Title: Procedure, Complaint Management

Document Number: 11103013, Version 14

Effective Date: 23-MAY-2022
Document Owner Function: Quality
Page 1 of 11

Title: Procedure, Complaint Management

Contents
Introduction ...................................................................................................................................... 2
1. Purpose ........................................................................................................................... 2
2. Scope …………………………………………………………………………………………………...2
3. Roles and Responsibilities................................................................................................. 2
4. Referenc es....................................................................................................................... 4
5. Definitions and Acronyms .................................................................................................. 4
Procedure ......................................................................................................................................... 6
6. Overview.......................................................................................................................... 6
7. Identify and Log ................................................................................................................ 6
8. Initial E valuation for Pot ential Reportability ......................................................................... 6
9. Troubleshoot .................................................................................................................... 7
10. Completion/ Closure .......................................................................................................... 7
11. Elevate ............................................................................................................................ 7
12. Investigat e ....................................................................................................................... 8
13. Review & Approve ............................................................................................................ 8
14. Implement & Close ........................................................................................................... 8
15. Analysis of Data................................................................................................................ 8
16. Records ........................................................................................................................... 9
17. Release History ................................................................................................................ 9

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
Page 2 of 11

Introduction
1. Purpose
The purpose of this procedure is to provide the roles, responsibilities, and process for complaint management.

2. Scope
This procedure applies to Complaint Management for all Illumina products released for commercial distribution,
including Illumina Investigation Use Only (IUO) products that are the same or similar to on-market Illumina regulated
IVD products. This procedure applies to Illumina sites and functional areas listed under the scope of the Illumina
Quality Manual, 11204017.

This procedure does not apply to complaints within the scope of WI, Investigational Use Only Device Clinical Trials
Complaint Management 1000000022776 for products that are not the same or similar to an on-market Illumina IVD
product.

3. Roles and Responsibilities

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
Page 3 of 11

Function/ Role Responsibilities

Any employee • Identify feedback that meets the definition of a Business Issue (complaint ) and
report complaint to Frontline Support
• Submit request for a complaint Quality Investigation (QI) to QA Complaint Group
Channel Partner • Identify feedback that meets the definition of a Business Issue (complaint)
• When possible, log such feedback as a complaint case in Salesforce.com
(SFDC), and when not possible, redirect the complaint to the Illumina Frontline
Team
• Perform initial evaluation for potential reportability of all SFDC-logged complaints
• Troubleshoot complaint cases to resolution
• Document complaint details, evaluations, activities, investigations , and resolution
(as applicable), and apply appropriate coding to each case in SFDC

Frontline Support (Technical • Identify feedback that meets the definition of a complaint
Application Scientist, Field
• Log such feedback as a complaint case in SFDC as soon as possible after
Service Engineers, Field
receipt
Applications Scientists,
Service and Support • Perform initial evaluation for potential reportability of all SFDC-logged complaints
Technicians, and other • Troubleshoot SFDC complaint cases to resolution
Illumina-trained field • Document complaint details, evaluations, activities, investigations, and resolution
personnel) (as applicable), and apply appropriate coding to each case
Quality Assurance (QA) • Review all regulated medical device complaints for which Illumina has
Complaint Group
reporting responsibility to ensure compliance with 15004045 WI, Case
Handling
• Assess regulated medical device complaints for which Illumina has reporting
responsibility for potential reportability per 1000000002058, Assessment of
Potentially Reportable Event
• Determine whether complaints involving regulated medical devices for which
Illumina has reporting responsibility need further investigation and elevate to
Regulatory Affairs as appropriate
• Own, manage and facilitate complaint Quality Investigations (QI) per
1000000029885 WI, Complaint Further Investigation.
• Review and close any regulated medical device complaints or complaints with
one or more “Yes” answer to pAE/pFA evaluation questions
Regulatory Affairs • Determine whether complaints elevated by QA represent reportable adverse
events and/or whether field actions (e.g., recall) are necessary
• File reports with appropriate regulatory agencies as needed
Second line Support (Global • Provide support to Frontline Support staff via phone, email, or personal
Product Support/Regional
interaction
Product Support)
• Identify individual complaint case or product trends that may need further
investigation, and elevate as appropriate
• Track, trend, and report on complaint data to management
• Initiates tracking escalations per 1000000003421, WI Tracking Escalations

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
Page 4 of 11

4. References
This procedure shall be stored and maintained in accordance with the Procedure, Control of Documents, 11307796.

