Pharma Focus Asia

Buying into Lean Pharma

William Botha, Director,Pharma Manufacturing & QLP, Baxter Healthcare.

The article is a 30,000 feet fly-by of the essential stepping stones leading to a sustained lean deployment. This pragmatic approach, based on personal successes and failures, has been proven in several industries and across three continents by the author.

Leadership
My teeth were chattering against one another with my uncontrolled shivering. I was physically exhausted, mentally drained after three days of continual marching, thinking and worrying about walking off the edge of the mountain. Everything was damp. It had been raining all night and we hadn’t been able to make a dry camp. We had just heard the news that snow was rolling in across the mountain. And I had just volunteered for more. What had made me choose the route of more hardship over the seemingly logical choice of warmth, safety and comfort?

It was the fourth day of the School of Infantry’s annual cross-country march. Each company of around 120 candidate officers had been given a series of way points to make over a five-day period with minimal rations and even more minimalistic comforts. It had started raining on Day Two. We had repeatedly lost our way in the foothills since we had lost the advantage of taking visual bearings. It was like stumbling through an ethereal misty Harry Potter-like maze.

Our Company Commander had formed us up in front of a huge roaring bonfire and had told us the truth under the soggy, dripping trees; “The weather has forced you all to reconsider how badly you want to be an Army Officer? So this phase is now considered complete. We really did not need this weather to make this exercise more effective. Yet we should have another day of marching in front of us to finish this the right way. You have a choice now; one, you remain in ranks and when we’re done, you get your gear on the trucks that will be here in about an hour to truck you out of here. Two, you break ranks and step across here and stand with me. We will complete the march as expected. Some of us may be injured in the next 24 hours. There will be no demerits for those who choose to stay in ranks, who choose to get in the trucks.” Followed by dead silence.

Most of Charlie Company broke ranks and formed up behind the Major. We all made it through that day and the long night that followed.

Why do I start what should be a dry, theoretical article about Lean deployment with this story from my experience? Because it carries all of the elements of the answer to the real question; “How do I deploy Lean into my organisation?”

Like a classic Greek tragedy; Act One introduces the players and describes the stage they’re playing on—and the audience they’re playing to.

Environment – Market
This is fundamental to the course chosen by the actors, this first Act lays out the minefield. What state is your industry in? What opportunities and threats are there out there? With the global economy in the tank right now—you are in a very, very different position if you’re selling a discretionary product like high-end cosmetics versus those of us who are producing life-saving therapies. Is your API supply constrained or not? Who are you selling your drugs to? (I know, I know—that should have been ‘To whom are you selling your pharmaceuticals’ but as Winston Churchill would have said—“That is English up with which I will not put!”) What is your vision? How deeply ingrained is your vision in your workforce? Is it a Lean vision?

Vision
So my first piece of advice is spend a lot of time asking what is going on outside of the firm, then turn inside and delve into the real machinations of the ‘company’ upon which you’re about to inflict Lean. The link between the two is the Vision. Who knows it? Who believes it? These are two very different questions. If you asked 10 senior members of the company the same question: “What is the company going to look like in five years’ time?” I would hazard a guess that nine of the ten will differ significantly from the Boss’s vision. The tenth vision is the Boss’s. Then you need to dissect the vision and see how truly Lean it is. Then you have to try and align it.

Structure, staff, skills
The structure of the company must fit the vision. It doesn’t help to take a knife to a gunfight and neither will it suffice to take a functionally-oriented behemoth to Lean (For functionally-oriented read ‘silos, lots of isolated silos’). Lean demands tight, incessant teamwork and silos do not support team work. A team architecture is easy to design yet very difficult to build. You have to break down the territorial domains of entrenched managers at the middle level by training, educating and leading them to more mature styles of leadership.

The positions within the structure have to be filled. In this case it is better to have the position filled rather than to wait for the ‘right’ person for the role. I shudder every time I hear a fellow Lean practitioner say that they budget to staff a hundred people, then they plan to only have 95 of those positions filled at any one time! How much sense does that make?

Finally select your people in a focussed fashion; technical skills for technical positions, change skills for Lean senses and finally the most critical positions of all—leadership skills for supervisory positions. You can train technical skills in and some say that you can train leadership skills in. That is not my experience. So recruit leaders, proven leaders, with hard degrees (engineering or sciences) from the military. The confidence these leaders bring to the game are invaluable at the front-line supervision level.

Style
Silos work very well in an autocratic system but they make inter-function communication almost impossible to achieve while a team-oriented structure demands its leaders use influencing skills rather than positional or informational power bases. This is where my story comes in.

Consider the Major’s style. Note how he changes from acknowledging that the march has been hard, to the use of ‘you’ singular to isolate the individual, followed by ‘we’—insinuating that he, too, is going to continue the march. His mind is made up. He has decided where he wants to go. He is merely affording his friends the opportunity to do it with him because it is a worthwhile thing to do. Great sales skills. He also then closes the deal by forcing those who are ‘on side’ to DO SOMETHING! He asks them to ‘break ranks’ and form up behind him (Which, now that I think of it, was much closer to the comforting heat of the fire!).

That brings me to the vector of change—top-down or bottom-up.

Top-down / Bottom-up?
There is no bottom-up. When last did an entry-level employee recruit a change agent, force everybody round them to respond to an analysis and start doing something new? Eh? Never.

