Standard Operating Procedure: A Guide
Imagine starting a job at a company that doesn't have clear operating procedures. Instead of having a clear guide or Standard Operating Procedures (SOPs) to follow, you have to ask coworkers about each task, from how to access the company software to how to handle customer inquiries. Each coworker has a different way of doing things, so you receive conflicting advice, leading to confusion and mistakes.
Without Standard Operating Procedures (SOPs), you spend a lot of time figuring out basic processes, which slows down your work and can be frustrating. It’s like trying to bake a cake without a recipe; you might know the ingredients but not the right amounts or the order they should be mixed. This lack of direction not only affects an employee’s ability to perform but also impacts the quality of work, customer satisfaction, and the overall efficiency of the company.
For Software as/in a Medical Device companies, SOPs are important for maintaining the rigorous standards required in the Medical Device field, ensuring that software not only meets regulatory and safety requirements but also functions reliably and effectively for end-users. In short, it’s a crucial element of your business. This article will provide you with the information you need to create your Standard Operating Procedures to ensure your Medical Device can be legally sold in its intended markets.
What is a Standard Operating Procedure (SOP)?
A Standard Operating Procedure (SOP) is a set of step-by-step instructions that outline standardized methods and protocols for a process in a consistent way. These tasks could range from manufacturing processes, quality control testing, handling of raw materials, to regulatory compliance and reporting. They help ensure that the work being done meets regulatory standards, maintains high quality, and is systematically documented, contributing to the overall reliability and safety of your Medical Device.
SOPs bring order to your company preventing delays, quality variations, and communication breakdowns that hinder a company from excelling in the market. By following SOPs, you can ensure that your products are both effective and safe for use, while also protecting the company from potential legal or regulatory penalties.
Benefits of having Standard Operating Procedures
SOPs are fundamental in ensuring operational excellence, compliance, and safety, contributing to the overall effectiveness and success of an organization. Let’s dive into five main benefits of having Standard Operating Procedures (SOPs) and why they are crucial for success.
Consistency and Quality Control
SOPs ensure that tasks are performed the same way every time, leading to uniformity in product quality and service delivery. This consistency is vital in industries like medical devices, where product reliability can affect patient health and safety.
Example: An SaMD company develops software for monitoring patient heart rates. The SOPs ensure that every software release has undergone the same rigorous testing protocols, including automated testing and human factor assessments, to maintain consistent quality and functionality in each update.
Efficient Training and Onboarding
SOPs provide clear instructions for performing tasks, making it easier to train new employees. They act as a reference tool that new staff can rely on to understand their roles quickly and accurately, which speeds up the training process and helps maintain operational efficiency.
Example: A company specializing in cloud-based EHR (Electronic Health Record) systems for clinics uses SOPs to train new developers and support staff. These procedures cover system troubleshooting, software update protocols, and customer support processes, enabling new employees to quickly become effective and reduce the time senior staff spend on training.
Enhanced Safety
By outlining the correct way to handle equipment, processes, and materials, SOPs help minimize the risk of workplace accidents and health hazards. This is particularly important in settings where employees handle dangerous substances or complex machinery.
Example: In developing mobile apps for patient self-management of chronic diseases, SOPs ensure that all data handling and storage are compliant with safety standards. This includes protocols for data integrity checks and emergency data recovery plans, vital for protecting patient data from being lost or corrupted.
Improved Performance and Accountability
SOPs clarify job expectations by defining how tasks should be done, which helps employees understand their responsibilities better. This clarity can improve performance by removing ambiguity and can help managers hold staff accountable for their work, leading to overall better operational performance.
Example: For a company that offers telemedicine solutions, SOPs define the process for routine performance audits of the platform, specifying how to monitor uptime, response times, and user feedback. This ensures that the team remains accountable for maintaining high service levels, directly impacting user satisfaction and trust.
Various forms and types of SOPs
The purpose of Standard Operating Procedures (SOPs) depends on the task at hand therefore various forms and types exists. Using the right type of SOP in Software as/in a Medical Device (SxMD) is critical because it ensures that the intended procedures are clearly understood and correctly followed. Here’s why it’s important to choose the appropriate SOP format and examples of when each might be used in SaMD:
Step-by-Step SOPs
These are the most detailed SOPs, providing sequential instructions on how to perform specific tasks. They are written in a straightforward list format, ideal for tasks requiring precision and clarity, such as laboratory procedures or manufacturing processes.
Example: Writing a step-by-step SOP for the coding and validation procedures of a new algorithm in a diagnostic app. This ensures that every developer and tester follows the exact same procedures, minimizing the risk of software bugs that could affect patient diagnosis.