Title Document Number/Source

Illumina Quality Manual 11204017
Procedure, Analysis of Data & Feedback 11226443
Procedure, Control of Documents 11307796
Procedure, Control of Records 11244414
Procedure, Nonconformance 11223269
Procedure, Post Market Surveillance 15044347
Procedure, Management Responsibility and Review 11223357
Procedure, Recall Reporting Worldwide 15004278
Procedure, Unique Device Identifier (UDI) 1000000013729
Regulatory and Illumina Glossary 11317468
Work Instruction, Assessment of Potentially Reportable Events 1000000002058
Work Instruction, Case Handling 15004045
Work Instruction, Complaint Further Investigation 1000000029885
Work Instruction, Complaint Review of Regulated Products 1000000059714
Work Instruction, Complaint Monitoring Activities 1000000059713
Work Instruction, Investigational Use Only Device Clinical Trials 1000000022776
Complaint Management
Work Instruction, Quality Complaint Management Review 1000000160616
Work Instruction, Quality Investigation 1000000153708
Work Instruction, Tracking Escalation 1000000003421

5. Definitions and Acronyms

The following table defines terminology used in this procedure that is not included in the Regulatory and Illumina
Glossary; 11317468 or Assessment of Potentially Reportable Event; 1000000002058.

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
Page 5 of 11

Term/Acronym Definition
Assessment (pAE/pFA) • A review performed by the QA Complaints group and Regulatory Affairs on
complaints having one or more “Yes” answers to pAE/pFA evaluation questions
for which Illumina has reporting responsibility for potential reportability (per
1000000002058, Assessment of Potentially Reportable Event).
Business Issue • Case Record Type in SFDC that can be separated into the subtypes Complaint
and General Issue.

Complaint • A written, electronic, or oral communication that alleges deficiencies related to the
identity, quality, durability, reliability, usability, safety, effectiveness or
performance of a medical device that has been released from the organization’s
control or related to a service that affects the performance of such medical
devices.
• Complaint is the subtype for Business Issue cases for issues that meet this
definition.
• The terms “complaint case”, “case” and “complaint” are used interchangeably in
this procedure
Complaint Quality • A complaint that is elevated for further investigation in EtQ
Investigation (QI)
CRM • Customer Relationship Management System
Evaluation (pAE/pFA) • A series of five questions Frontline Support or Channel Partner will ask the
complainant to determine whether the complaint requires assessment for
potential reportability. SFDC will automatically route any case with one or more
“Yes” answers to these questions to the QA Complaint group (per 15004045, WI,
Case Handling).
pAE • Potential adverse event
• An event and/or incident requests for assessment of potential reportable event
when it suggests Illumina IVD product or same or similar to the IVD product have
caused or contributed to death or serious injury or would be likely cause death or
serious injury if the malfunction were to recur
pFA • Potential field action
• An event requests for assessment of potential field action (correction, removal,
recall, field safety corrective action, market withdrawal, defined in 15004278,
Recall Reporting Worldwide)
Potentially Reportable • A potentially reportable adverse event for medical devices
Event
• A potential field safety corrective action, field safety notice, or recall for medical
devices
EtQ • Excellence Through Quality- Quality management software
SFDC • Salesforce.com, validated repository for complaint case records
UDI • An identifier that adequately identifies a device through its distribution and use by
meeting the applicable requirements. A unique device identifier is composed of a
(1) device identifier (DI), a mandatory, fixed portion of a UDI that identifies the
labeler and the specific version or model of a device and (2) production identifier
(PI) a conditional, variable portion of a UDI that identifies one or more of the
following when included on the label of a device: lot, batch or serial number,
expiration date or date of manufacture (note that this definition may vary slightly
from country to country. Specific country definitions may be found in
1000000013729 Procedure, Unique Device Identifier (UDI))
Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
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Procedure
6. Overview
The visual aid below is for informational purposes only.

