Handling Cust Complaints (Global)

Corporate Procedure
Handling Customer
Complaints
▼ C2 Ensure and Monitor Customer and Stakeholder Satisfaction
► C2.02 Customer complaints
Scope
This procedure describes the global process for handling customer complaints in Novo
Nordisk (NN) for pharmaceutical products and medical devices, hereinafter referred to as
‘products’.
A customer complaint is any alleged deficiency related to the technical quality as well as
the safety and efficacy of a product outside of NN’s control. The complete definition of a
customer complaint is provided in the Definitions section.
Any alleged deficiency related to products within NN control is handled according to [1].
All customer complaints must be registered in NN’s global complaint handling system,
CCGloW. The pharmacovigilance process is handled in another system according to the
process for handling adverse events and other safety information, see [2].
In scope
 All marketed products manufactured by or on behalf of NN, including products

being counterfeited, stolen, diverted (smuggled, see definition table) or parallel-
imported.
Marketed products that are both manufactured and marketed by another company
are in scope only if they are reported as concomitant products in adverse event
cases together with an NN product.
 All clinical trial products manufactured by or on behalf of NN, as well as external

comparator products and auxiliaries that are re-packed or re-labelled for use in
clinical trials conducted by NN.
Document no.: 008782 Edition no.: 20.0

Internal no.: - Page no.: 1 of 33
Out of scope
 Customer ideas, see [3]. These are customer suggestions where no product
deficiency is alleged.
 Product enquiries and other contacts with a customer that do not fall under the
definition of a customer complaint, see definition in the definition table.
If a user (and only a user, not a health care professional or a relative) can confirm
that a perceived problem is no longer a problem after he/she has been trained in
using the product, then the situation is not to be handled as a customer complaint,
see [4].
 Product refund: products returned to an NN affiliate for refund purposes with no

alleged deficiencies.
Exceptions from the process described in this document
All customer complaints related to products within scope must be handled according to
the process described in this document. However, the following exceptions exist:
 For products manufactured by NN but marketed by another company, the complaints

are not initially received by an NN affiliate. The complaints will instead be reported by
the other company to the NN affiliate.
 Concomitant products in adverse event cases are registered in CCGloW but not
investigated, as by definition they are not covered by the alleged product deficiency.
 Affiliates or production sites may be authorised to investigate certain complaint types

on behalf of Customer Complaint Center (CCC). This is referred to as ‘locally
investigated complaints’ (LIC) when investigation is done by affiliates and as ‘Local
NN investigator’ when investigation is done by production sites, see [5] and [6].
 For technical complaints received from all NN sponsored clinical trials and non-
interventional studies investigating medical devices, exceptions from this procedure
are described in [7], [8] and [9]. In the event of clinical trial cases the following
sections do not apply: sections 2, 6 and 8.1-8.2; [7] must be followed instead.

Applies to
The procedure applies to NN employees who are involved in the complaint handling
process and processing customer complaints. The following roles are included:
Role Description
Affiliate complaint handler Personnel in NN affiliates or NN local offices in Regions
who are processing any steps of the complaint handling
processes as described in this procedure.
NN complaint investigator Personnel in any department in NN who are requested by
CCC to perform investigations of customer complaints.
Investigators can come from many parts of the
organisation, e.g.:
 Product Supply and QA for Product Supply,
including the following areas:
o Diabetes Finished Products
o Biopharmaceuticals
o Device & Supply Chain Management,
including the Koriyama Factory in Japan
 CMC Development and QA for CMC Development
 Device R&D
 Marketing
 Regulatory Affairs
If required due to the nature of the complaint case, CCC

may appoint other departments in addition to those
mentioned above as NN complaint investigators.
QA for NN complaint Personnel in QA departments for the NN complaint
investigator investigators. For certain investigators, it is a requirement
that the investigation results are approved by the QA for
that complaint investigator. See Section 4.3.
CCC complaint handler Personnel in CCC in headquarters or personnel in CCC-
Global Service Center (GSC) in Bangalor, India.
The split in responsibilities between CCC and CCC-GSC is

described in detail in [10].
In some countries receipt and registration of customer complaints is outsourced to

external companies, i.e. external call centres. Training of call centre personnel in any
parts of the complaint handling process is managed according to [4]. This procedure
therefore does not apply to call centre personnel outside of NN.

Table of Contents
Scope .......................................................................................... 1
Applies to.................................................................................... 3
Table of Contents ........................................................................ 4
Introduction................................................................................ 5
Process ....................................................................................... 5
1 Event.................................................................................... 6
2 Registration ......................................................................... 7
2.1 Registration ........................................................................ 7
2.2 Reporting ........................................................................... 9
2.3 Shipment of complaint samples............................................. 9
2.4 Registration of CCGloW offline cases ...................................... 9
3 Evaluation .......................................................................... 10
4 Investigation...................................................................... 10
4.1 Investigations performed by CCC..........................................10
4.2 Investigations performed by investigators .............................11
4.3 QA approval of investigation results ......................................12
5 Verification and Approval ................................................... 13
6 Reply and Closure .............................................................. 14
7 Archiving............................................................................ 15
7.1 Documentation...................................................................15
7.2 Complaint samples .............................................................15
8 Timelines............................................................................ 16
8.1 Case reporting to CCC.........................................................17
8.2 Shipment of complaint samples............................................17
8.3 Completion of investigations ................................................17
8.4 Approval of customer complaints ..........................................18
9 Trending and surveillance of customer complaints............. 18
10 References...................................................................... 19
Definitions ................................................................................ 21
Appendix 1 - Classification of verified product defects.............. 25
Change log ................................................................................ 26