SOP Title: Coding and Validation of New Algorithm in Diagnostic App
Objective: To standardize the development and validation of new algorithms within the diagnostic app to ensure accuracy, reliability, and regulatory compliance.
Scope: This SOP applies to all software development and quality assurance team members involved in the coding and validation of new algorithms.
Process Steps:
Requirements Specification
Product Manager
Define and document the clinical and technical requirements of the new algorithm.
Ensure the requirements are clear, measurable, and aligned with patient safety standards.
Algorithm Design
Lead Developer
Design the algorithm based on the specified requirements.
Create a detailed design document that includes data flow diagrams, logic diagrams, and pseudocode.
Code Development
Development Team
Code the algorithm according to the design document using the designated programming language and coding standards.
Use version control systems to manage code changes and maintain code integrity.
Code Review
Peer Review Team
Conduct peer reviews of the code to identify any potential issues or deviations from the design specifications.
Document the review findings and ensure all critical issues are resolved before proceeding.
Unit Testing
Developers
Write and execute unit tests for each component of the algorithm to verify the correct functioning of individual parts.
Use automated testing tools where applicable and ensure high test coverage.
Integration Testing
QA Engineers
Integrate the new algorithm with existing modules of the app.
Conduct integration tests to ensure that the algorithm interacts correctly with other app components.
Validation Testing
Validation Team
Perform rigorous validation testing to confirm that the algorithm meets all clinical and technical requirements.
Simulate real-world scenarios to validate the accuracy and reliability of the algorithm.
Documentation
Technical Writers
Update the software documentation to include details about the new algorithm.
Ensure that the documentation is clear and comprehensive for future reference and audits.
Regulatory Review
Regulatory Affairs Specialist
Review the algorithm and all associated testing and documentation to ensure compliance with relevant healthcare regulations.
Prepare and submit any necessary regulatory filings before release.
Final Approval and Release
Project Manager
Obtain final approval from the software development manager and QA manager.
Coordinate with the deployment team to schedule the release of the updated app.
Post-Release Monitoring
Support Team
Monitor the performance of the algorithm post-release.
Collect user feedback and report any issues back to the development team for future improvements.
Completion: Ensure that all steps are documented and approved by the respective responsible parties. Store all documentation securely for audit purposes and future reference.
Hierarchical SOPs
These SOPs are structured with main steps and several sub-steps. They are used for complex processes where some steps require more detailed explanations. This format helps users understand the context of each task and its subcomponents, useful for multifaceted operations like software deployment or emergency response procedures.
Example: Deploying an update to an existing SaMD, where major steps like initial testing, regulatory review, and final deployment are broken down into detailed sub-steps to ensure thorough execution and compliance at each stage.
SOP Title: Deployment of Software Update for SaMD
Objective: To ensure a seamless, compliant, and efficient deployment of updates to the existing SaMD, maintaining high standards of quality and regulatory adherence.
Scope: This SOP applies to all teams involved in the development, testing, regulatory approval, and deployment of software updates.
Process Steps:
Pre-Deployment Preparation
Development of Update
Code Development: Develop new features or fixes according to the product roadmap and issue tracker.
Code Review: Conduct peer reviews to ensure code meets internal coding standards and addresses the intended functionality.
Initial Internal Testing
Unit Testing: Perform comprehensive unit testing to verify individual components function correctly.
Integration Testing: Test the integration of new code with existing code to ensure system-wide coherence.
Detailed Testing and Validation
System Testing
Performance Testing: Evaluate the performance of the software under various conditions to ensure it meets predefined benchmarks.
Security Testing: Conduct security assessments to identify and mitigate vulnerabilities.
User Acceptance Testing (UAT)
Beta Testing: Release the update to a select group of real users to validate functionality in a live environment.
Feedback Collection and Analysis: Gather and analyze user feedback for any critical issues.
Regulatory Review and Compliance
Documentation Review
Update Documentation: Ensure all changes and functionalities are accurately documented.
Compliance Check: Verify documentation and software changes meet all relevant regulatory standards.
Regulatory Submission
Prepare Submission Packet: Compile all necessary documentation and results from testing to submit to regulatory bodies.
Submission Follow-up: Address any queries from regulatory bodies and ensure all concerns are resolved.
Final Deployment
Deployment Planning
Release Scheduling: Determine optimal timing for deployment to minimize impact on users.
Resource Allocation: Assign technical resources for deployment and post-deployment support.
