The document discusses implementing a quality risk management (QRM) approach within existing quality systems. It notes two main challenges: the variety of uses for QRM and complexity of integrating it into existing processes. It recommends acknowledging what activities already utilize QRM principles and accepting existing terminology, in order to integrate QRM without creating redundant activities. QRM should be seamlessly integrated into existing business processes to add value rather than be an add-on requirement.

1. Pharmaceutical Quality systems have shifted in
recent years from a traditional model to a
more global, dynamic and risk-based
approach, enhanced especially by regulatory
authorities and the economic environment.
The integration of quality risk management is
not anymore an option for pharmaceutical
companies, which need to improve and
strengthen the robustness of their process
along the life cycle of their products to
facilitate innovation, improvement and
compliance. An effective quality system is also
guaranteed by continual verification of the
data, processes and products, which also need
to be implemented within the global quality
architecture.
Ahead of Quality Risk Management & Process
Validation in the Product Life Cycle
Conference, we spoke with Michael Schousboe,
Principal Specialist Quality Risk Management
at Novo Nordisk, who analyses how a risk
management approach can be implemented
and deployed in the existing quality system.
Could you please explain how a risk
management approach can be
implemented and deployed in the existing
quality system?
I think that the challenge of implementing a
risk based approach across an existing quality
management system is major because of the
following:
• The huge variety or spread in what QRM
should be used for
• The complexity of fitting in to existing
systems which are already in function
What we are facing, is an expectation to use
QRM as a mean of obtaining a lot of different
purposes. Authorities call QRM an enabler and
I think the key to success here is to linger at
exactly that statement. We need to figure out
a way to manage risk by selecting or adapting
methods that fit the value creation needed in
the different activities. QRM has no value on
its own. Only if you use it for something that
can bring value, and the combination of
domain knowledge and knowledge of QRM
methods is what makes it work.
When it comes to fitting into an existing and
operating Quality Management System, I find
that the key here is to stop considering QRM
as something new. QRM is just systematic
common sense, and the systems we already
have running are built the way they are to
protect our patients and ensure product
quality. To a large extent most systems
already utilise some form of QRM in the way
they operate, if built according to the GMPs.
However you may not be conscious about how
it works.
What I find, is that, once you acknowledge
what is already there, and accept the other
terms that may be used for what are
essentially QRM activities, then you get to a
value adding QRM integration. This way you
will be able to use existing systems and
reporting flows, and not create redundant
activities.
You may have to improve the choice of
methods and alter the level of formality but
that becomes a means to value creation rather
than a purpose in itself.
Which monitoring system can be the most
efficient?
That very much depends on what you are
looking for. However, any system that gives
you frequent data points on achievement of
specific quality characteristics, or how the
trends of these are moving, will provide value.
What you want from a monitoring system is to
see whether you are in control or not. If, for
example, you are looking directly at
manufacturing processes, then control charts
of the individual process parameters and the
quality of the output can be highly valuable as
a monitoring system in order to see if the risk
picture changes.
How Novo Nordisk re-deploy a QRM
program?
Novo Nordisk originally deployed a QRM
program when the ICH Q9 guideline came out,
and so we have a risk based approach to many
things across the Quality management system.
However, some time back we understood that
we were not realising the full potential of the
concept. We had a tendency to choose the
same fairly complex method for most uses,
and we were not good at recognising the
flexibility in terms of level of effort and
formality. We could see examples where the
QRM activities were becoming an add-on to
other activities that sometimes was redundant.
With a combination of knowledge about the
business process and what should be
achieved, and solid knowledge about QRM
principles, methods and activities, we decided
to re-deploy with a clear focus on integration
in the existing business processes
We want to achieve a future state where
people do not implement QRM for the purpose
of being compliant. They simply do the
activities they should do to operate the
business, with QRM seamlessly integrated in
that.
We make this a combined effort between our
QRM experts and the persons responsible for
each business process across the company.
We can evaluate what is currently being done
compared to the topics below, in order to
identify potential for improvement:
1) Expected uses of QRM
2) QRM principles including choice of method
3) Clear integration of the steps of activities
seen in ICH Q9
We are just starting, but we have already seen
the first examples of this approach making
more sense to users.
What would you like to achieve by
attending the Quality Risk Management &
Process Validation in the Product Life
Cycle conference?
I hope to meet a lot of peers, to exchange
both experience and ideas about integration of
QRM across the Quality Management System,
and have some good discussion about practical
approaches and solutions.
About the speaker:
Michael Schousboe is Principal Specialist
Quality Risk Management in Novo Nordisk.
Situated in Corporate Quality, he has the
overall responsibility for maintaining a well
performing and compliant process of Quality
Risk Management across the quality
management system of Novo Nordisk. The
past few years he has worked as a project
manager improving the Quality Management
System, and originally led the implementation
of Quality by Design in Novo Nordisk.
Michael holds a Master’s degree in
pharmaceutical science (M.Sc. Pharm.) from
the Royal Danish School of Pharmacy, a
Design for Six Sigma Black Belt, and has 18
years of experience within the pharmaceutical
industry.
With a QC laboratory background and later as
a QA professional Michael has worked with
qualification and validation within the areas of
computerised systems, laboratories, as well as
production of drug products and API in
different Danish pharmaceutical companies. He
is experienced as a speaker on the aspects of
QRM, validation, Quality by Design and Quality
Systems. Furthermore Michael is an
experienced auditor and has served as a
qualified person
About the event:
This marcus evans conference will help
delegates implementing a quality risk
management approach into their existing
quality systems, understanding how to assess
and evaluate risks in their companies and with
their Third party partners. They will also gain
insights from various companies with the
development of continuous process
verification, approaching the management of
data and preventing potential pitfalls in its
implementation.
Quality Risk Management & Process Validation
in the Product Life Cycle
Conference will take place from the 28th until
the 30th of September 2016 in Berlin,
Germany.
For more information about the event, please
click here or contact:
Yiota Andreou
T: +357 22849 404
E: Yiotaa@marcusevanscy.com
How a risk management approach can be implemented in the existing quality system