The Enterey Blog

Modern Rules of Quality Management

Posted by Tita Tavares on Thu, Jun 12, 2014 @ 10:30 AM

 

Modern Rules of Quality Management
From classic to clever

 

 

Quality management is the golden goose of all business organizations. In our last blog, we explained the benefits of adopting Lean Six Sigma into your business and how it aids in improved product quality.  So now, let’s take it to the next level by giving you a step by step strategy to maintain and manage quality. By implementing Lean Six Sigma-based principles of quality assurance and control, consistent, high quality products should be guaranteed.

 

Here’s a C.L.E.V.E.R. way to remember classic steps of Quality Management.

 

Consumer focus

Understand consumer needs, meet their requirements, and exceed their expectations

Leadership

Leaders should be knowledgeable, problem-solvers who are always striving to exceed business goals

Enhancement

Continual business process improvement of company performance should be a permanent goal

Value teamwork

Promote unity and collaboration within the work environment and approach problems as a team

Effective decision-making

Decisions should be based on the analysis of collected data and information

Routine approach

Managing related processes as a system is more effective and efficient

 

Let’s take a deeper look at consumer focus, leadership, and effective decision-making.

 

Life sciences companies need to look beyond their labs for answers. Quality management goes beyond just product invention.  Consumer focus is a top priority because creating commerce around their needs is essential.  In an article published in Bloomberg BusinessWeek, authors Maddock and Viton discuss this very thought of targeting specific insights to build a business around.  When a company is able to fulfill a need with their inventions, they become innovators who are seen as offering solutions.  Don’t just look to invent something, look to solve a problem.  

 

Secondly, organizations need firm, flexible leaders who are aware that success starts with knowledge and knowledge starts with a thought.  Leaders who are continuous students of the trade become industry thought leaders and organizational influences. Business growth relies on bringing new perspectives to the table that inspires advanced improvements. As published in Boston’s BusinessWire posting, it’s no doubt that the Life Sciences industry is complex and forever changing.

 

Lastly, effective decision-making is at the core of quality management. How one debates and deliberates what is most important when trying to make a decision comes down to prioritization. What is the priority of your job? What is the objective of your project? What are the goals of the company? Questions alike come into mind when anyone in an organization is trying to operate on a daily basis. If we look at our previous PRO Dilemma blog, we learn how to break down the decision-making process. Quality decisions lead to hitting targets.

 

Are you inventors or innovators? 

 

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Published by Enterey's Marketing & Communciations Team

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Tags: Life Sciences, Lean Six Sigma, Quality Management

Supply Chain Management: How Globalization is Affecting Your Business

Posted by Tita Tavares on Thu, May 29, 2014 @ 10:42 AM


Supply Chain Management:
 How Globalization is Affecting Your Business

As the demand for pharmaceutical and biotechnology products increases around the world, the market for them is more competitive than ever before. This supply and demand relationship has contributed to the growing trend of globalization in the life sciences industry.
Supply Chain - Enterey

Globalization in a word is outsourcing; the outsourcing of ideas, products, and jobs. Its popularity stems from the attraction of cheap labor and fast production. What sounds too good to be true, is too good to be true indeed, as most companies know that outsourcing comes with its fair share of problems. It seems to have become a euphemism for sweatshops and below par products. Couple these issues with the lack of regulation in foreign countries and you have a disaster in the making. Counterfeiting and contamination are becoming rampant problems for pharma and biotech companies that engage in outsourcing. These dangerous product defects are gaining notoriety for the increasing amount of public health risks they are causing. 

 

Even if your company does not outsource, this negative globalization affects you. The FDA and other regulatory agencies are tightening standards to ensure that products are protected in all steps of the supply chain. There is a demand for more information at each production stage so that activities can be monitored and validated by regulators. All companies must be compliant with the new standards by 2015, but until then, it is smart to start preparing your business for this transition.

In a Forbes article, Managing the Risks of a Globalized Supply Chain, Milosz Majta accounts for the increasing complexity, lack of data, and need for greater quality, faster, and cheaper as factors of risk. To continue on this thought, read his article for a simplified yet detailed argument as to why it's imperative to think before decided on what’s best for your organization.

