Interchangeable Parts and Quality Control: An Old Concept and New Control for BOM Dependent Medical Device Companies

Current manufacturing practices aren’t 100 percent foolproof but they do represent the conglomerated evolution of various ingenious manufacturing ideas and quality control solutions. For example, one of these ideas---though it is often taken for granted today---includes the world altering concept of interchangeable parts.

Interchangeable Parts
Perhaps interchangeable parts meant as much for past generations and personalities as digital devices mean for consumers today. For instance, consider the fact that at one time (i.e. before the 18th century) most tools and machines were created singly and were in many respects unique to other objects designed with the same final purposes in mind. Quality control for these types of objects was also distinct from the tasks and procedures we deem to be "quality control" today. A creator of a machine was his own judge of quality control as was the consumer. It wasn’t common for 3rd party quality groups to become involved.

At any rate, the production processes employed for these items were slow and tended towards inefficiency, especially in the sense that an object such as a sewing machine or a gun with only one defective part would often be thrown to waste for lack of a part replacement and/or the expertise to build it. However, inventive personalities such as the Frenchman Honere Blanc (around 1778) began to create gun parts that were interchangeable with other parts. Honere’s parts had to be built---as do all interchangeable parts---to meet standardized specifications and matched each other almost perfectly. The determination of whether or not these parts met specifications was a more advanced form of quality control.

Blanc’s interest in interchangeable parts as well as the interest shown for the concept by other inventive personalities helped raise awareness of mass production potential but especially enabled engineers and manufacturers to take advantage (both intellectually and monetarily) of creating parts replacements that would allow for the easy repair of an only slightly defective gun, sewing machine or medical device.

Then and Now for Medical Device Companies
In the past, doctors---like farmers and soldiers---constructed tools and their own forms of quality control for the furtherance of their own professions and according to their own standards. The concept of interchangeable parts and strict parts specifications was thus a welcome one to those interested in the advanced development of medical devices.

Today medical devices are produced in vast amounts and in multiple iterations for products that are almost identical. Each iteration set requires its own group of interchangeable parts and the data associated with these iterations has become absolutely essential for the application of best practices in highly regulated medical device environments.

The BOM (Bill of Materials)
Many---if not all---medical device companies utilize BOM (bill of materials) documentation. The BOM documentation contains the data associated with---among other things---interchangeable parts (for every product iteration) and is designed to be the forerunner of quality control in the med device environment. However, various problems face all departments that utilize the BOM (i.e. engineering, QA, manufacturing, purchasing, service/maintenance, etc.) This article will focus on only those problems faced by service and maintenance groups.

Challenges Associated with a Typical BOM
A variety of BOM related challenges include those that occur when a med device product has had multiple iterations or revisions and one of those iterations has been found to be faulty. It is then that service and maintenance professionals are called to the scene but have difficulty identifying the exact interchangeable parts because there are multiple versions of the BOM and companies aren’t sure which version is the most recent one. This practice simply isn’t providing the quality control necessary for better service and maintenance.

Better Quality Control: Better BOM Management
To achieve better BOM management and thus better quality control, med device companies should consider a BOM software solution that will provide the following:

• Automated tracking of BOM versions and automated audit trail information;
• Immediate access to the latest BOM version by all service and maintenance personnel;
• Interface capability with service and maintenance systems.

Conclusion
Time continues marching forward and inventions and quality control measures will continue to evolve. For now however, medical device companies would do well to consider advanced automation solutions for BOM management and quality control practices.

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality control solutions, please feel to contact a MasterControl representative.