INTERNAL AUDIT CHECKLIST

Issued by: QA Refs Requirements Date: 00-00-00 What to look for and how Compl Revision: A

QF-82-02-3
Auditor notes and evidence

4
4.1
4.1 820.5

Quality Management System

General requirements
Is the quality management system documented, im lemented 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.)? 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)?

4.1

+!e outsou!ced !ocesses adequately cont!olled*

4.2 4.2.1
4.2.1 820.20,e-

Documentation requirements General

+!e the #ollo"ing ty es o# documents established, maintained and cont!olled: quality olicy and quality ob.ectives/ quality manual/ o e!ational !ocedu!es/ device s eci#ications including d!a"ings, com osition, #o!mulation, com onents, so#t"a!e etc. ,Device 0aste! Reco!d-/ !oduction !ocess s eci#ications including equi ment, !oduction methods and !ocedu!es, o e!ato! ,"o!1- inst!uctions, !oduction envi!onment s eci#ications, etc. ,Device 0aste! Reco!d-/ quality assu!ance !ocedu!es and s eci#ications including cont!ol lans, ins ection equi ment and !ocedu!es, acce tance c!ite!ia, etc. ,Device 0aste! Reco!d-/ ac1aging and labeling s eci#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

Refs Requirements ,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 o e!ation o# the quality system/ and !eco!ds ,!e# to I$% 1&485 4.2.4-* What to look for and how

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4.2.2
4.2.2 820.20,e-

Quality manual
Does the quality manual include: the sco e o# the quality management system and e2clusions, o e!ational !ocedu!es o! !e#e!ences to them, desc!i tion 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
4.2.& 820.40,a-

Control of documents
Is the!e a "!itten !ocedu!e de#ining the cont!ols needed to !evie" and a !ove documents !io! to issue, !evie", u date 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 im lemented*
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? 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

4.2.&

Is the e!iod #o! !etention o# obsolete cont!olled documents de#ined*

INTERNAL AUDIT CHECKLIST

Refs Requirements What to look for and how
device? Is it coordinated with the retention period for corresponding records? Are regulatory requirements considered?

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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 s eci#ically designated othe!"ise-* +!e change !eco!ds maintained, including desc!i tion 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
4.2.4

Control of Records
Is the!e a documented !ocedu!e #o! the identi#ication, sto!age, !otection, !et!ieval, !etention, and dis osition o# !eco!ds* +!e !etention e!iods #o! !eco!ds de#ined* +!e !eco!ds !etained #o! at least the e!iod o# time equivalent to the e2 ected li#e o# the device, and no less than 2 yea!s* +!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 ins ections* +!e elect!onic !eco!ds bac1ed u *
Are there documented instructions how to identify, organi3e, store, protect, and retrieve records? Are storage locations for records defined? 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? 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? 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

4.2.4 820.180,b-

4.2.4 820.180

4.2.4 820.181

(o! each ty e o# device, is the!e a Device 0aste! Reco!d ,D0R- including, o! !e#e!!ing to a !o !iate device s eci#ications, !oduction !ocess s eci#ications, quality assu!ance !ocedu!es, ac1aging and labeling

INTERNAL AUDIT CHECKLIST

Refs Requirements s eci#ications, and installation, maintenance and se!vicing !ocedu!es and methods* 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+!e 8uality $ystem Reco!ds ,8$Rmaintained, 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.* +!e su##icient !eco!ds maintained to !ovide evidence o# con#o!mity and e##ectiveness o# the quality management system* What to look for and how
the 670 correctly identified, reviewed, approved and otherwise controlled? Are the 670 documents the same (and the same revisions) as those used in production? Are 6 0 records properly identified to specific batches, lots or units8 and are the records easily retrievable? (/or other questions refer to 2.-.%)

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4.2.4 820.187

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? 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?

4.2.4

5
5.1
5.1

Management Res onsi!ility

Management Commitment
Is the to management communicating to the o!gani4ation the im o!tance o# meeting custome! and othe! a licable !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
5.2

Customer "ocus
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
5.&

Quality #olicy
Is the!e a documented quality olicy/ and
Is the quality policy appropriate (relevant to the types of

INTERNAL AUDIT CHECKLIST

Refs 820.20,aRequirements Is it a !o !iate to the u! ose o# the o!gani4ation* Does it include a commitment to com ly "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* What to look for and how
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?

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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.