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Lab Manager Where Science and Management Meet ™ A Nominal Agenda to Reduce Work Stress Improving Customer Relationships in the Lab Mutual Recognition Agreements Compliance-based Lab Operations ® MAGAZINE INSIDE : December 2006 Volume 1 • Number 5 www.labmgr.com
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LabManagerWhere Science and Management Meet™
A Nominal Agenda to Reduce Work StressImproving Customer Relationships in the Lab
Mutual Recognition AgreementsCompliance-based Lab Operations
®MAGAZINE
INSID
E:
December 2006 Volume 1 • Number 5
www.labmgr.com
pp1 11/08/06 08:49 PM Page 1
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contents
departmentsfeatures
LabManagerWhere Science and Management Meet™
®MAGAZINE
31THE SAFETY GUYSThe Chemical Hygiene OfficerGlenn Ketcham, CIH and Vince McLeod, CIH
40 LAB DIAGNOSISLabeling Technology IncreasesLaboratory Efficiency Matt Luger
45 CAREER NOTEBOOKThe Common Mistakes NewManagers MakeJulie Bennett
52 HUMAN FACTORSYear’s End – A Time for CareerAssessment and PlanningJohn K. Borchardt
54 THE INTERVIEWEdward J. Dunphy, University ofWisconsin-MadisonF. Key Kidder
8 Upfront
30 Lab Agenda
33 How It Works
34 Product News
38 News Notes
53 Lab Bratz®
53 Advertiser Index
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Lab Manager Magazine® (ISSN:1931-3810) is published five times a year by Vicon Publishing, Inc., 4Limbo Lane, Amherst, NH 03031. Postage paid at Fulton, MO 65251. Permit #38. A requester publi-cation, Lab Manager® is distributed to qualified subscribers. Non-qualified subscription rates in theU.S and Canada: $120 per year. All other countries: $180 per year, payable in U.S. funds. Back issuesmay be purchased at a cost of $15 each in the U.S. and $20 elsewhere. While every attempt is madeto ensure the accuracy of the information contained herein, the publisher and its employees cannotaccept responsibility for the correctness of information supplied, advertisements or opinionsexpressed. POSTMASTER: Send address changes to Lab Manager Magazine® , 4 Limbo Lane,Amherst, NH 03031.
©2006 Lab Manager Magazine® by Vicon Publishing, Inc. All rights reserved. No part of this publica-tion may be reproduced without permission from the publisher. Permission is granted for those regis-tered with the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923(phone: 978-750-8400; fax: 978-750-4470) to photocopy articles for a base fee of $1 per copy of thearticle plus $.35 per page.
10A NOMINAL AGENDA TO REDUCE WORKSTRESS
An unstructured approach to problem solving may not ensurethat all voices are heard — that's when the nominal grouptechnique is effective.Scott Warner
17 IMPROVING CUSTOMER RELATIONSHIPS IN THELABORATORY
A customer relationship management system means a phonecall from a client doesn’t require them telling a potentially longstory, all over again to each person they talk to. It means con-sistent and updated information as well as satisfied customers.Deborah Farnham
21ONE TEST, ONE ACCREDITATION — ACCEPTEDEVERYWHERE
Mutual Recognition Arrangements (MRAs) are drawing theglobal accreditation community closer to accepting the out-comes of each other’s accreditation. Peter Unger
25COMPLIANCE-BASED OPERATIONAL EXCELLENCEIN PHARMACEUTICAL GMP LABORATORYOPERATIONS
The FDA has increased its focus on modernizing the regulationof pharmaceutical manufacturing and drug product quality. Asa result, innovative pharmaceutical companies are re-examiningwhether traditional drug development and commercializationprocesses are sufficient.John P. Helfrich
DECEMBER 2006
pp2-7 11/12/06 09:26 PM Page 4
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EDITORIALPATRICE GALVIN - Editor In Chief • [email protected] | 603-672-9997, x112
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EDITORIAL ADVISORY BOARDMICHAEL BROWNSTEIN, Ph.D., MD • J. Craig Venter Institute
WAYNE COLLINS, Ph.D. • Thermo Electron Corporation
LYN FAAS • Consultant, Past-President of ALMA
GLENN KETCHAM, CIH • University of Florida
MARY KEVILLE • Massachusetts Biologic Laboratories
VINCE MCLEOD, CIH • University of Florida
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6 LabManager labmgr.com
Author GuidelinesLab Manager Magazine® is aprinted publication of resources,products, and information fortoday’s laboratory manager.Articles should address someaspect of laboratory manage-ment from the perspective of aprofessional who is both a scien-tist and a manager. Topics areaswould include: managing budg-ets, personnel, technology, infor-mation, funding, training, safety,risk, expansion, building or reno-vation, among others related tothe role of a lab manager.
The article review processshould begin with a query by e-mail or phone followed by abrief abstract or outline. Pleasestate your topic and objective,and indicate your perspective aswell as your professional rela-tionship to the topic. Contentmust be unbiased and cannotpromote a particular product orcompany. Article length mayrange from 1500-2500 words.All manuscripts must be submit-ted electronically by email ordisk.
To submit an article
query contact:
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Editor in Chief
Lab Manager Magazine
603-672-9997 x112
pp2-7 11/12/06 09:26 PM Page 6
upfront
YOUstress and DistressThe first article in this issue of Lab Manager offers a method for managing stress in the workplace. Itfocuses on a group technique to uncover and identify stressors and begin the process of addressingcircumstances that affect performance and job satisfaction. As a manager, it is important to be awareof dynamics within your staff and move toward making positive changes.
But stress management may need to start with the saying, “Physician heal thyself” — essentiallyreminding us to take care of our own behaviors before “fixing” them for others.
From the “Ten Commandments of Stress Management” to “Stress-busters,” to laughter clubs,mediation and relaxation techniques, endless websites, consultants, quizzes, self-help books, andtime-management tools, there is no lack of information on how to handle stress. The key is to han-dle or manage stress. Most experts will tell you that it is not possible to avoid or eliminate it.
Hans Seyle, a Canadian endocrinologist who studied the effects of stress, wrote, “The onlyescape from stress is death.” His statement was not a dire view of the human condition but rather acall to understanding that life involves taking risks, making choices, facing challenges, and that notall stress is bad. In fact, his studies led him to coin the term eustress (from the Greek eu meaningeither “well” or “good”). Eustress is stress that is deemed healthful or giving one the feeling of fulfill-ment. Examples of this in the workplace can be associated with successful completion of a project orachieving a promotion. Both events assume that expectations were set and needed to be met. Whatmight have been a stressful situation becomes positive when the outcome results in a feeling thatthe effort was worth it.
Negative stress, or distress, in the workplace can take many forms including lack of appropriateautonomy or authority, work overload, or even the inability to say no or ask for assistance. Workstress is often related to time management. Two of the biggest time wasters are interruptions andpoor delegation skills — assessing the impact of these on your workday is a good place to start “dis-tress” reduction.
Take a few minutes to think about stress and ask these four questions:1• What is stressful to me?• How does stress affect me?• When am I most vulnerable to stress?• When is stress good for me?
By identifying stressors and responses to stress, you can help yourself and go on towardhelping your staff, individually and as a whole, create a “stress for success” atmosphere.
Patrice Galvin
1. M. Heitt, PsyD. Managing Stress, www.jhu.edu/~hr1/fasap/stress, accessed 11/2/06.
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A Nominal Agenda to Reduce Work Stress
managing performance
AN UNSTRUCTURED APPROACH TO PROBLEM SOLVING MAY NOTENSURE THAT ALL VOICES ARE HEARD — THAT’S WHEN THE NOMINAL
GROUP TECHNIQUE IS EFFECTIVE.
Work stress has become a dominant factor in our workplace and it affects all of us. As a man-ager, you may be coping with a chronic staffing shortage, recent layoffs, a rash of errors thathas eroded confidence, or a turnover in senior administration. If you’re new to the job, youmay not understand the problem. Your secret weapon to create a work agenda that combatsstress just might be the nominal group technique.
Work has always been stressful, you say. And you’re right. After all, if it were fun, itwouldn’t be called work. It’s tempting to view stress as an individual’s problem. But the latesttrends suggest that our society is changing in ways that create even more stress, making it dif-ficult to shrug off.
Information technology and a global economy contribute to an out-of-control work envi-ronment. As customer demands increase, we depend more on technology to deliver. This“informatization” of our workplace is double-edged; we not only use but need to produce infor-mation in ever-increasing amounts. Productivity may be higher, but more skill is needed.
THE PRICE OF STRESSOne study cites a third of U.S. workers as overwhelmed and seven out of ten want a differentjob. One reason is technology. Cell phones, pagers, computers, and other devices that didn’texist a few decades ago create a constant need to be accessible and add stress.1
There are disturbing signs that the trends are real. Similar to the phenomenon of “roadrage” on overcrowded highways, work stress is causing “desk rage” on the job. One studyreports that 42 percent of Americans say that yelling or verbal abuse takes place at their job,and nearly a third of those have themselves yelled at co-workers. One in seven report rage-driven destruction of property. The end costs are employee tardiness, absenteeism, andturnover.2
Most alarmingly, work stress is linked to heart disease in a 14-year study published recent-ly by the British Medical Journal.3 Civil servants exposed to chronic stressors are nearly twiceas likely to develop metabolic syndrome that increases the risk of heart disease and type-2 dia-betes. Physiological disorders as well as lifestyle changes may be the cause. The study shows a“dose-response relationship” in which workers’ health-damaging behaviors are in proportionto the amount of stress.
As a manager, you may think that stress is unavoidable for some people, a feeling buoyedby research that focuses on how it affects individuals. But we also know that workers needfreedom in how to respond to job demands in order to reduce stress. Those in high-strain, low-control jobs are three times more likely to have a heart attack as those in executive positions.4
The little research done on group stress shows that overall performance suffers. One studycomparing groups of Navy technical school personnel suggests that a higher level of stress nar-rows the focus of the group from team to individual goals.5
Scott Warner
It’s tempting toview stress as an
individual’s problem.But the latest trends
suggest that oursociety is changingin ways that create
even more stress,making it difficult to
shrug off.
>>LabManager 11labmgr.com
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A new manager can be blind-sided by agroup culture that may have developedwithout the awareness of upper man-agement. Long-term effects of an “eachman for himself” mentality may fomenthostility, dissolve a team, or empower a“shadow organization” negative cultureas the group loses perspective. In thelong term, work stress can make yourjob all the more difficult.
It’s also tempting to accept thisstress as part of our world, perhaps as aprice for new technology. To somedegree, a work culture that views stressas not only inevitable but necessary inorder to compete and generate profitpays an ultimate human cost.
THE NOMINAL GROUPTECHNIQUEAs the National Institute forOccupational Safety and Health pointsout, there is a difference betweenharmful stress and a work challenge orso-called “good stress.” Work that ischallenging is energizing and motivat-ing. Work stress occurs when expecta-tions are too high, which, in the longrun, makes a job unsafe and unhealthy.The good news is that some of theworking conditions that can createstress listed in Table 1 are probablyunder your control.6 You may be ableto turn bad stress into good.
Lack of individual control in howto respond appears to be at the root ofwork stress. Other causes are a lack ofparticipation in decision making anduncertainty about expectations. A goodfirst step is to allow the group to identi-fy these subjective perceptions.
