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Similar to our cars, manufacturing facilities require periodic maintenance. Most facilities are shutdown every 6-18 months to perform preventative maintenance or repair tasks on facility and utility systems. What’s the worst that can happen if these are skipped? There’s probably no significant damage to systems if caught in relatively short time. But despite the low risk, there is a possibility of failure of equipment and systems when operating outside of the manufacturers’ recommended maintenance intervals. These repairs can cost a significant amount of money, cause facility downtime, and most importantly potential contamination or loss of product. Most importantly, it will also require a resource draining assessment of the impact to manufacturing processes and products.
Knowing this, the U.S. Food and Drug Administration requires that facilities and equipment be maintained and kept in good repair in 21 Code of Federal Regulations (CFR) Part 110. One manufacturer, a pharmaceutical manufacturing facility in North Carolina, who ignored this warning learned the hard way when in November of 2007, they underwent an inspection by the FDA. The inspector found environmental monitoring excursions in the purified water loop dating back to February and March of 2007 – eight months earlier.
While the company noted that a modification to the purified water loop would correct the problem, the necessary parts had not been ordered or installed. In fact, the company waited until June 2008, during the plant’s semi-annual plant maintenance shutdown, to install it. In the meantime, production was compromised by this and other issues which they failed to address or rectify.
As a result of this and other significant violations, the FDA issued a warning letter and advised the company to take prompt action to correct all deviations. Failure to do so would result in regulatory action including seizure and/or injunction.
Had this company taken the necessary steps to schedule the maintenance and modification of their purified water loop during their annual or semi-annual plant maintenance shutdowns, they could have identified issues causing the environmental excursions, then successfully taken corrective action. Their inspection would have gone smoother and they could have avoided receiving the dreaded “483 - FDA Warning Letter” and the prospect of fines, penalties and expensive repairs.
Most importantly, they would not have compromised their manufacturing facility with potential contaminants which could lead to risks for patients, loss of contracts, the destruction of inventory, and a public relations nightmare.
By scheduling periodic facility maintenance shutdowns, complete preventative maintenance designed to improve equipment life can be performed along with any modifications and system updates. With the appropriate time afforded for a shutdown, operations can be expected to run at the greatest efficiency, eliminating or minimizing the need for unplanned facility downtime.
To ensure the longevity of your operations, schedule your facility maintenance shutdowns. You’ll sleep better knowing that all systems are on track.
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