PROJECT QUALITY MANAGEMENT PLAN
This plan will guide you through the production of a Quality Management Plan that communicates the stakeholders, project team and third parties
the importance of vaccine procurement, quality and services involved. This plan ensures that we prepare a detailed and well thought out approach
to quality management of the entire project.
It clearly indicates the quality requirements and boundaries of acceptance for all parameters and shows how to measure quality assurance and
control to guarantee our project’s success.
Project Title: Distribution of
Covid-19 Vaccine
Version: 1.0
Project Description: The procurement, storage, distribution and administration of
Date: 05-03-2021
the Covid-19 vaccine in the province of Ontario
Project Sponsor: Government of Ontario
Plan: Quality Management
Organization: Covid-19
Contact no.:
Contact
tel:
+1
4168865011
Vaccine Distribution Task
email:
Author: Nikita Rajda
email:
Force
Nikita.rajda15@gmail.com
CIRCULATED TO:
- Justin Trudeau, Prime Minister, Government of Canada
- Doug Ford, Government of Ontario
- Christine Elliot, Minister of Health
- Peter Bethlenfalvy, Ontario Ministry of Finance
- Stephen Lecce, Ontario Ministry of Education
- Harjit Sajjan, Ontario Ministry of Defense
External Contractors
- Sudharshan Nandakumar
- Reem Hassan
- George
- Pothan Chakravarthy
Nikita Rajda
QUALITY MANAGEMENT PLAN APPROVAL
Printed Name & Job Title
Project Role
Doug Ford, Premier of Ontario
Project Sponsor
Sudharshan Nandakumar
Project Manager
Signature
Date Approved
Reem Hassan
George
Pothan Chakravarthy
Nikita Rajda
INTRODUCTION: Describes the purpose of the quality management plan to define how quality will be managed within the project lifecycle. Its a im is
to make sure that all the stakeholders, members of the project team and third parties are familiar with the process and procedures that plan the
management of quality ensuring proper controls are in place and quality can be assured.
The purpose of this document is to effectively describe the necessary information required to effectively manage quality in the Covid19 vaccine deployment project.
This Quality Management Plan defines the acceptable level of quality and describes how the project will ensure in its deliverables and work processes. It serves as
a reference for all related project members to identify their roles and responsibilities and to address quality related project processes.
The intended audience is the project team and any related stakeholders involved in the successful implementation of execution of the Covid19 vaccine in the
population of the province of Ontario.
4.5.2. QUALITY MANAGEMENT APPROACH: This section of the plan describes how quality will be managed during the lifetime of the project. It
describes quality from the aspects of ‘product’ and ‘process’ so that time wasting, higher costs, rework and wastage are kept to a minimum or
eradicated completely. This approach must be agreed and approved by all stakeholders.
To enable smooth facilitation of this project, the foremost important thing is that the timeline of this project is maintained to achieve maximum effectiveness. For
this to be possible, all the stakeholders involved in the project need to work collaboratively.
Product Quality: The vaccine quality will be determined by the approval of the Covid19 vaccine by Health Canada, which will be then procured buy
us from the Government of Ontario. Its quality will then be maintained by the timely delivery of vaccines, proper storage and handling and
administration of the vaccines as per the defined guidelines In addition to that, timely delivery of vaccines for the two dosages is necessary to achieve
its effectiveness.
Process Quality: This will be defined by the timely procurement and delivery of vaccines at the vaccination provider site, proper storage and
handling and administration of the vaccines as per the defined guidelines. It will focus on all the parameters involved in achieving the project
deliverables, right from the preparation of the database to monitoring of the vaccinated patients and administering of the second dosage of the
vaccine. Healthcare workers are required to be adequately trained and proper safety measures are expected to be followed to maintain the sanctity of
the process. All the stakeholders involved are expected to adhere to the guidelines and the process requirements and deliverables meted out to them. 
4.5.3. QUALITY STANDARDS: this section of the plan is concerned with defining and documenting the quality standards required
for the project. This is communicated to all members of the quality and the project team.
