Inadequate

Good control of practices

documentation records. (GDP)
Specifically,
not followed. For example:
a. There When were tryingmultiple
to source “9900086.A
instances
- Rev Athe
where Validation
date wasSummary,”
not handwrittenit was
not found
and instead astyped
it hadinnever been
(an example
submitted
shown to be filed with a
below)
Configuration
b. Overwriting Analyst.
found in the below
b. When in
examples, trying to source
document# “9900043
9900073,
Rev A59,
page JIRA Traceability and 9900043
Rev B JIRA Traceability
In document# Issue matrix”
9900074, Page 29 only
of Due Date for Response Plan Respone Plan Due
Finding# Date Issued Criticality Assigned To Status Tracking Comments
Rev A was able
84 Description
to be sourced in Response Approved On Date
Windchill
In document# and Rev B was Page
9900077, not found.
6 of 31
-c.overwriting
Document Change Notice (DCN) 9/30/19- initial
numbers
In document# not entered
9900077, in thepageRevision
15 of 31 response Completed
IA-19-001-01 30-Aug-19 Major
History
– of document
correction not done#s as9900073,
a 11/19/19- plan
990074, and 990076.
strikethrough completion
d. Receivedreport
c. Incorrect two documents
number; for labeled
one
9/30/19- initial
9900019
of the reportsrev B. They
(total had different
pages: 10)
response Completed
IA-19-001-02 30-Aug-19 page numbers
supporting and inconsistent
document# 9900072, the Major
11/19/19- plan
information
report number andissignatures.
mentioned One as was
completion
labeled “9900019
9900077 instead of REV
990072 B Windchill
Installation
d. MissingQualification
signatures and (Production)
date on -
IA-19-001-03 Data incorrectly Minor 30-Oct-19 31-Mar-20 Open -967
Report
pages 13, 14, 15,marked.
Approved” and18,
16, Specifically,
the other
20, 25in
23,was of
document
labeled “9900019 # 9900059, REV B Windchill118
page labeled
document # 9900019.
(347 in PDF) test case 7.19, test step 15
Installation
e. saysMultiple
fail butQualification
passed withof(Quality)
instances empty cells
deviation. -Per
IA-19-001-04 30-Aug-19 Report
and section Approved”.
blank pages
5.1, this testIt is
noticed
case not
in clear
should why
document
have Minor 13-Nov-19 21-Feb-20 Completed
there
#s are
9900085,
been two990059
marked different version
as “pass(page 3), of the
with limitation”
same
9900039
however report.
it(pages
was marked20 and as 37),
“pass” 9900057
on page
119 (348
(page 16,in17,PDF).
19,Same
21). comment for test
f. case 7.10 on page
Document #99005964 (254 in PDF).
Pages were
Personnel not trained.
not numbers correctly. The table of For example,
a. Document
contents said a total # 9900059; trainingbut
of 183 pages,
record missing as required per 9900018
the PDF was section 354 pages.6.1.5.The page
numbering was inconsistent. Plan Approved
IA-19-001-05 30-Aug-19 b. Dileep Aruru and David Llewelyn Minor 22Nov19 21-Feb-20 20-Dec-19 Completed
g. were Document
not aware#9900058; several for
of any procedures
typos in section 1 and section 3change
says Due 20Dec19
software validation or software
FS when
instead prompted
of CS. how or where they
would find the process for software
change and validation.

Document # 9900059; traceability matrix Plan Approved

IA-19-001-06 30-Aug-19 missing as required per 9900018. section Minor 22Nov19 21-Feb-20 20-Dec-19 Completed
6.1.9. Due 20Dec19

Purchase orders were not signed.

Specifically, there was no authorized
signature for the following indirect
IA-19-002-01 5-Apr-19 purchase orders; 4900026525, Minor 22-Apr-19 21-Feb-20 Completed
4900036125, 4900030981, 4900037111,
4900047659, 4900040885, and
4900029136.

