SOURCES SOUGHT
U -- Quality Management Consulting and Bowtie Workshop/Study Services
- Notice Date
- 4/12/2013
- Notice Type
- Sources Sought
- NAICS
- 611430
— Professional and Management Development Training
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1113300
- Point of Contact
- James G. Whitt, Phone: 3018271022
- E-Mail Address
-
james.whitt@fda.hhs.gov
(james.whitt@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of potential qualified small business sources and their size classifications (i.e., HUBZone 8(a), 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, and Small Disadvantaged Business) relative to the North American Industry Classification System (NAICS) code. Responses to this sources sought synopsis will be used by the Government to make appropriate determinations about potential sources. Only small business sources shall respond to this sources sought synopsis. Project Title: Quality Management Consulting and Bowtie Workshop/Study Services Project Description: Background: Managing information plays a critical role in enabling the Government's efforts to transform Agency operations and respond accurately and timely to emerging scientific, technological, and economic trends affecting its regulatory mission. By continually improving control of critical business operations, the Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), can reliably increase its capacity to manage discernible threats (e.g., registered hazards). CFSAN is committed to the continual improvement of a Quality System focused on, among other business operations already in place, our CiQMS (CFSAN integrated Quality Management System). The Center Director, Deputies, and CFSAN Management Council require objective data to maintain strategic and design control over the Center's Quality System. The Bowtie eXPerience (hence BowtieXP) methodology will greatly facilitate these objectives (see below). Success in protecting the health of the American public depends, in part, on continually improving two ‘best practices' in our Center's CiQMS - namely: (i) its organizational Safety Culture, and (ii) Hazards and Effects Management. In essence, the CiQMS is simply a ‘management Plan-Do-Check-Action (PDCA)' cycle; cf. FDA Staff Manual Guide (SMG) 2020. And at a general level, quality management is indistinguishable from error management. Above all, persuasive evidence indicates that organizations that use a BowtieXP methodology have a significantly more mature safety culture than organizations that do not. The operationalized core of an effective CiQMS and of a bowtie cause-consequence diagram is a Hazards and Effects Management Program (HEMP); without the latter, a risk management system is destined to fail. Construction of a bowtie diagram involves asking a structured set of questions about the adequacy of internal control. It is also critical that all relevant stakeholders understand not only what the risks are, but how those risks are controlled and what measures are necessary to ensure that those controls will continue to be effective. HEMP is simply a risk-oriented variant of PDCA. In short, BowtieXP software provides a cost-effective means to perform, on-line, Hazards and Effects Management. When BowtieXP methods have been correctly implemented, CFSAN management can more fully ensure that registered hazards and their effects - in the event of loss of control - have been fully identified, assessed, controlled and recovered from. HEMP improves the adequacy of internal control by helping determine how well an organization's plans cover its discernible threats: Identification (1. identification of hazards and effects); Assessment (2. evaluation of risks, 3. recording of major hazards and effects); Assessment, Control (4. comparison with objectives and performance criteria); and Control, Recovery (5. establishment of risk reduction measures). For most levels of risk, HEMP is demonstrated through a combination of experience/judgment, procedures, checklists, standards, and structured review techniques - ranked here in an increasing level of detail. Demonstration of HEMP in its most complex form is adopted only when the risks from a hazard are assessed as being extreme. Requirements: Key functional needs of the Government for this contract include, but are not limited to: (1) Assistance in determining: (i) if organizational safety in CFSAN is sufficiently managed; (ii) if the BowtieXP methodology (i.e., barrier diagram development study) is a good ‘fit' for our organization; and (iii) whether all key aspects of a risk management system can be run through bowties; (2) Steps to begin to reinforce a reliable core of a sustainable CiQMS; defining recommended actions, including respective roles & accountabilities, anticipated challenges, estimated timeframes, etc.; (3) Detailed guidance about how CFSAN can fully utilize the operationalized ends of bowtieXP software; (4) Guidance about how to create a risk inventory and perform a risk assessment on the identified risks; and (5) Apply a risk ranking on the risks and define the minimum risk level applicable for applying the Bowtie assessment. To accomplish the above, the Government has a functional need for consulting services of qualified subject matter experts (SMEs). On-site bowtie workshops have been found to be a key step to identifying real controls and capturing current business operations and past incidents. A major objective of such workshops - attended by operational staff and supported by an independent facilitator (Contractor) - is to build out bowtie diagrams. By comparison, a bowtie study also includes numerous tasks and activities initiated before, as well as after, a Bowtie barrier diagram development workshop has taken place. The Contractor will be required to provide: (i) the technical services, qualified personnel, materials, and facilities, not otherwise provided by the Government, to support the required consulting services; and (ii) a structured approach towards the analysis of hazards throughout the life cycle of an asset(s). A preliminary focus of the contract shall be to carry out at least two (2) (and up to five (5)) BowTieXP studies in the 12-month base period to help determine: (i) if the BowTieXP methodology (i.e., barrier diagram development study) is a good ‘fit' for our organization; and (ii) whether all key aspects of a risk management system can be run through bowties. The period of performance is expected to comprise a 12-month base period and four (4) 12-month option periods. Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance is 12 months, plus four 12-month option periods. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published in the Federal Business Opportunities. Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions: 1. Is your business a small business under the NAICS code? 2. Does your firm qualify as a small disadvantaged business? 3. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small Business Act? 4. Are you considered a certified HUBZone firm? 5. Are you considered woman-owned or operated business? 6. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business? 7. Please describe your organization's subject matter experts (SMEs) capabilities with respect to the BowtieXP methodology/software and its associated best practices, especially including SMEs with proven success in independently facilitating Bowtie workshops/studies (e.g., to be performed on-site at FDA facilities)? 8. Please describe how applying the BowtieXP methodology in-house can help improve an organization's safety culture in particular subunits and in the general organization overall. 9. Please describe how your organization has helped to successfully implement the bowtie methodology in other organizations (Government or Commercial) you have worked with. 10. Please describe the demonstrable command of English language - both spoken and written - of your organization's subject matter experts. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this notice can be mailed to: U.S. Food and Drug Administration Attn: James G. Whitt Office of Acquisitions and Grant Services 5630 Fishers Lane, Room 2081 Rockville, MD 20857 Electronic mail responses will also be accepted at: James.Whitt@fda.hhs.gov. Telephone responses will not be accepted. Responses must be received in writing, by no later than April 24, 2013, 4:00 PM, Eastern Time. No solicitation is currently available. Responses to this sources sought synopsis will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Reference No. 1113300.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1113300/listing.html)
- Place of Performance
- Address: Contractor facility and Government facility., United States
- Record
- SN03035889-W 20130414/130412234858-cf29cf89d952b6763ead05a514317d71 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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