Good Manufacturing Practices (GMP) are an essential foundation for successful manufacturing companies. To uphold these practices effectively, companies must establish robust systems and procedures. Among the critical elements of GMP is ensuring and validating workforce compliance with established policies. However, the implementation of these validation processes often comes with significant challenges for manufacturers.
Building on a Solid Foundation
A major focus for quality management professionals is the creation, approval and maintenance of policies and procedures for GMP. Comprehensive documentation is vital for GMP compliance. Developing detailed Standard Operating Procedures (SOPs) is a cornerstone of GMP best practices, but the foundation for GMP documentation extends across all aspects of the company.
From company quality goals to full assessments of risks and responses to the development and production of products to guidelines for suppliers and commitments to customers, all procedures and processes should be well-documented. This documentation is critical to implementing GMP and serves as an important level of evidence of compliance, but GMP compliance is not just about written procedures. Compliance depends on the practical implementation of those procedures in daily operations.
Top Challenges of Workforce GMP Compliance
Even with the most thorough documentation, consistent GMP compliance can be difficult to achieve and maintain. Manufacturers must manage the interaction of people, production, equipment, facilities, suppliers and customers and the ripple effect of any changes. Regular maintenance and calibration of systems, facilities, and equipment are imperative for GMP compliance, along with supplier audits and ongoing customer feedback. However, supporting and validating workforce compliance poses certain unique challenges that are often difficult to address for manufacturers.
Developing and Validating Job Competence
One of the primary challenges in workforce GMP compliance is ensuring that all employees are adequately trained and aware of GMP policies. Training programs should ensure all personnel understand their roles in maintaining GMP standards. Too often, training is considered a job-shadowing experience, or solely an onboarding activity, which may not adequately support GMP success. And, employee turnover, experienced workers retiring, or the introduction of new staff can degrade GMP compliance practices as well.
Regular communication updates should be utilized to keep employees continuously informed about changes in procedures, regulations, and industry best practices. Refresher courses, and on-the-job, interactive training methods can help maintain a well-informed workforce. It is also essential to verify the completion of training programs and the practical application of GMP principles in daily tasks. Implementing competency assessments, layered process audits (LPA) and conducting periodic skill evaluations in real-world scenarios are vital steps in validating workforce compliance
Enforcing and Validating SOPs
The existence of SOPs is not enough; they must be actively enforced and implemented. Beyond training frontline workers, a framework to ensure adherence to the SOPs is what can deliver the best outcomes. Regular monitoring and supervision are essential to verify compliance, and any deviations should be promptly addressed through corrective actions. In addition, it is important to look for differences between locations, teams or shifts, across processes and at handoffs. Variations in procedures and practices may lead to compliance gaps
Along with enforcement comes the companion requirement for regular validation of SOPs to confirm that they are both effective and in compliance with GMP standards. This involves assessing the outcomes of processes, identifying any deviations, and implementing corrective actions. Continuous improvement is key, and feedback from the workforce, suppliers and customers should be considered in the validation process.
Integrating GMP into Every Process
Quality should not be an afterthought, but an integral part of the workflow on the frontline. Workforce tasks at each stage of the manufacturing process should prioritize GMP. This is particularly challenging given that the typical manufacturing workforce operates in a world of paper SOPs and training. With the advances in digital tools, manufacturers should seek out ways to modernize their frontline workers’ access to digital guidance and information that assists adherence to SOPs and GMP processes.
Frontline workers should also be empowered to identify and address issues that may compromise GMP. Here again, modern digital tools can enhance workforce abilities to both spot and communicate issues as they arise. These tools can also incorporate on-the-spot guidance and micro-training to ensure adherence to GMP. In addition, integrating GMP into the daily workflow of frontline workers promotes a culture of continuous improvement and accountability.
After All the Planning, it Depends on People
In addition to equipment and processes, manufacturing is powered by people. The workforce plays a pivotal role in GMP compliance, but resistance to change or lack of employee engagement can impede compliance efforts. Manufacturers can address this challenge by fostering a culture of GMP ownership, recognizing, and rewarding compliance efforts, and involving workers in the decision-making processes related to GMP policies.
The workforce may view GMP compliance as an additional burden in the production process. Not only does this challenge manifest itself in the continuity of training, but also in tasks directly related to GMP compliance validations. Language and cultural differences may introduce additional obstacles. The key is to simplify and streamline compliance practices, considering the time and effort required by the workforce as partners in the delivery of GMP.
Taking a Digital Approach to Ensure Workforce GMP Compliance
While the journey toward workforce GMP compliance has many challenges, manufacturers can overcome these obstacles with thorough planning and proactive approaches that facilitate workforce adoption of GMP policies. Modern digital platforms specifically designed for frontline workers, like ROO.AI, deliver a significant boost for workforce GMP compliance.
ROO.AI’s advanced visualizations simplify and speed up inspections, safety checks, equipment maintenance, and LPA and other GMP audits while making it more visually intuitive to adhere to GMP standard operating procedures. Automating the data capture for GMP validation process also reduces time and effort for workers, addressing the resistance that additional quality steps may face from the workforce. Digitalizing the frontline empowers workers to be more proactive about identifying potential quality issues and communicating with their team and managers to make improvements. With ROO.AI, work instruction with access to micro-training can be accessed on-the-spot, training courses and updates delivered directly to workers as tasks, and completions and certifications tracked to ensure workforce job competency.
Ensuring workforce compliance with GMP is a multifaceted process that requires a comprehensive approach. By creating robust SOPs, enforcing and implementing them effectively, documenting processes meticulously, validating procedures regularly, and combining these efforts with a frontline digital platform to ensure understanding, adherence and accountability, manufacturers can prioritize quality at every stage of the manufacturing process to establish a strong foundation for GMP compliance.
