Going Digital for Medical Device Visual Inspection

Currently, often visual inspection of medical device parts or components is done using a workflow that involves paper-based documentation and reporting. However, there are several factors related to the use of paper which cause inefficiency in the overall inspection workflow. For the visual inspection workflow, refer to figure 1 below [1]. When paper-based documentation and reporting is done, these tasks occur in work steps 1, 3, 5, 6, and 7. There is also handling and management of paper documents, records, and reports in work steps 2, 8, and 9. All inspection and quality control steps that require documentation and reporting and which result in paper documents, records, and reports must be kept for audit purposes concerning compliance with regulations for medical device quality control [2].

There are some terms that should be defined so it is clear what is meant when they are mentioned here:

• Document: An approved instruction or procedure for inspection which is recorded, noted, or documented on paper;
• Record: The results or data from inspection which is recorded, noted, or documented on paper;
• Report: An approved summary of results on paper, plus collection of appropriate records and documents serving as evidence for the report, concerning a production batch;
• Documentation: The act of providing evidence to authenticate something which is done by documenting some type of information, i.e., recording, noting, or saving of texts, numbers, or images on paper; and
• Reporting: The creation or generation of paper reports which show results and data from inspection for a production batch.

With paper-based documentation and reporting, there can be quite easily an accumulation of a large mass of paper documents, records, and reports. With regular updates of documents due to things like maintaining compliance with changing, ever-stricter regulations and the creation of more documents for an increasing number of products, over time a company or organization ends up creating and storing a massive amount of these papers. With paper-based documentation and reporting, keeping track of, reviewing, revising, filing in cabinets, storing, and refinding these paper documents, records, and reports quickly becomes impractical. Now add to that the modern way of working with colleagues situated in different geographical locations, then it becomes even clearer that the transmission of data and information is less efficient when paper is involved, compared to a paperless (electronic) format from the start. Another potential disadvantage when relying on paper documentation and reporting is that managers and operators do not draw conclusions from the most recent quality control results and data obtained, leading to the risk that the product quality does not meet specifications. In this article, the reasons behind inefficient microscope inspection of medical devices when using paper-based documentation and reporting are described. A workflow exploiting digital reporting, rather than a paper-based one, can offer a more efficient way. The ultimate goal is to optimize visual inspection and make continuous improvement of quality control more straightforward. How a digitally enhanced visual inspection approach [1]​​​​​​​​​​​​​​, using the Exalta smart device for traceable microscopy, can lead to more reliable and efficient quality control is also explained.

There are a number of challenges with paper-based documentation and reporting used for visual inspection of medical devices. They arise during the inspection and reporting and analysis steps of the visual inspection workflow (refer to figure 1), e.g., documentation of the results and the creation, approval, transporting, handing over, and storage of paper documents, records, and reports. These steps can entail the gathering of all necessary images, checking all the boxes on paper, filling in all measurement values, or even changing or correcting paper-based documents or records. These challenges which occur with paper make the steps more time-consuming. Specific examples of these challenges are discussed below.

Errors during documentation and filing/archiving

Errors can happen more easily when users must document inspection results and data directly on paper. Incorrect information or data can be noted due to human error. It can also be very complicated to find and correct such errors afterwards. Additionally, once the paper documents are filed away for later reference, it may be more difficult to find specific documents due to filing errors or even loss.
Sharing documents worldwide
The need to share and distribute paper documents rapidly between colleagues in different geographic locations is another challenge. It becomes obvious that digitization is critical for efficient transmission of information and data, allowing those responsible to stay up to date at all times on the current level of quality control at each location.

Trending data analysis

In order to do data analysis for risk management and process optimization, information documented only on paper must be manually entered into a digital database which requires much effort and time. So, paper-based documenting and reporting is inefficient and can make the analysis
more complicated.

Storage space and eventual digitization

Much space can be needed for the storage of paper documents, records, and reports from inspection and quality control. In addition, for the purposes of freeing up or reducing storage space at a later time, scanning or manual digitization of the papers is time-consuming and costly. This physical space can be used for more valuable things or activities leading to cost savings.
Traceability of results
The factors mentioned above for errors during documentation and filing also make the traceability of inspection results, i.e., tracking acquisition, editing, and approval, as well as audit preparation, with paper-based documenting and reporting more cumbersome.

Cost for paper and the environment

The more obvious disadvantage of paper-based reporting is the need to regularly provide paper. Eliminating paper would not only mean less expense, but a more environmentally conscientious approach to doing business.

Digitally enhanced inspection, which can be established with the help of products like the Exalta smart device for traceable microscopy [1], is more efficient than visual inspection exploiting paper-based reporting.
Digitally enhanced inspection offers automated storage of data in a centralized database enabling easy traceability of electronic documents, records, reports, approvals, and signatures. Approvals of and changes to documents, records, and reports can be traced readily back to individual users for transparent user management and a clear audit trail. There is also the advantage of rapid and easy revision of electronic documents which can be distributed immediately to all microscope workstations, unlike with paper documents.

Digital report generation can reduce sources of error during data collection and reporting, as it eliminates the manual entering of data, noted on paper, into a central digital database, making the overall workflow more efficient. It also makes transmission of data and information between colleagues in different geographic locations trivial and essentially instantaneous.

As the workflow is entirely digital (refer to figure 2) [1]​​​​​​​​​​​​​​, there is absolutely no need to use, store, and scan papers, saving space, time, and money.
Yet another important advantage is that the data is available at all times in a database, so it can be used more readily for trend analysis with the goal of improving quality control processes.

Overall, a smart device for traceable microscopy like Exalta [1]​​​​​​​ provides a digitally enhanced inspection approach that eliminates the challenges of paper-based documentation and reporting and makes visual inspection of medical device parts and components more reliable and efficient.

1. J. DeRose, D. Barbero, Why is Manual Visual Inspection of Medical Devices so Challenging? How the Challenges can be Overcome with a Digitally Enhanced Solution, Science Lab (2021) Leica Microsystems.
2. FDA Guidance Document, Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry, September 2003, Docket Number: FDA-2003-D-0143, Food and Drug Administration (FDA), p. 5, lines 164-199.