Authorized signature does not include a

printed name and is not present in the
IA-19-002-02 5-Apr-19 signature log. Specifically, for the Minor 5-Jun-19 21-Feb-20 Completed
following direct purchase orders;
4700237685 and 4700237686, were
signed by ZW.
 OP00016, “QMS-MD Supplier
Qualification”, Rev. B does not clearly
define the documentation of a supplier
audit decision for indirect suppliers.
Specifically, there is lack of definition in
OP00016 section 5.1.3 when it states;
IA-19-002-03 5-Apr-19 “Upon review of the supplier Minor 20-May-19 21-Feb-20 Completed
questionnaire, the QMS-MD Quality
Manager shall determine if an on-site
supplier audit is necessary... In case of
Indirect suppliers, an onsite audit is not
required but may be considered based on
risk.”

The process of ensuring a supplier is on

the Medical Preferred Supplier List (MPSL)
prior to creating a direct or indirect
purchase order is not followed.
IA-19-002-04 5-Apr-19 Minor 20-May-19 30-Apr-20 Completed
Specifically, Noblitt & Rueland performed
the 2018 supplier audits for Flextronics
Dallas and Flextronics Zhuhai, but Noblitt
& Rueland was not on the MPSL.

Supplier didn’t response to the audit

report within the designated timeframe.
Specifically, the audit response from
IA-19-002-05 5-Apr-19 Flextronics Dallas dated November 7, Minor 3-May-19 23-Mar-20 Completed
2018 in response to the 2018 Flextronics
Dallas supplier audit
Inadequate which
training was conducted
on appropriate
in procedures
June 2018 which exceeded
and work 30 days.
instructions.
Specifically,
a) The PCN Process Owner (DP) was not
trained to OP00148 “QMS-MD Product-
IA-19-002-06 5-Apr-19 Process Change Notification” and WI0140 Minor 5-Jun-19 23-Mar-20 Completed
“QMS-MD Criteria for Supplier to Submit
PCN”
IA-19-005-01 b) The ESC Quality Engineer (JK) was not Major 23-Mar-20 29-May-20 Open -908
trained to OP000148 “QMS-MD Product-
Process Change Notification”
IA-19-005-02 Major 23-Mar-20 28-Feb-20 AAA