Introduction
NN is legally obliged to handle all customer complaints related to the products mentioned
in Scope. Thus, NN has a global process for complaint handling, which is described in this
procedure.
The procedure covers all steps in the process, from first receipt of the complaint in the
NN affiliate or local office (hereinafter referred to as ‘NN affiliates’) to closure of the
complaint case, including answering the customer.
Customer complaints are handled in NN’s global complaint handling system, CCGloW.
Process
The overall customer complaint handling process is shown in Figure 1, below.
All employees in affiliates that are handling customer complaints must have reading
access to CCGloW in order to receive replies from CCGloW and look up cases. This
includes affiliates which otherwise do not use CCGloW, i.e. affiliates that register
customer complaints via the Customer Complaint Form (CCF) [11].
Figure 1 - Overall process for complaint handling for marketed products
The steps handled by the safety department are part of the pharmacovigilance process
and are therefore not covered by this document, see [2] and [12].
Quality Risk Management principles are applied throughout the complaint handling
process where the case is evaluated for its criticality; however, they are predominantly
present in the Registration, Evaluation and Investigation phases.
The process for technical complaints received from clinical trials is described in [7].

1 Event
An event is when a customer complains to NN about an alleged product deficiency.
Examples of customers are patients, relatives to the patient, wholesalers, pharmacies,

health care professionals (HCP) and health authorities (HA).
The NN affiliate receiving a customer complaint is responsible for the further processing
of the case. This also applies if the customer has bought the product in another country.
If the NN affiliate receives a customer complaint about a product that is not in scope of
this procedure, they should advise the customer to contact the marketing authorisation
holder for the product.
If a customer complains directly to CCC, CCC must forward the complaint information to
the NN affiliate in the customer’s country, with instructions to register the customer
complaint according to this procedure.
Technical complaints from clinical trials are reported directly to CCC and are, therefore,
registered by CCC, see [7].

2 Registration
After receipt of the customer complaint, the NN affiliate must register and report the
complaint to CCC. In addition, they must forward any complaint samples received to CCC
for investigation, except if handled as LIC [5] or local NN investigator [6].
2.1 Registration
Registration
What How Who
Affiliates  Register the customer complaint in the global complaint
that are handling IT system [13].
online to  Create an individual case for each customer complaint.
CCGloW  A unique case number is automatically assigned to the
customer complaint case in CCGloW.
 Personal data must be protected [14]. Only redacted
copies of documents (with personal data deleted),
including the CCF, can be attached in CCGloW where they
are available to other parts of the organisation than the
affiliate (e.g. on the Patient/Reporter tab, as attachment in
the Affiliate Update Log).
Affiliates  Register the customer complaint information according [4].
that are not
online to
CCGloW
Suspected  If the same complaint case covers more than one batch
products number of the same product, create a product sub form for
each batch number.
For durable devices, create one product subform per
complaint sample received. Affiliate
 Create a product subform for each returned sample that complaint
could have contributed to the alleged fault. If in doubt, handler
register all returned samples as suspected (pen, Penfill®
and needle).
Liability  If the customer complaint may lead to a liability claim,
claims inform the local legal department in the affiliate.
Request of  If a local health authority in connection to a customer

reserve complaint requests reserve samples for their own
samples by investigation, contact CCC before confirming to the health
health authorities that the samples will be sent to health
authorities authorities.
Veterinary  If the case covers an adverse event (AE) or technical

cases complaint (TC) related to veterinary use, choose the case
category ‘TC’.
 Tick ‘Veterinary’ on the Complaint tab.
 If the case covers solely other safety information (no

Registration
What How Who
adverse event or technical complaint) related to veterinary
use, do not registered the case in CCGloW or Argus.
Products  If the customer complaint involves only a technical
used complaint and the customer complaint covers both NN and
together non-NN products, only the NN products should be
with non-NN registered and marked as suspected.
products  If the customer complaint involves adverse events or other
safety information, non-NN products must also be
registered.
Collect  Collect as much information as possible about what the
information customer complains about [15], and the affected product.
A thorough and specific complaint description allows NN to
perform the correct investigations
Parallel  When relevant, contact the parallel importer in order to
imported obtain the necessary information to investigate the
product, see customer complaint, e.g. batch numbers.
definition Affiliate
table complaint
Complaint  Translate the complaint description into English. handler
description  As far as possible, ensure that the complaint description
covers:
o Product part affected, e.g. content, container,
labelling
o Product function affected, e.g. click sound is
missing, empty cartridge
o How the fault occurred, e.g. product was stored
incorrectly with a needle attached, product was
exposed to frost
o Any health consequences experienced by the
patient
Further guidance is given in [15].

Complaint  Collect as many affected products as possible.
samples  Document the attempts made to try to obtain the batch
number and the complaint sample(s).
 If relevant for the complaint, collect any auxiliaries
supplied by NN with the product, e.g. syringes used for
reconstitution and vial adaptors.
 Check that the trade name and the batch number on the
complaint sample are the same as stated in the
information received by the customer.

