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Main Subject - Issue Management Methodology for Tracking Project Issues
1. What is an Issue?
An issue is an incident, circumstance, problem or inquiry that affects or potentially affects the timely delivery of the project, product or service, it may also impact the quality of deliverables and the cost of production.
Some projects are ongoing and the definition of an issue is a little different. A help desk defines an issue as a request for help that requires a response. A service department keeps track of service requests as issues. A software maintenance group tracks reports of software bugs and enhancement requests as issues.
Because of the impact issues have on a project, product developme
An issue is an incident, circumstance, problem or inquiry that affects or potentially affects the timely delivery of the project, product or service, it may also impact the quality of deliverables and the cost of production.
Some projects are ongoing and the definition of an issue is a little different. A help desk defines an issue as a request for help that requires a response. A service department keeps track of service requests as issues. A software maintenance group tracks reports of software bugs and enhancement requests as issues.
Because of the impact issues have on a project, product developme
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
nt or ongoing service, issue management is an important aspect in any management methodology. This issue management methodology promises to make the handling of issues a seamless part of your larger scoped methodologies rather than a process separate from them.
It is usually not hard for team members to identify issues, but it is still worth having a working definition of an issue. Remember that the more ambitious your project the more issues will arise.
2
It is usually not hard for team members to identify issues, but it is still worth having a working definition of an issue. Remember that the more ambitious your project the more issues will arise.
Action item: The project team must be made aware of what issues are, provide some examples, and ask other team members to provide some examples.
2
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
. Requirements
A central repository of issue information easily accessible to all team members, because it is good for team morale and productivity to know that their issues are being addressed. An automated central repository like Issue Tracker is desirable because it make the issue management and reporting much easier.
An issue manager is the person chosen to oversee all issues. It can be the project manager, team leader or another person in a responsible leadership position.
A central repository of issue information easily accessible to all team members, because it is good for team morale and productivity to know that their issues are being addressed. An automated central repository like Issue Tracker is desirable because it make the issue management and reporting much easier.
Action item: Choose a central repository for your issues.
An issue manager is the person chosen to oversee all issues. It can be the project manager, team leader or another person in a responsible leadership position.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
The issue manager is responsible for making sure that there is consistent, disciplined and continuous progress made on all issues. The issue manager is accountable to upper management for the progress made on all issues. The issue manager communicates issue progress to the team, upper management and all stakeholders.
This issue management methodology represents best practice for managing issues. However, the goal is to have a successful project, product development or service, the goal is not
Action item: Appoint an Issue Manager and notify the issue manager of their role and responsibilities.
This issue management methodology represents best practice for managing issues. However, the goal is to have a successful project, product development or service, the goal is not
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to follow a methodology fanatically.
3. Steps
3.1 Discovery
Issues can arise at any time. When an issue is discovered it is recorded in the central repository.
It is important to allow issues to be recorded by a broad group of people including team members, upper management, users, customers, stakeholders, vendors and contractors. It is important because if there are barriers to reporting an issue then there is an increased chance that the issue will go unrecorded. You cannot address issues that you do
Action item: Adapt the methodology so your project's success is maximized.
3. Steps
3.1 Discovery
Issues can arise at any time. When an issue is discovered it is recorded in the central repository.
It is important to allow issues to be recorded by a broad group of people including team members, upper management, users, customers, stakeholders, vendors and contractors. It is important because if there are barriers to reporting an issue then there is an increased chance that the issue will go unrecorded. You cannot address issues that you do
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
not know about. It is not necessary that everyone has access to central repository, but the more you can allow the better.
3.2 Recording
Training people to identify issues is often unnecessary, however getting people to record the issue in the central repository will take some training and encouragement. For example, a team member may mention an unrecorded issue to the project manager during a coffee break or other informal occasion, this team member needs some encouragement to record such issues in the cent
Action item: Set up access to the central repository for those people that need it.
3.2 Recording
Training people to identify issues is often unnecessary, however getting people to record the issue in the central repository will take some training and encouragement. For example, a team member may mention an unrecorded issue to the project manager during a coffee break or other informal occasion, this team member needs some encouragement to record such issues in the cent
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ral repository.
For all kinds of issues, prevention is better than correction. Also, issues tend to be less severe if they are addressed earlier rather than later. This means that every effort should be made to report issues as soon as they are discovered, instead of waiting for the issue to become "serious enough" before recording it. Do not be afraid of duplicating an issue or overlapping with existing issues, it is better than missing an issue.
A complete description of the cause of the issue should be recorded in the central repository. Resist the temptation to describe the issue in terms of a solution. Any implication of the iss
For all kinds of issues, prevention is better than correction. Also, issues tend to be less severe if they are addressed earlier rather than later. This means that every effort should be made to report issues as soon as they are discovered, instead of waiting for the issue to become "serious enough" before recording it. Do not be afraid of duplicating an issue or overlapping with existing issues, it is better than missing an issue.
