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Quality Assurance for Health Products Procedures

1
Step

Before starting health procurement services for a government, Business Units (BU) (e.g. COs, RBx, GPSD-Health) should be aware of the UNDP QA Policy for health products and inform the partners of the need to comply with the Policy. The BU should seek guidance from the QA team to ensure that the health products to be supplied will comply with the requirements of the UNDP QA Policy for health products.
Responsible Party

CO Director and Programme Manager,

RBx,

GPSD-Health

Template/Guideline
Explanatory Notes

Quality Assurance Policy should be implemented by all business units doing health procurement (e.g., COs, RBxs, GPSD-Health).

Introductory and regular trainings of UNDP staff involved in health procurement activities in COs, RBx and in Copenhagen will be conducted by UNDP QA team to ensure full understanding and implementation of the Quality Assurance Policy.
 

2
Step

If the procurement strategy defined is to do health procurement using the global procurement architecture, the COs/RBx engages the services of GPSD-Health. In this case, the GPSD-Health must engage the services of the QA Team as outlined in 4 below
Responsible Party

CO or RBx Procurement team,

GPSD-Health

Template/Guideline
Explanatory Notes

GPSD-Health will ensure the SOPs are regularly updated on QA aspects in close collaboration with the UNDP QA Team and shared with CO procurement colleagues and UNDP QA team will guide them to implement the QA aspects.
 
The UNDP QA team will review and clear all new procurement processes, based on category and related risks involved, in line with the QA policy and will validate new suppliers and conduct assessment of the manufacturing site and the product as required by the QA policy. 

3
Step

In case local procurement is justified, the BU must engage the services of the QA Team as per step 4. The QA Team should be engaged before the procurement starts to facilitate smooth QA process. 
Responsible Party

CO,

RBx,

UNDP QA Team

Template/Guideline
Explanatory Notes

The project implementation should be carried out in close collaboration with UNDP QA CO.

4
Step

QA services in a procurement process: The UNDP QA Team must be involved to review the list of products to be supplied, develop technical TORs (including review of technical specifications), in developing the QA criteria used in solicitation documents to select the products and sources, in evaluating technical offers received and to approve the products and sources before contracts are awarded.
Responsible Party

UNDP QA Team

Template/Guideline
Explanatory Notes

UNDP QA Team will follow relevant SOPs to ensure the Technical TORs of the solicitation documents include the technical and regulatory requirements and that the products to be procures comply (technical and regulatory) with UNDP QA Policy.

5
Step

All business units should maintain a record of the health’ products supplied to governments/partners (key documents: POs, delivery notes, certificate of analysis, and batch numbers) and details of suppliers to justify the sources selected with National Regulatory Authorities and to facilitate recalls, handling quality alerts or quality complaint.
Responsible Party

CO/RBx Procurement teams GPSD-Health team,

GPSD-Health team

Template/Guideline
Explanatory Notes

All business units doing health procurement should keep files with all documents related to:
1.    Products supplied (POs, delivery notes, certificate of analysis, and batch numbers). 
2.    Suppliers – regulatory certificates/approvals, contact details, supplier master file etc.
 

6
Step

Quality Control (QC) activities (testing of samples) are part of the general QA policy.
All QC activities initiated at CO level must be managed in accordance with the “Guidance for UNDP Country Offices on Health Products Quality Assurance in the Supply Chain”.

Any non-compliant QC results (Out of Specifications = OOS) should be reviewed under the supervision of the UNDP QA team.
Responsible Party

CO/RBx Procurement teams,

UNDP QA Team,

GFPHST PSM Country focal points

Template/Guideline
Explanatory Notes

The second template for this step, “SOP on QC testing of health products” is forthcoming.

COs should share with  UNDP QA team any non-conformed results found through Quality Control testing and follow the instructions on how to interpret these results.

