1. Quality Management and Opportunities for Synergy How Quality Management Impacts the Global Business Right First Time: Quality & Regulatory Initiative
What is Right First Time (RFT)?
RFT is an initiative to improve efficiency of document reviews by ensuring quality and accuracy.
This need has prompted the organization to review how we can deliver documents, Right the
First Time.
Analysis Process
In order to identify the potential root cause(s), we analyzed different documents by focusing on
the compliance to SOPs.
Where are we now?
Possible Solutions for Future Documents
Doing now what patients need next
A Business Perspective of Design Quality Assurance (DQA)
Carlota Balcells Garcia
Roche Molecular Systems, Inc. Pleasanton, CA
Tiffany Procopio, DQA Manager; Todd Barker, DQA Manager
Robust
customer
requirements
Differentiated
Quality
Products
Competitive
Advantage
Customers
to choose
Roche
Products
C. experience:
satisfaction,
loyalty, reliability
& reputation
Revenue
increase:
high profit
margins
Research &
Market
Research
Focused on Risk Management
(RM) Documents
Analyzed 200+ Risk Management
documents.
Classified the documents into level
of compliance & issues categories
1. Check
list
3.
Templates
or SOPs
2.
Training
With the new organizational change, where RMD, RSS and RTD are structured under a
single Business Unit, Roche Molecular Solutions, opportunities for synergy can be
identified:
• Capitalize and explore the benefits of connecting colleagues from similar functions.
• Identify and evaluate similarities and differences between Business Areas.
Quality & Regulatory Goal:
 Explore the feasibility of synergistic opportunities between
the various functions in the newly created Molecular
Solutions function.
Quality has fun too: Quality & Regulatory Summer Picnic
Getting to know each
other and strengthen
relationships between
team members is
essential to drive
success! We enjoyed
a barbecue and
organized fun team
building activities.
Quality & Regulatory Goals:
 Increase product compliance and Q&R efficiency.
 Reduce revision time and improve quality of submissions.
RDI RMD
Before Document
Approval
After Document
Approval
RMD is working collaboratively with
RDI and Regulatory Affairs, towards
a common goal.
0
5
10
RiMP RiMR FMEA RMFI
High Medium Low
During the analysis process the team came
up with several ideas to improve the review
of documents in the future.
To ensure
Create
Drives
Understanding them
allows us to develop
How a DQA internship can benefit my business career?
More funds
for
RDI RMD
RFT team has sent a questionnaire to
their stakeholders to gain a deeper
understanding of the potential root
cause(s).
RFT team has shared the issues found
with the stakeholders and will begin
measuring the improvement on the
upcoming milestones.
World leader
in Molecular
Diagnostics!
Great place
to work!
Eliminate
redundancy
Maintain compliance
Increase Efficiency
Reduce costs
Design Quality Assurance is a function involved in each phase of
the design control process, from customer requirements,
development of the product, execution of clinical trials,
submission to the FDA and finally to the product launch.
Possible synergies between sites for Design Control
Number of findings per risk level
by type of document
Knowing and understanding
the inputs and outputs of
the phases will help me in
my business career to
partner with quality to
support the development
and the launch of quality
products.
We are focusing on evaluating documents
with high & medium risk items.
RMD & RSS colleagues
Creating synergies across sites can
lead to multiple benefits:
• strengthens collaboration and
can inspire INNOVATION.
• provides opportunities for
professional DEVELOPMENT.
• it is just the first step to realizing
legitimate COST SAVINGS.
When analyzing possible synergies we observed that there are commonalities including
markets and customers, regulations and divisional standards to which we are
compliant. However, we acknowledge and respect that there are differences between
the sites, in terms of site and business specific processes.
During my DQA internship an initial analysis was conducted to identify some synergies;
Design Control in the Standard Operating Procedures (SOPs) was evaluated across
sites and similarities were found between business units.
Getting to know our colleagues from other business
units is another step in support of identifying synergies.
RDI RMD
Resulting in