IA-19-005-03 Major 23-Mar-20 10-Mar-20 Open -988

IA-19-005-04 Major 23-Mar-20 28-Feb-20 Open -999

IA-19-005-05 Major 23-Mar-20 6-Apr-20 Open -961

IA-19-005-06 Major 23-Mar-20 Open

IA-19-005-07 Minor 23-Mar-20 Open

IA-19-005-08 Minor 23-Mar-20 Open

IA-19-005-09 Minor 5-Feb-20 Open

IA-19-005-10 Minor 5-Feb-20 Open

IA-19-005-11 Minor 5-Feb-20 Open

IA-19-005-12 Minor 18-Feb-20 Open

IA-19-005-13 Minor 19-Dec-19 Open

IA-19-005-14 Minor 27-Sep-19 Open

IA-19-005-15 Minor   Oct 12, 2019 Open

IA-19-005-16 Minor   Nov 12, 2019 Open

IA-19-005-17 Minor 13-Dec-19 Open

IA-19-006-1 Minor 13-Dec-19 Open

IA-19-006-2 Minor 13-Dec-19 Open

IA-19-006-3 Minor 13-Mar-20 Open

Inadequate definition of approval
roles,
Devicespecifically
History Record HF844646 Rev 00,
did not include
“QMS-MD
record of release of labels. Specifically, for
IA-19-006-4 5-Dec-19
Engineering
DHR for serialApproval
number Matrix”
Minor 13-Mar-20 Completed
081573Z92420113AC,
identifies
Change Originator,
notice did not DHR
Peer,forQA
include serial
as
all
number 080964Z92240570AC,
approvers for and DHR
required
for approvers.
serial number Specifically,
080962Z91360362AC.
Purchased
AR837945_01 Components Per
lists an independent
Procedure,
Procedure,
reviewer that HP844501,
HP844501, “QMS-MD
“QMS-MD
did not provide
IA-19-007-1 12-Nov-19 Document
Document and
and
approval on“QMS-MD RecordProjectlink
CN-081198 Control”
to release Rev Minor 24-Jan-20 Completed
HI844505,
Record Control” Rev
00, Section
document
Access”, Rev5.2.2
00, does00,
SectionnotSection
identify
4.3 states all
5.2.1.3.
Lifecycle states that are in Windchill.
“Access to
“835933-0010.B Beanie QMS-MD
For example,
Windchill “Effective”
Projectlink will state was to
be limited
IA-19-007-2 12-Nov-19 Team Request”
evidenced identifies
in Windchill butwhonot is Minor 2-Jan-20 Completed
users who
authorized have
to completed training on
mentioned“QMS-MD
HI844507, in the procedure.
Projectlink
create and submit part approvals but
Navigation””.
the “Originator” This is requirement
not traceableisinnot
IA-19-007-3 12-Nov-19 being
Windchill. Minor 4-Dec-19 Completed
followed.
CN-080495 releases part # 826626-
1472F and has the correct approvals
IA-19-007-4 12-Nov-19 but the Minor 24-Jan-20 Completed
“Originator” is not traceable.

IA-19-008-1 Minor Open

IA-19-009-1 Major Open

TN-228 had an OOT and was documented

with FL292509, Equipment Out of
IA-19-009-2 19-Nov-19 Tolerance, 01.2. This form is not in the Major Completed
QMS-MD.

Plan Approved
AR841028-ER has Rev 00.01 crossed out 12/19/19
IA-19-009-3 19-Nov-19 and 00 handwritten in without an initial Minor Completed Completed
with the date.
12/17/9

The process of ensuring a supplier is on

the Medical Preferred Supplier List (MPSL)
prior to conducting business is not
IA-19-010-1 29-Jul-19 followed. Specifically, Southeastern Minor 1-Nov-19 Completed
Freight Lines is being used for shipment of
product but are not on the Medical
Preferred Supplier List.
Inadequate identification of stored
product. Specifically,
IA-19-010-2 a) Bose Frame Rondo Picking Area: Minor Open
Hanging visual identification above the Follow up with Rick
storage location listed 1082, rather than 11/1/19
1080 for the following batch numbers; Followed up on 2/27: Rick
IA-19-010-3 29-Jul-19 Z290523N21, Z290525D21, and Minor Completed replaced by Tracey Skelton
Z290527D21. who assigned to James
b) Bose Frame Alto Bulk Storage: Hanging McCormic;
visual identification above the storage Reminder on 3/2/20
Lot number
location not mentioned
listed BLKG01, in the
rather than
Certificate
G01BBM for of
theAnalysis.
followingSpecifically,
batch number; in
Z390529D11.
case of lenses received from Foresight
Optical, the Out-going Inspection
IA-19-010-4 29-Jul-19 Report, accepted as a Certificate of Minor Completed Completed 1/22/20
Conformance, specifically lot number
2019052008, 2019062806, and
2019062705 did not have a Lot
number.

IA-19-010-5 Major Open

IA-19-010-6 Minor Open

Follow up on 1-Nov-19;
followed up on 2/27, sent
draft NC on 3/4
Reply on 3/5: Hi Ajit,
Inadequate documentation of the Safety
Data Sheet (SDS) for the following Plan Approved
IA-19-010-7 16-Sep-19 Minor Completed I am currently covering for
pesticides Deltamethrin 0.06% and 12Nov19
Imidacloprid, Cyfluthrin. my admins who are on
vacation. I will try but
more than likely, will not
be able to finalize till after
the 12th.
 Inadequate training on appropriate
procedure. Specifically, Mike McClellan is Plan Approved
IA-19-010-8 16-Sep-19 Minor Completed Follow up on 1-Nov-19
not trained to OP00019, “QMS-MD 12Nov19
Material Handling”.
Inadequate identification of Bose Frames
lenses. Specifically, the following parts
IA-19-010-9 16-Sep-19 (827173-0030, 827143-0040, 813300- Minor 22-Nov-19 Completed
0030, 813300-0040) were received
without a lot number.

