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In my organization, every unit is built by hand, and every unit is tested. Every product has a written construction procedure and a written test procedure. We're in the process of updating and improving all those procedures. One potential problem we're trying to eliminate is when the checkout personnel skip a step during testing. If all you have is a list of fifty steps, and no step-by-step record of what you've already done, that's an easy thing to do.

One proposal is to require them to print a new copy of the procedure and check a box next to every step, every time a unit is checked. That's going to cost a lot of time and paper.

Another idea is to digitize the whole thing. Have a server running somewhere that the checkout tech logs into, which will show them the relevant procedure for the unit they're testing. They check the boxes as they go through the procedure, and it all gets stored electronically. This has a higher initial overhead, but should save a lot of resources in the long term.

The best proposal I've heard so far is to just roll our own checkout database and interface, but I feel like that must be reinventing the wheel. Is there software to support this sort of thing already in existence? Are there other, better ideas? Is there an accepted industry standard for solving this problem?

Ethan48
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Stephen Collings
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2 Answers2

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Have you looked at NI Test Stand? When I worked in the medical device industry that's what was used at every step along the way. The devices weren't built completely and then tested, but tested after each stage of production with a final programming and validation at the end. The devices were serialized by a ROM, which was tied to an engraved s/n on the exterior of the part. Each test stand, read the ROM and then added the results of each test to the record for each device.

Each test consisted of several steps and Test Stand allows requiring different criteria to be met before proceeding to the next step and the data for all tests are stored under each device's sn/ROM ID.

DLS3141
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With out a cost benefit analysis it is hard to tell with method will bring the best financial value to your organization. I am assuming that the analysis suggest that using a test automation will bring the best value for your organization.

Base on the current industry standard test automation will bring you the best value in almost all cases. In one of my past experiences bar coding was used to serialize product. A manufacturing personal would scan the bar code and execute the automated test process. The product ID, test data, manufacturing personal ID (in some cases such as FDA), date, time etc were stored in server as suggested by your question. This enabled the quality organization to verify if all test and verification steps were executed prior to shipping the product.

These type of processors are followed in US automotive, and semiconductor industry. I believe similar processor are followed in Medical device manufacturing industry. Also some of the reputed semiconductor manufactures from the far east not only follow these practices but have taken to them to the next level.

Product such as LabView and LabWindows/CVI from National Instruments (NI) are the ones that I am most familiar. There is also BenchVue from Keysight Technologies with I believe originated from HP VEE. This product is evaluation from HP-VEE.

Alternatively you can use open source software such as Linux combined with a open source back-end server.

Most importantly data collection enable the use statistical analysis tools such as Minitab to improve product quality, statistical process controls (SPC), trending, operation optimization, cost improvement and many more.

References:

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Mahendra Gunawardena
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