Group exercises like brainstormingcan help identify stressors and get agroup back on track, but individualswho wield power within the group canmake this difficult. These individualsmay not be immediately apparent. Andan unstructured approach to problemsolving may not ensure that all voicesare heard. These conditions may occurwhen negative “groupthink” takes overafter prolonged periods of stress. That’swhen the nominal group technique
CONDITION STRESSORS
Task Design Heavy workload, infrequentrest breaks, long work hoursand shifts, hectic and routinetasks that have little inherentmeaning and do not utilizeworkers’ skills, lack of control
Management Style Lack of participation byworkers in decision-making,poor communication in theorganization, lack of family-friendly policies
Interpersonal Relationships Poor social environment, lackof support or help from co-workers and supervisors
Work Roles Conflicting or uncertain jobexpectations, too muchresponsibility, too many “hatsto wear”
Career Concerns Job insecurity, lack of oppor-tunities for growth, advancement, or promotion,rapid changes for whichworkers are unprepared
Environmental Conditions Unpleasant or dangerousphysical conditions such ascrowding, noise, air pollution,or ergonomic problems
Source: National Institute for Occupational Safety and Health (NIOSH)
TABLE 1: JOB CONDITIONS MAY LEAD TO STRESS
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(NGT) is effective.A nominal group is brought together solely to gener-
ate ideas. While brainstorming uses a freewheeling, spon-taneous approach, NGT is more structured. Both are suit-ed to dealing with poorly understood or complex prob-lems, but NGT keeps individuals from dominating meet-ings, insulating the process from politics. This helps agroup work together quickly to help find solutions.
HERE ARE THE STEPS:1. Begin with a group of five but no more than ten par-
ticipants, with you acting as a facilitator. You’ll needa board or flipchart to write on and a clock.
2. Choose a meeting space large enough to accommo-date members in a U-shape or around a table, andblock out a length of time during which you’ll beuninterrupted.
3. State the problem clearly as an open-ended question.Be sure that the issue framed by the question isunderstood by all participants. Your terms should beunambiguous. The issue itself is open-ended and mayrange from an overall agenda (What are the majorsources of stress in this laboratory?) to a specific prob-lem (How can we reduce cost?).
4. Ask the group members to silently jot down theirideas and responses in a set period of time (5–10minutes).
5. Collect the ideas in a round-robin fashion, askingeach group member in turn to state an idea aloud.You as the facilitator write down the ideas, asking forclarification from the respondent. No criticism or
discussion is allowed. A member may also “pass,” inwhich case no idea is recorded and the next personstates an idea. This continues for a set period of timeor until all ideas are recorded.
6. Briefly discuss each idea. This is the time to elimi-nate duplicates or combine similar ideas, changewording, or delete items by group consensus. Ratherthan judge the ideas, this step clarifies them withoutargument.
7. Number the items and ask members to silently rankorder the top 5–10, depending on the length of thelist, by writing them down on a piece of paper in aset period of time (5–10 minutes). If each memberhas five votes, for instance, the most important itemis worth five, the next worth four, and so on. Thecriteria for voting can be open-ended (individualpreference) or specific (cost) but should be madeclear by you in advance of voting.
8. Tally the scores either by the members reading theirchoices aloud in descending order (not anonymous)or by a scribe reading from their score sheets (anony-mous), then write the scores beside the individualitems.
What this gives you is a prioritized list of items thatanswer the question posed to the group in a short period oftime, maybe as little as 45 minutes. It’s up to you to devel-op action plans, perhaps with their help. And if you’re anew manager, this technique can give you an agenda thatcan be a roadmap for success, helping you gain early credi-bility.
If NGT seems like a complicated way to solve prob-lems, consider that a group is generally better than anindividual at solving an unstructured problem.7 Youwouldn’t use NGT to add a column of numbers, becauseaddition is clearly understood. It follows that a poorlyunderstood problem (How do we reduce work stress?)needs definition and clarification before taking action, themore creative the better.
The NGT, outlined above with a multi-voting, priori-tization method, isn’t perfect as briefly summarized inTable 2. But it has advantages over other techniques, par-ticularly if the group’s dynamics are unknown or the grouphas been under stress for an extended period of time. If allmembers in a group (or a series of groups, depending onthe size of your staff) are given a voice, NGT can be apowerful, team-building exercise.
Roadblocks can occur. Group members may be famil-iar with NGT to the point of manipulation; individualscan obstruct the process. You as a facilitator must firmlykeep the group focused. A phenomenon of “groupthink”may exist, in which some or all members agree collectivelyon an irrational course of action. NGT may not onlyexpose this but serve to keep the group grounded in its
PROS• Quickly generates creative ideas• Equal participation of group members• Influence of individuals is minimized• Team building exercise
CONS• Cross-fertilization of ideas doesn’t occur• Process may be too mechanical• Groupthink may prevent idea generation• Voting process may not reach consensus
TABLE 2: PROS AND CONS OFNOMINAL GROUP TECHNIQUE
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approach to the problem.Strict adherence to the technique may produce
uncomfortable results. It’s possible, for instance, that youor other members of a work team are causing stress. Asnoted in Table 1, there can be specific reasons foremployees’ dissatisfaction with management. It’s impor-tant that you separate the person from the process.
A structured, rational approach to consensus build-ing like NGT helps counter the destructive, chaoticeffects of work stress. You may even solve problems,which is a good thing. Managers are stressed, too.
REFERENCES:1. Yearwood, C. The overworked workplace. CNet
News.com page. 8/10/01. Available at:http://news.com.com/The+overworked+work-place/2010-1071_3-281532.html. Accessed8/15/6.
2. Overworked, overwrought: desk rage at work.CNN.com page. 11/15/00. Available at:http://archives.cnn.com/2000/CAREER/trends/11/15/rage/. Accessed 8/15/6.
3. Work stress leads to heart disease and diabetes.Science Daily page. 1/24/06. Available at:http://www.sciencedaily.com/releas-es/2006/01/060123170630.htm. Accessed8/15/6.
4. Adler, V. Little control=lots of job stress in low-echelonjobs. Psychology Today. Apr 1989. Available at:http://www.findarticles.com/p/articles/mi_m1175/is_n4_v23/ai_7502237. Accessed 8/15/6.
5. Driscoll J, Salas E, Johnston J. “Does stress lead to aloss of team perspective?” Group Dynamics: TheoryResearch and Practice. 1999; 3(4): 291-302.
6. NIOSH Publication 99-101: Stress at Work. CDC.compage. Available at: http://www.cdc.gov/niosh/stress-wk.html. Accessed 9/7/6.
7. Meredith J, Mantel S. Group creativity. University ofCincinnati Student Wave page. Available at:http://www.wiley.com/college/dec/mered-ith298298/resources/addtopics/addtopic_s_01e.htmlAccessed 8/18/6.
Scott Warner is a freelance writer and can contacted at38 School Street, Lincoln, ME 04457; 207-794-3392;[email protected].
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Improving Customer Relationships in the Laboratory
managing customers
A CUSTOMER RELATIONSHIP MANAGEMENT SYSTEM MEANS APHONE CALL FROM A CLIENT DOESN’T REQUIRE THEM TELLING A
POTENTIALLY LONG STORY, ALL OVER AGAIN TO EACH PERSON THEYTALK TO. IT MEANS CONSISTENT AND UPDATED INFORMATION
AS WELL AS SATISFIED CUSTOMERS.
Satisfied customers have always been critically important at BioTek Instruments, Inc. We recog-nize that high customer satisfaction will ultimately lead to increased loyalty and sales, while dis-satisfaction could potentially inflict lasting damage.
While we enjoy the reputation of providing excellent customer service, in addition to themicroplate instrumentation that we manufacture, we recently implemented a formal system ofself-improvement so that this reputation could be further enhanced. It was an eye-opening experi-ence at times, and we gained such tremendous value from this process that we believe others maybenefit as well — including the laboratory market.
Though not always readily appar-ent, every laboratory has customers. Infact, lab customers can be found in awide range of areas, from the far-reach-ing “consumer” to another lab down thehall — and anywhere in between. It’simportant to keep these customers happy— if they’re not, your lab’s credibilitycould suffer, or worse, existing and futureresponsibilities could be transferred toanother lab. In the normal course ofhuman nature, problems do arise anderrors are made, but ideally the relation-ship is as smooth as possible. So how canyou avoid bottlenecks and pitfalls toensure pleased customers? You may beable to find the answer through theimplementation of a CRM strategy.
CUSTOMER RELATIONSHIPMANAGEMENTCustomer Relationship Management(CRM) is a system or process thatenables organizations, regardless of spe-cialty or market, to manage, service,retain, and often strengthen relation-ships with customers. A successful andefficient CRM system encompasses the entire company, from the executive level to every depart-ment and employee. Through CRM, a synergistic effect is created between a pre-determined
Deborah Farnham
We found that implementation of a
streamlined CRM systemhelped to promote
communication bothinternally and
externally, and alldepartments now have
access to the sameinformation.
LabManager 17labmgr.com
Figure 1. A physical map of communicationmethods and information input often revealsa chaotic scenario. >>
pp16-19 11/12/06 10:29 PM Page 17
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process, the employees of the company, and the CRM tech-nology and database system creating one complete view ofeach customer, both internal and external, in real time.
FIND YOUR CUSTOMERSFrom the scope of the laboratory environment, do you knowwho your customers are? It may be surprising to learn thatsome people in your lab have differing opinions. To compli-cate matters further, do you know who your customer’s cus-tomers are? Your customer may be the lab down the hall butdo you know who depends on them? Often, you may have apiece or two of the puzzle, but not many people have the timeand/or resources to gather all of the pieces to create the com-plete picture. An ancient and well-known proverb puts thisinto perspective. Four wise men were led into a dark, win-dowless room with their hands outstretched. The first wiseman ran his hands along the rough trunk of a tree. The sec-ond wise man felt a large tropical leaf. The third wise mantrembled as he handled a giant serpent while the last feltnothing but a warm, rudimentary wall. As they voiced theirdiscoveries, confusion swept the room — torches were lit, andthe tree, leaf, serpent, and wall were revealed as the leg, ear,trunk, and body of a large elephant. The four wise men nod-ded their heads slowly as they realized the lesson that theyhad learned — only through collaborative knowledge will adeeper understanding be achieved.
This is where we found that the process of implementinga CRM system can be helpful, and the resulting picture ofinternal and external BioTek customers was greater and morecomplex than we could have anticipated. As each laboratoryand department identifies their customers, a CRM system cancombine the multifaceted data into a comprehensive model.
WHY CHANGE IS NECESSARYOnce the pieces are in place, and internal and external cus-tomers are identified and combined with existing databasesystems, a hectic picture will often emerge (Figure 1), alongwith areas that require improvement. This is where imple-menting a CRM system becomes a way to improve and iden-tify problem areas. We found that implementation of astreamlined CRM system helped to promote communicationboth internally and externally, and all departments now haveaccess to the same information. Customer service and inter-departmental service were both improved as a result of thiscollaborative knowledge, which in turn, benefits our cus-tomers. In addition to improvements that we experienced, lagtimes can also be reduced through implementation of a CRMsystem, along with an increase in efficiency. Future problemsthat may unavoidably arise can be identified, minimized, oreven eliminated before they become major issues. Finally, inour performance-driven world, a CRM system allows for con-tinued growth of the company by increasing loyalty, reducingunnecessary labor and material costs, and saving time.
GAINING COMMITMENTDr. W. Edwards Deming, esteemed author, consultant, andquality expert, once noted, “What we need to do is learn towork in the system, by which I mean that everybody, everyteam, every platform, every division, every component isthere not for individual competitive profit or recognition, butfor contribution to the system as a whole on a win-win basis.”The same applies here; a firm commitment from executive tolaboratory levels is necessary to create and sustain this broad-based and fundamental change. We realize that activeinvolvement of the entire team creates understanding,empowerment, and ultimately motivation to plan for andthen implement a CRM system.
MAKING THE CHANGESo how does one make this change? Once commitment hasbeen gained, the next step is to create a specific and detailedgoal. What is the known issue to address — purchasingdelays, incompatible research databases, etc…? Or are youlooking to proactively streamline communication andprocesses within your laboratory or organization? BioTek’sgoals included improving real-time communication bothinternally and externally, creating tangible metrics for proj-ects in various departments, and establishing a virtual profileof our customers so that complete information was availablein one convenient location, regardless of the departmentthat accessed it.
