Compliant. Connected. Complete. White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments

Transcription

1 Compliant. Connected. Complete. : SOP Management as a Compliance Tool in FDA and ISO Environments

2 Introduction From manufacturers to hospitals to the military, most organizations need standard operating procedures (SOPs) for a variety of reasons. An SOP may be as simple as a description of how to sanitize milk pails in a dairy factory, or as complex as the process of chemical isolation and purification of an active pharmaceutical ingredient in a chemical manufacturing company. An SOP describes a procedure and tells an operator how to perform it. SOPs are helpful in most workplace settings, but they are especially critical for organizations with process-oriented operations, such as life sciences and other manufacturing companies. SOPs, in conjunction with personnel training, help relay knowledge from one department to another. In a medical device firm, for example, R&D scientists pass their knowledge about a product they innovated to the manufacturing department through SOPs. Manufacturers with global operations also rely on SOPs to standardize processes in all of their facilities. For example, a Japanese automotive company will train its personnel in the United States on key manufacturing processes and then use SOPs to make sure that high quality is reflected in every car sold by the company regardless of where it was assembled. There are many other reasons why organizations use SOPs, including: To ensure consistent, repeatable processes; To facilitate training by giving trainees a point of reference; To facilitate cross-training of employees on tasks they don t normally perform, such as when they need to substitute vacationing or sick co-workers. To reduce safety risks and other hazards by specifying how to avoid and prevent them; To have a basis for evaluation and improvement of processes; and To comply with regulations and/or quality standards. Regulations and Standards The last reason compliance with regulations and quality standards is a key factor that drives many organizations to establish and maintain SOPs. In FDA and ISO environments, the concept of quality is made tangible by the information and processes captured in SOPs, and proper implementation of those SOPs helps ensure quality. FDA s Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR Parts ) require written procedures for production and process control to ensure that products have the identity, strength, quality, and purity they purport to possess (Section ). These written procedures, including any changes, must be reviewed and approved by the quality control unit. CGMP regulations for blood and blood components (21 CFR 606) state that written operating procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes (Section b). The Quality System Regulation (21 CFR Part 820) for medical devices similarly requires SOPs and documented instructions that define and control the manner of production (Section ). Manufacturers and other organizations that adhere to quality standards developed by the International Organization for Standardization (ISO) face similar requirements.

3 MasterControl s suite automates, and effectively integrates SOP management with change control, training control, audits, corrective/preventive action (CAPA), and customer complaint processes, under a single Web-based platform. ISO 9001: 2000 and ISO 13485:2003, widely used throughout the world, require companies to document their procedures, describe how those processes interact, and develop documents for implementation of the quality system. Compliance with ISO standards is voluntary, although certain countries require ISO certification and many customers prefer vendors and suppliers that are ISO-certified. Types of SOPs SOP formats are as varied as business operations. An SOP may come in the form of a checklist, or a linear flow chart (or some other type of flowchart), or hierarchical steps, or annotated photos. Neither the FDA nor ISO require any specific SOP formats. In general, however, SOPs in regulated environments are expected to be consistent and traceable. They should provide document identification and facilitate control. To be effective, an SOP should include company name, a descriptive SOP title, identification and control numbers, purpose, scope, responsibilities involved (specific tasks, who s performing what, certification and qualification requirements, etc.), and step-by-step procedure. Depending on the nature of the process being described, the SOP may include calculations for data handling. SOPs are usually categorized by procedure type, such as design, manufacturing, quality assurance, etc. Categories help determine the right format for each SOP and also facilitate appropriate review and approval for the document. For example, the maintenance department of a dairy factory may need a simple checklist of materials needed for cleaning milk pails, but the manufacturing department of a chemical company that produces active pharmaceutical ingredients may require a combination of hierarchical steps and a linear flowchart for its SOPs. A document categorized as maintenance

4 SOP for cleaning milk pails clearly does not need to be routed to the legal department. But an SOP identifying hazardous materials throughout the facility may very well need to go to the legal department or regulatory affairs for review because it may have some impact on compliance with Environmental Protection Agency regulations. SOP Management: Challenges Despite the much ballyhooed information age and computer revolution, most companies continue to rely on paperbased processes. Typically, SOPs are created using Microsoft Word, printed out, and stored in three-ring binders. The binders are then routed physically from one approver to the next. Once approved, the contents of the binder are photocopied so every affected department will have one binder handy. For a small organization, this process may be just fine. But for most companies, a manual system poses many challenges, including: Inefficiency The process of routing, reviewing, and approving an SOP can be slow and inefficient. This is especially true if an organization generates hundreds or thousands of SOPs and the people who need to review and approve them are in different locations or out of the office. It is likely that SOPs may get lost while being routed, either buried in someone s messy desk or computer in box (if routed via ). Search and retrieval of SOPs would entail sorting through voluminous paper work. Updating SOPs would be equally slow. In addition to going through the same routing and approval process during revision, obsolete paper documents must be disposed of. Poor Communication In a manual system, quality processes are not connected, making it hard for people who operate those processes to communicate. To speed up the approval of an SOP, the originator needs to make phone calls, send messages, or remind approvers in person and that s just one SOP. Multiply the number of phone, , and personal reminders a dozen times for an employee responsible for a dozen SOPs. In a fastpaced organization (i.e., a company with 24/7 operations in multiple facilities all over the world), SOPs are likely to change constantly, but people affected by the changes may not be notified in a timely manner. Lack of Training It s bad enough that employees are not notified about new (or newly revised) SOPs in a timely manner, but it s worse when they don t get the appropriate training on the new SOPs. This failure to keep up with training on new SOPs is inherent in a manual system that s not connected to the training control process. So, employees may be using new SOPs but they may be doing it poorly without the appropriate training. Ineffective Documentation Effective implementation of SOPs has a direct impact on product quality, and that is why it s critical for organizations to capture accurate and up-to-date information in SOPs. But it takes a lot of time and effort to manually update SOPs, so employees may sit on updates, jeopardizing conformance. It is equally difficult to rely on employees to always remember to document any changes in an SOP, including who made the change, why, and when. Poor Revision Control Companies that rely on a manual system often complain that it is difficult to get rid of obsolete documents. Even after SOPs have been revised and approved, old documents may resurface on the shop floor. Another problem is that employees may use documents that have not been approved simply because they are able to grab that binder sitting on someone s desk. In both cases, using uncontrolled SOPs could lead to nonconformance. Poor Collaboration Creating and updating SOPs usually require collaboration. For organizations that use manual processes, collaboration would entail face-to-face meetings and passing around a document that employees take turns editing. This manual process works when there are few collaborators who are based in the same facility and whose schedules are similar. But collaboration among employees with varied schedules and responsibilities and who are based in different facilities will be practically impossible.

