INTERNAL AUDIT CHECKLIST

Issued by: QA Date: 00-00-00 Revision: A QF-82-02-3

Refs Requirements What to look for and how Compl Auditor notes and evidence
4 Quality Management System
4.1 General requirements
4.1
820.5
Is the quality management system
documented, imlemented and maintained in
acco!dance "ith !equi!ements o# I$% 1&485
and '(R 21 )a!t 820*
Are processes needed for the quality management
system identified and established (process map)? Is the
sequence and interaction between these processes
determined (process map)? Are criteria and methods for
the operation and control of quality system processes
established (operational procedures)? Are required
resources available? Are quality system processes
monitored and measured (internal audit, customer
feedback, manufacturing process performance, etc.)?
4.1 +!e outsou!ced !ocesses adequately
cont!olled*
ow are outsourced processes controlled? Are outputs
of outsourced processes verified? Are subcontractors
and suppliers required to operate and maintain quality
management systems (I!" #$$%, for e&ample)?
4.2 Documentation requirements
4.2.1 General
4.2.1
820.20,e-
+!e the #ollo"ing tyes o# documents
established, maintained and cont!olled:
quality olicy and quality ob.ectives/
quality manual/
oe!ational !ocedu!es/
device seci#ications including d!a"ings,
comosition, #o!mulation, comonents,
so#t"a!e etc. ,Device 0aste! Reco!d-/
!oduction !ocess seci#ications including
equiment, !oduction methods and
!ocedu!es, oe!ato! ,"o!1- inst!uctions,
!oduction envi!onment seci#ications, etc.
,Device 0aste! Reco!d-/
quality assu!ance !ocedu!es and
seci#ications including cont!ol lans,
insection equiment and !ocedu!es,
accetance c!ite!ia, etc. ,Device 0aste!
Reco!d-/
ac1aging and labeling seci#ications,
including methods and !ocesses used
Are quality policy and quality ob'ectives documented?
(here?
Is there a quality manual? "perational procedures?
Are drawings, specifications, work instructions, work
orders, control plans, etc., issued and maintained as
controlled documents (as required in ).*.+)?
Are electronic documents (computer files) backed up?
INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. 2 o# !
Refs Requirements What to look for and how Compl Auditor notes and evidence
,Device 0aste! Reco!d-/
installation, maintenance and se!vicing
!ocedu!es and methods ,Device 0aste!
Reco!d-/
othe! documents needed to ensu!e the
e##ective lanning and oe!ation o# the
quality system/ and
!eco!ds ,!e# to I$% 1&485 4.2.4-*
4.2.2 Quality manual
4.2.2
820.20,e-
Does the quality manual include:
the scoe o# the quality management
system and e2clusions,
oe!ational !ocedu!es o! !e#e!ences to
them,
desc!ition o# the inte!action bet"een the
!ocesses o# the quality system, and
outline o# the st!uctu!e o# the quality system
documentation*
Is the quality manual addressing all relevant
requirements of I!" %+),- and ./0 *% 1art ,*$? Are
e&clusions from !ection 2, 1roduct 0eali3ation,
documented in the quality manual (if any)? Are
operational procedures included or referenced in the
quality manual? ow is the interaction between the
processes of the quality system documented (process
map, flowcharts, etc.)? ow is the structure of the
quality system documentation outlined in the manual?
4.2.3 Control of documents
4.2.&
820.40,a-
Is the!e a "!itten !ocedu!e de#ining the
cont!ols needed to
!evie" and a!ove documents !io! to
issue,
!evie", udate and !e3a!oved documents,
identi#y changes and cu!!ent !evisions o#
documents,
ma1e !elevant and cu!!ent documents
available at oints o# use,
ensu!e that documents a!e legible and
identi#iable,
identi#y and cont!ol the dist!ibution o#
documents o# e2te!nal o!igin, and
identi#y !etained obsolete documents and
!event thei! unintended use*
Is the !ocedu!e #ully imlemented*
Is there a written procedure for control of documents?
Are controlled documents reviewed and approved? ow
is the approval evidenced (signature)? Is there a process
for reviewing, updating and re4approving documents?
Are documents identified with their revision level? ow
are changes identified (change brief, highlighted, etc.?)
(hat measures are implemented to ensure that relevant
and current documents are available at points of use
(distribution lists, current master lists, etc.)? Are
documents uniquely identified (unique title and 5or code4
number) and are they legible? Is there a process for
receiving, reviewing, approving (for use) and distributing
documents of e&ternal origin (form customers,
regulators, suppliers, etc.) (hen obsolete documents
are retained, is it for a specific, stated reason? Are
obsolete documents clearly marked to distinguish them
from current revisions? (hat other measures are
implemented to prevent unintended use of obsolete
documents?
4.2.& Is the e!iod #o! !etention o# obsolete
cont!olled documents de#ined*
Is a retention period defined for each type of controlled
documents? ow is this period determined? Is the
retention period at least equal to the lifetime of the
INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. o# !
Refs Requirements What to look for and how Compl Auditor notes and evidence
device? Is it coordinated with the retention period for
corresponding records? Are regulatory requirements
considered?
4.2.&
820.40,b-
+!e document changes !evie"ed and
a!oved by the same #unction that e!#o!med
the o!iginal !evie" and a!oval ,unless
seci#ically designated othe!"ise-*
+!e change !eco!ds maintained, including
desc!ition o# the change, identi#ication o# the
a##ected documents, a!oval signatu!es and
date, and "hen the change becomes
e##ective*
Is there a clearly stated requirement that changes to
documents must be reviewed and approved by the same
function that issued the original document, or by another,
e&plicitly designated function? Is it implemented?
Are changes in documents (mostly product and process
specifications) backed by design change and5or process
change records, such as engineering change notices?
ow is it defined5documented when document changes
become effective?