After identifying the goal, document it, and refer to itoften to ensure that the process of change remains focused. Italso is essential to create a physical map or flowchart of theprocesses that are being automated. This step in particular willhelp identify problem areas that may need resolving beforeimplementing a CRM solution. Think of your project in termsof stages, rather than trying to accomplish everything at onetime. Then develop realistic timelines for each phase.Depending on the complexity of your needs, you may want totake advantage of a CRM consultant for extra assistance.Creation and implementation of a CRM strategy can be com-plex and labor-intensive, and if internally managed without atrue focus, the strategy is very easily pushed to the back burnerin favor of existing job responsibilities.
When you have developed a focused goal and knowwhat you wish to accomplish with a CRM system, look for aCRM vendor with the flexibility to develop a solution basedon your specific needs, or, if your implementation is fairlysimple, an off-the-shelf program might be all that’s necessary.We narrowed the field from fifteen candidates to four beforeawarding the project to a company based in the Midwest.Keep in mind during this search phase that internal depart-ments will certainly be involved in the overall process.
CREATION OF THE SYSTEMOnce you’ve chosen your CRM partner, a Project Manager
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will work closely with the entire team to understand the goals, fine-tune the business practice flowcharts, and combine co-dependent andassociated activities into an interconnected electronic application,allowing all information to be shared in real time. The pre-definedgoals, strategies, and processes all drive development and customiza-tion of the information technology.
SUMMARYResults from improvements can include streamlined processes (Figure2) resulting in less waste, less confusion, increased efficiency, andenhanced customer satisfaction — even from the lab next door.Although the results from a CRM system may not be readily apparentto outside customers, they’ll appreciate the prompt and high-qualitycustomer service they receive from every member of your laboratory.Our customers have appreciated our proactive approach; they spendless time explaining their needs and more time working with ustowards a solution. Our CRM system provides us with more time andresources to serve our customers.
Deborah Farnham is Marketing & Sales Operations Manager at BioTekInstruments, Inc., and spearheaded the implementation of a successfulCRM system within her organization to ensure the continued happiness ofBioTek’s internal and external customers. She may be contacted at 802-655-4040; or [email protected].
Figure 2. Implementation of a CRMsystem can improve communicationmethods and information input foroverall benefit.
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ONE TEST, ONE ACCREDITATION — Accepted Everywhere
managing standards
MUTUAL RECOGNITION ARRANGEMENTS (MRAS) ARE DRAWING THEGLOBAL ACCREDITATION COMMUNITY CLOSER TO ACCEPTING THE
OUTCOMES OF EACH OTHER’S ACCREDITATION.
Laboratories are understandably frustrated by the need to obtain duplicate accreditationsfor similar types of tests, measurements, and calibrations. The proliferation of accredita-tion bodies, each with users only accepting their preferred accreditation body tends toincrease the duplication. There are numerous examples where this is the case. The pointof this paper though is not to elaborate on this problem but to discuss the solution. It isgenerally agreed that the ideal of “one test, one accreditation — accepted everywhere” is aworthwhile and achievable aim. A2LA supports this aim and believes the way to achieveit is through Mutual Recognition Arrangements (MRAs) among the accreditation bodiesthemselves.
COOPERATION AT THE INTERNATIONAL LEVELEfforts to realize this ideal have a long history, both nationally and internationally. TheInternational Laboratory Accreditation Cooperation (ILAC) was established 30 years agoto develop accreditation as a trade facilitation tool. If the global accreditation communitywere to accept the outcomes of each other’s accreditations, it would need to operate withequivalent criteria and processes. Internationally accepted standards of practice for labora-tory accreditation were needed. The first international standard from the InternationalOrganization for Standardization (ISO), ISO Guide 25:1978, addressed the generalrequirements for the competence of laboratories based upon the work of ILAC. ASTMstandard E548 served as a primary source for Guide 25 text. The latest version is nowISO/IEC (International Electrotechnical Commission) standard 17025:2005.
Beginning in the early 1980s, standards for the operation and acceptance of accredita-tion bodies were published. ASTM standard E994 was the U.S. equivalent (using virtuallyidentical text) to ISO/IEC Guide 58, which was recently replaced by ISO/IEC17011:2004. In the 1990s, ASTM Committee E36 began to adopt ISO laboratory accredi-tation standards, which are now the generally accepted U.S. standards. ASTM E36 is rec-ommending the formal adoption of ISO/IEC 17011:2004 as an American NationalStandard. NIST, ANSI, and several federal agencies already use these standards.
ILAC also agreed to the rules for peer evaluation of accreditation bodies for MutualRecognition Arrangements (MRAs). The foundation for realizing “one test, one accredita-tion — accepted everywhere” was thereby laid. Acceptance would begin with the accredi-tation bodies themselves. The whole purpose of an MRA is to provide a mechanism wherereports from accredited laboratories can be accepted everywhere. MRAs, as agreed on theregional and international levels, oblige each signatory to recognize and promote theequivalence of the accreditations of the other signatories.
The ILAC MRA was established in October 2000. ILAC works through recognizedregions so that signatories to the MRAs of the European cooperation for Accreditation(EA) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC) automatically
Peter Unger
The whole purpose ofan MRA is to provide a
mechanism wherereports from accredited
laboratories can beaccepted everywhere.
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become eligible for recognition under the ILAC MRA.The Inter-American Accreditation Cooperation(IAAC) is in the process of having its MRA processrecognized and accepted by ILAC.
COOPERATION AT THE NATIONAL LEVELLaboratory accreditation has developed in many U.S.market sectors at different times and under different cir-cumstances. As accreditations overlapped and becameduplicative, ways for consolidating them have beenexplored.
In 1992, ACIL, ANSI, and NIST formed a tri-par-tite cooperation called the Laboratory AccreditationWorking Group (LAWG). After five years of intensediscussion of how to reduce the duplication and com-plexity of the U.S. laboratory accreditation scene,ACIL, ANSI, and NIST jointly established theNational Cooperation for Laboratory Accreditation(NACLA) in 1997.
NACLA developed a process for evaluation andmutual recognition of accreditation bodies based uponinternational standards and practice. In October 2000,
the first three signatories (i.e., A2LA, InternationalAccreditation Services (IAS), and NVLAP) to theNACLA Mutual Recognition Arrangement were recog-nized based on peer evaluations of the APLAC MRA.NACLA has added five more signatories, but the threeoriginal signatories have since resigned from theNACLA MRA for legitimate and compelling reasons.However, A2LA continues to support the goals ofNACLA and believes that an opportunity to realizethese goals is at hand.
A NEW AND BETTER APPROACH BY NACLATO ACHIEVE HARMONIZATIONNACLA has recently approached ILAC to exploreacceptance as a region. However, recognized regions ofILAC must be composed of a minimum of four coun-tries to have international credibility that the decision-making process is impartial. Accepting NACLA’srequest requires fundamental changes to which ILAC isunlikely to agree. ILAC is much more likely to encour-age interested NACLA members to participate in the
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ILAC mutual recognition process, either directly or through par-ticipation in the MRA of one of ILAC’s recognized regions (e.g.,APLAC or IAAC). This would ensure maintenance of a trulyinternationally-harmonized process for mutual recognition.
NACLA also intends to pursue closer association with IAAC.The combination of each body’s limited resources would strength-en the realization of their common goals. U.S.-based accreditationbodies can be evaluated by an internationally recognized process,enabling the accreditation bodies to get international (as well asnational) recognition with one evaluation, thus avoiding duplica-tion and the distinct possibility of differing standards of practice.Conflict-of-interest issues would be resolved. Unnecessary tradebarriers would be avoided. NACLA stakeholder members can par-ticipate in IAAC and ILAC and thus have more influence on thedevelopment of international standards of laboratory accreditationpractice, which as noted earlier, are also the national standards.
WHY SHOULD U.S. LABORATORIES CARE?Just as laboratories do not want duplicative assessments, accredita-tion bodies do not want duplicative evaluations. Separate evalua-tion schemes are costly and, if they are based on different stan-dards, they are even more costly. Such costs are inevitably passedthrough to the accredited laboratories. If an accreditation bodycan get an evaluation to serve both national and internationalrecognition, costs would be reduced.
Not withstanding growing discontent in some quarters, global-ization is here to stay. This is even more valid for accreditationand mutual recognition processes and the standards by which theyoperate. The global MRA processes are growing in coverage, effec-tiveness, and acceptability. Trade agreements are beginning toinclude references to the ILAC MRA. Recognition and accept-ance of the ILAC MRA will continue to grow in the marketplaceand with federal agencies. NIST, the Navy, and the NuclearRegulatory Commission are users of the ILAC MRA. Regulatorswill follow, albeit more slowly.
The U.S. with its multiplicity of accreditation bodies is notunique in the world. There are at least ten other countries withmore than one accreditation body, many of which are members ofILAC. It is in the self-interest of U.S. laboratory accreditationbodies and U.S. laboratories to follow the international (national)rules no differently than other countries. Doing our own thingwould be duplicative, wasteful, and ultimately counterproductive.
Peter Unger is President of A2LA, 5301 Buckeystown Pike, Suite 350,Frederick, MD 21704; 301-644-3248; [email protected]; www.a2la.org.
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Compliance-based Operational Excellence inPharmaceutical GMP Laboratory Operations
managing data
THE FDA HAS INCREASED ITS FOCUS ON MODERNIZING THE REGULATION OF PHARMACEUTICAL MANUFACTURING AND DRUG PRODUCT QUALITY. AS A RESULT, INNOVATIVE PHARMACEUTICAL COMPANIES ARE RE-EXAMINING WHETHER TRADITIONAL DRUG
DEVELOPMENT AND COMMERCIALIZATION PROCESSES ARE SUFFICIENT.
A major goal of the new regulatory environment is encouraging manufacturers to adopt newtechnological advances to enable high quality and efficient manufacturing. Many companiesare investigating “operational excellence” programs to create a “lean manufacturing” environ-ment with optimized controls for superior product quality. Supply sites have been challenged toreduce costs and gain efficiency through critical assessment of systems. Most resource head-counts at the supply sites are remaining static, thus moving forward, the gains in efficiency,cost, and error reduction will be achieved through investment in automation and technology.
For QC laboratories, management of data means that analysts input data into paper-basednotebooks, worksheets, log books, spreadsheets, LIMS, and chromatography data systems(CDS). For the most part, hybrid systems consist of paper-based records that either stand aloneor are combined with electronic records. This approach requires redundant checks, peer review,and time-consuming manual systems to maintain data integrity and compliance with regulatoryrequirements. Since most of the records are paper-based, they require additional efforts forarchival and retrieval.
The approaches that many pharmaceutical labs worked on were born out of Y2K initia-tives with the goal of going completely electronic. There were many systems identified duringY2K that were capable of generating and/or storing electronic records. The key issue to beresolved is the integration of all QC/QA lab equipment and IT systems so that management ofthe data, as a whole, is compliant, organized, complete, and capable of streamlining data andworkflow throughout the operation. Leading companies are adopting a new approach to“automating compliance” that is, utilizing innovative technologies and building quality directlyinto the compliance infrastructure (SOPs, work instructions, analytical methods, data sheets,batch records, and more). Many of these internal programs are sometimes called “Right theFirst Time” programs. Their key conclusion is that compliance activities can be automated, cre-ating a new, more compliant paradigm, reducing risk and providing higher productivity andimproved quality.
This paper will discuss the current situation in pharmaceutical quality laboratory opera-tions relative to compliance initiatives, manufacturing challenges, and “method-centric” soft-ware, designed for the analyst, to electronically execute and manage lab testing protocols, yield-ing significant reductions in operational costs while improving productivity.
INDUSTRY PRODUCTIVITY CHALLENGESThe pharmaceutical and biotech industries are challenged to improve product quality, produc-tivity, and assure regulatory compliance while, at the same time, generating an annual 10–15%growth for their stakeholders. This is becoming increasingly difficult due to the large number ofbranded products coming off patent over the next five years and vulnerable new productpipelines with ever increasing costs to discover new chemical and molecular entities. Many
John P. Helfrich
Many companies aretaking stock of the entire
product life cycle (discovery research,
development, and manufacturing) and
realize all areasmust be streamlined.
