Driving Ideal Behavior

Part 4 of the Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier Health, Xavier University. This is the fourth installment in a four-part series on supply chain management.

There is strong recognition that human factors play a large role in how the supply chain operates (as with everything else).  Success and positive impact cannot be attained without simultaneously addressing what drives human behavior in this space.  The contribution to the Good Supply Practices (GSPs) relative to this theme will include:

  • Relationships – understanding the cultural alignment between the manufacturer and the supplier, establishing and maintaining expectations with cross-functional involvement, critical factors to consider in quality and business cultural alignment, optimizing transparent communication, and identifying what the ideal behaviors are commensurate for each relationship.
  • Performance – establishing key triggers and associated escalation tied to performance improvement on both sides of the contract (yes, that means assessing yourself!), understanding the consequences (intended and unintended) of performance measures used for employee performance and pay versus business metrics, and establishing mechanisms for supplier recognition.

Many discussions throughout the entire initiative have centered on behavior.  For example, customers historically operate without caring what the cost or disruption to the supplier is, or how the supplier profit margins are impacted.  Forecasting changes are communicated without notice and on a regular basis, while the supplier is left scrambling to “make it work.”  Yet, there is a lack of realization that this churn increases opportunity for error, thus decreases the ability of the supplier to be reliable for the manufacturer.  So can we establish criteria that are helpful for both sides on an on-going basis?  Transparency is a key component, while recognizing what is actually important to competitive advantage versus current paradigms.  This will become more apparent as we demonstrate how other industries operate collaboratively despite fierce competition.  Suppliers have indicated that receiving conflicting information from various groups within their client’s organization is actually a big challenge.

Our data has also revealed that random metrics that do not trigger action create distraction that leads to dysfunction on multiple levels.  Additionally, there is a need to increase accountability and responsibility throughout the supply chain on both sides of the contract.

As noted in my previous blog (link), Working Groups have been developed to address the issues these themes present and provide GSPs for the industry.  Key elements that the Working Groups will keep in mind across all three themes is the need to address each theme from all phases of the product lifecycle:  different groups involved at various phases, different levels of control, centralized versus decentralized, etc.  In determining benefit of implementation, remember that our industries are mostly operating at a 6 sigma level already.  But due to the impact of failure, risk constantly needs to be evaluated, understood, and addressed.  And finally, there is a need to develop solutions that will work for small businesses (both suppliers and clients) as well as midsized and large firms.

Look for the GSPs established by the Working Groups to begin in 2016.  Until then, why not join us at the FDA/Xavier University PharmaLinkConference on March 24-27, 2015 at Xavier University, where you’ll learn more about each of the themes above, and how you can be a part of the solution.

See you there.

Previous Blogs from Dr. Phillips:

About Dr. Phillips

phillips_small

Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries.  These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries.  Phillips was the former Head of Quality for the Merck North Carolina Facility.

West’s Andy Polywacz and Jennifer Riter to Present at Interphex, April 21-22, 2015

West’s Andy Polywacz, VP Quality & Regulatory Affairs, and Jennifer Riter, Sr. Director, Global Analytical Services, will present at the 2015 Interphex conference on April 21-22, 2015. The conference will be held at the Javits Center, New York City, NY.

Andy and Jennifer will present, “Particles Causing End of Line Rejects and Drug Product Recalls: Overcoming Packaging Challenges and Need for Adequate Controls,” at the conference. The session is designed to provide insight into the various sources, causes and concern for particulates from primary and secondary packaging components.

Particles may originate from multiple sources throughout the lifecycle of a pharmaceutical product. Various types and sizes of particles can occur which can be foreign or extrinsic to the process, intrinsic (that is, from within the product or process such as product contact materials), or inherent , which is known to be associated with specific products. Particulates can cause unintended changes to the finished pharmaceutical resulting in potential delays to market, not to mention the risk of costly recalls and shortages. The pharmaceutical ingredients and stability issues can contribute to the particle load as does the environment and manufacturing equipment but it is a well-known fact that materials used in primary and secondary packaging components are often identified. Component manufacturers are tasked with minimizing the particulate load to reduce the contribution to the finished drug product.

Join Andy and Jennifer at Interphex to learn more. Visit http://www.interphex.com/ to register to attend.

Product and Process Knowledge and Development

Part 3 of the Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier Health, Xavier University. This is the third installment in a four-part series on supply chain management.

At the outset of the Integrity of Supply Initiative, an assumption was that suppliers cannot consistently supply what is needed.  However, it was discovered through our research that manufacturers often do not know what specifications are actually needed, do not involve suppliers in development discussions, do not explore the full expertise of suppliers, do not understand their own process well enough to know how the incoming material will impact their process, and do not ask for the process capability of their suppliers.

