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One of the key points of the article was what differentiates Quality Alternatives from their competition. Some key points made in the article were:

• Specializing in building design/review, functional layout and mechanical/control systems for pharmaceutical, biotech, laboratory and medical applications, as well as office space Upfront costs encompass detailed project objectives resulting in project completion without additional costs. Integrity is the cornerstone of the company foundation. The objective is to make the client's job easier and to do the job right the first time. Evaluate control programs frequently written by integrators to ensure the details necessary for continued operation are embedded in the program. Present weak points that may compromise the system performance.
• Understanding of the impact and coordination required to work within an operating manufacturing environment.

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The black box philosophy has the potential to maintain compliant operations provided the following criteria are consistent for all qualifications performed within the company which utilize the policy of "the black box".

• Are there well-established system and equipment acceptance criteria with corresponding research to define the operating parameter limits, for all products and locations worldwide? This will be needed to support the policies. Was there strong commissioning documentation of the system and its challenges to allow future troubleshooting? Certainly, K factors and loop tuning constants parameters are not as critical in an HVAC system, as temperature, pressure, humidity, but they sure as hell are required to maintain the system performance. How about the equation to define the airflow accuracy for the flow device use for tray dryers, seasoning rooms or coating pans over the entire range of operation? Is it clearly documented so that each calibration cycle knows to incorporate the instrument and system correction factor into the control loop?
• Are there strong change control procedures reaching into the supporting utilities to prevent fluctuations in the water, air, steam, vacuum and electric utilities to qualified equipment?

If not, the ramifications can be extremely costly. Once the system is out of tolerance for any parameter, no matter how slight, manufacturing operations are suspended, the material quarantined and the pressure mounts to resolve the issue, release the product and operate in a reliable, consistent state, as documented by the qualification effort. So the unfortunate lowly person who is responsible, launches into an investigation to locate the reason, provide a detailed explanation, document, make correction(s) and execute re- qualification of the end results, all the while cursing his plight. He may hardly be able to get a grasp of the intricate details of how the system works, (if there is not detailed commissioning documentation) much less determine what went awry within "the black box" documentation. And so, I re-define "the black box" to be his black box of despair that he continues to struggle to get out of. The negative black box ramifications are this, a potential for long downtimes, due to cyclic problems, creation of black boxes of despair for employees and blame and finger-pointing, all less than efficient productive use of time and resources. The end result, costly delays and uncertainty of when it will re-occur. However, with strong; commissioning documentation, strong company policies and procedures and change control, the black box offers a tremendous financial benefit.

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