Training, documentation, inspection readiness activities, and development processes all help drive process improvement and any changes based on these internal factors within the CRO will drive SOP updates.
When a change to an SOP is required, the author will review and make the necessary updates.
At this stage the SOP could either be sent back to the author if edits are required or sent on to top management for final approval.
Once all three approvals have been achieved, the SOP can be released for use by the CRO after sign-off by all signatories.
Creating SOPs is time consuming, but the process is less cumbersome when employers maintain a simplified documentation format.
Restaurant owners develop SOPs for food storage to ensure food is kept at appropriate temperatures to prevent spoilage and food-borne illnesses among patrons.
A roofing company may require that workers install a specific number of nails in shingles every foot to maintain the quality of roofing installations.
Step-by-step SOPs that are easy to follow also are easy to update, and they help ensure the review process takes place in a timely manner.
Frances Burks has more than 15 years experience in writing positions, including work as a news analyst for executive briefings and as an Associated Press journalist.