The contribution to the Good Supply Practices (GSPs) related to this theme will address measures that can be taken to improve product and process development, including:

  • Understanding finished process and material requirements
  • Standardized stage gate model that can guide development practices
  • Exploring the capabilities of suppliers
  • True involvement of suppliers in development and improvement opportunities
  • Knowledge transfer

A key element of this theme is doing it right to begin with, so involving the right functional groups upfront and understanding how to effectively engage suppliers are critical to the success of product and process development.

It is critical that any GSPs developed out of the Integrity of Supply Initiative be pragmatic (i.e. business smart), provide harmonization where possible, and establish best practices that can be implemented irrespective of company size.  To that end, Working Groups have been established and charged with the task of including decision making tools where possible, such as flow charts and matrices, such that the practices can be implemented in a meaningful way.  It is important to keep in mind that the GSPs are not to be prescriptive and confining, but rather provide options and best practices to apply appropriately relative to the need and commensurate with the criticality.

My next blog will discuss Driving Ideal Behavior.  To learn more about any of those topics, I’d like to invite you to join me at the FDA/Xavier University PharmaLink Conference, March 24-27, 2015.  At the conference, you’ll work side-by-side with regulators to deepen the understanding on both sides of the challenges and opportunities the Initiative is seeking to uncover.

I look forward to seeing you there!

Previous Blogs from Dr. Phillips:

phillips_small

About Dr. Phillips

Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries.  These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries.  Phillips was the former Head of Quality for the Merck North Carolina Facility.

West Launches High-Quality Flip-Off® PlusRU Seals

West is pleased to announce the availability of a new sterile drug vial seal, the Flip-Off® PlusRU seal. Part of West’s Flip-Off® seal product family, these new ready-to-use seals help pharmaceutical and biopharmaceutical manufacturers protect the safety and integrity of their drug products while meeting regulatory requirements for increased drug cleanliness and safety.

For Martin FOS 1

Based on the West Flip-Off seal, the Flip-Off Plus RU seal is bioburden controlled and specified before sterilization, and compliant with clean crimping requirements.  The seals are available ready to use and play an essential role in keeping injectable drugs safe.

They ensure that drug products in vials are sterile and free of contaminants and particulates that could present risks to patients.  This sterile, high-quality seal helps pharmaceutical customers consistently achieve reproducible and safe container integrity for drug products while ensuring low levels of bioburden and particulates, which may help make drugs safer for patients.

“Clean sealing matter now more than ever. Changing regulatory guidelines have increased the demand for reliable seal solutions,” said Dr. Mike Schäfers, Vice President, Global Marketing, Pharmaceutical Packaging Systems. “Using high-quality sterile packaging components minimizes the risk of external contamination, line stoppages and equipment down-time. With Flip-Off® PlusRU seals we can help our customers to increase their operational efficiency significantly while meeting the highest market and regulatory challenges for increased drug integrity and safety.”

Flip-Off® PlusRU seals are manufactured using the TrueEdge® manufacturing production process providing precise, consistent and reproducible seals with a smooth, even bottom edge, which addresses requirements for high-speed filling and reliable capping success.

For more information on West products and services please visit us online at www.westpharma.com.

Flip-Off® and TrueEdge® are registered trademarks or trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

Supply Chain Development and Management

Part 2 of the Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier Health, Xavier University. This is the second installment in a four-part series on supply chain management.

In my previous blog, I mentioned the three overarching themes that need to be addressed to help ensure the integrity of the materials supplied throughout the pharmaceutical and medical device supply chains through the development of Good Supply Practices (GSPs).

Many manufacturers have supplier selection and supplier approval processes in place, yet demands on speed to market often result in circumvention of these processes.  Additionally, it has been found that supply agreements often conflict with the requirements of other agreements (such as Quality Agreements) and drive the wrong behavior, as it is difficult to satisfy both sets of expectations.

It’s not hard to imagine that if industry agreed upon some key supply chain practices to harmonize on, that suppliers would be able to focus resources on more critical aspects of supply reliability than managing more than one-hundred different ways to perform the same task.

The contribution to the GSPs related to this theme will address the topic of transparency in conjunction with trust, forecasting ability related to stability, and the standardization of several practices – including internal alignment processes and risk considerations versus need.

The supplier relationship must be maintained throughout the product lifecycle, which often requires different decisions to be made at different points in time.  The exploration of which functional groups to involve and when will be added to the GSPs for companies to consider in their processes.

Financial aspects as well as quality, safety and brand will be addressed, as well as lack of leverage and risk factors (internal and external) that need to be explored.

