7. Attachment E Past Performance Questionnaire 1242552.pdf

Solicitation FDA-21-RFQ-1242552

Center for Biologics Evaluation & Research (CBER)

Quality Systems Regulation Training: 21 CFR 820 and ISO 13485

Attachment E

PAST PERFORMANCE QUESTIONNAIRE

Please complete the following questionnaire and return via email: Please reference “Past Performance Questionnaire - FDA-21-RFQ-1242552 Title: Quality Systems Regulation Training:

21 CFR 820 and ISO 13485.RFQ No. 1242552,” in the subject line. Send to Sharon Masciana at Sharon.Masciana@fda.hhs.gov. Quality Systems Regulation Training: 21 CFR 820 and ISO 13485

Contract Specialist, Sharon Masciana by August 20, 2021, 4:00 PM, Eastern Time

(Name) (Title, Name) (Date & Time)

Contracting Officer, Sharon Masciana (Title, Name)

The U.S. Food and Drug Administration (FDA) intends to award a purchase order to a commercial vendor for Food Safety Culture Training.

The purpose of this contract is to procure the Commercial Off the Shelf (COTS) in fully virtual format and in-person format; Quality System Regulation Training: 21 CFR

820 and ISO 13485 to ensure FDA staff are able to explain the scope and applicability of the requirements of 21 CFR 820 and ISO 13485.

FDA needs a commercial contractor to provide a total of 11 sessions of the above course in a fully virtual and/or in-person format for four days for up to 20 adult learners to support their learning and development needs. This scope consists of four (4) functional task areas, including, but not limited to:

1. Training Requirements

2. Training Instructor Qualifications and Expectations

3. Training Facilities

4. Class Materials

This survey pertains to Contractor: ________________________________________

Department/Component:

Contract Number: Date of Survey: ________________

Name of Person Completing Survey: ______________________________________

Your Company/Agency: ________________________________________________

Your Role in this Contract (circle one): Contracting Contract Project Other

Officer Specialist Officer

Contract Value (including options): $_________________________________

Performance Period: _____________________________________________

(Including option periods)

Type of Contract:

Approximate percentage of work being performed (or completed) by subcontractor(s): %

Information on subcontractor(s) (where more than 51% of work was completed by the subcontractor):

Subcontractor Program Manager Phone

Subcontractor Program Manager Phone

Subcontractor Program Manager Phone

General description of products/services required under the contract:

RATINGS

Please answer each of the following questions with a rating that is based on objective measurable performance indicators to the maximum extent possible. Commentary to support rating shall be noted on page 4.

Assign each area a rating of, 1 (Poor), 2 (Fair), 3 (Good), or 4 (Excellent). Use the attached Rating Guidelines as guidance in making these evaluations. Circle the appropriate rating. If you do not have enough personal knowledge or feedback from internal customers who directly received products and services from the contractor to make a determination on any of the performance criteria below, please circle "N/A" (not applicable/no opinion).

BUSINESS RELATIONS

1. Contractor provides knowledgeable, experienced, trained and qualified personnel.

1 2 3 4 N/A

2. Effective management, including management of subcontracts

3. Reasonable/cooperative behavior 1 2 3 4 N/A

4. Responsive to contract requirements 1 2 3 4 N/A

5. Notification of problems 1 2 3 4 N/A

6. Flexibility 1 2 3 4 N/A

7. Pro-active vs. reactive

QUALITY OF SERVICE

1. Compliance with contract requirements

2. Contractor is responsive to technical direction.

1 2 3 4 N/A

3. Accuracy of reports 1 2 3 4 N/A

4. Effectiveness of personnel 1 2 3 4 N/A

5. Technical Excellence

COST CONTROL

1. Record of forecasting and controlling target costs 1 2 3 4 N/A

2. Current, accurate and complete billings 1 2 3 4 N/A

3. Relationship of negotiated costs to actuals 1 2 3 4 N/A

4. Cost efficiencies

TIMELINESS OF PERFORMANCE

1. Met interim milestones

2. Reliability 1 2 3 4 N/A

3. Responsive to technical direction 1 2 3 4 N/A

4. Completed on time including wrap-up and contract administration

5. Contractor Met contract delivery schedules/deadlines

6. Contractor provided sufficient notification of contract problems to appropriate government personnel.

1 2 3 4 N/A

7. Contractor is pro-active and is reasonable/cooperative

8. Liquidated damages assessed: Yes No (circle one)

CUSTOMER SATISFACTION

1. The contractor is committed to customer satisfaction. Yes No (circle one)

2. Would you recommend this contractor for award (Yes or No)? Please explain.

Yes No (circle one)

3. Are you satisfied with the service you received and would you hire the contractor again

(Yes or No)? If not, why not? Please be specific.

4. Do you feel the quality of the services received was worth the cost/price? Please circle one of the statements below.

A). Extremely well worth the cost.

B). Well worth the cost.

C). Worth the cost.

D). Cost was more than the value received.

E). Cost was greatly in excess of value received.

F). Government derived no value from cost spent.

RATING GUIDELINES

QUALITY OF PRODUCT

OR SERVICE

COST CONTROL

TIMELINESS OF

PERFORMANCE

BUSINESS

RELATIONS

1-Poor

Major problems have been encountered

Contractor is having major difficulty managing costs effectively

Contractor is having major difficulty meeting milestones and delivery schedule

Response to inquiries, technical/ service/ administrative issues is marginally effective

2-Fair

Some problems have been encountered having some problems managing costs effectively

Contractor is having some problems meeting milestones technical/ service/ administrative issues is somewhat

3-Good

Minor inefficiencies/ errors have been identified usually effective in managing costs

Contractor is usually effective in meeting milestones and delivery schedule technical/ service/ administrative issues is usually

4-Excellent

Contractor is in compliance with contract requirements and/or delivers quality products/services effective in managing costs and submits current, accurate, and complete billings

Contractor is effective in meeting milestones technical/ service/ administrative issues is effective