The Client

The client is a diversified, multinational, life sciences company. The consumer division of this company manufactures and sells health care products worldwide.

The Situation

In one of the company’s divisions, the US Food and Drug Administration (FDA) found several violations during routine inspections. These included a variety of problems such as the performance of operations outside of approved standard operating procedures, outdated procedures, mislabels and more. As a result, the FDA issued warning letters.

Unfortunately, the company could not consistently demonstrate sufficient control of its quality systems to the FDA in compliance with current good manufacturing practices. After the company recalled several products, and received inspectional observation reports, called 483s, and a warning letter from the FDA, the FDA placed this company under a consent decree.

A consent decree is a legal agreement between a company and the FDA under which the company agrees to address specific violations and implement oversight processes. Consent decrees include heavy fines, reimbursement to the government for applicable inspection oversight costs, commitments to due dates for specific actions and penalties for non-compliance. Entering a consent decree can have a major impact on the affected manufacturing sites, and obtaining a release from a consent decree typically takes many years. As a result, a consent decree could cost a life sciences company millions of dollars in regulatory fines, additional expenses, and lost revenue.

The Solution

While implementing quality system changes may seem straightforward on the surface, changing a corporate culture along with its legacy quality management systems is a large and complex task, involving people, processes and technologies. The client chose to secure release from the consent decree by embarking on an eight-year program.

During the first three years under its consent decree, the company:

  • Remediated known issues
  • Improved its quality systems
  • Defined new quality processes
  • Implemented external oversight
  • Ensured internal governance oversight
  • Implemented quality reporting metrics

Over the remaining five years, the company will:

  • Sustain new quality processes
  • Continue external oversight
  • Monitor and measure performance
  • Implement additional quality system improvements
  • Participate in routine regulatory audits

The company started consent decree remediation by defining the quality standards for applicable business functions, implementing interim controls and organizing the overall quality system into distinct quality system elements, such as quality assurance, documentation control, new product development, technology transfer, manufacturing operations, etc. Each quality system element was broken down into multiple process steps, each of which was addressed in the following approach:

  1. Process – The implementation of new procedures to address critical business functions.
  2. Remediation – The execution of specific activities to address known product- and process-related gaps. Remediation steps included updating legacy documents, such as finished product specifications, to comply with new procedures provided by related process steps.
  3. Information Technology (IT) – The updates to legacy IT systems to address known issues and the implementation of new IT systems to ensure compliance with new procedures.

Although the approach to executing process, remediation and IT can vary significantly, each of these steps were remediated through the following four phases.

  1. Plan and Design

The intent of the plan and design phase is to define the process for effective and compliant quality procedures. During this phase, teams organized by quality system elements:

  • Reviewed applicable quality standards and known gaps and issues
  • Assessed “as is” processes and developed “to be” processes with detailed process maps
  • Developed a detailed project plan and metrics for measuring compliance
  • Signed a deliverables concurrence document to align participant expectations with respect to deliverables
  1. Implementation

The intent of the implementation phase is to make the quality system effective by training employees to run quality operations according to approved procedures supported with validated quality IT systems. During this phase, teams organized by quality system elements:

  • Developed and approved new standard operating procedures
  • Implemented and updated IT systems required to support new procedures
  • Implemented metrics reporting
  • Trained users on the new processes
  • Developed trace matrices to ensure that all quality standard elements and gaps were addressed
  • Conducted an independent assessment to confirm that new processes were adequate and in place
  1. In Use

The intent of the “in use” phase is to have employees run the business according to the new quality procedures while assembling compliance documentation in an evidence binder for inspection by the FDA. During this phase, teams organized by quality system elements:

  • Conducted routine business using newly effective procedures
  • Gathered “in use” evidence to support subsequent verification
  • Captured and reported applicable metrics
  • Received “hypercare” support for six months by core team members to feel comfortable with the new quality standards and procedures
  1. Verification

The intent of the verification phase is to have internal and third-party auditors review the evidence binders and resolve and remediate any findings through the non-conformance quality process. During this phase, auditors organized by quality system elements:

  • Assessed evidence to ensure that “in use” business activities were compliant with applicable quality procedures
  • Appraised points for future evaluation to ensure that deferred “in place” confirmation observations were addressed and closed


Results to Date

The company has met all of its commitments to the FDA so far. The development of the company’s quality system elements and procedures have followed the process described above and have been confirmed and verified when required. Since this is the first time that the company entered a consent decree, this process had to be modified along the way to address issues and implement improvements based on lessons learned and evolving best practices. 


Future Outlook

The company is on track to re-establish its quality system with strong standards and processes within the first three years of its consent decree. The company has demonstrated its ability to successfully execute every aspect of its consent decree work plan. The next milestone is to obtain certification for each affected site to manufacture quality products for US consumers. After certification, the FDA will perform two audits in the fourth year and then one annual audit in the subsequent three years. The company will demonstrate the sustainability of its quality system by successfully completing FDA audits over a five-year period, with the goal of emerging from its consent decree over a total of eight years.


Glemser’s Involvement

Glemser consultants combined deep domain knowledge, a practical understanding of regulatory requirements and a proven track record of successfully implementing enterprise compliance software to help the client with several critical quality system element work streams.

Specifically, Glemser consultants:

  • Performed project management activities including:
    • Program management of project consultants
    • Project planning and coordination of activities and deliverables
    • Definition of risks and management of mitigation strategies
    • Facilitation of project meetings
    • Submission of status reports
    • Issue escalation and management of resolution
  • Gathered and assessed IT requirements in support of new processes
  • Performed process analysis and modeling
  • Maintained budgets and resource requirements
  • Facilitated various process excellence activities
  • Coordinated and managed training activities
  • Managed interdependencies between different quality system elements
  • Facilitated workshops to analyze processes and develop process maps

Glemser helped the client meet critical project needs by providing consultants that have deep life sciences domain experience, knowledge of regulations, expertise in applying information technology, an ability to drive client behaviors, and the strong desire to make clients successful.