Six Sigma Green Belt Project Charter

Project Name Yields Improvement DRUG PHARMA S.A.S.

Today’s Date 15 July 2020
Project Start Date 15 July 2020
Target Completion 2 September 2020
Date

Project Element Response

Problem Statement
 Includes time, In last nine months, the processes’ yields has decreased 30%. We need to
measurable item, gap review our processes to see the flaws.
and business impact
Business Case
 Why is this project
important to do now? If the problem isn’t solved, the company won’t sell the amount of products
 What is the project’s that are in the planification, and it will cause a huge loss. The scrap will be
financial impact? about the 30% of the total production. There won’t be enough product in the
 What is the impact on market to cover the costumer demand.
DPMO/ Sigma level?
 What is the impact on
customer service
Goal Statement Goal is to:
 Specific Reduce wastes in Processes
 Measurable Improve Quality
 Achievable Increase Processes’ Yields
 Realistic Increase Sales
 Time-bound
List of Improvement Goals Measure (units) Baseline Goal
1. Reduce wastes in Waste in Processes 30% 5%
Processes Number of returns per 20 0
2. Improve Quality 3.Increase month
Processes’ Yields Processes’ Yields 85% 100%
4. Improve Sales Sales per month 1000 2000
5.
Process In the Pharmaceutical Industry, the supplies in form of dust are granulated
 Describe the process in to then be compressed and create the tablets that are the best way of
which the problem administration of the medicine.
exists
Project Scope
 What part of the
process will be
addressed?
 What are the The Compression phase of the Tablets manufacturing process will be
boundaries of the addressed
project or process? The boundaries are Technical and Financial The
 What areas are inside areas are Quality and Production
or outside the team’s
focus or authority?
 Attach a SIPOC
diagram if necessary

Team Member Name

Project Sponsor Technical Director
Key Stakeholders Pharmacist Chemistry
Team Lead Production Leader
Team Members Process Engineer, assistant engineer, Chemistry
Process Owner General plant manager

Timeline by Project Stage Milestone Target Completion Date

Define Project Charter and kickoff 15 July 2020
Measure Define and collect data 20 July 2020
Analysis Find causes 10 August 2020
Improve Fix causes 25 August 2020
Control Standardize the fix 28 August 2020
 Team Charter
Project Title Yields Improvement
Expectation Example Team Rule
Attendance is required at all team meetings. Changes in
Attendance meeting times must be made at least 24 hours ahead of All Team Members must attend to every meetings. If a team
time. member has 3 miss, will be out of the team.

Every team member must participate at least 3 times in every meeting. If

Team members may not be substituted unless approved
Participation a team member doesn’t participate, won’t be able to attend to the next
by team leader.
meeting.
We will stay on task and on topic, using the Project
The Project charter will be the guide for every meeting. An agenda will be
Charter as our guide. A meeting agenda will be
Focu published one day before. In this agenda will be the topic and task that will
publishedat least one day in advance.
s be discuss for every team member.

Phones must be in silent. The meeting won’t be

Interruptions for emergencies only. Phones turned to
Interruptions interrupted at least it is an emergency. Only the Team members will
silent.
be able to speak during the meetings.
All deliverables are expected to be completed in a
Every team member will have a deliverable that must be accomplished
Preparation timely manner. Each meeting will have a published
before every meeting. All deriverable will be available in the agenda.
agenda.
The team members must be in the meeting room at the time specified in
Timeliness Meetings will begin promptly as scheduled. the agenda. Those who arrived later won’t be able to be in the meeting.

We will choose the best decision-making method for Every continuous improvement tool will be considered to the decision-
Decisions each situation. We will support decisions made by making method. Every decision made will be considered.
the team.

Data We will rely on data to make decisions. The decisions that doesn’t be made based in data won’t be considered.
Project Title Yields Improvement
Expectation Example Team Rule
We welcome honest disagreements, as long as
everyone is treated with respect. A facilitator will be The respect will be the base of every meeting. It will be a facilitator to
Conflict lead conflicts and difficulties.
used if conflict cannot be resolved.

Othe
r

Team Member Role Signature

Technical Director

Team Lead
Pharmacist
Chemistry Team Member
Production Leader

Team Member
Process Engineer,
assistant
engineer, Team Member
Chemistry
General plant
manager
Facilitator
 Data Collection Plan
What will be measure?
To detect in which part of the compression process is the most waste, the quantitative variables that will be measure
are:

- Operational Speed of the machine

- The compression force
- The particle size (granulometry) previous the process
- The number of tablets outs of specifications
- The amount of dust that result of the process
- Process’ Yield

What is the Data Type?