Project Requirements:
Product Quality: The chain begins from procurement of the COVID-19 vaccine from the government of Ontario manufacturing plant, includes
delivery to and storage at the COVID-19 vaccination provider site, and ends with administration of COVID-19 vaccine to a person as per the
defined guidelines. Vaccination providers are expected to submit the storage and safety equipment requirement within the defined timeline and the
external contractors are expected to adhere to their respective timelines to facilitate Jurisdictions and vaccination providers are responsible for
maintaining vaccine quality from the time a shipment arrives at a vaccination provider site until the dose is administered.
Process Quality: The process quality will be maintained by following the guidelines for each step involved for the respective stakeholders
and proper documentation of each stage. The vaccines are to be stored, handled, distributed, and administered as per the guidelines
for each step. In order to maintain the efficacy of the vaccine, it is imperative that a second dose is administered within the prescribed
timeframe and is of the same manufacturer. The process steps to achieve this are to be followed.
QUALITY ASSURANCE: an essential part of quality management is the process of auditing and measuring the quality of the work package. This is
for both the initial project requirements and the resulting products or services produced. This section of the manag ement plan defines the
operational and quality standards plus the metrics to be used during the project to everyone involved. Reporting formats and contents will be
defined here to monitor standards of work packages and the interval between assessments of work will be stated
Product Quality: The product quality is to be assured by following the vaccine storage, handling and administration guidelines as per the respective
manufacturers.
Vaccinated patients are supposed to be closely monitored for a period of 7 days from the date of vaccination for an adverse event, which may or may not be
caused by the vaccine. They are to be reported as per the guidelines set up by the Vaccine Adverse Event Reporting System. The patients infected with the
Covid19 virus after vaccination are to be mapped in the same database to determine the efficacy of the vaccine. The vaccination database is to be uploaded to the
central server within 24 hours throughout the three phases of the vaccination.
Process Quality: The health workers are to be provided with proper safety equipment in order to avoid an outbreak. Also, power backups should be available with
the healthcare partners responsible for vaccine administration to avoid spoilage of the vaccine. Proper process logs are to be maintained.
QUALITY CONTROL: is vital to a successful project and this section outlines the monitoring process that will be used during its lifespan. It a lso
describes how these results will be documented so that an assessment of performance can be done and adjustments made where necessary.
Quality control applies to the ‘products’ of the project only it is not applicable to the processes.
Sr. No.
Deliverable
1
Approval, Selection and
Awarding of Vaccine Supply
Contract
2
Public Health Preparedness
Planning
Assessmen
t Interval
Weekly
Bi-Weekly
Metric
98%
Target
Timelin
e
Performance Standards
6 weeks
Approach the vaccine manufacturers,
receive approval from Health Canada
and execute the vaccine contracts as
per phases and establish a timeline.
4 weeks
This outbreak requires collaboration
between multiple internal and
external partners. A proper strategic
approach is requried with
documentation. Taking in account
the urgency of the project, the
capability assessment and the
finalization of the partners based on
the scale should be completed in a
month.
3
4
COVID-19 Organizational
Structure and Partner
Involvement
Phased Approach to COVID19 Vaccination
Bi-Weekly
99%
Bi-weekly
36
weeks
Establish the requirements, float the
RFQs and receive quotes from atleast
three external contractors for each of
the outsourced service. Pandemic
vaccination planning is a combined
state, territorial, tribal, and local
responsibility that requires close
collaboration between public health,
external agencies, and community
partners.
40
Weeks
Since the manufacturers have a
limited vaccine production capcity,
the vaccines will be received in three
phases. Defined delivery timelines
need to be met and the logistics and
distribution partners need to be
prepared accodingly.
5
Identification of Critical
Populations
Bi-Weekly
99%
4
weeks
6
COVID-19 Vaccination
Provider Recruitment and
Enrollment
Weekly
98%
4
weeks
This will involve assessment of the
high risk population of Ontario, who
needs to be administered the vaccine
first as per Health Canada guidelines.