Deployment Execution
Update Deployment: Roll out the update to users according to the deployment plan.
Monitoring and Support: Monitor the deployment process for issues and provide immediate support to resolve any emergent problems.
Post-Deployment Review
Performance Monitoring
Collect System Metrics: Gather data on system performance post-update.
User Feedback: Obtain feedback from users on the update’s performance and functionality.
Review and Documentation
Analyze Findings: Review all collected data and feedback to assess the update’s impact.
Update SOPs as Needed: Refine this SOP based on lessons learned during this deployment cycle.
Completion: Upon completion of each step, ensure all relevant documentation is updated and stored securely. Obtain approvals from respective managers at key stages to move forward with the next steps.
Flowchart SOPs
Flowchart SOPs use visual diagrams to represent the sequence of steps. This format is particularly effective for processes involving decision points, branching paths, or multiple outcomes, making them suitable for troubleshooting guides or processes where different actions are taken based on situational criteria.
Example: Establishing a troubleshooting process for customer support teams handling software errors reported by users, where the flowchart directs the support team through different diagnostic steps depending on the user’s issue.
SOP Title: Troubleshooting Process for Customer Support Handling Software Errors
Objective: To efficiently diagnose and resolve user-reported software errors, ensuring timely and effective support.
Scope: This SOP is applicable to the customer support team responsible for diagnosing and resolving user-reported errors in the software.
Flowchart Description:
User Reports Issue
Begin when a user contacts support with a software issue.
Initial Assessment
Gather Information: Collect detailed information about the issue, including error messages, system environment, and user actions prior to the error.
Identify Issue Type: Determine if the issue is a Known Error or an Unknown Error.
Route Decision Based on Issue Type
If Known Error
Consult Knowledge Base: Refer to the documented fixes or workarounds in the knowledge base.
Apply Solution: Guide the user to implement the solution.
Verify Resolution: Check if the user’s issue is resolved.
Close Ticket: If resolved, close the issue ticket.
Escalate: If not resolved, escalate to the next level of support.
If Unknown Error
Perform Standard Diagnostic Tests: Guide the user through a series of diagnostic steps to further identify the issue.
Collect Logs/Additional Info: Ask the user to provide system logs or additional information.
Analyze Collected Data: Analyze the data to diagnose the problem.
Escalation for Further Analysis
Escalate to Technical Specialist: If the initial support cannot resolve the issue, escalate to a technical specialist with deeper expertise.
Technical Specialist Diagnosis:
Further Testing and Analysis: Conduct in-depth testing and analysis.
Identify Solution/Workaround: Identify a potential solution or workaround.
Implement Solution: Guide the user to implement the solution.
Verify Resolution: Confirm with the user that the issue has been resolved.
Resolution and Feedback
Close Ticket: Once the issue is resolved, close the ticket.
User Feedback: Optionally, ask the user for feedback on the resolution process.
Document the Resolution: If the error was previously unknown, document the resolution process in the knowledge base for future reference.
Review and Update SOP
Regularly Review Troubleshooting Steps: Regularly review and update the troubleshooting steps and flowchart based on new issues and resolutions encountered.
Completion: Ensure all team members are trained on navigating the flowchart and understand each step clearly. Maintain records of all issues and resolutions to improve the troubleshooting process over time.
Checklist SOPs
These SOPs are presented in the form of checklists and are used to ensure that all necessary steps in a process are completed. They are ideal for final inspections, routine maintenance, or tasks where compliance with every step is critical for safety and quality assurance.
Example: A pre-release checklist for an SaMD, where each item must be ticked off before the software can be released, ensuring that all regulatory, safety, and functional requirements have been met.
SOP Title: Pre-release checklist for patient monitoring app
Objective: To ensure that the patient monitoring app meets all regulatory, safety, and functional requirements before public release.
Scope: This SOP applies to the final stages of development and pre-release review for the patient monitoring app.
Pre-Release Checklist:
1. Code Review
All code has been peer-reviewed and approved by at least two senior software engineers.
Code complies with the latest coding standards and practices.
2. Testing Completion
Unit testing completed with 100% code coverage.
Integration testing verified all components interact correctly.
System testing confirmed app functions as intended on all supported platforms.
User acceptance testing (UAT) completed with positive feedback from test users.
3. Regulatory Compliance
All necessary regulatory documents have been prepared and reviewed.
Compliance with HIPAA (or relevant local regulations) for patient data privacy verified.
FDA (or relevant regulatory body) approval obtained, if required.
4. Security Audit
Security audit completed and all potential vulnerabilities addressed.