7
Step

Any quality complaints, quality alerts, recalls should be reported to UNDP QA Team. Each case will be reviewed, and relevant instructions and guidance will be provided by UNDP QA Team to BU doing health procurement (e.g. COs, RBx, GPSD-Health).
Responsible Party

Procuring entity e,g, GPSD-Health, CO, RBs,

Suppliers UNDP QA Team

Template/Guideline
Explanatory Notes

All quality-related complaints should be carefully treated since it may lead to a risk of reputational damage. The role of the CO is to collect information and to transfer it immediately to the UNDP QA team and to follow the instructions given by the UNDP QA team to handle the case (communication with national counterparts, with suppliers, with media).

8
Step

Submission of an Annual Quality Assurance Report to the Associate Administrator.
Responsible Party

UNDP QA Team

Template/Guideline
Explanatory Notes

In the UNDP QA Policy, it is agreed BPPS/HHG will submit an annual Quality Assurance Report to the Associate Administrator with copy to Regional Bureaux, Bureau of Management Services, and the Office of Audit and Investigations. 

Uncertified Sick Leave - from 1 April to 31 March – USL (Illness – without medical certificate; family emergency)

1
Step
Inform supervisor and leave monitor as soon as possible of absence due to illness/family emergency.
Responsible Party

Staff member

Template/Guideline
Explanatory Notes
Staff member must inform the office immediately that he/she will be absent from the office due to illness/family emergency.
 
All staff members are expected to familiarize themselves with the sick leave policy and other relevant leave entitlements, and are responsible for providing copies of the required specific documents for attendance recording purposes.

2
Step
Submit request for uncertified sick leave (USL) in Quantum self-service (absence module).
Responsible Party

Staff member

Template/Guideline
Explanatory Notes
Verify uncertified sick leave balance prior to submitting request.
Initiate a leave request in Quantum self-service.
Select “Uncertified Sick Leave” and, depending on the reason, select
(1) ”Uncertified Sick Leave” OR
(2) “Uncertified sick leave/Family Emergency”
Staff members can use a maximum of seven consecutive or cumulative working days for illness (without medical certificate) or family emergencies during the annual leave cycle, i.e., 1 April one year to 31 March the following year.
Record USL in Quantum self-service no later than on the 1st day upon return in the office.

3
Step
Ensure leave is appropriately recorded in Quantum self-service.
Responsible Party
Template/Guideline
Explanatory Notes
The request for uncertified sick leave due to illness is automatically approved in Quantum. Supervisor and leave monitor will be notified of approval. However, if the leave type selected is family emergency, supervisor’s approval is required.
If leave is not recorded in Quantum, supervisor/leave monitor requests the staff member to submit uncertified sick leave in Quantum on the 1st day upon return from leave.
Number of days of uncertified sick leave (illness/family emergency) taken is automatically monitored in Quantum. Staff member will not be allowed to request uncertified sick leave in excess of seven days.

Development and Institutional Effectiveness Project

1.0
Step
Approve annual workplan and budget.
Responsible Party
Template/Guideline
Explanatory Notes

The workplan and budget must be approved annually by the programme manager, or staff with Delegated Authority.

Programme Extension

1.0
Step

For programme extension requests, submit required documentation to the BPPS/Quality and Impact Hub (through the Regional Bureau, for country programmes) for clearance.
Responsible Party
Template/Guideline

RMT

Routing and Clearance Form for Extensions of Country Programmes

Explanatory Notes

Required supporting documentation:

  • Signed clearance form with reason for extension
  • Letter from the government requesting/agreeing with the extension of the Cooperation Framework or equivalent
  • Signed agreement from UN country team confirming harmonized approach to the extension
  • RMT cleared by the Bureau for Management Services/Office of Financial Resources Management covering complete programme period.

2.0
Step

Submit request for extension to Executive Board for approval.
Responsible Party

BPPS/Quality Programming Team

Template/Guideline
Explanatory Notes

This is included in the note of the Administrator to the Executive Board.

