TimeKeeper America

Relating Certain Concepts

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Courtesy of TimeKeeper America

I wrote about a forty year logarithmic growth of technology in the April 2007 issue of Lab Manager . We talked about increasing numbers and kinds of instruments, the increasing number of analytes, the need for greater and greater sensitivity, and the need for data validation and normalization. Let’s now tackle that first facet – instrumentation. Instruments are developed for a few basic reasons:

1. R&D driven needs for QA and QC of new products,
2. The need for greater sensitivity,
3. The need for greater productivity, efficiency and profitability,
4. Instrument manufacturers’ entrepreneurial fight for market share.

Instrument manufacturers are happy to surge forward meeting these ever demanding needs for industry, environment and academia.

In good old bookkeeping terms manufacturers provide assets. We can fill out the concept of assets by including your physical plant, all of your employees and your contracts or job orders. You the Lab Manager can be entrusted with the protection, nurturing and management of all these assets.

The Instruments Asset
Instruments and equipment are the backbone of your lab. You can’t accept orders if you don’t have the instruments to process samples. Have you seen the cost of an ICP these days? With different instruments costing from $25,000 to a million dollars you can have more money wrapped up in equipment than in your physical lab itself. Big investment means big responsibility, and all of this requires a comprehensive working plan.

By “working plan” we mean a maintenance schedule for everything. Let’s tie those three words together from the top of this article. Asset management means knowing where everything is - on a bench, in a closet, in a truck or at a remote location. Asset management also means that the maintenance and repair records are readily available and that the state of readiness is documented. Instruments that are not fully maintained should not be on line. Having this information readily available is one major measure of compliance.

Every instrument and every piece of equipment even remotely related to sample acquisition, sample storage, sample preparation and/or analysis must be conscientiously maintained to manufacturer’s recommendations. Compare your lab to a symphonic orchestra. Every instrument must perform to the manufacturer’s specifications. This, in part, is how we keep an orchestra playing in tune. Also this is how we keep analytical instruments and equipment performing to the specifications that were important when you made your purchase. These performance characterizations help guarantee that data will be significant according to the standards of each specific project.

Certifying agencies pay you routine visits (inspections). In part they want to verify that all your instruments and equipment are indeed being maintained to manufacturer’s recommendations. Maintenance records must be current, complete and legible. A forward looking plan demonstrates your level of control. Forward looking maintenance programs are a demonstration of compliance and also are a great management tool.

As you think in terms of being compliant and demonstrating this compliance you must keep more in mind than just your main-line analyzers. The laboratories’ chemical showers, eye wash stations and hoods all need routine inspections. Vents and HVAC systems need periodic attention. And all sample handling, sample storage and sample pre-treatment equipment has recommended or required maintenance checks and actions.

Sample Prep Equipment
Maintenance of sample prep equipment is just as important as is maintenance for main-line analyzers. It’s impossible to get good TKN results if half of the digestion block fails to reach full temperature or if you don’t achieve even heating. The same is true for microwave digesters, autoclaves and even your everyday pipetters and balances.

More and more laboratories are setting up programs for testing fluid delivery systems and for their balances. The challenge here is to enact a consistent and rigid program. You must insure weights, volumes temperatures and pressures are always within specified limits. And performance confirmations must be reported in a defensible manner. More and more auditors are paying attention to the handling and preparation stages prior to analysis. And keep in mind – there is a significant difference between generating meaningful data and just running samples that have been prepared in a process not fully documented.

Today’s Challenges
Newly acquired analyzers or equipment are either state of the art or are a technologically new breed of analyzer. New analyzers (state of the art or technologically new) require the same demonstrations of equivalency or of capability. Where the real challenges arise are when you try to introduce new technology to a certifying agency – especially an agency that does not have the resources to validate new technologies. Another certifying agency disaster is when you try to introduce a “modified” version of a test. But that is not necessarily an instrument issue. We will not (today) delve into PBM.

I personally have faced the issue of bringing new technology on-line in a licensed laboratory. Sure you have to do a fair amount of testing. Quite a bit of data needs to be generated. All possible matrices need to be run. Crossover studies, serial dilution studies, recovery, linearity and correlations all need to be run. All this work should be done with any new analyzer – existing technology or new technology. This work should be run bringing on any analyzer – new or existing technology. Only through persistence does new technology become existing technology

Where do You go for Help?
Instrument manufacturers know and understand the challenges of adding a new analyzer to your lab – both standard and new technology. They also know what actions are required to keep your (any age) analyzer performing as new. A well written manual will devote one section to addressing routine maintenance. As a lab manager you need to put your trust in the instrument companies. Do your homework. Check their performance claims. Check their references. And check their support systems. In the end they want to make sales and they want happy users (positive referrals) A new tool in today’s marketplace lies with some of the software products that are entering the marketplace. Some of the new software pays special attention to asset management, tracking maintenance and demonstrating compliance. Mr. Lab Manager, how are you managing your assets?

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