| Based on a wild guess by a close associate of mine, | | | | And most importantly, clearly communicate your |
| there are well over 2,000 restaurants in the | | | | expectations and demand bottom line results from |
| Manhattan area and its surrounding boroughs. | | | | early on. |
| Although I cannot validate the absolute accuracy of | | | | Relevant Knowledge and Experience |
| his count, I do trust it is in the ballpark, since he | | | | There is no single, official Six Sigma training program |
| happens to be one of those guys who seem to | | | | or consistent requirements for green, black and |
| know everything about everything in life (and more). | | | | master black belts. There are many organizations that |
| His dream is to be on Jeopardy; if it ever happens, I | | | | certify people, but are not all the same. Make sure |
| already feel sorry for the other two contestants, | | | | the consultants you are dealing with are certified with |
| who will undoubtedly be decimated on national TV. | | | | a reputable organization. |
| And, oh yes, he also happens to be a food- lover. | | | | Avoid letting this be a training ground for your |
| There is definitely some credibility to his estimate. | | | | external resources. Certification may a good |
| There is a point to be made by this story (trust me!). | | | | indication, but it is often insufficient. Being an expert |
| Despite the overwhelming number of restaurants in | | | | means much more than just getting the required |
| the city-that-never-sleeps, there are only a dozen or | | | | training and holding a certificate. It takes several |
| so which I truly enjoy and actually look forward to | | | | years of applying various Six Sigma tools in real- life |
| visiting. I am certain that even if I try every single | | | | settings (specifically in life science industry) to be of |
| one of these 2,000 locations, the "can't-miss" list will | | | | true value. Remember one simple rule--any external |
| be no longer than 50. So, assuming my buddy's figure | | | | resource you hire should be significantly better |
| is fairly accurate, what do I make of the other 1,950 | | | | qualified in his/her specific area of expertise than |
| establishments? Not much, I am afraid. Unfortunately, | | | | your internally available capabilities. |
| there are plenty of examples like this in life. Having | | | | Prior to making your final selection, insist on meeting |
| spent many, many years in several universities (too | | | | the people who will actually be working with you and |
| embarrassing a number to admit), I have studied | | | | your team. This may not be an issue when you are |
| under approximately 100 professors. However, there | | | | dealing with independent contractors, but can be a |
| are only three whom I regard as great | | | | major point when dealing with large consulting |
| teachers--individuals who have significantly influenced | | | | companies. Look for actual industry experience--avoid |
| my life and whose lessons I actually remember. | | | | lifetime consultants. There is no suitable substitute for |
| Tragically, the example does not stop here. There | | | | real- life experience. Although it is not impossible, it is |
| are a plethora of Six Sigma experts out there. A | | | | very difficult for someone who lacks the actual |
| simple search on Google on "six sigma consultant" | | | | experience to relate to the issues you may be facing. |
| yielded a whopping 70,000+ returns. Most of these | | | | Someone who can recite a hundred cookbooks |
| folks, I am afraid, are mediocre at best. | | | | verbatim but has no real- life cooking experience is |
| So, as you consider or embark on a Six Sigma | | | | not a real chef, in my opinion. |
| program, how do you select your competent and | | | | Check your consultants' background. Check |
| trust-worthy advisor(s)? With so many | | | | references and speak with previous clients. Ask |
| self-proclaimed experts, how do you find one who is | | | | about a specific FDA requirement during your initial |
| right for you? Should you involve outsiders at all? | | | | screening. If ever in doubt, politely walk away--there |
| How do you know if you can do this successfully | | | | are literally hundreds more who will be more than |
| only with your internal resources? As you ponder | | | | happy to do business with you. Some time and |
| these fundamental questions, the following guidelines | | | | effort spent on the selection process will save you |
| may be of interest. | | | | lots of headaches and easily hundreds of thousands |
| Proper Training and Development of Internal | | | | of dollars (or perhaps millions) in the future. |
| Resources | | | | Fair Evaluation of Results |
| The word "internal" should be emphasized here, since | | | | If there is ever a doubt whether a program was a |
| it is my strong belief that long term and/or ongoing | | | | success or not, chances are that it wasn't. Success, |
| dependence on external resources is not | | | | when it comes to bottom line improvements, should |
| healthy--financially or strategically. Rather, the external | | | | not be an entirely subjective thing. A true Six Sigma |
| help should be utilized on an as-needed basis for very | | | | success should transform the biggest doubters into |
| specific reasons. We do not depend on our medical | | | | enthusiastic believers. |
| doctors to keep us healthy--rather, we best make | | | | Be sure to ask for and to check references. Have |
| use of them for regular check-ups and to help us | | | | the former clients truly achieved success? How long |
| quickly recover from an illness. A business | | | | did the relationship last? Any project lasting in excess |
| organization utilizing external resources is no different. | | | | of six to 12 months may indicate some potential |
| As a guideline, the rationale for external assistance | | | | issues ahead. Any good consultant should work him |
