Supply by Design for the 21st Century: Development of Good Supply Practices (GSPs)

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Impact of Initiative

Good Supply Practices (GSPs) are being developed by FDA officials and industry professionals across the Life Sciences industry (pharmaceutical/biotech and medical device) through a methodical Supply-by-Design process that increases the reliability of incoming supply, and therefore reduces the risk to finished product quality, patient safety and business success. 

This impact has been achieved by determining the source of dysfunction affecting the integrity of supply, and implementing sustainable solutions that can be tied to return on investmentsuch as increased safety, improved quality and enhanced reliability—commensurate with the need.

Problem Statement

During the 2010 and 2011 FDA/Xavier University pharmaceutical/biotech and medical device conferences, both industries expressed repeated concerns related to not being able to reliably and consistently ensure the supply of incoming materials used in products to serve the Life Science. As a result, Xavier University formed a team of FDA Officials and industry professionals in 2012 to investigate root causes and develop impactful solutions using the DMADV (Define, Measure, Analyze, Design, Verify) process (current team members are listed at the end of the page).

 

Scope of Work

  1. Incoming material and contracted services procured to support the manufacture of finished product.
  2. The pharmaceutical/biotech and medical device industries.
  3. The upstream and downstream supply chain.

 

Results

It has been, and still is today, widely believed that the lack of reliability of incoming material is based on poor performance of suppliers, and is therefore the basis of many supply chain management practices. In order to explore root causes, the Life Science manufacturers developed a comprehensive list of failure modes associated with the defined process flow shown in Figure 1.

Figure 1:  Supply chain process flow

Through the failure mode analysis work, a major paradigm shift was recognized in that all of the failure modes were related to risks either induced by the manufacturers themselves, or could have been avoided by the manufacturers. The failure modes were not solely related to poor performance of suppliers as originally surmised (Figure 2). This critical paradigm shift has enabled the Life Science industry to focus solutions on reducing risk caused by the manufacturers, and therefore, actually reduce risk to the final product.

Figure 2:  Major paradigm shift revealed through failure mode analysis

Figure 2:  Major paradigm shift revealed through failure mode analysis

The identified failure modes were then incorporated into a cause and effect matrix that each manufacturer and FDA officials scored against six critical customer criteria. A survey was sent to 162 suppliers who supply the pharmaceutical, medical device, and food industries. In every case, the suppliers corroborated the findings of the manufacturers and importantly, did not identify an obvious failure missed by the manufacturers.

The direct impact of this paradigm shift is that it:

  • Shifts resources from trying to improve supplier performance to improving internal performance that affects the ability of the suppliers to perform well.
  • Enables industry to take ownership of the failure modes impacting supply chain integrity.
  • Enables industry to develop solutions that will reduce risk to product quality.
  • Enables global regulators to understand critical root causes to supply chain integrity and therefore product quality risk.

Table 1:  Current state versus Xavier Approach

Identified Areas of Opportunity

A Pareto analysis of the resulting Cause & Effect scores yielded a rank order of the failure modes in alignment with the critical criteria, and also enabled the team to identify high-level themes of failures present in the data—again, related to risks they themselves induce into the supply chain management process:

  1. Lack of Product and Process Knowledge and Development
  2. Poor Supply Chain Development and Management
  3. Misaligned and Conflicting Internal Behaviors
     

I. Lack of Product and Process Knowledge and Development

The original assumption at the outset of this Supply Chain Initiative 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 at all or at the right time, 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. 


II. Poor Supply Chain Development and Management

Many manufacturers have supplier selection and supplier approval processes in place, yet demands on speed to market often result in circumvention of these processes.  It has also been found that supply agreements often conflict with the requirements of other agreements and drive the wrong behavior on both sides of the relationship. Additionally, although supplier qualification is not a new concept, it has been found that the elements of risk assessed are often not representative of key cross-functional requirements, and therefore, do not provide a complete representation of risk.   