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companies are taking stock of the entire product life cycle(discovery research, development, and manufacturing) andrealize all areas must be streamlined. Today, most laboratoryoperations rely on the ubiquitous use of paper-based “sys-tems” to capture and catalog data. This is particularly evi-dent in the quality control labs where paper notebooks,binders, and data work sheets are used and are fraught withpotential human — generated errors requiring constant“checking” and manual verification steps. These processesadd no value to the operations and significantly contributeto the costs. Complying with cGMP requirements is anadded challenge for the life science industry further addingcosts stemming from manual activities centered on compli-ance.
21 CFR Part 11 emerged as a demanding regulation forthe pharmaceutical and biotechnology industries in 1997.Part 11 has recently been modified to lesson the totalenforcement scope and provide a more rational frameworkfor implementation, however, the rule still applies if theelectronic record is in a high-risk area as defined by thedata’s impact on human health. The QA/QC activitieswithin the pharmaceutical production arena clearly fall intothis high-risk definition. Systems that generate electronicrecords include analytical instruments (chromatographydata systems, balances, pH meters, titrators, and spectropho-tometers, etc.), office applications (Microsoft Word andExcel) used for documentation, and laboratory informationmanagement systems (LIMS). In addition, the data can beused in higher-order systems such as ERP/MRP systems.
THE PAPERLESS QC LAB Automation initiatives in production are typically drivenby the need to precisely control synthetic reactions or bio-process conditions and cut operational costs. That paradigm
is now being further enhanced by reviewing the costs asso-ciated with non-value added tasks. An identified area is thelarge amount of paper processes still used in manufacturing,particularly quality control and quality assurance functions.The key non-valued added functions are the analysts’records of method execution and the re-typing of data intoIT systems such as LIMS or ERP systems. This paperprocess requires significant review and audits to check thedata and assure compliance with the SOP and expectedprocess norms. To investigate an analytical value furthercomplicates the situation as the source data is inside apaper notebook and/or binders that must be manuallyfound and reviewed. If one could capture and catalog allthe data and metadata at its source and drive it direct to adatabase, the entire process could go totally electronic andsignificantly reduce any manual processes. These “e-manu-facturing” initiatives have received attention as one of asmall number of critical-path issues that, if solved, will yieldsignificant cost savings for decades.
An automated data capture software applicationembedded within a company’s existing SOPs or test meth-ods captures all the critical data and metadata created dur-ing the process of implementing a method on the lab orprocess floor. Data elements include method preparationdata (reagent info, weighing operations, metrology, etc.),analytical instrument data (chromatography and spec-troscopy), and analyst or operator observations (color, tex-ture, shape, etc.).
Electronic software systems take existing written proto-cols (methods or SOPs) and present it as an electronic ver-sion with embedded data capture technology. It is essential-ly a “method-under-glass” with direct connection to all thelab instruments. These systems allow analysts and operatorsto interact with the digitized test method or SOP throughPCs or hand-held tablet PCs that force sequential dataentry and capture either manually or automatically (directfrom instruments). The technology can be thought of as aGMP electronic notebook.
There are many benefits to incorporating an electronicnotebook system. At the end of the process all the data isaggregated in a reviewer screen (Figures 1 and 2) with alldata flagged for valid method norms and a direct link to theoriginal data source. Review times are typically reduced bya factor of 50% or more. Instrument data files are automati-cally captured and organized in a secure repository forfuture needs. Access to the platform is controlled via asecure privilege grid with full audit trail and electronic sig-nature capability providing compliance with the FDA’s 21CFR Part 11 regulations. The result data is accessible toany authorized member of the QA review or managementteam. Tailored reports, including certificates of analysis forbatch release documents, can then be automatically createdwith on-line review and approval. Data and trending
Figure 1: A digital version of a standard operating proce-dure (or method) is presented to an analyst with automaticcapture of critical method-based data. This process eliminatestranscription errors associated with paper-based notebooks.
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reports can also be exported to other in-house IT infrastruc-ture requirements such as a LIMS or ERP system. In manyrespects, this technology represents the “process analyticaltechnology” (PAT) applied to the QC laboratory processes.Just like physical manufacturing processes, the lab environ-ment utilizes “method processes” conducted by analysts andthrough embedded “method-centric” software the PAT phi-losophy can be applied to the lab with equivalent produc-tivity improvements and significant returns on investment.
OPERATIONAL EXCELLENCE – PRODUCTIVITY METRICS IN USEMany top pharmaceutical, biotech, CRO, and genericorganizations have fully validated or are in process ofimplementing a GMP electronic notebook system. Eachyear key managers from these companies convene at theInternational Meeting on Automated ComplianceSystems (IMACS)1 and report on their results and plans.The following summaries outline several reports:
Top 10 Large Pharmaceutical CompanyA GMP electronic notebook system was rolled out inconjunction with a scheduled LIMS deployment. A sin-gle product in manufacturing was converted to an allelectronic operation. Analysis of data for the year in thissingle product was reported as follows:• Time Savings — three hour savings in analyst time for an
assay/content uniformity method. The method requiredmany calculations that are now automated. Thistranslated into approximately 30 hours per weekgained by the lab and data review for a singlemethod. A total savings of approximately 79 hoursof analyst time per week based on multiple batchesor product per week.
• Error reduction (documentation, transcription, cal-culation) — errors were reduced to zero.
• Data Review — Reviewers benefited by having allof the data centralized and in electronic format forreview.
As a result, the QA labs were able to eliminate theneed for planned head count additions in support ofproduct testing. Overall this system has saved theoperation several hundred thousand dollars per yearfor a single product.
Mid-tier Pharmaceutical CompanyThis company reported that it had multiple manu-facturing sites and installed an electronic notebooksystem in a European plant. This plant producesseveral products for worldwide distribution. TheDirector of Quality Control reported the following:• The system was installed as an alternative to a
planned LIMS implementation and did everythingrequired in terms of traditional LIMS capabilities whileproviding an electronic notebook for GMP operations.
• The timeliness of final lot release documentation sig-nificantly reduced the “quarantine value” for opera-tions. Estimated impact on over $20M/year of product.
• Eliminated “silly errors” and automatically checks fordata completeness and has built-in compliance flags foratypical data collections (if made by analysts).
• Percent savings varied depending on activity and com-plexity but in general they reported a 30—50% reduc-tion in testing time and 50—70% reduction in reviewand approval time.
Large Pharmaceutical Company — New PlantInstallationThis large pharmaceutical company installed an electron-ic system at their main development facility and isexpanding the capability to a production plant involvedin production and delivery of time-sensitive imagingproducts. The Senior Research Investigator reported thefollowing:• Estimated resource liberation of 1 FTE on a base of 8
FTE’s in the quality operation.• 16 analytical methods, 19 instruments, a LIMS and CDS
interfaced to the method-centric system and GMP “go-live” in less then six months.
• Analysts and reviewers saved significant time with
Figure 2: After a method is completed all data is presented toreviewers with visual “flags” for all specifications and materialsexpiration requirements along with instrument calibration dates,audit trails, annotations, e-signatures, and direct “drill-down” links tothe raw data sources at the click of a mouse button.
“At-a-glance”flags for reviewer
Meta-data automaticallycaptured and stored
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removal of manual calculations and transcriptions.Eliminated the need for Excel for one method.
CONCLUSIONSThe pharmaceutical industry is seeking to “control” costsas a result of questionable new product pipelines and theerosion of business due to the large number of products
coming off patent over the next few years. For decades,most of the data management processes in QA/QC havebeen paper-based requiring numerous non value-addedmanual checks to insure data integrity and product qualitystandards have been made. In today’s modern computer-based environments, technology can be used to totallyeliminate these paper systems and replace them with a
fully all electronic methodexecution and data captureand review system. Thisprocess eliminates operatormethod error or transcrip-tion issues in working with apaper-based notebookprocess. The data is auto-matically grouped and pre-sented to a QA reviewerwith compliance flags forspecification verification, e-signatures, and full audittrail of activity. Systemshave been implemented inGMP labs with significantoperational excellencereports given at the annualIMACS conference. Thisprocess can typically reducereview times by over 50%,reduce re-work and internalinvestigations yielding over-all operational QA/QC costimprovements of hundredsof thousands of dollars/prod-uct line. This technologycan be viewed as operationalexcellence technology forthe GMP QC/QA lab environment.
REFERENCES:1. IMACS 2005 –
International Meeting onAutomated ComplianceSystems, May 18-19,2005, Princeton, NJ(www.imacs-world.com).
John P. Helfrich is Director,GMP Automation Programs,VelQuest Corporation, 25South Street, Hopkinton, MA01748; 508-497-0128;[email protected].
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lab agendaDECEMBER 2–4, 2006 2nd Modern Drug Discovery & Development SummitPhiladelphia, PAwww.gtcbio.com
DECEMBER 9–13, 2006American Society for Cell Biology (ASCB) 46th Annual MeetingSan Diego, CAwww.ascb.org/meetings
JANUARY 25, 2007“Congratulations, You’re a Supervisor. Now What?” (Proven Rules New Managers Should Know)Audio/Web seminarVicon Publishingwww.viconpublishing.com/audio.asp
JANUARY 27–31, 2007LabAutomation2007Palm Springs, CAwww.labautomation.com
FEBRUARY 25–MARCH 2, 2007PittconChicago, ILwww.pittcon.org
MARCH 24–27, 2007Clinical Laboratory Management Association, Inc. (CLMA) ThinklabHouston, TXwww.clmathinklab.org
MARCH 25–29, 2007Society of Toxicology (SOT) Annual Meeting & Tox ExpoCharlotte, NCwww.toxicology.org
MARCH 25–29, 2007American Chemical Society (ACS) Meeting & ExpoChicago, ILwww.chemistry.org
APRIL 14–18, 2007American Association for Cancer Research (AACR)Los Angeles, CAwww.aacr.org
APRIL 15–19, 200713th Annual SBS Conference and ExhibitionMontreal, Canadawww.sbsonline.org
APRIL 28 – MAY 2, 2007Experimental Biology (FASEB)Washington, DCwww.faseb.org
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SAFETYGUYSthe
Within the lab of a newly formed research group, a small flask containing anarsenic compound (a known human carcinogen) is accidentally knockedagainst a ring stand in the fume hood. The flask drops and breaks. The solu-tion splashes the technician and hits his exposed wrist above his glove. Mostof the spill is contained in the hood. The technician calls to his co-workersto tell them what happened and hurries to the emergency douse station bythe sink to begin decontaminating the area. One co-worker closes the hoodsash to contain the spill and its vapors while another prints out the MSDSand prepares to drive the exposed worker to the on-site clinic. The spillresponse team has been called. A post-accident review at the next lab meet-ing identified some things that should probably have been done differently.The accident and response raises concerns for the principal investigator andas a result she tasks you to be the safety coordinator for the lab. You areasked to do a complete review of the lab and procedures for chemical safetyand OSHA compliance and get it into shape. Now what?
OSHA formally recognized the unique nature of the research laboratoryas a workplace more than 15 years ago. It was generally accepted that mostexisting OSHA standards related to chemical use in general industry andmanufacturing often provided little measure of overall safety improvementin the lab while sometimes imposing very challenging obstacles for compli-ance. As such, OSHA developed the standard occupational exposure to haz-ardous chemicals in laboratories — 29 CFR 1910.1450. This is commonlyreferred to as the "Lab Standard."
As we discussed in past issues, under this standard, a laboratory isrequired to produce a Chemical Hygiene Plan that identifies and addressesthe specific hazards found in its operations. This plan serves as one of thecornerstones for chemical safety and health in the laboratory. It formalizes aportion of the process of experimental design to address the hazards associat-ed with chemicals used in experiments and the controls used to limit expo-sure to those chemicals or their reaction products.