| can fall under two high- level categories. These are: | | | | herself out of a job. If the consultant you are dealing |
| Assistance in Training of Internal Resources | | | | with seems more interested in finding ways to stick |
| For on- going success of your Six Sigma program, it | | | | around longer, rather than helping you deliver results, |
| is crucial that internal knowledge and competence are | | | | then I am afraid you got the wrong person in there. |
| first developed then continually retained. Your specific | | | | Ask very specific and pointed questions to judge |
| training needs depend on your existing capabilities and | | | | their life science industry knowledge. Are they |
| the level and timing of your targets. First, get an idea | | | | up-to-date on the latest biotech trends? How many |
| for the number of certified "master black belts," | | | | other pharmaceutical clients have they had? Ask |
| "black belts" and "green belts" currently in your | | | | about one or two compliance issues they have |
| organization. There are numerous ways out there to | | | | solved (without compromising confidential |
| obtain these titles, so find out how, when and via | | | | agreements with other clients, of course). Have them |
| which organization these individuals were certified. | | | | provide case studies from other organizations that |
| Next, consider the Six Sigma project experience of | | | | have faced similar situation/issues you are now |
| these individuals and the significance of the past | | | | attempting to resolve. Ask about their approaches, |
| results. As a basic rule of thumb, each black belt | | | | outcomes and the satisfaction of the clients. Ask for |
| should deliver approximately $1M in savings or in | | | | references and check them to make sure their clients |
| cost-avoidance each year. As another rule of thumb, | | | | share the same opinion. |
| the ratio of black belt to green belt should be | | | | Based on the external resources' previous |
| between 1:3 and 1:6. One master black belt for each | | | | experiences, what range of lead time reduction can |
| division or location with as many as 1,000 to 1,500 | | | | you expect? Have they performed significant |
| people is often sufficient. In deciding which individuals | | | | projects dealing with complaints and/or CAPA? What |
| should be trained, consider the candidate's interest | | | | were the results? What did it take them to |
| level, current position and background on basic | | | | implement these improvements? What level of |
| statistical tools (or willingness to learn). These | | | | success can you expect in three months? With |
| individuals should also possess the knowledge of the | | | | respect to quality, what tools and techniques do they |
| business (i.e., do not pick someone who just joined | | | | have to identify sources of variability? Once |
| the company last week) as well as the respect from | | | | identified, how do they reduce/eliminate the |
| his/her peers (i.e., do not pick someone because you | | | | variability? How many companies have they worked |
| do not have any other plans for him/her). Lastly, | | | | with that were operating under consent decrees? |
| resist the temptation to over-train. It is of no benefit | | | | What (if any) specific Six Sigma tools and techniques |
| to the organization to have everyone trained, unless | | | | do they adopt to help with FDA audit process? What |
| the skills are put to use and bottom- line benefits are | | | | (if any) specific experiences do they have in |
| realized from early on. | | | | migrating from clinical to commercial production? If a |
| Assistance in Delivering Bottom-Line Results | | | | productivity gain was achieved, has the client been |
| In this role, you are asking the external resources to | | | | able to sustain it after the initial jump? Be sure to get |
| deliver specific results using Six Sigma and perhaps | | | | a rough estimate of what the consultants can deliver. |
| other tools and techniques. Prior to the selection of | | | | Make sure they are consistent with your own |
| external resources, it is essential that you take the | | | | expectations and, most importantly, hold them |
| lead in defining the objectives and setting the | | | | accountable for delivering real bottom line results. |
| success criteria. Having the consultants define their | | | | Cost/Benefit Analysis of In-House vs. Outsourcing |
| own scope of work can be a dangerous thing. Can | | | | Consider the level of knowledge, experience, available |
| you imagine getting in a cab and letting the driver | | | | resources and bottom line improvements gained in |
| decide on where you want to go? In this approach, | | | | the past. If an organization has consistently achieved |
| clearly communicate your objectives and goals--the | | | | the highest levels of success on its own, there are |
| cab driver (external resources) can decide and/or | | | | no compelling reasons to involve external resources. |
| advise you on specific routes to take, but you need | | | | If, on the other hand, there are disputes as to the |
| have a clear picture of your goal and destination. | | | | effectiveness of your program or you currently lack |
| Resource and Management Time Requirements | | | | the knowledge/experience/resources, having the |
| You can tell a lot about a person by observing where | | | | right external resources to fill in the gap can be a |
| he/she spends most of his/her time and money. You | | | | very smart move. |
| spend your time and money on the things you regard | | | | In choosing external help . . . shop around! With so |
| as important. This point (other than being a reminder | | | | many providers, the difference in cost can be |
| that I should give my fiancée a call) has | | | | mind-boggling. If you are used to dealing with hourly |
