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


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


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

Enterey News September 2012

Posted by Tita Tavares on Thu, Sep 20, 2012 @ 03:18 PM


Community Corner

Enterey Community Corner

Helping Those In Need Get Dressed to Impress

At Enterey, our business is providing growing life sciences companies with operations solutions that allow them to focus on what they do best. As a company-wide initiative, we also like to focus on doing our best, not just with the services we offer but also for our community. Partnering with companies like Robert Half International—an organization that has helped over 5,000 people return to the workforce after poverty, abuse, or military duty—our contributions become even more impactful. 
Last month, Enterey participated in Robert Half’s suit drive benefiting Working Wardrobes of Orange County. The goal was to collect donations of professional attire and accessories to help empower people of all backgrounds to confidently enter the workforce and achieve self-sufficiency. With the help of our friends and family, we donated everything from well-kept designer suits to bags full of barely worn shoes, all of which will soon help people seeking employment get “dressed to impress.” 
Thanks to Office Team Laguna Niguel, a Robert Half Company, for allowing us to participate in this initiative and make a difference in our community.

What's in The News for Enterey?

Enterey Consulting Partners With DEI to Support the Creation and Protection of Shareholder Value for the Life Sciences

Enterey DEI Risk Management 5
IRVINE, CA--(Marketwire - Sept 05, 2012) - Enterey Life Sciences Consulting, a leading provider of consulting services focused on manufacturing and quality operations for life sciences companies, introduces Decision Empowerment Institute (DEI) PRO-Enterprise Management Risk Quantification Approach for assessing operational and compliance risk, resulting in a sustainable risk-mitigation strategy and protecting potentially billions in shareholder value. 




Risk Management Seminar with DEI - October 4, 2012 at 11:30 am

Can you, as a stakeholder in your organization, answer the following "Five Questions" related to your company's problems, risks, and opportunities (PRO)? Find out why you should be concerned and learn how to prioritize your risks. Registration information will be announced soon. 


8th Annual Quality & OPEX in Pharma & Biotech - Frankfurt, Germany | October 4-5, 2012

Enterey CEO, Mike Ferletic, will present a Case Study on The Importance of Proactive Compliance and Preparing for GMP Inspections.

Register for the conference >>


Project Update: Consultant Assists in Successful PAI to Support Commercial Launch

A small drug-development company in Southern California set out with the goal of acquiring a commercial license for its oligonucleotide manufacturing facility in 2012. See how the Enterey consultant was able to assist in a successful European PAI to support the client's commercial launch.

View details >>




Project Update: Tech Transfer Leads to Spend Analysis & Increased Utilization

A prominent biotech/pharmaceutical manufacturer requested assistance in transferring its clinical manufacturing capabilities to a newly commercialized facility. Read more about how Enterey's consultant led the client to refrain from a site closure.

View details >>


Tags: Enterey News, Life Sciences Industry News, Life Sciences News & Hot Topics, Quality Risk Managment, Risk Management, Life Sciences, Proactive Compliance

Process Improvement Award Winner with Global 500 Biotech Company

Posted by Tita Tavares on Thu, Feb 23, 2012 @ 10:58 AM


Austin Srejma Enterey Senior Consultant

Austin Srejma, Enterey Senior Consultant


"Enterey Project Wins Process Improvement Award From Global 500 Biotech Company"

See how we introduced a more efficient change control process to help the growth of a current biotech client. Congratulations to Austin Srejma for being awarded a process improvement award. 

"Austin Srejma has served as Senior Consultant with Enterey since July 2009. This is the second time one of her projects has received a process improvement award. Enterey Life Sciences Consulting, founded in 2002, provides Life Sciences Consulting expertise across both process and system-related projects. Enterey provides solutions for a wide range of client needs, from strategic planning to business-integration activities, implementation and specialized efforts, such as clinical and commercial facility start-ups. Enterey has a proven track record for successfully delivering projects within the biotech and pharmaceutical space"

Read further current press details highlighted in LA Daily News.



Tags: Enterey, Enterey News, Life Sciences News & Hot Topics, Facility Start-up, Life Sciences, Process Improvements, Life Sciences Communication, Life Sciences Consulting

The Five Critical Areas of Project Management

Posted by Tita Tavares on Thu, Feb 09, 2012 @ 11:21 AM

We’ve all been involved in projects that seem to go on forever and ever or seem to take on additional resources. As project management specialists, we’ve come up with a list of five key components necessary for project management.

 Project Management Five Qualities

The five, explained below, are:

  1. Scope definition at the start of the project

  2. Set milestones and goals

  3. Define your team and resources/Ensure you have the expertise to identify problems

  4. Maintain good communication throughout the project

  5. Track progress and review results

cope definition at the start of the project: In this first, important step, we establish exactly what the project’s goal is, what’s in the scope and what is outside of the scope of the project. Experience has shown us that it is just as important to define what the project WILL accomplish as what it WILL NOT in order to control the direction of the project. Part of defining the scope is to also to define the timeline and deadline for the project’s completion.

