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Improving Quality Control & Process Protection: Developing an Effective SOP Process

technical_writing_outsourcing.jpgFor companies in regulated industries, effective Standard Operating Procedures (SOPs) are important to the ability to manage quality control and process protection. Below we share best practices and tips for developing and managing an SOP process that can help companies meet the challenges that come with regulation standards.

Developing an effective SOP process

Before the development process begins, make sure the business needs and goals have been outlined. Understanding the objectives of the SOP helps prioritize the work and serves as the content outline. An SOP process that effectively serves the identified needs, improves quality control and impacts every-day company processes includes:

  • Planning for results
  • Developing and writing SOP documents with audits and regulations in mind
  • Writing easy-to-follow and user-friendly documents
  • Incorporating user feedback to verify the information written in the documents is accurate
  • Monitoring the documents to make sure the content stays relevant and current

The SOP process should include document reviews by individuals qualified to evaluate the SOP in terms of its safety, environmental and operational components, ease of understanding, and completeness.

 

Using a team of developers adds the most value to the SOP process

Many SOPs are written by a single writer and reviewed and approved by a single subject matter expert (SME). Although this scenario works for simple SOPs, using a team of developers with various specialties adds the most value to the SOP process. Ideally, the development team may include but not be limited to:

  • Engineers who designed the equipment and processes
  • Technical writers
  • Safety personnel
  • Environmental personnel
  • Quality personnel
  • Regulatory representatives
  • People who performed maintenance on any equipment described in the SOP
  • Employees who will actually be using the SOPs to perform their jobs
Using a team in the SOP development process offers many benefits. With a team of developers managing the SOP process, an atmosphere for buy-in is created by those involved. This increases the likelihood that the SOPs will be used and your target audience will be more proactive about FDA compliance. Including individuals with varying perspectives and knowledge also helps apply tacit knowledge to the SOP process.
 
Incorporating a team of developers also encourages feedback when new or modified processes are implemented, which means SOPs stay up to date. The team approach to SOP development provides an opportunity for training from the members who worked to put the documentation together.
 
For more help creating effective SOPs and developing a process that supports your company's needs...

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Topics: Quality System documentation, Business productivity, Process documentation, SOPs

 EU MDR