Medical device customer complaint

survey was filled out incorrectly.
Specifically,
1.For service request 702238700 the
question "Did the issue occur during
product use" should have been Follow up on 2/26/2020,
IA-19-011-1 18-Oct-19 "unknown" rather than "no" based on the Minor Completed
information from RDG webform. 3/2/20
2.For MED-2576 and MED-3756, the
“patient status” was listed as
“hospitalized”, but the complainant was
never asked the medical device survey
questions.

The “Patient Status” medical device

IA-19-011-2 18-Oct-19 survey question is not included on the Completed
Minor
RDG webform, therefore was not
Completed 1/16/20
asked during complaint intake.
Follow up needed -
Crediting Process sales document number Procedure was updated
BT13165692 was dispositioned as ZSCR
IA-19-011-3 18-Oct-19 (scrap with no credit), but did not include Minor Completed this past week, can close
rationale for scrap without credit. out; followed up on
3/4/2020

IA-19-011-4 Minor Open

IA-19-011-5 Minor Open

IA-19-011-6 Minor Open

Inadequate training on appropriate

procedures and work instructions.
Specifically,
1.Global Retail Operations (CM) was not Follow up on 2/26/2020,
IA-19-011-7 18-Oct-19 trained to HI844574, “QMS-MD RDG Minor Completed
Complaint Submission”. 3/2/20
2.Customer Service Representative (PH)
was not trained to HI844572, “QMS-MD
Complaint Intake”

Marketing Assets is not adequately

stored. Specifically, marketing asset
IA-19-012-1 8-Jan-20 RG845785-0001 approved on 9/16/19 did Minor Completed
not contain the video content in the file
cabinet or in Windchill.
 Attendance for the management review
meeting conducted on 25 Oct 2018
was not recorded. Specifically, per section
5.7, Meeting Confirmation, “Once
the meeting has been completed, a
Attendance for the management
meeting confirmation form will bereview
routed
meeting conducted on 25 Oct 2018 Completed on
IA-19-013-1 7-Nov-19 for Minor Completed
was not recorded.
signature. This form Specifically,
confirms the per section 2/24/2020
5.7,
ScopeMeeting
attendance
of QMS ofConfirmation,
the
doesindividuals “Once
not include andthetheir
two
the
FDA meeting
agreement to
registered has
the been
actioncompleted,
Distribution items a
identified,
Centers.
Audit
meetingIA-19-008 Calibration and be PM was
as well asconfirmation
their
Specifically,
performed insection
the 2.5form
agreement Scope
July/August
will
to in routed
the
timeframe. Completed on
IA-19-013-2 7-Nov-19 for
suitability the
HP844500_00,of the QMS-MD”.
Quality Manual There
Bose was
forno
Minor Completed
However,
signature. report has no timeline 2/24/2020
evidence
Corporation
the ofThis
reports to
form confirms
meeting
located
be at the
confirmation.
its Framingham,
completed although Completed on
IA-19-013-3 7-Nov-19 attendance
MA Corporate of the individuals
Center facility theirthe
and does
and Minor
2/24/2020
Completed
standard
agreement of regulation
to Bose
the action state “The
items identified,
IA-19-014-1 13-Jan-20 not cover the
management Distribution
responsible for the Centers in Minor 9-Dec-19 Completed
as well asand
Tolleson their agreement
Jefferson thattoarethe area
being audited
suitability of shall ensure that the
registered
necessary asthe QMS-MD”.
Initial Importers There
with was no
the US
IA-19-014-2 evidence
FDA. ofcorrections and corrective
meeting confirmation. Minor Open
actions are taken with undue delay to
eliminate detected nonconformities and
their causes.
IA-19-014-3 Minor Open

IA-19-015-1 Minor Open

IA-19-015-2 Minor Open

IA-19-015-3 Minor Open

IA-19-015-4 Minor Open

If Response Plan Due Date (H), the Tracking (J) will look for Due Date for Response (G).

Green 0 0%
Yellow 0 0%

Red 5 100%

Total 5

Chart Title
 100%

Green
Yellow Red