I presented this topic a few years ago at the RQA event and wanted to re-visit it as I believe it is just as relevant today as it was more than two years ago, if not more. We’ve seen the growth of virtual companies increase over the past few years with more and more businesses starting with one or two individuals and an idea. While a full quality management system is not necessary, it’s believed by many (including most regulators) that even a basic QMS is an essential business component to foster future growth. As the virtual company expands from the founders to thousands of employees a standard operating process like a higher performing quality management system is critical to documenting decisions and risks, so growth is well-supported.
As I described in the downloadable poster, I believe there are three significant risks if a company does not have a basic Quality Management System (QMS) in place. The risks are as follows:
- Regulatory action by a health authority if no QMS is required (regulatory compliance)
- Loss of business if a new client audits the company and determines no QMS is available (business risk)
- When a customer complaint is noted, and no QMS is available to support the investigation (loss of customer risk).
Any of these risks should be considered significant by any company, let alone a virtual company. Mitigating these risks should be top of mind for the virtual company, and I believe the following seven elements should be considered by all virtual companies when developing a QMS.
What Are the 7 Quality Management System Principles?
If you’ve ever wondered what the main principles are, you’re not alone. Here are the minimum elements of a Quality Management System for a virtual company:
- Documentation Controls and includes the appropriate guidance on which documents and records need to be maintained and the retention period for those documents.
- Change Controls to establish a uniform process for controlling the creation and issuance of new documentation (including SOPs), and changes to existing documentation and labeling. This process also incorporates the approval and distribution methods to comply with the Quality Manual, the Quality System Regulation, and any applicable International Standards.
- Personnel Training is to ensure that all employees obtain the necessary training to correctly perform the duties of their job position. These procedures should be prepared in accordance with the regulatory requirements, International Standards, and Quality Manual.
- Material and Vendor Management to define the process for the selection, approval, and continued evaluation of suppliers of products.
- Non-conformances and Out Of Specifications to define the oversight requirements and processes to be followed for the control of product or materials that do not meet specified requirements.
- Deviation and Corrective and Preventative Action (CAPA) to describe the process for oversight, identification, and handling of product and material deviations that may occur.
- Clinical Trial Material (CTM) / Investigational Product (IP) lot release to describe the expectations for and circumstances under which IP may be released for shipment to approved clinical research sites.
Based on those seven quality management system principles, I believe regulatory compliance can be achieved for most virtual companies who implement them effectively. Although these elements do not consider the need for HR, Finance, or Operations procedures, and they merely capture the quality attributes for a virtual QMS, it’s what will keep a business healthy, in compliance and capable of scalable growth.
If you’re a virtual company, does your business have the essential seven elements in place and a functional quality management system? If not, have you completed a risk evaluation, and has it been properly documented?