2.2 Reporting
Reporting
What How Who
Reporting  Report the customer complaint case to CCC via CCGloW
cases online [13].
Reporting  Report the customer complaint via the CCF [11].
cases off-
line Affiliate
complaint
Reporting  Report the customer complaint case to CCC within the
handler
deadline deadline stated in Section 9.
Inform CCC  If the case requires urgent handling, send an e-mail to CCC
about urgent using the mailbox complaintcenter@novonordisk.com.
cases
2.3 Shipment of complaint samples
Complaint samples must be sent to CCC for investigation. The only exceptions are cases
that can be handled as LIC [5] or as local NN investigator [6].
Shipment of complaint samples

What How Who
Send  Send the complaint samples to CCC according to [16]. Affiliate
complaint complaint
samples handler
2.4 Registration of CCGloW offline cases
CCC must register the case in CCGloW according to [17].
Registration of CCGloW off-line cases

What How Who
Registration  Register the information reported on the Customer CCC
of off-line Complaint Form [11] in CCGloW. complaint
cases handler

3 Evaluation
All customer complaint cases are initially evaluated by CCC, except cases handled as LIC
[5].
Evaluation
What How Who
Evaluate  Evaluate the customer complaint case, regardless of
whether a sample is available or not, according to [10]. CCC
Significant  If a significant product defect is suspected and the defect complaint
product may affect products which are no longer under NN’s handler
defects control, handle the case according to [18].
4 Investigation
4.1 Investigations performed by CCC
In all customer complaint cases where a batch number is available, a batch trend
investigation is performed. In addition, all returned samples are visually examined.
Below investigations can also be performed by LIC [5] and local NN investigators [6].
Investigation by CCC is described in detail in [10] and [19].
Investigations performed by CCC
What How Who
Visual  Perform a visual examination of all available complaint
examination samples.
 Document the results of the examination in the case.
Batch trend  Perform a batch trend analysis for all products where a
analysis batch number is available and initiate trend actions if
relevant.
 Document the result of the batch trend analysis.
Determine  Based on the complaint description, the visual examination
the need for of the complaint sample and the batch trend analysis,
further determine the need for further investigations, e.g.: CCC
investigation o Further investigation of the complaint sample complaint
o Investigation or analysis of reserve samples handler
o Batch record review for the relevant process step(s)
If the fault could potentially have occurred in more than one

process (e.g. formulation, filling, inspection, assembly and
packaging) all potentially affected processes must be
investigated.
Further  Send the complaint sample, if relevant, and investigation
investigation instructions to the appropriate investigator(s).
of the
complaint

Investigations performed by CCC
What How Who
sample
outside CCC
Adverse  Initiate analysis of the content of the returned product
events related to the reported adverse event, if requested by the
safety department.
4.2 Investigations performed by investigators
The investigator receives instructions for investigation from CCC via CCGloW. If an
investigator does not have access to CCGloW, instructions will be sent by CCC via e-mail.
Investigations must be completed according to the timelines described in [20].
When a product defect on a complaint sample is verified as an NN fault, it should be

classified as either minor, major or critical. The classification depends on the possible
medical consequences, influence on the product quality and regulatory impact of the fault
(i.e. influence on the registration files and violation of the legislation), see [21] and
Appendix 1.
For major and critical product defects, specific requirements for investigations apply as
described below.
Investigations performed by investigators

What How Who
Investigator’s  Perform the investigations requested by CCC.
instructions  Additional investigations besides the ones requested by
CCC may be performed if it is necessary to investigate
the complaint sample(s) thoroughly.
 Investigate all questions mentioned in the investigator’s
instructions. If the requested investigations are not
relevant, include a rationale for not performing the
investigations.
CCC will inform the investigator if destructive tests are not

acceptable, or if preliminary approval by CCC is needed.
Reserve  If production is requested by CCC to perform non-
samples destructive physical examination of reserve samples, all
NN
reserve samples available at the production site must be
complaint
examined.
investi-
 If the customer complaint is related to particle
gator
contamination, a minimum of 20 reserve samples must
be examined.
Batch record  When the batch trend analysis requires further actions,
review as a CCC can request a batch record review. The batch record
trend action review is selected according to all customer complaints
received on the batch and does not necessarily reflect the

Investigations performed by investigators
What How Who
complaint in the specific case, see Section 4.1.
 Perform the investigations requested by CCC.
Major or  If a major or critical product defect is discovered or
critical suspected, initiate an NC report (for definition, see [1]) in
product the relevant department. If relevant in the specific case,
defect caused the investigation must cover the following aspects:
by any Novo o Examination of reserve samples
Nordisk o Review of the batch records for the relevant production
processes processes
o Impact on other batches
o Any other relevant documentation to support the
investigation conclusion
 Document the results in an NC report, see [1].
If it is verified that the fault is covered by an existing NC

report and the fault occurred before implementation of the
corrective actions in the NC report, a new NC does not need
NN
to be created.
complaint
investi-
Completion of the complaint investigation is not dependent
gator
on completion of the NC report.
Document  Document the results of the investigations in CCGloW.
results of  If the investigator does not have access to CCGloW,
investigations document the result according to local procedure and
send the relevant results and conclusions to CCC by e-
mail to complaintcenter@novonordisk.com.
Raw data  Store raw data in local records according to [22].
Timeline for  Complete investigations within the time limits defined in
investigation [20].
4.3 QA approval of investigation results
For NN complaint investigators in Product Supply and CMC Development, the QA for the
NN complaint investigators must approve the investigation results. If the complaint is
suspected to be associated with, or caused by, production discrepancies, based on
investigations of the product, QA must review the batch documentation and any
potentially related nonconformities as part of the investigation to confirm or deny above
suspicion. If the batch documentation has already been reviewed in connection with a
previous similar customer complaint related to the same issue, a new review is not
required. If the investigator is a QA department in Product Supply or in CMC
Development, further QA approval of the investigation results is not required.
QA approval of investigation results

