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U.S. Department of Health and Human Services

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2010 Compliance Strategic Plan

Strategy : Develop a Framework for an Effective Cross-Center Compliance Program

Objective of this strategy :

Staff across the Center for Devices and Radiological Health (CDRH) shares an understanding of compliance work and how their work supports medical device and radiation-emitting electronic product compliance. Staff engaged in compliance work (Compliance staff) has the training, resources, and organizational structure to perform work at a level of excellence. Compliance staff performs work as part of an integrated Center-wide structure that includes the input and expertise of stakeholders across FDA.

Compliance staff achieves success by identifying important compliance problems, taking prompt, strategic, clear, and visible actions to address those problems, and applying metrics that confirm the positive impact of compliance actions on public health.

The success of the Compliance program is predicated on three key elements: operational excellence, substantive excellence, and organizational excellence.

Goal 1: Promote among Compliance staff a shared view of risk-based strategic planning and build a model to support strategic compliance planning in 2011 and later years.

Possible Actions To Achieve This Goal :
  1. Enhance capacity for strategic planning (i.e., working with agency-wide partners to choose and fix important problems) as a routine way of doing business, and use metrics to focus on outcomes, not outputs.
  2. Create a forum for input on areas of concern and best compliance strategies and targets.
  3. Create a database to identify compliance targets based on weighted factors.
  4. Develop systems to allocate resources, track compliance initiatives, and measure the effect of those initiatives.

Goal 2: Review and, as required, revise the quality management system approach to developing and clearing compliance actions.

Possible Actions To Achieve This Goal :
  1. Streamline the process for issuing, reviewing, and clearing assignments.
  2. Conduct after-action reviews of selected matters to identify lessons learned and adjust processes accordingly.
  3. Establish a quality-system approach to process changes (e.g., validation of proposed changes, change-control requirements, communication of and training on new processes, etc.).
  4. Work with the Office of Chief Counsel (OCC) to develop and maintain boilerplate language for compliance documents. Standardize compliance document language to foster consistency and understanding.
Possible Big Urgent Goals (BUGs) :1
  1. Launch a plan to reduce the time required for the Warning Letter, Untitled Letter, and Radiological Health Letter development and clearance processes. The Implementation Team will: (1) map the "as is" Warning Letter, Untitled Letter, and Radiological Health Letter development and clearance processes; (2) define the “to be” development and clearance process, i.e., steps that reduce the time required to develop and clear Warning Letters, Untitled Letters, and Radiological Health Letters; and (3) initiate a plan for achieving the "to be" state.
  2. Develop a “portal” for the Warning Letter preparation process. This will be an automated, interactive flow process that permits step-by-step development of Warning Letters. Links will be included to existing databases to populate fields, and a letter template will be embedded so that the draft Warning Letter produced meets current style and content requirements.

Goal 3: Collaborate with the Office of Regulatory Affairs (ORA) to improve inspections of CDRH-regulated firms.

Possible Actions To Achieve This Goal :
  1. Partner with ORA to communicate to field staff regarding the CDRH Compliance program and strategies developed by CDRH and ORA to assure timely, high-quality inspections. These strategies include feedback mechanisms to share areas of improvement on case development.
  2. Engage in CDRH and ORA cross-training on the organizations’ roles in inspections.
  3. Develop a standard operating procedure (SOP) to front-load certain risk-based device inspections at the beginning of the fiscal year, which ORA commits to complete within the fiscal year.
  4. Support ORA staff training on device compliance.
  5. Partner with ORA to develop level two and level-three certified investigators and a foreign inspection cadre.
Possible BUG :
  1. Work with ORA to develop and launch a pilot initiative for close collaboration on inspections and efficient development of follow-on enforcement action. The collaboration will begin while the inspection is underway and will continue during ORA’s preparation of the establishment inspection report (EIR), thereby assuring that CDRH supports any resulting enforcement action and that evidence and charges are developed to back the action. In place of a formal enforcement memo submitted to the Center, in a single meeting after CDRH review of the EIR, CDRH and ORA will collaboratively develop and clear the enforcement action so it may be immediately issued or forwarded to OCC.

Goal 4: Conduct a workforce assessment to account for the capabilities of Compliance staff and available resources. Use this assessment to best direct resources toward compliance outcomes.

Possible Actions To Achieve This Goal :
  1. Understand our work processes and document our workload– what we do and the resources needed to do it.
  2. Identify and assess our compliance goals to determine the resources (staff and otherwise) necessary to meet those goals.
  3. Develop a strategy to dedicate and obtain resources to close any gaps between current capabilities and compliance goals.

Goal 5: Recruit and integrate new employees into a culture that exemplifies mutual respect, collaboration, and alignment toward common goals. Enhance the staff development program to provide the training needed to maximize performance, identify and develop leaders, and retain high-performing staff. Use a hiring strike team to recruit and bring on-board high-quality staff and develop a long-term hiring strategy to be shared across Center Compliance areas.

Possible Actions To Achieve This Goal :
  1. Create an employee hiring and on-boarding program to bring on board high-quality candidates to support the Compliance programs’ objectives.
  2. Provide organizational orientation for new hires that provides introductory training on topics such as the Quality System regulation (QS regs), medical device reports, bio-research monitoring, electronic product radiation control, the Mammography Quality Standards Act, and case development.
  3. Develop staff through an established training and mentoring program. Training includes cross-training and development of expertise in technical and functional areas like QS regs and recalls, as well as a continuing-education program for new issues and technologies. Training also includes review of how compliance work integrates with Center-wide functions. Additional training subjects may include creating and using SOPs, decision-making skills, and analytical training that matches industry trends.
  4. Identify emerging leaders; develop emerging and current leaders.
  5. Implement a program to assess the workplace culture among Compliance staff. Use this assessment to enhance a culture of mutual respect, collaboration, and alignment toward common goals.
  6. Make available resource directories of individuals with technical and functional expertise. Develop informal information-sharing sessions for experts and new employees.
Possible BUG :
  1. Create a pilot in at least one Branch that establishes details for Team Leader positions in order to expand capacity for training and mentoring. Team Leader tasks may include training of team members or oversight of the teams’ day-to-day work, thereby enabling Branch Chiefs to focus on training.

Goal 6: Assess how effectively CDRH-specific information-technology (IT) systems support Compliance needs, including the need for accurate, readily accessible, and current data. Use this determination to modify CDRH-specific IT systems or to identify and adopt alternative IT systems to advance compliance activities.

Possible Actions To Achieve This Goal :
  1. Understand Compliance data needs and how CDRH-specific IT systems answer those needs.
  2. If CDRH-specific data systems do not adequately respond to Compliance data needs, determine whether those systems can be modified to do so. If not, determine whether Agency-level or external IT systems can adequately meet Compliance data needs.
  3. Validate that changes to current IT systems, or adoption of new IT systems, adequately meet Compliance data needs.
Possible BUG :
  1. Develop and launch a plan to expand use of total product lifecycle (TPLC) sheets to support compliance activities such as warning letter reviews, recall classifications, and preparation of directed inspections. The plan will include identification of points in the development of compliance actions where TPLC sheets should be used, as well as support training, outreach, and continued improvement methods.

1 “BUGs” are initiatives that respond to significant challenges identified by Compliance staff. BUGs are part of strategic goals, but strategic goals are broader than BUGs.