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