Causes of non-compliance
Once plant personnel become aware that a potential problem exists, they are eager to take action in order to correct the problem. Therefore, a plant audit at a food or beverage processing plant generally consists of:
• informing the client of potential problems and their causes
• suggesting practical solutions to solve the problems
• offering to educate personnel in the areas that will improve operations, and
• providing energy cost savings analyses.
However, compressed air system auditors cannot act as regulatory agents or government inspectors. Their primary commitment is to the client, not the various regulatory or standards organizations. Therefore, clients’ confidentiality takes precedence over any non-compliance issue encountered during the course of an audit.
Although most personnel at food and beverage processing plants try to correct oil contamination situations when they become aware that problems exist, a small percentage (about 5 to 7% from our experience) choose to ignore such problems. Several reasons exist why situations go unresolved, but cost is the primary one. Correcting a non-compliant or potentially non-compliant compressed air system can be expensive. However, in most cases, corrections are not prohibitively expensive. If a plant has operated in violation of FDA regulations for 10 or 15 years without having been caught, there may be little impetus to spend any money to correct a violation that goes unpenalized. The philosophy behind this apathy is simple — if it was not been a problem before, it is not a problem now. Also, a plant may be operating at only a slight profit margin, at a loss, or may be available for acquisition. In these situations, management may view investing capital for a problem that has existed for a long time as out of the question.
Consequences of non-compliance
If the FDA identified a product contamination problem in a food and beverage processing plant, fines would almost surely be levied. If management was aware of problems but chose not to correct them, more drastic action would be taken — such as closing the facility until it became CFR Title 21 compliant.
A facility may also face significant civil penalties if a contaminated product injures or impairs someone. In today’s heavily litigious environment, this is a serious concern that every company should consider as a potential consequence.
What to do
Every facility manager in the food or beverage processing industry should take the time to evaluate his or her compressed air system for potential contamination hazards. Plant personnel should examine their system to determine:
• whether or not their compressed air contains compressor lubricant
• if so, the kind of lubricant in use
• whether or not the compressed air comes into contact with the product or product containers, and
• what kind of filtration is in use.
If a company’s staff feels that it cannot evaluate its compressed air system effectively, then it should consider hiring a skilled, professional compressed air systems consulting company to perform the evaluation. In addition to improving the compressed air quality and helping to bring the plant into FDA compliance, a skilled consultant may also identify energy savings opportunities, offer system performance improvements, improve process equipment up-time, and reduce process equipment maintenance costs.
Most importantly, evaluating the air system can increase awareness of its existence, which overcomes the out-of-sight, out-of-mind attitudes. After all, it is what’s for dinner.
Richard M. Evonitz is director of audit services, and Joseph J. Augustine is auditor, Armstrong Compressed Air Services, Spartanburg, S.C. For more information, visit www.armstronginternational.com.