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Creating a SOP Review Checklist

Written by ComplianceBridge Policies & Procedures Team on July 21, 2017

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The ins and outs of business are often organized as lists. A list of people to contact, a list of things to do, a list of revenue earned, and a list of bills to pay, among others. The way you organize these lists can improve the way you conduct business or hamper every aspect of it. Formalizing your lists into Standard Operating Procedures (SOPs) is the best way to improve the management of your business. But regardless of how much work you put into this initial set of SOPs, the way you do things are bound to change.

As your organization evolves, so will its SOPs. While you could rewrite your procedures, it will likely be more time efficient to create a procedure—a review checklist—to follow when you go back and update your original SOPs.

Do you really need a SOP for the SOP Review process? Yes, you do

An SOP review represents more than going back to edit the language to fit the needs of today. The best SOP reviews also integrate fundamental changes to improve the way the original SOP performs in the organization. In some cases, change involves automating much of the system.

Your original SOPs may have been written more than a decade ago by subject-matter experts who are no longer working at your organization. For this, and many other reasons, SOPs require regular review and validation to ensure that original document remains relevant for new hires. The review process should include a checklist comprising five control procedures: self regulation, expiration dates and reminders, an element of ownership, influence management, and formatting (1).

At the top of your SOP checklist should be to search for expirations, looking for SOP that may have become obsolete. For SOP that do not already include an expiration date (or a reminder about when the next update should take place), you should specify expiration or some other mechanism to ensure that the document remains in good standing. Ideally, you will build in self regulation.

The next part of the SOP checklist is to modify the SOP so that it is continuously updated rather than updated after reaching expiration. Self regulation is a procedure that can actually be built into the original SOP. Essentially, the goal is to create a step in the SOP where it makes sense to review and update the SOP as needs evolve.

If not already chosen, each SOP should have defined owners who are responsible for the review process. The owner is someone who is responsible for completing the review and updating the SOP. The ownership responsibility should also include a procedure to pass along ownership. Most importantly, the owner is the go-to person who receives input from influencing factors, which leads us to the next component.

Managing influencing factors is all about dealing with anything that can impact your SOPs. The review checklist will ensure that you manage the influencing factors by controlling the person or team responsible for keeping up on changes.

Dotting the i’s, crossing the t’s, and getting all the format right

The final part of your SOP checklist should be to correct formatting. In a survey published in Applied Clinical Trials, the authors found that users valued the ability to navigate the SOP system as a whole far more than the size of each SOP or even the number of SOP present. What matters most to individuals, is the ability to quickly find what they need. And to do that, SOP formatting should be clear and consistent (2).

The U.S. Environmental Protection Agency published a best practice document about SOPs and provided a template of five components they believe every SOP should include: title page, table of contents, purpose, procedures, quality assurance/quality control, and references (3).

Simplifying your life with TotalCompliance

Creating SOPs is challenging, creating a procedure to review and update them is difficult, and coordinating with an entire organization on both fronts can prove to be a nightmare. An automated SOP system like TotalCompliance by ComplianceBridge has built in all the necessary controls you need to maintain a modern system with a robust SOP checklist. TotalCompliance gives your review team the ability to see the real-time status of each document as they are being edited or rewritten. Powerful templating tools allow you to reproduce the structure of any existing SOP to use as the starting point for new documentation. Finally, you can assign certain SOP tasks to groups that can be customized by you, to manage who influences each revision.

Curious about how you would transition the SOP system at your organization into a cloud-based, automated version? Request a free demo of TotalCompliance to receive a complete walkthrough of how the system can make a difference at your organization in time for your next SOP review.

Citations

  1. “Standard Operating Procedures – A complete guide! – Review & Update.” Collaboris. July 14, 2016. Accessed July 19, 2017. https://www.collaboris.com/standard-operating-procedures-a-complete-guide-review-update/.
  2. Gabriele B. Schmidt PhD Dieter Baier PhD Arthur Hecht * Michael Herschel MD. “An Ideal SOP System.” Pardon Our Interruption. January 29, 2016. Accessed July 19, 2017. http://www.appliedclinicaltrialsonline.com/ideal-sop-system?pageID=1.
  3. “Guidance for Preparing Standard Operating Procedures (SOPs).” EPA. 2007. Accessed July 19, 2017. https://www.epa.gov/sites/production/files/2015-06/documents/g6-final.pdf.
  4. “Powerful Policy Management Software from ComplianceBridge.” ComplianceBridge. Accessed July 06, 2017. http://compliancebridge.com/products/policy-management-software/.

ComplianceBridge Policies & Procedures Team

The ComplianceBridge Team has more than a decade of experience in compliance management and solution development. We cover stories of interest to Compliance Officers and provide tips and tricks for maximizing compliance.

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