Integrity of Supply Initiative

Goal: 

To develop and implement pragmatic Good Supply Practices (GSPs) for the pharmaceutical and medical device industries that increase the reliability of incoming supply, and therefore reduce the risk to finished product quality, patient safety and business success.

This goal will be achieved by determining the source of dysfunction affecting the Integrity of Supply, and to implement sustainable solutions that can be tied to return on investment – such as increased safety, improved quality and enhanced reliability – commensurate with the need.

Statement of the Perceived Problem:

During the 2010 and 2011 FDA/Xavier University pharmaceutical 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 pharmaceutical and medical device industries.  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 in Appendix I and II).

Scope of Work:

  1. Incoming material procured to support the manufacture of finished product.
  2. The pharmaceutical and medical device industries, with the potential to add food and cosmetics.
  3. The downstream supply chain and other industries will be assessed after the initial solutions are developed.

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, including Supplier Relationship Management (SRM).  In order to explore root causes, the pharmaceutical and medical device manufacturers developed a comprehensive list of failure modes associated with the defined process flow shown in Figure 1.

Supply Chain Process Flow - Integrity of Supply

 


Figure
1:  Supply Chain Process Flow

Through the failure mode analysis work, a major paradigm shift was recognized for the first time in these two industries 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 related to poor performance of suppliers as originally surmised (Figure 2).  This critical paradigm shift has enabled the pharmaceutical and medical device industries 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

 

Major Paradim Shift - Integrity of Supply

 

 

The identified failure modes were then incorporated into a Cause & 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:

  • 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 prove to reduce risk to product quality.
  • Enables global regulators to understand critical root causes to supply chain integrity and therefore product quality risk.

Issues to be Resolved

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

Lack of Product and Process Knowledge and Development Theme

The original assumption at the outset of the Integrity of Supply 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.

Poor Supply Chain Development and Management Theme

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.

Misaligned and Conflicting Behaviors Theme

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.

The goals of the proposed Good Supply Practices are:

  • Develop pragmatic (i.e. business smart) supply practices that will include harmonization where possible, and establish best practices that can be implemented irrespective of company size.
  • Develop stage gate model approaches for product and process development that address cross-functional involvement, the goals of each stage to maximize alignment, what to measure to determine the success of each stage, who the decision makers are, and when to involve suppliers.
  • Establish 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.
  • Establish key risk elements to assess during supplier qualification that include quality and business success factors.
  • Clarify for industry what information truly is confidential, versus what opportunities there are for transparency with suppliers that will enable suppliers to better support the manufacturers.
  • Provide examples of how the pharmaceutical and medical device industries can improve scheduling stability with suppliers so as to reduce opportunities for error that are introduced by the manufacturers.
  • Provide a clearer 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:

 

Timeline - Integrity of Supply

 

Diana Lewis

Diana Lewis

Senior Specialist – Quality  (Supplier Development and Performance Management)
Merck & Co

Steve Wolfgang

Steve Wolfgang

Acting Associate Director for Risk Science Intelligence and Prioritization. Office of Drug Security, Integrity and Recalls
FDA