Quality Assurance Strategy shaping
Item Details:
- Organisation: The Global Fund to Fight AIDS, Tuberculosis and Malaria
- Reference Number: TGF-20-029
- Published: 8th April 2020
- Deadline: 6th May 2020 at 17:00 PM CEST
- Time zone: CEST (Swiss Time)
- Street: Chemin du Pommier 40
- City: Geneva
- Country: Switzerland
- Zip/Postal Code: 1218
- Expires: This ad has expired
Item Description:
The Global Fund is looking for a (group of) expert(s) to support the development of a strategic framework for assisting the Supply Operations Department of the Global Fund in shaping its Quality Assurance Strategy to provide increased assurance of availability of quality assured health products to users.
Background & Context
Recently established Supply Operations Department
The Supply Operations (SO) Department was created in 2019 as a result of the merge of the Sourcing and Supply Chain departments with the mandate to secure end-to-end supply chain management of health commodities of assured quality from manufacturers to health consumers in the countries supported by Global Fund Grants.
The SO Department has engaged the others departments of the Global Fund to better articulate the various roles and responsibilities including Quality Assurance among the institution putting mechanism in place to share information, manage interface and improve collaboration.
Fragmented framework of Quality Assurance requirements
The Global Fund is currently operating in an unregulated environment as there is currently no international law on health products. However, it has developed a framework of Quality Assurance requirements based on Quality Assurance Policies, Guidelines and contractual agreement
The Global Fund Quality Assurance Policy for Pharmaceutical Products was restated on 14 December 2010.The Quality Assurance Policies for Diagnostics Products recently amended on 4 May 2017. The Quality Assurance requirements for Condoms and Vector Control Products are currently recalled in the Guide to Global Fund Policies on Procurement and Supply Management of Health Products.
The Global Fund Quality Assurance Framework refer to multiple guidelines developed mostly developed by World Health Organization (WHO) or other United Nations Program such as United Nations Population Fund (UNFPA). covering procurement, market surveillance or vigilance. The Global Fund has also developed its own guidance document on quality Assurance in order to attune to its own internal mechanisms.
Contractual Agreements passed with selected suppliers in the framework of the Pool Procurement Mechanism refer to specific quality assurance requirements detailing their responsibilities.
This Quality Assurance framework covers most part of the product life cycle from pre-market Authorization until Market surveillance and Vigilance but allocating different responsibilities to different actors not always in a consistent way by product category.
The Quality Assurance Team has to propose a revision of the current QA arrangements in order to consider the changing environment, technology advances resulting in new products or emerging risks for the quality, safety and efficacy/risk of health commodities provided to countries.
The Global Fund works on Quality Assurance has inspired by numerous international agency and donors which developed their own Quality Assurance (QA) Policy. Retrospectively, and to certain extend, The Global Fund was considered as one of leading institution in shaping global QA Ecosystem which should be maintained.
Objective
The Objective is to deliver a comprehensive strategy framework, proposed objectives. We expect a roadmap with defined actions, which highlights the most efficient approach to both coordinate internally and between partners and implement agreed changes.
Amongst others, this will also include a way to measure progress of implementations, measurement of performance including keys indicators and metrics.
This should envisage resourced implementation plan on how to achieve these, on what is already part of the existing strategy of the global fund and a focus on change management as an essential enabler to make this strategy applicable to the ground.
The deliverable of this work is expected to be built with joint input from other funding agencies and many partnering institutions.
Milestones Points
Because of the complexity and multidimensional aspect of this work, it is envisaged that the framework roadmap be delivered including but not limited to the following areas of works points.
- Mapping of current Global Fund Quality Assurance requirements taking into consideration a product category dimension as well as a life cycle dimension;
- Identification of actors involved in implementing quality assurance requirements, their current roles and responsibilities across the institutions;
- Level of implementation of current Global Fund Quality Assurance requirements;
- Existing enforcement mechanisms and their efficiency;
- Evidence of the performance of the current GF Quality Assurance framework and impact;
- Comparison of Global Fund Quality Assurance Requirements with other quality assurance framework implemented by other donors and/or similar institutions;
- Effectiveness and limitations of the current Partnership, collaboration and reliance mechanisms at country, regional or global level
- Current Resources allocated to Quality Assurance: Systems, Process and Tools including sub-contractors such as Procurement Service Agent (PSA)
Scope
All Health commodities procured with Global Fund Funds including Pharmaceuticals, Diagnostics products, Condoms and other medical devices, Vector Control products for HIV, Malaria, TB disease as well as for commodities for Co-Infections and Co-Morbidity.
All types of procurement channels such as Pooled Procurement Mechanism (PPM) and national procurement.
All departments with the Global Fund involved in the procurement of the above-mentioned commodities such as Quality Assurance Team / Supply Operations, Health Product Management Specialist in Country Team within Grant Management Department and recipients of Global Fund funds.
Deliverables
The Objective is to deliver a comprehensive strategy for the Supply Operations department of The Global Fund with proposed vision, objectives and plan of actions. This should be articulate clearly in two separates scenarios which are supplementing each other such as:
- Scenario A – “As it is”: Quality Assurance Requirements remaining identical;
- Scenario B- “As it should be”: Improving current Quality Assurance requirements;
These two scenarios should help the SO department to pave the way for short to medium term improvement plan (Scenario A) to a more ambitious vision achievable on a longer term (scenario B) in a coherent manner.
Based on the areas identified where improvements are necessary, the bidder is expected to propose a roadmap with defined actions, which highlights the most efficient approach to implement agreed changes as well as to both coordinate internally and between partners.
Amongst others, the bidder should also include a way to measure progress of implementations, measurement of performance including keys indicators and metrics.
In addition, the bidder should prepare the materials to allow presentation of the outcomes of the work in adequate format.
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