What How Who
QA approval  Review and approve the investigation QA for the NN
results. complaint investigators

5 Verification and Approval
When the scheduled investigations are completed, CCC evaluates the investigation
results and verifies the case in CCGloW.
Below actions can also be performed by LIC [5].
Verification of customer complaint

What How Who
Review and  Check that the investigations performed are consistent
verification of with the complaint description, and request further CCC
investigation investigations if necessary. complaint
results  When the above is fulfilled, verify the investigation results handler
according to [10].
When the investigation results are verified, a reply text is created and the case is
approved in CCGloW.
Approval of customer complaint

What How Who
Review the  Check that there is consistency between what the
case customer complains about, the investigation results and
the final conclusion of the case.
Inform the When the customer complaint is approved, the conclusion is
Qualified made available to the Qualified Person (QP) in CCGloW for
Person the affected manufacturing site, or to his/her deputies as CCC
stated in the current version of the manufacturer’s complaint
authorisation [23]. No further action is required from CCC to handler
inform the QP.
 Add the relevant QP to the case.

Approval of  Route the case from the approval phase to the next
the case phase.
Notification of Upon case approval, the respective affiliate is notified via an

case approval automatically generated email. Affiliates that are online with Affiliate
CCGloW may choose not to receive such notifications since complaint
this information is also available directly in CCGloW. handler
No notifications are sent when a clinical trial case is

approved.

6 Reply and Closure
Reply to the customer

What How Who
Send reply to  Send a reply to the customer according to local authority
the customer requirements.
 Document the customer reply according to local
procedures.
Parallel-  Inform the customer that the product has been re-packed Affiliate
imported outside the control of the NN supply chain, and that this complaint
products might reduce the possibilities for a full investigation of the handler
complaint.
 Upon request from CCC, inform the local health
authorities when a fault on a complaint sample can be
due to a parallel importer.

7 Archiving
7.1 Documentation
The affiliate complaint handler, the NN complaint investigator and the CCC complaint
handler must each ensure that their part of the customer complaint case is complete and
archived according to [22]. The original complaint from the customer (e.g. e-mail, letter)
is archived at the affiliate.
7.2 Complaint samples
The required retention time for complaint samples is described below in Table 1, [25].
Stricter requirements apply to special cases, and these are described below in Table 2.
The requirements apply to CCC, affiliates and investigators. Other requirements for
archiving samples must be documented in written agreements with CCC.
The sample retention time is calculated from the date CCC approves the case for the first
time after the sample is received.
Sample
Case type Product
retention time
Drugs, needles and prefilled
Adverse events and technical complaints 3 months
devices
Adverse events and technical complaints Durable devices 3 years
Table 1 - Sample retention time
For the following cases, the complaint samples must be kept for a longer period of time
and for all products (except needles), the complaint sample must be returned to CCC for
storage:
Sample retention
Case type Product
time
Confirmed counterfeit, stolen or diverted products not
All 1 year
covered by any ongoing legal cases
Legal cases where the Legal department has requested To be agreed with Legal
All
additional investigations department
PumpCart® All 1 year
Table 2 – Sample retention time for special cases

8 Timelines
There are four steps in the customer complaint handling process that are covered by
timelines:
Case reporting to CCC by the affiliates (or clinical trial site)
 Shipment of complaint samples to CCC by affiliates
 Completion of investigation by the NN complaint investigator
 Approval of case by CCC
The timelines for marketed products are indicated on the figure below and are described
in detail in the following sub-sections.
Figure 2 - Four timelines in the customer complaint handling process for marketed products

8.1 Case reporting to CCC
Timelines for reporting customer complaints

What How Who
All customer  Report the complaint case and follow-up information to
complaints and CCC within seven calendar days from the initial receipt
follow-up date of the customer complaint or follow up
information information.
Damage during  Report immediately the complaint case or follow-up
transportation of information to CCC.
products outside
of NN control Affiliate
complaint
Indication of a  Report immediately the complaint case or follow-up handler
significant information to CCC and in accordance with [18].
product defect,
e.g. product
mix-up
Incidents  If the case concerns an incident, report the complaint
or followup information to CCC within the specific
timeline given in [2].
8.2 Shipment of complaint samples
Timelines for shipping complaint samples

What How Who
Customer  Send the complaint sample to CCC as soon as possible Affiliate
complaint and at least within seven calendar days from the initial complaint
samples receipt date of the customer complaint sample at Novo handler
Nordisk.
8.3 Completion of investigations
The timelines for investigators to complete their investigations are described in [20].

8.4 Approval of customer complaints
Customer complaints must be investigated and approved by CCC or LIC as fast as

possible. All customer complaints must, as far as possible, be approved within 90
calendar days as described in Table 3 below.
Table 3 - Timelines for approval of customer complaints by CCC

Sample availability Typical timeline for case approval
Complaint sample is Within 90 calendar days after receipt of the
available sample by CCC
Complaint sample is not Within 90 calendar days after receipt of the
available complaint case by Global Safety
9 Trending and surveillance of customer complaints

CCC continuously monitors customer complaints with regard to complaint types and
verified faults in order to detect potential quality issues, see [24].