 

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Published by Tita Tavares | Enterey Marketing & Communications Team  

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Tags: Risks, Supply Chain, Globalization

Risk Management. Get Your Head in the Game

Posted by Tita Tavares on Fri, Aug 30, 2013 @ 12:23 PM

Risk Management
Get Your Head in the Game

 Risk Management

 

Regulated industries are taxed with unavoidable risks ranging from reasonable to severe. All it takes to handle these varying obstacles is a simple mind-shift.

Risk management is the detection, assessment, and ranking of risks followed by the application of resources to minimize the likelihood of failure by the identified risk. Translation: assuming and preparing for worst case scenarios. Sounds tedious and complicated, right? Not necessarily. 

Developing a thorough plan to tackle risk management helps identify and address risks in an efficient manner. This “game plan” is best when put into action through two effective decision-making components: the approach and the preparation.

The Approach

You must have the right frame of mind when making your decisions. An open, realistic mindset is essential to approaching risk management. You must accept the fact that risks are unavoidable and be willing to take chances. The more objective and honest you are when looking at risks, the better prepared you will be to take them on.

 

The Preparation

After identifying all possible threats, it is important to compliment an objective mindset with comprehensive preparation. Premeditative actions you should consider are: simplifying the risk, investigating, and collecting relevant data. Thorough research will increase your confidence. Additionally, considering long term goals prior to making a decision will reduce future risks.

 

Putting the Game Plan into Action

So you’ve cleared your head and prepared yourself, now what? How do you organize all the information in front of you? Consider the following 5 questions and the given examples before you make your next decision:

1. What are your problem, risk, and opportunity items?

  • Below-sales forecast for products/services (Problem)
  • Unreported adverse drug events and inconsistent NDA safety database (Risk)
  • Improve clinical trial supply forecasting (Opportunity)

2. Which, if NOT pursued, erode the most value?

3. Which, if pursued, create or protect the most value?

4. Which should you pursue?

5. What are the implications to your plan and budget?

 

Can you, as a stakeholder in your organization, answer these questions? If so, then you're on your way to making solid decisions. These questions all lead to what we call the PRO Dilemma, a method developed by DEI. For more information, click here. 

 

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Published by Katie Georgi | Enterey Marketing & Communications Team  

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Tags: Risk Management, Decisions, Decision-making, Identify Risks, DEI

Enterey's On Cloud 9. Happy Friday!

Posted by Tita Tavares on Fri, Aug 02, 2013 @ 01:16 PM

Enterey Word Cloud
 Enterey's On Cloud 9 with Wordle.net. We're having a fun Friday in the office. Have a great weekend everyone!

Tags: Enterey

2 Reasons Why Life Sciences Should Adopt Lean Six Sigma

Posted by Tita Tavares on Fri, Jul 19, 2013 @ 11:53 AM

 Enterey Helps Eliminate Risks

The Parallels Between Manufacturing and Pharma:

  • Process Improvement
  • Quality Management
  • Verified Data And Statistics
  • Simplicity

Lean Six Sigma principles of business management are making nothing but positive impacts on our pharmaceutical and biotechnology industries.

Lean Six Sigma was developed by combining Motorola’s original Six Sigma business management strategy with Taiichi Ohno’s “lean” philosophy first utilized in the Toyota Production System. The two ideologies share similar goals of reducing process variation and eliminating waste, and when combined form the optimum approach to business management.

Due to its origins, Lean Six Sigma was originally applied to the manufacturing industry, aiding in improved system design for companies such as General Electric. Over time, however, it has become clear that the benefits of Lean Six Sigma are applicable in many industries beyond manufacturing.

The seamless transition of Lean Six Sigma from manufacturing to pharmaceutical and biotech industries can be contributed to parallel needs.

Lean Six Sigma provides substantial results within pharma, biotech, and medical device organizations by increasing efficiency, cutting costs, and improving process steps, while trimming waste without sacrificing quality. Avoiding errors and reducing consumer risks are the two most significant benefits of adopting Lean Six Sigma into your business.

The quality of your products is directly related to success.  Consumer satisfaction is what keeps you in business. Lean Six Sigma allows you to protect your consumers while improving efficiencies.

If your approach to business doesn’t protect your customers then how do you measure your success?

 

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Published by Katie Georgi | Enterey Marketing & Communications Team  

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Tags: Lean Six Sigma, Pharma, White Belt, Yellow Belt, Black Belt, Green Belt, LTAC, Process Improvement, Quality Management, Manufacturing, Biotech, Medical Device

5 GREAT Ways to Get Rid of Conflict in Project Management

Posted by Tita Tavares on Thu, Jul 11, 2013 @ 12:35 PM

 
  

Projects are necessary evils in the business world. The use of collaboration to achieve specific goals makes them essential to meeting industry needs, however; with a timeline, costs, and constraints these temporary endeavors can easily become burdens if they are not managed properly.  