The complete database and
administration planning should be
complete in a span of 4 weeks. All
the data should be uploaded in a
central repository, which will serve as
a guideline to all the healthcare
providers for planning.
Assess the region wise requiremnet,
availability and capability of
healthcare partners. Float
partnership advisories and enroll
them accordingly.
7
8
9
10
Understanding a
Jurisdiction’s COVID-19
Vaccine Administration
Capacity
COVID-19 Vaccine Allocation,
Ordering, Distribution, and
Inventory Management
COVID-19 Vaccine Storage
and Handling
COVID-19 Vaccine
Administration
Documentation and
Reporting
Weekly
Daily
Bi-weekly
Weekly
98%
99%
99%
99%
4
weeks
Assess the region wide facility and
personnel requirements to
administer the phased dosage of the
vaccines. Provde the missing
infrastructure for the storage and
handling to the respective
jurisidictions
36
Weeks
Distribute the vaccine as per the
designated region wise priority based
on the risk asessment. Prepare a
database and follow the guidelines.
Partner with external suppliers to
facilitate the distribution of vaccines
and for storage of vaccines. A daily
report is to be submitted.
36
Weeks
The individual regions are required to
submit the missing equipments
required to follow the vaccine
storage protocols along with the
details of the healthcare partners. A
database of estimated healhcare
workers in the vaccination effort is to
be submitted, based on which a
safety kit will be provided for each
one of them for the number of days
they are scheduled to administer the
vaccine.
36
Weeks
Recruitment of healthcare workers as
per the density of vaccine
administration. All healthcare
workers should be trained for the
vaccine administration and
precautions prior to the supply of
vaccines as per the distribution plan
11
COVID-19 Vaccination
Second-Dose Reminders
12
COVID-19 Requirements for
Immunization Information
Systems or Other External
Systems
13
COVID-19 Vaccination
Program Communication
Weekly
Weekly
98%
99.50%
98%
44
Weeks
A vaccine recipient’s second dose
must be from the same
manufacturer as their first dose and
should be administered as per the
most recent dosage timeline. Failure
to do so will result in a strict penalty.
A basic vaccination record should be
provided to each patient and should
receive the reminder using the
smartphone app (if available)
automated calls, emails and text
messaging service.
36
Weeks
Mandatory submission of duly filled
digital forms with the complete
details of the healthcare worker,
citing the completion of the vaccine
administration training program and
training evaluation report.
40
Weeks
Follow the communcation plan and
educate the population about the
gravity of the situation and the safety
of the vaccination process.
Messaging should be as per the
target audience defined in the
communication plan. This is to be
executed via an exernal agency,
which will conduct surveys to
quantify the impact of the
communcation plan. A database of
the deliverables and its effectiveness
is to be submitted digitally. The
communication plan needs to evolve
as per the situation, with prior
authorization from the responsible
authorities.
14
15
16
Regulatory Considerations
for COVID-19 Vaccination
COVID-19 Vaccine Safety
Monitoring
External Contractor Services
100%
Weekly
Weekly
99%
99%
4 weeks
The list of vaccines authorized for
general use and for emergency use is
to be strictly followed. Prior
authorization needs to be taken
before employing vaccines meant for
emergency use. Failure to do so will
result in a legal action.
44
Weeks
Any adverse event whether minor or
major is to be reported in the
Vaccine Adverse Event Reporting
System, even if it is unsure if the
vaccine caused the event.
Vaccinated patients are to be
monitored for 14 days and should be
provided immediate assistance in
case of a medical complaint.
40
Weeks
At all times, the contractor must
establish a communication link to the
government furnished systems in
order to provide services rendered
under this contract. If the failure
occurs and it is determined to be the
fault of the contractor, and the
failure lasts more than 4 hours, the
contractor will be penalized.
