Amendment 00001 QA-FDA -20-RFQ- 1228728 .pdf
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- Solicitation number
- 1228728
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This document is an amendment to a request for quote for quality management maturity assessments at up to nine domestic facilities for the Food and Drug Administration. The contractor will be required to assess the quality management maturity level of FDA regulated facilities using their established assessment tool. The contractor must train FDA staff on conducting assessments with their model. The expectation is for resumes of no more than three pages each for contract staff. There will be no key personnel designations under the firm fixed price order. The amendment provides responses to vendor questions for clarification, such as confirming September 4, 2020 as the due date for past performance questionnaires, that the assessments are intended to evaluate establishment quality management maturity level, and that the FDA has not developed an assessment tool.
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FDA -20-RFQ- 1228728
Title: Quality Management Maturity Assessments At Up To Nine Domestic Facilities (FDA)
Questions 1: Attachment A --PAST PERFORMANCE QUESTIONNAIRE--On the PPQ provided the date of September 9th is filled in as the due date for return to the government, however in the SOW it states that the PPQ is due on the procurement due date which September 4th is. Can the government please confirm that September 9th is the correct date for the return of the PPQ’s?
Response: Please use September 4, 2020 as the due date for the Past Performance Questionnaire. However, the Government may accept PPQ information after the quote due date of September 4, 2020.
Question 2: Section 4.0 Deliverables: Has FDA developed an assessment tool, or is tool development part of this procurement?
Response: The FDA has not developed an assessment tool. The expectation is the contractor has an established tool.
Question 3: Section 4.0 Deliverables: Question 2--Will onsite inspections be done of the nine facilities or will all work be remote? If onsite, can the govt provide a line item for travel? There is no mention of travel in the SOW.
Response: The nature of the assessment will be dependent upon the contractor’s assessment tool.
Question 4: Section 4.0 Deliverables: Is the expectation for us to train the FDA staff and then they accompany us?
Response: Yes, the expectation is for the contractor to train the FDA staff on conducting assessments using their model.
Question 5: Section 4.0 Deliverables: Can the govt clarify if the 9 facilities are FDA facilities or industry owned facilities?
Response: FDA regulated facilities.
Question 6: Section 4.0 Deliverables: Can the govt clarify if the only standard we are assessing is CGMP or are there other standards we need to assess?
Response: The assessments are intended to assess and score the establishment’s quality management maturity level.
Question 7: On page 7, Section "Quotation Preparation Instructions"--the govt lists #2 as Resumes of at least two (2) or more highly qualified trainers and other key contract staff. Can the govt confirm the trainer is "key staff" and can the govt clarify if there are other "key contract staff" roles on this contract?
FDA -20-RFQ- 1228728
Title: Quality Management Maturity Assessments At Up To Nine Domestic Facilities (FDA)
Response: Please revise #2: In your quote, please attached resumes for contract staff of no more than 3 pages each. There will be no key personnel designations under the Firm-Fixed Price Order when awarded.
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