Set milestones and goals: Once we define the scope, we can then define the different tasks that go along with it. The purpose of identifying milestones is to set intermediate measuring points to rate the project. By grouping milestones together, we can then establish more specific timelines.

On some projects, a milestone will serve as a marker to make a decision or to reassess a previous decision. For instance, while going through the review of a bidding process for a facility or in processing equipment, you will need to review different bid packages. In this case, a milestone will represent a decision point during the evaluation process to select a contract. Your overall goals will incorporate a number of milestones and you’ll need to create a schedule that ties all of these components together.

Define your team and resources: Depending on the project, you will need to identify the disciplines that your project requires. If it is technical, you will need people with certain problem-solving or trouble-shooting expertise. If there are trades involved, you might need somebody from electrical or quality. Whatever the project requires, you’ll need to identify all the stakeholders as well as what role each would play. You’ll also need to establish who would be reviewing/managing the work that gets done to make sure it is completed satisfactorily.

Also, when putting your team together, you’ll need to take into consideration the time commitment involved and ensure that each person involved is able to dedicate the time to work on it.

Maintain good communication throughout the project: Good communication is key to the success of any project. Each team player needs to be aware of the overall schedule, of the work they need to complete or what they will have to review. They will also need to be aware of what is going on with the rest of the project as it moves along.

In addition to making sure that those involved know their responsibilities, they also may need to know the milestones that have been set. Throughout the project, maintain a central repository of information, whether it is on a shared drive, online, or at a physical location. This will be where the team can get the latest information or whatever else they may need. Make sure that everybody has proper access to it.

Track progress and review results: Initially, you’ll need to establish how often your team or key players will need to meet: Will it be daily or weekly? Then you’ll need to track the progress that has been made in between each meeting for each of the tasks. Is everything on schedule? What tasks have been completed?

It’s helpful to identify any obstacles you may run into ahead of time so that you can account for them. Do you need any additional resources or departments to complete a task?

When additional resources have been requested, track whether they have been provided. When reviewing the results, you will need to identify when each tasks was completed, acknowledge that it was completed, and share this information with the stakeholders so that a task is not revisited and time is not wasted. By following through on the Five Critical Areas of Project Management, you can ensure that you meet your deadlines on time, on target and on budget.


Now we’d like to hear from you. What areas of project management have been problematic for your team? Where has your project hit a snag or lost or gained time? With these tips, do you think you can be more effective in your project management?

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Published by Murtaza Kapadia | Senior Manager, Enterey

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Next special article blog:
More on Project Management 

Tags: Life Sciences, Project Management, Resources, Project, Project Management Specialist

4 Rules to Facility Start-up. The Final Rule of Facility Start-up.

Posted by Tita Tavares on Thu, Aug 25, 2011 @ 02:40 PM

We’ve reached our final rule for facility start-ups:

The law of “The Jungle”

This rule is a play on two literary references that are applicable to a Life Sciences facility start-up.  The first is a reference to the book The Jungle by Upton Sinclair.   This book, published in 1905, exposed unsanitary conditions in the Chicago meat packing industry and served as a catalyst for the Pure Food and Drug Act passed in 1906.  This act is a pre-cursor to today’s current good manufacturing practices (cGMPs) that govern Life Sciences companies.  These cGMPs are non-negotiable and must be followed regardless of impact to the schedule of the start-up.  I know for most this goes without saying, but it is worth driving home the point.  Yes cGMPs are guidelines, and yes most companies go above and beyond cGMPs but in the thick of some of the financial pressures that occur during a highly visible capital projects like a facility start-up these sometimes can and do get forgotten. 

I realize in rule #3 we stressed not placing invisible boundaries to problem solving, cGMPs are very real boundaries and should always be followed.

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The second literary reference is to the last line of Rudyard Kipling’s poem The Law of the Jungle which is as follows


“…For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.”


This one line summarizes the type of teamwork that is required through a successful start-up.  There is no one individual or functional area that is more important than another.  All groups / individuals play their part and need to work together to both solve problems and drive towards success.   There will be problems, there will be delays but a start-up team will always succeed if they focus on the appropriate level of detail, are balanced in their approach, don’t create artificial boundaries, all while adhering to cGMPs and working as a TRUE team.

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Published by Carlo Odicino | Former Director, Client Services


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Next week’s blog:
Laboratory Information Management System (LIMS) toward Streamlined Biotechnology and Pharmaceutical Operations



Tags: Facility Start-up, Life Sciences, cGMPs, Law of the Jungle, Final Rule to Facility Start-up