We know that all the members within the lab have responsibility to actresponsibly and safely within that institutions guidelines and requirements.The Lab Standard goes on however to require the designation of specificpersonnel responsible for implementation of the Chemical Hygiene Planincluding the assignment of a Chemical Hygiene Officer[1910.1450(e)(3)(vii)].
A Chemical Hygiene Officer (CHO) is defined as “an employee who isdesignated by the employer, and who is qualified by training or experience,to provide technical guidance in the development and implementation ofthe provisions of the Chemical Hygiene Plan.” This is what the principalinvestigator has just asked you to become.
As the work in the lab is often very specialized, it makes sense to devel-op safety expertise within the lab organization itself as in the case above. Sowhat makes an individual qualified for such a role? There aremany approaches taken to achieve compliance. Many of these arequite effective and meet the spirit and letter of the law. Othersmay not be so effective and could leave the institution open to
Glenn Ketcham, CIH and Vince McLeod, CIH
TheChemicalHygiene
Officer
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citation should an inspection occur. An individual may start by conducting a thorough
review of the Lab Standard and its appendices. Thereare some excellent references such as Prudent Practices inthe Laboratory1 and CRC Press Handbook of LaboratorySafety2 that should be in every Chemical HygieneOfficers library. Attendance in laboratory safety coursessuch as the ones provided through the LaboratorySafety Institute (www.labsafety.org) or presented byother organizations can also be of great benefit in com-ing up to speed in the lab safety arena.
Due to the variety of labs and approaches taken,the American Chemical Society recognized a need toestablish a certification system consistent with therequirements of the OSHA standard and other recog-nized health and safety certification organizations. Thiscertification is now managed by the National Registryof Certified Chemists (NRCC)(www.nrcc6.org/cho.htm).
The certification requires general laboratory safetyknowledge and an understanding of fundamental safetyprinciples along with competency in the content areasof the sections of the Laboratory Standard — 29 CFR1910.1450. These include:
• Standard operating procedures• Hazard assessment• Safe work practices• Personal hygiene practices• General laboratory practices• Special procedures (by hazard class)• Procedures for select carcinogens, reproductive
toxins, highly toxic substances, and substanceswith unknown toxicity
• Finding information sources• Control measures, including respirators, other
personal protective equipment, and laboratoryventilation
• Exposure monitoring• Employee training and information• Medical consultation and examination
The Chemical Hygiene Officer examination con-sists of 150 multiple-choice questions covering both thetheoretical, fundamental, and practical aspects of chem-ical health and safety. Three hours are allowed for com-pletion of the exam and these are scheduled at variousnational and regional meetings. The exams may also bescheduled at local sites within reasonable distances ofcandidates with local proctors. Certifications are validfor the year of initial certification and may be renewedand reissued thereafter in one- or three-year incrementsafter a review of continuing experience and educationand training.
So now you are set to start, sharpen your pencil,and pull up the OSHA websitewww.osha.gov/SLTC/laboratories/index.html. Give theLab Standard a thorough read. Contact other institu-tions or labs with good programs, most are very happyto share. Try to network with other CHOs, many prob-lems and hurdles have already been addressed by othersand there is often no need to completely recreate thewheel. Attend a short course or participate in web-based training to learn the fundamentals. And finally, ifyou so choose, apply for and take the certified ChemicalHygiene Officer examination to add a recognized cre-dential to your resume.
REFERENCES1. Prudent Practices in the Laboratory Handling and
Disposal of Chemicals. National Academy Press,1993.
2. Furr, A. Keith. CRC Handbook of Laboratory Safety,Fifth Edition. CRC Press, 2000.
Glenn Ketcham is a Certified Industrial Hygienistwith 22 years experience in the health and safety field. He iscurrently the Risk Manager for the University of Floridawith responsibility for the loss prevention, ergonomics, disas-ter preparedness, and the occupational medicine surveillanceprograms. He has managed the laboratory safety programsfor both the University of California, San Diego (UCSD)and the University of Florida. In addition, he served as anindustrial hygienist with federal OSHA compliance and hasa masters degree in environmental engineering sciences witha health physics concentration.
Vince McLeod is a Certified Industrial Hygienist andthe senior IH with the University of Florida’s EnvironmentalHealth and Safety Division. He has 17 years of occupationalhealth and safety experience in academic research with focusin the research laboratory. His specialties are in hazard eval-uation and exposure assessments.
The Safety Guys welcome your comments and ques-tions. You can email them [email protected].
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HOW IT WORKS
Problem: Ion chromatogra-phy (IC) instrumentation and therespective operating software haveincreased in complexity and cost.Instrument maintenance, consum-ables, and training requirements toproduce a valid data package arecomplex and expensive.
Solution: Metrohm AG hasintroduced a new ion chromatogra-phy instrument, the 861 AdvancedCompact IC, designed withadvanced features, user-selectableoptions, and simplified one-buttonoperation. Each instrument includesstandard features, such as a serialdual-piston pump with non-metallicflow path, an electronically-actuatedinjection valve, and a multi-rangedigital conductivity detector in asmall integrated cabinet. User-selec-table options include a MetrohmMSM-II Suppressor Module, col-umn oven, and the new 853 MCSCO2 Suppressor. Metrodata ICNetsoftware, allowing full control of thesystem, sample processor, and chro-matography data management, isincluded.
Separations, such as EPA 300,are performed routinely with resolu-tion of all seven anions. Using the853 MCS CO2 Suppressor in com-bination with the column oven andthe Metrohm MSM-II Suppressormodule improves sensitivity25–40%. Baseline disruptions areeliminated, improving peak resolu-tion and reproducibility (Figure 1).
The Metrohm SuppressorModule-II (MSM-II) is the secondgeneration of this rotary designed,three-chambered suppressor device.Advantages of the MSM-II are lowmaintenance, reproducibility, lownoise, solvent compatibility, and anon-industry standard 10-year war-ranty.
This instrument allows the ana-lytical laboratory to increase its sepa-rations power while managing thebudget, simplifying operations, andoptimizing space. Space require-ments are minimized because thedimensions are only 10 inches wideby 13 inches deep and 18 incheshigh with a built-in eluent organizer.
Metrodata ICNet software con-trols the IC and manages the data.ICCap software allows one-clickoperation of the instrument andsample automation. ICNet controlsthe instrument, manages data, and
organizes the data for reporting andstorage. All system parameters aresaved with each chromatogram forfuture reference. Multi-staged secu-rity administrative passwords pro-tect the integrity of the method,data, and system files, allowing useraccess approved by the systemadministrator.
Flow specifications for thepump are 0.2 mL/min up to 2.5mL/min with a maximum operatingpressure of 35 MPa. The conductivi-ty cell has four operating ranges,controlled to better than 0.01 °C andoperates between 25°C and 45 °C in5 °C increments. The optional col-umn heater operates at + 5 °Cambient up to 80 °C and is fullysoftware controlled.
Instrument maintenance onthe 861 is reduced by design. Thepump head assembly is easilyremoved for seal replacement. A pis-ton cassette containing the pistonand piston spring is self-aligning intothe pump head and is easilyremoved and reassembled withouttools. Once the seals and checkvalve maintenance is completed, theself-aligning pump head is easilyreplaced by re-tightening the fourhex screws.
For more information on theMetrohm-Peak 861 AdvancedCompact IC, visit www.mp-ic.com.
Figure 1: Comparison of anions on aMetrosep A Supp 5-250 column withand without the use of the 853 MCSCO2 Suppressor. Peaks: 1-water dip, 2-chlorite, 3-bromate, 4-chloride, 5-carbonate, 6-bromide, 7-chlorate, 8-nitrate, 9-phosphate, and 10-sulfate.
Ion Chromatography with CO2 Suppression
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FLUORESCENCEFILTER SETThese fluorescence filter sets featuredurable surface coatings, environ-mental stability, high signal-to-noise,zero-pixel shift, and a five-year war-ranty. They are capable of deepblocking to the limits of CCD detec-tion at 1150 nm on both excitationand emission filters. A selection offluorophore-specific filter sets isoffered for single and multi-labelingmicroscopy applications. Omega Opticalwww.omegafilters.com
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SEPARATINGCOLUMNSThe Luna® 2.5 µm C18(2)-HST(High Speed Technology)columns provide HPLC separa-tions without the need for ultra-high pressures. The columnsare compatible with HPLC andUHPLC systems and are avail-able in 2- and 3-mm internaldiameter and 50- and 100-mmlengths.Phenomenexwww.phenomenex.com
productnews
MODULARBENCH SETS The modular bench set can beintegrated into existing areas toimprove the functionality of thespace. The 6700 series featuresunder-table storage shelves, cordand tube management ports onboth unit ends and back, a 2”tubular framework, fixed, swivel,or lockable casters, a selection ofvarious work surface materials,and optional add-on accessoriesto customize the work space.Workplace Systemswww.workplacesystemsinc.com
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MASS SPECTROMETERThe new ultraflex® III smart-beam™ MALDI-TOF/TOF massspectrometer, for LC-MALDI andMALDI molecular imaging, hasan improved laser with focus sizefrom 10 µm to 80 µm. Absorbingtissue areas can be scanned witha very small laser focus andadjustable repetition rates from 1Hz to 200 Hz. The WARP-LC™ workflow software supportsLC-MALDI acquisition, protein sequence validation, PTMscreening, and accurate quantitative proteomics. Bruker Daltonics www.bruker-biosciences.com
AIR AND LIQUIDFILTRATIONHybrid Membrane Technology (HMT)for air and liquid filtration is comprisedof continuous sub-micron fibers.Available on a commercial scale in theform of “membrane-like” sheet struc-tures, HMT delivers a balance offlux/barrier performance. HMT will bethe leading technology offered throughDuPont Separations Solutions to deliverenhanced performance across a vari-ety of air and liquid filtration applica-tions.DuPontwww.dupont.com
ULTRACENTRIFUGATIONThe AW Promatix 1000™, acontinuous-flow ultracentrifuga-tion system, employs buoyantdensity accumulation to auto-mate the separation, fractiona-tion and enrichment of sub-cel-lular particles in a single step.he separated components arefractionated into a 96-wellplate format. Researchers canuse the organelles directly inexperimental studies, or theycan conduct proteomic studieson the organelles by perform-ing subsequent 2-D gel electrophoresis and massspectrometry analysis.Alfa Wassermann Proteomic Technologies, LLCwww.awpt.us
tools of the trade
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MULTI-CHANNEL LIQUID HANDLERZephyr handles key applications for compound man-agement, HTS, genomics, proteomics and bio-analyti-cal assays, and is compatible with numerous commer-cially available kits. For medium throughput labs seek-ing out-of-the-box automatedsolutions, Zephyr includes anintuitive interface to guide theset-up process and initial use.It also includes pre-config-ured applications to ensurethat researchers immediatelyexperience the advantagesof the system.Caliper Life Scienceswww.caliperls.com
>>
WASHERSThe LX family of washers consists of five models withthree different chamber sizes. From undercounterthrough 3-level upright, all units have the capability ofsharing the same racks, resulting in lower rack costs andreduced storage requirements. The commonality of rackusage reduces the cost of increasing washer capacitywhen moving from an undercounter to an upright unit.Lancer USAwww.lancer.com
REFRIGERATORS ANDFREEZERSThe i.Series™ laboratory refriger-ators and freezers feature thei.Center™ integrated monitoringsystem which offers automaticalarm testing, an event log withalarm dates and times, and apassword-protected configuration.The refrigerators and freezershave bacteria-resistant interiorsand exteriors and are available inboth single and double door mod-els with capacities from 20.2 to56 cu. ft.HELMERwww.helmerinc.com
