As a consultancy firm, we are regularly contacted by companies after they have been inspected by the regulators and been told they need help in compliance, or when there is a looming threat of an inspector turning up soon. Having now visited a few companies (WDA holders, Pharmacies and CQC Registered Service Providers), it is evident that the purpose and use of Standard Operating Procedures (SOPs) are not widely understood. SOPs have been in operation for well over 10 years within the community pharmacy sector at least and for much longer within other sectors.
It is pretty clear that companies and/or Directors have not grasped that SOPs are there to protect you, your employees and your business (provided these are operational, of course)
The International Conference on Harmonisation(ICH) defines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function”.
The written instructions (or procedures) must detail what you actually do: not what you aspire to do; nor what you think you should do; it IS what you actually do!
An inspection will more often than not start with the inspector looking at your procedures to establish whether you have tailored these to reflect what your business does or whether you have a general overview of what is expected of you. This will usually depict how the inspection proceeds. So write what you do and do what you have written.
SOPs are not meant to make the business look knowledgeable or to take up shelf space: it’s to keep your employees informed on what is required and how your business works so there is less room for ambiguity and uncertainty, and everyone works to the expected standard of quality you want for your business.
Not sure where to start? Start with the overall process of what you need to achieve and list the procedures involved in accomplishing the whole process. Work with the regulations governing your business and aim to ensure your procedures meet these regulations. If the procedures do not meet the regulations, then you may be considered non-compliant!