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Tuesday, October 17, 2017

Lab Management Trends: Data Management

The quality control laboratories in manufacturing environments are continuing to evolve. Most of us

can remember the typical QC lab:
  • Purchased instruments
  • Full-time employees to operate instruments
  • Employees calibrated and maintained the instruments
  • Each test was performed on dedicated instruments
  • Data was logged in a physical book
  • Physical data book was rarely looked at (usually only when a customer complaint was being reviewed)
So many of these old ways of doing things have changed or have totally disappeared over the last 10-20 years.

Automated Testing
Laboratory equipment was purchased for each individual test for many years. If an end-use customer

required some specific test parameter or requirement, the equipment was purchased.  Full-time employees were hired and trained on the calibration, operation and maintenance of each piece of test equipment. Several testers on each shift sat in the lab. They prepared samples for testing after each turn up or batch. Each tester would run a series of tests on the samples that were prepared.

That system and process has changed dramatically for many organizations. It is continuing to evolve around the globe for others.  Most have automated all or at least part of their laboratories. Automation gives more data in a much shorter amount of time. CD, MD, top and bottom measurements can be made in a manner of seconds with automated equipment. At the same time, the real variation in the system can be seen because the automated testing removes any effect of the tester. Many know that testers can effect the results by manually changing data, accidentally entering the wrong data, searching for the best data by manipulating the sample, accidentally damaging the sample, etc. Automated testing removes these factors from the data and provides significantly more detailed information more quickly and electronically.

Big Box vs. Modular Automated Testing

If the decision is made to automate, there are different approaches available. The big-box automation is where a large, fixed-size system is purchased with a significant cost for the "bed" and at the same time any number of tests (usually 1-8) are purchased at the same time. The cost is usually quite high (US$500k to over US$1M) and depends on the specific tests and the total number of modules. In many instances modifications to the existing laboratory are required to accommodate the size (10 ft. x 3 ft. x 5 ft.) of the device. This is an additional expense. Ongoing preventative maintenance and service work is quite high (US$30k+ per year).

Technidyne PROFILE/Plus
modular automated system
In the case of modular automated testing, each test has the same footprint (11 in. x 15 in. x 24 in.) and the modules are priced slightly higher than a normal stand alone instrument because they have the feed mechanism and software for automation built-in. The cost is usually quite reasonable (US$15k to US$350k) and as the big-box system, depends on the specific tests and the total number of modules. However, there is no need to modify the existing laboratory to accommodate the modular automated testing system. Ongoing preventative maintenance and service work is much lower than the big-box and is based on the number of modules in the system.

Choice of big-box automation, modular automation or stand alone testing equipment for lab varies with different factors. Understanding these factors helps in deciding which path to take with equipment. Some factors and the rationale behind it at different scenarios are given below.

A. Ability to get ROI/payback:

  • If the estimated cost of the equipment is high but there are a number of people that can be replaced through automation, and the ROI/payback can be achieved quickly (less than a year), the purchase of a big-box or modular automated system is suggested
  • A modular automated system is the best option when an older automated system is being replaced. This is the case when the bigger dollar figure of a big-box system is going to make ROI/payback difficult over a 1-3 year period of time.
  • When personnel reductions are not possible or practical, and smaller operational efficiencies will be achieved through automation, a modular automated system is preferred to get ROI/payback one piece at a time (6 months - 1 year per module).
  • If budgets do not allow for large expenditures at one point in time, but it does allow for smaller purchases each year, a modular automated system or stand alone testing would make sense.

    B. Tenure of equipment usage:

    • If the expected usage of the equipment is more than three years and its frequency of usage is high, big-box or modular automated testing is suggested, provided the need to upgrade the equipment is low.
    • If the expected usage of the equipment is less than three years or the product mix/grade structure of the facility is likely to change in the future acquisition of a modular system is suggested.
    • Stand alone testing is preferred if the equipment will be used for a short term and its frequency of usage is low.

    C. Need to upgrade:

    • Regulations and technology developments will require upgrading lab equipment regularly. High-end equipment that involves high technology is subjected to a high rate of change in technology, which results in regular upgrades.
    • It is preferable to acquire equipment with a low to moderate need for upgrades through big-box or modular automated testing, as acquiring equipment with high upgrade requirements could result in owning obsolete equipment.
    • It is preferable to procure equipment associated with frequent technological changes and frequent upgrades in a modular automated testing system or stand alone, as it is easier to upgrade and avoids owning a big-box system with obsolete equipment.
    • Stand alone equipment is suitable for all types of users irrespective of the industry or size of the company when the technology is changing frequently and there is a need for constant upgrading of the equipment.

    D. Frequency of usage:

    • It is preferable to acquire big-box or modular automated equipment for medium to high frequency of usage tests, as return on equipment is high because the cost of the equipment is spread over the hundreds or thousands of tests.
    • Even if the test frequency is high for up to 4 or 5 tests, if there are very few tests that require a high frequency and others are low frequency, modular automated testing
    • Stand alone testing is preferred for equipment that is used less frequently or by ad-hoc requests. Acquiring equipment for temporary usage incurs more cost and less return.
    • If equipment is going to be used very infrequently, paying for testing by the manufacturer or a testing lab has become an option.
    E. Correlated data:
    • Big-box automated systems do not have all tests according to the applicable international testing standards, therefore, correlations are used for many tests.
    • Modular automated systems offer standard testing just like stand alone equipment.
    Automation has become a normal part of today's testing laboratories. There are many factors that can help determine what version of system is best for your situation. Careful consideration must be given to determine how to bring the benefits of fast testing with more relevant data (MD, CD, top, bottom) to the production facility.

    Other topics in blog posts:

    • Procurement
    • Data Management
    • Outsourcing

    Contact me with  your observations related to Data Management.