Project management is the act of initiating, organizing, and executing resources to achieve goals within a defined project. It is the job of a project manager to assemble and direct a specialized team in the undertaking of a project. Due to the provisional and collaborative nature of projects, teams are often comprised of people who do not normally work together. Projects require a large amount of human resources, communication, and time which can put strain on the project team. Combine unfamiliar coworkers with a stressful project and you have a recipe for disaster. So the question becomes: Is there such a way to avoid conflict in project management?

 

The acronym GREAT provides 5 easy measures that can be taken to prevent conflict in project management:

GOALS

Establish project goals thoroughly and clearly at the beginning of the project to avoid misdirection that could lead to conflict later on.

RESPONSIBILITIES

Explicitly define responsibilities to avoid work overlap which is inefficient and can provoke conflict amongst team members.

EXPECTATIONS

Establish clear expectations for the team including a code of conduct so that team members understand what is expected of them and respect their coworkers.

APPROACHABILITY

As the project manager, establish yourself as approachable at the start of the project so that your team feels comfortable interacting with you. Remember, you are the ultimate conflict resolver.

TEAMWORK

Emphasize the “team” in project team and ensure that everyone is aware that the project is a group effort to avoid alienating team members which can also be a source of conflict.                    

 

 Conflict Entereyresolve enterey

 

Get Rid of Conflict and Start High-fiving

 

The challenge for project managers is to try to maintain the right balance of conflict in project management. Get rid of conflict now by implementing these 5 GREAT steps and you will increase personal growth and morale, enhance communication, and improve project outcomes. What are you waiting for?
 
 

__________________________________

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Published by Katie Georgi | Enterey Marketing & Communications Team  

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Tags: Project Management, project manager, project managers

ENTEREY LIFE SCIENCES CONSULTING WELCOMES BACK A FORMER CONSULTANT

Posted by Tita Tavares on Thu, Jun 20, 2013 @ 11:04 AM

Irvine, California (March 05, 2013) – Enterey Senior Director of Operations, Carlo Odicino, returns to the life sciences consulting company after working in the field for a biotech company and a medical device manufacturer. He explains how the hands-on knowledge he gained primed him for his return to Enterey.

“My job at Enterey is to ensure the quality and consistency of the work from our consultants,” says Odicino. “It is much more valuable to have, or to be, a consultant who understands how things run on a day-to-day basis from the client perspective. The more we can put ourselves in our clients’ shoes—the more we have lived what they live—the more effective we can be.”

“I was driven to go out into the field to continue learning, build teams, and have ownership of internal strategic projects. I did that, and then I realized that the knowledge I gained could be highly useful to Enterey, so I came back,” he explains.

According to Inc. Magazine, rehiring a former employee is a “much more informed decision on both [sides].” Also, because there is little recruiting and vetting effort with a former employee, there are direct time and cost savings.

Knowledge retention is another benefit of embracing a past employee. This idea is aligned with the Lean Six Sigma methodology of Enterey and its partner, Lean Training and Consulting, Inc. And Odicino puts the Lean Six Sigma principles to work for Enterey clients. “Lean Six Sigma helped me when I worked in the industry, and it helps us now in consulting,” he says. “Lean Six Sigma is a powerful tool set and problem-solving methodology that is highly effective when applied to situations  appropriately. It is not a ‘one-size-fits-all’ solution. When we help train a client’s workforce to become more efficient, they’re able to increase output and improve quality, while maintaining the same size staff.”

“Meeting expectations isn’t good enough,” he says. “We need to exceed expectations in every single engagement. And we do this by paying attention to detail. We commit to the training of our consultants, and standardize both our delivery methodology and our tool set. I call it ‘The Enterey Way,’ and it means serving our clients in a consistent manner that consistently exceeds their expectations.”

“I’m excited to welcome Carlo back to the Enterey team,” says Enterey CEO Mike Ferletic. “His addition to our team will allow us to further increase our focus on high-quality service delivery and improve support to our consultants, and ultimately to our clients. Carlo’s experience working both as a consultant and as a client make him uniquely positioned to take on this role.”