Identif y & Ev aluate f or

Potential Implement &
Log Troubleshoot Elev ate Inv estigate Approv e Close
Reportability

The first three steps are detailed in 15004045, WI, Case Handling. The remaining steps are detailed in
1000000029885 WI, Complaint Further Investigation.

Complaint cases are maintained in Illumina’s CRM (Customer Relationship Management) system (SFDC or EtQ as
applicable).

7. Identify and Log

Identify & Ev aluate f or
Implement &
Potential Troubleshoot Elev ate Inv estigate Approv e
Log Reportability
Close

7.1 Identify
Complaints are received via, but is not limited to, phone, email, and personal communication from sources internal
and external to Illumina. They are logged upon receipt or as soon as possible after receipt based on logistics.

Complaints are recorded and identified by unique case number. The case record includes:
• Date of Issue Awareness
• pAE/pFA Awareness Date, if applicable
• Case Number
• Case Owner
• Complainant or Customer contact information
• Name or description of the product(s) being used
• Product quantity, serial numbers, lot numbers, and/or part numbers when applicable and available, and any
product returns associated with the event
• Nature and details of the complaint
• Dates and results of all actions and investigations, including any corrective actions
• Any reply to the complainant or customer
• UDI/DI, if applicable, refer to 1000000013729 Procedure, Unique Device Identifier (UDI) for additional
details
• Other relevant information as needed

8. Initial Evaluation for Potential Reportability

Identif y &
Evaluate for
Implement &
Log Potential Troubleshoot Elev ate Inv estigate Approv e Close
Reportability

8.1 Evaluate

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
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Document Owner Function: Quality
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All complaints require initial evaluation for potential reportability within one (1) business day of complaint creation for pAE
and seven (7) business days for pFA and continuously as more details about the event are discovered, per 15004045, WI,
Case Handling. Complaints that represent potential adverse events or potential field actions are automatically flagged. QA
Complaint Group is automatically notified via the SFDC system and will conduct an assessment
8.2 QA Review
QA Complaint Group is responsible for conducting assessment of complaints that have been initially evaluated and routed
for QA review. Assessments are conducted per 1000000059714, WI, Complaint Review of Regulated Products and
1000000002058, Assessment of Potentially Reportable Events
8.3 RA Assessment
Regulatory Affairs (RA) assesses potentially reportable events that are forwarded to them by the QA Complaint Group
per 1000000002058, Assessment of Potentially Reportable Events. RA documents the final decision and references,
or attaches associated document(s) regarding reportability on the complaint record

9. Troubleshoot
Identif y & Ev aluate f or
Implement &
Log Potential Troubleshoot Elev ate Inv estigate Approv e Close
Reportability

The Case Owner, in collaboration with other product specialists as necessary, performs the following activities:
• Reviews, evaluates, and troubleshoots the complaint case to resolution, including identification of root/likely
cause based on available information
• Documents all actions, investigations, immediate corrections, and corrective actions as appropriate to reflect
end-to-end activity
• Requests product returns and/or customer specimens (as applicable)
• Initiates tracking escalation as appropriate per 1000000003421 WI, Tracking Escalations

10. Completion/Closure
Once troubleshooting is completed, complaints are closed by Frontline Support or Channel Partners as applicable.
Complaint cases initiated against regulated product or with one or more “Yes” answer to pAE/pFA evaluation
questions are automatically routed to QA Complaint Group for review and closure. Frontline Support and Channel
Partners are gated by SFDC from closing these cases directly.

