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Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Are You Getting Your Money’s Worth from Your SOPs?

Standard Operating Procedures (SOPs) are the proactive strategy companies use to systematize processes within their operation. Typically, they are developed as a means to remove variation in work performance caused by individual employees completing the same work processes in different ways. For example, in a technical documentation department, an SOP for file naming can reduce the time required to locate documents. The key for getting your money's worth from any SOP development program is to make sure the procedures that are created are well-written so that they actually get used by your employees. For SOPs to be considered as well-written, they must be complete, clear, and concise.

SOP StrategyBenefits associated with well-written SOPs

  • Simplifies training
  • Reduces uncertainty in how to perform a process or procedure
  • Assures consistency in job performance
  • Facilitates a more productive use of an employee’s time
  • Speeds compliance for regulated companies
  • Cuts costs

Well-written SOPs also serve as an historical record of how an existing process was initially performed and what changes were added as a result of process improvements. Undocumented knowledge and skills disappear from the workplace as workers move on to other jobs either internally or outside the company. Regularly maintained SOPs help preserve that knowledge so it can be leveraged to train new hires.

Attribution: Image used above is courtesy of KROMKRATHOG at freedigitalphotos.net.

10 Ways to Get Your Money’s Worth from Your SOP Program

People need consistency to be their most productive. When they have guidelines that spell out whether a piece of equipment should be cleaned and how to do it, or what in what format a technical documentation plan should be, they can simply perform their jobs without stopping and wasting time to ask questions. The following list provides a refresher of ways to improve quality control in your organization by developing a well-written SOP program:

  1. Know where your company is most vulnerable and start documenting SOPs for the highest risk areas first.
     
  2. Decide on the best format for reporting results based on the employees who will be performing the procedure and where they will be performing the procedure.
     
  3. Determine how and when employees will access the SOPs after they are developed. Then, establish a retrieval system that ensures the procedures will be easy to find.
     
  4. Select and use the best team of quality control experts and technical writers to create your SOPs so they are complete, clear, and concise. Using professional technical writers that know the difference between essential content and content that interferes with the document’s purpose helps keep the procedures short and focused so they’re easier to understand.
     
  5. Include updating methods as a part of the document format. Intranets, social media, twitter, wikis, and SharePoint are just a few of the ways employees can use to provide timely feedback.
     
  6. Set up a testing process to confirm the accuracy of each SOP before it is released.
     
  7. For regulated companies, make sure the SOPs are written with the regulatory body's requirements in mind. Many of the FDA 483 observations and FDA warning letter citations received by medical devices manufacturers during an FDA inspection are the result of poorly crafted and incomplete SOPs, and failure to revise and maintain the SOPs properly.
     
  8. Set up a documentation process program to monitor each SOP to make sure it stays current.
     
  9. Assign approved SOPs a designated control number and make sure everyone in your company is aware that they are version-controlled documents that can only be found via the company’s Intranet or Internet in a read-only format.
     
  10. Discipline your employees to use the approved version-controlled documents as part of their job requirement. This way, they’ll more likely be followed.

For additional Novatek blogs that discuss SOPs, read:

To make sure that all required information is included in each SOP and that all procedures are consistent, Novatek recommends using our guide when developing SOPs.

Download our free guide:
A Guide to Standard Operating Procedures

Get the Guide

What challenges have you faced when developing SOPs? How have your resolved them? Share your thoughts and experiences in the comments below.

Topics: controlling cost, Quality System documentation, SOPs

 EU MDR