Data encryption and secure data storage solutions verified.
Compliance with cybersecurity best practices confirmed.
5. Performance Metrics
Application meets all performance benchmarks, including load time and response time under maximum expected user load.
Failover and recovery procedures tested and effective.
6. Documentation
User manual completed and easy to understand.
Installation and troubleshooting guides updated.
All documentation reviewed for clarity and accuracy.
7. Marketing and Training Materials
Marketing materials prepared and reviewed.
Training materials for end-users and internal staff completed and ready for distribution.
8. Final Approval
Final sign-off by project manager.
Final sign-off by legal department to confirm all legal and compliance issues are addressed.
Executive approval from the company leadership.
9. Deployment Preparation
Deployment strategy finalized and reviewed.
Rollout schedule prepared, with considerations for time zones and peak usage times.
Support team briefed and ready for deployment.
Completion: Upon completion of all checklist items, the Patient Monitoring App is approved for release. Ensure all stakeholders sign off on the final release form attached to this SOP.
Process SOPs
These focus on the overall flow of an operation rather than individual tasks. They provide a high-level overview of an entire process, useful for understanding how different tasks interconnect within departments or across the organization, like in product development or client onboarding processes.
Example: Mapping the overall process of user feedback incorporation into SaMD development, detailing how feedback is collected, analyzed, and integrated into product updates, involving multiple teams from customer service to software development.
SOP Title: Incorporation of user feedback into SaMD development
Objective: To systematically incorporate user feedback into the continuous improvement of the SaMD to enhance user satisfaction and product functionality.
Scope: This SOP covers the entire process of gathering, analyzing, and implementing user feedback into the SaMD development cycle.
Process Steps:
Feedback Collection
Customer Service Team
Collect feedback from users through various channels including direct support calls, emails, user forums, and surveys.
Document all feedback in the Feedback Management System (FMS) with details such as user contact information, feedback category, urgency level, and initial assessment.
Initial Feedback Assessment
Customer Service Manager
Review the collected feedback weekly for urgency and impact.
Prioritize feedback based on predefined criteria (e.g., safety issues, usability improvements, feature requests).
Feedback Analysis
Product Management Team
Conduct monthly meetings to review prioritized feedback.
Analyze feedback for patterns and potential impacts on existing and future product functionality.
Prepare a Feedback Analysis Report summarizing findings and recommendations for the development team.
Development Review
Software Development Team Lead
Review the Feedback Analysis Report in a bi-monthly cross-functional meeting with Product Management and Customer Service teams.
Discuss technical feasibility, resource requirements, and timelines for integrating feedback into the product.
Action Plan Development
Project Manager
Coordinate with all relevant stakeholders to draft an Action Plan for feedback integration.
Define specific tasks, assign responsibilities, and set deadlines for completion.
Implementation
Software Development Team
Implement the changes as per the Action Plan.
Conduct thorough testing of the new features or modifications to ensure they address the feedback adequately and do not introduce new issues.
Quality Assurance
QA Team
Perform rigorous testing on the updated software to ensure compliance with all regulatory standards and operational requirements.
Approve updates only when all quality benchmarks are met.
Feedback Loop Closure
Customer Service Team
Inform users who provided feedback about the updates and changes made.
Close the feedback loop in the FMS and document user responses to the changes.
Review and Continuous Improvement
Management Team
Review the effectiveness of the feedback incorporation process quarterly.
Make necessary adjustments to this SOP based on lessons learned and new operational insights.
Documentation: Maintain records of all feedback and the subsequent actions taken. Ensure all documentation is stored securely and accessible for audits and future reference.
Revisions: This SOP should be reviewed annually or as necessary to adapt to new feedback mechanisms, technology updates, or regulatory changes.
How to write Standard Operating Procedures
Writing an effective Standard Operating Procedure (SOP) involves a clear and methodical approach to documenting processes that ensure tasks are executed consistently and correctly. Writing SOPs is an essential part of quality management in any operation ensuring consistency, compliance, and efficiency in the performance of tasks. When writing SOPs follow these steps:
Define the Purpose
Involve the expert or the employee responsible for performing the task to define the procedure and provide information on what tasks they need to complete. Clearly state the purpose of the SOP. This should include what the procedure will achieve and why it is important. The purpose sets the direction and scope of the SOP.
Identify the Audience
Determine who will be using the SOP. Understanding the audience helps in tailoring the language and complexity of the document to suit their level of expertise and responsibilities. Factors to consider include: familiarity with the organization and procedures, knowledge level, experience level, roles and responsibilities, language and comprehension skills, industry terminology knowledge.