11. Elevate
Identif y & Ev aluate f or
Implement
Log Potential Troubleshoot Elevate Inv estigate Approv e & Close
Reportability

Any complaint may be elevated for further investigation. Criteria for elevating a complaint may include but is not
limited to:
• Adverse events or other potentially reportable events for regulated medical devices which Illumina has reporting
responsibility (e.g., false positive, false negative results or safety issues)
• Failure of a regulated medical device which Illumina has reporting responsibility (e.g., failure of labeling, or
packaging to meet any of its specifications including product stability, or safety)
• Potential safety related events (e.g., electrical or chemical events)
• Customer-issued Supplier Corrective Action Requests (SCAR)
Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
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• Trend analysis indicating increased failure rate

• High impact event (aggregate or individual)
• New complaints regarding a recalled product or previously resolved issue

Elevated complaint investigation requests are processed per 100000029885 WI, Complaint Further Investigation.

QA Complaint Group reviews all complaints related to regulated medical device products, for which Illumina has
regulatory reporting responsibility per 1000000059714 WI, Complaint Review of Regulated Products. QA may reopen
complaint cases for clarification, further documentation, or investigation as appropriate. At the conclusion of the QA
review, a determination of whether additional investigation is needed will be made. The record will be documented
with results of QA review and required follow-up activities as appropriate promptly upon completion. When no further
investigation is deemed necessary, the record will include the reason no investigation was made and the name of the
individual responsible for the decision.

12. Investigate
Identif y & Ev aluate f or
Implement
Log Potential Troubleshoot Elev ate Investigate Approv e & Close
Reportability

Quality Investigation (QI) is initiated and conducted for complaint further investigation per 1000000153708 WI, Quality
Investigation.

Objectives of the investigation include, but are not limited to, determination of whether a product deficiency exists,
risk assessment, determination of likely root cause, and appropriate, risk-based disposition. During the investigation,
regulated medical devices for which Illumina has reporting responsibility will be continually assessed for potential
reportability. All information related to the investigation, including actions, investigation, root cause determination,
resolution (as appropriate) will be documented in Quality Investigation (QI) record in EtQ

13. Review & Approve

Identif y & Ev aluate f or
Implement &
Log Potential Troubleshoot Elev ate Inv estigate Approve Close
Reportability

QIs are reviewed and approved per 1000000153708 WI, Quality Inves tigation.

14. Implement & Close

Ev aluate f or
Identif y &
Potential Troubleshoot Elev ate Approv e
Implement &
Log Inv estigate
Reportability Close

After approval, QIs are complete and actions will be implemented in CAPA/other records.

15. Analysis of Data

Complaint data is reviewed and monitored at each step of the process per 11226443 Procedure, Analysis of Data &
Feedback:
Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
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Document Owner Function: Quality
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• Complaint Case Intake

o Average Case completion target is 30 calendar days
o Case open time from case intake to case completion is monitored monthly
• Cases open >30 days are reviewed and actioned by Regional and Global Compliance, and Regional Field
Service/Technical Support stakeholders as appropriate to determine if improvement actions are needed and
document a justification if not.
o Objective evidence of review is located in EtQ per 1000000153570 WI, Global Business Compliance
Case Review
This data is also presented in Corporate Quality Management Review per 11223357 Procedure, Management
Responsibility and Review
• Regulated product complaints for QA Review
o Cases are targeted to be reviewed within fifteen (15) days from “Date Completed”
o Potential pAE/pFA Cases are reviewed within 24 hours from automated notification from SFDC to QA
mailbox (qacomplaintunit@illumina.com)
o Quality Complaint Board Review reviews cases on a monthly basis
▪ Objective evidence of review is located in EtQ per 1000000160616 WI, Quality Complaint
Management Review
• Post Market Surveillance
o Complaint cases are an input into the Post Market Surveillance process per 15044347 Procedure,
Post Market Surveillance, which facilitates the identification and analysis of trends. These t rends are
reviewed, during PMS Meetings, per the frequency specified in the approved PMS Plan and PMPF
Plan, (as applicable.)
• When target(s) are not met, the data will be reviewed to determine if improvement actions are needed and/or
document a justification if not.

