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Standard operating procedures are often a focal point in our support engagements with RA/QA teams across the FDA-regulated industries. We typically see SOP problems boil down to a few common root causes:
They’re inadequate. We often find that procedures don’t comprehensively cover the required aspects of an operation. They lack sufficient detail to ensure consistent task execution or adherence to regulatory requirements.
The company isn’t compliant with them. Even when procedures are well-written and managed, organizations are often cited — both in our audits and by regulators — if there’s evidence that employees are not following the procedures as outlined.
They’re outdated. This is one of the biggest issues we see. SOPs that aren’t regularly reviewed and updated will become outdated, failing to reflect current practices, technologies, or regulatory changes.
They’re hampered by poor documentation. Proper documentation is crucial for demonstrating compliance. Insufficient or inaccurate record-keeping related to SOP changes and employee training on new SOPs can lead to citations and other cascading problems.
We recently spoke with Klaus Goodwin, a former biopharma senior executive, and now independent consultant, to gain some frontline insight into common SOP issues he frequently encounters in the field and explore his playbook of best practices.
Watch the video for the edited audio of our conversation and read the written companion guide below, which also has been edited for brevity.
Need expert SOP assistance? We provide extensive support for organizations aiming to enhance compliance and operational efficiency. Our SOP services encompass developing and writing clear, compliant SOPs and rigorous reviews to ensure these procedures meet the latest regulatory standards and industry practices.
We also specialize in training on and implementing SOPs, providing comprehensive training sessions and materials to ensure staff can effectively implement and adhere to these procedures. This extends to compliance audits, identifying potential risks and non-conformance that could impact regulatory inspections.
Talk to us when you need to ensure that SOPs remain effective and relevant.
1. What common pitfalls do firms face in developing, writing, and implementing SOPs, and how can these be mitigated?
One of the most significant pitfalls in developing SOPs is the tendency to draft them with excessive detail and a direct tie to specific job titles rather than broader functional roles. Teams are often told to get specific in their SOPs. But too much specificity makes a procedure vulnerable to frequent revisions whenever there are minor changes in business strategy or personnel changes, which can disrupt continuity and compliance. To avoid this, I urge teams to focus on the functional roles involved rather than specific individuals.
I also see some SOPs unnecessarily specify particular systems or tools by name, which can also become problematic when those systems change. Using generic descriptions for tools or systems to ensure the SOP remains applicable even if the specific tools or systems are replaced or upgraded is more effective.
I also stress the importance of defining SOPs in a way that doesn’t strictly bind them to current technologies or vendor-specific services. For example, rather than naming a specific electronic document management system, SOPs should refer to the system more broadly. Rather than specifying a particular brand or vendor, such as "Data must be entered into the Oracle Clinical data management system," it’s typically better to say, "Data must be entered into a validated data management system." Again, this allows for flexibility if the organization decides to switch platforms or if new technologies emerge.
In general, I always suggest avoiding the “hyper-granularization” of SOPs to the extent that they become overly susceptible to minor operational changes. If you feel like you’re constantly updating your SOPs, this might be the problem.
2. What core principles do you follow when drafting an SOP to ensure its effectiveness?
I begin by precisely defining the scope, clarifying which functions or departments are affected. This step ensures that all relevant areas of the organization are aware of the SOP and understand its implications. I then recommend using process maps at the early stages of drafting. This helps visualize the entire process flow, ensuring that the SOP is comprehensive but also clear and straightforward. Visualizing the process can help spot potential bottlenecks and inefficiencies early, allowing for a smoother implementation and adherence to the SOP.
It’s also important to reference applicable regulations and guidelines within the SOP itself. This practice helps during inspections by making it easier for inspectors to understand how your processes align with regulatory requirements. It also ensures that the SOP remains aligned with industry standards and best practices. While it's beneficial to refer to specific guidelines, I advise doing so in a way that remains valid even as guidelines evolve. Mentioning guidelines generally, rather than citing specific sections, can prevent the SOP from becoming outdated due to changes in the regulatory landscape.
Another core principle I try to stress is embedding a culture that sees SOPs as living rather than static documents. SOPs must be regularly reviewed and updated in response to changes in technology, regulatory expectations, or operational shifts within the organization. Regular updates, driven by a structured review process that includes feedback from all stakeholders, help maintain the SOP's relevance and practicality over time.
I advise teams to set a predefined review schedule and form a cross-functional committee that includes feedback from all stakeholders. This committee should conduct thorough reviews based on the schedule, continually integrating feedback mechanisms to gather insights. Each SOP should be evaluated for its impact due to changes in technology, regulations, and operational shifts.
3. How can firms integrate user feedback and user-centric design into SOP creation to ensure practicality and adherence?
SOPs often fail to reflect the actual workflow and operational realities, leading to documents that are hard to follow and implement. To mitigate this, I recommend involving various stakeholders in the SOP development process, particularly during the review phase. This ensures that the SOP is practical and aligns with the actual needs and conditions of the workplace, which typically leads to greater adherence and effectiveness.
