Every organization has rules, policies, procedures, and standards by which its constituents must abide to.
The choice to abide must be a voluntary action by the employees to agree and to physically act in accordance with the standards of the organization.
This infographic explores Quality Process Improvement and Standard Operating Procedure (SOP) updates from a Clinical Research Organization (CRO) perspective.
To confirm compliance to regulatory requirements, processes must be put into place - but how do we ensure our SOPs comply?
Then, organize time for your management team to meet to review the lists keeping in mind that not all processes need to be formalized only those where there is a clear business requirement or need for standardization.
Once the processes to move forward have been identified, the management group must continue their assessment to identify redundancies or if there are any SOPs that need to be linked when departments are undertaking the same or similar processes.
The pharmaceutical industry is very highly regulated, and in the last few years, the regulatory bodies have released many new or updated standards and laws which drives Standard Operating Procedure (SOP) changes to ensure company polices are in line with new legislation.
These SOPs govern the internal processes of a CRO and at the ‘process improvement’ stage any changes made influenced by the external regulatory bodies circles back to SOP updates being required.
As you write SOPs, you’ll find you may be able to combine some processes while others may need to be split up into different SOPs.
If it is Critical To Quality (CTQ) than it is a candidate for a standard operating procedure.
Consistency is the goal or purpose of an SOP, to carry out all operations correctly and always in the same manner.
The SOP development process is a great way for managers and their teams to collaborate in the documenting of processes for everyone’s benefit.
Developing and following a framework for SOP development creates a positive sense of teamwork and will lead to improving the efficiency of your workforce.