10 References
No. Title
1 019467 - (QBIQ Document)
Nonconformities

Handling of Adverse Events and Other Safety Information

Handling of Customer Ideas

Logging and quality control of customer contacts

Handling of Locally Investigated Complaints - LIC

Handling Local NN investigator customer complaints

Technical Complaint Reporting from Clinical Trials and for Medical Devices Being
Investigated in Non-Interventional Studies
Technical Complaint Forms for Clinical Trials and for Medical Devices being
Investigated in Non-Interventional Studies
Handling technical complaints from clinical trials, non-interventional studies and
investigator initiated studies
Handling Customer Complaints in CCC and GSC
11 208036 - (Editable Form)

Customer Complaint Form (CCF)

Device vigilance in Global Safety

Using the Novo Nordisk Complaint Handling System (CCGloW)

Personal Data Protection

Write good Complaint Descriptions

No. Title
Transport and storage of Customer Complaint samples

Registration of Offline Customer Complaints

Handling Potential and Actual Recalls

Handling suspected counterfeit products in CCC

Time Limit for Investigations of Customer Complaints

Complaint Surveillance Groups (CSG)

Archiving business-critical physical records

Product Supply Quality Manual

Complaint Surveillance in CCC

Unpacking, shipment and clean-up of customer complaint samples in Customer
Complaint Center

Definitions
This list contains definitions of abbreviations and terms used in this document.
Term Definition
Adverse drug reaction See the definition in [2].

(ADR)
Adverse event (AE) Any untoward medical occurrence in a patient or clinical
investigation subject administered/using a Product and
which does not necessarily have a causal relationship with
this treatment.
An Adverse Event can therefore be any unfavourable and
unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of
a Product, whether or not it is considered to be related to
the Product.
Note: An Adverse Event may be associated with the use of
a drug, a Medical Device or both.
CCC Customer Complaint Center in Global Safety.
CCC-GSC Employees in Global Service Center in India handling
customer complaints.
CCGloW ‘Customer Complaint Global Workflow’.
CCGloW is the name of Novo Nordisk’s complaint handling
system accessed through the novoGloW complaints
handling application.
Clinical trial Clinical trials are also called investigational trials.
Any investigation in human subjects intended to discover
or verify the clinical, pharmacological and/or other
pharmacodynamic effects of one or more product(s);
and/or to identify any adverse reactions to one or more
product(s) and/or to study absorption, distribution,
metabolism and excretion of one or more product(s) with
the object of ascertaining its (their) safety and/or efficacy.
This includes clinical trials carried out at either one site or
multiple sites, in one or more than one member
state.
Concomitant product Any product used at the same time as the suspected
product. It is not suspected that this product is related to
the reported TC, AE, or ADR.
For clinical trials, ‘concomitant product’ is also used for a

product which is not described in the trial protocol but has
been used together with the investigational trial product.
Counterfeit product Counterfeit/falsified medicinal products are deliberately and
fraudulently mislabelled with respect to identity or source.
Counterfeit products may include products with the correct
ingredients but fake packaging, with the wrong ingredients,
without active ingredients or with insufficient active
ingredients.

Term Definition
Customer complaint Any written, electronic or oral communication that alleges

deficiencies related to the identity, quality, durability,
reliability, labelling, effectiveness, safety, performance or
medical device malfunction of a product placed on a market
or used in a clinical trial. Customer complaints include
reports of adverse events, product defects and
combinations thereof. Product inquiries are not product
complaints.
Diverted products Products sold by a manufacturer that are distributed in
markets other than those for which they were originally
intended, in violation of a contract, law or regulation.
Incident Only applicable to defects for durable devices and needles:
Any malfunction or deterioration in the characteristics
and/or performance of a Medical Device, as well as any
inadequacy in the labelling or the instructions for use which,
directly or indirectly
might lead to or might have led toDeath
Serious Deterioration in the state of health of a patient,
user, or other persons.
The concept ‘might lead to’ covers the situation whereby, if

suitable action had not been taken, intervention had not
been made or circumstances had been less opportune, the
event (Technical Complaint) might have led to a Serious
Adverse Reaction.
LIC Locally Investigated Complaint, see [5].
Local NN investigator Customer complaint cases investigated by the production
site on behalf of CCC.
NN control Products within NN control: Products that are legally
owned by NN.
This means that the product is in stock in Product Supply,
Chemistry Manufacturing Control (CMC) Development, local
depot, stock-holding affiliate or at a distribution partner
being controlled by an NN affiliate.
Products outside NNs control: Products that are no

longer legally owned by NN.
This means that the product is no longer in stock in Product
Supply, Chemistry Manufacturing Control (CMC)
Development, local depot, stock-holding affiliate or at a
distribution partner being controlled by an NN affiliate.
Distribution partner controlled by an NN affiliate:

Partner with whom NN has a quality agreement specifying
that NN has the right at any time for any reason to demand
that the partner put specified batches in quarantine, ship
specified batches back to NN, destroy or by any other
means immediately prevent the further distribution of the
specified batches.

