April 19, 2023
By Alexandria Carlson and Michael Orduz
During the course of our human factors engineering (HFE) consulting work for the medical device industry, it is essential that we perform high-quality work and prepare robust deliverables for our clients and, subsequently, for regulators’ review. But what does that mean in terms of implementing a quality management system (QMS)?
An obvious answer might be to follow the medical device industry standard for QMSs, ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes. However, while some sections of ISO 13485:2016 do apply to HFE consultancies, much of the standard does not apply to consultancies as it does to manufacturers or full-service product development firms. This is because Emergo by UL’s Human Factors Research & Design team and other HFE-focused consultancies are not responsible for implementing final designs, producing/manufacturing, sterilizing, installing, servicing or disposing of medical devices.
Seeking ISO 13485:2016 accreditation is not an industry standard for HFE-focused consultancies, nor is it expected by the US Food and Drug Administration (FDA) or other bodies regulating HFE work during the medical device life cycle. However, this does not mean HFE consultancies can throw all caution to the wind when it comes to planning and implementing a QMS. Rather, HFE consultancies might consider drawing inspiration from ISO 13485:2016 to develop a right-sized QMS that aligns with the scope of HFE consulting work they perform and provides maximum value to their clients.
Below, we describe just a few examples of how HFE consultancies might right-size their QMS.
Control of records
Records are the “bread and butter” of any QMS, including one for an HFE consultancy, because records serve as objective evidence that an organization is complying with its QMS requirements. As such, it is paramount to control how records will be generated with good documentation practices in mind (e.g., legibility, accuracy, completeness, consistency), and how such records will be stored, maintained, and accessible when needed (e.g., during a client review/audit). An HFE consultancy’s records could include, for example, a client deliverable (e.g., gap analysis, usability test protocol or report), a usability test session video recording, evidence of completed training for an HFE consultant, or a datasheet used to capture participant feedback during an interview. Undoubtedly, developing a detailed records control process is a key piece in establishing a robust QMS.
- Emergo by UL tip: Signing and dating records will ensure the information is attributable and traceable.
Clients will look to confirm HFE consultancy team members are able to work proficiently by verifying that they are well-versed in the latest HFE guidance documents, standards and internal/client QMS documentation (e.g., SOPs, work instructions). Introducing a structured training program that can track and assess training assignments, completion and effectiveness is critical to a successful QMS.
- Emergo by UL tip: Implementing and requiring training on controlled forms and templates will help establish a culture of consistency and completeness when generating records (e.g., client deliverables). To track training at Emergo by UL HFR&D, we leverage UL Solutions ComplianceWire®, enabling us to customize trainings to meet our QMS needs.
An HFE consultancy’s suppliers might include an Institutional Review Board (IRB), participant recruitment service, or a research facility. ISO 13485:2016 repeatedly emphasizes that a risk-based approach should be taken throughout an organization’s QMS processes, including supplier management. As such, an HFE consultancy should consider defining a risk categorization scheme for their suppliers (e.g., low, moderate, critical). Consultancies might then establish different evaluation and qualification requirements for each risk category; for example, an organization may only require critical suppliers to train to the organization’s relevant SOPs.
- Emergo by UL tip: Assessing an approved suppliers’ performance periodically (e.g., annually) will help ensure the supplier is complying with client and/or QMS requirements.
In the course of performing our HFE work, and in particular when conducting research and usability testing, our clients must provide and entrust us with product samples. Accordingly, HFE consultancies need an effective way to track samples during project execution and completion, when it might come time to return or discard samples. An effective sample management system requires consultants to promptly record key sample information such as shipping/receipt dates, quantities and locations.
- Emergo by UL tip: Designating sample administrators to manage sample tracking activities might help ensure compliance to QMS requirements and increase overall sample management record accuracy.
Choosing the appropriate ISO 13485:2016 QMS components
Fundamentally, right-sizing a QMS for HFE consultancies in the medical industry requires diligently reviewing the ISO 13485:2016 standard and determining which of the numerous requirements therein are or are not applicable to the consultancy’s scope of work. While it is obvious that HFE consultancies do not need procedures related to installing or servicing a medical device, it certainly seems appropriate for such consultancies to implement a rigorous employee training program, for example. At the same time, HFE consultancies must avoid implementing quality processes that are impractical and, ultimately, unsustainable. To control or not control, that is the question...
Alexandria Carlson is Lead Human Factors Specialist and Michael Orduz is Senior Human Factors Specialist at Emergo by UL's Human Factors Research & Design division.
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