What are SOPs? and Why Does My Organization Need Them?

An essential aspect of any Quality System the ability to work in alignment and according to standardized and explicit Standard Operating Procedures (SOPs).

To ensure you and your team are operating from a formalized and coordinated process not only increases productivity but reduces the risk of errors. While everyone may want to do the right thing, often everyone’s version of that right thing is likely to be somewhat different. This means that how a task is completed is likely to vary according to who is undertaking that task.

If the expectation at your organization is that everyone is to follow the same rules, then you must make it clear what those rules are. The best way to do this is to document them.

For those that are experiencing SOPs for the first time, or are working in a small organization that is looking to put SOPs in place, we’ve put together a light introduction to what Standard Operating Procedures are, and why your organization needs to implement them. 

What are SOPs?

Standard Operating Procedures (SOPs) are the documented processes that a company has in place to ensure that services and products are delivered consistently every time. SOPs are often used to demonstrate compliance with the regulation or operational practices and to document how tasks must be completed at your organization.

Often when a company is growing and just starting, the CEO or management team tend to make all the internal decisions. As the company reaches a specific size, this form of decision-making can limit its capacity to grow further as the CEO or management team can’t make all decisions in the appropriate time-frame or be involved in every aspect of the business. In this instance, your SOPs would typically take over and act as your governing word. SOPs can also be an effective way to communicate changes in the way your business operates to your employees.

The requirements for SOPs and their format will range from industry to industry. SOP requirements could also depend on the type of activity your organization is undertaking, or what regulations your business is governed by. In clinical research, these requirements are precise.

Why do you need SOPs at your organization?

Procedures are not a be-all, end-all solution – they will not guarantee excellent performance nor good results. However, what SOPs will do is ensure that you have a structured quality system and processes in place, qualified employees, and a motivating company culture. SOPs, in their purest form support the right people in the right environment.

SOPs help you to evaluate more than what you’re doing now but also help you decide how to move forward. Imagine if your organization is looking to implement new document management software.

To determine what software to purchase, you need to know how your employees will use the software and how it will affect your business processes. If you have complete and thorough SOPs, you can use them to evaluate the new software’s strengths and weaknesses. By fully understanding your current processes, you will make the best choice for your organizations.

An SOP is a useful business tool as it communicates the correct way of carrying out an activity within your organization. Standard Operating Procedures at a minimum give you the following:

• Consistency – The number one reason for procedures is consistency in the way an individual carries out a particular task or activity. The more consistent a process is from person to person, the less chance there will be quality problems.
  
  
• Reduction of errors – A written procedure details a set of instructions for performing a task. As long as each individual within your team performs the task as it is written, there's a greater chance of reducing errors.
  
  
• Communication – Another great reason you need SOPs in your organization is for the benefit of communication. With improvements made to processes, the operating procedures are updated, and each update requires new training. Updating SOPs provides a method to communicate the process changes to employees.

Benefits of having SOPs at your organization

Creating more structure in your business activities can dramatically improve productivity and reduce costs. Not every organization will benefit from this kind of standardization, and it depends on you, the business owner or manager, to determine if there are work processes that can be duplicated every day within your company and if it's worth teaching those processes to employees through SOPs.

Many great benefits can be realized by bringing standardizing processes and documenting formal SOPs to your organization. Here’s a great list we found from Sanjay Kumar Jain:

1. To provide people with all the safety, health, environmental and operational information necessary to perform a job properly. Placing value only on production while ignoring safety, health and the environment is costly in the long run. It is better to train employees in all aspects of doing a job than to face accidents, fines, and litigation later.
   
   
2. To ensure that production operations are performed consistently to maintain quality control of processes and products. Consumers, from individuals to companies, want products of consistent quality and specifications. SOPs specify job steps that help standardize products and, therefore, quality.
   
   
3. To ensure that processes continue uninterrupted and are completed on a prescribed schedule. By following SOPs, you assist in avoiding process shut-downs caused by equipment failure or other facility damage.
   
   
4. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community. Following health and environmental steps in SOPs ensures against spills and emissions that threaten plant neighbors and create community outrage.
   
   
5. To ensure that approved procedures are followed in compliance with company and government regulations. Well-written SOPs contribute to ensuring that government regulations are satisfied. They also demonstrate a company's good-faith intention to operate correctly. Failure to write and use proper SOPs will only signal government regulators that your business is not serious about compliance.
   
   
6. To serve as a training document for teaching users about the process for which the SOP was written. Thorough SOPs can be used as the basis for providing standardized training for employees who are new to a particular job and for those who need re-training.
   
   
7. To serve as a checklist for co-workers who observe job performance to reinforce proper performance. The process of actively caring about fellow workers involves one worker coaching another in all aspects of good job performance. When outlining the correct procedures in a good SOP, any co-worker can use that SOP to coach another and help improve work skills.
   
   
8. To serve as a checklist for auditors. Auditing job performance is a process similar to the observation mentioned previously, only it usually involves record-keeping. SOPs should serve as a solid foundation when developing detailed audit checklists.
   
   
9. To act as a historical record of the how, why and when of steps in an existing process. This provides a factual basis for revising those steps when a process or equipment are changed. As people move from job to job within and between companies, unwritten knowledge and skills disappear from the workplace. Properly maintained written SOPs can chronicle the best experience that can serve new workers when older ones move on.
   
   
10. To act as an explanation of steps in a process for review in accident investigations. Although accidents are unfortunate, view them as opportunities to learn how to improve conditions. A good SOP gives you a basis from which to start investigating accidents.

The Takeaway

Ready to automate the entire lifecycle of your controlled documents and create your SOPs? You may be interested in downloading our IT SOP Template starter pack to help outline what you need to maintain control and compliance with regulations. Montrium also offers an SOP writing and review service to assure compliance with the current GxP requirements.

To keep all of your SOPs managed in one place,  our Quality Connect electronic quality management system comes with an SOP Management module designed to manage all controlled documents that form part of your quality system. Easy access, centralized distribution, and intuitive workflows ensure that quality and compliance are at the heart of your operations.

References

K. Jain, Sanjay & Nikhil, Bhatwadekar. (2008). Standard operating procedures (SOP) - Back Bone of Pharmaceutical Industries. Pharmaceutical Reviews.