Formulate Programmes

1.0
Step

Contribute to the roadmap for an inclusive CCA and Cooperation Framework. 
Responsible Party
Template/Guideline
Explanatory Notes

UNSDG | Consolidated Annexes to the Cooperation Framework Guidance  

In transition settings, the UN country team must consult with the integrated mission task force or integrated task force to ensure coordination.

A roadmap is not required for regional and global programmes.

Involve the Regional Directors team and regional peer support groups as early and frequently as possible. 

1.1
Step

Once final, send the roadmap to all national partners, and to the Regional Directors team, peer support group, headquarters of all UN agencies and the United Nations Development Operations Coordination Office.
Responsible Party

Resident Coordinator

Template/Guideline
Explanatory Notes

This enables headquarters to position itself to support as appropriate.

2.0
Step

Prepare a quality analysis for the programme and contribute to the CCA as relevant.
Responsible Party
Template/Guideline
Explanatory Notes

UNSDG CCA guidance  

The analysis must provide inputs to the theory of change and define the UN's programming priorities, including UNDP's comparative advantage in the programming and larger financing context.

2.1
Step

Forward the integrated UN country team analysis to the regional peer support group mechanism for quality support and assurance.
Responsible Party
Template/Guideline
Explanatory Notes

UNSDG | Consolidated Annexes to the Cooperation Framework Guidance 

3.0
Step

Complete the country level macro-assessment of HACT.
Responsible Party
Template/Guideline
Explanatory Notes

UNSDG HACT Guidelines

Discuss arrangements for audit of government expenditures with the government development coordination authority as per the HACT framework.

4.0
Step

Develop inputs for the Corporate Framework theory of change.
Responsible Party
Template/Guideline
Explanatory Notes

Cooperation Framework Theory of Change Guidance 

A strategic prioritization exercise involving UN system entities and stakeholders should be led by the government to link the comparative advantages of the UN system to national development priorities.

UNDP's inputs to the theory of change should be developed in a participatory and evidence-based manner, identifying areas where the organization has a comparative advantage and potential to mobilize funding, based on evidence from evaluation and lessons learned.

5.0
Step

Contribute to the Cooperation Framework, attach the legal annex to the signed Cooperation Framework. 
Responsible Party
Template/Guideline

Cooperation Framework

Cooperation Framework Legal Annex

Explanatory Notes

Cooperation Framework Guidance

  • Following the strategic prioritization exercise, agree on a set of outcomes to support national development priorities. Prepare a SMART results matrix based on the country analysis.
  • If the Cooperation Framework will replace the CPD, a UNDP-specific country programme results matrix must be attached.

Country programmes will be assessed against UNDP quality standards.

*IMPORTANT: For individual project documents to be approved without signature of the government's development coordination authority, the Cooperation Framework legal annex must specify that all forms of assistance provided by UNDP further to the Cooperation Framework will be covered by the applicable standard basic assistance agreement (SBAA or predecessor agreement plus supplementary legal annex). The Legal Office must clear the text to confirm that it meets the requirements to consider the Cooperation Framework in lieu of a signed project document.

5.0 ALT 1
Step

If the legal annex is not attached to a signed Cooperation Framework or if there is no signed Cooperation Framework with a government, prepare and sign a country programme action plan with the government.
Responsible Party
Template/Guideline

Country Programme Action Plan Template

Explanatory Notes

5.0 ALT 2
Step

If there is no recognized government able to sign the country programme, seek approval from the Associate Administrator through the Bureau for Policy and Programme Support/Effectiveness Group for direct execution of the programme based on the country programme document.
Responsible Party
Template/Guideline

Direct Execution Modality (DEX) Approval Template

Explanatory Notes

This establishes a lack of a recognized national government that can accept national ownership of the programme; UNDP assumes the risks of directly executed programmes (DEX).

6.0
Step

Develop a country programme document that adheres to the quality standards.
Responsible Party
Template/Guideline

Country Programme Document Template

RBM Guidance on designing a CPD

Explanatory Notes

The CPD can specify up to four Cooperation Framework outcomes to which UNDP contributes.