Project
Deliverable
Assessment Interval
Phase
Approval, Selection and Awarding of
1
Weekly
Vaccine Supply Contract
Public Health Preparedness Planning
2
COVID-19 Organizational Structure and
Bi-Weekly
Partner Involvement
3
Phased Approach to COVID-19
Vaccination
4
Bi-weekly
Identification of Critical Populations
Weekly
COVID-19 Vaccination Provider
Recruitment and Enrollment
5
Understanding a Jurisdiction’s COVID19 Vaccine Administration Capacity
6
7: COVID-19 Vaccine Allocation,
Weekly
Ordering, Distribution, and Inventory
Weekly
Management
8: COVID-19 Vaccine Storage and
Handling
9: COVID-19 Vaccine Administration
Documentation and Reporting
10: COVID-19 Vaccination SecondDose Reminders
11: COVID-19 Requirements for
Immunization Information Systems or
Other External Systems
12: COVID-19 Vaccination Program
Communication
13: Regulatory Considerations for
COVID-19 Vaccination
14: COVID-19 Vaccine Safety
Monitoring
15 External Contractor Services
Measurement/
Metric
98%
Target
Timeline
6 weeks
99 %
4 weeks
99%
36 weeks
99%
99%
3 weeks
4 weeks
4 weeks
4 weeks
36 Weeks
95%
Performance Standards
Approach
the
vaccine
manufacturers, carry out the FDA
approval and execute the vaccine
contracts as per phases and
establish a timeline.
Establish the requirements, float
the RFQs and receive quotes from
atleast three external contractors.
At all times, the contractor must
establish a communication link to
the government furnished systems
in order to provide
services rendered under this
contract. If the failure occurs and it
is determined to be the fault of the
contractor, and the failure lasts
more than 4 hours, the
contractor will be penalized.
95%
Weekly
95%
36 Weeks
Weekly
36 Weeks
Bi-Weekly
4 Weeks
Bi-Weekly
36 Weeks
Weekly
Weekly
Daily
98%
4 Weeks
99%
99%
44 Weeks
98%
40 Weeks
Recruitment of healthcare workers as
per the density of vaccine
administration. All healthcare workers
should be trained for the vaccine
administration and precautions prior
to the supply of vaccines as per the
distribution plan
Mandatory submission of duly filled
digital forms with the complete details of
the healthcare worker, citing the
completion of the vaccine administration
training program and training evaluation
report.
Project
Phase
Product Description
Assessment
Interval
Physical Requirements
Performance Standards
QUALITY CONTROL MEASUREMENTS: this section defines how the quality logs should be used and they provide the documentation for the quality
control (Appendix D) and quality assurance (Appendix C) measures. It states what action must be taken if standards of performance do not meet
requirements and the reporting format and meetings that will be conducted as part of this process. It outlines how these logs feed in their data to
the project status meetings.
APPENDIX A – VERSION HISTORY
This appendix records the version history of this plan. For each new and approved version the reasoning behind its creation a re described below
Version
Number
1.0
Name of Implementation Author
Nikita Deben Rajda
Date
Revised
08th March
2020
Approved by
Date
Approved
Reasoning behind new version
First Version
APPENDIX B – GLOSSARY OF PROJECT TERMS
Each project uses standard acronyms and develops their own for the ease of communication. It is important to record them in this plan to ensure
clarity of description and terminology is consistent in every communication.
Acronym / Term
Standard or Project Definition
PMO
Project Management Office
CRB
Contract Review Board
APPENDIX C - QUALITY ASSURANCE LOG
This appendix shows a sample quality assurance log that can be used as part of quality control measures. It feeds into the re gular project status
meetings.
Date
Task
Required
Value
Process Measured
Actual
Value
Acceptance
Level
Recommendation / Action
Date Resolved
APPENDIX D – QUALITY CONTROL LOG
This appendix shows a sample quality control log that can be used as part of quality control measures. It feeds into the regu lar project status
meetings.
Date
Product
Required
Value
Process Measured
Actual
Value
Acceptance
Level
Recommendation / Action
Date Resolved
APPENDIX E – DOCUMENTATION REFERENCES
Any professionally managed project has extensive documentation the purpose of this appendix is to record which documents (plus the version
used, if applicable) have been used in the production of and conjunction with of the communications management plan.
Reference / Version
Document
Author