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DNADECONTAMINATIONDNA-Exitus Plus destroys DNAand RNA on all surfaces.Decontamination of equipmentand laboratory surfaces fromDNA molecules is important forbiological containment and safe-ty. It is non-toxic, non-corrosive,and biodegradable. It is useful forapplications in forensics, the lifesciences, medical hygiene, andfood production. Applichemwww.applichem.us
CONJUGATEDMONOCLONALANTIBODYThe IOTest® Anti-OSCAR-PE conju-gated monoclonal antibody is thefirst FcR� - associated moleculedescribed on human myeloid den-dritic cells. It is an activating mole-cule involved in antigen capture
and presentation that may modulate the response of both innateand adaptive immunity. With the Anti-OSCAR-PE MonoclonalAntibody, researchers can tag a new antigen that is thought to beimplicated in the tolerogenic function of dendritic cells.Beckman Coulter www.beckmancoulter.com
VERIFICATION SYSTEMCapable of volume verifications of multichannel, automatedliquid handlers, the MVS (Multichannel Verification System)can verify 384 channels using both aqueous and non-aque-ous solutions for vol-umes as small as0.03µl. It can readmicrotiter plates inbatches, interfacewith a variety of read-ers, and requires min-imal instrument down-time.ARTEL www.artel-usa.com
BACKLIT PIPETTEThe Finnpipette® Novusnow comes with a backlitdisplay, using backlighttechnology similar to that ofmobile phones. By eliminat-ing surrounding light reflec-tions and improving contrastin low light conditions such as safety cabinets and fumehoods, the integral backlit display ensures that the high-resolution menu characters are shown with more clarity. Thermo Electron Corporation www.thermo.com
PULSESTIMULATORThe Stimulator C fea-tures precise digital tim-ing control for all typesof tissues. It has a largeLCD display and mini-mum controls, recallsthe last settings used,and has an output that
allows stimulation of all tissue types from direct contactnerve to tissue bath field stimulation. Monophasic, biphasic,and alternating modes are available.Harvard Apparatus www.harvardapparatus.com
AUTOMATIC CELLCOUNTERCellometer™Model Auto T4™cell counter automates cellcounting to improve samplequality and accurate results.Samples are pipetted into thechamber and placed into theAuto T4. Imaging software auto-matically measures cell concen-tration and viability. Cells withina heterogeneous sample withvarious sizes and morphologycan also be measured, provid-
ing data not obtained by traditional methods. Nexcelom Bioscience www.nexcelom.com
productnews c o n t i n u e d
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DESICCATORThe Secador® Techni-Dome® VacuumDesiccator offers up to 65 L of volumeand space for items up to 45-cm tall orwide. Made of a plastic material that isresistant to most common chemicals, thedesiccator has a clear top and bottom.Two round polypropylene shelves canbe lifted out for easy access or to accom-modate awkward sized items.Bel-Art Products www.belart.com
OPTICAL FILTER CATALOGThis catalog presents six product families forapplications ranging from fluorescenceinstrumentation and microscopy, to Ramaninstrumentation, to biomedical laser sys-tems, all supported by a series of technicalnotes. New offerings include multi- and sin-gle-band bandpass filters, as well as triple-,dual- and single-edge diochroic beamsplit-ters in the BrightLine® series of fluorescencefilters.Semrockwww.semrock.com
AUTOMATED MICROPLATEHANDLINGA compact floor-standing unit, theElement™ features an open-accessplatform to facilitate configuration ofup to nine instruments for processing.The Element can be tailored to performmicroplate pipetting, mixing, sealing,barcode labeling, signal detection,and more. It is suited for applicationsthat include cell-based and enzymeassays, ELISA, plasmid and sequenc-ing preparation, PCR clean-up, solubil-ity, and more.Velocity11www.velocity11.com
ERGONOMIC PIPETTE The portable Pipet-Aid XL has a longer handle toreduce the amount of arm lift required. Included arean adjustable sliding hand rest and a removablestand that enables the unit to be put down withoutcontamination. The unit comes with a power supplycharger, four extra filters, and a holster-type wallbracket.Drummond Scientific www.drummondsci.com
BIOANALYZERThe 2100 bioanalyzer offers solutions for the analy-sis of DNA, RNA, proteins, and cells. It works in 30minutes, delivering automated digital data, offeringsupport for on-chip flow cytometry and 21 CFR part11 compliance in addition to electrophoresisassays. It also offers 2-color analysis of fluorescentlystained cells.Agilent Technologies www.agilent.com
EOSINOPHIL CATIONIC PROTEIN Eosinophil cationic protein derived from human neu-trophils is now available to the clinical research com-munity. Eosinophils are granulocytes that commonlyincrease in number in the presence of parasites andallergies. Eosinophils comprise roughly 1% to 4% ofthe blood’s cellular make-up. The cells are active inallergic diseases, parasitic infections, and other disor-ders.Lee Biosolutionswww.leebio.com.
COMPOUND ANALYSISmSelect™ is a service for researchers to select themost promising and lowest risk drug candidates forcontinued development. Based on advancedmetabolomic analysis where drug-induced biochem-ical changes are detected in a single assay system,mSelect provides an assessment of a compound’son- and off-target affects. Results can help prioritizelead candidates for the most viable compounds.Metabolonwww.metabolon.com
CDS REPORTING AND EVALUATIONThe SmartLab™ CDS ApplicationPak forEmpower automates post-run evaluation andreporting of output files from Waters®Empower™ Chromatography Data System(CDS). Typical CDS output data related to peakareas, tailing factors, LLQ calculations, and allpeak counts with final quantitative calculationsare all dynamically captured from Empower andcataloged, and can then be automatically trans-ferred to any output report or LIMS.VelQuest Corporationwww.velquest.com
MICROSCOPE CATALOGThe Irtron�, in-compartment micro-scope catalog, highlights the new fea-tures of the microscopes’ design. TheIrtron� sample compartmentmicroscopy system provides afford-able analysis of microscopic sampleswith the high-performance features ofan external FT-IR microscope accesso-ry. The microscope accessory installsinto the spectrometer sample com-partment without optical alignment.JASCOwww.jascoinc.com
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BRANDTECH SUPPORTS BREAST CANCERSCREENING
BrandTech Scientific, Inc., a proud sponsor of the National BreastCancer Foundation (NBCF), has announced a corporate dona-tion to the Foundation in association with the launch of its newaccu-jet® pro pipette controller line, which includes a specialpink model. The NBCF describes its mission as saving livesthrough its support for breast cancer awareness, research, andmammograms for the needy. BrandTech’s website,www.brandtech.com, describes the instrument and the work ofthe NBCF in detail, as well as an introductory offer of a freeaccu-jet® pro with the purchase of three of the instruments.
A2LA ADDS INSPECTION BODYACCREDITATION TO ITS APLAC SCOPE OFRECOGNITIONA2LA has successfully completed the Asia Pacific LaboratoryAccreditation Cooperation (APLAC) peer re-evaluation processand added inspection body accreditation to their scope ofrecognition. In March 2006 APLAC evaluated A2LA for contin-ued recognition as a Mutual Recognition Agreement (MRA)Signatory by verifying A2LA’s compliance with ISO/IEC17011 – Conformity Assessment: General requirements foraccreditation bodies accrediting conformity assessment bodies.At the APLAC MRA Council meeting in Taipei, Taiwan inSeptember, the Council agreed to continue A2LA’s signatorystatus within the APLAC MRA for testing and calibration labo-ratory accreditation and to add recognition for inspection bodyaccreditation.
2006 SBS PRESIDENT’S AWARD PRESENTED TOSTEPHEN REESDuring the 12th Annual Society for Biomolecular SciencesConference & Exhibition in Seattle, WA, SBS President AlKolb presented the 2006 President’s Award to Mr. StephenRees for his outstanding efforts in advancing and enhancingthe products and services offered by the Society forBiomolecular Sciences. Each year the President’s Award is
given to an SBS member for outstanding contributions to theSociety in support of the industry.
A member of the Society for Biomolecular Sciences since2001, Mr. Rees served as the conference committee chairsince 2005, program chair and session chair for 2004 and2003, and a conference speaker in 2002 and 2000. He isthe symposia organizer for 2007. Over the last 13 years, Mr.Rees has worked extensively in the area of mammalian geneexpression, assay design, and cell based compound screen-ing. He is now a Director within the Screening andCompound Profiling Department in GlaxoSmithKline, Harlowwhere he is responsible for cell based HTS and CompoundProfiling in support of local disease areas. Mr. Rees hasauthored more than 40 scientific papers and has spoken atmany international symposia including SBS.
GOW-MAC IRELAND CHANGES NAME TOAGC INSTRUMENTS LTDFollowing the successful management buyout by the present man-agement team at the Irish operation, GOW-MAC Instrument Co.(Ireland) Ltd announced a change of name to AGC InstrumentsLtd. Marcus Creaven, Sales Director noted, “We can now focusand deal personally with the many industrial, electronic, specialtygas manufacturers, coupled with our petrochemical and pharma-ceutical customers also around the globe. We are putting astrong emphasis into local ground support, particularly in Europe,Middle East, and South East Asian markets, to provide applica-tion and technical backup that is so important to our customers.”All current gas chromatographs, gas analysers, thermal conduc-tivity, patented discharge ionization and argon discharge detec-tors, and other products will be produced by AGC.
ALFA WASSERMANN PROTEOMICTECHNOLOGIES ANNOUNCES SCIENTIFICCOLLABORATION WITH DR. JENNIFER VANEYK, JOHNS HOPKINS UNIVERSITY SCHOOLOF MEDICINEAlfa Wassermann Proteomic Technologies, LLC (AWPT)announced an agreement with The Johns Hopkins UniversitySchool of Medicine under which Dr. Jennifer Van Eyk will workwith AWPT to develop methodologies and protocols for the isola-tion and enrichment of organelles and sub-cellular particles. AWPTapplies buoyant density accumulation (bda) through the use ofpreparative continuous-flow ultracentrifugation in the AW PRO-MATIX 1000™ instrumentation for proteomics research, specifical-ly for the automated separation, accumulation and enrichment oforganelles to identify low-abundance proteins not detected byother techniques.
Dr. Jennifer Van Eyk, director of TheJohns Hopkins NHLBI Proteomics Group and
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The Johns Hopkins Bayview Proteomics Center, is an associate pro-fessor in the departments of medicine, biological chemistry, and bio-medical engineering. Her work focuses on the use and optimizationof proteomic analysis of tissue and biomarkers for development oftreatment and diagnostics for heart disease.
MILLIPORE LAUNCHES R&D POSTER PODCAST SERIESMillipore Corporation announced the availability of its R&D posterpodcasts. Featuring Millipore’s industry experts, the weekly broad-casts help customers improve productivity on the lab benchand manufacturing floor. The podcasts include reviews of vari-ous technical posters as well as tutorials on the broad field ofmembrane technology.
Available via iTunes and RSS feeds, the technical sessions pro-vide the opportunity to download and listen to the latest develop-ment in filtration, separation, and lateral flow technology. For thoseunable to attend the industry’s top laboratory research, therapeuticproduction and diagnostic conferences, podcasts are an alternativesource of information that can drive protocols and research.Millipore’s R&D poster podcasts are accessible by searching for“Millipore” in the iTunes Podcast Directory, or selecting the RSSFeeds link from Millipore’s homepage at www.millipore.com.
AURORA® BIOTECHNOLOGIES ENTERS INTOMICROPLATE DISTRIBUTION AGREEMENT WITH BECKMAN COULTERAurora® Biotechnologies announced that it has entered into aworldwide distribution agreement with Beckman Coulter, Inc.Beckman Coulter is now a key distribution partner forAurora’s line of ChemLib™ microplates. Chris Neary, VicePresident of Automation at Beckman Coulter stated,“Beckman Coulter has recognized the importance that assayminiaturization brings to the discovery sciences. We are veryexcited to be able to offer Aurora’s ChemLib microplates toour customers. The ChemLib microplates, packaged with ourliquid-handling and detection instrumentation technologies,allow us to offer our customers a total miniaturization solution.”
