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Fighting compliancecomplacencyIt's easy to fall into the trap of running on autopilot, assumingthat your company is meeting FDA requirements. Ron Balloffers sound advice on how to avoid costly complacency in theworkplace.

One of the biggest factors thataffect compliance programs atUS Food and Drug Administration(FDA)-regulated companies is

complacency. This can be both organizationalas well as individual complacency. You wouldthink with all the attention our industry receivedfrom the FDA in the 1990s and early 2000s,every company would have their act togetherand be fully prepared for their next FDAinspection. Sadly, that is far from the realityof the situation. While there are numerouscontributory factors that can derail a company'sefforts to stay in compliance, one of themost important factors to guard against iscomplacency. This article will examine a numberof key factors that tend to generate compliancecomplacency and how to guard against it.

Compliance complacency definedWebster's Dictionary defines complacency:

"self-satisfaction especially when accompaniedby unawareness of actual dangers ordeficiencies." Compliance complacencyis therefore defined by B&R ComplianceAssociates as: "organizational satisfaction ofthe (compliance) status quo without regardto, or intent to leam of, potential compliancerisks in the business." Firms that have hadthe same compliance program in place fordecades see no reason to look for problems,especially where the FDA has never historicallycommented on any issues during inspections.These very firms are at high risk of developingcompliance complacency in their business. Anacknowledged element of any well-run FDAcompliance program is the means and methods

to prevent a company from falling into this kindof self-satisfaction trap.

FDA's audit intervalThe FDA's own site inspection process is one

of the key means whereby firms can developcompliance complacency in the first place.By statute, the FDA is required to audit everydrug manufacturing facility every two years.Historically the agency has always been short ofinspectional manpower, and over time the FDAfielded an organizational philosophy that auditswere conducted in two-year blocks. Under thisphilosophy firms audited in the first month ofa two year block, and who were subsequentlyre-audited in the twelfth month of the nextconsecutive two year block, were considered tohave met the every two year audit requirement,even though more than 46 months had elapsedbetween the two audits. Eventually, the FDA'savailable inspectors could not meet even thisoptimistic interpretation of the regulations. Thisled to the introduction of risk-based auditingin 2005. Today it is commonplace for manymedical gas companies to not have seen anFDA inspector in six-eight years. No wondersome firms become complacent. But don't befooled. The agency has not forgotten about you.

Never been a problem before ...Another key factor in compliance

complacency is that a particular issue has"never been a problem before this." We hearthis statement frequently from new customers,and after all this time we still cringe each timewe hear it. If you have been in FDA complianceas long as the B&R has, you recognize thatany company is potentially only one inspectionaway from an enforcement action. There is awide variance in the level of skill, experience,diligence, attentiveness, and aggressivenessof FDA field inspectors. These variances oftenare a key, determining factor between an auditexperience that is easy and one that is difficult.We commonly see the same issue at the samesite viewed by two different FDA investigatorsduring two different audits, where the resultsof the two audits end up completely different.While the first inspector saw no problem withthe issue, the second auditor found the exactsame issue to be a major non-conformanceproblem. Obviously, the company beingaudited gets very confused over this, as it hadchanged nothing with its compliance programor documentation in the interval betweenaudits. In the medical gas industry this issue ismuch more common than you would think. Ifyour company has always had a steady diet ofeasy audits, then you are at risk of developingcompliance complacency.

To better understand this issue you have to

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look at the underlying regulatory requirements.21 CFR § 210.1 (b) states that the failure tocomply with any regulation set forth in 21 CFR§ 210 and § 211 through § 226 shall rendera drug to be adulterated, and in addition,the person responsible for the failure tocomply will be subject to regulatory action. Inpractice this means companies, by law, mustbe in compliance at all times. It also meanscompanies, and not the FDA, are responsiblefor determining whether their programs andactivities meet the intent of the regulation. Itis easy to see where firms that have a historyof the FDA performing virtual "drive by"inspections could become complacent. But thisdoes not let you off the proverbial hook with theFDA.

The agency does not view its job as providingcompanies a free compliance program reviewservice. It is an enforcement agency sent to lookfor fraud and non-compliance with regulations.This situation resembles the traffic cop whosaw you drive by on the way to work at sevenmph over the speed limit, but did not give you aticket. In no way should the fact that the policedid not issue a ticket be construed to meanyou were in compliance with the applicabletraffic laws at the time. In this same scenarioyou could easily become complacent abouttraffic regulations, but you should never letyourself be surprised when the first traffic copgoes on vacation and their replacement startshanding out tickets. Firms that have becomecomplacent and begin to rely on FDA inspectorsto find their potential non-conformances withtheir compliance program run the risk of beingvery surprised at their next, and probably everysubsequent, audit.