The data is Quantitative, because it is all about operational variables that will be studied through inferencial
statistics to determine which of all the variables represent the root cause.
 Compression Process

Granulation Friability Control

Not Pass Pass

Not Pass
Granulometry Packing process
Control

Pass
Warehouse

Compression

Not Pass
Costumer
Hardness
Control Pass
 Hypotheses
Measures Null Hypothese
Before Improvement: The Operational
speed has increased to 500 c/h (H0: v
= 500 c/h)
Operational Speed
After Improvement: The Operational
speed has decreased to 300 c/h (H0: v
= 300 c/h)
Before Improvement: The
Compression force has decreased to
150 kN (H0: v = 150 c/h)
Compression After Improvement: The Compression
Force force has increased to 400 kN (H0: v =
400 kN)
Before Improvement: The proportion of
low size particles is greater than 60%
(H0: P ≤ 0,60)
Particle Size After Improvement: The proportion of
low size particles is less than 15% (H0:
P  0,15)
Before Improvement: The number of
tablets out of specifications is greater
Number of tablets than 35% (H0: P ≤ 0,35)
out of After Improvement: : The number of
specifications tablets out of specifications is less
than 10% (H0: P  0,10)
Before Improvement: The amount of
dust is greater than 70% (H0: D ≤ 0,70)
Amount of Dust After Improvement: : The amount of
dust is less than 30% (H0: P  0,30)
Before Improvement: The Process’
Yield has changed from 80% (H0: R =
Process’ Yield 80%)
After Improvement: The Process’ Yield
has changed from 95% (H0: R = 95%)
Alternative Hypothese
Before Improvement: The Operational
speed has increased to 500 c/h (H1: v 
500 c/h)
After Improvement: The Operational
speed has decreased to 300 c/h (H1: v 
500 c/h)
Before Improvement: The Compression
force has decreased to 150 kN (H1: v 
150 c/h)
After Improvement: The Compression
force has increased to 400 kN (H1: v 
400 kN)
Before Improvement: The proportion of
low size particles is greater than 60% (H1:
P  0,60)
After Improvement: The proportion of low
size particles is less than 15% (H1: P
 0,15)
Before Improvement: The number of
tablets out of specifications is greater
than 35% (H1: P  0,35)
After Improvement: The number of
tablets out of specifications is less than
10% (H1: P  0,10)
Before Improvement: The amount of dust
is greater than 70% (H1: P  0,70) After
Improvement: The amount of dust
is less than 30% (H1: P  0,30)
Before Improvement: The Process’ Yield
has changed from 80% (H1: R ≠ 80%)
After Improvement: The Process’ Yield
has changed from 95% (H1: R ≠ 95%)
 List of Possible
Improvements
Possible Improvements
Considering the quantitive variables, here is a list of possible improvements of the compression process where is
the most waste:

- Reduce Operational Speed of the machine

- Adecuate the compression force
- Increase the particle size (granulometry) previous the process
- Decrease the number of tablets outs of specifications
- Decrease the amount of dust that result of the process
- Increase Process’ Yield

Improvement Selected
Reduce Operational Speed of the machine to a speed that doesn’t generate too much dust, increasing
the Process’ Yield.
 Control Plan
How will we maintain the gains?
We implement de improvement, reducing the Operational Speed by 20%, that bring our Process’ Yields up in 15%.
In order to maintain this significant gain we develop a control plan based in:

- Modify procedures for the new Operational Speed

- Modify quality appraisal and audit criteria
- Change information systems
- Revise forecast
- Modify training to adapt the new equipments to new Operational Speed

Dinamic Control Planning

We combine all the facets of the new process into one document to plan, monitor, control, study and
maintain. Then, with constant communication with operators, we update this document regularly.

We include SOP’s and quality planning sheets in this Document to standardize the new
procedure to ensure the appropriate Operational Speed.
 Reflection

After all Green Belt training, I have learned to measure and analyze the collected data, to identify the critical control
points in the processes and improvement opportunities. I have known the different tools to implement the continuous
improvement of the processes and I have recognized that the most important element in any process is the
customer.