# Presentation: 518367

## Briefing on Development of QMS for CDER and CBER 

**Jon Clark, MS**
- Associate Director,
- OPS Policy Development OPS/CDER/FDA

## Background

- Analyses of the CMC review process have identified issues and opportunities for improved *efficiency, transparency, consistency*in the CMC decision making process
- FDA contracted with Neptune and Company to develop a Quality System for the CMC review process within CDER and CBER
- Build on quality components that are in place and working

## Starting Point

- SMG 2020 provides a Quality System Framework for FDA internal activities
- SMG 2020 is based, in part, on American National Standard ANSI/ISQ/ASQ Q9001-2000, *Quality Management Systems – Requirements*
- Other quality guidelines
- cGMP, EPA, CDC, ANSI, ASQ
- Current guidance to CMC reviewers and industry

## What Is a Quality System?

- 	“a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services.” (ANSI/ASQ E4-2004)

## How We Will Proceed

- Start with existing procedures, policies, and guidance
- Understand projects underway to modernize FDA review processes
- Work with individuals at multiple levels in the organization to understand their roles and concerns
- Build on what is already being done right
- Establish meaningful metrics to evaluate components of the (CMC) review process
- Provide a Quality System for facilitating the achievement of goals that is embraced by all levels of the organization

## Quality System Goals

- Optimize performance practices and results
- Facilitate cross-organization communication and information sharing
- Share best practices to enhance work products
- Serve as a mechanism for understanding, managing and enhancing performance
- Promote organizational and personal learning
- Enhanced transparency of the FDA review process leading to increased quality of industry submissions

## Overview of QMS Work Scope

- Review background documents to value where the process currently has advanced
- Develop a Work Plan
- Develop an annotated outline of the Quality Management Plan (QMP)
- Assist in eliciting a quality policy
- Conduct two sets of interviews with managers/staff/ stakeholders at various management levels
- To understand current practices
- To establish where and what change would be most beneficial

## Overview of QMS Work Scope (cont)

- Develop the content of the Quality System (this is the heart of the work)
- Draft the Quality Management Plan
- Develop a deployment strategy
- Conduct a lessons learned forum

## Quality System Content

- Infrastructure, e.g.:
- Scope definition
- Identification of upper-tier technical and policy requirements/guidelines
- Management and distribution of quality documents/records
- Strategic management, e.g.:
- Program-specific quality policy
- Identification of internal/external customers
- Organizational structure/roles and responsibilities
- Management leadership

## Quality System Content (cont)

- Resource management, e.g.:
- Training and qualifications identification
- Process for integration of related FDA sectors/services
- Identification of Quality needs for extramural services/products
- Lifecycle management, e.g.:
- Analysis of work processes
- Identification of quality system tools

## Quality System Content (cont)

- Quality system evaluation, e.g.:
- Establishment of performance metrics
- Monitoring/quality control
- Recommended audits and assessments
- Development of tools for ongoing improvement

## Significant Milestones

- Work Plan and Annotated Outline
- Conduct interviews
- Elicit Quality Policy and Mission
- Major work activities and quality tools
- Quality metrics and roles and responsibilities
- Training Strategy
- Quality Management Plan
- Deployment Strategy
- Lessons Learned Forum

## Project Status

- Kickoff meeting with FDA contacts mid-February 2006 with ongoing in-person and phone dialogue
- Work Plan completed April 2006
- Review of background documents for current process activities is ongoing
- Draft of annotated outline submitted in mid-April 2006

## Next Steps

- Refine the annotated outline
- Continue background research
- Prepare for first set of interviews
- Elicit and document a quality policy