This goes back to engaging stakeholders from all relevant departments, including both management and end-users, right from the initial stages of SOP development. Once a draft SOP is developed, it should be tested through a prototyping phase and temporarily implemented to gather iterative feedback, allowing for adjustments before wide-scale deployment.
4. Can you outline a process for regularly updating SOPs to accommodate changes in technology, regulations, and organizational practices?
My typical process for ensuring that SOPs remain up-to-date and reflect current practices, technologies, and regulations involves several key steps. First, I suggest implementing planned process deviations for minor changes that do not substantially affect the core procedures or outcomes. This method allows for quick adaptation without the need to rewrite the SOPs. It's a flexible way to address minimal yet necessary changes, ensuring that SOPs maintain compliance and relevancy without undergoing full revisions.
When significant changes occur, such as reorganizations, mergers, or major shifts in technology or regulatory requirements, a complete overhaul of the SOPs may be necessary. This should involve thoroughly reviewing all existing SOPs to determine their relevance and accuracy in light of the new conditions. This step is critical to aligning with the company's current operational and compliance landscape.
I suggest all teams establish a regular review cycle for all SOPs and include feedback mechanisms for users to report issues or suggest improvements. This ongoing review helps identify potential areas for updates before they become compliance issues or operational bottlenecks. Whenever SOPs are updated, document the changes clearly and provide updated training to all relevant staff. This ensures that everyone understands and adheres to the new processes, minimizing the risk of errors and non-compliance.
Klaus’s SOP action items at a glance:
When drafting SOPs, define the scope, outlining which functions or departments are impacted. Utilize process maps to visualize the process before writing the SOP to ensure clarity and avoid convoluted text.
Avoid mentioning specific job titles or systems by name to prevent frequent updates. Focus on roles and functions at a more generic level so that SOPs remain relevant even when minor organizational changes occur.
Make sure the SOP's owning function is clear and that all roles involved in the process participate in the review process. While this collaboration may slow the process, it ensures the SOP is practical and aligned with operational needs.
Employ planned process deviations to manage minor changes without revising the SOP frequently. A thorough overhaul of the SOP might be necessary for substantial changes like reorganizations or mergers. This approach minimizes disruptions and maintains continuity.
Establish key quality indicators and protocol tolerance levels, especially from phase two onwards. Quality professionals should assess these protocols and help set metrics for monitoring these indicators throughout the trial.
Develop quality agreements with vendors (e.g., CROs) to communicate quality metrics and expectations clearly. These agreements should define the metrics vendors must report, enhancing oversight and compliance.
Foster a quality culture from the top down and engage stakeholders by using quality data from clinical programs. Implement a Quality Council that involves different functional levels to ensure continuous oversight and compliance of the quality management system.
Review and update SOPs regularly to adapt to regulatory, business, or technological changes. This proactive change management ensures SOPs remain relevant and functional over time.
A few questions for self-assessment
Below are a few key questions that often trigger SOP support projects. Talk to us if you don’t know or aren’t satisfied with your answers to any of them.
Have you received frequent non-compliance notices from regulatory bodies recently?
Are you aware of any recent regulatory changes that might impact your SOPs?
Are there noticeable inefficiencies, errors, or variations in product quality within your operations?
Are you dealing with operational bottlenecks that improved SOPs could alleviate?
Have you recently expanded, added new products, or entered new markets requiring updated or new SOPs?
Have you implemented new technologies or systems that necessitate a revision of your existing SOPs?
Are you concerned about your readiness for upcoming regulatory inspections or audits?
Do internal audits frequently uncover issues that external audits might also flag?
Is there a lack of standardization in operations across different departments or locations?
About Klaus Goodwin
Klaus is a distinguished biopharma senior executive with over 25 years of experience, now serving as an independent consultant. His career is marked by success in providing quality oversight and direction, utilizing a risk-based and stakeholder-driven approach to enhance operational efficiencies and ensure compliance across all phases of clinical development. Klaus's expertise spans Clinical Compliance, Auditing (Phase I – IV), Vendor Quality Governance (GMP/GLP/GCP/GVP), Clinical Quality Management System Design, M&A Due Diligence, and QMS Integration.
His approach combines empowering leadership with strategic execution, emphasizing education and supportive frameworks to achieve high-quality outcomes. He is also a Lean Six Sigma Black Belt, skilled in GCP Process Development and Design, Quality Risk Management, and CAPA program design and execution. Based in Dubois, Wyoming, Klaus continues to influence quality assurance and auditing practices globally, ensuring his strategies align with current industry standards and regulatory expectations.
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How to Write Effective SOPs: A Q&A with Klaus Goodwin, EQSM, LSS BB