 

Enterey Life Sciences Consulting provides consulting expertise in both business process- and systems-related projects for biotech, medical device, and pharmaceutical clients. Enterey provides solutions ranging from strategic planning to business integration, and has a proven track record of success supporting both clinical and commercial facility start-ups.

 

Contact Enterey at (800) 691-2349 or visit http://www.enterey.com for more information. 

 

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Tags: Enterey News, Product Lifecycle, Lean Six Sigma

ICH Q8 through Q10 Guidances on Quality Impact CMC

Posted by Tita Tavares on Fri, Mar 08, 2013 @ 02:06 PM

How familiar are you with their details?
With help from FDA guidance for industry documents, Enterey extracts key
take-away information and provides a quick, downloadable reference.

Reference Guide Download

ICH Guide

Tags: FDA, Risk Management, ICH, Q8, Q9, Q10, FDA Guidance, Quality Impact on CMC, CMC, Quality, 21 CFR Part 11

Enterey Launches LTAC's Lean Six Sigma Program for the Life Sciences

Posted by Tita Tavares on Tue, Nov 20, 2012 @ 11:54 AM

Continuous Improvement Meets Waste Elimination

Lean Six Sigma White Belt

IRVINE, CA--(Marketwire - Nov 20, 2012) - Enterey Life Sciences Consulting teams up with Lean Training and Consulting, Inc (LTAC) to offer certified Lean Six Sigma courses for businesses and individuals in the life sciences.

Six Sigma is a system used to train individuals to solve business-related problems in a calculated way. Created in the 1980s by Motorola, its purpose was to drive creation of error-free products. Six Sigma has its origin in statistics and rests on the idea of DMAIC, which stands for define, measure, analyze, improve, and control.

Lean methodology evolved from the Toyota Production System (TPS) that embraces the Japanese idea of the seven wastes, which, in manufacturing, includes the wastes of transport, inventory, motion, waiting, overprocessing, overproduction, and defects. The idea is to eliminate waste in order to enhance profitability.

Combined, Lean Six Sigma is a problem-solving technology aimed at reducing waste while striving for quality and continuous improvement. It's a best-of-both-worlds methodology.

LTAC founder and Certified Lean Six Sigma Master Black Belt, Tom Lawless, implemented Lean Six Sigma while serving in the military. "I was an operations officer, and my job involved tracking anything that moved -- by air, truck, or rail. When I started, tracking was at about 10%, but we brought it up to around 97% using Lean Six Sigma to increase truckloads and track convoys."

Lawless also brought his knowledge of Lean Six Sigma to the business world and has been working with manufacturing companies to improve productivity for over 20 years. One case study illustrating his success is that of a private equity group who acquired a major automotive manufacturer and sought help bringing the business back to life after the acquisition.

"People called it 'Gotham City.' Not only was productivity low, but so was morale," Lawless says. "In three years, we created one of the best turnarounds I've seen over the course of my career using Lean Six Sigma." He explains, "We trained people, which is one of the key premises of Lean Six Sigma, and showed them what they need to do to be successful."

Lawless recommended a workflow change from two simultaneous eight-hour shifts to one 12-hour shift in order to reduce cost and increase efficiency. But, as Lawless describes, employees were not laid off: "Lean is not mean; we don't advocate firing people, but instead move them to positions where they can be more productive."

"We took the plant from making 60 units a day on one [manufacturing] line to 160, and each unit sold for about $1,200, so revenue was significantly increased," he adds.

In fact, Lawless stresses the utility of Lean Six Sigma for any company involved in manufacturing, particularly in the life sciences and biotech. "We can manufacture anything in the U.S. and North America at a more competitive price and with better quality than the rest of the world," he says.

With LTAC's accredited program, learning is online in a self-paced environment, allowing for more flexibility with demanding work schedules and eliminating classroom burnout. The program is enhanced with weekly webinars with Lawless, who guides learners through the material and helps them apply it to real-world problems.

According to Lawless, "All companies have their bad turns, but they come out of them a lot quicker by figuring out what went wrong and implementing change using Lean Six Sigma."

The Enterey/LTAC partnership can benefit manufacturing companies in the life sciences by providing them with the knowledge and tools necessary to create a culture of continuous improvement, creating the potential for consistent and increasing ROI.

For more information or to register for Lean Six Sigma courses, contact Enterey at (800) 691-2349 or visit www.enterey.com.