A complete description of the cause of the issue should be recorded in the central repository. Resist the temptation to describe the issue in terms of a solution. Any implication of the iss
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
e should be recorded. Attach any supporting documentation, screenshots, report output, faxes, error messages and other media that describes the issue.
The person who is recording the issue can make a recommendation for a solution, if they have one. This person should also assign the issue if possible, even if it is only assigned to the issue manager for re-assignment.
When an issue is initially recorded it should be recorded in the central repository with a status code that reflects the fact that it is new issue and has not been reviewed. An attempt should also be made to categorize and rank the severity of the issue.
The date and
The person who is recording the issue can make a recommendation for a solution, if they have one. This person should also assign the issue if possible, even if it is only assigned to the issue manager for re-assignment.
When an issue is initially recorded it should be recorded in the central repository with a status code that reflects the fact that it is new issue and has not been reviewed. An attempt should also be made to categorize and rank the severity of the issue.
The date and
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
who created the issue should be recorded in the central repository. This is done automatically for you in systems like Issue Tracker.
Many teams describe issues in terms of the desired solution, leaving others to deduce the actual issue. This is not best practice since it limits the scope of possible creative solutions. As an example a badly worded issue: "We need more people." There is no indication in this example of what the issue actually is, so finding alternative solutions is impossible. If the example issue had been worded as "The shipping department has swamped us with product, there is a possibility of spoilage if we cannot g
Many teams describe issues in terms of the desired solution, leaving others to deduce the actual issue. This is not best practice since it limits the scope of possible creative solutions. As an example a badly worded issue: "We need more people." There is no indication in this example of what the issue actually is, so finding alternative solutions is impossible. If the example issue had been worded as "The shipping department has swamped us with product, there is a possibility of spoilage if we cannot g
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
et the product delivered." With the issue worded this way perhaps the shipping department can become aware of how there actions are causing issues down the line and adapt their actions.
3.3 Initial Review
The initial review is a triage of new issues. It is usually performed by the issue manager or deputies who are familiar with the scope and priorities of the project. If the team is small the entire team can meet for the review. For each new issue the status, category and severity are reviewed and the issue assigned to someone for action and optionally an owner is identified as follows.
Sometimes the same person wh
3.3 Initial Review
The initial review is a triage of new issues. It is usually performed by the issue manager or deputies who are familiar with the scope and priorities of the project. If the team is small the entire team can meet for the review. For each new issue the status, category and severity are reviewed and the issue assigned to someone for action and optionally an owner is identified as follows.
Sometimes the same person wh
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o records the issue may be doing the initial review, so these two steps can be fused into one in this situation.
3.3.1 Issue Status
A decision is made about the next state of the issue. (The previous state was "new".) The next status of the issue reflects the nature and timing of the action to address the issue. It is one of the following:
3.3.1 Issue Status
A decision is made about the next state of the issue. (The previous state was "new".) The next status of the issue reflects the nature and timing of the action to address the issue. It is one of the following:
- open: immediate action will be taken to address the issue
- deferred: action will be deferred until some future time
- referred: action will be taken by some other group, probably because the issue is beyond the current scope
- cancelled: no action wil
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
l be taken now or in the future
3.3.2 Categorize the issue
A first attempt at categorizing the issue was made when it was first recorded. But, now during the initial review the category can be refined.
The proper issue category is helpful when prioritizing the resources required to address issues. It is especially useful for reporting purposes.
3.3.3 Rank the issue severity
The severity reflects the importance of getting the issue r
3.3.2 Categorize the issue
A first attempt at categorizing the issue was made when it was first recorded. But, now during the initial review the category can be refined.
The proper issue category is helpful when prioritizing the resources required to address issues. It is especially useful for reporting purposes.
Action item: Discuss with the team how best to categorize the issues you expect to get, and document the categories that will be used.
3.3.3 Rank the issue severity
The severity reflects the importance of getting the issue r
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
esolved. Obviously, you want to direct resources at the most important issues before the lesser ones.
3.3.4 Assignment
From the start, the next person to take action on the issue must be assigned to the issue and notified. Issue Tracker will automatically notify the person assigned to the issue via email.
If the issue description is incomplete, the issue can be assigned to the appropriate party to gather the info
Action item: Choose a small set of severity codes that have a clear ranking. For example: Trivial, Standard, Important, Critical. Some people prefer: Low, Medium, High, Very High.
3.3.4 Assignment
From the start, the next person to take action on the issue must be assigned to the issue and notified. Issue Tracker will automatically notify the person assigned to the issue via email.