16. Records
Records generated as an output of this process shall be stored and maintained in accordance with the related QMS
process per the Procedure, Control of Records, 11244414.

17. Release History

Release
Version Reference
A 159
B 7635
C E13873
D E23214
E E23321
F E27548
Originator Description of Change
J. Hernandez Initial Release
B. Clemons Update of procedure to address requirements from 21 CFR 820.198 for complaint
handling
B. Clemons Updated criteria for ongoing investigation, added clarification to reopening complaint
cases, and formalized complaint handling process stages.
S. Wistar Format change only. Put into new Tier 2 template.
S. Wistar Changed name of procedure from Field Action to Field Recall Reporting.
K. Daniels Update to generalize language, allow ing for global sites to use local procedures for
M. Lopez processing complaints w hile following the general requirements set forth in this
H. Schoenhoefer procedure. Added Canadian complaint handling requirements, clarified QA/RA roles in
Cindy G. process, and corrected minor formatting issues. Moved complaint classification
information to section 1.0 eliminating complaint classification section. Added corrective
action rationale in Stage 3,

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
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Release
Version Reference Originator Description of Change
G E35110 C. Gilchrist • Clarified that the procedure applies to complaints arising from any source.
• Removed Quality Manual from references section.
• Clarified section 1.1 to include classification of incoming feedback as representing
inquiries or complaints.
• Clarified section 1.3 to encompass all components of products and to specify
documentation of decisions regarding investigations of complaints related to In Vitro
Diagnostic products.
• Section 1.5: Added identifying information for consumables.
• Section 2, 3: changed “reportable” to “potentially reportable” throughout.
Section 3.5: Added documentation of decision regarding further investigation to QA
Review activities. Clarified that QA has the ability to reopen cases w ithout GIS
involvement
H E35247 M. Ruktoume Added detail to section 1.3 regarding Diagnostic complaints. Restored Section 1.4
regarding general complaints, w hich was inadvertently removed in Rev G.
I E35811 R. Harb Administrative change to update effective date and w atermark. Corrected 15004278
description to Product Recall
Reporting Procedure.
J E36319 C Gilchrist Complete rew rite
• Clarifications regarding connections to related processes, and updated references
accordingly
C Gilchrist • Clarifications regarding documentation requirements in each step of the process
K E39663
J. Tao • Added criteria for Elevation to ensure alignment w ith 21 CFR 820.198
• Minor updates to align w ith revisions to 15065780
Added document map
• Introduce Assessment of Potentially Reportable Event, 1000000002058 in Section 2.2
01 1002308 J. Tao and 2.4 and remove redundant information
• Update document map
02 1002954 B. Asman Updated references to complaint investigation and disposition (15065780) process steps
J. Tao Update to include UDI Device Identifier recording requirement,
03 1009392
N. Throw er Clarify ECI process
Update to include new Investigational Device Clinical Trials Complaint Management
04 1012319 N. Throw er
Procedure 1000000022776 and update scope to include same or similar IOU devices
05 1015806 N. Throw er Updated to include details related to launch of EtQ complaint module
Updated to include channel partners in the complaint management process.
06 1024981 S. Rego
Defined core responsibilities of the channel partners.
Placed content in the latest Tier 2 Template (1000000019189). The follow ing sections
w ere added per the new template:
• Analysis of Data
B. Asman • Records
07 1027079 A. Kelleher Clarified roles and responsibilities
B. Brigham-Ortega Revised Channel Partner responsibilities related to pAE and complaint investigation
Updated references and document map to include new complaint-related documents
Clarified initial intake process and elevation to CAPA/SCAR
Additional minor clarifications listed throughout
Updated 1000000029885 title to reflect current title in SAP
Added Definition of Business Issue and EtQ Reliance (EtQ)
DIR
08 M. Verzosa Added additional Channel Partner responsibilities
Workflow
Updated to align w ith DCP w orkflow
Updated document map to reflect new titles
• Revised Sec. 2 Scope to be consistent with Tier 2 document w ording
• Clarified Sec. 3 Channel Partners responsibilities
• Clarified Sec. 3 GPS/RPS tracking escalation responsibility
09
DIR
A. Kelleher • Corrected Sec. 3 & 5 Overall spelling/capitalization/punctuation
Workflow • Revised Sec. 6-10 to clarify/strengthen requirement for documentation
• Revised Sec. 11 & 12 to clarify requirements for documentation follow ing ECI
review /determination
• Corrected Sec. 14 Overall spelling/capitalization/punctuation

