Our SOP management system provides training notifications and quizzes to demonstrate that document-related training is complete and effective. Once you’ve produced the first draft of your SOP template, run through it yourself to look for improvements, but more importantly have a colleague or associate who is unfamiliar with the process work through it. These are good examples of processes and procedures that are so critical, it’s a matter of life and death. Choose your format. High-level processes are broken into smaller steps and the tasks required to accomplish the step. SOP 101: Standard Operating Procedures Preparation and Maintenance. Plus, our SOP document management system and electronic signature capabilities capture employee and manager signoff, while helping you maintain compliance and SOP document management. Add sub-topics, tasks, and detailed work instructions as needed. Ask yourself if there is a specific reason why this goal should be accompanied by a standard operating procedure document. Or when a manager leaves and standardized performance reviews are needed. When you use the templates and the examples above, you’ll be on the right track for a clear and concise SOP. While you’re working through this step, this is a great opportunity to define the KPIs and metrics by which you can judge your SOPs. Some SOP formats such as ISO-9001 and ISO-9001:2015 can be very long and detailed to meet international standards compliance. The three most basic SOP templates are, in order of simplest to the most complex: In most cases, the ISO-9001 QMS manuals are composed of a master document and many sub-documents. Retention 6. As a given, all of your key employees should have access to either software. However, larger companies want to work at an internationally-recognized level such as ISO-9001 standards, which are based on Quality Management Systems (QMS). A standard operating procedure (SOP) is a set of instructions that describes the steps required to perform a process to accomplish an objective. TeamworkIQ can turn the bullets of your SOP’s first draft into a collaborative checklist for revisions and sign-off. Depending on setup, changes to any SOP document can trigger any of the following actions within the LMS: A notification email is sent out to all employees affected by the change. They can always be further refined and updated. Key aspects of the process are easy to see at a glance. SOP 102: Document Development and Change Control. This 11-page Standard Operating Procedure (SOP) describes the procedures for completing all GMP-relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. These are simple yet powerful. Document management controls the life cycle of documents in your organization — how they are created, reviewed, and published, and how they are ultimately disposed of or retained. TeamworkIQ provides built-in revision control tools so that one version of the SOP can remain in use while updated versions are being created, then rolled out. Maintaining high-quality standards helps retain existing customers and get new ones. Remember to set your standards and scope and be consistent and clear in your steps then test, asses, fix and finalize. An SOP that your teams use as reference point needs to be educational as well as instructional. The automation of document management and SOPs is not an apples-to-apples move. A SOP Template will help with all that needs to be done and will get that done quickly. Disposition 7. Good manufacturing practice (GMP) regulations require that all documentation be issued, managed and controlled using a document management system. Once you know how complex you need your SOP to be, the next step is to assign it a structure and a scope. Give it to a colleague with a critical eye who can go through it from start to finish and ask: Fixes, tweaks, and amendments should happen at this stage. Identification 2. Typical SOP sections include: Document header – with the title, date, author, document ID, approved by, department, company logo, and so on. The main focus is consistency and clarity. A great one outlines steps (so you don’t have to announce them over and again) for routine, business-growing actions like: SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why. You do not have a lot of time to spend working on creating a SOP document and need to know how someone can quickly write up something that will be put to use in your business. Portland . The effectiveness of the SOP document management and change management processes that are enacted when updating SOPs will be nullified without enacting effective. For those organizations who are still taking an “old-school” approach to SOP document management, they’re also taking a big risk. While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. If not, you have a few options: A simple steps format. Process Street is an easy to use workflow and process management software which lets users quickly create, track and schedule workflows and processes, create checklists and standard operating procedures (SOPs), collaborate with the user’s team, control permissions, use forms, and integrate with over 400+ other apps. This will be a useful publication in the hands of decision makers and executives in our Training and Stores Departments. With TeamworkIQ that process becomes easy to discover, easy to learn, and easy to execute and track. SOP & Document Management ICON Central Laboratories maintains over 350 standard operating procedures (SOPs) that are reviewed annually These SOPs guide our daily operations and serve as the foundation for ICON Central Laboratories’ employee training programs. Click here to customize and use this template. The Document Management SOP defines the procedures and controls for managing the standard operating procedures (SOPs) for computerized systems used in regulated activities. Use numbered lists to outline step-by-step processes. MasterControl has an SOP Management Solution for you. Process 10.06.001.001, LBNL Document Management Process, specifies management of documents and flows from this policy. It’s uniquely qualified to be the focal point of a standard operating procedure management system because it can handle all types of documents regardless of the software used to create them. These are simple. By following the above steps you’ve developed a consistent and easy-to-follow SOP. These documents can always be built up into full manuals later. A document management system (DMS) is a system used to receive, track, manage and store documents and reduce paper.Most are capable of keeping a record of the various versions created and modified by different users (history tracking). The name of the user is also appended at the time of updating the document. Training Documentation Form. Document and Records Management Procedure is to ensure that documents and records are appropriately created, captured, accessed, managed and stored in a manner that reflects business, corporate and regulatory compliance requirements. Release Management Standard Operating Procedure The purpose of this standard operating procedure (SOP) is to ensure that all staff responsible for release and deployment management are aware of the objectives, roles, and procedures involved in every process applied throughout the lifecycle of a release. Then it’s time to finalize the process and get it into active use. If you’re leading a department within a large business, or manage a small or medium-sized business then procedure documents or checklists are likely suitable. Although the term "management" implies that information is controlled from the top of the organization, an effective document management system should reflect the culture of the organization that uses it. With these steps in mind, you will be able to develop a concise SOP template – no matter how detailed or complex the process is. But do not let simplicity mean they are not powerful. This combination of functions saves workers and management time and effort. If … Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities. This SOP will be revised once a year. Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions, an IQVIA company. We’re strong believers in the power of collaborative creation. 25 Free SOP Templates and Best Practices for Creating Standard Operating Procedures, different for different types of businesses. Not-So-Standard SOPs: What You Need to Know, Reduce Product Risk, Improve Patient Safety, Limit the Stakes with Risk-Based Employee Training, Distinguish Your Organization with Risk-based Supplier Inspections, Proposal to Delay EU MDR Implementation Brings Manufacturers Some Good News. http://templatelab.com also has many SOP templates that you can download for free. Determine if it is more effective to create a new SOP document than attempting to simply modify the existing one. 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