In my next blog, I’ll discuss the product and Process Knowledge and Development theme.  In the meantime, if you’d like to learn more about the Integrity of Supply Initiative, join me at PharmaLink 2015.  The conference, co-sponsored by the FDA and Xavier University, will be held on Xavier University’s campus March 24-27, 2015.

You’ll learn more about the initiative, identify solutions that will protect patients around the world and work through real working models that can improve the reliability of your product.

See you there!

About Dr. Phillips

phillips_small

Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries.  These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries.  Phillips was the former Head of Quality for the Merck North Carolina Facility.

Previous Blogs from Dr. Phillips:

Integrity of Supply Initiative – Developing Good Practices

Part 1 of a 4-part Good Supply Practices Series

West is pleased to welcome guest blogger Dr. Marla Phillips, Director, Xavier Health, Xavier University.

Materials and products used to serve the drug and device industries are supplied from areas all over the world. From raw materials such as sand to highly processed components for delivery systems, the materials that are used to create packaging systems are presumed to be safe.  But how can pharmaceutical manufacturers be sure that incoming materials used in these products are consistently safe and reliable?

Through the Integrity of Supply Initiative, Xavier Health is developing Good Supply Practices (GSPs) for the pharmaceutical and medical device industries to provide solutions to increase the reliability of supply.  Perhaps the greatest discovery revealed through the initiative to date is the paradigm shift that every area of dysfunction related to the reliability of supply is caused by and/or can be controlled by the manufacturers themselves, not their suppliers. It is through this greater understanding that our solutions will shift from increasing supplier controls to improving how manufacturers work with their suppliers.  The solutions will be tied to return on investment, will be commensurate with risk-based need, and will provide cross-industry best practice options.

It is the mission of the Integrity of Supply Chain Initiative to determine the source of the dysfunction affecting the integrity of supply, and to implement sustainable solutions that can be tied to return on investment, including increased safety, improved quality and/or enhanced reliability.

Pharmaceutical manufacturers, and ultimately, the patients they serve – need a reliable and consistent supply chain of safe, quality materials and products to limit adverse impact on the end user.

However, research results generated by manufacturers through the Xavier initiative has revealed that most of the issues begin with dysfunctions caused by the manufacturers themselves.

Areas of identified improvement opportunities fell under three main themes:

  • Supply Chain Development and Management
  • Product and Process Knowledge and Development
  • Driving Ideal Behaviors

Identified by pharmaceutical and medical device manufacturers and corroborated by suppliers, these themes help to identify dysfunction that can be mitigated or avoided through the improvement of internal supply practices and/or through harmonization across the industry.

In future blogs, I’ll address each of these themes and next steps to help ensure greater reliability in our supply.

Interested in learning more?  Then register now for PharmaLink 2015!  The conference, co-sponsored by the FDA and Xavier University, will be held on Xavier University’s campus March 24-27, 2015.  Join us!

About Dr. Phillips

phillips_small

Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries.  These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries.  Phillips was the former Head of Quality for the Merck North Carolina Facility.

The Customer Driven Organization: Employing the Kano Model

Why is meeting customer needs no longer enough? In an expanding global economy with international competition, meeting customer needs is simply not enough. Meeting customer needs leads to customer satisfaction but does not lead to customer loyalty, which is what keeps companies in business.

Delighted customers however, are loyal customers. The Kano Model developed by Noriaki Kano describes delightful performance as that which surprises and excites the customer in addition to meeting their basic needs. In order to “delight” a customer, an organization or individual must become aware of not just what is asked for, but rather what is needed. They have to look to the future as inspiration for innovation today.

Quotes from two of our greatest innovators born almost 100 years apart would tend to agree. Steve Jobs is known to have often said, “A lot of times, people don’t know what they want until you show it to them.” Henry Ford is reported to have said, “..if I had asked my customers what they wanted, they would have said a faster horse.”

Providing delightful service is more than just a nice thing to do, it is an imperative for business/professional survival both for the organization and the individual. What I have tried to share with the reader in The Customer Driven Organization: Employing the Kano Model, was threefold : why a philosophical paradigm shift is required to provide truly delightful service, how to practically apply the concepts espoused by the Kano model and finally, why one should care to do so.

Tech Group is always working to achieve superior customer service. We are known throughout our industry for it. I had the opportunity to attend the annual CMNA corporate meeting at the Wigwam Resort her in Phoenix for the first time this year. A repeated theme at this year’s CMNA meeting was  cross functional focus on how we can continue to improve, stay ahead of our competitors, anticipate our customers’ future needs, while continuing to excel in meeting their current needs.  In other words, how to provide “delightful” service to our customers as explored and explained by the Kano Model.

Author:

Lance B. Coleman
Senior Quality Engineer
ASQ CQE/CQA/CSSGB/CBA
Lance.Coleman@techgroup.com

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