Proper Training and Development Of Internal Resources
The word “internal” should be emphasized here, since it is my strong belief that long-term and/or ongoing dependence on external resources is not healthy—financially or strategically. Rather, the external help should be utilized on an as-needed basis for very specific reasons. We do not depend on our medical doctors to keep us healthy—rather, we best make use of them for regular check-ups and to help us quickly recover from an illness. A business organization utilizing external resources is no different.

As a guideline, the rationale for external assistance can fall under two high-level categories. These are:

Resource and Management Time Requirements
You can tell a lot about a person by observing where he/she spends most of his/her time and money. You spend your time and money on the things you regard as important. This point (other than being a reminder that I should give my fiancée a call) has applicability in business as well. If you want to ensure a successful Six Sigma initiative, be sure to fall in love with the program. Allocate enough budget and resources to get it off the ground properly. If your organization already has a Six Sigma program (perhaps running for several years) that has hit a plateau, be the change agent to rejuvenate it and turn things around.

Perhaps your organization has had too many distractions in the past and never quite successfully implemented a Six Sigma program. These distractions, in the Biopharma and Pharma industries, can come in many flavors. Typical list of distractions for most FDA-regulated organizations include:

Avoid the common mistake of believing that the Six Sigma program is yet another thing to worry about in addition to the urgent items listed above. Instead, view Six Sigma initiative as a means to effectively resolve the above issues. For example, Six Sigma is not another separate effort on top of your ongoing attempt to improve your quality issues or to shorten a long turnaround time, etc. Rather, Six Sigma tools and techniques should be used as tools to help resolve your quality problems, shorten your lead time, etc.

The management also needs to devote some time on its own to learn the basics of Six Sigma. Management does not need to know how to perform DOE and ANOVA but, at a minimum, it should be familiar with the key terms and be aware of the overall approach. There are many operational improvement tools and techniques available—however, understanding of Six Sigma’s well-defined, consistently followed and established approach will prove exceptionally valuable.

If the management lacks either the knowledge or the experience of running Six Sigma programs, seek external help. In doing so, resist the temptation of letting the external resources taking control of your program. They are your helpers, but the client must take the ownership, set the direction and make the final key decisions. From a potential pool, seek out the ones with both Six Sigma and life science industry-specific knowledge/experience. During the initial screening, make sure that you will feel comfortable with your selection at a personal level. And most importantly, clearly communicate your expectations and demand bottom line results from early on.

Relevant Knowledge And Experience
There is no single, official Six Sigma training program or consistent requirements for green, black and master black belts. There are many organizations who certify people, but are not all the same. Make sure the consultants you are dealing with are certified with a reputable organization.

Avoid letting this be a training ground for your external resources. Certification may a good indication, but it is often insufficient. Being an expert means much more than just getting the required training and holding a certificate. It takes several years of applying various Six Sigma tools in real-life settings (specifically in life science industry) to be of true value. Remember one simple rule—any external resource you hire should be significantly better qualified in his/her specific area of expertise than your internally available capabilities.

Prior to making your final selection, insist on meeting the people who will actually be working with you and your team. This may not be an issue when you are dealing with independent contractors, but can be a major point when dealing with large consulting companies. Look for actual industry experience—avoid lifetime consultants. There is no suitable substitute for real-life experience. Although it is not impossible, it is very difficult for someone who lacks the actual experience to relate to the issues you may be facing. Someone who can recite a hundred cookbooks verbatim but has no real-life cooking experience is not a real chef, in my opinion.

Check your consultants’ background. Check references and speak with previous clients. Ask about a specific FDA requirement during your initial screening. If ever in doubt, politely walk away—there are literally hundreds more who will be more than happy to do business with you. Some time and effort spent on the selection process will save you lots of headaches and easily hundreds of thousands of dollars (or perhaps millions) in the future.

Fair Evaluation of Results
If there is ever a doubt whether a program was a success or not, chances are that it wasn’t. Success, when it comes to bottom line improvements, should not be an entirely subjective thing. A true Six Sigma success should transform the biggest doubters into enthusiastic believers.

Be sure to ask for and to check references. Have the former clients truly achieved success? How long did the relationship last? Any project lasting in excess of six to 12 months may indicate some potential issues ahead. Any good consultant should work him/herself out of a job. If the consultant you are dealing with seems more interested in finding ways to stick around longer, rather than helping you deliver results, then I am afraid you got the wrong person in there.

Ask very specific and pointed questions to judge their life science industry knowledge. Are they up-to-date on the latest biotech trends? How many other pharmaceutical clients have they had? Ask about one or two compliance issues they have solved (without compromising confidential agreements with other clients, of course). Have them provide case studies from other organizations that have faced similar situation/issues you are now attempting to resolve. Ask about their approaches, outcomes and the satisfaction of the clients. Ask for references and check them to make sure their clients share the same opinion.

Based on the external resources’ previous experiences, what range of lead time reduction can you expect? Have they performed significant projects dealing with complaints and/or CAPA? What were the results? What did it take them to implement these improvements? What level of success can you expect in three months? With respect to quality, what tools and techniques do they have to identify sources of variability? Once identified, how do they reduce/eliminate the variability? How many companies have they worked with that were operating under consent decrees? What (if any) specific Six Sigma tools and techniques do they adopt to help with FDA audit process? What (if any) specific experiences do they have in migrating from clinical to commercial production? If a productivity gain was achieved, has the client been able to sustain it after the initial jump? Be sure to get a rough estimate of what the consultants can deliver. Make sure they are consistent with your own expectations and, most importantly, hold them accountable for delivering real bottom line results.

Cost/benefit Analysis of In-House vs. Outsourcing
Consider the level of knowledge, experience, available resources and bottom line improvements gained in the past. If an organization has consistently achieved the highest levels of success on its own, there are no compelling reasons to involve external resources. If, on the other hand, there are disputes as to the effectiveness of your program or you currently lack the knowledge/experience/resources, having the right external resources to fill in the gap can be a very smart move.

In choosing external help . . . shop around! With so many providers, the difference in cost can be mind-boggling. If you are used to dealing with hourly rates for outside help, expect to pay anywhere between $100/hour (usually for an independent contractor who is getting desperate for work) and up to $500/hour (for a well-established and well-marketed consultancy or an individual regarded as one of leading experts). Keep in mind that more expensive consultants or better known organizations do not necessarily deliver better results.

With the right approach during negotiations, most consultants will be more than happy to tie their paychecks to performance and/or savings delivered. This can create a mutually beneficial relationship. It will minimize your risk and give competent yet lesser known consultancies/organizations an opportunity to prove its capabilities. If you are willing to go this route, clearly define the roles for the outside consultants and communicate your expectations both verbally and in writing.

Another option may be to have your selected external resources to work for a few weeks at a deep discount with the understanding that after the trial period, the rates will increase to a pre-defined level provided that you, as the client, decide to continue the relationship. Despite the long-awaited uptick in the economy, the supply still far outnumbers the demand with regards to Six Sigma consultants. Use this to your advantage and be selective.

The success of the program depends mostly on you. Seek external resources to compliment specific areas where you currently lack sufficient knowledge/ experience/resources. Most importantly, be demanding of both your internal and your carefully selected consultants. The journey is not an easy one, but the rewards can be quite satisfying.