Gather Information
While you might be tasked to write SOPs, you may not have detailed knowledge and experience with every process. Collect all necessary details about the process from subject matter experts, existing documents, and regulations. This might involve observing the process in action, interviewing employees who perform the task, and consulting regulatory requirements.
Outline the Structure
Decide on the format of the SOP. It could be a simple step-by-step list, a hierarchy with sub-steps, a flowchart, or a combination of these formats. The structure should match the complexity of the task and the needs of the users.
Draft the SOP
Title: Give the SOP a clear, descriptive title.
Scope: Define what the SOP covers and any exceptions.
Materials and Equipment: Detail any tools, materials, or conditions necessary to perform the task.
Procedure: Write down the steps in the order they must be performed. Each step should be clear and concise, using action-oriented language. Include decision points, safety warnings, and tips where necessary.
Review and Test
Have the SOP reviewed by both peers and those who perform the task. It’s crucial to test the SOP in practice to ensure it works as intended and is understandable by its users. You should get their feedback regarding ease of execution, language clarity, etc. After being reviewed and accepted by all stakeholders, it is ready to implement.
Finalize and Format
Incorporate any feedback from the testing phase, and format the document for clarity and accessibility. This could include adding diagrams, photographs, or charts to help explain complex steps.
Approve and Distribute
Obtain approvals from necessary management or regulatory bodies. Once approved, distribute the SOP to all stakeholders and make sure it is easily accessible when needed.
Train and Implement
If process updates will result from improvements or regulatory changes, employees likely need training to reinforce the new procedure. Train all relevant staff on the SOP to ensure they understand and are competent in following the steps detailed in the SOP.
Review and Update Regularly
SOPs should be reviewed periodically to ensure they remain current and effective. This is particularly important when processes change, new technology is introduced, or after any incident that suggests the SOP may need revision. To keep track of changes and the location of your documents, decide on a document control process. A version control program can help with tracking document revisions and archiving old versions.
Why Matrix Requirements for Standard Operating Procedures?
A QMS offers a framework for managing SOPs effectively, ensuring they contribute to the quality, efficiency, and compliance of organizational processes. MatrixQMS digitizes your Standard Operating Procedures and quality standards in a controlled manner to help ensure your project meets regulatory compliance.
Consistency and Standardization
MatrixQMS provides a structured environment to develop, review, and implement SOPs consistently across the organization to ensure that all procedures meet the company’s quality standards and regulatory requirements. And, with the built-in search functionality it’s easy for users to find information they need.
Document Control
MatrixQMS offers robust document control capabilities like tracked changes, versions are controlled and can be signed electronically with a compliant eSignature, gives every employee access to up-to-date versions which prevents the use of outdated or incorrect procedures.
Compliance
MatrixQMS facilitates audits by keeping records that are easy to trace to demonstrate compliance effectively. You can give access to auditors or easily download the information you need to prove your commitment to quality. It also comes with a simplified interpretation of ISO 13485:2016 standards and an exact copy of the FDA Part 820 which can be linked to your procedures. And, you can easily build your gap analysis against any standard and link it to the required processes for better quality.
Training and Competency
With MatrixQMS, you can set up training for staff, or user groups, track training activities, automate notifications and reminders, and assess the competency of employees which is crucial for maintaining high-quality outputs. Your entire company can access the LiveQMS to read, take comprehensive quizzes, and complete their training. The dashboard makes It easy to see who is behind on training, who has training coming up and who doesn’t need training on a topic so you can have at-a-glance visibility to ensure your team is trained on the right information.
Continuous improvement
A key principle of a QMS is the continuous improvement of processes. SOPs are regularly reviewed and updated as part of a QMS to enhance effectiveness and efficiency. This ongoing process helps identify areas where SOPs can be optimized or need adjustment, driving better performance across the organization.
With MatrixQMS, you can assign responsibilities and create accountability for the creation, approval, and revision of SOPs. It clearly defines roles and ensures that there are checks and balances in the process, which enhances compliance and adherence to procedures.
Quality records
You can manage more than your SOPs in MatrixQMS, with projects to enable you to manage other quality processes such as audits, corrective and preventive actions (CAPAs), complaints, non-conformities, supplier management, calibration management, hr records, performance metrics. Managing these in one centralized place helps identify trends that suggest SOP-related issues, prompting timely revisions or additional training.
To learn more about MatrixQMS, contact us to request a demo with a product expert who can show you how Matrix Requirements can help you get your Medical Device to market faster.