III. Misaligned and Conflicting Behaviors

Throughout product, process and supply chain development the data from the manufacturers revealed that a lack of internal involvement of cross-functional representatives consistently leads to a lack of alignment that results in increased risk. There is not a harmonized approach to understanding how to align internal objectives, involving the right groups at the right time, delineating roles and responsibilities, and knowing when and how to engage suppliers. There is a perception that manufacturers cannot share important information with their suppliers, and thus the lack of transparency hinders suppliers from being able to perform well for the manufacturers. Additionally, manufacturers historically conduct supplier qualifications to determine risk level of their suppliers, but do not assess the risk they bring to the relationship, which does not allow them to avoid false starts, delayed timing, poor product performance and increased risk to product quality.


Key Aspects of the Good Supply Practices:

  • Development of pragmatic (i.e. business smart) supply practices that establish best practices that can be implemented irrespective of company size.
  • Development of an Alignment Optimization model for product and process development that guides purpose-driven cross-functional involvement, the goals of each stage to maximize alignment, what to measure to determine the success of each stage of development, who the decision makers are, and when to involve suppliers.
  • Establishment of a process for manufacturers to conduct a self-assessment to understand and ultimately mitigate risk they induce into the product, process and supply chain development.
  • Establishment of key risk elements to assess during supplier qualification that include quality and business success factors.
  • Clarification for industry of what information truly is confidential, versus what opportunities there are for transparency with suppliers that will enable suppliers to better support the manufacturers.
  • Examples of how the Life Science industry can improve scheduling stability with suppliers so as to reduce opportunities for error that are introduced by the manufacturers.
  • Clear understanding of product, process and supply chain risk for both industry and regulatory authorities.

The following timeline was established at the beginning of the initiative in August 2012:

Current Team Members

  • M. Bhupathy, Senior Director, Global Pharmaceutical Technology, Shire
  • Dale Carter, Global Director of Quality, Huber
  • Troy Fugate, Vice President, Compliance Insight
  • Patrick Henry, Director of Business Development, Puritan Products
  • Cindy Ipach, President, Compliance Insight
  • Elaine Jai, Supply Chain and Procurement Manager, Eli Lilly
  • Viliam Kovac,Head of Global Supply Quality,Roche
  • Michael Landberg, Strategic Global Sourcing, Boston Scientific
  • Neil Lewis, Global Technical Leader Microbiology Delivery, P&G
  • David Lowndes, Head of Small Molecule Operations, Shire
  • Kristen Lyons, Quality Engineer, Cook
  • Marla Phillips, Director, Xavier University
  • David Rothenberger, Consultant - QA Procurement, Eli Lilly
  • Jack Solomon, Practice Leader, Supply Chain, Core Risks
  • Kelly Taylor, Director - QA - Procurement, Eli Lilly
  • Andre Warren, Vice President, WLS Enterprises, Inc.
  • Rebecca Bishop, Procurement Manager, Eli Lilly
  • Christopher Claeboe, Director, Contract Manufacturing & Product Management, Codexis
  • Tony Durand, Senior Quality Assurance Manager, Abbott
  • Hanna Edstrom-Valsinger, Sourcing Process Leader, GE Healthcare
  • Dave Gault, Senior Manager Risk, Compliance & Security, CPKelco
  • Steve Greer, Corporate QA External Engagement Leader, P&G
  • Al Kentrup, Head, Global Quality and Compliance Systems, Takeda
  • Stephanie Leonardos, President & CEO, Amerikam
  • Lingli Lin, Associate Director, Supplier Quality Management, Impax Laboratories
  • Bei Ma, Strategic Business and Technology Leader, BSI
  • Paul Nelson, Vice President, Supply Chain and Project Management, Amring Pharmaceuticals
  • Shonte Pettiford, Supplier Quality Program Manager, Abbott
  • Greg Pierce, President and Founder, Engisystems
  • Susan Rolih, Executive Vice President, Regulatory Affairs and Quality Assurance, Meridian Bioscience
  • Elaine Shannon, Senior Director, Global Quality Compliance and Systems - Knowledge Management, Takeda
  • Michelle Smith, Senior Director, Regulatory Affairs and Design Assurance, Meridian Bioscience
  • Stelios Tsinontides, Sr. Director, Drug Product Manufacturing Sciences & Technology, Shire
  • Juan Vargas, Director, Supplier Quality, Johnson & Johnson
  • Sherry Warren, President, WLS Enterprises, Inc.
  • Steve Wolfgang, Consumer Safety Officer, CDER FDA