State Vs. FDA inspectionsSome states now contract with the FDA to

perform site inspections of in-state medicalgas facilities. In other states both the FDA andstate inspectors still audit medical gas facilities.This outsourcing of audit talent has usheredin a patchwork quilt of enforcement at thestate level. Many state inspectors are usingFDA's 2003 Medical Gas Guidance documentas their outline to conduct an inspection, andare generally very diligent in reviewing a firm'sactivities. Getting an annual audit by a well-trained state inspector is one method to helpstay out of the complacency trap. However,there are some state medical gas inspectionalprocesses that border on comedy. The sameinspector shows up year after year, spends anhour or two, looks at the same issue and neversees a problem. Whatever the reason for this,under these circumstances it would be hardfor a company to avoid becoming complacent.However, this does not alleviate that company's

requirement to comply with applicable FDAregulations, and firms that have fallen into thisstate inspector-generated complacency trapneed to recognize they may someday receivea serious FDA wake up call. They also needto recognize that the FDA does not acceptthe excuse that the previous inspectors nevercommented on an issue.

Regulatory creepAs new, and heretofore unknown compliance

problems manifest themselves to the FDA, itdevises solutions, changes its opinion on whatconstitutes compliance, and moves forward

"Organizations like theCompressed Gas Association(CGA) and firms includingB&R Compliance are effectiveconduits passing on informationto the medical gas industry tomake people aware of changesin FDA compliance policy:'

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with site inspections using this new definition ofcompliance for that specific issue. Regulatorycreep also occurs where the FDA changes itsopinion on what constitutes compliance fora particular issue. Often these start as grassroots issues, with a particular FDA districteither observing something that troubles it, orsimply by changing its mind on a particulartopic and then beginning to issue 483 citationsand warning letters accordingly. The thirdway compliance creep occurs is as a resultof a single or series of well-publicized tragicincidents in the industry. Organizations likethe Compressed Gas Association (CGA) andfirms including B&R Compliance are effectiveconduits passing on information to the medicalgas industry to make people aware of changesin FDA compliance policy. Firms that havefallen into the compliance complacency trapoften just don't have the interest to learn what isnew or has changed, and even if they did learnabout something new, complacency would likelykeep them from doing anything about it. Thekey to fighting complacency where regulatorycreep is involved is to stay abreast of changes,keep informed about shifts in FDA enforcementtactics and policies, and to take proactive actionto incorporate these changes into your programas you learn about them.

Fighting compliance complacencyThe most reliable method of fighting

complacency is to periodically assess where ~

First Quarter 2011 • SpecialityGasReport 45

~ the weaknesses are in your FDA complianceprogram and to have plans and processes inplace to rectify any issues that could result innon-conformances being issued. Even if aparticular issue has not been fully addressedat the time of an FDA audit, most agencyinspectors generally will not issue a citation forissues the firm had previously identified andproactively addressed by implementing plans toclose the compliance gap.

The best means to find and understandpotential compliance program deficiencies is to

perform an audit. We typically recommend usingthe services of a third party auditing firm, or atthe very least, use an audit checklist and auditguideline prepared by a knowledgeable thirdparty firm. Preferably this should be someoneexperienced in medical gas manufacturing.These periodic audit events are excellenttools to prevent compliance complacencyfrom gripping your organization. We generallyfind that most small and medium-sized firmsthat try to audit themselves generally fallshort of making this a productive process.

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Commonly the same individual responsiblefor FDA compliance is also the same personconducting the audit, typically using audit toolsthey generated. It is poor practice to expectsomeone to audit their own program and to beeffective in identifying program deficiencies.

A final consideration related to audits is thatin the near future the FDA is expected to makesome sort of annual audit a requirement, withthird party audits the recommended practice.We expect to see the agency promulgate newrequirements regarding audits in 2011.

Finally, some tips on how best to deal directlywith complacency itself. Companies whoselast FDA visit lasted just three or four hoursand then the inspector left with no findings- or companies that haven't had an audit insix or seven years - would be prime sites forcompliance complacency to set in. The mosteffective method to deal with compliancecomplacency is for a company to endure theFDA's meat grinder-type inspection process.These can literally be life-changing events, andI can guarantee that once your company hasbeen through that process, complacency willnever be a problem again. Unfortunately thecure can be as or more painful than the disease.This is not a process I would ever recommendto anyone, and we have dedicated our businessto helping our customers avoid this fromhappening.

Fighting the onset of complacency is bestaccomplished by keeping your complianceresources tapped into an outside source ofinformation on the latest FDA compliancetrends. Firms whose compliance and operationsmanagers sit inside their own little bubble andspend little if any time in learning what is neware at the highest risk of developing compliancecomplacency. Firms that never ask themselvesin any meaningful manner: "is my programdeficient, and what do I need to do to improve?"also risk the onset of compliance complacency.

One of the more popular and effectiveprograms we offer to prevent complacency isour monthly tele-web training programs, whereindustry trends are discussed, and individualscan ask questions and share experiences. Thistype of forum helps to bring home the latestinformation and tips from both experts andpeers. Just like rust, the FDA never sleeps,and neither should your company's efforts tostay trained and abreast of relevant changesand avoid the heavy costs of the compliancecomplacency trap. C"

Ron Ball

Formore informationon regulationsthat affect medicalgas producersandend-users,contact:RonBallatB&RComplianceAssociatesLLC:+1 (317) 297 8518; email: ron.ball@brcompliance.com; www.brcompliance.com

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