6 minute read
A Quality Management System (QMS) serves more purpose than just maintaining regulatory compliance for pharmaceutical companies.
A good QMS provides assurance of the safety, efficacy, and quality of a pharmaceutical company’s products throughout their entire lifecycle. Thus, the QMS itself must be of high quality and soundness to continue producing favorable results.
One key way to improve your quality system is by simplifying your procedures and documentation.
However, I have found that while a QMS plays a critical role in the development lifecycle of a drug, it can quickly add complexity, bottlenecks, and regulatory non-compliance if it is not developed and maintained in a functional and scalable manner.
In my experience, one key way to improve your quality system is by simplifying your procedures and documentation.
A QMS has a multitude of components, but organizations often face complexity when it comes to effectively managing their procedures (SOPs) and documentation.
Establishing procedures and documentation can appear to be a rigid and straightforward task. But, confusion can quickly arise if stakeholders are unsure which procedure to follow, which version of the document is the most up-to-date and appropriate, and where to find the latest version of the documentation.
This complexity can make it increasingly difficult to reproduce the desired outcomes, and process compliance can begin to vary across the organization as operations expand. As a result, issues can quickly rise up in audit and inspection findings, adding further challenges and roadblocks for the organization down the line.
Instead, life science organizations must find a way to pare down and simplify their documentation and procedures for clarity and efficiency–without detracting from any of the critical QMS functionalities.
Whether your organization is designing a new QMS from scratch or is evaluating an existing quality system that’s already in place, developing a QMS that is scalable and purpose-built will improve its overall functionality and usability.
Based on our decades of experience designing, managing, and implementing Quality Management Systems for clients, we have developed the following principles to assess and simplify the procedures and documentation for any QMS.
When you start developing QMS procedures and documentation, it is easy to get caught up in an “everything at once” approach. However, this can quickly grow convoluted and inefficient if you don’t have a goal-driven approach that’s tailored to the unique needs of your organization.
In other words, more documentation and SOPs do not necessarily mean more productivity or success. This approach can represent a lack of strategic alignment across the organization while you should be focused on prioritizing the activities that move the needle forward.
To create a more manageable system, it’s crucial to first assess what documentation will be needed to effectively support the organization’s strategy. For instance, an organization that is developing its own drugs and performing its own trials will have many more SOPs to document than a newer company that is outsourcing all of these processes.
Thus, a company that is in the earlier stages with a pipeline of just a few prospects in early development should not focus its efforts on developing post-marketing surveillance procedures. This would be a mismanagement of their resources, and the procedures that would actually be meaningful to their operations current day could fall through the cracks.
Instead, a QMS should be a continuously improving structure that grows from its previous iterations. So, always keep in mind what is currently most relevant and beneficial to the organization, and act accordingly.
Once you have identified the scope of the QMS documentation given your organization’s unique circumstances, you can start building out a hierarchical structure for it. This includes developing standardized document structures and naming schema that is consistent and predictable across the organization.
Having a clear documentation structure will help you group procedural documents together for ease of access, and provide a way to define their importance within the organization. This provides clarity on what SOPs cover which regulated activities, but also lays out who has ownership of different SOP groupings for document management purposes.
Further, once this is in place, it becomes much easier to add new procedures to the QMS as needed. It removes the ambiguity on where a procedure will sit within the organization, and who will be the owner responsible for that procedure.
In the earlier stages of development, it’s easier to keep document structure consistent across the organization. But, as a QMS evolves and an organization scales, the procedures and documentation can start to transition to more varied structures and naming conventions. Each functional group within the organization may have its own preferences for how to name and structure documents, which can quickly spiral out of control if left unchecked.
To maintain uniformity and reduce potential complexity and confusion, all QMS documentation should adhere to standardized templates and naming schema.
In my experience, organizations often fall victim to wanting to include all possible actions and information within an SOP–whether the included actions are required by regulations or not. Out of fear of omitting something important that could leave them non-compliant, they include every detail that they feel could be relevant. But, this tends to be overkill and unnecessarily complicates the QMS.
At the end of the day, what regulators evaluate is whether or not an organization’s procedures cover the required regulations, and if the organization is following the steps laid out in a procedure–nothing more.
To reduce complexity and drive compliance, a procedure should only capture the actions that are required by a regulation, and remove all non-regulated actions. Then, if the organization’s leaders deem that additional clarity is needed, they can leverage the creation of job aides or work instructions to provide supplemental details on the procedure.
Additionally, creating a clear scope for procedures reduces any ambiguity when it comes to which procedure a stakeholder should utilize in a given scenario, and what the expected inputs and outputs of the said procedure are.
Lastly, as a QMS is utilized, the amount of related documentation that’s produced will grow at a rapid pace. To effectively manage the scale of documents being created, organizations must establish robust document management procedures to sustainably manage and support their growing volume of documents through all stages of the document life cycle.
This includes having clear procedures for document creation, version control and revisions, document storage, retention, and periodic reviews.
Document management procedures ensure that documentation is being managed in a sustainable manner, but they also provide thoughtful oversight into how documents are being created and managed. This establishes uniformity across the organization and ensures that their document management processes will remain feasible as they scale.
How an organization handles the documentation and procedures in its QMS can result in a system that is straightforward and simple to follow or one that is clunky and unnecessarily complex.
Again, a QMS should improve over time, only getting better and more refined as the years progress. But, the proper priorities and procedures need to be in place in order for this to happen.
Given the ramifications of utilizing a poor QMS that is hard to follow, organizations should prioritize simplifying their documentation and procedures as a way to improve their quality system. However, if this isn’t done correctly, issues could be discovered during an audit, which could result in penalties and fines for the organization depending on the severity of the incident.
At Scimitar, we rely on the principles I’ve laid out here to help our clients simplify their SOPs and documentation while ensuring their QMS supports the quality results of their organizations, not hinder their progress.
Adam Hook is a Scimitar Engagement Manager and Operations Management Consultant with a diverse background in supply chain and operations. He leverages his experiences to lead businesses in the strategic transformation of their operations and digital capabilities.
If you would like to learn more. Write to Adam Hook at [email protected] or contact him on