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

Developing Effective Standard Operating Procedures

Many businesses develop Standard Operating Procedures (SOPs) to ensure consistency in their processes, improve product quality, and prevent health and safety issues. An SOP is a written set of step-by-step instructions on how employees should complete a specific task or process. Its purpose is to ensure the successful outcome of the activity each time it is completed. For example, medical device manufacturers establish SOPs to make sure that employees comply with FDA regulations and follow quality management best practices.documentation_training_alignment.jpg

Beyond quality and compliance, SOPs are useful for maintaining equipment, processing customer orders, or any task requiring consistent execution. Well-written SOPs also simplify employee training by making sure that all employees receive the same information and instructions.

Areas that Benefit from SOPs

Safety and Regulatory Requirements

  • Government regulations environmental protection
  • Workplace safety and accident prevention
  • Food safety and bio-security

Quality Management

  • Quality control
  • Process improvement

Human Resources

  • Job description development
  • Performance appraisals
  • Worksite reminders
  • Employee orientation and training
  • Cross training, refresher training, and advanced training

4 Ways to Maximize Your SOP Investment

There is more to creating user-friendly documentation than just sound writing. Use these tips to make sure your SOPs are truly providing value.

  1. Know where your company is most vulnerable, and start documenting SOPs for the highest risk areas first. 
  2. Select the best team of quality control experts and technical writers to create your SOPs. The procedures should be written clearly and concisely and designed to pass usability testing. Consider hiring an outsourced technical writing and documentation partner with knowledge in your industry.
  3. Determine how and when employees will access the SOP after it is developed. Make it easy for them to find.
  4. Decide on the best format for reporting results based on who will be performing the task, where they will be performing the task, and how these records will be used in the future.

How to Organize Your SOP Writing

Developing a complete set of quality documents or SOPs for a business can be daunting. However, taking the time up front to organize and prioritize the SOP development process will help it run smoothly. Start by identifying:

  • Top one or two areas in which more controls are required or desired
  • Areas that will have the greatest economic return on investment
  • Areas that are likely to yield the greatest successes early in the process so that you can build on the momentum of the project

Based on these considerations, decide which SOPs you will create first. Work with your internal or outsourced documentation team to create a schedule detailing when each step of the writing process will be completed.

The Final Steps

Once the SOP development process is finished:

  • Train your employees on the new SOP. Don't just distribute it!
  • Verify that the SOP is followed consistently through regular monitoring.
  • Evaluate the SOP periodically to make sure it stays current.
  • Update or retire the SOP as the need for it changes.

Novatek recommends using a template when developing an SOP to ensure that all required information is included and that all procedures are consistent and predictable. If your company does not have a standard template, consider using our tip sheet to help you get started.

Download our free guide:
10 Steps to Effective Standard Operating Procedures

SOP Tip Sheet

 

Topics: technical writing services, Business productivity, Process documentation

 EU MDR