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only
 Title: Procedure, Complaint Management
Document Number: 11103013, Version 14
Effective Date: 23-MAY-2022
Document Owner Function: Quality
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Release
Version Reference Originator Description of Change
• Update definition of complaint in Section 5 Definitions and Acronyms to align
w ith ISO 13485:23016 definition
• Remove 15025157 Procedure, Feedback, w hich is being obsolesced, from
DIR
10 J. Tao Section 4 References and Section 16 Analysis of Data
Workflow
• Update Appendix Document map to remove obsoleted document and update
document name
• Update to the current Tier 2 template
• Placed content in latest Tier 2 template
• Replaced 15071636, WI, Complaint Intake & Triage w ith 15004045, WI, Case
L. Cow an
Document Handling in the Reference table and text body.
11 A. Kelleher
Workflow • Updated Section 16 to provide additional detail on Analysis of Data
J. Tao
• Removed reference to Complaint Intake & Triage WI, 15071636 from Appendix
A
• Updated to latest Tier 2 template specs
• Updated Reference name for 1000000029885
• Update Reference table
Document
12 J. Tao • Add definition of pAE, pFA, PMPF and PMS
Workflow
• Replace ECI process with Quality Investigation (QI)
• Change the regulated QA review storage to EtQ
• Remove Document map
• Section 4: References: Added 1000000013729 Procedure, Unique Device
Identifier (UDI), updated title of the Analysis of Data & Feedback procedure
(11226443).
• Section 5: Definition & Acronyms: Added UDI.
• Section 7.1: Revised Device Identifier to UDI/DI to reference UDI procedure
w hen a UDI/DI is applicable.
• Section 8.1: Revised evaluation timeline for pAE and pFA to align w ith
15004045, WI, Case Handling.
CN
13
1063184
N. Mabrey • Section 9: Included reference to tracking escalation WI.
• Section 15: Clarified review timeline for QA review , updated Analysis of Data &
Feedback title and reference in section, included clarification for actions or
justification requirements for AoD. Revised review of cases from Global Quality
to Global Compliance for clarification of role. Clarified notification for potential
pAE/pFA is received via automated notification from SFDC to QA mailbox
(qacomplaintunit@illumina,com).
• Overall update of minor grammatical corrections
(spelling/capitalization/punctuation).
• Updated to the latest Tier 2 template
• Updated Definition of business issue in Section 5 Definitions and Acronyms to
exclude General issue from complaint
CR
• Updated Definition of complaint in Section 5 Definitions and Acronyms to clarify
1068318 /
14
CN
J. Tao case subtype “Complaint” in SFDC is complaint.
1068662 • Updated potential reportable event in Section 5 Definitions and Acronyms to
clarify the scope
• Updated Section 14 to reflect the process in EtQ.

Templ ate, QMS Tier 2 Proc edure 1000000019189, Ver. 05, Effecti ve Date: 08-Feb-2022 Proprietary & Confidential - For Internal Use Only