It must include indicative outputs consistent with the theory of change, and prospective UNDP and partner financial resources.

Consider using the RBM Guidance to assist in developing the CPD in 10 steps.

6.0 ALT 1
Step

Develop the regional programme document.
Responsible Party

Programme manager/ Regional Bureau Director

Template/Guideline

Regional Programme Document Template

Explanatory Notes

6.1
Step

Prepare a costed evaluation plan with sufficient programme coverage, consistent with the Cooperation Framework evaluation plan if relevant.
Responsible Party
Template/Guideline

Evaluation Plan Template

Evaluability Checklist

Fully-Costed Evaluation Plan

Explanatory Notes

UNDP Evaluation Guidelines

6.2
Step

Ensure the programme budget is realistic and reflects an efficient use of resources.
Responsible Party
Template/Guideline

RMT

Explanatory Notes

UNSDG guidance

6.3
Step

Ensure incorporation of the PCAP into programme design. 
Responsible Party
Template/Guideline

PCAP

Explanatory Notes

The RM Toolkit and Communications Toolkits contain guidance with the required elements and a suggested format for the Partnerships and Communication Strategy and Action Plan (PCAP).

Consider using the RBM Guidance to assist in developing the PCAP.

7.0
Step

In high-risk security settings, contribute to the UN-wide programme criticality assessment to determine acceptable security risk levels for UN personnel in the required frequency.
Responsible Party
Template/Guideline

Programme Criticality

Explanatory Notes

In a prolonged crisis with elevated security risk, a UN programme criticality assessment is required to determine acceptable risk levels for different outputs, and to indicate where additional security risk management measures or alternative delivery modalities would be required.

8.0
Step

Participate in joint results groups and associated joint workplans, if applicable.
Responsible Party
Template/Guideline

Final - ANNEXES to UNSDG Guidance Note on a New Generation Joint Programmes.

Explanatory Notes

UNSDG | Guidance Note on a New Generation of Joint Programmes

Performance Monitoring

1
Step

Hold regular check-in discussions with the supervisee about performance, provide feedback, and discuss support needs; record their results in the Quantum PMD module, as appropriate 
 
Responsible Party

Supervisor (initiative) Supervisee (participate, request)

Template/Guideline

Quantum PMD module

Explanatory Notes

While the supervisor is responsible for providing feedback to supervisees on performance, in line with the principle of mutual accountability for performance, supervisees should also proactively seek feedback on performance and indicate support and development needs​.
 
Records of the periodic reviews are strongly encouraged for all staff but optional. For staff with performance shortcomings, however, the supervisor must make a record of performance discussions and agreements on improvement, next steps, consequences, etc.

2
Step

Hold a formal mid-term review of the supervisee’s performance and record its results in the on-line PMD tool
 
Responsible Party
Template/Guideline

Quantum PMD module

Explanatory Notes

Unless confirmed otherwise, the mid-term reviews of performance are expected to be conducted in July-August of the year​.
The record of the mid-term review in the on-line PMD tool should include an update on progress in the achievement of annual goals, confirmation of any modifications in the annual plan, if required, and brief feedback on performance to-date and support needs (the latter part is optional).
 
Detailed comments are required for supervisees with identified performance shortcomings. Performance Improvement Plans (PIPs) should be attached to the mid-term reviews in the on-line PMD tool.
 
In case of matrix reporting, both direct and matrix supervisors should be part of the mid-term review discussion/decisions. 

