Introduction to

Quality
Management
System
ROFE
MRA
 The Novo Nordisk Environment
Investors Competitors

Regulatory Agencies

Customers Quality
 Quality Management System

Vision
Novo Nordisk Values
Way of Management Fundamentals
Policies

QBIQ Quality Manual

Top Level Procedures
Quality Cross Functional
Agreements Procedures
Local Procedures
Instructions
QMS
KSSQMIT

NNE R&D Operations

NNS NNIT
Staffs & Finance
Quality
Quality Management System
• The system name is QBIQ: Quality and Business Integration
to Quality
 The applicability of Top level procedures from QBIQ is
mandatory to all department.
 Cross functional procedures from QBIQ is defined the
applicability and trained locally using the - Read and
Understood Form- to register the training
 Department Level: ROFE Procedures such as:
 040337 Handling Non Conformities
 040326 ROFE Training
 NOVO NORDISK WAY OF MANAGEMENT Ed. 11

 Novo Nordisk Way of Management is the framework within

which we all work, and it helps grow our culture of
empowerment and innovation - of coaching and learning -
of business and people. Rather than restricting us, this
framework expands our options because the principles for
how to work and behave as an employee at NN are clear.
• Contains
• Our Vision
• Charter
• Values
• Commitments
• Fundamentals
• Methodology
• Policies
NNWoM
• OUR VALUES
• Accountable
 Ambitious
• Commitments to the
 Responsible triple bottom line – we
will be...
 Engaged with • economically responsible
stakeholders
 environmentally
 Open and honest responsible

 Ready for change  socially responsible

Quality Policy
• Novo Nordisk is committed to quality in
everything we do
This means that we will:
• Set ambitious quality goals
• Secure that all employees share the commitment to quality
• Measure and evaluate the quality, in order to continuously
improve our products, service to customers, and the way
we work
• Maintain the Quality System building on relevant laws,
requirements, ISO 9000 standards, and Novo Nordisk
values and fundamentals
Quality Manual Ed. 7
• Covers all Novo Nordisk organisational units,
products and devices
• Describes the Quality Management
System QBIQ that governs Novo
Nordisk
• Introduces structure and strategy
and outlines operational procedures
• which cross functional or local
procedures need to be in place ?
• Outlines the general requirements
for all Novo Nordisk personnel,
functions and operations.
• Numbering system of the sections in
the Quality Manual is based on the
chapters in ISO 9000:2000 plus
additional NN sections
 Quality Manual Ed 7.0

• Quality Management System:

• 4.1 Novo Nordisk processes

• Management Responsibilities
• 5.1 Vision and Policies
• 5.2 Strategies, business planning
• 5.2.1 Strategies and goal setting
• 5.2.2 Follow-up on plans, goals and QMS effectiveness
• 5.3 Organisation and Responsibility

• Customers and stakeholders

• 6.1Determination and review of customer and stakeholder requirements
• 6.2 Customer and stakeholder communication
• 6.3 Measurement of customer and stakeholder satisfaction

• Core Process:
• 7.1Research and development
• 7.2Manufacture
• 7.3 Storage and distribution
• 7.4 Sales and marketing
Quality Manual Ed 7.0
• Support process:
• 8.1 Procurement and contracts
• 8.1.1 Procurement
• 8.1.2 Contracts
• 8.2 Legal and trademark issues
• 8.3 Buildings, installations and equipment
• 8.4 IT systems
• 8.5 People
• 8.6 Communication
• 8.7 Finance and budgeting
• 8.8 Regulatory licensing
• 8.9 Quality Management
• 8.9.1 Maintenance, control and retention of documents
and records
• 8.9.2 Continuous improvement
• 8.9.3 Monitoring the QMS
Continuous Improvement
Novo Nordisk Quality

Quality is our ability to meet or exceed

customer expectations
What tools are you given to improve ?

• Use the tools given to you by the Quality

Management System:

• Quality Actions: Adherence to procedures

• Quality Services: Customer Satisfaction Survey
• Corrective Action: Non-conformities, audits
• Preventive Action: Change Control, Trending, non-
conformities, audits
• Quality Planning: QAP Continuous Improvement
• Quality Review: QMR - Evaluate our processes which
are critical for your business?
Quality Activity Plan
• QAP must be issues annually: includes, but is not
limited to:
• Compliance improvement activities
• Recommendations from audits and facilitations
• Corrective actions defined at QMR
• Improvements to key business routines
• Activities related to the Balanced Score Card
• Activities related to unit specific goals
Quality Management Review (QMR)

• QMR to be perform twice a year: agenda

and minutes.
• Formal evaluation by top management of the
status and adequacy of the quality system in
relation to quality policy and objectives.
• The QMR is another improvement tool
 Quality Management Review
Affiliate Level QMR
(GM, CM)

Business Area (BA) Level QMR

(VP)

QMR in Int’l Marketing Regional Level QMR QMR in Product Supply

(SVP) (SVP) (SVP)

Operations Level QMR

(EVP)
Operational Documents
• Operational Document Control and
Distribution - 040300
• Non-conformity - 040337
• Change Control - 112409
• Handling Costumer Complaints/Adverse
Events and Safety Information - 116589
• Training and Development - 040326
Operational Document Structure and
Distribution Doc. 116586
ROFE Applicability Master List Address for Consulting
Link: \\fcinbg03\ROFEQA
What to do:
1- Go to Start
2- Run
3- Type \\fcinbg03\ROFEQA
4- Click OK
5-Open the ROFE Applicability Master List and your Department Work
sheet (Excel File)
6- Check for new edition/procedures highlighted in Yellow
7- Affiliates record self-training in the R&U form doc 040326
What is a non-conformity ?

Failure to meet specified requirements (Doc. No.

040337)
Requirements being:
• NN Quality System
• Your local Quality System
• A contract
• Your local registration of a product
For example:
• Tasks described in SOPs are not performed , or are
erroneously performed
• There is a deviation from the registration parameter
• There is an observed quality defect
• An unintended occurrence might affect the product quality
or safety
What are YOUR responsibilities ?
According to Doc.No. 040337:

• Be able to recognize Non-conformities when they happen

• Any employee discovering NC’s must inform the relevant
unit responsible
• Managers of units or departments from whom an NC
originates must ensure that the “product” is not used and
that actions are taken and followed up.
• QA of the unit need to ensure that all the documentation is
in place and needs to approve any suggested actions
1. Flow Diagram for a Non Conformity
• Discover possible NC
• Fill out NC form (if the cause comes from
your affiliate) Get input from other parties
• Send to QA Responsible (Local/BA) / QA logs NC
into NC database
• QA Follow up and closure
• Discussion at the QMR
• Time frames
• Repeat NC / Planned NC

• If the NC is in another unit or Head Quarters

you need to notify THEM via a Notification Form
What if I need to change something ?

USE YOUR CHANGE CONTROL PROCEDURE !

• Why should I use Change Control ?
Why should I use Change Control ?

• To change things in a controlled manner

• To evaluate possible impact of the change
on products and services
• To inform people about upcoming changes
• To track changes in a system
So Change Control is applicable to:

• Operational documents (e.g. Procedures)

• Critical processes
• Contracts
• Equipment (e.g. cold storage warehouse)
• Critical computer systems and their
documentation
Is Change Control needed here ?

The affiliate decides it would like to use an

off site archive facility as there are just
too many requirements for the continued
local archiving of documents. The financial
manager finds a company down the road
that is suitable.
YES !
What about this one ?

The affiliate warehouse will be expanded

as business is growing. A new storage
area for solid dosage forms will be built.
(India)
YES !!!!
Quality is BEING THERE !