Top 5 Ways to Write and Manage Quality System SOPs
Marci L. Crane
March 29, 2008
From foundational SOPs (those SOPs that tell employees how to create other SOPs) to QA SOPs and from SOPs that determine analytical methodologies to safety SOPs, one would assume that writing SOPs throughout the quality system would now be little more than a simple science. However, the FDA continues to hand out 483s and provide warnings regarding faulty SOPs or employee deviations from SOPs on a regular basis. This continuous issue then begs the question: How can regulated companies create more effective quality system SOPs that employees actually want to adhere to?
1) Quality System SOPs with Clarity
Life science companies and other regulated companies may have quality system management personnel that assume that employees choose not to conform with SOPs because employees don´t care about those processes to which they are assigned. However, many times the fault lies not with the employees but with the SOPs themselves. Many SOPs are simply not clear enough.
Determining the Clarity of an SOP
To determine whether or not a company´s SOPs are sufficiently clear, management should determine whether entry level employees can immediately follow the SOPs they are subject to. If entry level employees continually make errors in relation to SOPs, then chances are strong that those SOPs need to be simplified for the more effective management of the quality system.
Another way to determine whether or not an SOP is sufficiently clear is to hold a company wide training meeting regarding the SOPs. An exam may be offered to determine comprehension of SOPs but an even more effective tactic is for the training instructor to pay careful attention to the response of the employees during and after training. If employees look confused, ask questions that don´t seem to be fully answered and exit the training still asking questions, then the company SOPs definitely need to be clarified.
2) SOPs Should Define Terms
The specificity of an SOP is also of the utmost importance. Specificity requires that all terms that an entry level employee or an FDA investigator might not understand the full implications of should be effectively described. The definitions section of an SOP allows a company to define its own projects and goals more effectively.
To determine whether any SOP within the quality system is specific enough, company reps can contact an FDA representative assigned to their company or ask an entry level employee to summarize how certain SOP terms are related to the project goals of a company. SOP writers may find that the company SOPs have not been specific enough to maintain compliance within the quality system.
3) Justification and Scenarios
Writing clear justification for expected changes or "deviations" that are likely to occur within the control of the quality system is also essential when writing an effective SOP. It is important for employees concerned with a well maintained quality system to realize that it is not the FDA that justifies many actions within a company but the company´s documentation that justifies actions.
If for instance an SOP is clearly written with valid reasons for justifying a particular change then the FDA is likely to find the associated changes valid. However, without justification, audits will take longer periods of time and 483s may be issued. For this reason it is important to justify in clear writing those changes that are expected. Some changes will of course be unexpected but these changes should be managed with an effective change control system.
4) Well Defined Responsibility
Those employees assigned to approve whether a change is justified enough to be documented in an SOP must have responsibilities that are clearly defined within foundational or change control SOPs.
5) Document Control within the Quality System
SOPs should be consistently controlled so that old SOP versions are not updated while "current" versions remain on the manufacturing floor. Regulated companies should strongly consider automated document control systems that provide version control and reporting features. A document control system that can automatically trigger training tasks is also valuable as training meetings need to be scheduled and planned when SOPs are updated. A document control system that can be integrated within an electronic quality system is also a valuable time saving tool for many regulated companies.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For information in regards to quality system management, please feel free to contact a MasterControl representative.
1) Quality System SOPs with Clarity
Life science companies and other regulated companies may have quality system management personnel that assume that employees choose not to conform with SOPs because employees don´t care about those processes to which they are assigned. However, many times the fault lies not with the employees but with the SOPs themselves. Many SOPs are simply not clear enough.
Determining the Clarity of an SOP
To determine whether or not a company´s SOPs are sufficiently clear, management should determine whether entry level employees can immediately follow the SOPs they are subject to. If entry level employees continually make errors in relation to SOPs, then chances are strong that those SOPs need to be simplified for the more effective management of the quality system.
Another way to determine whether or not an SOP is sufficiently clear is to hold a company wide training meeting regarding the SOPs. An exam may be offered to determine comprehension of SOPs but an even more effective tactic is for the training instructor to pay careful attention to the response of the employees during and after training. If employees look confused, ask questions that don´t seem to be fully answered and exit the training still asking questions, then the company SOPs definitely need to be clarified.
2) SOPs Should Define Terms
The specificity of an SOP is also of the utmost importance. Specificity requires that all terms that an entry level employee or an FDA investigator might not understand the full implications of should be effectively described. The definitions section of an SOP allows a company to define its own projects and goals more effectively.
To determine whether any SOP within the quality system is specific enough, company reps can contact an FDA representative assigned to their company or ask an entry level employee to summarize how certain SOP terms are related to the project goals of a company. SOP writers may find that the company SOPs have not been specific enough to maintain compliance within the quality system.
3) Justification and Scenarios
Writing clear justification for expected changes or "deviations" that are likely to occur within the control of the quality system is also essential when writing an effective SOP. It is important for employees concerned with a well maintained quality system to realize that it is not the FDA that justifies many actions within a company but the company´s documentation that justifies actions.
If for instance an SOP is clearly written with valid reasons for justifying a particular change then the FDA is likely to find the associated changes valid. However, without justification, audits will take longer periods of time and 483s may be issued. For this reason it is important to justify in clear writing those changes that are expected. Some changes will of course be unexpected but these changes should be managed with an effective change control system.
4) Well Defined Responsibility
Those employees assigned to approve whether a change is justified enough to be documented in an SOP must have responsibilities that are clearly defined within foundational or change control SOPs.
5) Document Control within the Quality System
SOPs should be consistently controlled so that old SOP versions are not updated while "current" versions remain on the manufacturing floor. Regulated companies should strongly consider automated document control systems that provide version control and reporting features. A document control system that can automatically trigger training tasks is also valuable as training meetings need to be scheduled and planned when SOPs are updated. A document control system that can be integrated within an electronic quality system is also a valuable time saving tool for many regulated companies.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For information in regards to quality system management, please feel free to contact a MasterControl representative.
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