AACR ANNOUNCES MAJOR GIFT FOR BREAST CANCER RESEARCHThe American Association for Cancer Research announced a$200,000 gift from the Breast Cancer Research Foundationwhich will create the BCRF-AACR Fund for Translational BreastCancer Research.
news notes CONTINUED
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Announced at a Breast Cancer Research Foundation researchsymposium, the gift will be supplemented with a matching grantfrom the AACR Foundation for the Prevention and Cure of Cancerto create a $400,000 research grant fund for translational breastcancer research. Translational research is defined as a “two-waybridge” that conveys new ideas and discoveries between the labo-ratory and the clinic, bringing the benefits of basic science knowl-edge to patients more quickly and effectively. Grants in the amountof $200,000 will be awarded to cancer researchers throughAACR’s rigorous and competitive scientific review process begin-ning in 2007.
The American Association for Cancer Research celebrates its100th anniversary on May 7, 2007. To commemorate this event,the AACR Foundation launched a Centennial Research GrantCampaign with a goal of raising $6 million by May 2009 to sup-port a number of vitally important areas of cancer research. TheBCRF gift brings the AACR’s Centennial Research Grant Campaignto $2 million. To contribute to the AACR Centennial Research GrantCampaign, visit www.aacrfoundation.org.
WATERS CORPORATION SPONSORS TWOAMERICAN CHEMICAL SOCIETY AWARDSWaters Corporation announced its sponsorship of two AmericanChemical Society Achievement Awards. The annual awards recog-nize outstanding accomplishments in the fields of separations sci-ence and technology, and mass spectrometry.
The ACS Award in Separations Science & Technology recog-nizes outstanding accomplishments in fundamental or appliedresearch directed to separations science and technology. The FrankH. Field and Joe L. Franklin Award for Outstanding Achievement inMass Spectrometry honors the work of Drs. Field and Franklin,research chemists at Humble Oil & Refining Co. in the 1950s.Their work was of great fundamental importance to understandingof ion/molecule reactions in the gas phase and they are creditedwith the development of the first ionization techniques for massspectrometry.
The presentation of ACS national awards is an annual featureof the ACS spring national meeting. Additional information aboutthe award program and the nomination process can be found atwww.chemistry.org.
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lab diagnosis
Lab managers face numerous challenges when balanc-ing research integrity, productivity, and budgets for thedaily operations of their facility. Finding the mostcost-effective way to do even the most routine tasks isnow a necessity. One such task — labeling samples —presents the opportunity to improve productivity,lower costs, and maintain or even increase the integri-ty of research projects.
THE PROBLEM WITH HANDWRITTEN LABELSSurprisingly, many labs still arm their personnel with apen and a package of standard labels. Not surprisingly,many of these sample labels are smeared, destroyed bylaboratory chemicals, or just plain illegible due to poorhandwriting. Further, the amount of information thatcan be placed onto a small handwritten label is limit-ed. Some labs use a basic office printer and officelabels. This may resolve the legibility issue, but stillleaves sample labels vulnerable to smearing from fre-quent handling and destruction from harsh lab condi-tions.
OBSTACLES TO EFFECTIVE LABELINGIdentifying the obstacles to effective labeling is the firststep in improving the labeling process, lowering costs,and increasing both productivity and sample integrity.
Illegibility: Samples with missing or illegible labelsare a big problem for most labs. Whether due to illegi-ble penmanship or smeared text, if researchers can’ttell what it is, who worked on it and when, the integri-ty of the research is compromised. Labels should be read-able by everyone, every time.
Durability: Many labs have their own horror sto-ries of opening a –80°C freezer to find their samplesneatly in place and the labels piled up on the floor ofthe freezer. Labs need sample labels that remain inplace despite contact with moisture, autoclave, sol-vents, freezers, and liquid nitrogen. Labels should bepresent for everyone, every time.
Content: When sample ID data is cryptic or tooabbreviated, it becomes more difficult for otherresearchers or collaborating labs to clearly understandthe data or intended message. When labels include all the relevant data in a way that is compre-hensive and clearly understood by everyone, then error rates go down and productivity goes up.Labels should be understood by everyone, every time. >>
Labeling Technology IncreasesLaboratory Efficiency
LabManager 45
Matt Luger
labmgr.com
Proper labeling of samples with labels designed foruse in a lab assures that labels are legible, won'tsmear, fall off, crack or peel.
Using labeling equipment specifically designed forlab use improves productivity and lowers costs whilemaintaining the integrity of research samples.
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Time: Labeling with accurate, legible information is atime-consuming process when done by hand. Yet mostresearchers still spend countless hours labeling samples witha marking pen. Modern lab labeling systems and printersproduce clear, legible labels up to eight times faster thanhandwriting. Labels should be quick to apply for everyone,every time.
A MORE EFFECTIVE METHOD OF LABELINGNew printers, software, and label options that have beendeveloped for the laboratory environment, directly addressthese common labeling challenges. These lab-specific label-ing systems reduce lost, damaged, or otherwise compromisedsample labels, save lab staff hours per project, and help labmanagers better track projects and control costs.
LAB-SPECIFIC PRINTERS Label printing systems designed for the lab environment fea-ture non-smearing print technology and extremely durablelabels and inks. This allows labs to produce crisp, readablelabels that are resistant to chemical corruption and tempera-ture extremes — including labels that will adhere to analready frozen tube. Many of these printing systems areportable, offering more versatility and a small footprint in anoften crowded lab. Benchtop models connected to a PC arealso available for labs with higher label throughput require-ments.
These printing systems can clearly print small fonts,allowing labs to accommodate more information per label,giving researchers more of the facts they need at a glance.Printers with barcoding capabilities can also help labs devel-
op and maintain scanning and tracking systems that savetime in sample retrieval and help prevent lost samples — aproblem that can be a disaster for researchers.
There are immediate productivity benefits with labelingsystems that allow lab staff to create more clear, easy-to-readlabels in less time.
CHOOSING THE RIGHT LABEL PRINTING SYSTEMLook for the following features in a laboratory label printingsystem:
• 300 dpi print resolution for crisp, readable text even atsmall font sizes
• Small font sizes in the offering to accommodate smalllabels for small tubes
• Durable labels that withstand temperatures down to–196 °C and solvents, moisture and heat
• Built-in lab templates for vials and slides• Time and date stamping• Auto-serialization for aliquots• Greek and laboratory symbols consistent with current
scientific nomenclature• Bar coding capabilities — for sample scanning and
tracking• PC connectivity — important for access to existing sam-
ple information• Battery or AC power operation
CHOOSING THE RIGHT LABEL MATERIALLab-specific labels protect samples and research integrity. Besure to choose durable labeling materials that have been test-ed to withstand the extreme conditions found in most labo-ratories. These labels will not fall off, crack, peel, or smudgewhen exposed to extreme temperatures such as liquid nitro-gen (¯196 °C), freezer (¯80 °C), autoclave (+121 °C), andeverything in between. Testing for harsh chemicals shouldensure that xylene, ethanol, DMSO, IPA, toluene, and boil-ing water do not affect the integrity of the labels. Also lookfor low-profile label materials that will not jam in centrifugeor other equipment, and that are easy to handle, even whenwearing gloves.
Labeling already-frozen samples presents a particularlabeling challenge for laboratory personnel. Until recent-ly, materials were simply not designed to stick to frozensurfaces, leaving lab technicians to scrape frost off frozenvials prior to labeling. Conversely, these old labels wouldoften slide off of samples when they thawed, creating thepotential for lost data. Innovative new materials allow alabel to stick to an already-frozen surface and help toensure the integrity of research because the samples canbe quickly and easily labeled in their frozen state, thusavoiding the potential damage to samples caused by thaw-ing and refreezing.
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New materials allow a label to stick to an already-frozen surface.
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LABEL CONSTRUCTIONThere are two label construction options available for label-ing most samples:
Self-laminating labels feature a white printable areawith a clear “tail” which wraps around the rest of the labelto cover the text and create a clear protective barrier. Thislabel is particularly effective when the sample is handledfrequently. These labels also create a “viewing window” sothe liquid level in the tube remains visible.
Free-Standing labels stick to vial or tube without aneed to overlap, thus keeping the contents of sample vialsvisible. Both label styles are available in a variety of sizesfor identifying tubes, vials, vial tops, straws, dishes, cryo-canes, bags, cardboard boxes, and more.
In addition to label construction, label opacity is aconcern for laboratories involved in patient care andresearch. These labs should choose opaque labels (“non-see-through”) for the protection of private information inaccordance with HIPAA requirements. To meet HIPAAstandards, labels should be opaque enough to completelycover legally protected patient information.
LABELING SOFTWARE Increase efficiency and speed in labeling by combining alabel printing system with one of the lab labeling softwarepackages now available. These programs allow users to cre-ate files and templates, provide hundreds of lab-specificgraphics and characters, and expand the user’s text format-ting options. Some programs also offer database importcapabilities, multi-label data entry view, and 2-D bar codesupport. Many of these programs will also work withWindows®-based printers, if necessary.
INVENTORY TRACKINGStoring and tracking frozen lab samples is vital for researchfacilities, clinical laboratories, and specimen repositories. Aneffective labeling system can integrate seamlessly into a labora-tory’s inventory tracking system, especially when the lab usesthe bar coding capabilities of the newest labeling software andprinting systems. Then laboratory staff can simply scan theirsamples to enter them into an existing inventory control sys-tem. Lab-specific inventory tracking systems are also available.
For labs that do not yet utilize an inventory tracking sys-tem, managers should consider one of the stand-alone softwareproducts currently available. Such a system makes it much eas-ier for labs to quickly and efficiently locate the correct sampleamong thousands of stored frozen samples. This saves time andis another way to avoid costly, time-consuming errors or miss-ing samples.
THE COST-QUALITY EQUATIONChoosing a high-quality, lab-specific label printing systemwill help to save countless hours on labeling, while helpingto ensure that all lab samples are clearly, permanently, andaccurately labeled. Many easy to use, cost-effective printermodels are now available that specifically address the needof the laboratory environment and offer lab managers anintegrated solution for increasing lab efficiency, controllingcosts, and protecting valuable research.
Matt Luger is Senior Product Manager, Portable LaboratoryPrinting Systems, Brady Worldwide, www.bradyid.com/lab;Laboratory Labeling Solutions Center 1-888-311-0775;www.bradycorp.com.
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Date: January 25, 2007 – Time: 1:00PM ET
ABOUT THE SPEAKER:Dr. Martin Seidenfeld has some 30 years experienceas a clinical psychologist, organizational consultant,university professor and seminar presenter. He wasformerly the National Vice President of AmericanManagement Psychologists, Inc. He has taught atnumerous institutions. A past President of the IdahoPsychological Association, he has served by gover-nor's appointment to a state commission. Presently, Dr. Seidenfeldserves as President of the Human Resources Corporation, providingconsultation and training on stress management, supervision and otheraspects of management and organization development.
People trained as scientists and technicians have a certain view of the worldthat is quite different from what is needed in the world of professionalmanagement. Instead of focusing on technical problems, the technicallytrained person promoted into supervision must focus on people.
LEARN HOW TO:• Delegate • Motivate• Train • Oversee • Evaluate• Form Effective Relationships with Employees
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The Common Mistakes New Managers Make
career
From CareerJourna l .com.
Initiative, skill, and dedication may be the reasons you were promoted to management, but those qual-ities may not make you a good manager.
Most new managers make plenty of mistakes, says Nicole Morgenstern, practice consultant to theAmerican Management Association in New York, which offers management training. “It's unfortu-nate,” she says, “but managers typically do learn on the job.”
Here, we examine five common new-manager missteps and ways they can avoid them.
1. TAKING ON TOO MUCH YOURSELFWhen he was in his 20s, Larry Runge's employer put him in charge of a design project because he wasa top computer programmer. After getting the new position, “I spent long nights writing code myselfand stayed up all night to get everything running before our deadline, at nine the next morning,” hesays.
Mr. Runge fell victim to a classic trap for new managers: taking on too much work while failing todelegate. “I should have spent my time encouraging my employees to do the work. When you step inyourself, you're disenfranchising the folks working for you. And no matter how good you are, you'renot better than 20 people put together,” says Mr. Runge, now 50 and the chief information officer of aconsulting company in Northbrook, Illinois.
