GxP Lifeline

Simplified Guide to Writing Superior QMS SOPs


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An arsenal of accurate and timely standard operating procedures (SOPs) is a critical part of any successful quality system. However, writing one from scratch, let alone managing an entire catalogue of SOP templates, can be daunting—to say the least. When written and managed correctly, SOPs can help ensure accuracy and repeatability when completing a task, as well as contribute to compliance and audit preparedness. When written and compiled poorly, they can lead to employee frustration, indifference, and potentially serious non-compliance.

Luckily, all is not lost. The following SOP guidelines can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.

1 SOP Template Research and Preparation

Starting can be the hardest part. You may have been assigned to come up with an SOP for something your team does or uses daily. Or it might be something just as important that comes up less frequently. Regardless, you may be wondering how to even get this thing off the ground. There are a few questions to consider before jumping into writing your first draft.

What is the SOP objective?

The first thing to establish when tasked with developing or updating an SOP is its business objective. Are you documenting an existing process to standardize it? Is the goal to optimize performance of an existing process? Or do you need to document the process for a new piece of equipment? There are myriad reasons for building an SOP. However, pinpointing your main objective will help focus all aspects of the SOP creation and reduce the dreaded “scope creep.”

What SOP standards must you meet?

Nothing is worse than drafting, reviewing, and receiving approval only to find out your SOP does not comply with specific SOP templates or standards, be it GxP, ISO, internal quality standards, etc. Get clear on the standards that need to be met before diving in and work with your document control group to ensure you follow internal documentation procedures.

Once you've done this:

  • Make sure you have the latest version of the SOP.
  • Determine who your reviewers and approvers are.

And most crucially...

  • Find any existing SOPs, work instructions, forms, or SOP templates that could be impacted by your new or updated SOP.

Identifying these items in advance will help determine the scope of your SOP as well as reduce redundancies later on in the process.

Seek out user input.

If you think it's time to start filling in that SOP template, think again. Before you go off to build your first draft, get initial feedback on current processes, or lack thereof. The best people to get feedback from are those actively performing the job function your SOP covers. In addition to the reviewers and approvers you've identified, seek out feedback from users in the departments affected by the change. Survey as many users as possible, especially if the impact will be companywide. Users' first-hand experience is invaluable to improving processes and creating new efficiencies. Incorporating their feedback ensures your initial draft will be more precise and applicable, ultimately decreasing time spent revising in the review and approval process.

2 SOP Template First Draft

Now that you have all the pertinent information from the previous steps, it is finally time to create your initial draft. Do not expect perfection at this point. Just do your best with the information available. The review and approval processes will fill in any gaps in your subject matter knowledge.

An SOP usually includes the following sections:

  • Statement of Purpose: Start by describing the rationale and intent of the document.
  • Scope: Identify the users and work functions governed by the SOP. To provide 100% clarity, also note items that are out of scope. Your statement of purpose and scope sections should be separate and distinct.
  • Responsible Parties: List all the people and roles required to complete the process defined in the SOP. If you find yourself with a large list of contributors, consider narrowing the scope of your SOP and create smaller, related SOPs or work instructions.
  • References: List all documents related to the SOP and provide citations. This may include governing policies, work instructions, forms, or other pertinent documents. If referencing internal documents, include the document number and revision. If references are external, include the URL(s).
  • Assumptions, Precautions and Warnings: List any assumptions made in the drafting or execution of the procedures as well as any precautions or warnings to the user.
  • Materials and Equipment: List all materials and equipment the user will need to complete the procedure.

Include visual representations in your SOP

Oftentimes, typing up a list of steps and procedures is not enough to garner understanding and thus compliance. We live in a visual age full of screens and infographics; accustomed to spending only seconds looking at something to glean information. Don't be afraid to use pictures and diagrams in your SOP: flowcharts, outcome comparisons, graphs, pictures, etc. Visuals provide context quickly and can clear up confusion during the SOP review, approval, and training stages.

Get team feedback.

Once you have compiled your initial draft, it is time to collaborate with your team to review the SOP template draft and get feedback. This could mean setting up a virtual or in-person review session where you look at the document together and make updates in real time. Or it could mean requesting feedback individually and investigating any conflicting information you receive to determine what is correct for the SOP.

Do a dry run.

Now that you've received feedback, the next step is to perform a dry run of the activity the SOP governs to assess whether it will hold up in a real-world scenario. This can help identify any gaps or blind spots to be addressed prior to moving forward.

A dry run can also help determine if your SOP scope is appropriate to the task. If necessary, consider splitting a larger SOP into two supporting documents or creating separate forms and instructions. An effective way to determine if your SOP is sized correctly is to think of it from a training perspective. Will trainees need to review the entire document to be fully compliant? Or will they just need to review portions of it? If a large pool of users will only need training on a section of the document, it could be a sign that splitting out a particular portion into a separate SOP template would be an effective use of time and energy. If the dry run brings up major changes to your SOP, consider holding another set of reviews prior to sending the document out for approval.

3 Approval from Quality Stakeholders

The time has finally come to get approval. Make sure all changes and comments have been resolved in your SOP template before sending. The document sent for approval should be completely clean. If stakeholders reject your draft, make the appropriate changes and be sure to get all approvals again. If someone approved the first draft, have them approve it again once you have made the necessary changes.

Make the SOP as complete as possible before sending to reviewers:

  • Fill in your acronyms, definitions, and reference documents.
  • Make sure your headers and footers are correct throughout the document.
  • Review and update the boilerplate information included in the SOP template, if necessary.
  • And it goes without saying, run a spelling and grammar check.

4 SOP Training and Delivery

Your SOP is ready to be released into the wild. Ensuring a successful launch requires planning ahead and knowledge of your resources.

Prepare users for the change.

You went through all these steps to do one thing—to have the process laid out in your SOP followed by all those governed by it. Training is an integral part of making sure everyone is on board with the new or updated SOP. It is vital to prepare employees for the procedure change prior to having them use it in their everyday environment to avoid the risk of a potential non-compliance. Training could include something as simple as a quick read and acknowledge, or an exam or performance of the process defined in the SOP.

Where will your finalized SOP template live once it has been approved?

You could write the most perfect SOP in the world. But, if it is not easily accessible to those who need it, your efforts will have been for naught. If future revisions need to be made (which let's face it, they likely will), how will you collaborate and view revisions? Lastly, how will users access training on your new or updated SOP?

SOP management and delivery is just as important as building robust individual documents. It's important to determine where and how employees will access the SOP. Is there a specific physical or digital folder location or SOP software solution you can utilize to make sure everyone sees and understands the SOP you've worked so hard to create? Look for options externally if your company doesn't have a document management solution robust enough to fulfill this step.

5 You're ready to write superior SOPs.

By now you have the information needed to go forth to build and manage outstanding SOPs. Remember, preparation, collaboration, and ease of access are critical to the success of your endeavor. Following these guidelines, within the framework of your company's policies and procedures, will help you deliver more accurate SOPs with shorter review cycles, more trainable content, and easier accessibility. To learn how a digital quality management system can help you on your SOP management journey and ensure regulatory compliance visit MasterControl's quality management solutions page.

MasterControl_JohannaBlair_027_chest_up

Johanna Blair is a marketing content writer at MasterControl, contributing her distinctive voice to varied content including white papers, industry briefs, blog posts, and social media. She has a background in health care and medical education administration, where she witnessed the profound impact life science innovation has on the lives of patients and trainees, daily. She holds a Bachelor of Fine Arts with an emphasis in theatre performance from the University of Utah.


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