If the issue description is incomplete, the issue can be assigned to the appropriate party to gather the info
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
rmation necessary to make the issue description clear.
Assign a person and not a group. Experience has shown that assigning issues to individuals leads to greater accountability than assigning issues to groups. An individual can be confronted about lack of progress, it is much harder to confront a group of people. A group can be represented by a group leader, so you can assign an issue to the group leader who will take action to reassign the issue to correct group member who will actually address the issue.
3.3.5 Ownership
It should be possible to decide which stakeholder is the owner of the issue. Having an issue
Assign a person and not a group. Experience has shown that assigning issues to individuals leads to greater accountability than assigning issues to groups. An individual can be confronted about lack of progress, it is much harder to confront a group of people. A group can be represented by a group leader, so you can assign an issue to the group leader who will take action to reassign the issue to correct group member who will actually address the issue.
3.3.5 Ownership
It should be possible to decide which stakeholder is the owner of the issue. Having an issue
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
wner is a way of recording who is accountable for the issue's resolution.
Owners must review the issues they own for progress to resolution. If the progress is not sufficient the issue manager should be told so that the situation can be remedied.
3.4 Taking Action
The process to address an issue iterates over the following sub-steps until the issue is resolved.
Owners must review the issues they own for progress to resolution. If the progress is not sufficient the issue manager should be told so that the situation can be remedied.
3.4 Taking Action
The process to address an issue iterates over the following sub-steps until the issue is resolved.
- The person assigned to the issue, takes action to address the issue.
- The person assigned to the issue, documents the action taken as an issue event in the central repository. An issue event has the person's name, the date and a de
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
scription of the action taken.
Some issue processes require an approval step before further action can be taken. This approval should take the form of signing off on a proposal. While paper based signatures are acceptable, an automated system is better. Issue events in Issue Tracker can by used to sign off, since a user is required to log in to identify themselves, this is as good as a paper signature.
If there is documentation to support the action taken, like a cost-benefit analysis of a proposed system change, the supporting files are attached to the issue.
The process of finding a solution may h
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
elp refine the issue description. This refinement should be reflected in updates to the issue description and title, as well as attaching further supporting files. It may also require that the issue be re-categorized.
If the next iteration is the responsibility of another person the issue is reassigned.
If the issue is resolved in this iteration, the status is updated to reflect the fact that the issue is inactive.
Notice that the action taken may involve reassigning the issue, changing status, refining the issue description, changing the category of the issue. All of these changes
Notice that the action taken may involve reassigning the issue, changing status, refining the issue description, changing the category of the issue. All of these changes
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
should be recorded in the central repository. Changing of status, category and severity are automatically logged for you in an automated system like Issue Tracker.
3.5 Ongoing Oversight
Consistent and continuous evaluation of issues by the issue manager and the team must take place to bring the issues to resolution. This can take place through a periodic review of all active issues in the central repository with the team and a separate review with the stakeholders.
Escalate issues as needed by re-assigning or by changing issue ownership.
Report and communicate progress on all issues to upper management and
3.5 Ongoing Oversight
Consistent and continuous evaluation of issues by the issue manager and the team must take place to bring the issues to resolution. This can take place through a periodic review of all active issues in the central repository with the team and a separate review with the stakeholders.
Escalate issues as needed by re-assigning or by changing issue ownership.
Report and communicate progress on all issues to upper management and
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
to the team, subscriptions can be used by upper management and the team to follow progress on individual issues. This reporting can be integrated into project status reporting.
Analyze issue progress and adapt actions. The central repository should be able to provide feedback on how efficiently the issues are proceeding from creation to resolution. If it is taking too long to resolve important issues, then the issue manager must find ways to improve the turn-around time.
4. Finally
The following are a few further action items
Analyze issue progress and adapt actions. The central repository should be able to provide feedback on how efficiently the issues are proceeding from creation to resolution. If it is taking too long to resolve important issues, then the issue manager must find ways to improve the turn-around time.
4. Finally
The following are a few further action items
Action item: Distribute copies of this issue management methodology to team
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
members and stakeholders so that everyone knows how and why issues are managed.
This issue management methodology has evolved over many years. It evolved from experience on projects with budgets from $500,000 to $50,000,000 which had a total number of issues ranging from a few hundred issues to many thousands. In half the cases the project team was physically dispersed in several countries
Action item: Adapt and scale this issue management methodology to suit you project's scale and quirks.
Action item: Create your central repository, and get started today.
This issue management methodology has evolved over many years. It evolved from experience on projects with budgets from $500,000 to $50,000,000 which had a total number of issues ranging from a few hundred issues to many thousands. In half the cases the project team was physically dispersed in several countries
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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