What do people mean when they say they took a ‘bottom-up’ approach? They mean that either
a)they could not convince the top dog or
b)the top dog did not have the intestinal fortitude to drive the change.

What would have been the outcome if one of the sergeants had gathered a bunch of his people round the fire and asked who wanted to finish the march? I suspect that he would have been laughed out of court.

Whenever a change evolution has been successful it has been led by inspirational leaders within the organisation. And when this person has not been the head honcho, their leadership skills and ability to influence has been momentous—prior to the change, not because of it. The controlling keiretsu of Toyota kept Mr Taaiichi Ohno in place when Toyota workers went on strike midway through the last century—and he was not the CEO of the company.

So simply stated, find the real leaders in your firm and spend your time with them; learning what turns them on, because it is their wants and needs that you are going to use to illustrate the benefits of turning the firm into a Toyota lookalike. These people are not going to be at the bottom of the organisation. Are they?

So my preferred change vector is neither top-down nor bottom up – it is ‘leader-forward.’

Benefits and sales skills
The words ‘buy-in’ in the tag line to the sub-title are important. If there is a buyer—then there must be a seller, no? And what skills must good salespeople have? Sales skills! Go straight to the top of the class.

The first thing they’re going to learn when you send them on a sales skills course is the need to identify the benefit to the customer. This ‘customer’ is not the customer of the product; the customer we’re talking about is the customer of the change; the person either asking you to lead the change. This is either the person either asking you to lead the change or, and this is important; write it down—the employees who are going to have to change the most.

If you can’t identify these individual benefits, you’re going to feel like a one-legged man in a butt-kicking contest. You will have no leverage. Why do you think the used-car salesgirl asks you so many questions when you sidle up to that luscious wine-red ten year-old Suburban? She is searching for the ‘benefit’—the Holy Grail of the sales world. If she discovers you have four young kids and you crave safety then she is most likely going to subtly direct you to a Volvo sedan somewhere. And won’t it be a Jeep if it is the great outdoors you crave?

When I started in plasma therapeutics I used to try and sell the ability to cut cost until a senior VP sat me down and said very carefully and slowly so that even a slow South African like myself could understand; “William, don’t tell me about cost when I can sell everything I make and I don’t have enough API to fill the market—tell me about yield, tell me about the ability to limit discards—but DO NOT TELL ME ABOUT COSTS!” I still smile when I recollect that little session.

Your change agents will get to those benefits by asking questions, lots of them. If they stop asking questions and start making statements that is a red flag warning of a firestorm of assumptions. And even when they’re selling, they’re going to be selling by asking questions.

So send your change agents to class again—sales skills classes.

First steps
Where do you start? Why, at the beginning of course! Remember the Toyota model—or house of Lean? What is in the top left-hand corner? Forget that. It is a house, remember? Where do you start with a house? At the bottom!

What is at the bottom of the house? The fundamental disciplines of 5S, mistake proofing, standard work, that’s what. It will take two to five years for these fundamentals to be instilled in your business. And how do you do that? You need to start a formal training process to develop specialist skills in house, yet—simultaneously—you need to engage the employees on the floor with kaizen activity.

Offer voluntary classes on skills that are going to make them more valuable to the company, and – incidentally—will make them more marketable in the marketplace. Record carefully who attends and who doesn’t. They will notice and the message will be clear. Short topics like ‘Presentation Skills,’ ‘Root Cause Analysis’ and ‘Mistake Proofing’ will not only lead to fewer repeat process excursions in your business but will also develop depth in the crew. But get them to DO SOMETHING.

Them? Oh. Sorry, I meant the informal leaders in the work force.

Start a Kaizen Promotion Office. Led by a specialist, it is an office that is responsible for supplying the resources to map value streams, prepare for and facilitate kaizens. And, train the employees in the kaizen. And that is probably the most important function of a Kaizen Promotion Office—to train your employees. The first morning of a kaizen is spent in training the members on the specific skills they will be using in the next couple of days, isn’t it? And won’t their skill retention be awesome since they will be practicing that skill immediately?

Lean enterprise or lean toolkit?
I started this article with Vision and so we come full circle. What is it that you really need? A slightly better firm that only runs out of gas every six months as opposed to every other day? Or an agile, responsive, customer-focussed, profit-pumping business enterprise? They’re equally honourable objectives.

The Major in my story was sincere. And we could tell he told us the truth. The trucks did arrive. He did walk with us. In front. All the way. He stopped and took a rest only when we could not continue, or to keep the company together.

So, if you only want to use some of the tools—say so. They’re good tools. They’ll work for you. They work wonderfully in concert with the Six Sigma tools of DMADV and DMAIC. But remember that when the kaizen fails or when the 5S campaign does not drop your Recordable Injury Rate—“A Bad Workman Always Blames His Tools.”

Author Bio

William Botha

William Botha has installed and sustained significant changes across three continents and within many diverse industries. His most recent success is his appointment to a senior manufacturing position in the quality-critical biologics pharmaceutical industry where he has lifted customer fulfillment, driven inventories down, erased cost and maintained world-beating low rates of discard. Known by his reports, his peers and superiors as a results-driven leader, he still inspires his team and those around him with an engaging style and a warm, self-deprecating sense of humour.

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