Term Definition
NN product In this document, an NN product is defined as a

pharmaceutical product or medical device that is:
 Manufactured by NN and marketed by NN
 Manufactured by NN and marketed by another company
Manufactured by another company and marketed by NN
Non-interventional studies After marketing authorisation has been obtained, Novo
Nordisk sponsors non-interventional studies to gain
additional clinical evidence and get real life experience with
the marketed compound or device, particularly from a
safety perspective.
Non-interventional studies were formerly called

observational studies.
Parallel importer Organisation performing repackaging and distribution of
Novo Nordisk A/S products without prior consent by Novo
Nordisk A/S.
Product defect Non-fulfilment of a requirement related to an intended or
specified use of a product. If required, affiliates can
quarantine Novo Nordisk-owned stock without asking
permission from CCC. CCC should be informed about the
quarantine.
Reserve sample Reserve samples are samples taken from a production
batch to document the quality of the batch.
Other terms for reserve samples are ‘retention samples’ and
‘reference samples’. ‘Retention samples’ are typically
samples of the finished product, kept by the production
department for physical identification. Reference samples
are typically kept by the product support department for
chemical analyses.

Term Definition
Serious Adverse Event A Serious Adverse Event is an experience that at any dose
results in any of the following:
 Death
 Life-threatening experience
 Inpatient Hospitalisation or prolongation of existing
 Hospitalisation
 A persistent or significant disability/incapacity or is a
 congenital anomaly/birth defect
 Important medical events that may not result in
death, be life-threatening, or require Hospitalisation
may be considered a Serious Adverse Event when,
based upon appropriate medical judgement, they
may jeopardise the patient or subject or require
medical or surgical intervention to prevent one of
the outcomes listed in this definition. Suspicion of
transmission of infectious agents must always be
considered a SAE.
Note: The term ‘life-threatening’ in the definition of serious

refers to an event in which the patient was at risk of death
at the time of the event. It does not refer to an event that
hypothetically might have caused death if it
was more severe.
Significant product defect Significant product defects include, but are not limited to:
 Product defects that constitute a potential risk to
patients. This includes incidents that are caused by the
product or its labelling being mistaken for, or applied to,
another article.
Any bacteriological contamination, and any significant
chemical, physical, or other change or deterioration of the
product, or any failure to meet specifications established for
the product either in the registration file or in the clinical
trial application.
Suspected NN product Any Novo Nordisk product taken by the patient which is
suspected to have contributed to an adverse reaction or
suspected to have deficiencies related to identity, quality,
reliability, labelling, actions, safety, effectiveness or
performance (medicine or device).
Technical complaint (TC) Any written, electronic, or oral communication that alleges
product (medicine or device) defects. The technical
complaint may be associated with an Adverse Event, but
does not concern the Adverse Event itself.

Appendix 1 - Classification of verified product defects
The table below shows the classification of the severity of the medical consequences,
product quality and/or regulatory impact of a verified product defect
Classification Definition
Critical Considered to potentially pose a threat to the life, health or rights of
patients and/or to have regulatory impact. Includes complaints
regarding devices reported as serious adverse events or incidents if
they are considered to be related to the device fault.
Major Considered to have insignificant medical consequences and/or to have
significant influence on product quality. An adverse event cannot be
ruled out.
Minor Considered to have no medical consequences and no significant
influence on product quality.

Change log
Edition no. 1.0 Effective date: 06-May-1996

CR number Unknown
Replaced N/A
document(s)
Edition no. 2.0 Effective date: 01-Nov-1997

CR number CR006654
Replaced N/A
document(s)
Edition no. 3.0 Effective date: 01-Jul-1998

CR number CR013624
Replaced N/A
document(s)
Edition no. 4.0 Effective date: 01-Feb-2000

CR number CR022175
Replaced N/A
document(s)
Edition no. 5.0 Effective date: 15-Sep-2000

CR number CR033275
Replaced N/A
document(s)

CR number CR035136
Replaced N/A
document(s)

CR number CR047502
Replaced N/A
document(s)

CR number CR056345
Replaced N/A

document(s)
Edition no. 9.0 Effective date: 22-Jan-2003

CR number CR060831
Replaced N/A
document(s)

CR number CR103511
Replaced N/A
document(s)
Edition no. 11.0 Effective date: 02-Sep-2009

CR number CR153207
Replaced N/A
document(s)
Edition no. 12.0 Effective date: 29-Oct-2010

CR number CR174069
Replaced N/A
document(s)
Edition no. 13.0 Effective date: 14-Dec-2011

CR number CR186966
Replaced N/A
document(s)

CR number CR196865
Replaced N/A
document(s)
Edition no. 15.0 Effective date: 30-Jun-2012

CR number CR203241
Replaced N/A
document(s)
Edition no. 16.0 Effective date: 01-Oct-2012

CR number CR205522
Replaced N/A

document(s)

CR number CR217311
Replaced Handling of Customer Complaints Doc. No. 008782, Edition 16.0.
document(s)
Edition no. 18.0 Effective date: 30-Jun-2013

CR number CR222473
Changes to Update due to implementation of change related to FDA GMP
document inspection on Medical Devices in March 2013 and FDA GMP inspection
on NovoSeven in April 2013.
Section “Scope” has been updated:

Durable devices reported as > 6 years old do not require reporting as
they are not considered to be customer complaints as the device is
expired
The country (affiliate) which receives the customer complaint is

responsible for reporting the case to GS, regardless of whether the
customer purchased the NN product or experienced a customer
complaint in that country e.g. customer is travelling or has relocated.
Section “Applies to”:

 E-Learning link has been updated
 All line managers involved (or with employees involved) in
complaint handling must read this document
Section 1.4 “Reporting deadlines” has been updated:

For incidents stricter timelines apply. Specific timelines are given in
SOP 014048 (Handling of Adverse Events and Other Safety
Information) and here referred to as NDeSAE (Near Device Serious
Adverse Event), NDeSAE (Near Device Serious Adverse Event) and
NDeSAR (Near Device Serious Adverse Reaction).
Section 2.5 “Investigation” has been updated:

For complaints sent to Product Supply (e.g. formulation, filling,
inspection, packaging and labelling departments) for investigation,
QA must review the batch record documentation and any non-
conformity report related to the involved batch as part of the
investigation for complaints to determine whether the nature of the
complaint could be associated with, or caused by, production
discrepancies. The investigation and QA approval will be documented
in the IT system for complaint handling.
If production is requested by CCC to perform non-destructive physical

examination of reserve samples, all reserve samples available at the

production site must be examined.
Section 2.7 “Case closure and reply to affiliate and customer”:

The sentence “If more time consuming investigations are necessary,
CCC informs the reporting affiliate about the status of the
investigations and when they are expected to be completed” has
been removed as the affiliates now have access to the complaint
handling system
Definition of customer complaint has been changed to:

 “Any written, electronic or oral communication
that alleges deficiencies related to the identity,
quality, durability, reliability, safety, performance
or medical device malfunction of a product placed
on a market or used in a clinical trial. Customer
complaints include reports of adverse events,
product defects and combinations thereof.
Product inquiries are not product complaints”
Definition of a technical complaint has been included
Furthermore minor changes due to Novo Nordisk global SOP review.

Rationale for N/A
document change
Replaced N/A
document(s)
Edition no. 19.0 Effective date: 01-Mar-2015

CR number CR0608021
Changes to The document has been totally rewritten and made process-based.
document Section numbers have therefore been changed and new sections
introduced.
The section numbers and titles below refer to the present version of
the document.
The following specific changes to the process are introduced with the
present version:
Scope:
1. DELETED: Durable devices reported as > 6 years old do not
require reporting.
Applies to:
2. CHANGED from ‘All line managers involved (or with employees
involved) in complaint handling’ – to - ‘NN employees who are
involved in the complaint handling process’.
3. DELETED: The overall managerial responsibilities for the
process has been taken out.

4. ADDED: A new role, ‘QA for NN complaint investigator’, has
been introduced.
Registration
5. ADDED: If the case has a classification or requires urgent case
handling for other reasons, send a notification to CCC by e-
mail to complaintcenter@novonordisk.com.
6. ADDED: If the customer complaint may lead to a liability
claim, inform CCC immediately by sending an e-mail to
complaintcenter@novonordisk.com.
7. ADDED: For cases with liability claims affiliate must inform the
local legal department
8. ADDED: The fact that attempts have been made to try to
obtain the complaint sample(s) from the complainant must be
documented (to address new requirement in updated EU
legislation: “Chapter 8: Complaints, Quality Defects and
Product Recalls”, effective 1st of March 2015).
9. ADDED: If relevant for the complaint type, collect any
auxiliaries supplied by NN with the product, e.g. syringes used
for reconstitution and vial adaptors.
Evaluation
10. DELETED: ‘If CCC has received information or assesses that a
customer complaint may lead to a liability claim, they inform
the Legal and Risk Management departments. In such
situations no destructive investigations (e.g. breaking the
product seal) may be carried out without acceptance from
Legal Department’.
Investigation
11. ADDED: The current requirement for initiation of a NC in
relation to major or critical product defects applies to faults
caused by any of Novo Nordisk’s processes.
12. ADDED: Completion of the complaint investigation is not
dependent on completion of the non-conformity.
13. ADDED: The requirement about QA approval also applies to
investigators in CMC Supply.
14. CHANGED from: ‘For complaints sent to Product Supply (e.g.
formulation, filling, inspection, packaging and labelling
departments) for investigation, QA must review the batch
record documentation and any non-conformity report related
to the involved batch as part of the investigation for
complaints to determine whether the nature of the complaint
could be associated with, or caused by, production
discrepancies. The investigation and QA approval will be
documented in the IT system for complaint handling’
– to -
‘For NN complaint investigators in Product Supply and CMC
Supply, the QA for the NN complaint investigator must
approve the investigation results. QA must review the batch
documentation and any potentially related NCs as part of the
investigation to determine whether the nature of the

complaint could be associated with, or caused by, production
discrepancies. If the investigator is a QA department in
Product Supply or in CMC Supply, further QA approval of the
investigation results is not required’.’
Approval
15. DELETED: If appropriate, CCC states corrective actions.
Closure
16. DELETED: CCC must state in the conclusion of the
investigation that the product has been re-packed and re-
distributed outside the control of the Novo Nordisk supply
chain.
Reply
17. CHANGED from ‘Customer replies must be documented’ – to -
‘Document the customer reply according to local procedures.’
Archiving
18. ADDED: For legal cases it is specified that the stricter sample
retention times only apply in cases where the Legal
department has requested additional investigations to be
performed.
19. ADDED: In cases related to confirmed counterfeit, stolen or
diverted products and liability claims, the investigators must
return the complaint sample to CCC for storage for one year.
Timelines
20. ADDED: It is specified that the reporting deadline also applies
to follow up information.
CHANGED: Deadline for closing cases is changed so it is now
specified that the aim is to close complaint cases within 90 calendar
days from receipt of the complaint sample in CCC or, if no sample is
available, from receipt of the complaint case in Global Safety.
Rationale for N/A
document change
Replaced N/A
document(s)
Edition no. 20.0 Effective date: See Signature

