Why QMS Products Pricing About Us
"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.
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.
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 Module, 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.
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.
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