18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl
For Medical Device
"SOPs! We don't need no stinking SOPs!"
This is how many companies feel when asked about their standard operating procedures (SOPs). They may think they don't need the proper documentation to do a good job. What companies fail to understand is that working without SOPs is becoming increasingly impossible—and even dangerous—in the world of regulated industry.
SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task.
SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. While this ensures compliance with internal processes it also helps ensure compliance with regulating bodies, such as the FDA.
Different divisions of the FDA have different CGxP regulations and requirements. For instance, in pharmaceutical manufacturing, CGMP - Current Good Manufacturing Practices, 21 CFR Part 210-211, section 211.00 - states directly: "There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit." Every company that is audited by any sort of regulating body needs to ensure they are closely adhering to the regulations set forth by their industry standards.
SOPs are meant for any person who performs any task described in the SOP or who needs to be aware of any task described in the SOP. Awareness means a person may not be on the manufacturing floor performing the task but may need to know that this type of task exists for other purposes, such as reporting or auditing. When training on these SOPs, different competencies can be set for people with different responsibilities. One person may need to demonstrate the ability to perform the task for a supervisor, while another person may only need to read the SOP and have general knowledge that it exists.
The FDA or ISO have no specific requirements for sections that must be included in a SOP. Although there are no specific requirements, there are some sections that typically appear in many SOPs. These are: Purpose, Scope, Related Documents, Responsible Parties, Definitions and Procedure.
- Purpose: Gives a brief summary of what is entailed in the SOP and why it is being written.
- Scope: Details what areas are affected by this procedure.
- Related Documents: Lists every document that is referenced in the SOP. When creating or updating an SOP, it is always best to review any Related Document to ensure it does not need to be updated, as well. Any existing forms related to this procedure need to be listed in this section. They may also be placed as appendices to the SOP for easy reference.
- Responsible Parties: Any group or position that has any sort of responsibility with any part of the SOP.
- Definitions: Defines any key word that may not be common knowledge for the intended audience.
- Procedure: A detailed, step-by-step synopsis of what takes place with this particular task. The writing should be clear and concise so that anyone would be able to fully understand and perform the task.
First and foremost, a Quality System needs to be established where the SOP guidelines are created. It is always best to have a SOP template available to your SOP writers so that consistency is achieved in sections and formatting.
A document change procedure should also be established. This will put into place the correct procedure in which employees can revise an existing SOP or create a new SOP. Built into this document change procedure will be pre-determined approvals. A company needs to decide who has the authority to approve changes to or the creation of SOPs. Typically, if a SOP "touches" a department in any fashion, someone from that department needs to review and approve the changes made to the document.
Next, determine the document approval route. Do people need to collaborate on the changes before the document is put into its final stages for the approval route? This can help cut down on rejections further along in the process. Once the document is on the approval route, determine who needs to see the document first and who needs to see it last. If you are using an electronic approval process, can multiple people receive the document at once to approve it? Many companies will put the Document Control Coordinator at the end of the document route, so that they can ensure all formatting is correct and then release the SOP on the appropriate date.
Another item to consider is who needs to train on the SOP. Determine how training is going to be rolled out to the employees. Some methods for rolling out training include group training, sending an email notification or using a Training system, such as MasterControl Training™, that will notify those who need to train as soon as the document is released. When training is completed, the Trainee Record will need to be updated with the date they trained and the revision of the SOP on which they trained.
A company should always consider how often they need their SOPs reviewed. This will ensure the material in the SOP is always up to date and compliant with the latest regulatory standards. Many regulated companies need to review their documents once a year or every two years. When you think of maintaining SOPs, it is not just about setting up a review period for the document type. It is also about maintaining knowledge and comprehension of the SOPs throughout the list of affected users. When an employee joins the company or enters a new position within the company, it is easy to hand him the SOPs that pertain to his job and tell him to train on them. Veterans of the same job need oversight to see that they remain trained and competent. For these individuals, it is always a good idea to have them re-train on job tasks on a specified schedule. Many companies will send out re-training on their SOPs once a year to ensure training comprehension and compliance with regulatory standards.
Regardless of what industry your company is in, it is going to be regulated by some sort of governing body and chances are, they will require SOPs. When a company creates a solid SOP system, chances are they are going to be more compliant with regulatory standards. Processes will fall into place once the standards are set for document change and creation, approval, release, training and maintenance.
Katy McMullin, Senior Professional Services Consultant at MasterControl, has been with the company since August of 2006. Ms. McMullin works with clients to consult on both MasterControl Software and Industry Best Practices, helping them to determine the best way to set up their systems. She is also proficient in the configuration of the MasterControl system for the Portal, Documents, Training, Projects and BOM modules. Every client's needs are different and McMullin helps the client determine which direction is best for their individual needs.
Prior to joining MasterControl, McMullin worked at an international medical device company in their Quality Assurance Department. Working with the entire company to develop and implement their Standard Operating Procedures, McMullin became familiar with the process requirements set forth by the FDA. McMullin played an integral part in the planning and implementation of the company's electronic data management system.
McMullin is a member of ASQ and is a Certified Quality Improvement Associate (CQIA). She holds her BS in Business Management - Marketing from the University of Missouri. In 2006 she completed her MBA with an emphasis in Marketing from the University of Missouri - St. Louis.
"You Need to Create an SOP...Now What?" Lab Manager, Feb. 23, 2009. http://labmanager.com/articles.asp?ID=218
"Don't Write Yourself Out of Compliance With SOPs," Paula Rutledge. Medical Device Guru. www.medicaldeviceguru.com/showthread.php?t=3090