Medical Insurance: UN Worldwide Medical Insurance Plan

1
Step

Flowchart
Responsible Party
Template/Guideline

UN Worldwide Plan (WWP) Insurance Flowchart

Explanatory Notes

2
Step

Enrollment of staff: 

Application/Request for Change Form completed and submitted together with supporting documents in respect of staff member’s participation, including his/her eligible family members, where relevant
Responsible Party

Staff member

Template/Guideline
Explanatory Notes

Staff members who have no insurance coverage under a United Nations plan or through a family member must be strongly urged to obtain medical insurance coverage for themselves and their eligible family members, as the cost of medical care can result in financial hardship for individuals who fall ill and/or injured and have no coverage 

If a staff member or eligible family members is/are not enrolled within 31 days after an event that gives rise to an entitlement for coverage, an application for coverage may be submitted during the annual enrolment campaign. See  https://www.un.org/insurance/content/un-wwp for more information
In the case of a staff member married to another staff member, the insurance coverage, whether at the two-person or family level, must be carried by the higher salaried staff member 

Education of staff about the provisions under the insurance plan and distribution of materials by the person most familiar with the scheme is absolutely necessary 

If an office administers personnel on behalf of another agency, the same rules procedures for UNDP staff must be followed

3
Step

Enrollment of staff: 

The completed application for enrollment form is certified and submitted to the Insurance and Disbursement Services within 31 days of eligibility for the entitlement
Responsible Party
Template/Guideline
Explanatory Notes

Entitlements Services Unit  in BES/GSSC in Copenhagen 

The UN Health and Insurance Unit administers the workflow of enrolment and reporting directly with the insurance carrier on behalf of UNDP.

4
Step

Enrollment of staff: 

Staff member records in Quantum are validated, contributions are computed, and coverage is activated
Responsible Party

UN Health and Life Insurance Unit

Template/Guideline
Explanatory Notes

5
Step

Managing eligibility data in Quantum: 

Data on enrollment form is verified and validated and any change in coverage is processed into Quantum promptly
Responsible Party

,

UN Health and Life Insurance Unit

Template/Guideline
Explanatory Notes

6
Step

Issue ID card: 

Electronic ID cards are available in the staff member’s personal web page. If requested
Identity cards are issued to the staff member and eligible dependent(s)
Responsible Party

Staff member,
Template/Guideline
Explanatory Notes

It is the responsibility of the staff member to ensure the correct mailing address is submitted. Incomplete or incorrect mailing addresses in Quantum will result in misdirected mail or failure to receive important information.

7
Step

Claims: 

Insurance claims are submitted through Online Claiming tool or, in a sealed envelope together with supporting documents, on a claim form directly to the insurance carrier, following the instructions on the claim form
Responsible Party

Staff member

Template/Guideline

Online claiming guide

Explanatory Notes

Subscribers should note that claims for reimbursement must be submitted to the insurance carrier no later than two years from the date on which the medical expense was incurred. Claims received later than one years after the date on which the expense was incurred will not be eligible for reimbursement.

The administration and management of the health insurance plans for internationally recruited staff governed by the UN Staff Regulations and Staff Rules are administered by the UN Health and Life Insurance Unit. Any questions/queries on the provisions under the plan or any disputes regarding claims must be submitted directly to this unit, located at 304 East 45th Street, 3rd Floor; or by email: hlis@un.org.

8
Step

Verification and reimbursement of claims: 

Insurance carrier reimburses staff member directly
Responsible Party
Template/Guideline

P-2 Form Designation of Beneficiaries

HR_Insurance Plans_Designation, Change or Revocation of Beneficiary Form P-2

Explanatory Notes

Payment is made to the insured person, but, if the subscriber is no longer alive, payment will be made to his/her beneficiary as per P-2 Form Designation of Beneficiaries

9
Step

Request a review if a claim is denied: 

A claim denied in whole or in part must be submitted to the insurance carrier. The insurance carrier will provide the subscriber with a written notice explaining the reason for the denial and the appeal procedure.
Responsible Party

Staff member,
Template/Guideline
Explanatory Notes

The request for review must be submitted in writing within 60 days of receipt of the notice. The subscriber should include the reasons for requesting the review and submit the request to the insurance carrier. The insurance carrier will review the claim and ordinarily notify the subscriber of its final decision within 60 days of receipt of the request. If special circumstances require an extension of time, notification will be given to that effect.