2. REFUSING TO ASK FOR HELPTreava Lewandowski of Addison, Texas was made an assistant manager of a Bath & Body Works storein Plano, Texas when she was 22. Working in a high-volume store during the holidays managing 20 to25 stockers, cashiers, salespeople, and greeters “was pretty crazy,” she says. She says she fell behind onpaperwork — staying at work until 1 a.m. and returning at 8 a.m. — and didn't let anyone know thatshe was struggling. Ms. Lewandowski's mistake was allowing the work overwhelm her instead of lettingsomeone else share the load. “It's a sign of maturity to ask for help,” says Ms. Morgenstern.
When a sales clerk came to work wearing a shirt that didn't match the store's dress code, she toldher to take it off, and the clerk stormed off to complain to another manager, Ms. Lewandowski says.That's when she realized asking for some support was okay. “I thought I'd be in real trouble, but theother managers supported me. Until then, I'd been afraid to ask them for help,” says Ms. Lewandowski,who is now 29.
3. FAILING TO PLANDavid Stevens, 37, of Manasquan, New Jersey says he was “thrown into a management position” fouryears ago. His biggest mistake, he says, was a lack of planning. “Whenever a superior asked for some-thing, I was so anxious to perform and please, I'd dive right into it,” says Mr. Stevens, now a solution-consulting manager. “I finally learned that if I spent half a day mapping a project out first, and delegat-ing the work to my team, I could save 10 to 15 days on the back end,” he says.
4. JUMPING THE GUNHarrison Lewis, now 45, learned the limits to this approach the hard way. When he entered a manage-ment-training program at Kroger’s Atlanta-area grocery stores after college, he began managing union-ized workers, so he studied the union contract until he knew it “better than the shop stewards,” he says.
Julie Bennett
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When an employee refused an order, behav-ior that came under insubordination in the con-tract, Mr. Lewis says, he fired him. The next day,the employee was back on the job after seekingthe help of his union. Mr. Lewis says he laterrealized that his job “wasn’t about reading con-tracts, but about my ability to get a job donethrough others.” If he had talked out the problemwith the employee and gone through the properchannels with union representatives, the situa-tion may have been resolved without conflict, hesays. Thereafter, when problems arose, he says, hewent to the union representative first. “Learningto listen made my job easier and made me a bet-ter manager,” says Mr. Lewis.
5. OVERRELYING ON YOUR TITLEPerhaps the hardest lesson for young managers tolearn is that a management title does not elicitautomatic respect and obedience. “Authority,”says Ms. Morgenstern, “will come with time.When managing, actions speak louder thanwords. If you show a level of competence, anddemonstrate the skills that come with your title,the respect of your workers will follow.”
Christopher Tucker admits to barking orderswhen he was first made a manager. While he wasin college, Mr. Tucker worked for a call centerselling mobile phones in his native Swansea,Wales. “The company expanded so quickly,” hesays, “that they made a lot of us managers tooquickly for our own good.”
Some of the young managers would requireemployees who didn’t make a sale in an hour tostand on their chairs. If they failed again, themanagers would tie balloons to the employees’wrists or belts.
The tactics demoralized the whole office. “Ilearned that you should always praise workers infront of their peers, but discipline them private-ly,” says Mr. Tucker, now 27 years old, who man-ages an Act-1 Personnel Services office inSchaumburg, Illinois.
It actually was a music course that gave hima lesson in management: “When an orchestragets out of synch, the conductor doesn’t makebig, exaggerated motions. His moves becomesmaller and more precise,” Mr. Tucker says.Likewise, “when I stopped shouting and quietlyexplained what was needed, people actually didwhat I wanted.”
This article is reprinted by permission fromCareerJournal.com © 2006 Dow Jones & Co. Inc.All rights reserved.
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Mark your calendar for Pittcon: February 25–March 2, 2007McCormick Place • Chicago, Illinois USA • www.pittcon.org
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human fac to r s
Just as your health can benefit from an annual physi-cal check-up, you can improve your career healthwith an annual career check-up. December is an idealtime to assess your 2006 professional accomplish-ments, learn from your experiences, and plan for2007. This will improve your productivity and aidyour professional growth and career advancement inthe new year.
LOOKING BACKBegin by reviewing the past year. List your accom-plishments. Don’t neglect professional society accom-plishments. Determine the factors that made theseaccomplishments possible. These include your per-sonal and professional strengths and workplace fac-tors. Workplace factors include abilities of your co-workers, your employer’s facilities, and opportunitiesoffered by your employer. Do the same for your disap-pointments.
By doing this, you’ll identify strengths on whichto build for a professionally successful and fulfilling2007. You’ll also identify areas where you need toimprove. When you assemble this list, also considerwhat skills and resources you did not exploit in 2006.In planning for 2007, consider how you could capital-ize on these under-utilized assets.
In addition to the strengths and resources thatyou can build upon, identify the abilities you need tostrengthen. Your list of your disappointments willhelp you do this. Determine why you did not achievesome of your 2006 goals. Unachieved goals may bedue to inadequate planning and organization, ineffi-cient use of time, insufficient coordination with co-workers, and other factors. Some causes of yourunachieved goals may be external such as lack of cor-porate resources. Can these be overcome by fundingoutsourcing or some other strategy in 2007?
LOOKING FORWARDBy now you probably know your project assignmentsand coworkers for the coming year. Armed withyour 2006 assessment, you can enter the 2007 withgoals and a career plan will let you capitalize onyour strengths and rectify or overcome your weak-nesses.
Setting goals will help you focus your work andprofessional activities to keep your career on track.
Goals should be clearly defined and easily measured.They should be challenging but realistic. Forinstance, developing and commercializing one newproduct in 2007 may be a realistic goal while devel-oping three is not. Most of your professional goalsshould contribute to your employer’s goals: deliver-ing improved products and services to customerswhile increasing profits.
However, you should have additional goals thatsupport your own professional and personal needs.These can include acquiring specific new job-relatedskills or improving areas of weakness you identified inyour 2006 assessment. Determine what is necessary tokeep up to date in your specialty. Use a current aware-ness service to alert you to new developments in yourfield.
Review what opportunities there may be in 2007to patent the results of your work and publish or pres-ent papers. Don’t limit publishing to research journals.Also consider publishing your work in trade associa-tion and industry magazines.
Most professionals can benefit from making aconscious effort to improve their networking in 2007.Writing in "The Joy of Science," Carl Sindermanndefined networking as regular and frequent discussionwith peers and colleagues. It’s not an activity thatshould be confined to job hunting. These discussionscan take place by letter, fax, e-mail, or telephone aswell as face-to-face. Company seminars and seminarsat local universities as well as regional and nationaltechnical conferences provide opportunities to main-tain and expand your network. Attending theseevents can be part of your 2007 career plan.
While staying up to date in your specialty is criti-cal, it is also important to develop skills in other areas.These include time management, managerial, andteamwork skills plus the interpersonal skills that makeyou a well-liked and sought-after coworker. These“soft skills” can be critical to obtaining a promotion, acoveted reassignment, or a new job. Professional soci-eties and trade associations offer opportunities todevelop these skills. Consequently these activities canbe an important part of your 2007 career plan.
CONTINGENCY PLANNINGThe best career plan can become irrel-evant if you become an unexpected
Year’s End – A TIME FOR CAREER ASSESSMENT AND PLANNING
John K. Borchardt
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victim of a corporate downsizing or take-over. It probablyisn’t necessary to develop a detailed plan for this circum-stance. However, it is best to have some courses of actionclearly in mind should you lose your job or face unexpect-ed reassignment. Keeping your résumé up to date is an essen-tial component of this plan. This contingency planning canmake such unplanned events less traumatic.
Your 2007 plan can also help you coordinate your profes-sional activities with your personal life. For instance, by coor-dinating a business trip with vacation plans, you may be ableto visit distant family members and friends or see an interest-
ing part of the country. At home, planning will enable you tobudget time for family, civic, charitable, and other personalactivities that are important to you.
Dr. Borchardt is a consultant and technical writer. The author ofthe book “Career Management for Scientists and Engineers,” hewrites often on career-related subjects. He can be reached at [email protected].
labmgr.com
Lab Bratz © 2005-2006 Edward Dunphy http://LabBratz.comicgenesis.com
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t he in te r v iew
Scholars who take humor seriously may not subscribe to a unifying general theory of laugh-ter, but most agree it resides in things gone wrong.
The trial and error world of a research lab sure works for Ed Dunphy, whose comicstrip “Lab Bratz” is a distillation of miscreants and mishaps he’s encountered in 25 years of“very experimental” lab work in academe.
The strip’s characters inhabit two adjacent biological research labs, one rich withgrant money, the other struggling to cut corners. The former is run by natty PrincipalInvestigator David Chang, who stays on top of his game and avoids all manner of drudgery.Working for Chang is the droll and balding lab manager Mike Nanz, who is modeled onDunphy and is the object of many self-directed zingers.
“Experience,” says Nanz, “is overrated. It just means I’ve made more mistakes thananyone else.”
Leave it to Dunphy — “I tossed out my first joke in the second grade and neverlooked back” — to extract humor from the worst lab nightmare. In the course of his“organic” career, he trekked through university labs as a researcher and teacher beforetouching down at the University of Wisconsin-Madison in 1995, where he now manages a
prostate cancer/immuno-therapy research lab with “a clinical relevance to my bench science.”Even after landing in Madison as an associate researcher, Dunphy, 44, assumed he’d return to the
University of Rochester to complete his graduate studies. But he enjoyed his work, “troubleshooting, train-ing, and teaching new protocols,” and took stock as he moved up the ladder. “I asked myself how differentthis would be from having my own lab, except I don’t get to choose the overall direction. Then I realized Icontrolled that, based on who I worked for.”
The work life, says Dunphy, has taught him two overarching lessons: “Do what you love, and don’twork for jerks.”
Many managerial consultants regard humor as a learned skill valued to combat ennui and boost produc-tivity, but Dunphy contends he doesn’t “have much choice,” in terms of cracking jokes and kidding around.“I’m ‘on’ all the time, which can be a little embarrassing if the director of the cancer center is walking by.I’ve always been good at getting the whole room laughing.”
His managerial repertoire allows for “being a good listener without being judgmental” and serving as acatalyst “to let others know you expect them to move forward.
“Everybody — glass washers, students, techs — wants to be respected. When you catch somebodydoing something well, congratulate them.
“Misunderstandings happen. Different personalities handle stress differently. I often run interference,like a wrangler. A lab is a team, where everybody has to work toward the same goal. Publishing papers andgetting grant money are important markers, but is everybody happy? Do people in the lab want to be there?When there’s tension in the lab, you don’t get your best work. And communication is so important; it’s howthe big picture goes from the primary investigator out to everyone else.”
Dunphy ticks off the pros of working in academia. “There’s a bonus being a researcher/manager, but notfaculty, since almost every lab in the country needs an experienced manager. I love teaching students. Theyhave so much energy, and are so inquisitive and so bright, and they help keep me young. And the freedomto explore what interests me is a powerful incentive.” Cons? “Lower pay and worries about long-term fund-ing. Funds are drying up, especially from NIH. More money is coming in from big pharmaceutical compa-nies, but that’s starting to drive research away from ‘pure’ science toward applied, product-based research.”
He recalls an old bumper sticker that read: “It will be a great day when our schools get all the moneythey need, and the Air Force has to hold a bake sale to buy a bomber.”
Naturally, it turns up in his strip, where “the Ruby lab never has money, but Chang’s lab has tons,including DoD grants.”
Francis Key Kidder started out as a journalist before moving on to politics and government relations, where he still keeps his hand in writing. He may be reached at 410-828-6529; [email protected].
F. Key Kidder
Edward J. DunphySenior Research Specialist (Laboratory Manager)Department of MedicineUniversity of Wisconsin - Madison
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