5 Lack of Visibility Paper-based processes are not connected, making it difficult for management to monitor the effectiveness of SOPs and make timely decisions. For example, if the customer complaint process is not connected to either corrective/preventive action (CAPA) or change control, it may take a while before management realizes that a certain complaint should have been escalated to CAPA and should have resulted in a change in a manufacturing SOP, perhaps preventing a product recall. MasterControl Solution The MasterControl quality management suite consists of configurable, easy-to-use, and integrated applications for automating, streamlining, and effectively managing SOPs and other documents, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other forms-based quality and business processes under a single Web-based platform. Hundreds of companies worldwide use MasterControl to facilitate compliance with FDA regulations and ISO quality standards. Here s how MasterControl can address the challenges discussed earlier. Efficient System MasterControl automates routing, delivery, and storage of SOPs, greatly increasing the efficiency of SOP management. The system provides a secure, centralized repository that makes search and retrieval easy. SOPs will not get lost because the system can track every document s exact location. Effective Communication With MasterControl, follow-up is automatic. The system will continue to send notifications until the person acts on an SOP. It incorporates escalation, so if the person is unavailable for a period of time, the SOP will move to the next person authorized to approve it. A Web-based platform allows even offsite or traveling employees to participate in the review and approval process through the Internet. Even suppliers, consultants, and other third parties may be given limited access to the system so they can be immediately notified upon approval of changes to SOPs that affect them. As an alternative, external links can be created to make selected documents and processes available without giving them system access. Integrated Training By integrating training control with SOP management and other quality processes, all employees affected by new or revised SOPs will be automatically sent training tasks. MasterControl automates assignment, monitoring, and verification of training tasks. The system also automates grading of online exams. It allows implementation of a progressive training program by sequencing training courses. Once a prerequisite is completed, the next course is automatically launched. Effective Documentation MasterControl makes it easier to keep SOPs accurate and current. To update or revise documents, there is only one place to make a change because all SOPs will be stored in a centralized, Web-based repository that can be accessed by authorized users from virtually anywhere. There is no need for employees to remember to document changes because the system provides a time-stamped audit trail that captures the identity of anyone who creates, views, or changes an electronic record, when the action occurred, and the changes made. Along with the stamp, users are asked to enter a reason for every change. Automatic Revision Control Employees will no longer use uncontrolled SOPs because only approved documents will be released and made available to them. Obsolete SOPs will not re-surface. With MasterControl, when an SOP is revised, the original version is automatically archived upon approval and release of the revision. Also, setting an expiration date will make an SOP obsolete on that date and it will automatically be archived. Automatic revision control will ensure that when an SOP is being revised, it will not be available for check out until approval of the revision.

6 Improved Collaboration A virtual collaboration workspace allows individuals to participate at their convenience. They can review, comment on, revise, or approve an SOP without having to be physically present with the rest of the team. Redlines will be visible to all team members so there won t be duplication of efforts. A Web-based platform allows even off-site or traveling employees to collaborate. Increased Visibility MasterControl makes the entire quality system visible by integrating different processes and connecting different departments. Management will be able to monitor the effectiveness of SOPs in a single, integrated system better than in separate processes. For example, a serious customer complaint will be automatically escalated to CAPA, which in turn will trigger a change in all relevant SOPs. Advanced analytics and reporting capability will also help management get a real-time view of the quality system to continuously improve it. Conclusion For FDA-regulated and ISO-certified companies, SOPs are more than just a tool of operation. SOPs directly affect product quality, and therefore, compliance. Development of effective SOPs and implementing them properly require commitment from the entire organization. Choosing the right software solution that will facilitate and improve SOP management should be a part of this commitment. Once established, an efficient and effective SOP management system will serve as a foundation for an organization s sustainable compliance and long-term success in the market. About MasterControl Inc. MasterControl Inc. has been at the forefront of providing quality management software solutions since Hundreds of companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, , 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements. In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support, including product training, implementation, and validation services. For additional industry white papers about automating quality and regulatory processes, visit or call, MasterControl Inc. All rights reserved.

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