Page
CR number CR0682709
Changes to Q027542 ‘Customer Complaint Form’ included in this document.
document Minor editorial changes throughout the document.
Scope

- Clarified what is meant by ‘diverted products’.
Outside scope
- Product enquiries rephrased and further explained.
- Product refund added.
Process
- Quality Risk Management Principles included.
2.1 Registration
- Included that personal data must not be visible to others than
the affiliate.
- Included what is a suspected product
- Included that request of reserve samples by HA for their own
investigation must be reported to CCC before any action is
taken.
- Addition of how to handle veterinary cases.
- Included parallel imported products section and deleted from
3. Evaluation
- Included to check that the batch number is the same on the
complaint sample and in the information received by the
customer.
Registration of off-line cases moved from 3. Evaluation to new
section 2.4 Registration of CCGloW off-line cases.
4.2 Investigation performed by investigators
- Included influence on product quality when the classification of
a customer complaint is determined.
- Included that investigators must answer all questions
mentioned in the investigator’s instructions and if the
requested investigations are not relevant, a rationale must be
included.
- Repharsing of the section batch record review as trend action.
- Non-conformity replaced by NC.
4.3 QA approval of investigation results
- Rephrased to specify that review of batch documentation and
NC should only be performed if the complaint is suspected to
be associated with, or caused by, production discrepancies.
- Included that the batch record review can be reused.
5. Approval renamed Verification and Approval.
- Legal cases section removed as Legal does not need
information on a case basis.
6. Reply renamed Rephy and Closure.
- Addition that CCC can ask the affiliate to contact health
authorities if a fault on a customer complaint sample is
suspected to be due to a parallel importer.
7.2 Complaint sample
- Table 1 updated to include needles to be handles as drug and
prefilled devices.
- Table 2 updated to include that needles involved in special
cases should not be sent back to CCC.
- Inclusion of the retention time for PumpCart.
8.4 Closure of customer complaints renamed to Approval of
customer complaints.

10. Training and support deleted as the e-learning is not valid
anymore.
Definition
- NN control aligned with 011411 ‘Handling Potential and Actual
Recalls’
Appendix 1
- Section updated to include product quality as a parameter to
define the classification of a customer complaint.
- As potential recall situations are not only customer complaints
classified as critical, this sentence was removed.
Rationale for Three years review.
document change
Replaced Q027542 ‘Customer Complaint Form’ disabled and included in this
document(s) document.

Novo Nordisk A/S Electronic Signature Page Page no. 1 of 1
Handling Customer Complaints
Effective Date:
01-Mar-2018
This is a representation of an electronic record that was signed electronically and this page is the
manifestation of the electronic signature.
Document signed by:
Initials Full Name
Meaning Date and Time of Signature
(Server Time)
nhxn NHXN - Nathalie Hélix-Nielsen
Author Approval 13-Dec-2017 10:45 GMT+0000
hpma HpMa - Haiping Ma
Quality Assurance Approval 13-Dec-2017 11:30 GMT+0000
esff ESff - Erik Steffensen
Management Approval 13-Dec-2017 13:01 GMT+0000
kalo KaLo - Karsten Lollike
Management Approval 14-Dec-2017 07:07 GMT+0000
qatw QATW - Monica Athwani
Document Release Approval 14-Dec-2017 10:15 GMT+0000
Object ID Edition: Document ID: QBIQ Number:

090239b78194df3b 20.0 000014184 008782

Handling Cust Complaints (Global)

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Corporate Procedure

► C2.02 Customer complaints

 All marketed products manufactured by or on behalf of NN, including products

 All clinical trial products manufactured by or on behalf of NN, as well as external

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 Product refund: products returned to an NN affiliate for refund purposes with no

Exceptions from the process described in this document

 For products manufactured by NN but marketed by another company, the complaints

 Affiliates or production sites may be authorised to investigate certain complaint types

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If required due to the nature of the complaint case, CCC

The split in responsibilities between CCC and CCC-GSC is

In some countries receipt and registration of customer complaints is outsourced to

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Figure 1 - Overall process for complaint handling for marketed products

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Examples of customers are patients, relatives to the patient, wholesalers, pharmacies,

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Request of  If a local health authority in connection to a customer

Veterinary  If the case covers an adverse event (AE) or technical

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Further guidance is given in [15].

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2.3 Shipment of complaint samples

Shipment of complaint samples

2.4 Registration of CCGloW offline cases

CCC must register the case in CCGloW according to [17].

Registration of CCGloW off-line cases

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4.1 Investigations performed by CCC

If the fault could potentially have occurred in more than one

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4.2 Investigations performed by investigators

When a product defect on a complaint sample is verified as an NN fault, it should be

Investigations performed by investigators

CCC will inform the investigator if destructive tests are not

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If it is verified that the fault is covered by an existing NC

4.3 QA approval of investigation results

QA approval of investigation results

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Below actions can also be performed by LIC [5].

Verification of customer complaint

Approval of customer complaint

 Add the relevant QP to the case.

Notification of Upon case approval, the respective affiliate is notified via an

No notifications are sent when a clinical trial case is

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Reply to the customer

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7.2 Complaint samples

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Timelines for reporting customer complaints

8.2 Shipment of complaint samples

Timelines for shipping complaint samples

8.3 Completion of investigations

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Customer complaints must be investigated and approved by CCC or LIC as fast as

Table 3 - Timelines for approval of customer complaints by CCC

9 Trending and surveillance of customer complaints

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