18 December, 2013 Robyn Barnes, Public Relations Specialist, MasterControl Inc.
Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value. Using the following 10 guidelines, you can create a successful SOP document.
Ask yourself, what is the business objective for the SOP? Are you merely documenting an existing process so it can be executed uniformly? Are you trying to optimize the performance of an existing process? Do you have a new piece of equipment whose use needs to be documented? Once this is determined, use this objective to drive all aspects of the SOP creation. This will help reduce “scope creep” as well as keep the SOP appropriately sized for the task at hand.
1. Determine business goals
2. Determine standards compliance
What standards will your SOP comply with? GxP? ISO? EMEA? Internal Quality Standards and Policies? Once you are clear on which standards you need to meet, make sure you read and understand them. It’s inefficient to go through the entire draft, review and approval process only to find out you need to modify your SOP to comply with a standard.
3. Engage with the document control group
Work with your document control group to ensure you are following your internal documentation procedures.
Collecting these items in advance will help you determine the scope of your SOP as well as reduce re-work later in the process.
- Get the latest version of your SOP template.
- Determine who your reviewers and approvers are.
- Find any SOPs, work instructions or forms which may be impacted by your new or updated SOP.
4. Engage with your team members
In addition to the reviewers and approvers identified above, seek out individuals who currently perform the job function your SOP is covering. If the SOP covers more than one department or is companywide, seek out as many users as possible; they will have the most valuable feedback for process improvements and efficiencies. By incorporating user feedback, your initial draft of the SOP will be more complete and accurate, ultimately reducing time spent revising the document in the Review and Approval process.
5. Draft your SOP
Using all the information gathered in the previous steps, create your initial version of the SOP. There is no expectation of perfection in this phase of the SOP’s life. Draft it as best you can with the information on hand. The review and approval processes will fill in any gaps in your knowledge of the subject matter. Make the SOP as complete as possible prior to sending it out for review.
An SOP usually includes:
- 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 template as necessary.
- Be sure to run a spelling and grammar check.
- Purpose – The purpose statement describes the rationale and intent of the document.
- Scope – The scope statement identifies who and what is governed by the SOP. It’s also important to note those items which are out of scope to provide 100% clarity. Be sure to keep your purpose and scope separate and distinct.
- Responsibilities – List all the actors required to complete the process defined in the SOP. If you find yourself with a large list of actors, consider narrowing the scope of your SOP and create smaller, related SOPs or work instructions.
- References – List all documents related to the SOP as clearly as possibly. This could include governing policies, work instructions, forms, standards or other documents. If you are referencing internal documents, include the document number and revision. If your references are external, include the URL.
- Assumptions / Precautions / Warning – List any assumptions made in the drafting or execution of the procedures as well as any precautions or warnings to the user.
- Materials & Equipment – List any of the materials the user will need to complete the procedure as well as any equipment needed.
6. Use pictures and diagrams
Don’t be afraid to use pictures and diagrams in your SOPs, including flow charts or pictures of a good or bad outcome. Graphical representations are a great way to clear up confusion in the review and approval process as well as for training to the SOP.
7. Conduct reviews
Re-engage your team members to review the draft SOP and provide feedback. Depending on your team’s membership, it may make most sense to conduct a review session where everyone gets together and the document is reviewed and updated during the meeting. If you cannot conduct a review session, be sure to take note of any conflicting information you may get back from your team. In this instance, you will need to work with the differing team members to determine what is the correct information for the SOP.
8. Perform a dry run of the SOP
After your reviews are complete, perform a dry run of the activity the SOP governs. Try to simulate as close to a real world scenario as possible. This will facilitate the identification of any gaps in your SOP which will require updates to capture the full process.
Verify that your SOP is a manageable size. If it becomes too large, consider splitting it into two supporting SOPs or create separate work instructions and forms to support it. One way to ensure your SOP is sized properly is to think about it from a training standpoint. Ask yourself: Will my trainees need to train on this entire document or just portions? If a large portion of your trainees are only training to a section of the document, that may be a good time to split that portion of the document off into a separate SOP.
If there are major changes to your SOP as a result of the dry run, consider conducting another set of reviews prior to sending the document out for approval.
9. Prepare approval version
Combine all comments into a final version to be sent out for approval. Make sure you accept all changes and comments; the document sent for approval should be completely clean. If your document is rejected, make the appropriate changes and be sure to get all approvals again. If people had previously approved, they will need to approve again.
10. Train your users
Make sure employees are trained prior to using the procedure in a real world environment. This could include a simple read and acknowledgement, an exam or performance of the process defined in the SOP.
Following these guidelines within the framework of your company’s policies and procedures will help you deliver more accurate SOPs, with shorter review cycles and more trainable SOPs.
Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.
Robyn Barnes, a public relations specialist at MasterControl Inc., writes about the life sciences industry and other regulated environments. Her three decades of marketing and public relations experience include work with USAA, Morrison Knudsen Corp., and KBHome Inc. She holds a bachelor’s degree in journalism and a master’s degree in business from New Mexico State University.