Closing a Bank Account in a Regular Operating Environment

1
Step
Request to close the bank account.

Account with no activity for 6 months needs to be reviewed for closure or provide the explanation to Treasury to keep the account open.  
Responsible Party

RR/Business Unit Head

Template/Guideline
Explanatory Notes

2
Step
Provide current B2B, and last 3-month bank statements, clear all outstanding B2B issues, move the fund out of bank account and make available balance zero.
Responsible Party

RR/Business Unit Head

Template/Guideline
Explanatory Notes

3
Step
Review bank account closing request.
Responsible Party

Treasurer

Template/Guideline
Explanatory Notes

4
Step
Review B2B report, provide clearance to close the account.
Responsible Party

Chief, CFRA

Template/Guideline
Explanatory Notes

5
Step
Approve bank account closing request.
Responsible Party

Treasurer

Template/Guideline
Explanatory Notes

6
Step
Arrange for preparation of the official letter to close the bank account if the request is approved.
Responsible Party

Treasurer

Template/Guideline
Explanatory Notes

7
Step
Send Official Letter to close bank account to bank. 
Responsible Party
Template/Guideline
Explanatory Notes

8
Step
Obtain and provide in bank’s letterhead the confirmation that the account has been closed at bank.
Responsible Party

Bank,
Template/Guideline
Explanatory Notes

9
Step
Close the bank account in Quantum.  
Responsible Party

Treasurer

Template/Guideline
Explanatory Notes

Determination of Nationality (Where a staff member has more than one nationality at the time of appointment or the staff member acquires a new nationality during service)

1
Step

UNDP decides to review or staff member informs GSSC/JPOSC about nationalities at the time of appointment (P-11) or at the time of acquisition of a new nationality during service, including while on SLWOP.
 
Responsible Party

GSSC-Copenhagen/JPOSC,

Staff member

Template/Guideline
Explanatory Notes

Staff member is obligated to inform UNDP in advance of any additional nationality being acquired. New review of closest affiliation is required as per step 1.2.
 

1.2
Step

GSSC / JPOSC conducts a review of the closest affiliation of the staff member with the different nationalities to determine the official UN nationality which may include assessment of the following criteria:


-        The most recently acquired nationality;


-        Circumstances of acquisition of nationality


-        Cumulative years of residence in each country of nationality;


-        Years of education and professional experience in each country of nationality
-        Location of family members;


-        Recruitment into the UN Common system through a National Competitive Examination;


-        Other relevant factors such as ownership of property, voting rights, payment of taxes etc.
 
 
 
Responsible Party

GSSC-Copenhagen /JPOSC

Template/Guideline

HR_Recruitment and Selection_Matrix for Determination of Nationality

Explanatory Notes


 

​

1.3
Step

GSSC/JPOSC informs the staff member of the determination of the official UN nationality and impact on Benefits and Entitlements, including the determination of the new official place of Home Leave.

 
Responsible Party

GSSC-Copenhagen /JPOSC

Template/Guideline
Explanatory Notes

The effective date of any change in determination will be the date that the new nationality was acquired. 

 

2.0
Step

If the staff member is assigned to the country of UN recognized nationality or official place of Home Leave the staff member will not be eligible for international benefits.

 
Responsible Party
Template/Guideline
Explanatory Notes

3.0
Step

If the recognized nationality of the staff member is the United States, BES-GSSC/JPOSC authorizes staff member to sign the “ Waiver of Privileges Exemptions and Immunities ” (I-508). 

 
Responsible Party

GSSC-Copenhagen /JPOSC

Template/Guideline
Explanatory Notes

Link to form.
 

3.1
Step

Staff member signs I-508 and sends a copy to BES-GSSC/JPOSC together with his/her social security number.

 
Responsible Party

Staff member

Template/Guideline
Explanatory Notes

3.2
Step

BES-GSSC/JPOSC records the staff member as US tax payer in Quantum. The staff member will be entitled to tax reimbursements as of the date of the signature of the waiver. 

 
Responsible Party

GSSC-Copenhagen /JPOSC

Template/Guideline
Explanatory Notes
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