The Future of SOP Compliance for Life Science Companies

Does your business maintain dozens if not hundreds of Standard Operating Procedures (SOPs) to drive quality and compliance? Are employees, especially in Research & Development (R&D), quality and manufacturing, required to maintain qualification against SOP-based curricula and learning programs?  Do you have rigorous assessments and compliance tracking to help prove SOP understanding and qualification? And at the end of the day, even with all this, are you still looking for more – more quality, capability, capacity, agility?

If you are a typical pharmaceutical, medical device or biologic product manufacturer, the answer to all the above is yes. SOP definition, training and compliance are mission-critical for developing and producing safe and effective medicines and devices that adhere to Good Manufacturing Practices (cGMP) and other regulatory mandates. The real problem that needs solving is not so much SOP compliance, but how to close the gap between compliance and performance.

SOP compliance and learning effectiveness

Compliance against SOP-based curricula remains necessary to show traceability of individual job function qualification to good- and regulatory-enforced practices. But most organizations are not doing enough to measure and promote learning effectiveness against these practices.

Sure, quizzes and exams are commonplace, but these often focus on SOP understanding and do not necessarily promote or measure the skills and behaviors necessary to put these into real-life practice.  Many organizations utilize on-the-job training assessments, which can be much better indicators of performance, but lack a systematic approach to build organizational-wide capability and capacity to really drive quality outcomes.

Assessment against functional competencies

Organizations that have already made the shift from compliance to performance utilize defined competencies with multi-faceted skills assessments. Role-based technical competencies and supporting behaviors are defined to closely match the GxP quality and compliance outcomes desired. Then a variety of assessment techniques are utilized to measure on-the-job performance of individuals against competency benchmarks, with the most at-risk functions and behaviors getting the most attention. Only when individuals surpass benchmark expectations are they considered competent and qualified to move on to fulfill higher-risk, compliant or performance-intensive competencies.

The key here is that you are no longer simply measuring SOP understanding and compliance--you’re measuring behaviors to build out a more skilled and competent workforce, which in turn builds a culture of quality and performance.

Organizational agility and performance

Once organizational focus shifts from measuring SOP understanding and compliance to measuring behavior, the impact on quality culture is profound. The best competencies are those that directly support the quality goals and objectives of the organization, providing individuals with clear understanding of their role in achieving them. A succession of defined functional competencies along with a clear path of qualification by role promotes individual job performance within the quality space.

At the management level, defined functional and technical role-based competencies tied directly to quality goals and objectives forces better definition of desired quality outcomes, both of which are often best kept distinct and unique from broader human resources or learning and development goals and competencies due to their technical, compliance and mission-critical nature. With role-based progression against functional competencies and the resulting improved visibility into workforce capacity, management can now better prepare for required changes in production or respond to digital and technical disruptions.

Overall organizational alignment, capability, capacity and agility are greatly improved. SOP compliance remains, but now everyone has a much better understanding of how all these various SOPs relate to the bigger picture. SOP culture is no longer just about compliance, it’s now how individual skills and competencies drive quality outcomes resulting in improved performance for your business.

Mike Lawrence is Head of ComplianceWire Product Management at UL.

Learn more about SOP compliance and learning management systems (LMS):

• UL compliance training and LMS support for regulated industries
• Whitepaper: From regulatory compliance to competitive competence