| applicability in business as well. If you want to ensure | | | | rates for outside help, expect to pay anywhere |
| a successful Six Sigma initiative, be sure to fall in love | | | | between $100/hour (usually for an independent |
| with the program. Allocate enough budget and | | | | contractor who is getting desperate for work) and |
| resources to get it off the ground properly. If your | | | | up to $500/hour (for a well-established and well |
| organization already has a Six Sigma program | | | | marketed consultancy or an individual regarded as |
| (perhaps running for several years) that has hit a | | | | one of leading experts). Keep in mind that more |
| plateau, be the change agent to rejuvenate it and | | | | expensive consultants or better known organizations |
| turn things around. | | | | do not necessarily deliver better results. With the |
| Perhaps your organization has had too many | | | | right approach during negotiations, most consultants |
| distractions in the past and never quite successfully | | | | will be more than happy to tie their paychecks to |
| implemented a Six Sigma program. These distractions, | | | | performance and/or savings delivered. This can |
| in the Biopharma and Pharma industries, can come in | | | | create a mutually beneficial relationship. It will minimize |
| many flavors. Typical list of distractions for most | | | | your risk and give competent yet lesser known |
| FDA regulated organizations include:o Customer | | | | consultancies/organizations an opportunity to prove |
| complaints (written and verbal)--collection, analysis | | | | its capabilities. If you are willing to go this route, |
| and closure;o CAPA--both externally (as a result of | | | | clearly define the roles for the outside consultants |
| customer complaint, for example) and internally | | | | and communicate your expectations both verbally |
| generated (as a result of non-conforming product, | | | | and in writing. Another option may be to have your |
| for example);o Supplier quality problems and/or | | | | selected external resources to work for a few |
| inadequate process capability;o Potential major | | | | weeks at a deep discount with the understanding |
| contract manufacturing decisions (especially important | | | | that after the trial period, the rates will increase to a |
| for many Biopharma companies at this point in time); | | | | pre-defined level provided that you, as the client, |
| ando Compliance issues--perhaps an adverse FDA | | | | decide to continue the relationship. Despite the |
| audit results and/or receipt of warning letters. | | | | long-awaited uptick in the economy, the supply still |
| Avoid the common mistake of believing that the Six | | | | far outnumbers the demand with regards to Six |
| Sigma program is yet another thing to worry about in | | | | Sigma consultants. Use this to your advantage and be |
| addition to the urgent items listed above. Instead, | | | | selective. |
| view Six Sigma initiative as a means to effectively | | | | The success of the program depends mostly on you. |
| resolve the above issues. For example, Six Sigma is | | | | Seek external resources to compliment specific areas |
| not another separate effort on top of your ongoing | | | | where you currently lack sufficient knowledge/ |
| attempt to improve your quality issues or to shorten | | | | experience/resources. Most importantly, be |
| a long turnaround time, etc. Rather, Six Sigma tools | | | | demanding of both your internal and your carefully |
| and techniques should be used as tools to help | | | | selected consultants. The journey is not an easy one, |
| resolve your quality problems, shorten your lead time, | | | | but the rewards can be quite satisfying. |
| etc. | | | | Abstract: |
| Management also needs to devote some time on its | | | | There is very little doubt that a successful |
| own to learn the basics of Six Sigma. Management | | | | implementation of a Six Sigma program can benefit |
| does not need to know how to perform DOE and | | | | an organization. However, the probability and the level |
| ANOVA but, at a minimum, itshould be familiar with | | | | of success depend on several key factors including |
| the key terms and be aware of the overall approach. | | | | the overall strategy and approach, such as proper |
| There are many operational improvement tools and | | | | training and development of internal resources, and |
| techniques available--however, understanding of Six | | | | selection and appropriate utilization of outside |
| Sigma's well-defined, consistently followed and | | | | resources. The strategy and approach include |
| established approach will prove exceptionally valuable. | | | | numerous vital considerations, including proper project |
| If the management lacks either the knowledge or | | | | selection, resource and management time |
| the experience of running Six Sigma programs, seek | | | | requirements, relevant knowledge/experience, fair |
| external help. In doing so, resist the temptation of | | | | evaluation of results and cost/benefit analysis of the |
| letting the external resources taking control of your | | | | in- house vs. outsourcing options. We offer a handful |
| program. They are your helpers, but the client must | | | | of guidelines for making this crucial decision, taking |
| take the ownership, set the direction and make the | | | | into account unique issues and challenges in the |
| final key decisions. From a potential pool, seek out | | | | Biopharma and Pharma industries. Both advantages |
| the ones with both Six Sigma and life science | | | | and disadvantages of in- house and outsourcing |
| industry-specific knowledge/experience. During the | | | | options are provided along with critical success |
| initial screening, make sure that you will feel | | | | factors. |
| comfortable with your selection at a personal level. | | | | |