# Presentation: 535877

## CDRH Scorecard

## Why do we need a scorecard?

What does the scorecard measure? 

**What does the scorecard measure? **

**Notes:**
Strategic planning helps us achieve our goals and establish a vision for the future

Everyone is part of the plan, everyone is included.

## What is a scorecard?

**A tool that helps us monitor progress and track measurable (tangible) commitments and goals**

**Notes:**
Project Management Plans
Purpose: Effectively manage long term projects and new initiatives
	Project milestones
	Resource requirements
	Quarterly reviews
	19 Projects in FY 05
Scorecards 
Purpose: Help manage organizational performance in CDRH strategic areas
	CDRH Key Result Areas (KRAs)
1 	Public Health Promotion
2 	Public Health Protection
3	Effective Management According to TPLC
4	Knowledge Management and Stakeholder Collaboration
5	 Workforce Excellence

## Why scorecards?

**Because some commitments (e.g. Congress, HHS and FDA) require measuring and reporting**
**Because monitoring performance frequently enables us to take corrective action, if needed**

**Notes:**
Project Management Plans
Purpose: Effectively manage long term projects and new initiatives
	Project milestones
	Resource requirements
	Quarterly reviews
	19 Projects in FY 05
Scorecards 
Purpose: Help manage organizational performance in CDRH strategic areas
	CDRH Key Result Areas (KRAs)
1 	Public Health Promotion
2 	Public Health Protection
3	Effective Management According to TPLC
4	Knowledge Management and Stakeholder Collaboration
5	 Workforce Excellence

## What are we measuring? 

**Required outcomes**
**MDUFMA performance goals**
**Inspections**
**Overall performance**
**Meetings with sponsors**
**Training**** **
**Not all our commitments can be measured with scorecards**

**Notes:**
Project Management Plans
Purpose: Effectively manage long term projects and new initiatives
	Project milestones
	Resource requirements
	Quarterly reviews
	19 Projects in FY 05
Scorecards 
Purpose: Help manage organizational performance in CDRH strategic areas
	CDRH Key Result Areas (KRAs)
1 	Public Health Promotion
2 	Public Health Protection
3	Effective Management According to TPLC
4	Knowledge Management and Stakeholder Collaboration
5	 Workforce Excellence

## What’s on the Center scorecard?

**	****CDRH scorecard Key Result Areas (KRAs)**
**	****KRA 1  ****	****Public Health Promotion**
**	****KRA 2  ****	****Public Health Protection**
**	****KRA 3  ****	****Effective Management **
**	****KRA 4  ****	****Knowledge Management ****	****	****	****	****and Stakeholder ****	****	****	****	****	****Collaboration**
**	****KRA 5  ****	****Workforce Excellence**

**Notes:**
Project Management Plans
Purpose: Effectively manage long term projects and new initiatives
	Project milestones
	Resource requirements
	Quarterly reviews
	19 Projects in FY 05
Scorecards 
Purpose: Help manage organizational performance in CDRH strategic areas
	CDRH Key Result Areas (KRAs)
1 	Public Health Promotion
2 	Public Health Protection
3	Effective Management According to TPLC
4	Knowledge Management and Stakeholder Collaboration
5	 Workforce Excellence

## Where are we implementing scorecards?

**FY 04 Quarterly scorecard reports done**
**First quarter FY 05 scorecard report postponed to realign Center scorecard to what Offices manage by**
**FY 05 Center and Office scorecards just completed**
**FY 05 second quarter report in progress**

## Organizational Scorecards

**Organizational Scorecards**

## 1-Public Health Promotion

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1-A % on-time MDUFMA 	decisions and cycle actions |  |  | X | X |  |  |  |
| FY 05 Targets:
80% 	Original PMA and 	panel track supp
70% 	Expedited PMA
80% 	180 day PMA su
75% 	510(k) |  |  |  |  |  |  |  |

## 1- Public Health Promotion

**1- Public Health Promotion**

## 1- Public Health Promotion

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1-B % IDE originals 	approved first cycle
FY 05 Target:  75% |  |  | X | X |  |  |  |
| 1-C % On-time review consults
FY 05 Target:  90% | X | X |  |  | X | X |  |
| 1-D  App. review quality 	assessment
FY 05 Target:  Pilot assessments done |  |  | X | X |  |  |  |

## Organizational Scorecards

**KRA 1: Public Health Promotion**
**KRA 3: Risk Management (non-expedited)**
_**On-Time Review Consults**_
**Expedited Review Consults ****	****	****96% (44/46)**
**Pre-IDE & IDE Review Consults ****	****99% (629/636) **
**Non-Expedited Review Consults ****	****98% (2,189/2,227)**

## 2- Public Health Protection

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2-A Timeliness of CDRH 	monitoring systems to 	identify hazards to 	health
FY 05 Target:  Set Baseline | X | X | X | X | X | X |  |
| 2-B # sig public health 	protection actions
FY 05 Target:  SetBaseline | X | X | X | X | X | X |  |
| 2-C % Mammography 	facilities free of most 	serious violations
FY 05 Target:  97% |  |  |  |  | X |  |  |
| Develop baseline for RCHSA violations |  |  |  |  | X | X |  |

## 3- Effective TPLC Management 

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3-A % Operating $s spent;	% Payroll $s spent; and 	% Cash award $s spent
FY 05 Targets: For each area quarterly | X | X | X | X | X | X | X |
| 3-B % MDUFMA hires on 	board
FY 05 Target:  75% 3rd quarter | X | X | X | X | X | X | X |
| 3-C % On target project 	management plan 	milestones | X | X | X | X | X | X | X |

## 4- Knowledge Management and Stakeholder Collaboration

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4-A # Scheduled business 	meetings with 	industry
FY 05 Target: Set Baselines | X | X | X | X | X | X |  |
| 4-B Level of progress for 	major Office stakeholder 	projects
FY 05 Target:  Set Baselines | X | X | X | X | X | X | X |

## 4- Knowledge Management and Stakeholder Collaboration

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4-C % Favorable premarket customer survey responses
FY 05 Target: Improve assessments guidance and standards |  |  | X | X |  |  | X |
| 4-D % FY 05 High priority new and existing guidances completed
FY 05 Targets:  70% new  10% existing | X | X | X | X | X | X |  |
| 4-E # Standards FDA recognizes for review
FY 05 Target:  Set baseline
 | 

 |  |  |  |  | X | 

 |

## 5- Workforce Excellence

| Key Indicators | OC | OSB | ODE | OIVD | OCER | OSEL | OMO |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5-A Average training hours 	per employee; % Dollars 	spent on training; % 	Managers & supervisors 	meet core 	competencies
FY 05 Targets: 100% supervisors; Set baselines for others | X | X | X | X | X | X | X |
| 5-B % External expertise 	dollars spent
	# Contractors funded 	with external expertise 	dollars
FY 05 Targets: Set baselines | X | X | X | X | X | X | X |

## Organizational Scorecards

**THANKS!!! **
**To the Measurement Team for  their perseverance and ingenuity**
**Frances Benedict, Bob Gatling, Alberto Gutierrez, Sousan Altaie, Bonnie Markovitz, Howard Press, Jim Simpson, Patti Sylvia, and Al Thomas**
**To Center and Office managers for their support**