic Preparation……

Writing simple and comprehensive SOPs is an art. They should be clear, crisp and easily understandable. Most importantly, SOPs are for the staff, not for the inspecting authorities or for management to check a box.

When a facility “serves many masters” like GMP, bio/chem risk management, environmental protection etc. – the challenge rises. From an inspectors point of view it would be great if there was an SOP addressing each of these areas. The problem is that in this case the SOP would be written for the inspectors, not the staff.

Staff need ONE procedure for each process performed. Many procedures are impacted by GMP, ISO standards and Bio/chem risks management, and more.

This means that to work well for the staff, an SOP needs to address all these different perspectives as a whole. Staff needs ONE SOP and ONE sign-off sheet to sign for actions performed. Staff cannot work with “system GMP”, “system Biorisk” and “system environmental protection”. Some or all will suffer and not get the sign offs they need.

The challenge that arises now is how to write the SOP? It is important that the staff understands what drivers there are behind the different actions. Sometimes gloves are worn to protect the GMP product, sometimes to protect the employees.

Later, during GMP inspections, the same SOP needs to please several inspection agencies. All will come expecting to see a system that fits perfectly into their checklists and if SOP’s are not properly written, the inspectors will be sadly disappointed.

It takes practice to write SOP’s a way that makes it clear to the staff what drivers/rationales there are for the different actions and to design the sign-off sheets in such a way that the individual inspector understands what to look for and what to skip.