4.2.4 Control of Records
4.2.4 Is the!e a documented !ocedu!e #o! the
identi#ication, sto!age, !otection, !et!ieval,
!etention, and disosition o# !eco!ds*
Are there documented instructions how to identify,
organi3e, store, protect, and retrieve records? Are
storage locations for records defined?
4.2.4
820.180,b-
+!e !etention e!iods #o! !eco!ds de#ined*
+!e !eco!ds !etained #o! at least the e!iod o#
time equivalent to the e2ected li#e o# the
device, and no less than 2 yea!s*
Is a retention period defined for each type of record?
ow is this period determined? Is the retention period at
least two years or equivalent to the lifetime of the device,
whichever is greater? Are regulatory requirements
considered?
4.2.4
820.180
+!e !eco!ds o!gani4ed and maintained to
ensu!e that they !emain legible, !eadily
identi#iable and !et!ievable, and to !event
dete!io!ation and loss*
+!e !eco!ds accessible to the !egulato!y
insections*
+!e elect!onic !eco!ds bac1ed u*
Are records stored in dry, clean locations to minimi3e
deterioration? Is there a system for organi3ing the
records? Are bo&es, drawers, binders holding records
properly identified? Are records easily retrievable (test
by asking for retrieval of specific records)?
Are records kept in a location that is accessible to
regulatory inspections?
Are electronic records backed up? Are there specific
schedules, instructions, etc. for backing up data? (here
are the back4up media (tapes, disks, etc.) kept?
4.2.4
820.181
(o! each tye o# device, is the!e a Device
0aste! Reco!d ,D0R- including, o! !e#e!!ing to
a!o!iate device seci#ications, !oduction
!ocess seci#ications, quality assu!ance
!ocedu!es, ac1aging and labeling
ow is the 670 organi3ed? Is it a file containing the
actual specifications documents, or is it a list referring to
these documents and their locations? Is the 670
complete, e.g., includes all required categories of
documents? (ho decides, and how, which documents
are included in the 670? Are all documents included in
INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. " o# !
Refs Requirements What to look for and how Compl Auditor notes and evidence
seci#ications, and installation, maintenance
and se!vicing !ocedu!es and methods*
the 670 correctly identified, reviewed, approved and
otherwise controlled? Are the 670 documents the same
(and the same revisions) as those used in production?
4.2.4
820.184
+!e Device 5isto!y Reco!ds ,D5R- maintained
#o! each manu#actu!ed batch, lot o! unit*
,Re#e! also to I$% 1&485 'lause 6.5.1 and
820.184-
Are 60 records properly identified to specific batches,
lots or units8 and are the records easily retrievable? (/or
other questions refer to 2.-.%)
4.2.4
820.187
+!e 8uality $ystem Reco!ds ,8$R-
maintained, including cu!!ent and obsolete
quality system manuals and !ocedu!es, and
!eco!ds o# quality system activities such as
management !evie"s, co!!ective and
!eventive actions, inte!nal audits, etc.*
ow is it determined and documented what quality
system records are maintained (in 97! 7anual and lists
of procedures and quality forms, and in operational
procedures and work instructions)? Are retention periods
specified for obsolete quality system documentation and
for quality system records?
4.2.4 +!e su##icient !eco!ds maintained to !ovide
evidence o# con#o!mity and e##ectiveness o#
the quality management system*
Is there a list (or other documented specification) of
quality system records that are maintained by the
company? Are the records sufficient to demonstrate
product and process conformity, and the conformity and
effectiveness of the quality management system and its
implementation?
5 Management Resonsi!ility
5.1 Management Commitment
5.1 Is the to management
communicating to the o!gani4ation the
imo!tance o# meeting custome! and othe!
alicable !equi!ements,
establishing the quality olicy,
establishing quality ob.ectives,
conducting management !evie"s, and
ensu!ing availability o# !esou!ces*
ow is importance of meeting customer and other
requirements communicated? 6o employees understand
the consequences of failing to meet requirements? Is
there a quality policy? Are quality ob'ectives defined?
Are management reviews being conducted regularly?
Are adequate resources necessary for the quality
system provided?
5.2 Customer "ocus
5.2 Is the to management ensu!ing that
custome! !equi!ements a!e dete!mined and
a!e met*
(hat measures are implemented to ensure that
customer requirements are determined and met
(processes, procedures, training, monitoring, auditing,
etc.)?
5.3 Quality #olicy
5.& Is the!e a documented quality olicy/ and Is the quality policy appropriate (relevant to the types of
INTERNAL AUDIT CHECKLIST Doc: QF-82-02- Revision: A )g. ! o# !
Refs Requirements What to look for and how Compl Auditor notes and evidence
820.20,a- Is it a!o!iate to the u!ose o# the
o!gani4ation*
Does it include a commitment to comly "ith
!equi!ements and maintain the e##ectiveness
o# the quality management system*
Does it !ovide a #!ame"o!1 #o! establishing
the quality ob.ectives*
Is it communicated and unde!stood
th!oughout the o!gani4ation*
Is it e!iodically !evie"ed #o! continuing
suitability*
products, type of market, customer e&pectations, etc.)?
6oes it include e&plicit commitment to comply with
requirements and maintain (or improve) the
effectiveness of the quality system? Is it related to quality
ob'ectives? (ould achievement of the quality ob'ectives
bring the company closer to achieving its overall quality
policy? 6o employees know the meaning of the quality
policy and understand how they can contribute to
achieving the policy? Is the quality policy periodically
reviewed by management reviews? as the policy ever
been modified since it was initially formulated?
The remainder of Section 5 and Sections 6, 7 and 8 are not included in the Demo file
The complete checklist is 30 pages long.