 

Tags: Lean Six Sigma, White Belt, Yellow Belt, Black Belt, Green Belt, LTAC

The PRO Dilemma: Part 1

Posted by Tita Tavares on Tue, Oct 16, 2012 @ 04:41 PM

PRO Enterprise Management  

The PRO Dilemma: Part 1
How Does Your Company Decide
What to Pursue,
...and is it Working?

 

Debating & Deciding

A day in the life of a corporate decision-maker involves addressing a multitude of issues and striving to make the most of business. And, there are many styles of doing business, from conservative to liberal and free flowing with the cash. Imagine the “figure it out as we go” mentality of throwing cash at several projects to see where it will “stick” and generate profits. For most companies, though, a more calculated, safer approach is preferred. 

For companies with a sound risk-mitigation style, the decision-making process can be broken down into 3 parts: resolving problems, mitigating risks, and capturing opportunities. That is, addressing issues that arise, while trying to prevent others from occurring in the first place--all while trying to maximize profitability.

But which Problems? Which Risks? And which Opportunities should be pursued to protect and create the most value? That’s the PRO dilemma.

 

The PRO Plan

The Decision Empowerment Institute’s PRO risk-mitigation plan rests on the theory that the health and well-being of individuals directly influences a company’s cash flow and, therefore, a company’s health and well-being. In the life sciences, issues that can affect cash flow include poor sales due to lack of product efficacy, product recalls, safety issues, etc. In this way, quality is the backbone that supports a business and allows it to thrive.

The idea that cash is king is not new. In fact, risk-adverse businessman Warren Buffet was interviewed on Bloomberg about his interpretation of the saying, “cash flow is king.” He says he never wants to be unable to conduct a new business venture due to lack of cash flow, and the amount he like likes to keep around may be surprising.

To put it simply, it doesn’t matter how much profit is expected to come in if there’s nothing in the bank in the meantime. If you have no working capital, your business may be dead in the water. You may not be able to obtain the supplies you need to continue manufacturing, and employees will probably not hold off on cashing their paychecks until the profits come rolling in. In short, you need cash flow to maintain a healthy, vibrant business.

In the life sciences, issues that can impact cash flow need to be effectively managed. But how is this best done, given that there’s always an opportunity cost of pursing one action (ie, mitigating a certain risk or pursuing one opportunity) over another? Another known businessman, Benjamin Franklin, said it best when he coined the term “time is money.”

 

Putting the Plan into Action

In the life sciences, issues that can affect cash flow include clinical holds on new products, stock out from delayed tech transfer, glass-vial breakage, below-sales forecasts, and so on. Any of these things can impact cash flow by, for example, keeping a product from reaching the market on time, increasing manufacturing costs, and slowing sales. But which risks should be mitigated first, and then which opportunities should be pursued over others to create the best value?

PRO’s risk-mitigation plan paired can be used to make these determinations by asking the decision-maker to consider the following 5 questions:

1. What are your PRO items?

  • Below-sales forecast for products/services (Problem)

  • Unreported adverse drug events and inconsistent NDA safety database (Risk)

  • Improve clinical trial supply forecasting (Opportunity)

2. Which, if NOT pursued, erode the most value?

3. Which, if pursued, create or protect the most value?

4. Which should you pursue?

5. What are the implications to your plan and budget?

 

Can you, as a stakeholder in your organization, answer these questions? A solid risk-mitigation plan may include enlisting the help of a life-sciences consultant specializing in this area. Another way to think of this is “it takes money to make money.” Spending $300k on support staff during an NDA submission, for example, may protect $14MM in potential loss. And that’s just good business.

Join Us for A Complimentary Webinar!

Finally, A Risk Management Solution that Works!
Learn from Decision Empowerment Institute about the truth of decision making

Presenter: Brian Hagen, PhD. Risk Management from Stanford and Internationally Recognized Authority On Decision Making

Host: Tita Tavares and Rob Johnston of Enterey Life Sciences Consulting
Date: Thursday October 18, 2012
Time: 11:30 am Pacific | 2:30 pm Eastern
Duration: 45 minutes

Click here to register.

-------------------------------------------------

PRO Enterprise Management Methodology,
Rights of Decision Empowerment Institute
partners of Enterey, Inc.

www.empowerdecisions.com

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Next Blog
PRO Dilemma Part 2

 

Tags: Risk Management, PRO Enterprise Management, Decisions, Risk-Mitigation